Responding rapidly to FDA drug withdrawals: design and application of a new approach for a consumer health website.

PubMed

Embi, Peter J; Acharya, Prasad; McCuistion, Mark; Kishman, Charles P; Haag, Doris; Marine, Stephen

2006-09-06

Information about drug withdrawals may not reach patients in a timely manner, and this could result in adverse events. Increasingly, the public turns to consumer health websites for health information, but such sites may not update their content for days or weeks following important events like Food and Drug Administration (FDA) drug withdrawal actions. There is no recognized standard for how quickly consumer health websites should respond to such events, and reports addressing this issue are lacking. The objective of this study was to develop and implement an approach to enhance the efficiency with which a consumer health website (NetWellness.org) responds to FDA drug withdrawal actions. Evaluation of the current approach used by NetWellness staff to update content affected by FDA action revealed a slow process driven by the goal of performing thorough and comprehensive review and editing. To achieve our desired goal of accurately updating affected content within 24 hours of FDA action, we developed a strategy that included rapid updating of affected Web pages with warning boxes and hyperlinks to the information about the withdrawal. With the next FDA withdrawal event, that of valdecoxib (Bextra) on April 7, 2005, we applied this new approach, observed the time and resource requirements, and monitored the rate at which consumers viewed the updated information to gauge its potential impact. Application of the new approach allowed one person to modify the affected Web pages in less than 1 hour and within 18 hours of the FDA announcement. Using the old strategy, response to a similar event, the withdrawal of rofecoxib (Vioxx) 6 months earlier, had taken over 3 weeks and the efforts of several personnel. Updated valdecoxib content received 188 hits within the first month and 4285 hits within 1 year. Rapid updating of a consumer health website's content in response to an FDA drug withdrawal event was easily accomplished by applying the approach described. This allowed consumers to view accurate information regarding the withdrawn drug much sooner than would otherwise have been the case. Given that consumers increasingly turn to websites for their health information, adoption of a rapid response standard for important health events like FDA drug withdrawals should be considered by the consumer health informatics community.

Analysis of US Food and Drug Administration Warning Letters: False Promotional Claims Relating to Prescription and Over-the-Counter Medications.

PubMed

Salas, Maribel; Martin, Michelle; Pisu, Maria; McCall, Erin; Zuluaga, Alvaro; Glasser, Stephen P

2008-03-01

Recent studies have suggested that there has been an increase in the number of 'warning letters' issued by the US Food and Drug Administration (FDA) despite the publication of the FDA advertising guidelines. However, limited information is available on the description of warning letters. The objective of this study was to analyse the frequency and content of FDA warning letters in relation to promotional claims and discuss the influence of regulatory and industry constraints on promotion. All warning letters published by the FDA between 5 May 1995 and 11 June 2007 were reviewed. Warning letters related to promotional issues were included and analysed. Information related to the identification number, date of the warning letter, FDA division that issued the letter, drug name, manufacturer, specific warning problem, type of promotional material and requested action was extracted. Two independent investigators reviewed and classified each PDF file, any differences were discussed until a consensus was reached. Between May 1995 and June 2007 a total of 8692 warning letters were issued, of which 25% were related to drugs. Of these, 206 warning letters focused on drug promotion and were included in this study: 23% were issued in 2005, 15% in 2004 and 14% in 1998. In total, 47% of the warning letters were issued because of false or misleading unapproved doses and uses, 27% failed to disclose risks, 15% cited misleading promotion, 8% related to misleading labelling and 3% promoted false effectiveness claims. There is an important variation in the number of warning letters issued in the last decade, probably because of the increasing number of drugs approved by the FDA, drug withdrawal scandals, and the publication of the FDA and the Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines. We found that benefit-related claims, such as unapproved uses or doses of drugs, and failure to disclose risks, are the main causes of FDA issued warning letters for promotional claims related to medications.

The Conundrum of Online Prescription Drug Promotion Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".

PubMed

Wanasika, Isaac

2016-03-26

This commentary discusses pertinent issues from Hyosun Kim's paper on online prescription drug promotion. The study is well-designed and the findings highlight some of the consequences of the Food and Drug Administration's (FDA's) decision to deregulate online advertising of prescription drugs. While Kim's findings confirm some of the early concerns, they also provide a perspective of implementation challenges in the ever-changing technological environment. © 2016 by Kerman University of Medical Sciences.

We really need to talk: adapting FDA processes to rapid change.

PubMed

Lykken, Sara

2013-01-01

The rapidly evolving realm of modern commerce strains traditional regulatory paradigms. This paper traces the historical evolution of FDA crisis-response regulation and provides examples of ways in which the definitions and procedures resulting from that past continue to be challenged by new products as market entrants, some in good faith and others not, take actions that create disconnects between actual product and marketing controls and those that consumers might expect. The paper then explores some of the techniques used by other federal agencies that have faced similar challenges in environments characterized by rapid innovation, and draws from this analysis suggestions for improvement of the FDA's warning letter system.

Impact of the FDA warning of potential ceftriaxone and calcium interactions on drug use policy in clinical practice.

PubMed

Esterly, John S; Steadman, Emily; Scheetz, Marc H

2011-06-01

In September 2007, the FDA issued an alert recommending that ceftriaxone and calcium-containing solutions should not be administered to any patient within 48 h of each other. Due to the widespread use of ceftriaxone, significant concern was expressed by the greater healthcare community about the warning, which the FDA eventually retracted in April of 2009. We sought to quantify the impact of the warning on healthcare institutions. A survey was administered to the membership of the Society of Infectious Diseases Pharmacists to quantify perceived changes in ceftriaxone use among healthcare institutions across the United States. A survey of Infectious Diseases experts was conducted. Participants were queried for hospital policies/drug use statistics during two times: immediately after the FDA warning and approximately 13 months post warning (preceding the FDA retraction). Related changes in formulary, drug-use policy, and the number of employee hours that were devoted to addressing the FDA warning were assessed. Ninety-four surveys representing 94 hospital systems were included in the analysis. Approximately half (n = 49, 52%) of respondent institutions enacted at least one drug-use policy change based on the warning; one institution removed ceftriaxone from a clinical protocol. Institutions' final interpretations of the warning differed slightly from initial understanding of the warning, and there was an overall minor decrease in the perceived use of ceftriaxone. The majority of those surveyed (n = 70, 74%) estimated that their respective institutions devoted between 1 and 49 employee hours to address the warning. Hospitals with ID pharmacists had minimal changes to ceftriaxone use after the 2007 FDA warning. Specialized pharmacists may be uniquely situated to help hospitals interpret global recommendations locally.

Impact of the 2014 Food and Drug Administration Warnings Against Power Morcellation.

PubMed

Lum, Deirdre A; Sokol, Eric R; Berek, Jonathan S; Schulkin, Jay; Chen, Ling; McElwain, Cora-Ann; Wright, Jason D

2016-01-01

To determine whether members of the AAGL Advancing Minimally Invasive Gynecologic Surgery Worldwide (AAGL) and members of the American College of Obstetricians and Gynecologists Collaborative Ambulatory Research Network (ACOG CARN) have changed their clinical practice based on the 2014 Food and Drug Administration (FDA) warnings against power morcellation. A survey study. Participants were invited to complete this online survey (Canadian Task Force classification II-2). AAGL and ACOG CARN members. An online anonymous survey with 24 questions regarding demographics and changes to clinical practice during minimally invasive myomectomies and hysterectomies based on the 2014 FDA warnings against power morcellation. A total of 615 AAGL members and 54 ACOG CARN members responded (response rates of 8.2% and 60%, respectively). Before the FDA warnings, 85.8% and 86.9%, respectively, were using power morcellation during myomectomies and hysterectomies. After the FDA warnings, 71.1% and 75.8% of respondents reported stopping the use of power morcellation during myomectomies and hysterectomies. The most common reasons cited for discontinuing the use of power morcellation or using it less often were hospital mandate (45.6%), the concern for legal consequences (16.1%), and the April 2014 FDA warning (13.9%). Nearly half of the respondents (45.6%) reported an increase in their rate of laparotomy. Most (80.3%) believed that the 2014 FDA warnings have not led to an improvement in patient outcomes and have led to harming patients (55.1%). AAGL and ACOG CARN respondents reported decreased use of power morcellation during minimally invasive gynecologic surgery after the 2014 FDA warnings, the most common reason cited being hospital mandate. Rates of laparotomy have increased. Most members surveyed believe that the FDA warnings have not improved patient outcomes. Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.

Digital Direct-to-Consumer Advertising: A Perfect Storm of Rapid Evolution and Stagnant Regulation Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".

PubMed

Mackey, Tim K

2016-02-03

The adoption and use of digital forms of direct-to-consumer advertising (also known as "eDTCA") is on the rise. At the same time, the universe of eDTCA is expanding, as technology on Internet-based platforms continues to evolve, from static websites, to social media, and nearly ubiquitous use of mobile devices. However, little is known about how this unique form of pharmaceutical marketing impacts consumer behavior, public health, and overall healthcare utilization. The study by Kim analyzing US Food and Drug Administration (FDA) notices of violations (NOVs) and warning letters regarding online promotional activities takes us in the right direction, but study results raise as many questions as it does answers. Chief among these are unanswered concerns about the unique regulatory challenges posed by the "disruptive" qualities of eDTCA, and whether regulators have sufficient resources and oversight powers to proactively address potential violations. Further, the globalization of eDTCA via borderless Internet-based technologies raises larger concerns about the potential global impact of this form of health marketing unique to only the United States and New Zealand. Collectively, these challenges make it unlikely that regulatory science will be able to keep apace with the continued rapid evolution of eDTCA unless more creative policy solutions are explored. © 2016 by Kerman University of Medical Sciences.

Considering the Future of Pharmaceutical Promotions in Social Media

PubMed Central

Carpentier, Francesca Renee Dillman

2016-01-01

This commentary explores the implications of increased social media marketing by drug manufacturers, based on findings in Hyosun Kim’s article of the major themes in recent Food and Drug Administration (FDA) warning letters and notices of violation regarding online direct-to-consumer promotions of pharmaceuticals. Kim’s rigorous analysis of FDA letters over a 10-year span highlights a relative abundance of regulatory action toward marketer-controlled websites and sponsored advertisements, compared to branded and unbranded social media messaging. However, social media marketing efforts are increasing, as is FDA attention to these efforts. This commentary explores recent developments and continuing challenges in the FDA’s attempts to provide guidance and define pharmaceutical company accountability in marketer-controlled and -uncontrolled claims disseminated through social media. PMID:27239874

Influence of safety warnings on ESA prescribing among dialysis patients using an interrupted time series

PubMed Central

2013-01-01

Background In March, 2007, a black box warning was issued by the Food and Drug Administration (FDA) to use the lowest possible erythropoiesis-stimulating agents (ESA) doses for treatment of anemia associated with renal disease. The goal is to determine if a change in ESA use was observed following the warning among US dialysis patients. Methods ESA therapy was examined from September 2004 through August 2009 (thirty months before and after the FDA black box warning) among adult Medicare hemodialysis patients. An interrupted time series model assessed the impact of the warnings. Results The FDA black box warning did not appear to influence ESA prescribing among the overall dialysis population. However, significant declines in ESA therapy after the FDA warnings were observed for selected populations. Patients with a hematocrit ≥36% had a declining month-to-month trend before (−164 units/week, p = <0.0001) and after the warnings (−80 units/week, p = .001), and a large drop in ESA level immediately after the black box (−4,744 units/week, p = <.0001). Not-for-profit facilities had a declining month-to-month trend before the warnings (−90 units/week, p = .009) and a large drop in ESA dose immediately afterwards (−2,487 units/week, p = 0.015). In contrast, for-profit facilities did not have a significant change in ESA prescribing. Conclusions ESA therapy had been both profitable for providers and controversial regarding benefits for nearly two decades. The extent to which a FDA black box warning highlighting important safety concerns influenced use of ESA therapy among nephrologists and dialysis providers was unknown. Our study found no evidence of changes in ESA prescribing for the overall dialysis population resulting from a FDA black box warning. PMID:23927675

The Importance of Relevant Emotional Arousal in the Efficacy of Pictorial Health Warnings for Cigarettes.

PubMed

Shi, Zhenhao; Wang, An-Li; Emery, Lydia F; Sheerin, Kaitlin M; Romer, Daniel

2017-06-01

Warning labels for cigarettes proposed by Food and Drug Administration (FDA) were rejected by the courts partly because they were thought to be emotionally evocative but have no educational value. To address this issue, we compared three types of smoking warnings: (1) FDA-proposed warnings with pictures illustrating the smoking hazards; (2) warnings with the same text information paired with equally aversive but smoking-irrelevant images; and (3) text-only warnings. Smokers recruited through Amazon's Mechanical Turk were randomly assigned to one of the three conditions. They reported how many cigarettes they smoked per day (CPD) during the past week and then viewed eight different warnings. After viewing each warning, they rated its believability and perceived ability to motivate quitting. One week later, 62.3% of participants again reported CPD during the past week, rated how the warnings they viewed the week before changed their feeling about smoking, rated their intention to quit in the next 30 days, and recalled as much as they could about each of the warnings they viewed. Compared to the irrelevant image and text-only warnings, FDA warnings were seen as more believable and able to motivate quitting and at the follow-up, produced lower CPD, worse feeling about smoking, and more memory for warning information, controlling for age and baseline CPD. Emotionally evocative warning images are not effective in communicating the risks of smoking, unless they pertain to smoking-related hazards. In future versions of warning labels, pictorial contents should be pretested for the ability to enhance the health-hazard message. Our study shows that contrary to court opinions, FDA-proposed pictorial warnings for cigarettes are more effective in communicating smoking-related hazards than warnings that merely contain emotionally aversive but smoking-irrelevant images. The suggestion that FDA's proposed warnings employed emotionally arousing pictures with no information value was not supported. Pictures that illustrate the risk carry information that enhances the persuasiveness of the warning. The congruence between pictures and text should be a criterion for selecting warning images in the future. © The Author 2016. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The Trend of Voluntary Warnings in Electronic Nicotine Delivery System Magazine Advertisements.

PubMed

Shang, Ce; Chaloupka, Frank J

2017-01-10

Some manufacturers of electronic nicotine delivery systems (ENDS) voluntarily carried health warnings in their advertisements. This study examined these voluntary warnings in magazine ads and plotted their trends between 2012 and early 2015. ENDS magazine ads were obtained through Kantar media and warnings were collected from the Chicago Public Library or the Trinkets and Trash surveillance system. The prevalence of voluntary warnings, warnings with the specific capitalized word "WARNING", and MarkTen warnings were examined after being weighted using factors related to exposure between January 2012 and March 2015. Five brands (MarkTen, NJOY, MISTIC, and some Blu) carried warnings during the study period. The prevalence of warnings post 2012 that contained a description of nicotine did not significantly increase until the launch of MarkTen, which also happened several months before April 2014 when the U.S. food and drug administration (FDA) published its proposed deeming rule. In addition, none of these warnings met the criteria required by the FDA in the final rules. Voluntary warnings, particularly MarkTen warnings, significantly increased in ENDS magazine ads between 2014 and 2015. It is important to monitor how ENDS manufacturers will comply with the FDA regulation related to warnings and how this regulation will ultimately impact ENDS risk perceptions and use.

Have antiepileptic drug prescription claims changed following the FDA suicidality warning? An evaluation in a state Medicaid program.

PubMed

Mittal, Manish; Harrison, Donald L; Miller, Michael J; Farmer, Kevin C; Thompson, David M; Ng, Yu-Tze

2014-05-01

In January 2008, the Food and Drug Administration (FDA) communicated concerns and, in May 2009, issued a warning about an increased risk of suicidality for all antiepileptic drugs (AEDs). This research evaluated the association between the FDA suicidality communications and the AED prescription claims among members with epilepsy and/or psychiatric disorder. A longitudinal interrupted time-series design was utilized to evaluate Oklahoma Medicaid claims data from January 2006 through December 2009. The study included 9289 continuously eligible members with prevalent diagnoses of epilepsy and/or psychiatric disorder and at least one AED prescription claim. Trends, expressed as monthly changes in the log odds of AED prescription claims, were compared across three time periods: before (January 2006 to January 2008), during (February 2008 to May 2009), and after (June 2009 to December 2009) the FDA warning. Before the FDA warning period, a significant upward trend of AED prescription claims of 0.01% per month (99% CI: 0.008% to 0.013%, p<0.0001) was estimated. In comparison to the prewarning period, no significant change in trend was detected during (-20.0%, 99% CI: -70.0% to 30.0%, p=0.34) or after (80.0%, 99% CI: -20.0% to 200.0%, p=0.03) the FDA warning period. After stratification, no diagnostic group (i.e., epilepsy alone, epilepsy and comorbid psychiatric disorder, and psychiatric disorder alone) experienced a significant change in trend during the entire study period (p>0.01). During the time period considered, the FDA AED-related suicidality warning does not appear to have significantly affected prescription claims of AED medications for the study population. Copyright © 2014 Elsevier Inc. All rights reserved.

Risk management policy and black-box warnings: a qualitative analysis of US FDA proceedings.

PubMed

Cook, Daniel M; Gurugubelli, Rama K; Bero, Lisa A

2009-01-01

The US FDA increasingly applies risk management to drug safety policy. Little is known about the process by which the FDA approves labelling changes. Although advisory committees can recommend any of the risk management tools, including the use of 'black-box warnings', it is unknown whether they deliberate on these questions or how they apply the principles of risk minimization or management during their considerations of drug licensing. To examine the process by which risk management is considered by the FDA, including the role of FDA advisory committees. We also aimed to identify and describe drug labelling changes and additions, including the prevalence of black-box warnings. We electronically obtained publicly available information regarding drug approvals, drug revisions and advisory committee meetings over 3 years (2004-6) from the FDA. Data in the form of meeting transcripts and full histories of labelling changes were collected on drugs discussed by advisory committees. We then searched and qualitatively analysed the meeting transcripts to identify themes in the discussion. We also created a database of all prescription drug labelling changes for 3 years and examined which drugs have had the most changes. We describe the risk management consideration process and report the frequency and characteristics of labelling changes. Excerpts from the transcripts are selected to illustrate both typical and atypical features of the discussion. A total of 174 black-box changes were made in the 3-year period of our study, of which 77 were new black-box warnings and 97 were revisions in black-box warnings. Of 77 new black-box warning additions, only 11 drugs were discussed by the advisory committees. Of the 17 most frequently revised drug labels in these 3 years, two were discussed in the advisory committee meetings. Advisory meeting discussions revealed confusion about black-box warnings and emphasized potential consequences of the warnings rather than their content. The safety labelling of drugs on the market is changed often. Panels of advisors consider only a few drugs, rarely discuss the labelling requirements, and display confusion about applying black-box warnings. The creation and application of black-box warnings on prescription medications should receive closer attention from the FDA and its advisors.

The Trend of Voluntary Warnings in Electronic Nicotine Delivery System Magazine Advertisements

PubMed Central

Shang, Ce; Chaloupka, Frank J.

2017-01-01

Some manufacturers of electronic nicotine delivery systems (ENDS) voluntarily carried health warnings in their advertisements. This study examined these voluntary warnings in magazine ads and plotted their trends between 2012 and early 2015. ENDS magazine ads were obtained through Kantar media and warnings were collected from the Chicago Public Library or the Trinkets and Trash surveillance system. The prevalence of voluntary warnings, warnings with the specific capitalized word “WARNING”, and MarkTen warnings were examined after being weighted using factors related to exposure between January 2012 and March 2015. Five brands (MarkTen, NJOY, MISTIC, and some Blu) carried warnings during the study period. The prevalence of warnings post 2012 that contained a description of nicotine did not significantly increase until the launch of MarkTen, which also happened several months before April 2014 when the U.S. food and drug administration (FDA) published its proposed deeming rule. In addition, none of these warnings met the criteria required by the FDA in the final rules. Voluntary warnings, particularly MarkTen warnings, significantly increased in ENDS magazine ads between 2014 and 2015. It is important to monitor how ENDS manufacturers will comply with the FDA regulation related to warnings and how this regulation will ultimately impact ENDS risk perceptions and use. PMID:28075420

Impact of FDA Actions, DTCA, and Public Information on the Market for Pain Medication.

PubMed

Bradford, W David; Kleit, Andrew N

2015-07-01

Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most important classes of prescription drugs used by primary care physicians to manage pain. The NSAID class of products has a somewhat controversial history, around which a complex regulatory and informational environment has developed. This history includes a boxed warning mandated by the Food and Drug Administration (FDA) for all NSAIDs in 2005. We investigate the impact that various information shocks have had on the use of prescription medications for pain in primary care in the USA. We accomplish this by extracting data on nearly 600,000 patients from a unique nationwide electronic medical record database and estimate the probability of any active prescription for the four types of pain medications as a function of FDA actions, advertising, media coverage, and patient characteristics. We find that even after accounting for multiple sources of information, the FDA label changes and boxed warnings had a significant effect on pain medication prescribing. The boxed warning did not have the same impact on the use of all NSAID inhibitors. We find that the boxed warning reduced the use of NSAID COX-2 inhibitor use, which was the focus of much of the press attention. In contrast, however, the warning actually increased the use of non-COX-2 NSAID inhibitors. Thus, the efficacy of the FDA's black box warning is clearly mixed. Copyright © 2014 John Wiley & Sons, Ltd.

Single Cigarette Sales: State Differences in FDA Advertising and Labeling Violations, 2014, United States

PubMed Central

Lee, Joseph G. L.; Ranney, Leah M.; Goldstein, Adam O.

2016-01-01

Importance: Single cigarettes, which are sold without warning labels and often evade taxes, can serve as a gateway for youth smoking. The Family Smoking Prevention and Tobacco Control Act of 2009 gives the US Food and Drug Administration (FDA) authority to regulate the manufacture, distribution, and marketing of tobacco products, including prohibiting the sale of single cigarettes. To enforce these regulations, the FDA conducted over 335 661 inspections between 2010 and September 30, 2014, and allocated over $115 million toward state inspections contracts. Objective: To examine differences in single cigarette violations across states and determine if likely correlates of single cigarette sales predict single cigarette violations at the state level. Design: Cross-sectional study of publicly available FDA warning letters from January 1 to July 31, 2014. Setting: All 50 states and the District of Columbia. Participants: Tobacco retailer inspections conducted by FDA (n = 33 543). Exposure(s) for Observational Studies: State cigarette tax, youth smoking prevalence, poverty, and tobacco production. Main Outcome(s) and Measure(s): State proportion of FDA warning letters issued for single cigarette violations. Results: There are striking differences in the number of single cigarette violations found by state, with 38 states producing no warning letters for selling single cigarettes even as state policymakers developed legislation to address retailer sales of single cigarettes. The state proportion of warning letters issued for single cigarettes is not predicted by state cigarette tax, youth smoking, poverty, or tobacco production, P = .12. Conclusions and Relevance: Substantial, unexplained variation exists in violations of single cigarette sales among states. These data suggest the possibility of differences in implementation of FDA inspections and the need for stronger quality monitoring processes across states implementing FDA inspections. PMID:25744967

Single Cigarette Sales: State Differences in FDA Advertising and Labeling Violations, 2014, United States.

PubMed

Baker, Hannah M; Lee, Joseph G L; Ranney, Leah M; Goldstein, Adam O

2016-02-01

Single cigarettes, which are sold without warning labels and often evade taxes, can serve as a gateway for youth smoking. The Family Smoking Prevention and Tobacco Control Act of 2009 gives the US Food and Drug Administration (FDA) authority to regulate the manufacture, distribution, and marketing of tobacco products, including prohibiting the sale of single cigarettes. To enforce these regulations, the FDA conducted over 335,661 inspections between 2010 and September 30, 2014, and allocated over $115 million toward state inspections contracts. To examine differences in single cigarette violations across states and determine if likely correlates of single cigarette sales predict single cigarette violations at the state level. Cross-sectional study of publicly available FDA warning letters from January 1 to July 31, 2014. All 50 states and the District of Columbia. Tobacco retailer inspections conducted by FDA (n = 33 543). State cigarette tax, youth smoking prevalence, poverty, and tobacco production. State proportion of FDA warning letters issued for single cigarette violations. There are striking differences in the number of single cigarette violations found by state, with 38 states producing no warning letters for selling single cigarettes even as state policymakers developed legislation to address retailer sales of single cigarettes. The state proportion of warning letters issued for single cigarettes is not predicted by state cigarette tax, youth smoking, poverty, or tobacco production, P = .12. Substantial, unexplained variation exists in violations of single cigarette sales among states. These data suggest the possibility of differences in implementation of FDA inspections and the need for stronger quality monitoring processes across states implementing FDA inspections. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

FDA preemption of drug and device labeling: who should decide what goes on a drug label?

PubMed

Valoir, Tamsen; Ghosh, Shubha

2011-01-01

The Supreme Court decided an issue that is critical to consumer health and safety last year. In April 2009, the Supreme Court held that extensive FDA regulation of drugs did not preempt a state law claim that an additional warning on the label was necessary to make the drug reasonably safe for use. Thus, states--and even courts and juries--are now free to cast their vote on what a drug label should say. This is in direct contrast to medical devices, where the federal statute regulating medical devices expressly provides that state regulations are preempted. This Article discusses basic preemption principles and drugs, and explores the policy ramifications of pro- and anti-preemption policy in the healthcare industry.

Priapism caused by 'Tribulus terrestris'.

PubMed

Campanelli, M; De Thomasis, R; Tenaglia, R L

2016-01-01

A 36-year-old Caucasian man was diagnosed with a 72-h-lasting priapism that occurred after the assumption of a Herbal supplement based on Tribulus terrestris, which is becoming increasingly popular for the treatment of sexual dysfunction. The patient underwent a cavernoglandular shunt (Ebbehoj shunt) in order to obtain complete detumescence, from which derived negative post-episode outcomes on sexual function. All patients consuming non-FDA-approved alternative supplements such as Tribulus terrestris should be warned about the possible serious side effects.

An amphetamine isomer whose efficacy and safety in humans has never been studied, β-methylphenylethylamine (BMPEA), is found in multiple dietary supplements.

PubMed

Cohen, Pieter A; Bloszies, Clayton; Yee, Caleb; Gerona, Roy

2016-01-01

The amphetamine isomer β-methylphenylethylamine (BMPEA) was first synthesized in the early 1930s, but its efficacy and safety in humans has not been studied. Recently, the United States Food and Drug Administration (FDA) detected BMPEA in dietary supplements labelled as containing Acacia rigidula. Over a year after the FDA reported its findings, we analyzed Acacia rigidula dietary supplements to determine if BMPEA had been removed. Supplements were analyzed using liquid chromatography-quadrupole time-of-flight mass spectrometry. Diluted methanolic extract from each supplement was run three times and each data set obtained was analyzed using Agilent MassHunter Qualitative Analysis. The presence of BMPEA was confirmed by accurate mass, retention time and mass spectra match against a reference standard. Quantification of BMPEA was determined using an eight-point calibration curve of spiked standard to a matrix blank. Twenty-one brands of Acacia rigidula supplements were analyzed. More than half (11/21; 52.4%) of the Acacia rigidula supplement brands contained BMPEA. The stimulant was present at quantities such that consumers following recommended maximum daily servings would consume a maximum of 93.7 mg of BMPEA per day. Consumers of Acacia rigidula supplements may be exposed to pharmacological dosages of an amphetamine isomer that lacks evidence of safety in humans. The FDA should immediately warn consumers about BMPEA and take aggressive enforcement action to eliminate BMPEA in dietary supplements. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Future Challenges and Opportunities in Online Prescription Drug Promotion Research Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".

PubMed

Southwell, Brian G; Rupert, Douglas J

2016-01-16

Despite increased availability of online promotional tools for prescription drug marketers, evidence on online prescription drug promotion is far from settled or conclusive. We highlight ways in which online prescription drug promotion is similar to conventional broadcast and print advertising and ways in which it differs. We also highlight five key areas for future research: branded drug website influence on consumer knowledge and behavior, interactive features on branded drug websites, mobile viewing of branded websites and mobile advertisements, online promotion and non-US audiences, and social media and medication decisions. © 2016 by Kerman University of Medical Sciences.

The Tip of the Iceberg of Misleading Online Advertising Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".

PubMed

Mintzes, Barbara

2016-02-18

Kim's overview of Food and Drug Administration (FDA) regulatory actions from 2005 to 2014 is a comprehensive analysis of the US regulatory experience with online direct-to-consumer advertising (DTCA) of prescription medicines. This experience is of relevance internationally as online DTCA reaches the English-speaking public globally, despite the illegality of DTCA in most countries. The most common violations were omissions or minimizations of risk information, overstatements of efficacy, unsubstantiated claims, and promotion of unapproved ("off-label") use. Nearly one fourth of violations involved cancer drugs, raising additional concerns about patient vulnerability, limited treatment advance, and high costs. Based on content analyses of online DTCA, these cases likely reflect a small proportion of unbalanced and misleading promotional information available on the web. The FDA is only able to review a small proportion of promotional materials submitted to them, due to limited staffing, and the delay between first posting and regulatory action means that many people may be exposed to messages that are found to be inaccurate and misleading. The sheer volume of online DTCA, combined with the ability for content to shift continually, poses unique regulatory challenges. © 2016 by Kerman University of Medical Sciences.

76 FR 36627 - Required Warnings for Cigarette Packages and Advertisements

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-22

...The Food and Drug Administration (FDA) is amending its regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements. This rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics, depicting the negative health consequences of smoking, to accompany the nine new textual warning statements required under the Tobacco Control Act. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) to require each cigarette package and advertisement to bear one of nine new textual warning statements. This final rule specifies the color graphic images that must accompany each of the nine new textual warning statements.

Required warnings for cigarette packages and advertisements. Final rule.

PubMed

2011-06-22

The Food and Drug Administration (FDA) is amending its regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements. This rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics, depicting the negative health consequences of smoking, to accompany the nine new textual warning statements required under the Tobacco Control Act. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) to require each cigarette package and advertisement to bear one of nine new textual warning statements. This final rule specifies the color graphic images that must accompany each of the nine new textual warning statements.

The selling of olestra.

PubMed

Nestle, M

1998-01-01

The Procter & Gamble Company spent 30 years and an estimated $500 million to bring its non-digestible fat substitute, olestra, to market. The Food and Drug Administration approved olestra as a food additive but requires products containing olestra to carry a warning statement about its potential effects on gastrointestinal function. In obtaining approval for olestra, P&G conducted a lengthy, persistent, and comprehensive campaign to enlist support from members of Congress; FDA staff; and food, nutrition, and health professionals. This campaign raises larger questions about corporate influence on government policies, and the relationships of corporations to health professionals. To address these larger concerns, the author reviews the history of olestra's approval; describes P&G's campaign to obtain support from FDA and Congress, to defend olestra against critics, and to market it to professionals, the press, and consumers; and suggests implications for public health policies.

An analysis of the warning letters issued by the FDA to pharmaceutical manufacturers regarding misleading health outcomes claims

PubMed Central

Chatterjee, Satabdi; Patel, Harshali K.; Sansgiry, Sujit S.

Objective To evaluate the number and type of warning letters issued by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers for promotional violations. Methods Two reviewers downloaded, printed and independently evaluated warning letters issued by the FDA to pharmaceutical manufacturers from years 2003-2008. Misleading claims were broadly classified as clinical, Quality-of-Life (QoL), and economic claims. Clinical claims included claims regarding unsubstantiated efficacy, safety and tolerability, superiority, broadening of indication and/or omission of risk information. QoL claims included unsubstantiated quality of life and/or health-related quality of life claims. Economic claims included any form of claim made on behalf of the pharmaceutical companies related to cost superiority of or cost savings from the drug compared to other drugs in the market. Results In the 6-year study period, 65 warning letters were issued by FDA, which contained 144 clinical, three QoL, and one economic claim. On an average, 11 warning letters were issued per year. Omission of risk information was the most frequently violated claim (30.6%) followed by unsubstantiated efficacy claims (18.6%). Warning letters were primarily directed to manufacturers of cardiovascular (14.6%), anti-microbial (14.6%), and CNS (12.5%) drugs. Majority of the claims referenced in warning letters contained promotional materials directed to physicians (57%). Conclusions The study found that misleading clinical outcome claims formed the majority of the promotional violations, and majority of the claims were directed to physicians. Since inadequate promotion of medications may lead to irrational prescribing, the study emphasizes the importance of disseminating reliable, credible, and scientific information to patients, and more importantly, physicians to protect public health. PMID:24155837

75 FR 69523 - Required Warnings for Cigarette Packages and Advertisements

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-12

...The Food and Drug Administration (FDA) is proposing to amend its regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements. The proposed rule would implement a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany the nine new textual warning statements that will be required under the Tobacco Control Act. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) to require each cigarette package and advertisement to bear one of nine new textual warning statements. This proposed rule, once finalized, would specify the color graphics that must accompany each of the nine new textual warning statements.

[U.S. Food and Drug Administration (FDA) strengthens warning that non-aspirin non steroidal anti-inflammatory drugs (NSAIDs) can cause myocardial infarctions or strokes: the dentist's perspective].

PubMed

Rosen, E; Tsesis, I; Vered, M

2015-10-01

This short communication is aimed to update dental practitioners regarding the recently published warning of the U.S. Food and Drug Administration (FDA) regarding the risk for severe cardiovascular complications such as myocardial infarction or stroke following the use of non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs).

Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

PubMed

Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark

2017-06-01

An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post-marketing boxed warning. Although drugs approved with a boxed warning or priority review are more likely to experience serious post-marketing safety events, other information provided during the FDA drug review that is easy to quantify is generally not associated with post-marketing safety events. It appears that these post-marketing events are not discernible during a pre-marketing review and therefore might not be avoidable using current review data.

New and incremental FDA black box warnings from 2008 to 2015.

PubMed

Solotke, Michael T; Dhruva, Sanket S; Downing, Nicholas S; Shah, Nilay D; Ross, Joseph S

2018-02-01

The boxed warning (also known as 'black box warning [BBW]') is one of the strongest drug safety actions that the U.S. Food & Drug Administration (FDA) can implement, and often warns of serious risks. The objective of this study was to comprehensively characterize BBWs issued for drugs after FDA approval. We identified all post-marketing BBWs from January 2008 through June 2015 listed on FDA's MedWatch and Drug Safety Communications websites. We used each drug's prescribing information to classify its BBW as new, major update to a preexisting BBW, or minor update. We then characterized these BBWs with respect to pre-specified BBW-specific and drug-specific features. There were 111 BBWs issued to drugs on the US market, of which 29% (n = 32) were new BBWs, 32% (n = 35) were major updates, and 40% (n = 44) were minor updates. New BBWs and major updates were most commonly issued for death (51%) and cardiovascular risk (27%). The new BBWs and major updates impacted 200 drug formulations over the study period, of which 64% were expected to be used chronically and 58% had available alternatives without a BBW. New BBWs and incremental updates to existing BBWs are frequently added to drug labels after regulatory approval.

The return of rainbow diet pills.

PubMed

Cohen, Pieter A; Goday, Alberto; Swann, John P

2012-09-01

The US Food and Drug Administration (FDA) has recently warned consumers about the risks of weight loss supplements adulterated with multiple pharmaceutical agents. Some of these supplements combine potent anorectics, such as amphetamines derivatives, with benzodiazepines, beta-blockers, and other medications to suppress the anorectics' adverse effects. These weight loss supplements represent the most recent generation of rainbow diet pills, named for their bright and varied colors, which date back more than 70 years. Beginning in the 1940s, several US pharmaceutical firms aggressively promoted rainbow pills to physicians and patients. By the 1960s the pills had caused dozens of deaths before the FDA began removing them from the US market. We used a variety of original resources to trace these deadly pills from their origins in the United States to their popularity in Spain and Brazil to their reintroduction to the United States as weight loss dietary supplements.

The Return of Rainbow Diet Pills

PubMed Central

Cohen, Pieter A.; Goday, Alberto; Swann, John P.

2012-01-01

The US Food and Drug Administration (FDA) has recently warned consumers about the risks of weight loss supplements adulterated with multiple pharmaceutical agents. Some of these supplements combine potent anorectics, such as amphetamines derivatives, with benzodiazepines, beta-blockers, and other medications to suppress the anorectics’ adverse effects. These weight loss supplements represent the most recent generation of rainbow diet pills, named for their bright and varied colors, which date back more than 70 years. Beginning in the 1940s, several US pharmaceutical firms aggressively promoted rainbow pills to physicians and patients. By the 1960s the pills had caused dozens of deaths before the FDA began removing them from the US market. We used a variety of original resources to trace these deadly pills from their origins in the United States to their popularity in Spain and Brazil to their reintroduction to the United States as weight loss dietary supplements. PMID:22813089

Casting a global safety net--a framework for food safety in the age of globalization.

PubMed

Chyau, James

2009-01-01

In mid-March 2007, Ontario-based Menu Foods Inc. started recalling its "cuts and gravy" style pet food, after receiving information that pets that had eaten the product had fallen ill. Within a week, the company was inundated with complaints and expressions of concern from about 200,000 of its customers. The Food and Drug Administration (FDA) determined in late March 2007 that the most likely culprit in the illness, and in some cases death of the pet animals, was contaminated wheat gluten, a vegetable protein imported from China. One of the FDA identified contaminants was an industrial chemical called melamine. Reports of widespread adulteration of animal feed with melamine in China raised concern of similar contamination in the human food supply. In response, on April 27, 2007, FDA announced the detention of all vegetable proteins imported from China, whether for animal or for human consumption. But, FDA's action came too late. On May 1, 2007, officials from FDA and the U.S. Department of Agriculture (USDA) indicated that between 2.5 to 3 million people in the United States had consumed chickens that had been fed with contaminated vegetable proteins imported from China. The 2007 pet food recall incident provided an ominous early warning that, unless the international community can come up with a better food safety mechanism, more such food contamination disasters could happen in the future.

76 FR 55923 - Draft Guidance for Industry: Submission of Warning Plans for Cigarettes and Smokeless Tobacco...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-09

...] Draft Guidance for Industry: Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products... the availability of a draft guidance for industry entitled ``Submission of Warning Plans for... submitting warning plans to FDA under the Comprehensive Smokeless Tobacco Health Education Act, as amended by...

Effect of warning placement on the information processing of college students reading an OTC drug facts panel.

PubMed

Bhansali, Archita H; Sangani, Darshan S; Mhatre, Shivani K; Sansgiry, Sujit S

2018-01-01

To compare three over-the-counter (OTC) Drug Facts panel versions for information processing optimization among college students. University of Houston students (N = 210) participated in a cross-sectional survey from January to May 2010. A current FDA label was compared to two experimental labels developed using the theory of CHREST to test information processing by re-positioning the warning information within the Drug Facts panel. Congruency was defined as placing like information together. Information processing was evaluated using the OTC medication Label Evaluation Process Model (LEPM): label comprehension, ease-of-use, attitude toward the product, product evaluation, and purchase intention. Experimental label with chunked congruent information (uses-directions-other information-warnings) was rated significantly higher than the current FDA label and had the best average scores among the LEPM information processing variables. If replications uphold these findings, the FDA label design might be revised to improve information processing.

Believability of Cigarette Warnings About Addiction: National Experiments of Adolescents and Adults.

PubMed

Lazard, Allison J; Kowitt, Sarah D; Huang, Li-Ling; Noar, Seth M; Jarman, Kristen L; Goldstein, Adam O

2018-06-07

We conducted two experiments to examine the believability of three addiction-focused cigarette warnings and the influence of message source on believability among adolescents and adults in the United States. Experimental data were collected using national phone surveys of adolescents (age 13-17; n = 1125; response rate, 66%) and adults (age 18+; n = 5014; response rate, 42%). We assessed the believability of three cigarette warnings about addiction attributed to four message sources (Food and Drug Administration [FDA], Surgeon General, Centers for Disease Control and Prevention [CDC], no source). The majority of adolescents and adults reported the three cigarette warnings were very believable (49%-81% for adolescents; 47%-76% for adults). We found four to five times higher odds of adolescents believing a warning that cigarettes are addictive (warning 1) or that nicotine was an addictive chemical (warning 2) compared to a warning that differentiated the addictive risks of menthol versus traditional cigarettes (warning 3), warning 1 adjusted odds ratio (aOR): 4.53, 95% confidence interval (CI): 3.10, 6.63; warning 2 aOR: 3.87, 95% CI: 2.70, 5.50. Similarly, we found three to five times higher odds of adults (including current smokers) believing the same warnings, warning 1 aOR: 3.74, 95% CI: 2.82, 4.95; warning 2 aOR: 3.24, 95% CI: 2.45, 4.28. Message source had no overall impact on the believability of warnings for either population. Our findings support the implementation of FDA's required warnings that cigarettes are addictive and that nicotine is an addictive chemical. These believable warnings may deter adolescents from initiating smoking and encourage adults to quit smoking. This article describes, for the first time, the believability of different cigarette warnings about addiction. We now know that the majority of adolescents and adults believe cigarette warnings that highlight cigarettes as addictive and that nicotine is an addictive chemical in tobacco. However, a warning that highlighted the relative risk of addiction for menthol cigarettes compared to traditional cigarettes was not as believable among either population. Our findings support the implementation of FDA's required warnings that cigarettes are addictive and that nicotine is an addictive chemical that may deter adolescents from initiating smoking and encourage adults to quit smoking.

75 FR 32481 - Guidance for Industry: Enforcement Policy Concerning Rotational Warning Plans for Smokeless...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0276... Administration (FDA) is announcing the availability of a guidance for industry entitled ``Enforcement Policy... information relating to FDA's enforcement policy concerning section 3 of the Comprehensive Smokeless Tobacco...

Association of Attorney Advertising and FDA Action with Prescription Claims: A Time Series Segmented Regression Analysis.

PubMed

Tippett, Elizabeth C; Chen, Brian K

2015-12-01

Attorneys sponsor television advertisements that include repeated warnings about adverse drug events to solicit consumers for lawsuits against drug manufacturers. The relationship between such advertising, safety actions by the US Food and Drug Administration (FDA), and healthcare use is unknown. To investigate the relationship between attorney advertising, FDA actions, and prescription drug claims. The study examined total users per month and prescription rates for seven drugs with substantial attorney advertising volume and FDA or other safety interventions during 2009. Segmented regression analysis was used to detect pre-intervention trends, post-intervention level changes, and changes in post-intervention trends relative to the pre-intervention trends in the use of these seven drugs, using advertising volume, media hits, and the number of Medicare enrollees as covariates. Data for these variables were obtained from the Center for Medicare and Medicaid Services, Kantar Media, and LexisNexis. Several types of safety actions were associated with reductions in drug users and/or prescription rates, particularly for fentanyl, varenicline, and paroxetine. In most cases, attorney advertising volume rose in conjunction with major safety actions. Attorney advertising volume was positively correlated with prescription rates in five of seven drugs, likely because advertising volume began rising before safety actions, when prescription rates were still increasing. On the other hand, attorney advertising had mixed associations with the number of users per month. Regulatory and safety actions likely reduced the number of users and/or prescription rates for some drugs. Attorneys may have strategically chosen to begin advertising adverse drug events prior to major safety actions, but we found little evidence that attorney advertising reduced drug use. Further research is needed to better understand how consumers and physicians respond to attorney advertising.

Assessment of Web-Based Consumer Reviews as a Resource for Drug Performance

PubMed Central

Adusumalli, Swarnaseetha; Lee, HueyTyng; Hoi, Qiangze; Koo, Si-Lin; Tan, Iain Beehuat

2015-01-01

Background Some health websites provide a public forum for consumers to post ratings and reviews on drugs. Drug reviews are easily accessible and comprehensible, unlike clinical trials and published literature. Because the public increasingly uses the Internet as a source of medical information, it is important to know whether such information is reliable. Objective We aim to examine whether Web-based consumer drug ratings and reviews can be used as a resource to compare drug performance. Methods We analyzed 103,411 consumer-generated reviews on 615 drugs used to treat 249 disease conditions from the health website WebMD. Statistical analysis identified 427 drug pairs from 24 conditions for which two drugs treating the same condition had significantly and substantially different satisfaction ratings (with at least a half-point difference between Web-based ratings and P<.01). PubMed and Google Scholar were searched for publications that were assessed for concordance with findings online. Results Scientific literature was found for 77 out of the 427 drug pairs and compared to findings online. Nearly two-thirds (48/77, 62%) of the online drug trends with at least a half-point difference in online ratings were supported by published literature (P=.02). For a 1-point online rating difference, the concordance rate increased to 68% (15/22) (P=.07). The discrepancies between scientific literature and findings online were further examined to obtain more insights into the usability of Web-based consumer-generated reviews. We discovered that (1) drugs with FDA black box warnings or used off-label were rated poorly in Web-based reviews, (2) drugs with addictive properties were rated higher than their counterparts in Web-based reviews, and (3) second-line or alternative drugs were rated higher. In addition, Web-based ratings indicated drug delivery problems. If FDA black box warning labels are used to resolve disagreements between publications and online trends, the concordance rate increases to 71% (55/77) (P<.001) for a half-point rating difference and 82% (18/22) for a 1-point rating difference (P=.002). Our results suggest that Web-based reviews can be used to inform patients’ drug choices, with certain caveats. Conclusions Web-based reviews can be viewed as an orthogonal source of information for consumers, physicians, and drug manufacturers to assess the performance of a drug. However, one should be cautious to rely solely on consumer reviews as ratings can be strongly influenced by the consumer experience. PMID:26319108

Dosing of Selective Serotonin Reuptake Inhibitors Among Children and Adults Before and After the FDA Black-Box Warning.

PubMed

Bushnell, Greta A; Stürmer, Til; Swanson, Sonja A; White, Alice; Azrael, Deborah; Pate, Virginia; Miller, Matthew

2016-03-01

Prior research evaluated various effects of the 2004 black-box warning by the U.S. Food and Drug Administration (FDA) on the risk of suicidality among children associated with use of antidepressants, but the warning's effect on dosing of antidepressants has not been evaluated. This study estimated whether the initial antidepressant dose prescribed decreased and the proportion of patients who augmented the dose on the second fill increased following the 2004 warning and its 2007 expansion to young adults. The study utilized the LifeLink Health Plan Claims Database. The study cohort consisted of commercially insured children (ages 5-17), young adults (18-24), and adults (25-64) who initiated a selective serotonin reuptake inhibitor (SSRI) (citalopram, fluoxetine, paroxetine, or sertraline) from January 1, 2000, to December 31, 2009. Dose per day was determined by days' supply, strength, and quantity dispensed. Initiation with a low dose and augmentation of >1 mg/day on the second prescription before and after the 2004 warning were considered. Of 51,948 children who initiated an SSRI, 15% initiated with a low dose before the 2004 warning compared with 31% after the warning; there was a smaller change among young adults (6 percentage points) and adults (3 percentage points). The overall increase in dose augmentations among children and young adults was driven by the increase in patients initiating with a low dose. The proportion of commercially insured children initiating an SSRI with a low dose was higher after the 2004 FDA warning on the risk of suicidality among children, suggesting improved prescribing practices surrounding SSRI dosing among children.

Changes in antidepressant medications prescribing trends in children and adolescents in Hawai'i following the FDA black box warning.

PubMed

Hassanin, Hanan; Harbi, Al; Saif, Abdullah; Davis, Jim; Easa, David; Harrigan, Rosanne

2010-01-01

To study prescribing trends for antidepressants in Hawai'i following the FDA black box warning regarding the possible risk of suicide in children and adolescents. We also explored relationships between changes in prescribing trends and patient and provider characteristics. Analysis of an existing insurance data set of prescriptions to children and adolescents within the State of Hawai'i. Children and adolescents under 18-years-old insured through the largest (>60%) third-party insurance company in the state. Our results showed variations in changes in prescribing trends for different selective serotonin reuptake inhibitors (SSRIs) following the FDA black box warning. SSRIs with more evidence-based research supporting their safety and efficacy were least affected as were those that were less implicated by the FDA analysis of the possible link between SSRIs and Suicidality. Trends were apparent for all age groups examined and for both females and males. Changes in prescribing patterns of psychiatric medications for children and adolescents in Hawai'i were identified. Differing patterns have evolved since 2003 following the series of concerns raised regarding SSRIs and suicidality in children and adolescents.

Graphic Warning Labels in Cigarette Advertisements: Recall and Viewing Patterns

PubMed Central

Strasser, Andrew A.; Tang, Kathy Z.; Romer, Daniel; Jepson, Chris; Cappella, Joseph N.

2012-01-01

Background The Family Smoking Prevention and Control Act gave the U.S. Food and Drug Administration (FDA) legal authority to mandate graphic warning labels on cigarette advertising and packaging. The FDA requires that these graphic warning labels be embedded into cigarette advertising and packaging by September 2012. Purpose The aim of this study was to examine differences in recall and viewing patterns of text-only versus graphic cigarette warning labels; and, the association between viewing patterns and recall. Methods Participants (current daily smokers; N=200) were randomized to view a cigarette advertisement with either text-only or graphic warning labels. Viewing patterns were measured using eye-tracking, and recall was later assessed. Sessions were conducted between November 2008 and November 2009. Data analysis was conducted between March 2011 and July 2011. Results There was a significant difference in percentage correct recall of the warning label between those in the text-only versus graphic warning label condition, 50% versus 83% (χ2 =23.74, p=0.0001). Time to first view of the graphic warning label text, and dwell time duration (i.e., time spent looking) on the graphic image were significantly associated with correct recall. Warning labels that drew attention more quickly and resulted in longer dwell times were associated with better recall. Conclusions Graphic warning labels improve smokers’ recall of warning and health risks; they do so by drawing and holding attention. PMID:22704744

An evaluation of three statistical estimation methods for assessing health policy effects on prescription drug claims.

PubMed

Mittal, Manish; Harrison, Donald L; Thompson, David M; Miller, Michael J; Farmer, Kevin C; Ng, Yu-Tze

2016-01-01

While the choice of analytical approach affects study results and their interpretation, there is no consensus to guide the choice of statistical approaches to evaluate public health policy change. This study compared and contrasted three statistical estimation procedures in the assessment of a U.S. Food and Drug Administration (FDA) suicidality warning, communicated in January 2008 and implemented in May 2009, on antiepileptic drug (AED) prescription claims. Longitudinal designs were utilized to evaluate Oklahoma (U.S. State) Medicaid claim data from January 2006 through December 2009. The study included 9289 continuously eligible individuals with prevalent diagnoses of epilepsy and/or psychiatric disorder. Segmented regression models using three estimation procedures [i.e., generalized linear models (GLM), generalized estimation equations (GEE), and generalized linear mixed models (GLMM)] were used to estimate trends of AED prescription claims across three time periods: before (January 2006-January 2008); during (February 2008-May 2009); and after (June 2009-December 2009) the FDA warning. All three statistical procedures estimated an increasing trend (P < 0.0001) in AED prescription claims before the FDA warning period. No procedures detected a significant change in trend during (GLM: -30.0%, 99% CI: -60.0% to 10.0%; GEE: -20.0%, 99% CI: -70.0% to 30.0%; GLMM: -23.5%, 99% CI: -58.8% to 1.2%) and after (GLM: 50.0%, 99% CI: -70.0% to 160.0%; GEE: 80.0%, 99% CI: -20.0% to 200.0%; GLMM: 47.1%, 99% CI: -41.2% to 135.3%) the FDA warning when compared to pre-warning period. Although the three procedures provided consistent inferences, the GEE and GLMM approaches accounted appropriately for correlation. Further, marginal models estimated using GEE produced more robust and valid population-level estimations. Copyright © 2016 Elsevier Inc. All rights reserved.

ADHD medication use following FDA risk warnings.

PubMed

Barry, Colleen L; Martin, Andres; Busch, Susan H

2012-09-01

In 2006, the U.S. Food and Drug Administration (FDA) investigated cardiac and psychiatric risks associated with attention deficit/hyperactivity disorder (ADHD) medication use. To examine how disclosure of safety risks affected pediatric ADHD use, and to assess news media coverage of the issue to better understand trends in treatment patterns. We used the AHRQ's Medical Expenditure Panel Survey (MEPS), a nationally representative household panel survey, to calculate unadjusted rates of pediatric ADHD use from 2002 to 2008 overall and by parents' education. We examined whether children (ages 0 to 20) filled a prescription for any ADHD medication during the calendar year. Next, we used content analysis methods to analyze news coverage of the issue in 10 high-circulation newspapers, the 3 major television networks and a major cable news network in the U.S. We examined 6 measures capturing information conveyed on risk and benefits of ADHD medication use. No declines in medication use following FDA safety warnings overall or by parental education level were observed. News media coverage was relatively balanced in its portrayal of the risks and benefits of ADHD medication use by children. ADHD risk warnings were not associated with large declines in medication use, and balanced news coverage may have contributed to the treatment patterns observed. Self-reported surveys like the MEPS rely on the recall of respondents and may be subject to reporting bias. However, the validity of these data is supported by their consistency with other data on drug use from other sources. These findings are in direct contrast to the substantial declines in use observed after pediatric antidepressant risk warnings in the context of a news media environment that emphasized risks over benefits. Our findings are relevant to the ongoing discussion about improving the FDA's ability to monitor drug safety. Safety warnings occur amid ongoing concern that the agency has insufficient authority and resources to fulfill its mission to protect the public's health. Efforts to bolster the FDA's post-marketing surveillance system have the potential to incorporate more data in decision making to allow for earlier detection of health risks. Further research is needed to assess whether other treatment changes occurred following risk warnings. For example, it is important to determine whether an increase in cardiac screening prior to medication initiation occurred. Likewise, the FDA advises that children experiencing hallucinations or other psychiatric responses to medication be discontinued from drug treatment. If it is determined that instead of being discontinued from medication treatment, children experiencing hallucinations are put on additional medication (e.g., antipsychotics), additional efforts by the FDA to better inform the public are warranted.

Dose Matters: FDA's Guidance on Children's X-rays

MedlinePlus

... Consumers Home For Consumers Consumer Updates Dose Matters: FDA's Guidance on Children's X-rays Share Tweet Linkedin ... extra care to “child size” the radiation dose. FDA’s Role The FDA's Center for Devices and Radiological ...

Emotional reaction facilitates the brain and behavioral impact of graphic cigarette warning labels in smokers

PubMed Central

Wang, An-Li; Lowen, Steven B; Romer, Daniel; Giorno, Mario; Langleben, Daniel D

2015-01-01

Background Warning labels on cigarette packages are an important venue for information about the hazards of smoking. The 2009 US Family Smoking Prevention and Tobacco Control Act mandated replacing the current text-only labels with graphic warning labels. However, labels proposed by the Food and Drug Administration (FDA) were challenged in court by the tobacco companies, who argued successfully that the proposed labels needlessly encroached on their right to free speech, in part because they included images of high emotional salience that indiscriminately frightened rather than informed consumers. Methods We used functional MRI to examine the effects of graphic warning labels' emotional salience on smokers' brain activity and cognition. Twenty-four smokers viewed a random sequence of blocks of graphic warning labels that have been rated high or low on an ‘emotional reaction’ scale in previous research. Results We found that labels rated high on emotional reaction were better remembered, associated with reduction in the urge to smoke, and produced greater brain response in the amygdala, hippocampi, inferior frontal gyri and the insulae. Conclusions Recognition memory and craving are, respectively, correlates of effectiveness of addiction related public health communications and interventions, and amygdala activation facilitates the encoding of emotional memories. Thus, our results suggest that emotional reaction to graphic warning labels contributes to their public health impact and may be an integral part of the neural mechanisms underlying their effectiveness. Given the urgency of the debate about the constitutional risks and public health benefits of graphic warning labels, these preliminary findings warrant consideration while longitudinal clinical studies are underway PMID:25564288

Perceptions of "Natural" and "Additive-Free" Cigarettes and Intentions to Purchase.

PubMed

O'Connor, Richard J; Lewis, M Jane; Adkison, Sarah E; Bansal-Travers, Maansi; Cummings, K Michael

2017-04-01

In August 2015, the Food and Drug Administration (FDA) issued warning letters to cigarette manufacturers promoting brands as "natural" or "additive-free" because of concerns that such marketing claims might mislead consumers into believing that these brands are less dangerous to smoke than others. The current study examined consumer beliefs about the relative harms of "natural" cigarettes, and whether these beliefs influenced perceptions of advertising and purchase intentions when participants were shown an advertisement for American Spirit cigarettes. Data were collected using a web-based survey conducted in 2013 among 3,006 U.S.-based web panel members aged 15 to 65 years. Ratings of "natural" cigarette health risks (i.e., misperceptions) differed by sex, race, education, smoking status, and age. Controlling for perceived risks of other cigarette types, never smokers ( B = -0.31, p < .001) and ever/former smokers ( B = -0.15, p = .002) had significantly fewer misperceptions of "natural" cigarettes than current smokers. Current smoking (odds ratio [OR] = 17.8), believing the ad was truthful (OR = 1.18), and having more misperceptions about "natural" cigarette health risks (OR = 1.13) were independently associated with greater purchase intention. Consumers perceived cigarettes marketed as "natural" or "additive-free" as less harmful, and this influenced their perceptions of advertising claims and intention to purchase, controlling for other factors. These findings underscore Food and Drug Administration's recent warning letters.

FDA cigarette warning labels lower craving and elicit frontoinsular activation in adolescent smokers

PubMed Central

Do, Kathy T.

2015-01-01

Cigarette smoking is an economically and epidemiologically expensive public health concern. Most adult smokers become addicted during adolescence, rendering it a crucial period for prevention and intervention. Although litigation claims have delayed implementation, graphic warning labels proposed by the U.S. Food and Drug Administration (FDA) may be a promising way to achieve this goal. We aimed to determine the efficacy of the labels in reducing in-scanner craving and to characterize the neurobiological responses in adolescent and adult smokers and non-smokers. While undergoing functional magnetic resonance imaging, thirty-nine 13- to 18-year-old adolescent and forty-one 25- to 30-year-old adult smokers and non-smokers rated their desire to smoke when presented with emotionally graphic warning labels and comparison non-graphic labels. Compared with adult smokers, adolescent smokers exhibited greater craving reduction in response to the warning labels. Although smokers evinced overall blunted recruitment of insula and dorsolateral prefrontal cortex (DLPFC) relative to non-smokers, an effect that was stronger in adolescent smokers, parametrically increasing activation of these regions was associated with greater craving reduction. Functional connectivity analyses suggest that greater DLPFC regulation of limbic regions predicted cigarette craving. These data underscore a prominent role of frontoinsular circuitry in predicting the efficacy of FDA graphic warning labels in craving reduction in adult and adolescent smokers. PMID:25887154

The selling of olestra.

PubMed Central

Nestle, M

1998-01-01

The Procter & Gamble Company spent 30 years and an estimated $500 million to bring its non-digestible fat substitute, olestra, to market. The Food and Drug Administration approved olestra as a food additive but requires products containing olestra to carry a warning statement about its potential effects on gastrointestinal function. In obtaining approval for olestra, P&G conducted a lengthy, persistent, and comprehensive campaign to enlist support from members of Congress; FDA staff; and food, nutrition, and health professionals. This campaign raises larger questions about corporate influence on government policies, and the relationships of corporations to health professionals. To address these larger concerns, the author reviews the history of olestra's approval; describes P&G's campaign to obtain support from FDA and Congress, to defend olestra against critics, and to market it to professionals, the press, and consumers; and suggests implications for public health policies. Images p508-a p509-a p510-a p511-a p512-a p513-a p515-a p516-a p517-a PMID:9847922

Hepatitis B reactivation and rituximab: a new boxed warning and considerations for solid organ transplantation.

PubMed

Martin, S T; Cardwell, S M; Nailor, M D; Gabardi, S

2014-04-01

Use of rituximab, a chimeric monoclonal antibody directed at the CD20 antigen, continues to increase in solid organ transplantation (SOT) for several off-label uses. In September 2013, the United States Food and Drug Administration (FDA) issued a Drug Safety Communication to oncology, rheumatology and pharmacy communities outlining a new Boxed Warning for rituximab. Citing 109 cases of fatal hepatitis B virus (HBV) reactivation in persons receiving rituximab therapy with previous or chronic HBV infection documented in their Adverse Event Reporting System (AERS), the FDA recommends screening for HBV serologies in all patients planned to receive rituximab and antiviral prophylaxis in any patient with a positive history of HBV infection. There is a lack of data pertaining to this topic in the SOT population despite an increase in off-label indications. Previous reports suggest patients receiving rituximab, on average, were administered six doses prior to HBV reactivation. Recommendations on prophylaxis, treatment and re-challenging patients with therapy after resolution of reactivation remain unclear. Based on data from the FDA AERS and multiple analyses in oncology, SOT providers utilizing rituximab should adhere to the FDA warnings and recommendations regarding HBV reactivation until further data are available in the SOT population. © Copyright 2014 The American Society of Transplantation and the American Society of Transplant Surgeons.

Graphic warning labels in cigarette advertisements: recall and viewing patterns.

PubMed

Strasser, Andrew A; Tang, Kathy Z; Romer, Daniel; Jepson, Christopher; Cappella, Joseph N

2012-07-01

The Family Smoking Prevention and Control Act gave the U.S. Food and Drug Administration (FDA) legal authority to mandate graphic warning labels on cigarette advertising and packaging. The FDA requires that these graphic warning labels be embedded into cigarette advertising and packaging by September 2012. The aim of this study was to examine differences in recall and viewing patterns of text-only versus graphic cigarette warning labels and the association between viewing patterns and recall. Participants (current daily smokers; N=200) were randomized to view a cigarette advertisement with either text-only or graphic warning labels. Viewing patterns were measured using eye-tracking, and recall was later assessed. Sessions were conducted between November 2008 and November 2009. Data analysis was conducted between March 2011 and July 2011. There was a significant difference in percentage correct recall of the warning label between those in the text-only versus graphic warning label condition, 50% vs 83% (χ(2)=23.74, p=0.0001). Time to first viewing of the graphic warning label text and dwell time duration (i.e., time spent looking) on the graphic image were significantly associated with correct recall. Warning labels that drew attention more quickly and resulted in longer dwell times were associated with better recall. Graphic warning labels improve smokers' recall of warning and health risks; these labels do so by drawing and holding attention. Copyright © 2012 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Non-smoking male adolescents' reactions to cigarette warnings.

PubMed

Pepper, Jessica K; Cameron, Linda D; Reiter, Paul L; McRee, Annie-Laurie; Brewer, Noel T

2013-01-01

The U.S. Food and Drug Administration (FDA) is working to introduce new graphic warning labels for cigarette packages, the first change in cigarette warnings in more than 25 years. We sought to examine whether warnings discouraged participants from wanting to smoke and altered perceived likelihood of harms among adolescent males and whether these warning effects varied by age. A national sample of 386 non-smoking American males ages 11-17 participated in an online experiment during fall 2010. We randomly assigned participants to view warnings using a 2 × 2 between-subjects design. The warnings described a harm of smoking (addiction or lung cancer) using text only or text plus an image used on European cigarette package warnings. Analyses tested whether age moderated the warnings' impact on risk perceptions and smoking motivations. The warnings discouraged most adolescents from wanting to smoke, but lung cancer warnings discouraged them more than addiction warnings did (60% vs. 34% were "very much" discouraged, p<.001). Including an image had no effect on discouragement. The warnings affected several beliefs about the harms from smoking, and age moderated these effects. Adolescents said addiction was easier to imagine and more likely to happen to them than lung cancer. They also believed that their true likelihood of experiencing any harm was lower than what an expert would say. Our findings suggest that warnings focusing on lung cancer, rather than addiction, are more likely to discourage wanting to smoke among adolescent males and enhance their ability to imagine the harmful consequences of smoking. Including images on warnings had little effect on non-smoking male adolescents' discouragement or beliefs, though additional research on the effects of pictorial warnings for this at-risk population is needed as the FDA moves forward with developing new graphic labels.

Emotion in the Law and the Lab: The Case of Graphic Cigarette Warnings

PubMed Central

Peters, Ellen; Evans, Abigail T.; Hemmerich, Natalie; Berman, Micah

2017-01-01

The decision in RJ Reynolds vs. FDA (2012) to invalidate FDA’s proposed graphic health warnings was based in part on the reasoning that the proposed graphic warnings cued emotional responses and therefore could not be considered “factual.” However, this reasoning demonstrated the courts’ fundamental misunderstanding of current behavioral-science research. In contrast to the courts’ artificial separation of emotions from fact, we synthesize and interpret relevant research in basic decision sciences and describe an evidence-based characterization of how emotions influence consumer decision making through multiple mechanisms. We then explore how behavioral research gets “lost in translation” in the legal process and recommend ways that behavioral scientists can work with attorneys to remedy this problem. In order for science-based tobacco regulation to survive legal challenges from the tobacco industry, courts must have access to and be able to understand and apply the relevant research. Accordingly, behavioral laboratory researchers must consider the courts as an additional audience when designing research and reporting results. Researchers wishing to influence policy should also work closely with public health lawyers to have the greatest impact on the legal system. PMID:29057296

Medical Advice from Lawyers: A Content Analysis of Advertising for Drug Injury Lawsuits.

PubMed

Tippett, Elizabeth

2015-01-01

This study examined the medical information contained in a sample of television ads soliciting consumers for lawsuits against drug and medical device manufactures. Almost all such ads involved drugs or devices that have not been recalled and remain on the market. These ads raise important public health questions because they may influence the prospective medical decisions of viewers. The ads contained extensive descriptions of serious adverse events associated with the drugs or devices but almost uniformly failed to disclose information relating to the likelihood of such events. They also failed to effectively advise viewers to consult a doctor. Results also identified a subset of ads that mimicked public service announcements, claiming to be. a "medical alert" "consumer alert" or "FDA warning" at the start of the ad. Most such ads did not disclose the attorney source of the advertising until the final few seconds.

Emotional reaction facilitates the brain and behavioural impact of graphic cigarette warning labels in smokers.

PubMed

Wang, An-Li; Lowen, Steven B; Romer, Daniel; Giorno, Mario; Langleben, Daniel D

2015-05-01

Warning labels on cigarette packages are an important venue for information about the hazards of smoking. The 2009 US Family Smoking Prevention and Tobacco Control Act mandated replacing the current text-only labels with graphic warning labels. However, labels proposed by the Food and Drug Administration (FDA) were challenged in court by the tobacco companies, who argued successfully that the proposed labels needlessly encroached on their right to free speech, in part because they included images of high emotional salience that indiscriminately frightened rather than informed consumers. We used functional MRI to examine the effects of graphic warning labels' emotional salience on smokers' brain activity and cognition. Twenty-four smokers viewed a random sequence of blocks of graphic warning labels that have been rated high or low on an 'emotional reaction' scale in previous research. We found that labels rated high on emotional reaction were better remembered, associated with reduction in the urge to smoke, and produced greater brain response in the amygdala, hippocampi, inferior frontal gyri and the insulae. Recognition memory and craving are, respectively, correlates of effectiveness of addiction-related public health communications and interventions, and amygdala activation facilitates the encoding of emotional memories. Thus, our results suggest that emotional reaction to graphic warning labels contributes to their public health impact and may be an integral part of the neural mechanisms underlying their effectiveness. Given the urgency of the debate about the constitutional risks and public health benefits of graphic warning labels, these preliminary findings warrant consideration while longitudinal clinical studies are underway. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

FDA 101: Regulating Biological Products

MedlinePlus

... Home For Consumers Consumer Updates FDA 101: Regulating Biological Products Share Tweet Linkedin Pin it More sharing ... about this diverse and highly important field. What biological products does FDA regulate? The Center for Biologics ...

77 FR 70450 - Risk Communication Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-26

... barriers such as prevention or warning fatigue or inaccurate risk perception. FDA intends to make...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Risk...

21 CFR 814.39 - PMA supplements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... which does not affect the safety or effectiveness of the device. (c) All procedures and actions that... copies and additional information if requested by FDA. The time frames for review of, and FDA action on... strengthen a contraindication, warning, precaution, or information about an adverse reaction for which there...

76 FR 63303 - Guidance for Industry on Warnings and Precautions, Contraindications, and Boxed Warning Sections...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-12

...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products--Content and Format.'' This guidance is intended to assist applicants and reviewers in drafting the ``Warnings and Precautions, Contraindications, and Boxed Warning'' sections of labeling for human prescription drug and biological products. The recommendations in this guidance will help ensure that the labeling is clear, useful, informative, and to the extent possible, consistent in content and format.

Examining the FDA's oversight of direct-to-consumer advertising.

PubMed

Gahart, Martin T; Duhamel, Louise M; Dievler, Anne; Price, Roseanne

2003-01-01

Our analysis examined the effects of the Food and Drug Administration's (FDA's) 1997 draft guidance regarding advertisements for prescription drugs broadcast directly to consumers. We found that although direct-to-consumer (DTC) advertising spending by pharmaceutical companies has increased, more than 80 percent of their promotional spending is directed to physicians. DTC advertising appears to increase the use of prescription drugs among consumers. The FDA's oversight has not prevented companies from making misleading claims in subsequent advertisements, and a recent policy change has lengthened the FDA's review process, raising the possibility that some misleading campaigns could run their course before review.

Graphic warning labels and the demand for cigarettes.

PubMed

Starr, Martha A; Drake, Keith

2017-03-01

In 2010, the US Food and Drug Administration (FDA) proposed requiring tobacco companies to add graphic warning labels (GWLs) to cigarette packs. GWLs are large prominently placed warnings that use both text and photographic images to depict health risks of smoking. The companies challenged FDA's authority on First Amendment grounds; the courts accepted that FDA could compel companies to add GWLs, but argued that FDA had not established that GWLs would significantly reduce smoking. This paper adds new evidence on the question of whether GWLs would have reduced cigarette demand, by examining whether tobacco companies' share prices fell unusually after news indicating a higher likelihood of having GWLs, and rose on the opposite news. Such findings would be expected if investors viewed GWLs as likely to reduce cigarette demand. An event-study approach is used to determine whether the stock prices of US tobacco companies rose or fell unusually after news events in the period when GWLs were proposed, finalised, challenged and withdrawn. Tobacco companies' stock prices indeed realised significant abnormal returns after GWL news, consistent with expected negative effects on cigarette demand. Our estimates suggest investors expected GWLs to reduce the number of smokers by an extra 2.4-6.9 million in the 10 years after the rule took effect. These findings support the view that the GWLs proposed by FDA would have curbed cigarette consumption in the USA in an appreciable way. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

21 CFR 1141.1 - Scope.

Code of Federal Regulations, 2013 CFR

2013-04-01

... requirements for the display of health warnings on cigarette packages and in advertisements for cigarettes. FDA... violation of this part as it applies to the display of health warnings in an advertisement for cigarettes if... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) TOBACCO PRODUCTS...

Licorice abuse: time to send a warning message

PubMed Central

Komarova, Irina; El-Ghonemi, Mohamed; Fathy, Ahmed; Rashad, Rania; Abdelmalak, Hany D.; Yerramadha, Muralidhar Reddy; Ali, Yaseen; Helal, Engy; Camporesi, Enrico M.

2012-01-01

Licorice extract has always been recognized as a sweetener and a thirst quencher. Its nutritive value is overrated by many who consume significant amounts and are prone to complications. Glycyrrhetic acid, the active metabolite in licorice, inhibits the enzyme 11-ß-hydroxysteroid dehydrogenase enzyme type 2 with a resultant cortisol-induced mineralocorticoid effect and the tendency towards the elevation of sodium and reduction of potassium levels. This aldosterone-like action is the fundamental basis for understanding its health benefits and the wide spectrum of adverse effects. Herein, we present a comprehensive review of licorice along with the reported complications related to excess intake. Despite its apparent use in a few clinical scenarios, the daily consumption of licorice is never justified because its benefits are minor compared to the adverse outcomes of chronic consumption. The review highlights the importance of investigating the dietary habits and herbal remedies which are being used worldwide on cultural and habitual bases rather than reliable scientific evidence. Licorice is a US Food and Drug Administration (FDA) approved food supplement used in many products without precise regulations to prevent toxicity. Increased awareness among the public is required through TV commercials, newspapers, internet sites, magazines and product labels regarding the upper limit of ingestion and health hazards associated with excess intake. We hope that this review will serve as a warning message that should be transmitted from physicians to patients to avoid excessive licorice intake as well as a message to the FDA to start regulating the use of this substance. PMID:23185686

Ensuring that consumers receive appropriate information from drug ads: what is the FDA's role?

PubMed

Waxman, Henry A

2004-01-01

The promise of direct-to-consumer (DTC) prescription drug advertisements lies in their potential to educate consumers about medical conditions and the possibility of treatment. But this promise can only be fulfilled if consumers are given clear and accurate information. The responsibility for ensuring that this occurs falls on the Food and Drug Administration (FDA). Recent congressional investigations have indicated that the agency is failing at this task, as FDA enforcement actions against false and misleading ads have declined precipitously in recent years. Other FDA efforts, such as its recently released guidelines on prescription drugs, do not appear to be helpful, potentially confusing consumers more than helping them.

Making Decisions for Your Health: Getting the Info You Need

MedlinePlus

... Products For Consumers Home For Consumers Consumer Updates Making Decisions for Your Health: Getting the Info You ... is identified as unsafe, FDA informs consumers about market recalls and withdrawals . Create special initiatives. Many FDA ...

Mining FDA drug labels using an unsupervised learning technique--topic modeling.

PubMed

Bisgin, Halil; Liu, Zhichao; Fang, Hong; Xu, Xiaowei; Tong, Weida

2011-10-18

The Food and Drug Administration (FDA) approved drug labels contain a broad array of information, ranging from adverse drug reactions (ADRs) to drug efficacy, risk-benefit consideration, and more. However, the labeling language used to describe these information is free text often containing ambiguous semantic descriptions, which poses a great challenge in retrieving useful information from the labeling text in a consistent and accurate fashion for comparative analysis across drugs. Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive. In this study, a novel text mining method with unsupervised learning in nature, called topic modeling, was applied to the drug labeling with a goal of discovering "topics" that group drugs with similar safety concerns and/or therapeutic uses together. A total of 794 FDA-approved drug labels were used in this study. First, the three labeling sections (i.e., Boxed Warning, Warnings and Precautions, Adverse Reactions) of each drug label were processed by the Medical Dictionary for Regulatory Activities (MedDRA) to convert the free text of each label to the standard ADR terms. Next, the topic modeling approach with latent Dirichlet allocation (LDA) was applied to generate 100 topics, each associated with a set of drugs grouped together based on the probability analysis. Lastly, the efficacy of the topic modeling was evaluated based on known information about the therapeutic uses and safety data of drugs. The results demonstrate that drugs grouped by topics are associated with the same safety concerns and/or therapeutic uses with statistical significance (P<0.05). The identified topics have distinct context that can be directly linked to specific adverse events (e.g., liver injury or kidney injury) or therapeutic application (e.g., antiinfectives for systemic use). We were also able to identify potential adverse events that might arise from specific medications via topics. The successful application of topic modeling on the FDA drug labeling demonstrates its potential utility as a hypothesis generation means to infer hidden relationships of concepts such as, in this study, drug safety and therapeutic use in the study of biomedical documents.

21 CFR 1141.1 - Scope.

Code of Federal Regulations, 2014 CFR

2014-04-01

... CIGARETTE PACKAGE AND ADVERTISING WARNINGS General Provisions § 1141.1 Scope. (a) This part sets forth the requirements for the display of health warnings on cigarette packages and in advertisements for cigarettes. FDA... manufacturers or distributors of cigarettes that do not manufacture, package, or import cigarettes for sale or...

Testing for HIV

MedlinePlus

... and HIV Diagnostic Assays HIV (Human Immunodeficiency Virus) Consumer Information for Patients & Patient Advocates Contact FDA (800) ... 4709 (240) 402-8010 ocod@fda.hhs.gov Consumer Affairs Branch (CBER) Division of Communication and Consumer ...

An evaluation of the FDA's analysis of the costs and benefits of the graphic warning label regulation

PubMed Central

Chaloupka, Frank J; Warner, Kenneth E; Acemoğlu, Daron; Gruber, Jonathan; Laux, Fritz; Max, Wendy; Newhouse, Joseph; Schelling, Thomas; Sindelar, Jody

2015-01-01

The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration (FDA) regulatory authority over cigarettes and smokeless tobacco products and authorised it to assert jurisdiction over other tobacco products. As with other Federal agencies, FDA is required to assess the costs and benefits of its significant regulatory actions. To date, FDA has issued economic impact analyses of one proposed and one final rule requiring graphic warning labels (GWLs) on cigarette packaging and, most recently, of a proposed rule that would assert FDA’s authority over tobacco products other than cigarettes and smokeless tobacco. Given the controversy over the FDA's approach to assessing net economic benefits in its proposed and final rules on GWLs and the importance of having economic impact analyses prepared in accordance with sound economic analysis, a group of prominent economists met in early 2014 to review that approach and, where indicated, to offer suggestions for an improved analysis. We concluded that the analysis of the impact of GWLs on smoking substantially underestimated the benefits and overestimated the costs, leading the FDA to substantially underestimate the net benefits of the GWLs. We hope that the FDA will find our evaluation useful in subsequent analyses, not only of GWLs but also of other regulations regarding tobacco products. Most of what we discuss applies to all instances of evaluating the costs and benefits of tobacco product regulation and, we believe, should be considered in FDA's future analyses of proposed rules. PMID:25550419

An evaluation of the FDA's analysis of the costs and benefits of the graphic warning label regulation.

PubMed

Chaloupka, Frank J; Warner, Kenneth E; Acemoğlu, Daron; Gruber, Jonathan; Laux, Fritz; Max, Wendy; Newhouse, Joseph; Schelling, Thomas; Sindelar, Jody

2015-03-01

The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration (FDA) regulatory authority over cigarettes and smokeless tobacco products and authorised it to assert jurisdiction over other tobacco products. As with other Federal agencies, FDA is required to assess the costs and benefits of its significant regulatory actions. To date, FDA has issued economic impact analyses of one proposed and one final rule requiring graphic warning labels (GWLs) on cigarette packaging and, most recently, of a proposed rule that would assert FDA's authority over tobacco products other than cigarettes and smokeless tobacco. Given the controversy over the FDA's approach to assessing net economic benefits in its proposed and final rules on GWLs and the importance of having economic impact analyses prepared in accordance with sound economic analysis, a group of prominent economists met in early 2014 to review that approach and, where indicated, to offer suggestions for an improved analysis. We concluded that the analysis of the impact of GWLs on smoking substantially underestimated the benefits and overestimated the costs, leading the FDA to substantially underestimate the net benefits of the GWLs. We hope that the FDA will find our evaluation useful in subsequent analyses, not only of GWLs but also of other regulations regarding tobacco products. Most of what we discuss applies to all instances of evaluating the costs and benefits of tobacco product regulation and, we believe, should be considered in FDA's future analyses of proposed rules. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

FDA's regulation of tanning beds: how much heat?

PubMed

Knapp, Veronica

2011-01-01

This paper considers the problem of indoor tanning bed use by teenagers. The paper explores FDA's current authority to regulate tanning lamps as Class I medical devices, concluding that FDA's authority is poorly tailored to affect teenagers' repeated use of these products. An outright ban is unlikely; therefore, the best available options are to regulate access by minors and to amend the warning label requirements to reflect the current state of knowledge about the risks of tanning bed use.

Products Claiming to "Cure" Cancer Are a Cruel Deception

MedlinePlus

... Products For Consumers Home For Consumers Consumer Updates Products Claiming to "Cure" Cancer Are a Cruel Deception ... About FDA Contact FDA Browse by Product Area Product Areas back Food Drugs Medical Devices Radiation-Emitting ...

Medication Warnings: New Concerns for ADHD and Comorbid Motor Problems

ERIC Educational Resources Information Center

Obringer, S. John; Coffey, Kenneth

2007-01-01

The FDA committees and the manufacturers of the most common ADHD drugs have recently modified the prescription information to include warnings on sudden death, serious cardiovascular events, and suicidal ideation. The purpose of this article was to document the association between traumatic brain injury, cerebral palsy, and ADHD and to clarify the…

FDA Proposes New Safety Measures for Indoor Tanning Devices: The Facts

MedlinePlus

... Consumers Home For Consumers Consumer Updates FDA Proposes New Safety Measures for Indoor Tanning Devices: The Facts ... Website Policies U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888- ...

Analysis of warning letters issued by the US Food and Drug Administration to clinical investigators, institutional review boards and sponsors: a retrospective study.

PubMed

Shetty, Yashashri C; Saiyed, Aafreen A

2015-05-01

The US Food and Drug Administration (FDA) issues warning letters to all research stakeholders if unacceptable deficiencies are found during site visits. Warning letters issued by the FDA between January 2011 and December 2012 to clinical investigators and institutional review boards (IRBs) were reviewed for various violation themes and compared to similar studies in the past. Warning letters issued to sponsors between January 2005 and December 2012 were analysed for the first time for a specific set of violations using descriptive statistics. Failure to protect subject safety and to report adverse events to IRBs was found to be significant compared to prior studies for clinical investigators, while failure to follow standard operating procedures and maintain documentation was noted as significant in warning letters to IRBs. Failure to maintain minutes of meeting and to follow written procedures for continuing review were new substantial violations in warning letters issued to IRBs. Forty-six warning letters were issued to sponsors, the most common violations being failure to follow a monitoring schedule (58.69%), failure to obtain investigator agreement (34.78%), failure to secure investigators' compliance (30.43%), and failure to maintain data records and ship documents to investigators (30.43%). Appropriate methods for handling clinical trial procedural violations should be developed and implemented worldwide. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

ADHD Medication Use Following FDA Risk Warnings

PubMed Central

Barry, Colleen L.; Martin, Andres; Busch, Susan H.

2013-01-01

Background In 2006, the U.S. Food and Drug Administration (FDA) investigated cardiac and psychiatric risks associated with attention deficit/hyperactivity disorder (ADHD) medication use. Aims of the Study To examine how disclosure of safety risks affected pediatric ADHD use, and to assess news media coverage of the issue to better understand trends in treatment patterns. Methods We used the AHRQ’s Medical Expenditure Panel Survey (MEPS), a nationally representative household panel survey, to calculate unadjusted rates of pediatric ADHD use from 2002 to 2008 overall and by parents’ education. We examined whether children (ages 0 to 20) filled a prescription for any ADHD medication during the calendar year. Next, we used content analysis methods to analyze news coverage of the issue in 10 high-circulation newspapers, the 3 major television networks and a major cable news network in the U.S. We examined 6 measures capturing information conveyed on risk and benefits of ADHD medication use. Results No declines in medication use following FDA safety warnings overall or by parental education level were observed. News media coverage was relatively balanced in its portrayal of the risks and benefits of ADHD medication use by children. Discussion ADHD risk warnings were not associated with large declines in medication use, and balanced news coverage may have contributed to the treatment patterns observed. Self-reported surveys like the MEPS rely on the recall of respondents and may be subject to reporting bias. However, the validity of these data is supported by their consistency with other data on drug use from other sources. Implications for Health Care Provision and Use These findings are in direct contrast to the substantial declines in use observed after pediatric antidepressant risk warnings in the context of a news media environment that emphasized risks over benefits. Implications for Health Policies Our findings are relevant to the ongoing discussion about improving the FDA’s ability to monitor drug safety. Safety warnings occur amid ongoing concern that the agency has insufficient authority and resources to fulfill its mission to protect the public’s health. Efforts to bolster the FDA’s postmarketing surveillance system have the potential to incorporate more data in decision making to allow for earlier detection of health risks. Implications for Further Research Further research is needed to assess whether other treatment changes occurred following risk warnings. For example, it is important to determine whether an increase in cardiac screening prior to medication initiation occurred. Likewise, the FDA advises that children experiencing hallucinations or other psychiatric responses to medication be discontinued from drug treatment. If it is determined that instead of being discontinued from medication treatment, children experiencing hallucinations are put on additional medication (e.g., antipsychotics), additional efforts by the FDA to better inform the public are warranted. PMID:23001280

The impact of Wyeth v. Levine on FDA regulation of prescription drugs.

PubMed

Ausness, Richard C

2010-01-01

In Wyeth v. Levine, decided in March, 2009, the United States Supreme Court concluded that the plaintiff's failure to warn claim against the makers of the drug Phenergan was not impliedly preempted by the Food, Drug and Cosmetic Act. In doing so, the Court rejected the argument of the U.S. Food and Drug Administration (FDA) that tort claims of this nature stand as an obstacle to federal regulatory objectives. This Article evaluates the Court's opinion in Wyeth and examines that decision's impact on subsequent litigation in the area of prescription drug labeling. The Article first discusses the preemption doctrine and its application to state law tort claims against product manufacturers. It then reviews the history of implied preemption of tort claims against manufacturers of FDA-approved prescription drugs prior to Wyeth and then discusses the Wyeth decisions in the Vermont Supreme Court and the United States Supreme Court. Finally, the Article evaluates some of the prescription drug preemption cases that have been decided in the lower federal courts since Wyeth and suggests that these courts are now reluctant to preempt failure to warn claims unless a manufacturer affirmatively seeks permission from FDA to change a drug's labeling.

Encouraging Maternal Sacrifice: How Regulations Governing the Consumption of Pharmaceuticals During Pregnancy Prioritize Fetal Safety over Maternal Health and Autonomy.

PubMed

Donley, Greer

Pregnant women are routinely faced with the stressful decision of whether to consume needed medications during their pregnancies. Because the risks associated with pharmaceutical drug consumption during pregnancy are largely unknown, pregnant women both inadvertently consume dangerous medications and avoid needed drugs. Both outcomes are harmful to pregnant women and their fetuses. This unparalleled lack of drug safety information is a result of ill-conceived, paternalistic regulations in two areas of the law: regulations governing ethical research in human subjects and regulations that dictate the required labels on drugs. The former categorizes pregnant women as "vulnerable" and thus precludes them from most medical research. The result is that ninety-one percent of drugs lack any reliable safety information for pregnant consumers. The latter currently requires all drug labels to encourage drug avoidance during pregnancy, despite ample evidence that avoiding needed medications can harm pregnant women. On June 30, 2015, new pregnancy labeling regulations took effect. Though these regulations make important improvements, they continue to treat pregnant women unlike any population, including other unique subpopulations, such as children. As a result, the new regulations do not fix the problem of over-warning pregnant women about the risks of drug consumption. This article questions the legitimacy of both regulations and suggests three reforms for how to improve access to vital safety information: (1) amend the regulations governing ethical research in human subjects to reclassify pregnant women as non-vulnerable adults; (2) create incentives to generate safety data in pregnant women by granting a period of market exclusivity for drug companies that invest in this research; and (3) make the FDA pregnancy labeling regulations consistent with the routine FDA practice of requiring the display of balanced, human data on risk.

Beware of Fraudulent 'Dietary Supplements'

MedlinePlus

... Home For Consumers Consumer Updates Beware of Fraudulent Dietary Supplements Share Tweet Linkedin Pin it More sharing options ... phone at 1-800-FDA-1088 or online . Dietary Supplements and FDA Dietary supplements, in general, are not ...

The US Food and Drug Administration Modernization Act of 1997: impact on consumers.

PubMed

Golodner, L F

1998-01-01

This paper provides a consumer's perspective on an important issue that has a profound impact on all of us: the US Food and Drug Administration (FDA) Modernization Act of 1997. In addition, it provides some background information on the National Consumers League, an organization that promotes consumer safety and protection with the FDA and its predecessors.

The effect of e-cigarette warning labels on college students' perception of e-cigarettes and intention to use e-cigarettes.

PubMed

Lee, Hsiao-Yun; Lin, Hsien-Chang; Seo, Dong-Chul; Lohrmann, David K

2018-01-01

This study examined the effect of two e-cigarette warning labels on college students' perceived advantages and risks of e-cigarette use, as well as students' intentions to use e-cigarettes. The company-produced e-cigarette warning label carries abundant information with small font size while the governmental warning label has only two sentences presented in large font size. The effect of both labels have not yet been examined and verified. Data were collected in October 2015 from college students at a Midwestern university. A pretest-posttest design was employed with 338 students exposed to the warning label proposed by the FDA and 328 students exposed to the label created by e-cigarette companies. Structural equation modeling analysis was implemented to examine the effect of warning labels with the analytical model grounded in the Theory of Planned Behavior. Findings showed that college students' perceived advantages of e-cigarette use were positively related to their intentions to use e-cigarettes, while perceived risks were negatively associated with their intentions. When comparing two labels, the governmental label was found to reduce college students' intentions to use e-cigarettes via increasing perceived risks of e-cigarette use (β=0.10, p<0.05), however, not via decreasing perceived advantages of e-cigarette use. The warning label currently used by e-cigarette companies showed no influence on beliefs about or intentions to use e-cigarettes. The warning label proposed by the FDA is more effective than that created by e-cigarette companies, however, has room for improvement to make a greater impact on e-cigarette use intention. Copyright © 2017 Elsevier Ltd. All rights reserved.

Dosing of selective serotonin reuptake inhibitors in children and adults before and after the FDA black-box warning

PubMed Central

Bushnell, Greta A; Stürmer, Til; Swanson, Sonja A; White, Alice; Azrael, Deborah; Pate, Virginia; Miller, Matthew

2016-01-01

Objective Prior research evaluated various effects of the antidepressant black-box warning on the risk of suicidality in children, but the dosing of antidepressants has not been considered. This study estimated, relative to the FDA warnings, whether the initial antidepressant dose prescribed decreased and the proportion augmenting dose on the second fill increased. Method The study utilized the LifeLink Health Plan Claims Database. The study cohort consisted of commercially insured children (5–17 years), young adults (18–24 years), and adults (25–64 years) initiating an SSRI (citalopram, fluoxetine, paroxetine, or sertraline) from 1/1/2000 to 12/31/2009. Dose-per-day was determined by days supply, strength, and quantity dispensed. Initiation on low dose, defined based on guidelines, and dose augmentations (dose increase >1mg/day) on the second prescription were considered across time periods related to the antidepressant warnings. Results Of 51,948 children who initiated an SSRI, 15% initiated on low dose in the period before the 2004 black-box warning and 31% in the period after the warning (a 16 percentage-point change); there was a smaller percentage-point change in young adults (6%) and adults (3%). The overall increase in dose augmentations in children and young adults was driven by the increase in patients initiating on a low dose. Conclusions As guidelines recommend children initiate antidepressant treatment on low dose, findings that an increased proportion of commercially insured children initiated an SSRI on low dose after the 2004 black-box warning suggest prescribing practices surrounding SSRI dosing improved in children following the warning but dosing practices still fall short of guidelines. PMID:26567938

Anterior pelvic organ prolapse repair using synthetic mesh.

PubMed

Patel, Bhavin N; Lucioni, Alvaro; Kobashi, Kathleen C

2012-06-01

Since the U.S. Food and Drug Administration (FDA) statement on mesh in July of 2011, there has been controversy regarding synthetic mesh repairs for vaginal prolapse. In this article, we review the biochemical basis for the use of synthetic mesh in prolapse repair as well as clinical results of anterior compartment prolapse repair with synthetic mesh. Finally, we discuss the FDA warning regarding mesh.

The economics of counterfeit Avastin: a geospatial and statistical analysis of demographic correlates to FDA warning letters.

PubMed

Cuomo, Raphael E; Mackey, Tim K; Stigler, Paula

2015-07-01

In 2012, the Food and Drug Administration (FDA) sent warning notices to clinics and medical practitioners that may have purchased or administered counterfeited versions of the angiogenesis cancer drug Avastin Genentech, South San Francisco, California, USA. The purpose of this study was to explore potential differences in demographic, economic, and healthcare coverage characteristics between areas that received these counterfeit warning notices and those that did not receive notices. The aims of this study are to improve future counterfeit drug surveillance and better assess potential risk factors associated with counterfeit cancer drugs. Addresses for warning notices sent to healthcare practitioners were obtained from the FDA and then geocoded using arcgis. Variables chosen for statistical and geospatial analyses were then identified and assessed based on their potential association with Avastin access and affordability. These variables included demographic and economic factors (percent below the poverty line, percent uninsured, and median household income) and healthcare coverage data (percent Medicare enrollees) available from the US Center for Medicare and Medicaid Services. All variables were analyzed at the US county level. Our analysis uncovered 401 distinct US counties where the FDA sent at least one counterfeit Avastin warning notice. A hot spot analysis of notices and variables was carried out using arcgis software to identify and visualize risk features with high and low values of clustering. In a multiple logistic regression model reassessing visually observed geospatial associations, the receipt of a notice was not significantly associated with percent uninsured (p = 0.3121), but was significantly associated with percent Medicare enrollees (OR = 0.874 per 10% increase; p = 0.0121), individuals below federal poverty line (OR = 2.990 per 10% increase; p < 0.0001), and median household income (OR = 2.698 per $10 000 increase; p < 0.0001). Our study found that county-level economic and demographic factors are potentially associated with counterfeit Avastin warning receipt after controlling for the total number of people residing in each county. These geographic associations indicate that individuals in counties where patients have greater ability to afford more expensive treatment, and consequently where providers can seek higher reimbursement, may have been at higher risk to counterfeit Avastin exposure. These findings can help inform future efforts to improve drug safety surveillance and more proactively identify patients at the highest risk for counterfeit cancer drugs. Copyright © 2015 John Wiley & Sons, Ltd.

Alcohol Warning Label Perceptions: Do Warning Sizes and Plain Packaging Matter?

PubMed

Al-Hamdani, Mohammed; Smith, Steven M

2017-01-01

There is a dearth of research on the effectiveness of stringent alcohol warning labels. Our experiment tested whether increasing the size of an alcohol health warning lowers product-based ratings. We examined whether plain packaging lowers ratings of alcohol products and the consumers who use them, increases ratings of bottle "boringness," and enhances warning recognition compared with branded packaging. A total of 440 adults (51.7% female) viewed one of three warning sizes (50%, 75%, or 90% of label surface) on either a plain or branded bottle of distilled spirits, wine, and beer. Participants also rated alcohol bottles on product-based (assessing the product itself), consumer-based (assessing perceptions of consumers of the product), and bottle boringness ratings, and then attempted to recognize the correct warning out of four choices. As expected, the size of warning labels lowered product-based ratings. Similarly, plain packaging lowered product-based and consumer-based ratings and increased bottle boringness but only for wine bottles. Further, plain packaging increased the odds of warning recognition on bottles of distilled spirits. This study shows that plain packaging and warning size (similar to the graphic warnings on cigarette packages) affect perceptions about alcohol bottles. It also shows that plain packaging increases the likelihood for correct health warning recognition, which builds the case for alcohol warning and packaging research and policy.

Naturally Occurring Food Toxins

PubMed Central

Dolan, Laurie C.; Matulka, Ray A.; Burdock, George A.

2010-01-01

Although many foods contain toxins as a naturally-occurring constituent or, are formed as the result of handling or processing, the incidence of adverse reactions to food is relatively low. The low incidence of adverse effects is the result of some pragmatic solutions by the US Food and Drug Administration (FDA) and other regulatory agencies through the creative use of specifications, action levels, tolerances, warning labels and prohibitions. Manufacturers have also played a role by setting limits on certain substances and developing mitigation procedures for process-induced toxins. Regardless of measures taken by regulators and food producers to protect consumers from natural food toxins, consumption of small levels of these materials is unavoidable. Although the risk for toxicity due to consumption of food toxins is fairly low, there is always the possibility of toxicity due to contamination, overconsumption, allergy or an unpredictable idiosyncratic response. The purpose of this review is to provide a toxicological and regulatory overview of some of the toxins present in some commonly consumed foods, and where possible, discuss the steps that have been taken to reduce consumer exposure, many of which are possible because of the unique process of food regulation in the United States. PMID:22069686

Do consumers 'Get the facts'? A survey of alcohol warning label recognition in Australia.

PubMed

Coomber, Kerri; Martino, Florentine; Barbour, I Robert; Mayshak, Richelle; Miller, Peter G

2015-08-22

There is limited research on awareness of alcohol warning labels and their effects. The current study examined the awareness of the Australian voluntary warning labels, the 'Get the facts' logo (a component of current warning labels) that directs consumers to an industry-designed informational website, and whether alcohol consumers visited this website. Participants aged 18-45 (unweighted n = 561; mean age = 33.6 years) completed an online survey assessing alcohol consumption patterns, awareness of the 'Get the facts' logo and warning labels, and use of the website. No participants recalled the 'Get the facts' logo, and the recall rate of warning labels was 16% at best. A quarter of participants recognised the 'Get the facts' logo, and awareness of the warning labels ranged from 13.1-37.9%. Overall, only 7.3% of respondents had visited the website. Multivariable logistic regression models indicated that younger drinkers, increased frequency of binge drinking, consuming alcohol directly from the bottle or can, and support for warning labels were significantly, positively associated with awareness of the logo and warning labels. While an increased frequency of binge drinking, consuming alcohol directly from the container, support for warning labels, and recognition of the 'Get the facts' logo increased the odds of visiting the website. Within this sample, recall of the current, voluntary warning labels on Australian alcohol products was non-existent, overall awareness was low, and few people reported visiting the DrinkWise website. It appears that current warning labels fail to effectively transmit health messages to the general public.

The educational potential of direct-to-consumer prescription drug advertising.

PubMed

Kaphingst, Kimberly A; DeJong, William

2004-01-01

Food and Drug Administration (FDA) regulations for direct-to-consumer (DTC) prescription drug advertising allow broadcast advertisements with incomplete risk information if the ads refer consumers to physicians, pharmacists, and supplemental information sources. New research reveals several problems with both television advertisements and supplemental text materials that might compromise their ability to meet the FDA's requirement for "fair balance" in the presentation of risks and benefits. In response, we make several recommendations to improve the educational quality of DTC advertising, which can be implemented through either voluntary agreements or revised FDA regulations.

75 FR 70266 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-17

... Nutrition Facts label format to require, the Agency undertook consumer research to evaluate alternatives (Refs. 1, 2, and 3). More recently, FDA conducted qualitative consumer research on the format of the.... 5). In addition to conducting consumer research, in response to the OWG plan FDA issued two advance...

77 FR 32120 - Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-31

... require, the Agency undertook consumer research to evaluate alternatives (Refs. 1 to 3). More recently, FDA conducted qualitative consumer research on the format of the Nutrition Facts label on behalf of... consumer research, in the Federal Register of November 2, 2007 (72 FR 62149) FDA issued an Advance Notice...

Is the E-Liquid Industry Regulating Itself? A Look at E-Liquid Internet Vendors in the United States.

PubMed

Nikitin, Dmitriy; Timberlake, David S; Williams, Rebecca S

2016-10-01

The objective of this study was to assess whether the nascent, but rapidly growing e-liquid industry prohibits Internet sales to minors and employs safety measures to prevent accidental poisonings. A stratified simple random sample (n = 120) was selected from the target population (N = 1107) of US online vendors of e-liquid in July 2015. The vendors were stratified and subsequently oversampled by trade association membership and vendor popularity. Three minors aged 16 to 17, who were supervised by adult research staff, attempted to purchase e-liquid from the 120 online vendors using debit cards issued in their names. Measures included vendors' use of age verification, warning labels on e-liquid bottles, and child-resistant packaging. Statistically significant differences were observed by vendor popularity, but not by membership in a trade association. The differences by vendor popularity, however, occurred for measures that were limited to an age warning and list of ingredients. The most striking finding was the scant vendors (n = 4) who successfully prevented the sale of e-liquid to the minors. In contrast, 87.5% and 53.9% of the bottles contained child-resistant packaging and a health warning label, respectively. Irrespective of trade association membership or vendor popularity, online vendors of e-liquids are not taking the proper precautions in preventing sales to minors. The FDA's upcoming deeming rules on e-cigarette products should include explicit requirements for offline and online e-liquid vendors, particularly the use of effective age verification, warning labels, and child-resistant packaging. This study demonstrates that, in the absence of any current FDA regulation of e-liquid products, self-regulation among vendors is not effective in preventing product acquisition by minors. Lax oversight of the e-liquid industry may draw consumers to bypass current tobacco control restrictions implemented in face-to-face sales settings. As a consequence, there may be an increase in online sales to minors. Further regulation of the industry may increase the already prevalent use of child-resistant packaging, leading to fewer cases of accidental nicotine poisoning. © The Author 2016. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Trends in utilization of smoking cessation agents before and after the passage of FDA boxed warning in the United States.

PubMed

Shah, Drishti; Shah, Anuj; Tan, Xi; Sambamoorthi, Usha

2017-08-01

In 2009, the FDA required a black box warning (BBW) on bupropion and varenicline, the two commonly prescribed smoking cessation agents due to reports of adverse neuropsychiatric events. We investigated if there was a decline in use of bupropion and varenicline after the BBW by comparing the percent using these medications before and after BBW. We conducted a retrospective observational study using data from the Medical Expenditure Panel Survey from 2007 to 2014. The study sample consisted of adult smokers, who were advised by their physicians to quit smoking. We divided the time period into "pre-warning", "post-warning: immediate", and "post-warning: late." Unadjusted analysis using chi-square tests and adjusted analyses using logistic regressions were conducted to evaluate the change in bupropion and varenicline use before and after the BBW. Secondary analyses using piecewise regression were also conducted. On an average, 49.04% of smokers were advised by their physicians to quit smoking. We observed a statistically significant decline in varenicline use from 22.1% in year 2007 to 9.23% in 2014 (p value<0.001). In the logistic (Adjusted Odds Ratio=0.36, 95% CI=0.22-0.58) and piecewise regressions (Odds Ratio=0.64, 95% CI=0.41-0.99) smokers who were advised to quit smoking by their physicians were less likely to use varenicline in the immediate post-BBW period as compared to pre-BBW period. While the use of varenicline continued to be significantly low in the late post-BBW period (AOR=0.45, 95% CI=0.31-0.64) as compared to the pre-BBW period, the trend in use as seen in piecewise regression remained stable (OR=0.90, 95% CI=0.75-1.06). We did not observe significant differences in bupropion use between the pre- and post-BBW periods. The passage of the FDA boxed warning was associated with a significant decline in the use of varenicline, but not in the use of bupropion. Copyright © 2017 Elsevier B.V. All rights reserved.

FDA direct-to-consumer advertising for prescription drugs: what are consumer preferences and response tendencies?

PubMed

Khanfar, Nile; Loudon, David; Sircar-Ramsewak, Feroza

2007-01-01

The effect of direct-to-consumer (DTC) television advertising of prescription medications is a growing concern of the United States (U.S.) Congress, state legislatures, and the Food and Drug Administration (FDA). This research study was conducted in order to examine consumers' perceived preferences of DTC television advertisement in relation to "reminder" "help-seeking," and "product-claim" FDA-approved advertisement categories. An additional objective was to examine the influence of DTC television advertising of prescription drugs on consumers' tendency to seek more information about the medication and/or the medical condition. The research indicates that DTC television drug ads appear to be insufficient for consumers to make informed decisions. Their mixed perception and acceptance of the advertisements seem to influence them to seek more information from a variety of medical sources.

HIV Testing in the United States

MedlinePlus

... health facilities ;” May 2007. ← Return to text FDA Consumer Information, “Fourth Generation HIV Diagnostic Test Approved, permitting ... HIV): Screening; ” April 2013. ← Return to text FDA Consumer Information, “First rapid diagnostic test to detect both ...

FDA-approved drugs that are spermatotoxic in animals and the utility of animal testing for human risk prediction.

PubMed

Rayburn, Elizabeth R; Gao, Liang; Ding, Jiayi; Ding, Hongxia; Shao, Jun; Li, Haibo

2018-02-01

This study reviews FDA-approved drugs that negatively impact spermatozoa in animals, as well as how these findings reflect on observations in human male gametes. The FDA drug warning labels included in the DailyMed database and the peer-reviewed literature in the PubMed database were searched for information to identify single-ingredient, FDA-approved prescription drugs with spermatotoxic effects. A total of 235 unique, single-ingredient, FDA-approved drugs reported to be spermatotoxic in animals were identified in the drug labels. Forty-nine of these had documented negative effects on humans in either the drug label or literature, while 31 had no effect or a positive impact on human sperm. For the other 155 drugs that were spermatotoxic in animals, no human data was available. The current animal models are not very effective for predicting human spermatotoxicity, and there is limited information available about the impact of many drugs on human spermatozoa. New approaches should be designed that more accurately reflect the findings in men, including more studies on human sperm in vitro and studies using other systems (ex vivo tissue culture, xenograft models, in silico studies, etc.). In addition, the present data is often incomplete or reported in a manner that prevents interpretation of their clinical relevance. Changes should be made to the requirements for pre-clinical testing, drug surveillance, and the warning labels of drugs to ensure that the potential risks to human fertility are clearly indicated.

Regulation of prescription drug promotion: direct-to-consumer advertising.

PubMed

Baylor-Henry, M; Drezin, N A

1998-01-01

The US Food and Drug Administration (FDA) is responsible for regulating the information on prescription drugs disseminated by sponsors to health care providers and consumers to ensure that it is truthful and not misleading, and that it presents a fair balance of benefit and risk information. Thus the public health is both protected and promoted by the dissemination of honest, accurate information about regulated products. This paper discusses the regulatory requirements for promotional materials for prescription drugs and the standards used by the FDA to evaluate these materials. It also discusses the agency's views on direct-to-consumer advertising, the enforcement actions that are available to the FDA, the process used by the FDA to determine what action should be taken and when, and what remedies are available.

Banning front-of-package food labels: first Amendment constraints on public health policy.

PubMed

Lytton, Timothy D

2011-06-01

In recent months, the FDA has begun a crackdown on misleading nutrition and health claims on the front of food packages by issuing warning letters to manufacturers and promising to develop stricter regulatory standards. Leading nutrition policy experts Marion Nestle and David Ludwig have called for an even tougher approach: a ban on all nutrition and health claims on the front of food packages. Nestle and Ludwig argue that most of these claims are scientifically unsound and misleading to consumers and that eliminating them would 'aid educational efforts to encourage the public to eat whole or minimally processed foods and to read the ingredients list on processed foods'. Nestle and Ludwig are right to raise concerns about consumer protection and public health when it comes to front-of-package food labels, but an outright ban on front-of-package nutrition and health claims would violate the First Amendment. As nutrition policy experts develop efforts to regulate front-of-package nutrition and health claims, they should be mindful of First Amendment constraints on government regulation of commercial speech.

Transvaginal mesh in the media following the 2011 US food and drug administration public health notification update.

PubMed

Koo, Kevin; Gormley, E Ann

2017-02-01

Prompted by patients' changing perceptions of transvaginal mesh, this study examines how mesh has been reported in the news following the 2011 US Food and Drug Administration (FDA) updated notification about the use of mesh in the treatment of pelvic organ prolapse. Two national newspaper databases were queried for articles discussing transvaginal mesh published within 3 years of the FDA announcement. Content analysis included headline subjects, mesh-related complications, quoted sources, and the FDA recommendations. To determine whether more widely read sources publish higher quality reporting, a subgroup analysis was conducted based on newspaper circulation. Ninety-five articles met inclusion criteria. Mesh-related litigation was the most common headline subject (36 articles, 38%), and 54% of all articles referenced legal action. Fifty-seven articles (60%) cited at least one mesh-related complication. Only 18 articles (19%) quoted surgeons who use transvaginal mesh. For the FDA update, 40% of articles that first reported the announcement accurately specified that it applies to mesh for prolapse, not incontinence. This ambiguity persisted: half of all articles cited the warning, but only 23% distinguished between prolapse and incontinence. Higher newspaper circulation did not significantly improve the quality of reporting about the content or context of the FDA's recommendations. Despite frequent media coverage of transvaginal mesh and its complications since 2011, very few news sources that cited the FDA warning distinguished between prolapse and incontinence. Given prevalent reporting of mesh-related litigation, the findings raise concern about how patients perceive the safety and efficacy of transvaginal mesh, regardless of indication. Neurourol. Urodynam. 36:329-332, 2017. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

MS Disease-Modifying Medications

MedlinePlus

... see footnote, page 15 ) Glatopa™ (glatiramer acetate, generic equivalent of Copaxone 20 mg) Sandoz – a Novartis company ... Glatopa TM Warnings Because Glatopa is the generic equivalent of Copaxone ® (glatiramer acetate), the FDA prescribing information ...

Cigarette Graphic Warning Labels and Smoking Prevalence in Canada: A Critical Examination and Reformulation of the FDA Regulatory Impact Analysis

PubMed Central

Huang, Jidong; Chaloupka, Frank J.; Fong, Geoffrey T.

2014-01-01

Background The estimated effect of cigarette graphic warning labels (GWLs) on smoking rates is a key input to FDA's regulatory impact analysis (RIA), required by law as part of its rulemaking process. However, evidence on the impact of GWLs on smoking prevalence is scarce. Objective The goal of this paper is to critically analyze FDA's approach to estimating the impact of GWLs on smoking rates in its RIA, and to suggest a path forward to estimating the impact of the adoption of GWLs in Canada on Canadian national adult smoking prevalence. Methods A quasi-experimental methodology was employed to examine the impact of adoption of GWLs in Canada in 2000, using the U.S. as a control. Findings We found a statistically significant reduction in smoking rates after the adoption of GWLs in Canada in comparison to the U.S. Our analyses show that implementation of GWLs in Canada reduced smoking rates by 2.87 to 4.68 percentage points, a relative reduction of 12.1 to 19.6% — 33 to 53 times larger than FDA's estimates of a 0.088 percentage point reduction. We also demonstrated that FDA's estimate of the impact was flawed because it is highly sensitive to the changes in variable selection, model specification, and the time period analyzed. Conclusions Adopting GWLs on cigarette packages reduces smoking prevalence. Applying our analysis of the Canadian GWLs, we estimate that if the U.S. had adopted GWLs in 2012, the number of adult smokers in the U.S. would have decreased by 5.3 to 8.6 million in 2013. Our analysis demonstrates that FDA's approach to estimating the impact of GWLs on smoking rates is flawed. Rectifying these problems before this approach becomes the norm is critical for FDA's effective regulation of tobacco products. PMID:24218057

Extending FDA guidance to include consumer medication information (CMI) delivery on mobile devices.

PubMed

Sage, Adam; Blalock, Susan J; Carpenter, Delesha

This paper describes the current state of consumer-focused mobile health application use and the current U.S. Food and Drug Administration (FDA) guidance on the distribution of consumer medication information (CMI), and discusses recommendations and considerations for the FDA to expand CMI guidance to include CMI in mobile applications. Smartphone-based health interventions have been linked to increased medication adherence and improved health outcomes. Trends in smartphone ownership present opportunities to more effectively communicate and disseminate medication information; however, current FDA guidance for CMI does not outline how to effectively communicate CMI on a mobile platform, particularly in regards to user-centered design and information sourcing. As evidence supporting the potential effectiveness of mobile communication in health care continues to increase, CMI developers, regulating entities, and researchers should take note. Although mobile-based CMI offers an innovative mechanism to deliver medication information, caution should be exercised. Specifically, considerations for developing mobile CMI include consumers' digital literacy, user experience (e.g., usability), and the quality and accuracy of new widely used sources of information (e.g., crowd-sourced reviews and ratings). Recommended changes to FDA guidance for CMI include altering the language about scientific accuracy to address more novel methods of information gathering (e.g., anecdotal experiences and Google Consumer Surveys) and including guidance for usability testing of mobile health applications. Copyright © 2016 Elsevier Inc. All rights reserved.

Advertising and promotion of medical devices.

PubMed

Portnoy, Stuart

2006-01-01

Dr. Portnoy, a former senior clinical reviewer and manager for the FDA's Center for Devices and Radiological Health, provides guidance for determining acceptable practices for the claims, content, and appearance of advertising and promotional materials for medical devices. In the course of doing so, he discusses important regulatory and legal precedents, and provides examples of successful and problematic advertising and promotion strategies including those that resulted in FDA Warning Letters, enforcement activities, and in some cases, monetary and criminal penalties.

Medicines in My Home: Information for Adults on Using Over-the-Counter Medicines Safely

MedlinePlus

Medicines In My Home More about using medicines safely Medicines in My Home: www.fda.gov/medsinmyhome FDA Consumer Medicine Education: www.fda.gov/usemedicinesafely National Council on Patient Information and ...

Digital Direct-to-Consumer Advertising: A Perfect Storm of Rapid Evolution and Stagnant Regulation

PubMed Central

Mackey, Tim K.

2016-01-01

The adoption and use of digital forms of direct-to-consumer advertising (also known as "eDTCA") is on the rise. At the same time, the universe of eDTCA is expanding, as technology on Internet-based platforms continues to evolve, from static websites, to social media, and nearly ubiquitous use of mobile devices. However, little is known about how this unique form of pharmaceutical marketing impacts consumer behavior, public health, and overall healthcare utilization. The study by Kim analyzing US Food and Drug Administration (FDA) notices of violations (NOVs) and warning letters regarding online promotional activities takes us in the right direction, but study results raise as many questions as it does answers. Chief among these are unanswered concerns about the unique regulatory challenges posed by the "disruptive" qualities of eDTCA, and whether regulators have sufficient resources and oversight powers to proactively address potential violations. Further, the globalization of eDTCA via borderless Internet-based technologies raises larger concerns about the potential global impact of this form of health marketing unique to only the United States and New Zealand. Collectively, these challenges make it unlikely that regulatory science will be able to keep apace with the continued rapid evolution of eDTCA unless more creative policy solutions are explored. PMID:27239871

76 FR 66074 - Small Entity Compliance Guide: Required Warnings for Cigarette Packages and Advertisements...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-25

...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Required Warnings for Cigarette Packages and Advertisements--Small Entity Compliance Guide'' for a final rule published in the Federal Register on June 22, 2011. This small entity compliance guide (SECG) is intended to set forth in plain language the requirements of the regulation and to help small businesses understand and comply with the regulation.

Turning point or tipping point: new FDA draft guidances and the future of DTC advertising.

PubMed

Pitts, Peter J

2004-01-01

According to Food and Drug Administration (FDA) research, direct-to-consumer (DTC) drug ads are not as empowering as they were even three years ago. How will the FDA's new draft guidances reverse this trend and affect the future of DTC advertising? Will they be a turning point, resulting in pharmaceutical companies' embracing an educational public health imperative, or a tipping point with politicians and the public zeroing in on aggressively targeted DTC ads as the postimportation pharmaceutical bête noire? The FDA believes that its new guidances strengthen the strategic argument that a better-informed consumer lays the groundwork for a better potential customer.

Antipsychotic drug use since the FDA black box warning: survey of nursing home policies.

PubMed

Lester, Paula; Kohen, Izchak; Stefanacci, Richard G; Feuerman, Martin

2011-10-01

To use a nationwide survey to assess changes in antipsychotic utilization patterns and usage policies in nursing homes (NHs) in the United States since the introduction of the black box warning by the FDA. A survey was distributed online and was completed by 250 directors of nursing of NH. The directors of nursing answered questions concerning policies about and use of antipsychotic medications. The most commonly reported intervention to manage symptoms in residents with dementia since the black box warning was to lower doses of antipsychotics. Over half of facilities report obtaining more frequent psychiatry/psychology consults. One-hundred seven facilities have a policy regarding informing family members of residents about the black box warning. Most facilities (63.6%) with a policy require family to sign consent. In the NH setting, the presence or absence of a policy did not correlate with the reported change in use of antipsychotics or types of alternative interventions. Notably, a large number of NH facilities have policies regarding informed consent on the use of antipsychotics. However, in our study, the rate of use of antipsychotics did not change in many facilities since the black box warning. In addition, having a policy did not correlate with decreased antipsychotic use or with use of alternate agents or nonpharmacologic methods to address symptoms. The results of this survey suggest that NH administrators should worry less about the legal exposure of using antipsychotics and focus on actions that result in improved patient care. Copyright © 2011 American Medical Directors Association. Published by Elsevier Inc. All rights reserved.

Responses of young adults to graphic warning labels for cigarette packages

PubMed Central

Cameron, Linda D.; Pepper, Jessica K.; Brewer, Noel T.

2013-01-01

Background In 2010, the US Food and Drug Administration (FDA) proposed a series of 36 graphic warning labels for cigarette packages. We sought to evaluate the effects of the labels on fear-related emotions about health consequences of smoking and smoking motivations of young adults. Methods We conducted an experimental study in 2010–2011 with 325 smokers and non-smokers ages 18–30 years whom we recruited through community distribution lists in North Carolina and through a national survey company. Each participant viewed 27 labels (18 of the proposed labels with graphic images and text warnings and 9 with text-only warnings) in a random order, evaluating each label on understandability and its effects on fear-related reactions and discouragement from wanting to smoke. Results Respondents found most of the proposed labels easy to understand. Of the 36 labels, 64% induced greater fear-related reactions and 58% discouraged respondents from wanting to smoke more than the corresponding text-only labels did. Labels with the greatest effects had photographs (as compared with drawings or other art graphics) or depicted diseased body parts or suffering or dead people. In almost every comparison, smokers reported lower fear-related reactions and feeling less discouraged from wanting to smoke relative to non-smokers. Conclusions Most of the proposed labels enhanced fear-related reactions about health consequences of smoking and reduced motivations to smoke relative to text-only labels, although some had larger effects than others. All but one of the nine warning labels recently adopted by the FDA enhanced fear-related reactions and reduced smoking motivations. PMID:23624558

Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: quasi-experimental study.

PubMed

Lu, Christine Y; Zhang, Fang; Lakoma, Matthew D; Madden, Jeanne M; Rusinak, Donna; Penfold, Robert B; Simon, Gregory; Ahmedani, Brian K; Clarke, Gregory; Hunkeler, Enid M; Waitzfelder, Beth; Owen-Smith, Ashli; Raebel, Marsha A; Rossom, Rebecca; Coleman, Karen J; Copeland, Laurel A; Soumerai, Stephen B

2014-06-18

To investigate if the widely publicized warnings in 2003 from the US Food and Drug Administration about a possible increased risk of suicidality with antidepressant use in young people were associated with changes in antidepressant use, suicide attempts, and completed suicides among young people. Quasi-experimental study assessing changes in outcomes after the warnings, controlling for pre-existing trends. Automated healthcare claims data (2000-10) derived from the virtual data warehouse of 11 health plans in the US Mental Health Research Network. Study cohorts included adolescents (around 1.1 million), young adults (around 1.4 million), and adults (around 5 million). Rates of antidepressant dispensings, psychotropic drug poisonings (a validated proxy for suicide attempts), and completed suicides. Trends in antidepressant use and poisonings changed abruptly after the warnings. In the second year after the warnings, relative changes in antidepressant use were -31.0% (95% confidence interval -33.0% to -29.0%) among adolescents, -24.3% (-25.4% to -23.2%) among young adults, and -14.5% (-16.0% to -12.9%) among adults. These reflected absolute reductions of 696, 1216, and 1621 dispensings per 100,000 people among adolescents, young adults, and adults, respectively. Simultaneously, there were significant, relative increases in psychotropic drug poisonings in adolescents (21.7%, 95% confidence interval 4.9% to 38.5%) and young adults (33.7%, 26.9% to 40.4%) but not among adults (5.2%, -6.5% to 16.9%). These reflected absolute increases of 2 and 4 poisonings per 100,000 people among adolescents and young adults, respectively (approximately 77 additional poisonings in our cohort of 2.5 million young people). Completed suicides did not change for any age group. Safety warnings about antidepressants and widespread media coverage decreased antidepressant use, and there were simultaneous increases in suicide attempts among young people. It is essential to monitor and reduce possible unintended consequences of FDA warnings and media reporting. © Lu et al 2014.

America, you are digging your grave with your spoon--should the FDA tell you that on food labels?

PubMed

Card, Melissa M

2013-01-01

R.J. Reynolds Tobacco Co. v. Food & Drug Admin. discussed whether the FDA's promulgation of graphic images violated tobacco companies' First Amendment rights. While the tobacco companies contested the graphic images, the tobacco companies did not contest the promulgation of nine textual statements about the adverse effects of cigarettes. This uncontested mandate opens a door for the FDA to further expand its regulatory scheme. If the FDA can mandate textual statements about the adverse effects of cigarettes, can the FDA mandate textual statements about the adverse effects of sugar to combat the obesity crisis? This Article presents three textual statements about the adverse effects of sugar, to define the line between acceptable and unacceptable forms of compelled commercial speech under Central Hudson. Establishing this line ensures that the commercial speech doctrine does not deny the FDA from its authority to provide consumers with accurate information. While three textual statements are presented, this Article advocates that one of the textual statements is likely to serve as the best solution to the obesity crisis. The chosen textual statement serves as an effective solution because it presents meaningful information to the consumers enabling consumers to make healthful decisions about their food and encourages manufacturers to modify their products.

FDA wants tighter rules for indoor tanning.

PubMed

2013-07-01

Aiming to minimize skin cancer risk and other health drawbacks of tanning beds, the U.S. Food and Drug Administration proposed new rules to increase regulation of the devices and to require warning labels recommending increased screening for cancer.

75 FR 50770 - Guidance for Industry on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-17

... labeling requirements in plain language and provides answers to common questions on how to comply with the... consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency...

76 FR 20990 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-14

... Communication Research will design and administer the study. The proposed study will assess consumers' emotional... will help FDA to design more effective consumer food recall messages during and after a recall. FDA... collection of information is 354 hours (table 1 of this document). To help design and refine the...

76 FR 67197 - Small Entity Compliance Guide: Required Warnings for Cigarette Packages and Advertisements...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-31

...The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 25, 2011 (76 FR 66074). The document announced the availability of a guidance for industry entitled ``Required Warnings for Cigarette Packages and Advertisements--Small Entity Compliance Guide'' for a final rule that published in the Federal Register of June 22, 2011 (76 FR 36628). The notice published with an incorrect docket number. This document corrects that error.

Labeling of trans fatty acid content in food, regulations and limits-the FDA view.

PubMed

Moss, Julie

2006-05-01

With the scientific evidence associating trans fatty acid (TFA) intake with an increased risk of coronary heart disease (CHD), the U.S. Food and Drug Administration (FDA) issued a final rule that requires the declaration of the amount of TFA present in foods, including dietary supplements, on the nutrition label by January 1, 2006. The addition of TFA to the nutrition label will lead to the prevention of 600 to 1200 cases of CHD and 240-480 deaths each year saving Dollars 900 million to Dollars 1.8 billion per year in medical costs, lost productivity, and pain and suffering. For the purpose of nutrition labeling, TFA are defined as the sum of all unsaturated fatty acids that contain one or more isolated (i.e. non-conjugated) double bonds in a trans configuration. There are many issues that FDA has yet to resolve: (1) defining nutrient content claims for "free" and "reduced" levels of trans fat, (2) placing limits on the amount of TFA in conjunction with saturated fat limits for nutrient content claims, health claims, and disclosure and disqualifying levels, (3) a daily value, and (4) a possible footnote or disclosure statement to enhance consumer understanding of cholesterol raising lipids. FDA issued an Advanced Notice of Proposed Rulemaking (ANPR) requesting comments on the unresolved issues. FDA will also be conducting consumer research to determine consumer understanding of various TFA labeling possibilities. Comments to the ANPR, results of consumer research and current science will be used by FDA to resolve these issues and to determine future rulemaking for TFA labeling.

Examining the conspicuousness and prominence of two required warnings on OTC pain relievers

PubMed Central

Bix, Laura; Bello, Nora M.; Auras, Rafael; Ranger, Jon; Lapinski, Maria K.

2009-01-01

The labeling of over-the-counter (OTC) drugs is critical to their safe and effective use, and certain warnings are meant to be read at the point of purchase (POP). Examples include (i) warnings that alert consumers to the fact that the package is not child-resistant and (ii) warnings that alert consumers to potential product tampering. U.S. law mandates these warnings be “conspicuous” and “prominent” so that it is likely that consumers will read them before leaving the store. Our objective was to quantify the relative prominence and conspicuousness of these warnings. Sixty-one participants reviewed the packages of 5 commercially available analgesics to evaluate the prominence and conspicuousness of these warnings. Evaluated data included (i) the time spent examining the warnings compared with other areas of the label (using a bright pupil eye tracker), (ii) the ability to recall information from the OTCs viewed, and (iii) the legibility of the warnings relative to other elements of the labels (as measured by ASTM D7298-06). Eye-tracking data indicated that warnings were viewed by fewer participants and for less time than other elements of the packages. Recall and legibility data also indicated that the warning statements compared unfavorably with other elements of the labels tested. Evidence presented in this study suggests that 2 required warnings on 5 different OTCs are not prominent or conspicuous when compared with other elements of tested labels. PMID:19332798

The metoclopramide black box warning for tardive dyskinesia: effect on clinical practice, adverse event reporting, and prescription drug lawsuits.

PubMed

Ehrenpreis, Eli D; Deepak, Parakkal; Sifuentes, Humberto; Devi, Radha; Du, Hongyan; Leikin, Jerrold B

2013-06-01

We examined the effects of the black box warning about the risk of tardive dyskinesia (TD) with chronic use of metoclopramide on management of gastroparesis within a single clinical practice, and on reporting of adverse events. Medical records of gastroparesis patients were evaluated for physician management choices. The FDA Adverse Event Reporting System (FAERS) was analyzed for event reports, and for lawyer-initiated reports, with metoclopramide from 2004 to 2010. Google Scholar was searched for court opinions against metoclopramide manufacturers. Before the black box warning, 69.8% of patients received metoclopramide for gastroparesis, compared with 23.7% after the warning. Gastroenterologists prescribed domperidone more often after than before the warning. Metoclopramide prescriptions decreased after 2008. Adverse event reporting increased after the warning. Only 3.6% of all FAERS reports but 70% of TD reports were filed by lawyers, suggesting a distortion in signal. Forty-seven legal opinions were identified, 33 from 2009-2010. The black box warning for metoclopramide has decreased its usage and increased its rate of adverse event reporting. Lawyer-initiated reports of TD hinder pharmacovigilance.

75 FR 61490 - Agency Information Collection Activities; Proposed Collection; Comment Request; National Consumer...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0502... on Understanding the Risks and Benefits of FDA-Regulated Medical Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity...

Evaluation of strategies to communicate harmful and potentially harmful constituent (HPHC) information through cigarette package inserts: a discrete choice experiment.

PubMed

Salloum, Ramzi G; Louviere, Jordan J; Getz, Kayla R; Islam, Farahnaz; Anshari, Dien; Cho, Yoojin; O'Connor, Richard J; Hammond, David; Thrasher, James F

2017-07-13

The US Food and Drug Administration (FDA) has regulatory authority to use inserts to communicate with consumers about harmful and potentially harmful constituents (HPHCs) in tobacco products; however, little is known about the most effective manner for presenting HPHC information. In a discrete choice experiment, participants evaluated eight choice sets, each of which showed two cigarette packages from four different brands and tar levels (high vs low), accompanied by an insert that included between-subject manipulations (ie, listing of HPHCs vs grouping by disease outcome and numeric values ascribed to HPHCs vs no numbers) and within-subject manipulations (ie, 1 of 4 warning topics; statement linking an HPHC with disease vs statement with no HPHC link). For each choice set, participants were asked: (1) which package is more harmful and (2) which motivates them to not smoke; each with a 'no difference' option. Alternative-specific logit models regressed choice on attribute levels. 1212 participants were recruited from an online consumer panel (725 18-29-year-old smokers and susceptible non-smokers and 487 30-64-year-old smokers). Participants were more likely to endorse high-tar products as more harmful than low-tar products, with a greater effect when numeric HPHC information was present. Compared with a simple warning statement, the statement linking HPHCs with disease encouraged quit motivation. Numeric HPHC information on inserts appears to produce misunderstandings that some cigarettes are less harmful than others. Furthermore, brief narratives that link HPHCs to smoking-related disease may promote cessation versus communications that do not explicitly link HPHCs to disease. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Responses of young adults to graphic warning labels for cigarette packages.

PubMed

Cameron, Linda D; Pepper, Jessica K; Brewer, Noel T

2015-03-01

In 2010, the US Food and Drug Administration (FDA) proposed a series of 36 graphic warning labels for cigarette packages. We sought to evaluate the effects of the labels on fear-related emotions about health consequences of smoking and smoking motivations of young adults. We conducted an experimental study in 2010-2011 with 325 smokers and non-smokers ages 18-30 years whom we recruited through community distribution lists in North Carolina and through a national survey company. Each participant viewed 27 labels (18 of the proposed labels with graphic images and text warnings and 9 with text-only warnings) in a random order, evaluating each label on understandability and its effects on fear-related reactions and discouragement from wanting to smoke. Respondents found most of the proposed labels easy to understand. Of the 36 labels, 64% induced greater fear-related reactions and 58% discouraged respondents from wanting to smoke more than the corresponding text-only labels did. Labels with the greatest effects had photographs (as compared with drawings or other art graphics) or depicted diseased body parts or suffering or dead people. In almost every comparison, smokers reported lower fear-related reactions and feeling less discouraged from wanting to smoke relative to non-smokers. Most of the proposed labels enhanced fear-related reactions about health consequences of smoking and reduced motivations to smoke relative to text-only labels, although some had larger effects than others. All but one of the nine warning labels recently adopted by the FDA enhanced fear-related reactions and reduced smoking motivations. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Factors associated with intention to engage in self-protective behavior: The case of over-the-counter acetaminophen products.

PubMed

Sawant, R V; Goyal, R K; Rajan, S S; Patel, H K; Essien, E J; Sansgiry, S S

2016-01-01

Inappropriate use of acetaminophen products is a concern due to the severe liver damage associated with intentional or accidental overdose of these products. In 2009, the U.S. Food and Drug Administration (FDA) issued more severe organ-specific warnings for the acetaminophen Drug Facts label to improve protective behavior among patients. However, it is not clear how patients react to such interventions by the FDA. The objective of this study was to evaluate the factors influencing patients' intention to engage in protective behavior while using acetaminophen products after reading the Drug Facts label. The study specifically looked at the relationship between four Protection Motivation Theory-based risk cognition factors and the intention to engage in protective behavior. An experimental, cross-sectional, field study was conducted using self-administered questionnaires at four community pharmacies in Houston, TX. Two hundred surveys were collected from adults visiting the selected pharmacy stores. Participants were exposed to a simulated label (i.e. Drug Facts label) containing organ-specific warnings for over-the-counter (OTC) acetaminophen products. Risk cognition measures (i.e. measures of perceived severity, perceived vulnerability, response efficacy, and self-efficacy) and measures of intention to engage in protective behavior (always reading warnings, using products with more caution, and consulting a pharmacist/physician) were recorded. Pearson correlation and multiple linear regression analyses, controlling for demographic and behavioral characteristics of the participants, were performed. Bivariate analyses indicated that an increase in perceived severity, perceived vulnerability and response efficacy were associated with a higher intention to engage in protective behavior. Findings from the multiple regression indicated that increase in perceived severity of liver damage, belonging to a non-healthcare occupation, no history of acetaminophen use and no history of alcohol consumption were associated with a higher intention to engage in protective behavior. Higher risk cognition of liver damage associated with inappropriate use of OTC acetaminophen products leads to greater intention to engage in protective behavior while using such products. Developing interventions targeted towards improving reading and adhering to the Drug Facts label could improve risk cognition, and thus improve patients' intention to engage in protective behavior. Regular acetaminophen users, heavy alcohol consumers and healthcare professionals might need other interventions apart from the Drug Facts label to improve their likelihood to engage in protective behavior. Copyright © 2016 Elsevier Inc. All rights reserved.

A review of FDA warning letters and notices of violation issued for patient-reported outcomes promotional claims between 2006 and 2012.

PubMed

Symonds, Tara; Hackford, Claire; Abraham, Lucy

2014-06-01

To ascertain the frequency and types of patient-reported outcome (PRO) violations made in US pharmaceutical promotional materials between 2006 and 2012 and determine whether there were increases in violation warnings after issuance of the Food and Drug Administration (FDA) draft and final PRO Guidance. All warning letters (WLs) or notices of violation (NOVs) issued by the FDA's Office of Prescription Drug Promotion were reviewed for PRO violations (n = 213). Each letter containing a PRO violation was reviewed to determine the type of violation: 1) PRO measure not fit for purpose, 2) study design/interpretation of results, 3) statistical analysis, and 4) no treatment benefit. Forty-one (19%) letters contained information about PRO infringements. Noticeable spikes in letters were shown in 2007 (37%) and 2010 (31%) after the issuance of the draft and final PRO Guidance, respectively. The most common violation was PRO measure not fit for purpose (54%), specifically: use of individual items (45%), insufficient evidence of content validity (36%), and broadening of the claim beyond what the PRO measures (27%). Issues with study design/interpretation of results were also high (49%), particularly broadening of claim beyond what was measured in the trial (55%) and no PRO measure used (50%). A fifth of the letters issued to companies contained PRO violations, with most related to poor selection of the PRO measure used or trying to broaden the claim. More guidance from the Office of Prescription Drug Promotion about what is considered "substantial evidence" in this area could help reduce the number of letters issued. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Hyperbaric Oxygen Therapy: Don't Be Misled

MedlinePlus

... For Consumers Home For Consumers Consumer Updates Hyperbaric Oxygen Therapy: Don't Be Misled Share Tweet Linkedin ... ol Subscribe: FDA Consumer Health Information No, hyperbaric oxygen therapy (HBOT) has not been clinically proven to ...

Trends in anti-D immune globulin for childhood immune thrombocytopenia: Usage, response rates, and adverse effects

PubMed Central

Long, Michelle; Kalish, Leslie A.; Neufeld, Ellis J.; Grace, Rachael F.

2013-01-01

In 2010, the Food and Drug Administration (FDA) added a black box warning to anti-D immune globulin (Rho(D) immune globulin, anti-D) for immune thrombocytopenia (ITP) to warn of the complications related to severe hemolysis. The objective of this retrospective medical record review was to examine recent trends in anti-D use to treat ITP and rates of adverse events in a single large pediatric hematology program. Over a 7-year period, 176 (35%) of 502 ITP patients at our center received anti-D. Anti-D was the second most commonly prescribed drug for ITP from 2003 to 2010 overall and was given first most frequently (41%). Sixty-four percent of patients responded to anti-D, but 36% had adverse effects, including five patients requiring hospitalization. From 2003 to 2010, the use of anti-D as an initial therapy for ITP significantly decreased (P < 0.001). This trend preceded the 2010 FDA black box warning. In our experience, anti-D was associated with a significant number of adverse effects when used as a treatment for ITP, although none were life-threatening. Despite recent guidelines suggesting anti-D therapy for initial treatment for ITP, anti-D therapy for ITP has significantly decreased over the past 7 years. PMID:22190130

21 CFR 814.82 - Postapproval requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... periodic reporting on the safety, effectiveness, and reliability of the device for its intended use. FDA... a device and in the advertising of any restricted device of warnings, hazards, or precautions... extent required for the medical welfare of the individual, to determine the safety or effectiveness of...

21 CFR 10.115 - Good guidance practices.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., journal articles and editorials, media interviews, press materials, warning letters, memoranda of... document “Guidance Document Submission” and submit it to Division of Dockets Management (HFA-305), 5630... review. (iv) After providing an opportunity for public comment on a Level 1 guidance document, FDA will...

21 CFR 10.115 - Good guidance practices.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., journal articles and editorials, media interviews, press materials, warning letters, memoranda of... document “Guidance Document Submission” and submit it to Division of Dockets Management (HFA-305), 5630... review. (iv) After providing an opportunity for public comment on a Level 1 guidance document, FDA will...

21 CFR 10.115 - Good guidance practices.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., journal articles and editorials, media interviews, press materials, warning letters, memoranda of... document “Guidance Document Submission” and submit it to Division of Dockets Management (HFA-305), 5630... review. (iv) After providing an opportunity for public comment on a Level 1 guidance document, FDA will...

21 CFR 10.115 - Good guidance practices.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., journal articles and editorials, media interviews, press materials, warning letters, memoranda of... document “Guidance Document Submission” and submit it to Division of Dockets Management (HFA-305), 5630... review. (iv) After providing an opportunity for public comment on a Level 1 guidance document, FDA will...

Consumer perceptions of medication warnings about driving: a comparison of French and Australian labels.

PubMed

Smyth, T; Sheehan, M; Siskind, V; Mercier-Guyon, C; Mallaret, M

2013-01-01

Little research has examined user perceptions of medication warnings about driving. Consumer perceptions of the Australian national approach to medication warnings about driving are examined. The Australian approach to warning presentation is compared with an alternative approach used in France. Visual characteristics of the warnings and overall warning readability are investigated. Risk perceptions and behavioral intentions associated with the warnings are also examined. Surveys were conducted with 358 public hospital outpatients in Queensland, Australia. Extending this investigation is a supplementary comparison study of French hospital outpatients (n = 75). The results suggest that the Australian warning approach of using a combination of visual characteristics is important for consumers but that the use of a pictogram could enhance effects. Significantly higher levels of risk perception were found among the sample for the French highest severity label compared to the analogous mandatory Australian warning, with a similar trend evident in the French study results. The results also indicated that the French label was associated with more cautious behavioral intentions. The results are potentially important for the Australian approach to medication warnings about driving impairment. The research contributes practical findings that can be used to enhance the effectiveness of warnings and develop countermeasures in this area. Hospital pharmacy patients should include persons with the highest level of likelihood of knowledge and awareness of medication warning labeling. Even in this context it appears that a review of the Australian warning system would be useful particularly in the context of increasing evidence relating to associated driving risks. Reviewing text size and readability of messages including the addition of pictograms, as well as clarifying the importance of potential risk in a general community context, is recommended for consideration and further research.

76 FR 38186 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0502... Request; National Consumer Surveys on Understanding the Risks and Benefits of FDA--Regulated Medical... Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of...

Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products. Final rule.

PubMed

2016-05-10

The Food and Drug Administration (FDA) is issuing this final rule to deem products meeting the statutory definition of "tobacco product,'' except accessories of the newly deemed tobacco products, to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. With this final rule, FDA is extending the Agency's "tobacco product'' authorities in the FD&C Act to all other categories of products that meet the statutory definition of "tobacco product" in the FD&C Act, except accessories of such newly deemed tobacco products. This final rule also prohibits the sale of "covered tobacco products" to individuals under the age of 18 and requires the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements. FDA is taking this action to reduce the death and disease from tobacco products. In accordance with the Tobacco Control Act, we consider and intend the extension of our authorities over tobacco products and the various requirements and prohibitions established by this rule to be severable.

Emotional graphic cigarette warning labels reduce the electrophysiological brain response to smoking cues

PubMed Central

Wang, An-Li; Romer, Dan; Elman, Igor; Turetsky, Bruce I.; Gur, Ruben C.; Langleben, Daniel D.

2015-01-01

There is an ongoing public debate about the new graphic warning labels (GWLs) that the Food and Drug Administration (FDA) proposes to place on cigarette packs. Tobacco companies argued that the strongly emotional images FDA proposed to include in the GWLs encroached on their constitutional rights. The court ruled that FDA did not provide sufficient scientific evidence of compelling public interest in such encroachment. This study’s objectives were to examine the effects of the GWLs on the electrophysiological and behavioral correlates of smoking addiction and to determine whether labels rated higher on the emotional reaction (ER) scale are associated with greater effects. We studied 25 non-treatment-seeking smokers. Event-related potentials (ERPs) were recorded while participants viewed a random sequence of paired images, in which visual smoking (Cues) or non-smoking (non-Cues) images were preceded by GWLs or neutral images. Participants reported their cigarette craving after viewing each pair. Dependent variables were magnitude of P300 ERPs and self-reported cigarette craving in response to Cues. We found that subjective craving response to Cues was significantly reduced by preceding GWLs, whereas the P300 amplitude response to Cues was reduced only by preceding GWLs rated high on the ER scale. In conclusion, our study provides experimental neuroscience evidence that weighs in on the ongoing public and legal debate about how to balance the constitutional and public health aspects of the FDA-proposed GWLs. The high toll of smoking-related illness and death adds urgency to the debate and prompts consideration of our findings while longitudinal studies of GWLs are underway. PMID:24330194

Forewarning reduces fraud susceptibility in vulnerable consumers

PubMed Central

Scheibe, Susanne; Notthoff, Nanna; Menkin, Josephine; Ross, Lee; Shadel, Doug; Deevy, Martha; Carstensen, Laura L.

2014-01-01

Telemarketing fraud is pervasive and older consumers are disproportionally targeted. Given laboratory research showing that forewarning can effectively counter influence appeals, we conducted a field experiment to test whether forewarning could protect people who had been victimized in the past. A research assistant with prior experience as a telemarketer pitched a mock scam two or four weeks after participants were warned about the same scam or an entirely different scam. Both warnings reduced unequivocal acceptance of the mock scam although outright refusals (as opposed to expressions of skepticism) were more frequent with the same scam warning than the different scam warning. The same scam warning, but not the different scam warning, lost effectiveness over time. Findings demonstrate that social psychological research can inform effective protection strategies against telemarketing fraud. PMID:25328263

Influence of the dietary supplement health and education act on consumer beliefs about the safety and effectiveness of dietary supplements.

PubMed

Dodge, Tonya; Litt, Dana; Kaufman, Annette

2011-03-01

The authors conducted two studies to examine the influence of the U.S. Dietary Supplement Health and Education Act (DSHEA) on consumer beliefs about the safety and effectiveness of dietary supplements. Study 1 manipulated information about Food and Drug Administration (FDA) approval in the context of a dietary supplement designed to improve immune system functioning. Study 2 tested the effect of an educational intervention designed to improve knowledge about the DSHEA. Results of Study 1 highlighted deficits in consumer knowledge about FDA regulation of dietary supplements. Results also showed that information about FDA approval failed to have a statistically significant effect on beliefs about safety or effectiveness of the dietary supplement. Results of Study 2 showed that participants who were educated about the regulation of dietary supplements under the DSHEA rated dietary supplements as less safe and less effective than did participants in the control condition. The authors discuss the implications for consumers in the United States and for public policy.

Tattoos and Permanent Make-Up

MedlinePlus

... tattoos you have before any medical procedure. FDA's Role FDA-- has not approved any inks for injecting ... International Programs News & Events Training & Continuing Education Inspections & Compliance Federal, State & Local Officials Consumers Health Professionals Science & ...

Eye-Tracking Evidence that Happy Faces Impair Verbal Message Comprehension: The Case of Health Warnings in Direct-to-Consumer Pharmaceutical Television Commercials

PubMed Central

Russell, Cristel Antonia; Swasy, John L.; Russell, Dale Wesley; Engel, Larry

2017-01-01

Risk warning or disclosure information in advertising is only effective in correcting consumers’ judgments if enough cognitive capacity is available to process that information. Hence, comprehension of verbal warnings in TV commercials may suffer if accompanied by positive visual elements. This research addresses this concern about cross-modality interference in the context of direct-to-consumer (DTC) pharmaceutical commercials in the United States by experimentally testing whether positive facial expressions reduce consumers’ understanding of the mandated health warning. A content analysis of a sample of DTC commercials reveals that positive facial expressions are more prevalent during the verbal warning act of the commercials than during the other acts. An eye-tracking experiment conducted with specially produced DTC commercials, which vary the valence of characters’ facial expressions during the health warning, provides evidence that happy faces reduce objective comprehension of the warning. PMID:29269979

FDA Consumer Nutrition Knowledge Survey. Report II, 1975. A Nationwide Study of Food Shopper's Knowledge, Beliefs, Attitudes and Reported Behavior Regarding Food and Nutrition. Factors Related to Nutrition Labeling.

ERIC Educational Resources Information Center

Abelson, Herbert; And Others

During 1973, a nationwide study for the Food and Drug Administration (FDA) was conducted which provided information on nutrition knowledge, beliefs about nutrition, and first reactions to nutrition labeling among food shoppers. This initial research provided a baseline measurement of nutrition knowledge and attitudes among consumers, and in 1975…

"The Google of Healthcare": enabling the privatization of genetic bio/databanking.

PubMed

Spector-Bagdady, Kayte

2016-07-01

23andMe is back on the market as the first direct-to-consumer genetic testing company that "includes reports that meet Food and Drug Administration (FDA) standards…." But, whereas its front-end product is selling individual genetic tests online, its back-end business model is amassing one of the largest privately owned genetic databases in the world. What is the effect, however, of the private control of bio/databases on genetic epidemiology and public health research? The recent federal government notices of proposed rulemaking for: (1) revisions to regulations governing human subjects research and (2) whether certain direct-to-consumer genetic tests should require premarket FDA review, were reviewed and related to the 23andMe product, business model, and consumer agreements. FDA regulatory action so far has focused on the return of consumer test reports but it should also consider the broader misuse of data and information not otherwise protected by human subjects research regulations. As the federal government revises its decades-old human subjects research structure, the Executive Office of the President (EOP) should consider a cohesive approach to regulating private genetic bio/databanks. This strategy should allow the FDA and other agencies to play a role in expanding current regulatory coverage. Copyright © 2016 Elsevier Inc. All rights reserved.

The effectiveness of strategies such as health warning labels to reduce alcohol-related harms - an Australian perspective.

PubMed

Stockley, C S.

2001-07-01

The efficacy of health warning labels for products such as alcoholic beverages continue to be debated internationally and now in Australia as a means of mitigating the misuse of alcohol within community groups. This paper discusses evidence emanating primarily from the USA that has adopted a health warning label for both alcohol and tobacco, and from Australia that has adopted a health warning label for tobacco, on the effectiveness of such a strategy in changing consumer behaviour. The conclusion drawn is that such labelling is generally ineffective in changing consumer behaviour and hence such a strategy is inappropriate for reducing alcohol-related harms. The paper also discusses briefly what advertising and messages influence consumers, positively and negatively, and what specific strategies have been shown to better educate consumers and change their consumption from excessive to light to moderate as defined by the (Australian) National Health and Medical Research Council, which is the present premise of harm minimisation in Australia.

Nutritional information and health warnings on wine labels: Exploring consumer interest and preferences.

PubMed

Annunziata, A; Pomarici, E; Vecchio, R; Mariani, A

2016-11-01

This paper aims to contribute to the current debate on the inclusion of nutritional information and health warnings on wine labels, exploring consumers' interest and preferences. The results of a survey conducted on a sample of Italian wine consumers (N = 300) show the strong interest of respondents in the inclusion of such information on the label. Conjoint analysis reveals that consumers assign greater utility to health warnings, followed by nutritional information. Cluster analysis shows the existence of three different consumer segments. The first cluster, which included mainly female consumers (over 55) and those with high wine involvement, revealed greater awareness of the links between wine and health and better knowledge of wine nutritional properties, preferring a more detailed nutritional label, such as a panel with GDA%. By contrast, the other two clusters, consisting of individuals who generally find it more difficult to understand nutritional labels, preferred the less detailed label of a glass showing calories. The second and largest cluster comprising mainly younger men (under 44), showed the highest interest in health warnings while the third cluster - with a relatively low level of education - preferred the specification of the number of glasses not to exceed. Our results support the idea that the policy maker should consider introducing a mandatory nutritional label in the easier-to-implement and not-too-costly form of a glass with calories, rotating health warnings and the maximum number of glasses not to exceed. Copyright © 2016 Elsevier Ltd. All rights reserved.

The "natural" aversion: the FDA's reluctance to define a leading food-industry marketing claim, and the pressing need for a workable rule.

PubMed

Farris, April L

2010-01-01

As of 2009, the "natural foods" industry has become a 22.3 billion dollar giant and "all-natural" is the second-leading marketing claim for all new food products. Even in such a flourishing market, the Food and Drug Administration (FDA) has never defined the term "natural" through rulemaking. FDA and the U.S. Department of Agriculture (USDA) have instead created separate, non-identical policy statements governing the use of the term "natural," and FDA has abandoned efforts to define "natural" through rulemaking in the face of more pressing priorities. In absence of any governing federal standard, consumer advocacy groups and warring food industries have attempted to define "natural" to fit their preferences through high-stakes litigation of state law claims, leaving courts free to apply diverging standards without the expertise of FDA. Recent case law from federal district courts and the Supreme Court leaves little hope that FDA's current policy statement will preempt state law causes of action. To prevent a potential patchwork of definitions varying by state, and to create a legitimate standard resting on informed scientific expertise rather than consumer whims, FDA should engage in rulemaking to define the term "natural." This paper concludes by sketching potential formulations for such a rule based on FDA's previous successful rule-making ventures and standards used by natural foods retailers.

Dealing with ADHD: What You Need to Know

MedlinePlus

... Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products For Consumers Home For Consumers Consumer Updates Dealing with ADHD: ... Academy of Child & Adolescent Psychiatry, ADHD Resource Center Consumer Updates on Children’s Health Research Flash: FDA Scientists ...

Dry Mouth? Don't Delay Treatment

MedlinePlus

... and use (metabolize) the sugar to grow. “A by-product of the metabolized sugar is acid, which starts ... Releases Consumer Updates About FDA Contact FDA Browse by Product Area Product Areas back Food Drugs Medical Devices ...

What do consumers want?

PubMed

Apple, W

1992-01-01

A consumers' advocate discusses the needs of the consumer in evaluating dental products. Although commending the roles of the FDA and ADA in evaluating products, numerous questions are raised and recommendations made concerning advertising claims.

Treating Cushing's Disease in Dogs

MedlinePlus

... For Consumers Consumer Updates Treating Cushing's Disease in Dogs Share Tweet Linkedin Pin it More sharing options ... FDA Consumer Health Information Your 9-year old dog has been drinking a lot more lately and ...

Safety warnings and first aid instructions on consumer and pharmaceutical products in Nigeria: has there been an improvement?

PubMed

Nonyelum, Stanley Catherine; Nkem, Nwachukwu; Ifeyinwa, Chijoke-Nwauche; Orisakwe, Orish Ebere

2010-10-01

To investigate the adequacy of safety warnings and first aid instructions on the labels of pharmaceutical and consumer products in Nigeria. A market basket method (total collection of all available samples) was used to investigate the adequacy of safety warnings and first aid instructions on the labels of 600 pharmaceutical and consumer products in Nigeria. The results showed that 69.8% of the products had adequate warnings whereas 385 (64.1%) of the products screened had legible product warnings. Only 52 (8.7%) of the total number of products had appropriate first aid instructions while only 25 (4.12%) of the products described symptoms and full treatment of poisoning by the product and 319 (53.2%) products surveyed recommended calling a health professional. A total of 31 (5.2%) products had labels that were considered too technical (non English). Of the 600 products, 386 (64.3%) had dosage instructions that were considered adequate while 538 (89.6%) had adequate storage instructions. About 68% of the products had partially correct warnings while 44 or 7.3% had partially correct first aid instructions. Some products had neither warnings nor first aid instructions. This study suggests a not too impressive improvement in the correctness and appropriateness of label information.

76 FR 15986 - Food and Drug Administration/Xavier University Global Medical Device Conference

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-22

... Small Business ( http://www.XavierMedCon.com . FDA has verified the Web site address, but is not.... Combination Products Panel. Update on Quality System Regulations. Warning Letter and Enforcement Action Trends... Trends for Sponsor-Monitors and CRO's. Supplier Controls. Advertising, and Promotion and Labeling Pre...

Genetic gatekeepers: regulating direct-to-consumer genomic services in an era of participatory medicine.

PubMed

Palmer, Jessica Elizabeth

2012-01-01

Should consumers be able to obtain information about their own bodies, even if it has no proven medical value? Direct-to-consumer ("DTC") genomic companies offer consumers two services: generation of the consumer's personal genetic sequence, and interpretation of that sequence in light of current research. Concerned that consumers will misunderstand genomic information and make ill-advised health decisions, regulators, legislators and scholars have advocated restricted access to DTC genomic services. The Food and Drug Administration, which has historically refrained from regulating most genetic tests, has announced its intent to treat DTC genomic services as medical devices because they make "medical claims." This Article argues that FDA regulation of genomic services as medical devices would be counterproductive. Clinical laboratories conducting genetic tests are already overseen by a federal regime administered by the Centers for Medicare and Medicaid Services. While consumers and clinicians would benefit from clearer communication of test results and their health implications, FDA's gatekeeping framework is ill-suited to weigh the safety and efficacy of genomic information that is not medically actionable in traditional ways. Playing gatekeeper would burden FDA's resources, conflict with the patient-empowering policies promoted by personalized medicine initiatives, impair individuals' access to information in which they have powerful autonomy interests, weaken novel participatory research infrastructures, and set a poor precedent for the future regulation of medical information. Rather than applying its risk-based regulatory framework to genetic information, FDA should ameliorate regulatory uncertainty by working with the Federal Trade Commission and Centers for Medicare and Medicaid Services to ensure that DTC genomic services deliver analytically valid data, market and implement their services in a truthful manner, and fully disclose the limitations of their services. Federal agencies with relevant expertise should collaborate on standards and best practices for interpreting genetic information in light of scientific uncertainty, and an adverse event reporting system should be established to collect empirical data verifying or disproving the speculative harms resulting from individual access to genetic information. Most of all, FDA should take advantage of this opportunity to adapt its regulatory process to an increasingly informational health ecosystem.

Which prescription for the illegible and unreadable DTC (direct-to-consumer) brief summary--major surgery or euthanasia?

PubMed

Hochhauser, Mark

2002-01-01

Healthcare costs are rising, mostly because of increased prescription drug use, chiefly as the result of direct-to-consumer drug ads on television, newspapers, and magazines. However, the FDA's requirement for a brief summary in direct-to-consumer drug ads has produced summaries that are ineffective because they are illegible and unreadable, create information overload, and require literacy skills not possessed by most consumers. If the FDA wants brief summaries to be in a patient-friendly format, it should provide document design templates and plain language examples. Unless brief summaries are written so that they can be understood by the average patient, they should be overhauled or done away with.

Are Cigarette Smokers', E-Cigarette Users', and Dual Users' Health-Risk Beliefs and Responses to Advertising Influenced by Addiction Warnings and Product Type?

PubMed

Berry, Christopher; Burton, Scot; Howlett, Elizabeth

2017-10-01

This research examines cigarette smokers' and e-cigarette users' product-related health-risk beliefs across tobacco products and considers the effects of addiction warnings on consumers' responses to persuasion attempts. Study 1 used a cross-sectional survey with a sample of 195 adult cigarette smokers, e-cigarette users, and dual users to examine health-risk beliefs associated with combustible cigarettes and e-cigarettes (cancer, lung disease, stroke, heart disease, harm to an unborn baby, and addiction). Using a sample of 265 adult cigarette smokers, e-cigarette users, and dual users, Study 2 used a between-subjects experiment to examine the effects of an addiction warning presented in an advertisement on health-risk beliefs and willingness to try the promoted product. Study 1 results reveal that health-risk beliefs for cigarettes are extremely high, whereas health-risk beliefs for e-cigarettes are lower and vary across specific health-risk beliefs; specifically, beliefs related to addiction and harm to an unborn baby are greater than other risk beliefs. Extending these findings, Study 2 results demonstrate that health-risk beliefs associated with cigarette smoking are not affected by an addiction warning in a cigarette advertisement. However, an addiction warning in an e-cigarette advertisement does modify e-cigarette-related risk beliefs, which, in turn, reduces consumers' willingness to try the promoted e-cigarette. Findings indicate that the addition of an addiction warning may be effective in changing consumers' risk beliefs associated with e-cigarettes and consumers' responses to e-cigarette persuasion attempts. By examining cigarette smokers' and e-cigarette users' product-related health-risk beliefs and considering the effects of an addiction warning on consumers' responses to persuasion attempts, this research contributes to the understanding of how warnings in tobacco promotion affect cigarette smokers', e-cigarette users', and dual users' health-risk beliefs and willingness to try promoted products. Specifically, findings show that health-risk beliefs associated with e-cigarettes can be modified using an addiction warning in an e-cigarette advertisement, whereas health-risk beliefs associated with combustible cigarettes are not influenced by an addiction warning. © The Author 2017. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

FDA Response to the Fukushima Dai-ichi Nuclear Power Facility Incident

MedlinePlus

... products from Japan. This means that whole shipping containers are screened by CBP. FDA field staff also ... by consumers or doctors claiming amazing results; limited availability and advance payment requirements; promises of no-risk, ...

Development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the US food and drug administration: the class of 2008.

PubMed

Moore, Thomas J; Furberg, Curt D

2014-01-01

The US Food and Drug Administration (FDA) has advanced multiple proposals to promote biomedical innovation by making new drugs available more quickly but with shorter, smaller, and more selective clinical trials and less rigorous end points. To inform the debate about appropriate standards, we studied the development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the FDA in 2008, when most provisions of current law, regulation, and policies were in effect. Descriptive study of the drugs classified as new molecular entities using preapproval FDA evaluation documents, agency drug information databases, prescribing information, and other primary data sources. Comparison of drugs that received standard review and those deemed sufficiently innovative to receive expedited review with regard to clinical development and FDA review time, the size and duration of efficacy trials, safety issues, and postmarket follow-up. In 2008, the FDA approved 20 therapeutic drugs, 8 with expedited review and 12 with standard review. The expedited drugs took a median of 5.1 years (range, 1.6-10.6 years) of clinical development to obtain marketing approval compared with 7.5 years (range, 4.7-19.4 years) for the standard review drugs (P = .05). The expedited drugs were tested for efficacy in a median of 104 patients receiving the active drug (range, 23-599), compared with a median of 580 patients (range, 75-1207) for standard review drugs (P = .003). Nonclinical testing showed that 6 therapeutic drugs were animal carcinogens, 5 were in vitro mutagens, and 14 were animal teratogens. Other safety concerns resulted in 5 Boxed Warnings; 8 drugs required risk management plans. The FDA required 85 postmarket commitments. By 2013, 5 drugs acquired a new or expanded Boxed Warning; 26 of 85 (31%) of the postmarketing study commitments had been fulfilled, and 8 (9%) had been submitted for agency review. For new drugs approved by the FDA in 2008, those that received expedited review were approved more rapidly than those that received standard review. However, considerably fewer patients were studied prior to approval, and many safety questions remained unanswered. By 2013, many postmarketing studies had not been completed.

CPSC Warns of Carbon Monoxide Poisoning with Camping Equipment

MedlinePlus

... Warns of Carbon Monoxide Poisoning Hazard with Camping Equipment The U.S. Consumer Product Safety Commission (CPSC) warns ... about the carbon monoxide (CO) hazard with camping equipment. CO can kill you! From 2002–2006, CPSC ...

Medical devices; ovarian adnexal mass assessment score test system; labeling; black box restrictions. Final rule.

PubMed

2011-12-30

The Food and Drug Administration (FDA) is amending the regulation classifying ovarian adnexal mass assessment score test systems to restrict these devices so that a prescribed warning statement that addresses a risk identified in the special controls guidance document must be in a black box and must appear in all labeling, advertising, and promotional material. The black box warning mitigates the risk to health associated with off-label use as a screening test, stand-alone diagnostic test, or as a test to determine whether or not to proceed with surgery.

A decade of direct-to-consumer advertising of prescription drugs.

PubMed

Donohue, Julie M; Cevasco, Marisa; Rosenthal, Meredith B

2007-08-16

Evidence suggests that direct-to-consumer advertising of prescription drugs increases pharmaceutical sales and both helps to avert underuse of medicines and leads to potential overuse. Concern about such advertising has increased recently owing to the withdrawal from the market of heavily advertised drugs found to carry serious risks. Moreover, the Food and Drug Administration (FDA) has been criticized for its weak enforcement of laws regulating such advertising. We examined industry-wide trends in spending by pharmaceutical companies on direct-to-consumer advertising and promotion to physicians during the past decade. We characterized the drugs for which such advertising is used and assessed the timing of advertising after a drug is introduced. Finally, we examined trends in the FDA's regulation of drug advertising. Total spending on pharmaceutical promotion grew from $11.4 billion in 1996 to $29.9 billion in 2005. Although during that time spending on direct-to-consumer advertising increased by 330%, it made up only 14% of total promotional expenditures in 2005. Direct-to-consumer campaigns generally begin within a year after the approval of a product by the FDA. In the context of regulatory changes requiring legal review before issuing letters, the number of letters sent by the FDA to pharmaceutical manufacturers regarding violations of drug-advertising regulations fell from 142 in 1997 to only 21 in 2006. Spending on direct-to-consumer advertising has continued to increase in recent years in spite of the criticisms leveled against it. Our findings suggest that calls for a moratorium on such advertising for new drugs would represent a dramatic departure from current practices. Copyright 2007 Massachusetts Medical Society.

Review of Usnic Acid and Usnea Barbata Toxicity

PubMed Central

Guo, Lei; Shi, Qiang; Fang, Jia-Long; Mei, Nan; Ali, A. Afshan; Lewis, Sherry M.; Leakey, Julian E.A.; Frankos, Vasilios H.

2017-01-01

Usnic acid is a prominent secondary lichen metabolite that has been used for various purposes worldwide. Crude extracts of usnic acid or pure usnic acid have been marketed in the United States as dietary supplements to aid in weight loss. The US Food and Drug Administration (FDA) received 21 reports of liver toxicity related to the ingestion of dietary supplements that contain usnic acid. This prompted the FDA to issue a warning about one such supplement, LipoKinetix, in 2001 (http://www.cfsan.fda.gov/~dms/ds-lipo.html). Subsequently, usnic acid and Usnea barbata lichen were nominated by the National Toxicology Program (NTP) for toxicity evaluations. At present, a toxicological evaluation of usnic acid is being conducted by the NTP. This review focuses on the recent findings of usnic acid-induced toxicities and their underlying mechanisms of action. PMID:19034791

77 FR 16973 - Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-23

...The Food and Drug Administration (FDA) is reopening the comment period on specific data related to a proposed rule published in the Federal Register of March 29,, to establish standards that would be considered in determining whether the major statement in direct-to- consumer (DTC) television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans is presented in a clear, conspicuous, and neutral manner. In the Federal Register of January 27, 2012, FDA announced that it had added a document to the docket for the proposed rulemaking concerning a study entitled ``Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements'' (Distraction Study) and the public was given until February 27, 2012, to comment on this study as it relates to the proposed standards. FDA is reopening the comment period for the rulemaking proceeding in response to a request for more time to submit comments to the Agency.

Alcohol consumers' attention to warning labels and brand information on alcohol packaging: Findings from cross-sectional and experimental studies.

PubMed

Kersbergen, Inge; Field, Matt

2017-01-26

Alcohol warning labels have a limited effect on drinking behavior, potentially because people devote minimal attention to them. We report findings from two studies in which we measured the extent to which alcohol consumers attend to warning labels on alcohol packaging, and aimed to identify if increased attention to warning labels is associated with motivation to change drinking behavior. Study 1 (N = 60) was an exploratory cross-sectional study in which we used eye-tracking to measure visual attention to brand and health information on alcohol and soda containers. In study 2 (N = 120) we manipulated motivation to reduce drinking using an alcohol brief intervention (vs control intervention) and measured heavy drinkers' attention to branding and warning labels with the same eye-tracking paradigm as in study 1. Then, in a separate task we experimentally manipulated attention by drawing a brightly colored border around health (or brand) information before measuring participants' self-reported drinking intentions for the subsequent week. Study 1 showed that participants paid minimal attention to warning labels (7% of viewing time). Participants who were motivated to reduce drinking paid less attention to alcohol branding and alcohol warning labels. Results from study 2 showed that the alcohol brief intervention decreased attention to branding compared to the control condition, but it did not affect attention to warning labels. Furthermore, the experimental manipulation of attention to health or brand information did not influence drinking intentions for the subsequent week. Alcohol consumers allocate minimal attention to warning labels on alcohol packaging and even if their attention is directed to these warning labels, this has no impact on their drinking intentions. The lack of attention to warning labels, even among people who actively want to cut down, suggests that there is room for improvement in the content of health warnings on alcohol packaging.

75 FR 47606 - Strategic Plan for Consumer Education via Cooperative Agreement (U18)

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-06

... or quantitative research with stakeholders and meetings with stakeholder groups and consumer experts... and resulting from an extensive consumer research process. In 2007, PFSE joined with USDA to create... responsibilities of FDA. B. Research Objectives PFSE supports a large, complex, and multi-faceted consumer food...

Warning letters to sponsor-investigators at academic health centres - the regulatory "canaries in a coal mine".

PubMed

O'Reilly, Erin K; Blair Holbein, M E; Berglund, Jelena P; Parrish, Amanda B; Roth, Mary-Tara; Burnett, Bruce K

2013-12-01

This study highlights Warning Letter (WL) findings issued to sponsor-investigators (S-Is) by the Food and Drug Administration (FDA). The online index of WLs issued from October 1, 2007 through September 30, 2012 was reviewed [1]. Through a manual screening process, letters were evaluated if specifically issued to 'clinical investigators', 'sponsors' or 'sponsor-investigators'. A particular focus was given to S-Is at Academic Health Centres (AHCs). Each letter was scored for the presence of violations in 40 general regulatory categories. A review of FDA WLs issued over a five-year period (FDA Fiscal Years 2008-2012) revealed that WLs to S-Is represent half of the WLs issued to all sponsors (16 of 32 letters). A review of these letters indicates that S-Is are not aware of, or simply do not meet, their regulatory responsibilities as either investigators or sponsors. In comparing total sponsor letters to those of S-Is, the most cited violation was the same: a lack of monitoring. A review of publicly available inspection data indicates that these 16 letters merely represent the tip of the iceberg. This review of the WL database reveals the potential for serious regulatory violations among S-Is at AHCs. Recent translational funding initiatives may serve to increase the number of S-Is, especially among Academic Health Centres (AHCs) [2]; thus, AHCs must become aware of this S-I role and work to support investigators who assume both roles in the course of their research.

A pragmatic analysis of the regulation of consumer transcranial direct current stimulation (TDCS) devices in the United States

PubMed Central

2015-01-01

Several recent articles have called for the regulation of consumer transcranial direct current stimulation (tDCS) devices, which provide low levels of electrical current to the brain. However, most of the discussion to-date has focused on ethical or normative considerations; there has been a notable absence of scholarship regarding the actual legal framework in the United States. This article aims to fill that gap by providing a pragmatic analysis of the consumer tDCS market and relevant laws and regulations. In the five main sections of this manuscript, I take into account (a) the history of the do-it-yourself tDCS movement and the subsequent emergence of direct-to-consumer devices; (b) the statutory language of the Federal Food, Drug and Cosmetic Act and how the definition of a medical device—which focuses on the intended use of the device rather than its mechanism of action—is of paramount importance for discussions of consumer tDCS device regulation; (c) how both the Food and Drug Administration (FDA) and courts have understood the FDA's jurisdiction over medical devices in cases where the meaning of ‘intended use’ has been challenged; (d) an analysis of consumer tDCS regulatory enforcement action to-date; and (e) the multiple US authorities, other than the FDA, that can regulate consumer brain stimulation devices. Taken together, this paper demonstrates that rather than a ‘regulatory gap,’ there are multiple, distinct pathways by which consumer tDCS can be regulated in the United States. PMID:27774217

Alcohol Warnings and Moderate Drinking Patterns among Italian University Students: An Exploratory Study

PubMed Central

Annunziata, Azzurra; Vecchio, Riccardo; Mariani, Angela

2017-01-01

The introduction of health warnings on labels to correct externalities associated with alcohol consumption is heavily debated and has been explored from different perspectives. The current paper aims to analyse the interest and attitudes of Italian university students regarding health warnings on alcoholic beverages and to verify the existence of segments that differ in terms of attitudes towards such warnings. Our results show that young consumers consider health warnings quite important, although the degree of perceived utility differs in relation to the type of warning. Cluster analysis shows the existence of three groups of young consumers with different degrees of attention and perceived utility of warnings on alcoholic beverages, but also in relation to drinking behaviour and awareness of social and health risks related to alcohol consumption. In brief, Italian young adults with moderate consumption behaviour view label warnings positively, while this attitude is weaker among younger adults and those with riskier consumption behaviours. Our findings, albeit limited and based on stated and not revealed data, support the need for appropriate tools to improve the availability of information among young adults on the risks of excessive alcohol consumption and increased awareness of the importance of moderate drinking. PMID:28629138

76 FR 37817 - Cooperative Agreement With the World Health Organization Department of Food Safety and Zoonoses...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-28

... Environment Monitoring System for Food (GEMS/Food), Global Early Warning Systems for Animal Diseases Including... leafy vegetables and herbs also acknowledged the success of the FIVE KEYS to safe food as it reviewed..., working together with FDA, developed FIVE KEYS to Growing Safer Fruits and Vegetables: Promoting Health by...

Good manufacturing practice (GMP) compliance in the biologics sector: plasma fractionation.

PubMed

Ways, J P; Preston, M S; Baker, D; Huxsoll, J; Bablak, J

1999-12-01

The U.S. blood supply is the safest it has ever been. Due to blood safety and the introduction of viral inactivation/clearance technologies, protein therapies derived from human blood have also in recent years had a history of product safety. Nevertheless, since 1995, the plasma-fractionation industry has experienced increased compliance-related actions by the Food and Drug Administration (FDA), as shown by a substantive increase in the number of FDA 483 inspectional observations, FDA warning letters and other FDA regulatory action. An evaluation of these trends shows that they reflect the implementation by the FDA of increased inspectional interest in the plasma-fractionation industry and an evolution of inspectional practices and standards of current good manufacturing practice (cGMP). Plasma fractionators have responded to FDA actions by carefully evaluating and addressing each inspectional observation, assessing impact to product and taking appropriate actions, including corrective actions to prevent future occurrence. They have made major investments in facilities, quality systems, personnel and training to meet the evolving standards of cGMP and in an effort to implement these standards systemically. Through industry associations, manufacturers have further enhanced product safety by adopting additional voluntary standards for plasma to prevent the entry of potentially unsuitable plasma into the production process. The industry remains committed to application of cGMP and to working with the FDA in further evolution of these standards while striving to assure a continued supply of safe, pure and effective plasma-derived therapies.

A natural compromise: a moderate solution to the GMO & "natural" labeling disputes.

PubMed

Amaru, Stephanie

2014-01-01

In the United States, genetically modified (GM) foods are labeled no differently from their natural counterparts, leaving consumers with no mechanism for deciphering genetically modified food content. The Food and Drug Administration (FDA) has not formally defined the term "natural," which is frequently used on food labels despite consumer confusion as to what it means. The FDA should initiate a notice and comment rulemaking addressing the narrow issue of whether use of the word "natural" should be permitted oil GM food labels. Prohibition of the use of"natural" on genetically modified foods would mitigate consumer deception regarding genetically modified food content without significantly disadvantaging genetically modified food producers.

Communicating Tobacco Product Information to the Public.

PubMed

Berman, Micah L; Byron, M Justin; Hemmerich, Natalie; Lindblom, Eric N; Lazard, Allison J; Peters, Ellen; Brewer, Noel T

2017-01-01

The 2009 Family Smoking Prevention and Tobacco Control Act (TCA) requires tobacco companies to disclose information about the harmful chemicals in their products to the U.S. Food and Drug Administration (FDA). The law requires the FDA, in turn, to communicate this information to the public "in a format that is understandable and not misleading to a lay person." But how should the FDA comply with this requirement? What does it mean for information about complex chemicals to be "understandable and not misleading to a lay person"? These questions are not easy ones to answer. Disclosures about the amount of harmful chemicals (constituents) in different tobacco products may help to inform consumers, but may also conversely prompt consumers to reach incorrect or unsupported conclusions about products' relative health risks. This paper first analyzes the FDA's legal obligation to publish tobacco constituent information so that it is "understandable and not misleading to a layperson." Second, it discusses how that legal analysis has guided scientific research examining how members of the public interpret messages regarding tobacco constituents. Lastly, this paper concludes with policy recommendations for the FDA as it considers how to comply with the law's constituent disclosure requirement while still furthering its overall objective of promoting public health.

This Article Makes You Smarter! (Or, Regulating Health and Wellness Claims).

PubMed

Duranske, Sarah

2017-03-01

Information has power - to inspire, to transform, and to harm. Recent technological advancements have enabled the creation of products that offer consumers direct access to a level of personal health information unprecedented in history. But how are we to balance the promise of health and wellness information with its risks? Two agencies are tasked with protecting consumers from false claims of health products: the FDA and the FTC. This Article investigates if they are up to the task. In part a study of agency policymaking choices, and in part a prescription for more thoughtful and focused regulation, this Article compares both intra-agency and inter-agency regulation of informational health and wellness products. Certain procedural and substantive characteristics of FDA regulation are unsuited to informational health and wellness products, rendering comprehensive regulation by the FDA unrealistic. This gap creates an opportunity for the FTC to use its distinct and well-tailored enforcement tools to police harmful product claims that escape the FDA's purview. I posit that by tailoring the FDA's responsibility and sustaining the FTC's engagement with health claims, the agencies can dovetail into a cohesive and comprehensive regulatory regime.

The good, the bad, and the ugly: weighing the risks and benefits of seafood consumption.

PubMed

Morrissey, Michael T

2006-01-01

The health benefits that long chain omega-3 fatty acids contribute in the reduction of coronary heart disease are well established through a number of scientific publications. A number of studies are also examining their potential role in mitigating other diseases and health conditions such as Alzheimer's and mental disorders. Some of the latest research have shown the importance of omega-3 fatty acids such as docosahexaenoic acid in cognitive development in infants. Extensive scientific research and recommendations to consume fish regularly from professional societies, health organizations, and government agencies consistently support dietary guidance to consume fish regularly. Nevertheless, increasingly consumers are being warned to eliminate or minimize their consumption of certain species. The warnings, which have been issued due to risks associated with chemical contaminates such as mercury, PCB, and dioxin in fish, have received extensive coverage in news articles and stories in popular magazines. There have been a series of mixed messages to the consumer about the benefits or risks in eating seafood. In some cases, the warnings have been issued by government agencies such as the Food and Drug Administration and Environmental Protection Agency's Joint Fish Advisory on methylmercury. In other cases, the warnings have come from advocacy groups and others. Unfortunately, the advice is often miscommunicated and misunderstood by consumers. The emerging news about the benefits and risks of fish consumption will be discussed in the context of their impacts on consumer's health and well-being.

21 CFR 312.48 - Dispute resolution.

Code of Federal Regulations, 2010 CFR

2010-04-01

... division in FDA's Center for Drug Evaluation and Research or Center for Biologics Evaluation and Research which is responsible for review of the IND, beginning with the consumer safety officer assigned to the... director of the division in FDA's Center for Drug Evaluation and Research or Center for Biologics...

Methodological approaches to evaluate the impact of FDA drug safety communications.

PubMed

Kesselheim, Aaron S; Campbell, Eric G; Schneeweiss, Sebastian; Rausch, Paula; Lappin, Brian M; Zhou, Esther H; Seeger, John D; Brownstein, John S; Woloshin, Steven; Schwartz, Lisa M; Toomey, Timothy; Dal Pan, Gerald J; Avorn, Jerry

2015-06-01

When the US FDA approves a new prescription drug there is still a great deal remaining to be learned about the safe and proper use of that product. When new information addressing these topics emerges post-approval, the FDA may issue a Drug Safety Communication (DSC) to alert patients and physicians. The effectiveness of the communication-how drug safety messaging conveyed in FDA DSCs changes patient or prescriber behavior-may depend on multiple factors, including the way physicians and patients learn about the information, their understanding of the issues conveyed, and their perception of the importance of the information. In 2013, the FDA issued two DSCs addressing critical new warnings related to products containing the sedative/hypnotic zolpidem. In this article, we describe a core set of research initiatives that can be used to study how zolpidem-related DSCs affected subsequent physician and patient decision making. These research initiatives include analyzing drug utilization patterns and related health outcomes; comparing zolpidem-containing products against a comparator with similar indications [eszopiclone (Lunesta)] not covered by the 2013 DSCs; and surveying patients and qualitatively evaluating the dissemination of information regarding these drugs in traditional and social-media channels. Using an integrated, multidisciplinary approach, we can obtain information that can be used to optimize regulatory communications by seeking to understand the impact of the information contained in FDA risk communications.

Temporary Tattoos and Henna/Mehndi

MedlinePlus

... what may be harmful to consumers. How to Report a Reaction to a Temporary Tattoo or Other ... important for consumers and health care providers to report problems with cosmetics to FDA. This information helps ...

Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010

PubMed Central

Downing, Nicholas S.; Shah, Nilay D.; Aminawung, Jenerius A.; Pease, Alison M.; Zeitoun, Jean-David; Krumholz, Harlan M.

2017-01-01

Importance Postmarket safety events of novel pharmaceuticals and biologics occur when new safety risks are identified after initial regulatory approval of these therapeutics. These safety events can change how novel therapeutics are used in clinical practice and inform patient and clinician decision making. Objectives To characterize the frequency of postmarket safety events among novel therapeutics approved by the US Food and Drug Administration (FDA), and to examine whether any novel therapeutic characteristics known at the time of FDA approval were associated with increased risk. Design and Setting Cohort study of all novel therapeutics approved by the FDA between January 1, 2001, and December 31, 2010, followed up through February 28, 2017. Exposures Novel therapeutic characteristics known at the time of FDA approval, including drug class, therapeutic area, priority review, accelerated approval, orphan status, near–regulatory deadline approval, and regulatory review time. Main Outcomes and Measures A composite of (1) withdrawals due to safety concerns, (2) FDA issuance of incremental boxed warnings added in the postmarket period, and (3) FDA issuance of safety communications. Results From 2001 through 2010, the FDA approved 222 novel therapeutics (183 pharmaceuticals and 39 biologics). There were 123 new postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a median follow-up period of 11.7 years (interquartile range [IQR], 8.7-13.8 years), affecting 71 (32.0%) of the novel therapeutics. The median time from approval to first postmarket safety event was 4.2 years (IQR, 2.5-6.0 years), and the proportion of novel therapeutics affected by a postmarket safety event at 10 years was 30.8% (95% CI, 25.1%-37.5%). In multivariable analysis, postmarket safety events were statistically significantly more frequent among biologics (incidence rate ratio [IRR] = 1.93; 95% CI, 1.06-3.52; P = .03), therapeutics indicated for the treatment of psychiatric disease (IRR = 3.78; 95% CI, 1.77-8.06; P < .001), those receiving accelerated approval (IRR = 2.20; 95% CI, 1.15-4.21; P = .02), and those with near–regulatory deadline approval (IRR = 1.90; 95% CI, 1.19-3.05; P = .008); events were statistically significantly less frequent among those with regulatory review times less than 200 days (IRR = 0.46; 95% CI, 0.24-0.87; P = .02). Conclusions and Relevance Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 32% were affected by a postmarket safety event. Biologics, psychiatric therapeutics, and accelerated and near–regulatory deadline approval were statistically significantly associated with higher rates of events, highlighting the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle. PMID:28492899

Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.

PubMed

Downing, Nicholas S; Shah, Nilay D; Aminawung, Jenerius A; Pease, Alison M; Zeitoun, Jean-David; Krumholz, Harlan M; Ross, Joseph S

2017-05-09

Postmarket safety events of novel pharmaceuticals and biologics occur when new safety risks are identified after initial regulatory approval of these therapeutics. These safety events can change how novel therapeutics are used in clinical practice and inform patient and clinician decision making. To characterize the frequency of postmarket safety events among novel therapeutics approved by the US Food and Drug Administration (FDA), and to examine whether any novel therapeutic characteristics known at the time of FDA approval were associated with increased risk. Cohort study of all novel therapeutics approved by the FDA between January 1, 2001, and December 31, 2010, followed up through February 28, 2017. Novel therapeutic characteristics known at the time of FDA approval, including drug class, therapeutic area, priority review, accelerated approval, orphan status, near-regulatory deadline approval, and regulatory review time. A composite of (1) withdrawals due to safety concerns, (2) FDA issuance of incremental boxed warnings added in the postmarket period, and (3) FDA issuance of safety communications. From 2001 through 2010, the FDA approved 222 novel therapeutics (183 pharmaceuticals and 39 biologics). There were 123 new postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a median follow-up period of 11.7 years (interquartile range [IQR], 8.7-13.8 years), affecting 71 (32.0%) of the novel therapeutics. The median time from approval to first postmarket safety event was 4.2 years (IQR, 2.5-6.0 years), and the proportion of novel therapeutics affected by a postmarket safety event at 10 years was 30.8% (95% CI, 25.1%-37.5%). In multivariable analysis, postmarket safety events were statistically significantly more frequent among biologics (incidence rate ratio [IRR] = 1.93; 95% CI, 1.06-3.52; P = .03), therapeutics indicated for the treatment of psychiatric disease (IRR = 3.78; 95% CI, 1.77-8.06; P < .001), those receiving accelerated approval (IRR = 2.20; 95% CI, 1.15-4.21; P = .02), and those with near-regulatory deadline approval (IRR = 1.90; 95% CI, 1.19-3.05; P = .008); events were statistically significantly less frequent among those with regulatory review times less than 200 days (IRR = 0.46; 95% CI, 0.24-0.87; P = .02). Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 32% were affected by a postmarket safety event. Biologics, psychiatric therapeutics, and accelerated and near-regulatory deadline approval were statistically significantly associated with higher rates of events, highlighting the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle.

Tire aging: a human factors analysis of failure to warn and inform.

PubMed

Wogalter, Michael S; Laughery, Kenneth R

2012-01-01

A scenario of an automotive accident caused by tire failure is given followed by a human factors analysis of the information available to consumers on tire aging. Consumers have not been told that the age of the tire is a safety concern. It is not easy to decode the date of manufacture on tires. More publicity and prominent warnings are needed to communicate the dangers of older tires. Also, better ways to present the date of manufacture so that consumers can more easily and accurately assess tire age are needed.

Product reformulation in the context of nutritional warning labels: Exploration of consumer preferences towards food concepts in three food categories.

PubMed

Ares, Gastón; Aschemann-Witzel, Jessica; Curutchet, María Rosa; Antúnez, Lucía; Machín, Leandro; Vidal, Leticia; Giménez, Ana

2018-05-01

The reformulation of the food products available in the marketplace to improve their nutritional quality has been identified as one of the most cost-effective policies for controlling the global obesity pandemic. Front-of-pack (FOP) nutrition labelling is one of the strategies that has been suggested to encourage the food industry to reformulate their products. However, the extent to which certain FOP labels can encourage product reformulation is dependent on consumer reaction. The aim of the present work was to assess consumers' perception towards product reformulation in the context of the implementation of nutritional warnings, an interpretive FOP nutrition labelling scheme. Three product categories were selected as target products: bread, cream cheese and yogurt, each associated with high content of one target nutrient. For each category, six packages were designed using a 3 × 2 experimental design with the following variables: product version (regular, nutrient-reduced and nutrient-free) and brand (market leader and non-market leader). A total 306 Uruguayan participants completed a choice experiment with 18 choice sets. Reformulated products without nutritional warnings were preferred by participants compared to regular products with nutritional warnings. No apparent preference for products reformulated into nutrient-reduced or nutrient-free product versions was found, although differences depended on the product category and the specific reformulation strategy. Preference for reformulated products without nutritional warnings was more pronounced for non-market leaders. Results from the present work suggest that reformulation of foods in the context of the implementation of nutritional warnings holds potential to encourage consumers to make more healthful food choices and to cause a reduction of their intake of nutrients associated with non-communicable diseases. Copyright © 2018 Elsevier Ltd. All rights reserved.

Smoking - Medicines to Help You Quit

MedlinePlus

... Consumers Consumer Information by Audience For Women Smoking - Medicines To Help You Quit Share Tweet Linkedin Pin ... name of your product at: Drugs@FDA. Other Medicines to Help You Quit Some prescription medicines have ...

Is the E-Liquid Industry Regulating Itself? A Look at E-Liquid Internet Vendors in the United States

PubMed Central

Timberlake, David S.; Williams, Rebecca S.

2016-01-01

Abstract Introduction: The objective of this study was to assess whether the nascent, but rapidly growing e-liquid industry prohibits Internet sales to minors and employs safety measures to prevent accidental poisonings. Methods: A stratified simple random sample (n = 120) was selected from the target population (N = 1107) of US online vendors of e-liquid in July 2015. The vendors were stratified and subsequently oversampled by trade association membership and vendor popularity. Three minors aged 16 to 17, who were supervised by adult research staff, attempted to purchase e-liquid from the 120 online vendors using debit cards issued in their names. Measures included vendors’ use of age verification, warning labels on e-liquid bottles, and child-resistant packaging. Results: Statistically significant differences were observed by vendor popularity, but not by membership in a trade association. The differences by vendor popularity, however, occurred for measures that were limited to an age warning and list of ingredients. The most striking finding was the scant vendors (n = 4) who successfully prevented the sale of e-liquid to the minors. In contrast, 87.5% and 53.9% of the bottles contained child-resistant packaging and a health warning label, respectively. Conclusions: Irrespective of trade association membership or vendor popularity, online vendors of e-liquids are not taking the proper precautions in preventing sales to minors. The FDA’s upcoming deeming rules on e-cigarette products should include explicit requirements for offline and online e-liquid vendors, particularly the use of effective age verification, warning labels, and child-resistant packaging. Implications: This study demonstrates that, in the absence of any current FDA regulation of e-liquid products, self-regulation among vendors is not effective in preventing product acquisition by minors. Lax oversight of the e-liquid industry may draw consumers to bypass current tobacco control restrictions implemented in face-to-face sales settings. As a consequence, there may be an increase in online sales to minors. Further regulation of the industry may increase the already prevalent use of child-resistant packaging, leading to fewer cases of accidental nicotine poisoning. PMID:26995792

Testing consumer perception of nutrient content claims using conjoint analysis.

PubMed

Drewnowski, Adam; Moskowitz, Howard; Reisner, Michele; Krieger, Bert

2010-05-01

The US Food and Drug Administration (FDA) proposes to establish standardized and mandatory criteria upon which front-of-pack (FOP) nutrition labelling must be based. The present study aimed to estimate the relative contribution of declared amounts of different nutrients to the perception of the overall 'healthfulness' of foods by the consumer. Protein, fibre, vitamin A, vitamin C, calcium and iron were nutrients to encourage. Total fat, saturated fat, cholesterol, total and added sugar, and sodium were the nutrients to limit. Two content claims per nutrient used the FDA-approved language. An online consumer panel (n 320) exposed to multiple messages (n 48) rated the healthfulness of each hypothetical food product. Utility functions were constructed using conjoint analysis, based on multiple logistic regression and maximum likelihood estimation. Consumer perception of healthfulness was most strongly driven by the declared presence of protein, fibre, calcium and vitamin C and by the declared total absence of saturated fat and sodium. For this adult panel, total and added sugar had lower utilities and contributed less to the perception of healthfulness. There were major differences between women and men. Conjoint analysis can lead to a better understanding of how consumers process information about the full nutrition profile of a product, and is a powerful tool for the testing of nutrient content claims. Such studies can help the FDA develop science-based criteria for nutrient profiling that underlies FOP and shelf labelling.

Effect of Warning Placement on the Information Processing of College Students Reading an OTC Drug Facts Panel

ERIC Educational Resources Information Center

Bhansali, Archita H.; Sangani, Darshan S.; Mhatre, Shivani K.; Sansgiry, Sujit S.

2018-01-01

Objective: To compare three over-the-counter (OTC) Drug Facts panel versions for information processing optimization among college students.Participants: University of Houston students (N = 210) participated in a cross-sectional survey from January to May 2010.Methods: A current FDA label was compared to two experimental labels developed using the…

Metric Measures and the Consumer. Reprint from FDA CONSUMER, Dec. 1975-Jan. 1976.

ERIC Educational Resources Information Center

Food and Drug Administration (DHEW), Washington, DC.

Advantages of the metric system for the consumer are discussed. Basic metric units are described, then methods of comparison shopping when items are marked in metric units are explained. The effect of the change to the metric system on packaging and labelling requirements is discussed. (DT)

Update on medical and regulatory issues pertaining to compounded and FDA-approved drugs, including hormone therapy

PubMed Central

Pinkerton, JoAnn V.; Pickar, James H.

2016-01-01

Abstract Objective: We review the historical regulation of drug compounding, concerns about widespread use of non-Food and Drug Admiistration (FDA)-approved compounded bioidentical hormone therapies (CBHTs), which do not have proper labeling and warnings, and anticipated impact of the 2013 Drug Quality and Security Act (DQSA) on compounding. Methods: US government websites were searched for documents concerning drug compounding regulation and oversight from 1938 (passage of Federal Food, Drug, and Cosmetic Act [FDCA]) through 2014, including chronologies, Congressional testimony, FDA guidelines and enforcements, and reports. The FDCA and DQSA were reviewed. PubMed and Google were searched for articles on compounded drugs, including CBHT. Results: Congress explicitly granted the FDA limited oversight of compounded drugs in a 1997 amendment to the FDCA, but the FDA has encountered obstacles in exercising that authority. After 64 patient deaths and 750 adversely affected patients from the 2012 meningitis outbreak due to contaminated compounded steroid injections, Congress passed the DQSA, authorizing the FDA to create a voluntary registration for facilities that manufacture and distribute sterile compounded drugs in bulk and reinforcing FDCA regulations for traditional compounding. Given history and current environment, concerns remain about CBHT product regulation and their lack of safety and efficacy data. Conclusions: The DQSA and its reinforcement of §503A of the FDCA solidifies FDA authority to enforce FDCA provisions against compounders of CBHT. The new law may improve compliance and accreditation by the compounding industry; support state and FDA oversight; and prevent the distribution of misbranded, adulterated, or inconsistently compounded medications, and false and misleading claims, thus reducing public health risk. PMID:26418479

Stimulated reporting: the impact of US food and drug administration-issued alerts on the adverse event reporting system (FAERS).

PubMed

Hoffman, Keith B; Demakas, Andrea R; Dimbil, Mo; Tatonetti, Nicholas P; Erdman, Colin B

2014-11-01

The US Food and Drug Administration (FDA) uses the Adverse Event Reporting System (FAERS) to support post-marketing safety surveillance programs. Currently, almost one million case reports are submitted to FAERS each year, making it a vast repository of drug safety information. Sometimes cited as a limitation of FAERS, however, is the assumption that "stimulated reporting" of adverse events (AEs) occurs in response to warnings, alerts, and label changes that are issued by the FDA. To determine the extent of "stimulated reporting" in the modern-day FAERS database. One hundred drugs approved by the FDA between 2001 and 2010 were included in this analysis. FDA alerts were obtained by a comprehensive search of the FDA's MedWatch and main websites. Publicly available FAERS data were used to assess the "primary suspect" AE reporting pattern for up to four quarters before, and after, the issuance of an FDA alert. A few drugs did demonstrate "stimulated reporting" trends. A majority of the drugs, however, showed little evidence for significant reporting changes associated with the issuance of alerts. When we compared the percentage changes in reporting after an FDA alert with those after a sham "control alert", the overall reporting trends appeared to be quite similar. Of 100 drugs analyzed for short-term reporting trends, 21 real alerts and 25 sham alerts demonstrated an increase (greater than or equal to 1 %) in reporting. The long-term analysis of 91 drugs showed that 24 real alerts and 28 sham alerts demonstrated a greater than or equal to 1 % increase. Our results suggest that most of modern day FAERS reporting is not significantly affected by the issuance of FDA alerts.

77 FR 57092 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-17

... to FDA's decision not to authorize four dietary supplement health claims that failed to meet the SSA... study is to collect quantitative data to examine consumer interpretations of two dietary supplement... Conventional Human Foods and Human Dietary Supplements,'' 2003, available at http://www.fda.gov/Food/Guidance...

HEALTH AND DIET SURVEY (HDS)

EPA Science Inventory

The FDA conducts this periodic omnibus survey of American consumers to track consumer attitudes, knowledge, and reported behaviors related to diet and health issues including cholesterol awareness of diet-disease risk factors, food label use, dietary supplement use, and awarenes...

Reactions to FDA-Proposed Graphic Warning Labels Affixed to U.S. Smokers' Cigarette Packs.

PubMed

McQueen, Amy; Kreuter, Matthew W; Boyum, Sonia; Thompson, Vetta S; Caburnay, Charlene A; Waters, Erika A; Kaphingst, Kimberly A; Rath, Suchitra; Fu, Qiang

2015-07-01

Graphic warning labels have been shown to be more effective than text-only labels in increasing attention and perceived health risks, but most U.S. studies have involved single exposures in laboratory or Internet settings. We recruited a convenience sample (N = 202) of U.S. adult smokers from population subgroups with higher rates of smoking and smoking-related deaths who had participated in a larger survey about graphic warning labels. Participants were randomized to get 1 of 9 graphic + text labels or a text-only label. Research staff affixed a warning label sticker to participants' cigarette pack(s) at enrollment. Color graphic labels covered slightly more than the lower half of packs. Black and white labels of current U.S. text-only warnings covered the existing side warning to prompt attention to the label (i.e., attention control). Participants received extra stickers of the same label for subsequent packs, and completed 3 telephone interviews in 1 week. Participants reported low avoidance (<34%) and consistent use of the stickers (91%). Smokers consistently paid more attention to graphic than text-only labels. Only 5 of the 9 graphic warning labels were significantly associated with greater thoughts of health risks. Thinking about quitting and stopping smoking did not differ by label. Qualitative data illustrated differences in the "stickiness," self-referencing, and counterarguments of graphic warning labels. U.S. smokers' reactions to graphic warning labels on their own packs were similar to other, more controlled studies. Qualitative findings underscore the need for warning labels that encourage self-referential processing without increasing defensive reactions. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Reactions to FDA-Proposed Graphic Warning Labels Affixed to U.S. Smokers’ Cigarette Packs

PubMed Central

Kreuter, Matthew W.; Boyum, Sonia; Thompson, Vetta S.; Caburnay, Charlene A.; Waters, Erika A.; Kaphingst, Kimberly A.; Rath, Suchitra; Fu, Qiang

2015-01-01

Introduction: Graphic warning labels have been shown to be more effective than text-only labels in increasing attention and perceived health risks, but most U.S. studies have involved single exposures in laboratory or Internet settings. Methods: We recruited a convenience sample (N = 202) of U.S. adult smokers from population subgroups with higher rates of smoking and smoking-related deaths who had participated in a larger survey about graphic warning labels. Participants were randomized to get 1 of 9 graphic + text labels or a text-only label. Research staff affixed a warning label sticker to participants’ cigarette pack(s) at enrollment. Color graphic labels covered slightly more than the lower half of packs. Black and white labels of current U.S. text-only warnings covered the existing side warning to prompt attention to the label (i.e., attention control). Participants received extra stickers of the same label for subsequent packs, and completed 3 telephone interviews in 1 week. Results: Participants reported low avoidance (<34%) and consistent use of the stickers (91%). Smokers consistently paid more attention to graphic than text-only labels. Only 5 of the 9 graphic warning labels were significantly associated with greater thoughts of health risks. Thinking about quitting and stopping smoking did not differ by label. Qualitative data illustrated differences in the “stickiness,” self-referencing, and counterarguments of graphic warning labels. Conclusions: U.S. smokers’ reactions to graphic warning labels on their own packs were similar to other, more controlled studies. Qualitative findings underscore the need for warning labels that encourage self-referential processing without increasing defensive reactions. PMID:25589676

77 FR 4273 - Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-27

...The Food and Drug Administration (FDA) is reopening the comment period on specific data related to a proposed rule published in the Federal Register of March 29, 2010 (75 FR 15376), to establish standards that would be considered in determining whether the major statement in direct-to-consumer (DTC) television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans is presented in a clear, conspicuous, and neutral manner. FDA is announcing that it has added a document to the docket for the proposed rulemaking concerning a study entitled: ``Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to- Consumer Prescription Drug Television Advertisements'' (Distraction Study). This study was designed to investigate some advertising factors that could influence consumers' understanding of a drug's risks. This document reopens the comment period for the rulemaking proceeding to allow an opportunity for comment on the study as it relates to the proposed standards.

76 FR 22019 - Safety Standard for Toddler Beds

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-20

... warnings should increase consumers' understanding of the connection between the relevant behaviors and... CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1217 RIN 3041-AC79 Safety Standard for Toddler Beds AGENCY: Consumer Product Safety Commission. ACTION: Final rule. SUMMARY: The Consumer Product Safety...

FDA-Required Tobacco Product Inserts & Onserts–and the First Amendment.

PubMed

Lindblom, Eric N; Berman, Micah L; Thrasher, James F

In 2012, a federal court of appeals struck down an FDA rule requiring graphic health warnings on cigarettes as violating First Amendment commercial speech protections. Tobacco product inserts and onserts can more readily avoid First Amendment constraints while delivering more extensive information to tobacco users, and can work effectively to support and encourage smoking cessation. This paper examines FDA’s authority to require effective inserts and onserts and shows how FDA could design and support them to avoid First Amendment problems. Through this process, the paper offers helpful insights regarding how key Tobacco Control Act provisions can and should be interpreted and applied to follow and promote the statute’s purposes and objectives. The paper’s rigorous analysis of existing First Amendment case law relating to compelled commercial speech also provides useful guidance for any government efforts either to compel product disclosures or to require government messaging in or on commercial products or their advertising, whether done for remedial, purely informational, or behavior modification purposes.

The complications of controlling agency time discretion: FDA review deadlines and postmarket drug safety.

PubMed

Carpenter, Daniel; Chattopadhyay, Jacqueline; Moffitt, Susan; Nall, Clayton

2012-01-01

Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the quality of agency decisions. We examine whether administrative deadlines shape decision timing and the observed quality of decisions. Using a unique and rich dataset of FDA drug approvals that allows us to examine decision timing and quality, we find that this administrative tool induces a piling of decisions before deadlines, and that these “just-before-deadline” approvals are linked with higher rates of postmarket safety problems (market withdrawals, severe safety warnings, safety alerts). Examination of data from FDA advisory committees suggests that the deadlines may impede quality by impairing late-stage deliberation and agency risk communication. Our results both support and challenge reigning theories about administrative procedures, suggesting they embody expected control-expertise trade-offs, but may also create unanticipated constituency losses.

Differences in the Language and Design of Four PPIs for Valium. Technical Assistance Report No. 1.

ERIC Educational Resources Information Center

Redish, Janice C.

As part of the evaluation of four different versions of a patient package insert (PPI) for diazepam (Valium) created by the Food and Drug Administration (FDA), the content, organization, language, and design of the PPIs were compared. One PPI was a short prose piece with clear organization that did not particularly highlight warnings or, indeed,…

Sugar-Sweetened Beverage Warning Labels: Lessons Learned From the Tobacco Industry

PubMed Central

Popova, Lucy

2016-01-01

Tobacco warning labels effectively educate consumers about the harms of tobacco and reduce smoking behavior. Lessons from tobacco warning labels can be applied to developing and implementing warning labels for sugar-sweetened beverages (SSBs). Large pictorial rotating warnings are particularly effective. Dental professionals can be an important voice in countering the industry’s efforts to create controversy around the effects of SSBs and in advocating for effective warning labels based on the evidence from the tobacco warning labels. Sugar, rum and tobacco are commodities which are nowhere necessaries of life, which are become objects of almost universal consumption and which are therefore extremely proper subjects of taxation.1 PMID:28190943

76 FR 62810 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-11

... partnership between FDA and the University of Maryland. The CRCR will design and administer the study. FDA is... in the article. To help design and refine the questionnaire, we will recruit 25 participants in order...-four participants (20 consumers, 2 growers, 2 retailers) will complete the pretest. Each pretest will...

78 FR 71621 - Agency Information Collection Activities; Proposed Collection; Comment Request; Eye Tracking...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-29

... notice. This notice solicits comments on research entitled, ``Eye Tracking Study of Direct-to-Consumer... the FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(2)(c)) authorizes FDA to conduct research...

78 FR 8446 - Center for Drug Evaluation and Research; Prescription Drug Labeling Improvement and Enhancement...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-06

... products. \\5\\ Ibid. \\6\\ See http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 201, 314, and 601 [Docket No. FDA-2013-N-0059] Center for Drug Evaluation and Research; Prescription Drug Labeling...

Believability of Cigar Warning Labels among Adolescents

PubMed Central

Kowitt, Sarah D.; Jarman, Kristen; Ranney, Leah M.; Goldstein, Adam O.

2016-01-01

Purpose Despite high rates of cigar use among youth, little information exists about how cigar warnings are received by youth. We examined believability of different cigar warning messages with different sources among adolescents in a national phone survey. Methods Adolescents (age 13-17) in the US (N = 1,125; total response rate, 66%) were randomized to receive one of three health messages (“cigar smoking can cause cancers of the mouth and throat, even if you do not inhale”, “cigar smoking can cause lung cancer and heart disease”, “cigars are not a safe alternative to cigarettes”) and one of four warning sources (FDA, Surgeon General, CDC, no source). Believability was assessed with “how believable is this warning” and responses were dichotomized for “not at all or somewhat” vs. “very”. Results Weighted logistic regression results indicated that most youth found the cigar warnings very believable (60.5%). Messages about mouth and throat cancer (regardless of inhalation) and the safety of cigars in comparison to cigarettes were rated as significantly less believable than messages about lung cancer and heart disease related to cigars. There were no significant differences by source or other demographics. However, youth susceptible to using cigarettes were less likely to report the cigar warnings to be very believable. Conclusions The messages of cigar warning labels are not viewed as equally believable among adolescents. Future studies should examine how youth process messages about health effects of cigars and the impact of different cigar warnings on youth experimentation with and use of cigars. PMID:27965023

Appetitive drives for ultra-processed food products and the ability of text warnings to counteract consumption predispositions.

PubMed

David, Isabel A; Krutman, Laura; Fernández-Santaella, María Carmen; Andrade, Jéssica R; Andrade, Eduardo B; Oliveira, Leticia; Pereira, Mirtes G; Gomes, Fabio S; Gleiser, Sonia; Oliveira, José M; Araújo, Renata L; Volchan, Eliane; Braga, Filipe

2018-02-01

The present study aimed to (i) assess the appetitive drives evoked by the visual cues of ultra-processed food and drink products and (ii) investigate whether text warnings reduce appetitive drives and consumers' reported intentions to eat or drink ultra-processed products. In Study I, a well-established psychometric tool was applied to estimate the appetitive drives associated with ultra-processed products using sixty-four image representations. Sixteen product types with four exemplars of a given product were included. Pictures from the International Affective Picture System (IAPS) served as controls. The two exemplars of each product type rated as more appetitive were selected for investigation in the second study. Study II assessed the impact of textual warnings on the appetitive drive towards these thirty-two exemplars. Each participant was exposed to two picture exemplars of the same product type preceded by a text warning or a control text. After viewing each displayed picture, the participants reported their emotional reactions and their intention to consume the product. Controlled classroom experiments SUBJECTS: Undergraduate students (Study I: n 215, 135 women; Study II: n 98, 52 women). In Study I, the pictures of ultra-processed products prompted an appetitive motivation associated with the products' nutritional content. In Study II, text warnings were effective in reducing the intention to consume and the appetitive drive evoked by ultra-processed products. This research provides initial evidence favouring the use of text warnings as a public policy tool to curb the powerful influence of highly appetitive ultra-processed food cues.

Consumer advertising of psychiatric medications biases the public against nonpharmacological treatment.

PubMed

Lacasse, Jeffrey R

2005-01-01

In the United States, antidepressant medications are heavily promoted through direct-to-consumer advertising, which is regulated by the Food and Drug Administration (FDA). Advertisements for selective serotonin reuptake inhibitors frequently contain information inconsistent with the scientific evidence on the treatment of depression with antidepressants. The information presented serves to promote the use of antidepressants by biasing the public against nonpharmacological treatment of depression. While the FDA enforces regulations requiring fair and balanced presentation when comparing one medication to another, there appears to be no action taken against pharmaceutical companies that distort scientific evidence in order to disparage nonmedical approaches to depression.

Geographic Variation in Rosiglitazone Use Surrounding FDA Warnings in the Department of Veterans Affairs.

PubMed

Ahuja, Vishal; Sohn, Min-Woong; Birge, John R; Syverson, Chad; Budiman-Mak, Elly; Emanuele, Nicholas; Cooper, Jennifer M; Huang, Elbert S

2015-12-01

Geographic variation in the use of prescription drugs, particularly those deemed harmful by the FDA, may lead to variation in patient exposure to adverse drug events. One such drug is the glucose-lowering drug rosiglitazone, for which the FDA issued a safety alert on May 21, 2007, following the publication of a meta-analysis that suggested a 43% increase in the risk of myocardial infarction with the use of rosiglitazone. This alert was followed by a black box warning on August 14, 2007, that was updated 3 months later. While large declines have been documented in rosiglitazone use in clinical practice, little is known about how the use of rosiglitazone and other glucose-lowering drugs varied within the Department of Veterans Affairs (VA), surrounding the FDA alerts. Understanding this variation within integrated health care systems is essential to formulating policies that enhance patient protection and quality of care. To document variation in the use of rosiglitazone and other glucose- lowering drugs across 21 Veterans Integrated Service Networks (VISNs). We conducted a retrospective analysis of drug use patterns for all major diabetes drugs in a national cohort of 550,550 veterans with diabetes from 2003 to 2008. This included the time periods when rosiglitazone was added to (November 2003) and removed from (October 2007) the VA national formulary (VANF). We employed multivariable logistic regression models to statistically estimate the association between a patient's location and the patient's odds of using rosiglitazone. Aggregate rosiglitazone use increased monotonically from 7.7%, in the quarter it was added to the VANF (November 4, 2003), to a peak of 15.3% in the quarter when the FDA issued the safety alert. Rosiglitazone use decreased sharply afterwards, reaching 3.4% by the end of the study period (September 30, 2008). The use of pioglitazone, another glucose-lowering drug in the same class as rosiglitazone, was low when the FDA issued the safety alert (0.4%) but increased sharply afterwards, reaching 3.6% by the end of the study period. Insulin use increased monotonically; metformin use remained relatively flat; and sulfonylurea use exhibited a general declining trend throughout the study period. Statistically significant geographic variation was observed in rosiglitazone use throughout the study period. The prevalence range, defined as the range of minimum to maximum use across VISNs was 3.7%-12.4% in the first quarter (January 1 to March 31, 2003); 1.0%-5.5% in the last quarter of study period (July 1 to September 30, 2008); and reached a peak of 9.6%-25.5% in the quarter when the FDA safety alert was issued (April 1 to March 31, 2007). In 5 VISNs, peak rosiglitazone use occurred before the FDA issued the safety alert. The odds ratio of using rosiglitazone in a given VISN varied from 0.55 (95% CI = 0.52-0.59; VISN 10) to 1.58 (95% CI = 1.50-1.66; VISN 15), with VISN 1 being the reference region. The variation was higher in the periods after the FDA issued the safety alert. Much less variation was observed in the use of pioglitazone, metformin, sulfonylurea, and insulin. Our results show statistically significant variation in the way VISNs within the VA responded to the FDA alerts, suggesting a need for mechanisms that disseminate information and guidelines for drug use in a consistent and reliable manner. Further study of regions that adopted ideal practices earlier may provide lessons for regional leadership and practice culture within integrated health care systems.

Crowd-Sourced Global Earthquake Early Warning

NASA Astrophysics Data System (ADS)

Minson, S. E.; Brooks, B. A.; Glennie, C. L.; Murray, J. R.; Langbein, J. O.; Owen, S. E.; Iannucci, B. A.; Hauser, D. L.

2014-12-01

Although earthquake early warning (EEW) has shown great promise for reducing loss of life and property, it has only been implemented in a few regions due, in part, to the prohibitive cost of building the required dense seismic and geodetic networks. However, many cars and consumer smartphones, tablets, laptops, and similar devices contain low-cost versions of the same sensors used for earthquake monitoring. If a workable EEW system could be implemented based on either crowd-sourced observations from consumer devices or very inexpensive networks of instruments built from consumer-quality sensors, EEW coverage could potentially be expanded worldwide. Controlled tests of several accelerometers and global navigation satellite system (GNSS) receivers typically found in consumer devices show that, while they are significantly noisier than scientific-grade instruments, they are still accurate enough to capture displacements from moderate and large magnitude earthquakes. The accuracy of these sensors varies greatly depending on the type of data collected. Raw coarse acquisition (C/A) code GPS data are relatively noisy. These observations have a surface displacement detection threshold approaching ~1 m and would thus only be useful in large Mw 8+ earthquakes. However, incorporating either satellite-based differential corrections or using a Kalman filter to combine the raw GNSS data with low-cost acceleration data (such as from a smartphone) decreases the noise dramatically. These approaches allow detection thresholds as low as 5 cm, potentially enabling accurate warnings for earthquakes as small as Mw 6.5. Simulated performance tests show that, with data contributed from only a very small fraction of the population, a crowd-sourced EEW system would be capable of warning San Francisco and San Jose of a Mw 7 rupture on California's Hayward fault and could have accurately issued both earthquake and tsunami warnings for the 2011 Mw 9 Tohoku-oki, Japan earthquake.

Marketing nutrition & health-related benefits of food & beverage products: enforcement, litigation & liability issues.

PubMed

Roller, Sarah; Pippins, Raqiyyah

2010-01-01

Over the past decade, the liability risks associated with food and beverage product marketing have increased significantly, particularly with respect to nutrition and health-related product benefit claims. FDA and FTC enforcement priorities appear to have contributed to the increasing liability trends that are associated with these nutrition and health-related claims. This article examines key enforcement and litigation developments involving conventional food and beverage product marketing claims during the first 18 months of President Obama's administration: Part I considers FDA enforcement priorities and recent warning letters; Part II considers FTC enforcement priorities, warning letters, and consent orders; and Part III considers the relationship between FDA and FTC enforcement priorities and recent false advertising cases brought by private parties challenging nutrition and health-related marketing claims for food and beverage products. The article makes recommendations concerning ways in which food and beverage companies can help minimize liability risks associated with health-related marketing claims. In addition, the article suggests that federal policy reforms may be required to counter the perverse chilling effects current food liability trends appear to be having on health-related marketing claims for food and beverage products, and proposes a number of specific reforms that would help encourage the responsible use of well-substantiated marketing claims that can help foster healthy dietary practices. In view of the obesity prevention and other diet-related public health priorities of the Obama administration, the article suggests that this is an opportune time to address the apparent chilling effects increasing food liability risks are having on nutrition and health-related marketing claims for healthy food and beverage products, and potential adverse consequences for public health.

What is prescription labeling communicating to doctors about hepatotoxic drugs? A study of FDA approved product labeling.

PubMed

Willy, Mary E; Li, Zili

2004-04-01

The objective of this study was to evaluate the informativeness and consistency of product labeling of hepatotoxic drugs marketed in the United States. We searched the Physicians' Desk Reference-2000 for prescription drugs with hepatic failure and/or hepatic necrosis listed in the labeling. We used a six-item checklist to evaluate the 'informativeness' and consistency of the labeling content. An informativeness score equaled the proportion of checklist items present in each drug's labeling. Ninety-five prescription drugs were included in the study. Eleven (12%) of the drugs had information related to hepatic failure in a Black Boxed Warning, 52 (54%) in the Warnings section and 32 (34%) in the Adverse Reactions section of the label. The mean informativeness score was 35%; the score was significantly higher, 61%, when the risk was perceived to be high. The informativeness of labeling was not affected by the time of the labeling, but differed across the Center for Drug Evaluation and Research (CDER) Review Division responsible for the labeling. The information provided in labeling is variable and affected by many factors, including the perceived level of risk and review division strategy. Product labeling may benefit from current FDA initiatives to improve the consistency of risk-related labeling.

Antiepileptic drugs and suicidality

PubMed Central

Britton, Jeffery W; Shih, Jerry J

2010-01-01

The risk of suicide in patients with epilepsy is significantly higher than the general population. There are many hypotheses as to the reasons for this, but the potential role of anti-epileptic drugs (AEDs) in increasing suicidality has recently been brought into question. In 2008, the U.S. Food and Drug Administration (FDA) published a warning after a meta-analysis of data from all clinical trials involving AEDs found a suicidality risk of 0.43 per 1000 patients in active drug arms of these clinical trials compared to a rate in the placebo arm of 0.22. While an increased risk for individual AEDs was found in two, the FDA decided to issue a warning for the entire AED class. While this decision and the meta-analysis findings have been considered controversial, and have created concern that this stated risk may dissuade use of AEDs by patients who would benefit from them, it has led to increased awareness of the risk of suicidality and psychiatric co-morbidity in this patient group. In this article, the association of epilepsy and AEDs with psychiatric disease and suicidality are reviewed, perspective as to the significance and limitations of the FDA’s findings are discussed, and some options for suicidality screening and their potential utility in clinical care are evaluated. PMID:21701630

Operational early warning platform for extreme meteorological events

NASA Astrophysics Data System (ADS)

Mühr, Bernhard; Kunz, Michael

2015-04-01

Operational early warning platform for extreme meteorological events Most natural disasters are related to extreme weather events (e.g. typhoons); weather conditions, however, are also highly relevant for humanitarian and disaster relief operations during and after other natural disaster like earthquakes. The internet service "Wettergefahren-Frühwarnung" (WF) provides various information on extreme weather events, especially when these events are associated with a high potential for large damage. The main focus of the platform is on Central Europe, but major events are also monitored worldwide on a daily routine. WF provides high-resolution forecast maps for many weather parameters which allow detailed and reliable predictions about weather conditions during the next days in the affected areas. The WF service became operational in February 2004 and is part of the Center for Disaster Management and Risk Reduction Technology (CEDIM) since 2007. At the end of 2011, CEDIM embarked a new type of interdisciplinary disaster research termed as forensic disaster analysis (FDA) in near real time. In case of an imminent extreme weather event WF plays an important role in CEDIM's FDA group. It provides early and precise information which are always available and updated several times during a day and gives advice and assists with articles and reports on extreme events.

Health care providers and direct-to-consumer access and advertising of genetic testing in the United States

PubMed Central

2011-01-01

Marketing pressures, regulatory policies, clinical guidelines, and consumer demand all affect health care providers' knowledge and use of health-related genetic tests that are sold and/or advertised to consumers. In addition, clinical guidelines, regulatory policies, and educational efforts are needed to promote the informed use of genetic tests that are sold and advertised to consumers and health care providers. A shift in culture regarding the regulation of genetic tests that are sold directly to consumers is suggested: by recent actions taken by the US Food and Drug Administration (FDA), including letters sent to direct-to-consumer (DTC) genetic testing companies stating that their tests meet the definition of medical devices; by public meetings held by the FDA to discuss laboratory developed tests; and by the convening of the Molecular and Clinical Genetics Panel to gather input on scientific issues concerning DTC genetic tests that make medical claims. This review provides a brief overview of DTC advertising and the regulation of pharmaceuticals and genetic tests in the United States. It highlights recent changes in the regulatory culture regarding genetic tests that are sold to consumers, and discusses the impact on health care providers of selling and advertising genetic tests directly to consumers. PMID:22204616

Health care providers and direct-to-consumer access and advertising of genetic testing in the United States.

PubMed

Myers, Melanie F

2011-12-28

Marketing pressures, regulatory policies, clinical guidelines, and consumer demand all affect health care providers' knowledge and use of health-related genetic tests that are sold and/or advertised to consumers. In addition, clinical guidelines, regulatory policies, and educational efforts are needed to promote the informed use of genetic tests that are sold and advertised to consumers and health care providers. A shift in culture regarding the regulation of genetic tests that are sold directly to consumers is suggested: by recent actions taken by the US Food and Drug Administration (FDA), including letters sent to direct-to-consumer (DTC) genetic testing companies stating that their tests meet the definition of medical devices; by public meetings held by the FDA to discuss laboratory developed tests; and by the convening of the Molecular and Clinical Genetics Panel to gather input on scientific issues concerning DTC genetic tests that make medical claims. This review provides a brief overview of DTC advertising and the regulation of pharmaceuticals and genetic tests in the United States. It highlights recent changes in the regulatory culture regarding genetic tests that are sold to consumers, and discusses the impact on health care providers of selling and advertising genetic tests directly to consumers.

Hypnotic Medications and Suicide: Risk, Mechanisms, Mitigation, and the FDA.

PubMed

McCall, W Vaughn; Benca, Ruth M; Rosenquist, Peter B; Riley, Mary Anne; McCloud, Laryssa; Newman, Jill C; Case, Doug; Rumble, Meredith; Krystal, Andrew D

2017-01-01

Insomnia is associated with increased risk for suicide. The Food and Drug Administration (FDA) has mandated that warnings regarding suicide be included in the prescribing information for hypnotic medications. The authors conducted a review of the evidence for and against the claim that hypnotics increase the risk of suicide. This review focused on modern, FDA-approved hypnotics, beginning with the introduction of benzodiazepines, limiting its findings to adults. PubMed and Web of Science were searched, crossing the terms "suicide" and "suicidal" with each of the modern FDA-approved hypnotics. The FDA web site was searched for postmarketing safety reviews, and the FDA was contacted with requests to provide detailed case reports for hypnotic-related suicide deaths reported through its Adverse Event Reporting System. Epidemiological studies show that hypnotics are associated with an increased risk for suicide. However, none of these studies adequately controlled for depression or other psychiatric disorders that may be linked with insomnia. Suicide deaths have been reported from single-agent hypnotic overdoses. A separate concern is that benzodiazepine receptor agonist hypnotics can cause parasomnias, which in rare cases may lead to suicidal ideation or suicidal behavior in persons who were not known to be suicidal. On the other hand, ongoing research is testing whether treatment of insomnia may reduce suicidality in adults with depression. The review findings indicate that hypnotic medications are associated with suicidal ideation. Future studies should be designed to assess whether increases in suicidality result from CNS impairments from a given hypnotic medication or whether such medication decreases suicidality because of improvements in insomnia.

Hypnotic medications and suicide: risk, mechanisms, mitigation, and the FDA

PubMed Central

McCall, W. Vaughn; Benca, Ruth M.; Rosenquist, Peter B.; Riley, Mary Anne; McCloud, Laryssa; Newman, Jill C.; Case, Doug; Rumble, Meredith; Krystal, Andrew D.

2016-01-01

Objective Insomnia is associated with increased risk for suicide. The Food and Drug Administration (FDA) has warnings regarding suicide in the prescribing information of hypnotics. We conducted a review of the evidence for and against hypnotics increasing the risk of suicide. Method This review focused on modern, FDA-approved hypnotics, beginning with the introduction of benzodiazepines, limiting its findings to adults. PubMed and Web of Science were searched, crossing the terms ‘suicide’ and ‘suicidal’ with each of the modern FDA-approved hypnotics. The FDA website was searched for post-marketing safety reviews, and the FDA was contacted to provide detailed case reports for hypnotic-related suicide deaths reported through its Adverse Event Report system. Results The epidemiological studies show that hypnotics are associated with increased risk for suicide. However, none of these studies adequately controlled for depression or other psychiatric disorders that may be linked with insomnia. Suicide deaths have been reported from single-agent hypnotic overdoses. A separate concern is that benzodiazepine receptor agonist hypnotics can cause parasomnias, which in rare cases may lead to suicidal ideation or suicidal behavior in persons who were not known to be previously suicidal. On the other hand, ongoing research is testing whether treatment of insomnia might reduce suicidality in depressed adults. Conclusions This review indicates hypnotic medications are associated with suicidal ideation. Future studies should be designed to assess both types of possible effects: 1) an increase in suicidality due to central nervous system impairments from a given hypnotic medication; and 2) a decrease in suicidality due to improving insomnia. PMID:27609243

Era of faster FDA drug approval has also seen increased black-box warnings and market withdrawals.

PubMed

Frank, Cassie; Himmelstein, David U; Woolhandler, Steffie; Bor, David H; Wolfe, Sidney M; Heymann, Orlaith; Zallman, Leah; Lasser, Karen E

2014-08-01

After approval, many prescription medications that patients rely on subsequently receive new black-box warnings or are withdrawn from the market because of safety concerns. We examined whether the frequency of these safety problems has increased since 1992, when the Prescription Drug User Fee Act, legislation designed to accelerate the drug approval process at the Food and Drug Administration, was passed. We found that drugs approved after the act's passage were more likely to receive a new black-box warning or be withdrawn than drugs approved before its passage (26.7 per 100.0 drugs versus 21.2 per 100.0 drugs at up to sixteen years of follow-up). We could not establish causality, however. Our findings suggest the need for reforms to reduce patients' exposure to unsafe drugs, such as a statement or symbol in the labeling, medication guides for patients, and marketing materials indicating that a drug was approved only recently. Project HOPE—The People-to-People Health Foundation, Inc.

OpenFDA: an innovative platform providing access to a wealth of FDA's publicly available data.

PubMed

Kass-Hout, Taha A; Xu, Zhiheng; Mohebbi, Matthew; Nelsen, Hans; Baker, Adam; Levine, Jonathan; Johanson, Elaine; Bright, Roselie A

2016-05-01

The objective of openFDA is to facilitate access and use of big important Food and Drug Administration public datasets by developers, researchers, and the public through harmonization of data across disparate FDA datasets provided via application programming interfaces (APIs). Using cutting-edge technologies deployed on FDA's new public cloud computing infrastructure, openFDA provides open data for easier, faster (over 300 requests per second per process), and better access to FDA datasets; open source code and documentation shared on GitHub for open community contributions of examples, apps and ideas; and infrastructure that can be adopted for other public health big data challenges. Since its launch on June 2, 2014, openFDA has developed four APIs for drug and device adverse events, recall information for all FDA-regulated products, and drug labeling. There have been more than 20 million API calls (more than half from outside the United States), 6000 registered users, 20,000 connected Internet Protocol addresses, and dozens of new software (mobile or web) apps developed. A case study demonstrates a use of openFDA data to understand an apparent association of a drug with an adverse event. With easier and faster access to these datasets, consumers worldwide can learn more about FDA-regulated products. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved.

Epidural Steroid Injections are Safe and Effective: Multisociety Letter in Support of the Safety and Effectiveness of Epidural Steroid Injections.

PubMed

Kennedy, David J; Levin, Joshua; Rosenquist, Richard; Singh, Virtaj; Smith, Clark; Stojanovic, Milan P; Vorobeychik, Yakov

2015-05-01

In April 2014, the Food and Drug Administration (FDA) issued a Drug Safety Communication requesting that corticosteroid labeling include warnings that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. The International Spine Intervention Society spearheaded a collaboration of more than a dozen other medical societies in submitting the letter below to the FDA on November 7, 2014. We are publishing the letter to ensure that the readership of Pain Medicine is aware of the multisociety support for the safety and effectiveness of these procedures. A special note of thanks to all of the societies who signed on in support of the message. Wiley Periodicals, Inc.

Codeine and Tramadol Can Cause Breathing Problems for Children

MedlinePlus

... the FDA’s Consumer Updates page , which features the latest on all FDA-regulated products. April 20, 2017 back to top ... in Consumer Updates Animal & Veterinary Children's Health Cosmetics Dietary Supplements Drugs Food Medical Devices Nutrition Radiation-Emitting Products Tobacco Products Vaccines, Blood & ...

When health policy and empirical evidence collide: the case of cigarette package warning labels and economic consumer surplus.

PubMed

Song, Anna V; Brown, Paul; Glantz, Stanton A

2014-02-01

In its graphic warning label regulations on cigarette packages, the Food and Drug Administration severely discounts the benefits of reduced smoking because of the lost "pleasure" smokers experience when they stop smoking; this is quantified as lost "consumer surplus." Consumer surplus is grounded in rational choice theory. However, empirical evidence from psychological cognitive science and behavioral economics demonstrates that the assumptions of rational choice are inconsistent with complex multidimensional decisions, particularly smoking. Rational choice does not account for the roles of emotions, misperceptions, optimistic bias, regret, and cognitive inefficiency that are germane to smoking, particularly because most smokers begin smoking in their youth. Continued application of a consumer surplus discount will undermine sensible policies to reduce tobacco use and other policies to promote public health.

Amounts of artificial food dyes and added sugars in foods and sweets commonly consumed by children.

PubMed

Stevens, Laura J; Burgess, John R; Stochelski, Mateusz A; Kuczek, Thomas

2015-04-01

Artificial food colors (AFCs) are used to color many beverages, foods, and sweets in the United States and throughout the world. In the United States, the Food and Drug Administration (FDA) limits the AFCs allowed in the diet to 9 different colors. The FDA certifies each batch of manufactured AFCs to guarantee purity and safety. The amount certified has risen from 12 mg/capita/d in 1950 to 62 mg/capita/d in 2010. Previously, we reported the amounts of AFCs in commonly consumed beverages. In this article, the amounts of AFCs in commonly consumed foods and sweets are reported. In addition, the amount of sugars in each product is included. Amounts of AFCs reported here along with the beverage data show that many children could be consuming far more dyes than previously thought. Clinical guidance is given to help caregivers avoid AFCs and reduce the amount of sugars in children's diets. © The Author(s) 2014.

Legal considerations for social media marketing by pharmaceutical industry.

PubMed

Yang, Y Tony; Chen, Brian

2014-01-01

Social media marketing is the next frontier for direct-to-consumer advertising of pharmaceutical products, but represents an unchartered territory for regulatory action. With explosive growth in the use of social media, along with pharmaceutical companies' increasing adeptness at taking advantage of opportunities for social media marketing, the Food and Drug Administration (FDA) faces an urgent need to develop its own capacities to monitor and engage with social media marketing. In response to potential FDA action, pharmaceutical companies' marketing, regulatory compliance and legal staffs must work closely to design initiatives that are sensitive to FDA concerns. This article will address the current status of FDA regulations on social media advertising, their historical origins, challenges to implementation, and their likely future direction.

Evaluating the educational content of direct-to-consumer fulfillment materials.

PubMed

Chao, Blenda A

2005-03-15

The educational content of direct-to-consumer (DTC) fulfillment materials was evaluated. A list of prescription drug products advertised to consumers via broadcast media from August 1997 through April 20, 2002, was obtained from the Food and Drug Administration (FDA). The prescription products were categorized by disease state on the basis of their FDA-approved indications. Eight disease states were selected for analysis purposes and included acne, allergic rhinitis, depression, diabetes, hypercholesterolemia, migraine, overactive bladder, and osteoporosis. A total of 31 products were advertised directly to consumers for the eight targeted disease states, 26 of which met the inclusion criteria. The educational content of the advertisements for these 26 products was assessed by analyzing the materials' consistency, instructiveness, and consumer orientation. Two of the 26 materials analyzed contained claims that potentially broadened a drug's indication from that listed in the FDA-approved labeling. The majority of materials listed the condition name (92%), symptom information (77%), the drug's mechanism of action (65%), the drug's time to onset of action (54%), and supportive behaviors (62%). Twenty of 24 DTC fulfillment materials (83%) were not written at the reading level of eighth grade or lower. Fifteen of the 26 mailings contained educational diagrams, 52% of which met the criteria for necessity, and a greater percentage met the criteria for suitability (90%), familiarity (86%), overall layout (88%), single concept (86%), and lack of distracting elements (100%). DTC fulfillment materials appear to have more educational content than DTC print advertisements but are still overwhelmingly deficient in meeting the recommended sixth to eighth-grade reading level.

Non-steroidal anti-inflammatory drug administration after coronary artery bypass surgery: utilization persists despite the boxed warning.

PubMed

Kulik, Alexander; Bykov, Katsiaryna; Choudhry, Niteesh K; Bateman, Brian T

2015-06-01

In 2005, the US Food and Drug Administration (FDA) issued a boxed warning against the administration of non-steroidal anti-inflammatory drugs (NSAIDs) after coronary artery bypass graft (CABG) surgery because of cardiovascular safety concerns. We assessed utilization rates before and after the advisory and evaluated predictors of NSAID administration following CABG. We assembled a cohort of 277,576 patients who underwent CABG from 2004 to 2010. Temporal trends in NSAID exposure were evaluated, and predictors of postoperative NSAID use were identified using generalized estimating equations. Over the study period, 92,938 CABG patients (33.5%) received NSAIDs following surgery. The frequency of NSAID administration declined steadily over time, from a peak of 38.9% in 2004 to a low of 29.0% in 2010 (p < 0.0007). Ketorolac was the most frequent NSAID prescribed, commonly on the first postoperative day. Surgery performed after the boxed warning was independently associated with a 20% lower odds of NSAID administration [odds ratio (OR): 0.80; p = 0.0003]. Other factors that predicted a lower odds of NSAID use following surgery included a history of renal disease (OR: 0.33; p < 0.0001) and liver disease (OR: 0.66; p < 0.0001), and the need for concurrent valve surgery (OR: 0.78; p < 0.0001). A mammary graft at the time of surgery increased the odds of NSAID administration (OR: 1.23; p < 0.0001). The frequency of NSAID administration after CABG has declined since the FDA advisory, yet many patients continue to receive them in recent years. Our data highlight the need for future research initiatives to further define the risks associated with NSAID use in this population. Copyright © 2015 John Wiley & Sons, Ltd.

Challenging the FDA black box warning for high aspirin dose with ticagrelor in patients with diabetes.

PubMed

DiNicolantonio, James J; Serebruany, Victor L

2013-03-01

Ticagrelor, a novel reversible antiplatelet agent, has a Food and Drug Administration (FDA) black box warning to avoid maintenance doses of aspirin (ASA) >100 mg/daily. This restriction is based on the hypothesis that ASA doses >100 mg somehow decreased ticagrelor's benefit in the Platelet Inhibition and Patient Outcomes (PLATO) U.S. cohort. However, these data are highly postrandomized, come from a very small subgroup in PLATO (57% of patients in the U.S. site), and make no biological sense. Moreover, the ticagrelor-ASA interaction was not significant by any multivariate Cox regression analyses. The Complete Response Review for ticagrelor indicates that for U.S. PLATO patients, an ASA dose >300 mg was not a significant interaction for vascular outcomes. In the ticagrelor-ASA >300 mg cohort, all-cause and vascular mortality were not significantly increased (hazard ratio [HR] 1.27 [95% CI 0.84-1.93], P = 0.262 and 1.39 [0.87-2.2], P = 0.170), respectively. Furthermore, for major adverse cardiovascular events (MACEs), 30-day all-cause mortality, and 30-day vascular mortality, the strongest interaction is the diabetes-ASA interaction. That is, patients who had diabetes had significantly fewer MACEs through study end (0.49 [0.34-0.63], P < 0.0001), significantly less 30-day all-cause mortality (0.33 [0.20-0.56], P < 0.0001), and significantly less 30-day vascular mortality (0.35 [0.22-0.55], P < 0.0001), respectively, when given high-dose (300-325 mg) ASA, regardless of treatment (clopidogrel or ticagrelor) assignment. The black box warning for the use of maintenance ASA doses >100 mg with ticagrelor is inappropriate for patients with diabetes and not evidence based.

The future of direct-to-consumer clinical genetic tests.

PubMed

Frueh, Felix W; Greely, Henry T; Green, Robert C; Hogarth, Stuart; Siegel, Sue

2011-06-01

In light of the meeting of the US Food and Drug Administration (FDA) in March 2011 to discuss the regulation of clinical direct-to-consumer (DTC) genetic tests, we have invited five experts to consider the best means of overseeing the ordering and interpretation of these tests. Should these tests be regulated? If so, who, if anyone, should communicate results to consumers?

Consumers' perceptions of vape shops in Southern California: an analysis of online Yelp reviews.

PubMed

Sussman, Steve; Garcia, Robert; Cruz, Tess Boley; Baezconde-Garbanati, Lourdes; Pentz, Mary Ann; Unger, Jennifer B

2014-01-01

E-cigarettes are sold at many different types of retail establishments. A new type of shop has emerged, the vape shop, which specializes in sales of varied types of e-cigarettes. Vape shops allow users to sample several types. There are no empirical research articles on vape shops. Information is needed on consumers' beliefs and behaviors about these shops, the range of products sold, marketing practices, and variation in shop characteristics by ethnic community and potential counter-marketing messages. This study is the first to investigate marketing characteristics of vape shops located in different ethnic neighborhoods in Los Angeles, by conducting a Yelp electronic search and content analysis of consumer reports on vape shops they have visited. The primary measure was Yelp reviews (N = 103 vape shops in the Los Angeles, California area), which were retrieved and content coded. We compared the attributes of vape shops representing four ethnic communities: African American, Hispanic/Latino, Korean, and White. Vape shop attributes listed as most important were the selection of flavors or hardware (95%), fair prices (92%), and unique flavors or hardware (89%). Important staff marketing attributes included being friendly (99%), helpful/patient/respectful (97%), and knowledgeable/professional (95%). Over one-half of the shops were rated as clean (52%) and relaxed (61%). Relatively few of the reviews mentioned quitting smoking (32%) or safety of e-cigarettes (15%). The selection of flavors and hardware appeared relatively important in Korean ethnic location vape shops. Yelp reviews may influence potential consumers. As such, the present study's focus on Yelp reviews addressed at least eight of the FDA's Center for Tobacco Products' priorities pertaining to marketing influences on consumer beliefs and behaviors. The findings suggest that there were several vape shop and product attributes that consumers considered important to disseminate to others through postings on Yelp. Lack of health warnings about these products may misrepresent their potential risk. The main influence variables were product variety and price. There was only a little evidence of influence of ethnic neighborhood; for example, regarding importance of flavors and hardware. Shop observational studies are recommended to discern safety factors across different ethnic neighborhoods.

The FDA alert on suicidality and antiepileptic drugs: Fire or false alarm?

PubMed

Hesdorffer, Dale C; Kanner, Andres M

2009-05-01

In January 2008, the U.S. Food and Drug Administration (FDA) issued an alert about an increased risk for suicidality in 199 clinical trials of 11 antiepileptic drugs (AEDs) for three different indications, including epilepsy. An advisory panel voted against a black-box warning on AED labels, and the FDA has accepted this recommendation. We discuss three potential problems with the alert. First, adverse event data were used rather than systematically collected data. Second, the 11 drugs grouped together as a single class of AEDs have different mechanisms of action and very different relative risks, many of which were not statistically significant and some of which were smaller than one. These facts suggest that they should not be grouped as a class. Third, the risk of adverse effects from uncontrolled seizures almost certainly outweighs the small risk of suicidality. We place our comments in the context of a review of the literature on suicidality and depression in epilepsy and the sparse literature on AEDs and suicidality. We recommend that all patients with epilepsy be routinely evaluated for depression, anxiety, and suicidality, and that future clinical trials include validated instruments to systematically assess these conditions to determine whether the possible signal observed by the FDA is real.

The use of compound topical anesthetics: a review.

PubMed

Kravitz, Neal D

2007-10-01

The author reviewed the history of, federal regulations regarding, risks of and adverse drug reactions of five compound topical anesthetics: tetracaine, adrenaline/epinephrine and cocaine (TAC); lidocaine, adrenaline/epinephrine and tetracaine (LET); lidocaine, tetracaine and phenylephrine (TAC 20 percent Alternate); lidocaine, prilocaine and tetracaine (Profound); and lidocaine, prilocaine, tetracaine and phenylephrine with thickeners (Profound PET). The author reviewed clinical trials, case reports, descriptive articles, and U.S. Food and Drug Administration (FDA) regulations and recent public advisory warnings regarding the federal approval of and risks associated with the use of compound topical anesthetics. Compound topical anesthetics are neither FDA-regulated nor -unregulated. Some compounding pharmacies bypass the new FDA drug approval process, which is based on reliable scientific data and ensures that a marketed drug is safe, effective, properly manufactured and accurately labeled. Two deaths have been attributed to the lay use of compound topical anesthetics. In response, the FDA has announced the strengthening of its efforts against unapproved drug products. Compound topical anesthetics may be an effective alternative to local infiltration for some minimally invasive dental procedures; however, legitimate concerns exist in regard to their safety. Until they become federally regulated, compound topical anesthetics remain unapproved drug products whose benefits may not outweigh their risks for dental patients.

Consumer preferences for electronic cigarettes: results from a discrete choice experiment.

PubMed

Czoli, Christine D; Goniewicz, Maciej; Islam, Towhidul; Kotnowski, Kathy; Hammond, David

2016-04-01

E-cigarettes present a formidable challenge to regulators given their variety and the rapidly evolving nicotine market. The current study sought to examine the influence of e-cigarette product characteristics on consumer perceptions and trial intentions among Canadians. An online discrete choice experiment was conducted with 915 Canadians aged 16 years and older in November 2013. An online commercial panel was used to sample 3 distinct subpopulations: (1) non-smoking youth and young adults (n=279); (2) smoking youth and young adults (n=264) and (3) smoking adults (n=372). Participants completed a series of stated-preference tasks, in which they viewed choice sets with e-cigarette product images that featured different combinations of attributes: flavour, nicotine content, health warnings and price. For each choice set, participants were asked to select one of the products or indicate 'none of the above' with respect to the following outcomes: interest in trying, less harm and usefulness in quitting smoking. The attributes' impact on consumer choice for each outcome was analysed using multinomial logit regression. Health warning was the most important attribute influencing participants' intentions to try e-cigarettes (42%) and perceived efficacy as a quit aid (39%). Both flavour (36%) and health warnings (35%) significantly predicted perceptions of product harm. The findings indicate that consumers make trade-offs with respect to e-cigarette product characteristics, and that these trade-offs vary across different subpopulations. Given that health warnings and flavour were weighted most important by consumers in this study, these may represent good targets for e-cigarette regulatory frameworks. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

The Drug Facts Box: Improving the communication of prescription drug information.

PubMed

Schwartz, Lisa M; Woloshin, Steven

2013-08-20

Communication about prescription drugs ought to be a paragon of public science communication. Unfortunately, it is not. Consumers see $4 billion of direct-to-consumer advertising annually, which typically fails to present data about how well drugs work. The professional label--the Food and Drug Administration's (FDA) mechanism to get physicians information needed for appropriate prescribing--may also fail to present benefit data. FDA labeling guidance, in fact, suggests that industry omit benefit data for new drugs in an existing class and for drugs approved on the basis of unfamiliar outcomes (such as depression rating scales). The medical literature is also problematic: there is selective reporting of favorable trials, favorable outcomes within trials, and "spinning" unfavorable results to maximize benefit and minimize harm. In contrast, publicly available FDA reviews always include the phase 3 trial data on benefit and harm, which are the basis of drug approval. However, these reviews are practically inaccessible: lengthy, poorly organized, and weakly summarized. To improve accessibility, we developed the Drug Facts Box: a one-page summary of benefit and harm data for each indication of a drug. A series of studies--including national randomized trials--demonstrates that most consumers understand the Drug Facts Box and that it improves decision-making. Despite calls from their own Risk Communication Advisory Committee and Congress (in the Affordable Care Act) to consider implementing boxes, the FDA announced it needs at least 3-5 y more to make a decision. Given its potential public health impact, physicians and the public should not have to wait that long for better drug information.

The Drug Facts Box: Improving the communication of prescription drug information

PubMed Central

Schwartz, Lisa M.; Woloshin, Steven

2013-01-01

Communication about prescription drugs ought to be a paragon of public science communication. Unfortunately, it is not. Consumers see $4 billion of direct-to-consumer advertising annually, which typically fails to present data about how well drugs work. The professional label—the Food and Drug Administration's (FDA) mechanism to get physicians information needed for appropriate prescribing—may also fail to present benefit data. FDA labeling guidance, in fact, suggests that industry omit benefit data for new drugs in an existing class and for drugs approved on the basis of unfamiliar outcomes (such as depression rating scales). The medical literature is also problematic: there is selective reporting of favorable trials, favorable outcomes within trials, and “spinning” unfavorable results to maximize benefit and minimize harm. In contrast, publicly available FDA reviews always include the phase 3 trial data on benefit and harm, which are the basis of drug approval. However, these reviews are practically inaccessible: lengthy, poorly organized, and weakly summarized. To improve accessibility, we developed the Drug Facts Box: a one-page summary of benefit and harm data for each indication of a drug. A series of studies—including national randomized trials—demonstrates that most consumers understand the Drug Facts Box and that it improves decision-making. Despite calls from their own Risk Communication Advisory Committee and Congress (in the Affordable Care Act) to consider implementing boxes, the FDA announced it needs at least 3–5 y more to make a decision. Given its potential public health impact, physicians and the public should not have to wait that long for better drug information. PMID:23942130

Establishing Standards on Colors from Natural Sources.

PubMed

Simon, James E; Decker, Eric A; Ferruzzi, Mario G; Giusti, M Monica; Mejia, Carla D; Goldschmidt, Mark; Talcott, Stephen T

2017-11-01

Color additives are applied to many food, drug, and cosmetic products. With up to 85% of consumer buying decisions potentially influenced by color, appropriate application of color additives and their safety is critical. Color additives are defined by the U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act) as any dye, pigment, or substance that can impart color to a food, drug, or cosmetic or to the human body. Under current U.S. Food and Drug Administration (FDA) regulations, colors fall into 2 categories as those subject to an FDA certification process and those that are exempt from certification often referred to as "natural" colors by consumers because they are sourced from plants, minerals, and animals. Certified colors have been used for decades in food and beverage products, but consumer interest in natural colors is leading market applications. However, the popularity of natural colors has also opened a door for both unintentional and intentional economic adulteration. Whereas FDA certifications for synthetic dyes and lakes involve strict quality control, natural colors are not evaluated by the FDA and often lack clear definitions and industry accepted quality and safety specifications. A significant risk of adulteration of natural colors exists, ranging from simple misbranding or misuse of the term "natural" on a product label to potentially serious cases of physical, chemical, and/or microbial contamination from raw material sources, improper processing methods, or intentional postproduction adulteration. Consistent industry-wide safety standards are needed to address the manufacturing, processing, application, and international trade of colors from natural sources to ensure quality and safety throughout the supply chain. © 2017 Institute of Food Technologists®.

[Acidosis without marked hyperglycemia : Euglycemic diabetic ketoacidosis associated with SGLT2-Inhibitors].

PubMed

Valek, R; Von der Mark, J

2017-03-01

Sodium-glucose cotransporter 2 (SGLT2) inhibitors are new antidiabetic drugs that regulate blood glucose levels by increasing urinary glucose excretion. In May 2015, the U.S. Food and Drug Administration (FDA) issued a warning that SGLT2 inhibitors may lead to ketoacidosis. In this report, we describe a case of life-threatening euglycemic ketoacidosis associated with SGLT2 inhibition and evaluate possible mechanisms and triggers.

Reports of pathological gambling, hypersexuality, and compulsive shopping associated with dopamine receptor agonist drugs.

PubMed

Moore, Thomas J; Glenmullen, Joseph; Mattison, Donald R

2014-12-01

Severe impulse control disorders involving pathological gambling, hypersexuality, and compulsive shopping have been reported in association with the use of dopamine receptor agonist drugs in case series and retrospective patient surveys. These agents are used to treat Parkinson disease, restless leg syndrome, and hyperprolactinemia. To analyze serious adverse drug event reports about these impulse control disorders received by the US Food and Drug Administration (FDA) and to assess the relationship of these case reports with the 6 FDA-approved dopamine receptor agonist drugs. We conducted a retrospective disproportionality analysis based on the 2.7 million serious domestic and foreign adverse drug event reports from 2003 to 2012 extracted from the FDA Adverse Event Reporting System. Cases were selected if they contained any of 10 preferred terms in the Medical Dictionary for Regulatory Activities (MedDRA) that described the abnormal behaviors. We used the proportional reporting ratio (PRR) to compare the proportion of target events to all serious events for the study drugs with a similar proportion for all other drugs. We identified 1580 events indicating impulse control disorders from the United States and 21 other countries:710 fordopamine receptor agonist drugs and 870 for other drugs. The dopamine receptor agonist drugs had a strong signal associated with these impulse control disorders (n = 710; PRR = 277.6, P < .001). The association was strongest for the dopamine agonists pramipexole (n = 410; PRR = 455.9, P < .001) and ropinirole (n = 188; PRR = 152.5, P < .001), with preferential affinity for the dopamine D3 receptor. A signal was also seen for aripiprazole, an antipsychotic classified as a partial agonist of the D3 receptor (n = 37; PRR = 8.6, P < .001). Our findings confirm and extend the evidence that dopamine receptor agonist drugs are associated with these specific impulse control disorders. At present, none of the dopamine receptor agonist drugs approved by the FDA have boxed warnings as part of their prescribing information. Our data, and data from prior studies, show the need for more prominent warnings.

Depression--Medicines To Help You

MedlinePlus

... For Consumers Consumer Information by Audience For Women Depression--Medicines To Help You Share Tweet Linkedin Pin ... medicines for depression. Important Warnings about Medicines for Depression Children and teens who take antidepressants may be ...

Crowdsourced earthquake early warning.

PubMed

Minson, Sarah E; Brooks, Benjamin A; Glennie, Craig L; Murray, Jessica R; Langbein, John O; Owen, Susan E; Heaton, Thomas H; Iannucci, Robert A; Hauser, Darren L

2015-04-01

Earthquake early warning (EEW) can reduce harm to people and infrastructure from earthquakes and tsunamis, but it has not been implemented in most high earthquake-risk regions because of prohibitive cost. Common consumer devices such as smartphones contain low-cost versions of the sensors used in EEW. Although less accurate than scientific-grade instruments, these sensors are globally ubiquitous. Through controlled tests of consumer devices, simulation of an M w (moment magnitude) 7 earthquake on California's Hayward fault, and real data from the M w 9 Tohoku-oki earthquake, we demonstrate that EEW could be achieved via crowdsourcing.

Crowdsourced earthquake early warning

PubMed Central

Minson, Sarah E.; Brooks, Benjamin A.; Glennie, Craig L.; Murray, Jessica R.; Langbein, John O.; Owen, Susan E.; Heaton, Thomas H.; Iannucci, Robert A.; Hauser, Darren L.

2015-01-01

Earthquake early warning (EEW) can reduce harm to people and infrastructure from earthquakes and tsunamis, but it has not been implemented in most high earthquake-risk regions because of prohibitive cost. Common consumer devices such as smartphones contain low-cost versions of the sensors used in EEW. Although less accurate than scientific-grade instruments, these sensors are globally ubiquitous. Through controlled tests of consumer devices, simulation of an Mw (moment magnitude) 7 earthquake on California’s Hayward fault, and real data from the Mw 9 Tohoku-oki earthquake, we demonstrate that EEW could be achieved via crowdsourcing. PMID:26601167

When Health Policy and Empirical Evidence Collide: The Case of Cigarette Package Warning Labels and Economic Consumer Surplus

PubMed Central

Song, Anna V.; Brown, Paul

2014-01-01

In its graphic warning label regulations on cigarette packages, the Food and Drug Administration severely discounts the benefits of reduced smoking because of the lost “pleasure” smokers experience when they stop smoking; this is quantified as lost “consumer surplus.” Consumer surplus is grounded in rational choice theory. However, empirical evidence from psychological cognitive science and behavioral economics demonstrates that the assumptions of rational choice are inconsistent with complex multidimensional decisions, particularly smoking. Rational choice does not account for the roles of emotions, misperceptions, optimistic bias, regret, and cognitive inefficiency that are germane to smoking, particularly because most smokers begin smoking in their youth. Continued application of a consumer surplus discount will undermine sensible policies to reduce tobacco use and other policies to promote public health. PMID:24328661

The future of direct-to-consumer clinical genetic tests

PubMed Central

Frueh, Felix W.; Greely, Henry T.; Green, Robert C.; Hogarth, Stuart; Siegel, Sue

2013-01-01

In light of the meeting of the US Food and Drug Administration (FDA) in March 2011 to discuss the regulation of clinical direct-to-consumer (DTC) genetic tests, we have invited five experts to consider the best means of overseeing the ordering and interpretation of these tests. Should these tests be regulated? If so, who, if anyone, should communicate results to consumers? PMID:21629275

Exploring the e-cigarette e-commerce marketplace: Identifying Internet e-cigarette marketing characteristics and regulatory gaps.

PubMed

Mackey, Tim K; Miner, Angela; Cuomo, Raphael E

2015-11-01

The electronic cigarette (e-cigarette) market is maturing into a billion-dollar industry. Expansion includes new channels of access not sufficiently assessed, including Internet sales of e-cigarettes. This study identifies unique e-cigarette Internet vendor characteristics, including geographic location, promotional strategies, use of social networking, presence/absence of age verification, and consumer warning representation. We performed structured Internet search engine queries and used inclusion/exclusion criteria to identify e-cigarette vendors. We then conducted content analysis of characteristics of interest. Our examination yielded 57 e-cigarette Internet vendors including 54.4% (n=31) that sold exclusively online. The vast majority of websites (96.5%, n=55) were located in the U.S. Vendors used a variety of sales promotion strategies to market e-cigarettes including 70.2% (n=40) that used more than one social network service (SNS) and 42.1% (n=24) that used more than one promotional sales strategies. Most vendors (68.4%, n=39) displayed one or more health warnings on their website, but often displayed them in smaller font or in their terms and conditions. Additionally, 35.1% (n=20) of vendors did not have any detectable age verification process. E-cigarette Internet vendors are actively engaged in various promotional activities to increase the appeal and presence of their products online. In the absence of FDA regulations specific to the Internet, the e-cigarette e-commerce marketplace is likely to grow. This digital environment poses unique challenges requiring targeted policy-making including robust online age verification, monitoring of SNS marketing, and greater scrutiny of certain forms of marketing promotional practices. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Tobacco Regulation and Cost-Benefit Analysis: How Should We Value Foregone Consumer Surplus?

PubMed

Levy, Helen G; Norton, Edward C; Smith, Jeffrey A

2018-01-01

Recent tobacco regulations proposed by the Food and Drug Administration have raised a thorny question: how should the cost-benefit analysis accompanying such policies value foregone consumer surplus associated with regulation-induced reductions in smoking? In a model with rational and fully informed consumers, this question is straightforward. There is disagreement, however, about whether consumers are rational and fully informed, and the literature offers little practical guidance about what approach the FDA should use if they are not. In this paper, we outline the history of the FDA's recent attempts to regulate cigarettes and other tobacco products and how they have valued foregone consumer surplus in cost-benefit analyses. We advocate replacing the approach used in most of this literature, which first calculates health gains associated with regulation and then "offsets" them by some factor reflecting consumer surplus losses, with a more general behavioral public finance framework for welfare analysis. This framework applies standard tools of welfare analysis to consumer demand that may be "biased" (that is, not necessarily rational and fully informed) without requiring specific assumptions about the reason for the bias. This framework would require estimates of both biased and unbiased consumer demand; we sketch an agenda to help develop these in the context of smoking. The use of this framework would substantially reduce the confusion currently surrounding welfare analysis of tobacco regulation.

Health Warning Labels Correct Parents' Misperceptions About Sugary Drink Options.

PubMed

Moran, Alyssa J; Roberto, Christina A

2018-06-11

Noncarbonated sugar-sweetened beverages, such as fruit drinks, sports drinks, and sweetened teas are increasingly promoted to and consumed by youth. These beverages may be perceived as healthier options than soda. To educate consumers about beverages high in added sugar, several cities and states have proposed policies mandating health warning labels on sugar-sweetened beverages. In 2015, a total of 2,381 parents were randomized to a no label, calorie label, or warning label condition. An online survey asked about the healthfulness of different beverages, and asked parents to select a beverage for their child in a choice task. Regressions compared the warning and calorie label groups to the control group and measured mediating effects of health beliefs on beverage choice. Data were analyzed in 2016. Parents viewed fruit drinks, sports drinks, and sweetened teas as healthier and less likely to cause disease than soda. Compared with no label, warning labels significantly increased parents' risk perceptions for all beverages except soda. Warning labels significantly reduced the odds of selecting fruit drinks for the child (OR=0.42, 95% CI=0.32, 0.56), and this effect was mediated by changes in health beliefs and risk perceptions. Fruit drinks, sports drinks, and sweetened teas are increasingly promoted to youth. Parents believe these beverages are healthier and less likely to cause disease than soda, and warning labels may correct these misperceptions. Copyright © 2018 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Smokers' attitudes and support for e-cigarette policies and regulation in the USA.

PubMed

Wackowski, Olivia A; Delnevo, Cristine D

2015-11-01

In April 2014, the Food and Drug Administration (FDA) proposed a rule to extend its tobacco regulatory authority to e-cigarettes, which have been unregulated and growing in use since their 2006-2007 US introduction. The FDA will issue a final rule based on comments and data received from researchers, tobacco companies and the public. We aimed to present data about current smokers' awareness of and attitudes towards potential e-cigarette regulation and various policies in the USA. We conducted a cross-sectional online e-cigarette focused survey of 519 adult current smokers in April 2014, before the FDA's proposed rule was announced. Participants were recruited from a private research panel (GFK's Knowledge Networks) designed to be representative of the US population. The majority of respondents (62.5%) did not know that e-cigarettes are unregulated by the FDA but agreed that e-cigarettes should be regulated by the FDA for safety and quality (83.5%), carry warning labels about their potential risks (86.6%) and have the same legal age of sale as other tobacco (87.7%). Support was similarly high among current e-cigarette users. Support was substantial though lower overall for policies to restrict e-cigarette indoor use (41.2%), flavouring (44.3%) and advertising (55.5%), and was negatively associated with current e-cigarette use. Support for many e-cigarette regulatory policies is strong among smokers, including for policies that the FDA has recently proposed and potential future regulations. States considering indoor e-cigarette restrictions should know that a substantial number of current smokers support such regulations. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Neighborhood Inequalities in Retailers' Compliance With the Family Smoking Prevention and Tobacco Control Act of 2009, January 2014-July 2014.

PubMed

Lee, Joseph G L; Baker, Hannah M; Ranney, Leah M; Goldstein, Adam O

2015-10-08

Retailer noncompliance with limited US tobacco regulations on advertising and labeling was historically patterned by neighborhood in ways that promote health disparities. In 2010, the US Food and Drug Administration (FDA) began enforcing stronger tobacco retailer regulations under the Family Smoking Prevention and Tobacco Control Act of 2009. However, recent research has found no differences in compliance by neighborhood characteristics for FDA advertising and labeling inspections. We sought to investigate the neighborhood characteristics associated with retailer noncompliance with specific FDA advertising and labeling inspections (ie, violations of bans on self-service displays, selling single cigarettes, false or mislabeled products, vending machines, flavored cigarettes, and free samples). We coded FDA advertising and labeling warning letters (n = 718) for type of violations and geocoded advertising and labeling inspections from January 1 through July 31, 2014 (N = 33,543). Using multilevel models, we examined cross-sectional associations between types of violations and neighborhood characteristics previously associated with disparities (ie, percentage black, Latino, under the poverty line, and younger than 18 years). Retailer advertising and labeling violations are patterned by who lives in the neighborhood; regulated tobacco products are more likely to be stored behind the counter as the percentage of black or Latino residents increases, and single cigarettes are more often available for purchase in neighborhoods as the percentage of black, poor, or young residents increases. Contrary to previous null findings, noncompliance with FDA advertising and labeling regulations is patterned by neighborhood characteristics, sometimes in opposite directions. Given the low likelihood of self-service violations in the same neighborhoods that have high likelihood of single cigarette sales, we suggest targeted approaches to FDA retailer inspections and education campaigns.

Neighborhood Inequalities in Retailers’ Compliance With the Family Smoking Prevention and Tobacco Control Act of 2009, January 2014–July 2014

PubMed Central

Baker, Hannah M.; Ranney, Leah M.; Goldstein, Adam O.

2015-01-01

Introduction Retailer noncompliance with limited US tobacco regulations on advertising and labeling was historically patterned by neighborhood in ways that promote health disparities. In 2010, the US Food and Drug Administration (FDA) began enforcing stronger tobacco retailer regulations under the Family Smoking Prevention and Tobacco Control Act of 2009. However, recent research has found no differences in compliance by neighborhood characteristics for FDA advertising and labeling inspections. We sought to investigate the neighborhood characteristics associated with retailer noncompliance with specific FDA advertising and labeling inspections (ie, violations of bans on self-service displays, selling single cigarettes, false or mislabeled products, vending machines, flavored cigarettes, and free samples). Methods We coded FDA advertising and labeling warning letters (n = 718) for type of violations and geocoded advertising and labeling inspections from January 1 through July 31, 2014 (N = 33,543). Using multilevel models, we examined cross-sectional associations between types of violations and neighborhood characteristics previously associated with disparities (ie, percentage black, Latino, under the poverty line, and younger than 18 years). Results Retailer advertising and labeling violations are patterned by who lives in the neighborhood; regulated tobacco products are more likely to be stored behind the counter as the percentage of black or Latino residents increases, and single cigarettes are more often available for purchase in neighborhoods as the percentage of black, poor, or young residents increases. Conclusion Contrary to previous null findings, noncompliance with FDA advertising and labeling regulations is patterned by neighborhood characteristics, sometimes in opposite directions. Given the low likelihood of self-service violations in the same neighborhoods that have high likelihood of single cigarette sales, we suggest targeted approaches to FDA retailer inspections and education campaigns. PMID:26447548

Trends in internet search activity, media coverage, and patient-centered health information after the FDA safety communications on surgical mesh for pelvic organ prolapse.

PubMed

Stone, Benjamin V; Forde, James C; Levit, Valerie B; Lee, Richard K; Te, Alexis E; Chughtai, Bilal

2016-11-01

In July 2011, the US Food and Drug Administration (FDA) issued a safety communication regarding serious complications associated with surgical mesh for pelvic organ prolapse, prompting increased media and public attention. This study sought to analyze internet search activity and news article volume after this FDA warning and to evaluate the quality of websites providing patient-centered information. Google Trends™ was utilized to evaluate search engine trends for the term "pelvic organ prolapse" and associated terms between 1 January 2004 and 31 December 2014. Google News™ was utilized to quantify the number of news articles annually under the term "pelvic organ prolapse." The search results for the term "pelvic organ prolapse" were assessed for quality using the Health On the Net Foundation (HON) certification. There was a significant increase in search activity from 37.42 in 2010 to 57.75 in 2011, at the time of the FDA communication (p = 0.021). No other annual interval had a statistically significant increase in search activity. The single highest monthly search activity, given the value of 100, was August 2011, immediately following the July 2011 notification, with the next highest value being 98 in July 2011. Linear regression analysis of news articles per year since the FDA communication revealed r 2  = 0.88, with a coefficient of 186. Quality assessment demonstrated that 42 % of websites were HON-certified, with .gov sites providing the highest quality information. Although the 2011 FDA safety communication on surgical mesh was associated with increased public and media attention, the quality of relevant health information on the internet remains of poor quality. Future quality assurance measures may be critical in enabling patients to play active roles in their own healthcare.

The Food and Drug Administration advisory committees and panels: how they are applied to the drug regulatory process.

PubMed

Ciociola, Arthur A; Karlstadt, Robyn G; Pambianco, Daniel J; Woods, Karen L; Ehrenpreis, Eli D

2014-10-01

Food and Drug Administration (FDA) advisory panels and committees play a critical role in advising the FDA on the safety and efficacy of medical devices and drugs marketed in the US. Advisory panel recommendations are used by the FDA to make decisions regarding medical products. Currently, the FDA utilizes over 50 advisory panels that serve the three major FDA centers, including the Centers for Biologics, Drugs and Device Products. Members of an advisory panel typically include academicians, clinicians, consumers, patients, and industry representatives. The FDA establishes the schedules for advisory panel meetings on an annual basis and a panel usually meets several times a year for two consecutive days in Washington, DC. Typically, the advisory panel discusses issues highlighted by the FDA and is then asked to vote a response to the questions posed in advance by the FDA. Advisory panel recommendations have a strong influence on FDA's decision to approve a product, as evidenced by the 214 Advisory Panels FDA convened between January 2008 to November 2012, during which advisory panel members voted to approve the product (or use of the product) ∼74% of the time, with FDA ultimately approving the medical product (or use of the product) ∼79% of the time. The ACG membership are encouraged to consider serving the public's interest by participating in an FDA advisory panel utilizing their expertise for the evaluation of a new drug or medical device, and providing advice about whether the product should be sold in the US.

Enhanced labelling on alcoholic drinks: reviewing the evidence to guide alcohol policy.

PubMed

Martin-Moreno, Jose M; Harris, Meggan E; Breda, Joao; Møller, Lars; Alfonso-Sanchez, Jose L; Gorgojo, Lydia

2013-12-01

Consumer and public health organizations have called for better labelling on alcoholic drinks. However, there is a lack of consensus about the best elements to include. This review summarizes alcohol labelling policy worldwide and examines available evidence to support enhanced labelling. A literature review was carried out in June-July 2012 on Scopus using the key word 'alcohol' combined with 'allergens', 'labels', 'nutrition information', 'ingredients', 'consumer information' and/or 'warning'. Articles discussing advertising and promotion of alcohol were excluded. A search through Google and the System for Grey Literature in Europe (SIGLE) identified additional sources on alcohol labelling policies, mainly from governmental and organizational websites. Five elements were identified as potentially useful to consumers: (i) a list of ingredients, (ii) nutritional information, (iii) serving size and servings per container, (iv) a definition of 'moderate' intake and (v) a health warning. Alcohol labelling policy with regard to these aspects is quite rudimentary in most countries, with few requiring a list of ingredients or health warnings, and none requiring basic nutritional information. Only one country (Australia) requires serving size and servings per container to be displayed. Our study suggests that there are both potential advantages and disadvantages to providing consumers with more information about alcohol products. Current evidence seems to support prompt inclusion of a list of ingredients, nutritional information (usually only kcal) and health warnings on labels. Standard drink and serving size is useful only when combined with other health education efforts. A definition of 'moderate intake' and recommended drinking guidelines are best suited to other contexts.

The legal and scientific basis for FDA's assertion of jurisdiction over cigarettes and smokeless tobacco.

PubMed

Kessler, D A; Barnett, P S; Witt, A; Zeller, M R; Mande, J R; Schultz, W B

1997-02-05

On August 28, 1996, the US Food and Drug Administration (FDA) asserted jurisdiction over cigarettes and smokeless tobacco under the Federal Food, Drug, and Cosmetic Act. Under this Act, a product is a "drug" or "device" subject to FDA jurisdiction if it is "intended to affect the structure or any function of the body." The FDA determined that nicotine in cigarettes and smokeless tobacco does "affect the structure or any function of the body" because nicotine causes addiction and other pharmacological effects. The FDA then determined that these pharmacological effects are "intended" because (1) a scientific consensus has emerged that nicotine is addictive; (2) recent studies have shown that most consumers use cigarettes and smokeless tobacco for pharmacological purposes, including satisfying their addiction to nicotine; and (3) newly disclosed evidence from the tobacco manufacturers has revealed that the manufacturers know that nicotine causes pharmacological effects, including addiction, and design their products to provide pharmacologically active doses of nicotine. The FDA thus concluded that cigarettes and smokeless tobacco are subject to FDA jurisdiction because they contain a "drug," nicotine, and a "device" for delivering this drug to the body.

Estimating the 'consumer surplus' for branded versus standardised tobacco packaging.

PubMed

Gendall, Philip; Eckert, Christine; Hoek, Janet; Farley, Tessa; Louviere, Jordan; Wilson, Nick; Edwards, Richard

2016-11-01

Tobacco companies question whether standardised (or 'plain') packaging will change smokers' behaviour. We addressed this question by estimating how standardised packaging compared to a proven tobacco control intervention, price increases through excise taxes, thus providing a quantitative measure of standardised packaging's likely effect. We conducted an online study of 311 New Zealand smokers aged 18 years and above that comprised a willingness-to-pay task comparing a branded and a standardised pack at four different price levels, and a choice experiment. The latter used an alternative-specific design, where the alternatives were a branded pack or a standardised pack, with warning theme and price varied for each pack. Respondents had higher purchase likelihoods for the branded pack (with a 30% warning) than the standardised pack (with a 75% warning) at each price level tested, and, on average, were willing to pay approximately 5% more for a branded pack. The choice experiment produced a very similar estimate of 'consumer surplus' for a branded pack. However, the size of the 'consumer surplus' varied between warning themes and by respondents' demographic characteristics. These two experiments suggest standardised packaging and larger warning labels could have a similar overall effect on adult New Zealand smokers as a 5% tobacco price increase. The findings provide further evidence for the efficacy of standardised packaging, which focuses primarily on reducing youth initiation, and suggest this measure will also bring notable benefits to adult smokers. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

OpenFDA: an innovative platform providing access to a wealth of FDA’s publicly available data

PubMed Central

Kass-Hout, Taha A; Mohebbi, Matthew; Nelsen, Hans; Baker, Adam; Levine, Jonathan; Johanson, Elaine; Bright, Roselie A

2016-01-01

Objective The objective of openFDA is to facilitate access and use of big important Food and Drug Administration public datasets by developers, researchers, and the public through harmonization of data across disparate FDA datasets provided via application programming interfaces (APIs). Materials and Methods Using cutting-edge technologies deployed on FDA’s new public cloud computing infrastructure, openFDA provides open data for easier, faster (over 300 requests per second per process), and better access to FDA datasets; open source code and documentation shared on GitHub for open community contributions of examples, apps and ideas; and infrastructure that can be adopted for other public health big data challenges. Results Since its launch on June 2, 2014, openFDA has developed four APIs for drug and device adverse events, recall information for all FDA-regulated products, and drug labeling. There have been more than 20 million API calls (more than half from outside the United States), 6000 registered users, 20,000 connected Internet Protocol addresses, and dozens of new software (mobile or web) apps developed. A case study demonstrates a use of openFDA data to understand an apparent association of a drug with an adverse event. Conclusion With easier and faster access to these datasets, consumers worldwide can learn more about FDA-regulated products. PMID:26644398

Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety.

PubMed

Kesselheim, A S

2010-06-01

In 2008 and 2009, the Supreme Court reviewed the question of whether patients injured by dangerous prescription drugs or medical devices can bring tort lawsuits against pharmaceutical and device manufacturers. The Court ruled that claims against device manufacturers were preempted while claims against pharmaceutical manufacturers were not. The threat of product liability lawsuits promotes patient safety by encouraging manufacturers to take greater responsibility in providing clear warnings about known adverse effects of their products.

Direct-to-consumer advertising affects provider / patient relationship.

PubMed

1998-12-01

Family planning program clients are increasingly seeking oral contraceptive pills by brand name. Direct-to-consumer ads have spurred this recent increase in brand-specific requests for prescription drugs. While print consumer pitches for prescription drugs have been around for a long time, proposed guidance issued by the US Food and Drug Administration (FDA) in August 1997 allows pharmaceutical companies to more easily broadcast product claim commercials on television and radio. Now, half of all direct-to-consumer advertising dollars spent by pharmaceutical companies during January-February 1998 were directed to television ads, almost twice the share spent upon television last year. Last year, pharmaceutical companies spent more than $1 billion on direct-to-consumer advertising. The effects of this new policy are presenting in providers' offices. Before the FDA guidance, 41% of physicians participating in a national survey observed an increase in patients' requests for brand name drugs. However, since the change, 65% surveyed to date have observed an increase in such requests. With the increase in advertising comes a potential for violations of the US Food, Drug, and Cosmetic Act, which regulates provider and consumer prescription drug advertising. 125 companies were cited for violations in 1998, 6 specifically for violations connected with contraceptive information they disseminated.

78 FR 32394 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-30

... to account for the randomized, controlled, experimental design of the proposed research and..., the Agency undertook consumer research to evaluate alternatives (Refs. 1 to 3). More recently, FDA conducted qualitative consumer research on the format of the Nutrition Facts label on behalf of the Agency's...

21 CFR 810.14 - Cease distribution and notification or mandatory recall strategy.

Code of Federal Regulations, 2010 CFR

2010-04-01

... comply with the order, which FDA will fashion as appropriate for the individual circumstances of the case... mandatory recall order is to extend as follows: (A) Consumer or user level, e.g., health professionals...) Retail level, to the level immediately preceding the consumer or user level, and including any...

75 FR 15714 - Voting and Nonvoting Consumer Representative Members on Public Advisory Committees and Panels...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001... Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. The Food and... consumer interests on how to participate in the nomination and selection process for members representing...

FDA: polyurethane condom carries "extremely misleading" label. Federal agency allows distribution for public health's sake.

PubMed

1995-02-01

The labeling of the Avanti polyurethane condom selling in 10 Western states makes misleading claims about protection from pregnancy and sexually transmitted diseases (STDs) according to officials at the US Food and Drug Administration (FDA). Avanti is sold in a foil package printed with the claim that it is effective against pregnancy, HIV, and STDs. However, polyurethane condoms have not undergone clinical efficacy testing for contraception or STDs, according to officials. The manufacturer of the condom refuted this allegation, stating that latex condoms have the same claims on them. In early 1995 the FDA met with the manufacturer and other companies developing plastic condoms, and concluded that these condoms could not make such claims, nor any claims about slippage and breakage rates. Despite warnings in 1993 to the manufacturer of Avanti about labeling restrictions, the company printed pregnancy and STD efficacy claims on the boxes and individual packages. The FDA later worked out a compromise with the firm in which only the boxes had to be reprinted with the generic label. The FDA had to weigh the risk of the public health cost of delaying sale of the condom, which is the first impermeable condom proven safe for people with latex allergies. In 1991 the FDA was defining standards for clinical testing and labeling of polyurethane condoms under congressional mandate, but the manufacturer of Avanti began mass production based on a preliminary approval determining that the condom was equivalent to latex condoms already on the market. 7000 Avanti condoms were subsequently tested in five countries, but these user tests did not compare Avanti to latex condoms and did not test for pregnancy and STD protection. Test results submitted to the FDA by the company indicated that, although Avanti is more than 1/3 less elastic than latex condoms, it did not break more frequently in an in-use study involving 187 couples.

Crowdsourced earthquake early warning

USGS Publications Warehouse

Minson, Sarah E.; Brooks, Benjamin A.; Glennie, Craig L.; Murray, Jessica R.; Langbein, John O.; Owen, Susan E.; Heaton, Thomas H.; Iannucci, Robert A.; Hauser, Darren L.

2015-01-01

Earthquake early warning (EEW) can reduce harm to people and infrastructure from earthquakes and tsunamis, but it has not been implemented in most high earthquake-risk regions because of prohibitive cost. Common consumer devices such as smartphones contain low-cost versions of the sensors used in EEW. Although less accurate than scientific-grade instruments, these sensors are globally ubiquitous. Through controlled tests of consumer devices, simulation of an Mw (moment magnitude) 7 earthquake on California’s Hayward fault, and real data from the Mw 9 Tohoku-oki earthquake, we demonstrate that EEW could be achieved via crowdsourcing.

Implications of Tobacco Industry Research on Packaging Colors for Designing Health Warning Labels.

PubMed

Lempert, Lauren K; Glantz, Stanton A

2016-09-01

Health warning labels (HWLs) are an important way to educate the public about the dangers of tobacco products. Tobacco companies conducted research to understand how pack colors affect consumers' perceptions of the products and make packages and their labeling more visually prominent. We analyzed previously secret tobacco industry documents concerning the tobacco industry's internal research on how cigarette package colors and design influence the visual prominence of packages and consumers' perceptions of the harmfulness of the products. The companies found that black is visually prominent, placing dark pack elements on a contrasting light background makes them stand out more, and black text on a white background is more prominent than white text on a black background. Yellow most quickly and effectively seizes and holds consumers' attention and signals warning or danger, while white connotes health and safety. Using black text on a bright contrasting background color, particularly yellow, attracts consumers' attention to the message. Tobacco industry research on pack color choices that make pack elements more prominent, attract and keep consumers' attention, and convey danger instead of health should guide governments in specifying requirements for HWLs. These factors suggest that HWLs printed on a yellow background with black lettering and borders would most effectively seize and keep consumers' attention and signal the danger of cigarettes and other tobacco products. Tobacco companies' internal research on improving the prominence of pack elements suggests that HWLs using black lettering on a contrasting yellow background would most effectively seize and hold consumers' attention and signal the danger of cigarettes and other tobacco products. © The Author 2016. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Differences between dietary supplement and prescription drug omega-3 fatty acid formulations: a legislative and regulatory perspective.

PubMed

Collins, Nancy; Tighe, Ann P; Brunton, Stephen A; Kris-Etherton, Penny M

2008-12-01

The medical management of many diseases and conditions can include either restriction or provision of specific essential nutrients. When such nutrients are needed, there are often both prescription and nonprescription products available, as in the case of nicotinic acid or omega-3 fatty acids. Although they may seem to contain similar ingredients, there may be important differences between the prescription and dietary-supplement preparations. The manufacturing of prescription pharmaceutical products is regulated by the US Food and Drug Administration (FDA), which mandates standards for consistency and quality assurance. Dietary supplements are available to consumers under the provisions of the Dietary Supplement Health and Education Act of 1994, for which the FDA has the burden of proving a dietary supplement is harmful rather than requiring the manufacturer prove that the supplement is safe. Consumers and medical professionals should be aware of the important qualitative and quantitative differences between the FDA-approved prescription formulations and dietary supplements, particularly when an essential nutrient is part of the medical management of a disease or condition.

Hematology and pathology devices; reclassification; restricted devices; OTC test sample collection systems for drugs of abuse testing. Food and Drug Administration, HHS. Final rule.

PubMed

2000-04-07

The Food and Drug Administration (FDA) is reclassifying over-the-counter (OTC) test sample collection systems for drugs of abuse testing from class III (premarket approval) into class I (general controls) and exempting them from premarket notification (510(k)) and current good manufacturing practice (CGMP) requirements. FDA is also designating OTC test sample collection systems for drugs of abuse testing as restricted devices under the Federal Food, Drug, and Cosmetic Act (the act) and establishing restrictions intended to assure consumers that: The underlying laboratory test(s) are accurate and reliable; the laboratory performing the test(s) has adequate expertise and competency; and the product has adequate labeling and methods of communicating test results to consumers. Finally, FDA is adding a conforming amendment to the existing classification regulation for specimen transport and storage containers to clarify that it does not apply to specimen transport and storage containers that are part of an OTC test sample collection system for the purpose of testing for the presence of drugs of abuse or their metabolites in a laboratory.

Dietary Supplements are Not all Safe and Not all Food: How the Low Cost of Dietary Supplements Preys on the Consumer.

PubMed

Sax, Joanna K

2015-01-01

Dietary supplements are regulated as food, even though the safety and efficacy of some supplements are unknown. These products are often promoted as 'natural.' This leads many consumers to fail to question the supplements' safety, and some consumers even equate 'natural' with safe. But, 'natural' does not mean safe. For example, many wild berries and mushrooms are dangerous although they are natural. Another example is tobacco--a key ingredient in cigarettes: it is natural, but overwhelming studies have established the harm of cigarette smoke. The Food and Drug Administration (FDA) requires safety and efficacy testing prior to market entry for drugs. In contrast, the FDA only has limited ability to regulate the entry of new dietary supplements into the marketplace because supplements are treated as food. Two main arguments support the current regulatory structure of dietary supplements: (1) cost and (2) access. But lower cost and increased access to dietary supplements do not necessary have any relationship to safety and efficacy. Manufacturers' marketing techniques tout the health benefits of their supplements. Meanwhile, consumers are ingesting supplements without scientific studies indicating whether or not they are harmful. The FDA Food Safety and Modernization Act, signed into law on January 4, 2011, did not address the safety concerns regarding dietary supplements. This article discusses the regulatory deficiencies concerning dietary supplements and proposes novel solutions to address this specific sector of the food supply. This article advocates for the use of scientific data to support a multi-tiered classification system to ensure that dietary supplements on the market are safe.

The “Natural” vs. “Natural Flavors” Conflict in Food Labeling: A Regulatory Viewpoint.

PubMed

Goodman, Matthew J

Food branded with a Natural label can be found in any grocery store across the United States. Consumers consider this label to be an important attribute when making a purchasing decision and billions of dollars are spent annually on these products. While many consumers believe Natural foods are healthier, heavy reliance on that assumption is misguided as “Natural” has no formal legal definition—it’s merely defined pursuant to an FDA approved informal policy. Another important health attribute in a consumer’s purchasing decision is the presence of natural flavors in food. However, unlike the term Natural, FDA has promulgated legally binding regulations for natural flavors. These flavors are currently the fourth most common food ingredient listed on food labels. In reality, “natural flavors” are a far cry from what consumers might expect, as they can contain both artificial and synthetic chemicals (often used as processing aids). Nonetheless, without a legally binding Natural regulation, there has been little opportunity to contest the naturalness of natural flavors in the past. Recently, FDA has initiated a notification of request for comments on use of the term Natural, so an attempt to promulgate regulations may be underway. Thus, it is appropriate to consider where natural flavors will fall if binding regulations are set forth. This article looks at the Natural debate, its history, and model regulatory standards worth considering. Within that context, it also provides a critical discussion concerning a misunderstood, yet federally regulated, ingredient that our society so heavily consumes: natural flavors.

FDA actions against misleading or unsubstantiated economic and quality-of-life promotional claims: an analysis of warning letters and notices of violation.

PubMed

Stewart, Kate A; Neumann, Peter J

2002-01-01

The objective of this study was to understand the types of economic and quality-of-life promotional claims the FDA considers false or misleading. Publicly available FDA letters (n = 569) sent to pharmaceutical companies from 1997 through 2001 for inappropriate promotional claims were reviewed. A standard data collection form was developed, including six categories for economic violations and three for QOL violations. For QOL, only letters with explicit violations for false or misleading claims using the words "quality of life" or patient "well-being" were considered. Other information collected included type of regulatory letter and media in which violations were found. Twenty-eight (4.9%) letters cited false and/or misleading economic claims. The most common economic violation was "unsupported comparative claim of effectiveness, safety, or interchangeability" (n = 14). Twenty-eight (4.9%) letters cited QOL violations, of which four contained both economic and QOL violations. The most common QOL violation was "lack of substantial evidence for QOL claims" (n = 15). None of the FDA letters used the term "patient reported outcomes." Violations were found most frequently in brochure and Web site-based promotions. The body of evidence that is emerging illustrates how the FDA is regulating promotional material containing misleading or unsubstantiated economic and QOL claims. However, knowing what constitutes an appropriate claim remains challenging because there are no formal guidelines describing what constitutes a violation, nor what level of substantiating evidence is required. More guidance may be needed to ensure appropriate use of these claims in drug promotions.

Evaluation of Risk Versus Benefit Information in Direct-To-Consumer (DTC) Prescription Drug Television Advertisements.

PubMed

Fahim, Germin; Toscani, Michael; Barone, Joseph A; Wang, Chris; Gandhi, Shivani

2018-01-01

The FDA's Presenting Risk Information draft guidance from May 2009 states that the time of risk versus benefit is a factor taken into consideration when evaluating audio and video direct-to-consumer (DTC) broadcasts. The objective of the study is to evaluate the proportion of risk narration on television (TV) advertisements in comparison to the actual proportion of serious adverse effects findings across select therapeutic areas. The study reviews prescription drug TV advertisements between the years 2010 and 2015 separated by therapeutic class. Indicators to assess risk versus benefit are as follows: total benefit time, total risk time, total ad time, percentage proportion of risk, and number of serious adverse effects (SAEs) listed in the package insert. The objective is establishing proportion of risk-to-benefit narration across therapeutic areas and the proportion of risk narration compared to the number of SAEs in the package insert. These outcomes will reflect whether TV advertisements abide by the "fair balance" rule and if the time spent on risk narrations is proportional to the number of SAEs across therapeutic areas. An analysis of risk versus benefit showed that there was a vast range of percentage differences in risk versus benefit narration across the products selected. The majority of the products narrated showed a 40% to 60% risk-to-benefit ratio. Six out of the 10 products evaluated communicated applicable black box warnings. There was variability among the SAE percentages presented between products. Lack of consistency exists between risks versus benefit proportions among different drug products.

77 FR 38303 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-27

...The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Experimental Study: Effect of Promotional Offers in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Product Perceptions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Drugs and Diseases Interacting with Cigarette Smoking in US Prescription Drug Labelling.

PubMed

Li, Haibo; Shi, Qiang

2015-05-01

The US Food and Drug Administration (FDA) draft guidance for industry on drug interaction studies recommends, but does not mandate, that both cigarette smokers and non-smokers can be used to study drug metabolism in clinical trials, and that important results related to smoking should be included in drug labelling to guide medication usage. This study aimed to provide a comprehensive review of drugs or diseases interacting with smoking, as presented in all US drug labelling. The 62,857 drug labels deposited in the FDA Online Label Repository were searched using the keywords 'smoke', 'smoker(s)', 'smoking', 'tobacco' and 'cigarette(s)' on 19 June 2014. The resultant records were refined to include only human prescription drug labelling, for manual examination. For 188 single-active-ingredient drugs and 36 multiple-active-ingredient drugs, the labelling was found to contain smoking-related information. The pharmacokinetics of 29 and 21 single-active-ingredient drugs were affected and unaffected, respectively, by smoking. For the remaining drugs, the provided information related to smoking affecting efficacy, safety or diseases but not pharmacokinetics. Depending on the nature of specific drugs, the perturbation in pharmacokinetic parameters in smokers ranged from 13 to 500%, in comparison with non-smokers. Dosage modifications in smokers are necessary for four drugs and may be necessary for six drugs, but are unnecessary for seven drugs although the pharmacokinetic parameters of four of them are affected by smoking. Cigarette smoking is a risk factor for 16 types of diseases or adverse drug reactions. For one single-active-ingredient contraceptive drug and 10 multiple-active-ingredient contraceptive drugs, a black box warning (the FDA's strongest safety warning) is included in the labelling for increased risks of heart attacks and strokes in female smokers, and "women are strongly advised not to smoke" when using these drugs. This study presents the first comprehensive overview of cigarette smoking interacting with drugs and/or diseases, as presented in US drug labelling.

An exploration of counterfeit medicine surveillance strategies guided by geospatial analysis: lessons learned from counterfeit Avastin detection in the US drug supply chain.

PubMed

Cuomo, Raphael E; Mackey, Tim K

2014-12-02

To explore healthcare policy and system improvements that would more proactively respond to future penetration of counterfeit cancer medications in the USA drug supply chain using geospatial analysis. A statistical and geospatial analysis of areas that received notices from the Food and Drug Administration (FDA) about the possibility of counterfeit Avastin penetrating the US drug supply chain. Data from FDA warning notices were compared to data from 44 demographic variables available from the US Census Bureau via correlation, means testing and geospatial visualisation. Results were interpreted in light of existing literature in order to recommend improvements to surveillance of counterfeit medicines. This study analysed 791 distinct healthcare provider addresses that received FDA warning notices across 30,431 zip codes in the USA. Statistical outputs were Pearson's correlation coefficients and t values. Geospatial outputs were cartographic visualisations. These data were used to generate the overarching study outcome, which was a recommendation for a strategy for drug safety surveillance congruent with existing literature on counterfeit medication. Zip codes with greater numbers of individuals age 65+ and greater numbers of ethnic white individuals were most correlated with receipt of a counterfeit Avastin notice. Geospatial visualisations designed in conjunction with statistical analysis of demographic variables appeared more capable of suggesting areas and populations that may be at risk for undetected counterfeit Avastin penetration. This study suggests that dual incorporation of statistical and geospatial analysis in surveillance of counterfeit medicine may be helpful in guiding efforts to prevent, detect and visualise counterfeit medicines penetrations in the US drug supply chain and other settings. Importantly, the information generated by these analyses could be utilised to identify at-risk populations associated with demographic characteristics. Stakeholders should explore these results as another tool to improve on counterfeit medicine surveillance. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Elderly Patients with Dementia-Related Symptoms of Severe Agitation and Aggression: Consensus Statement on Treatment Options, Clinical Trials Methodology, and Policy

PubMed Central

Salzman, C; Jeste, D; Meyer, RE; Cohen-Mansfield, J; Cummings, J; Grossberg, G; Jarvik, L; Kraemer, H; Lebowitz, B; Maslow, K; Pollock, B; Raskind, M; Schultz, S; Wang, P; Zito, JM; Zubenko, GS

2009-01-01

Atypical antipsychotic drugs have been used off-label in clinical practice for treatment of serious dementia-associated agitation and aggression. Following reports of cerebrovascular adverse events associated with the use of atypical antipsychotic in elderly patients with dementia, the FDA issued black box warnings for several atypical antipsychotics, titled “Cerebrovascular Adverse Events, including Stroke, in Elderly Patients with Dementia.” Subsequently, the FDA initiated a meta-analysis of safety data from 17 registration trials across six antipsychotic drugs (five atypical antipsychotics and haloperidol). In 2005, the Agency issued a black box warning regarding increased risk of mortality associated with the use of atypical antipsychotic drugs in this patient population. Geriatric mental health experts participating in a 2006 consensus conference reviewed evidence on the safety and efficacy of antipsychotics, as well as nonpharmacologic approaches, in treating dementia-related symptoms of agitation and aggression. They concluded that, while problems in clinical trials design may have been one of the contributors to the failure to find a signal of drug efficacy, the findings related to drug safety should be taken seriously by clinicians in assessing the potential risks and benefits of treatment in a frail population, and in advising families about treatment. Information provided to patients and family members should be documented in the patient’s chart. Drugs should be used only when non-pharmacologic approaches have failed to adequately control behavioral disruption. Participants also agreed that that there is a need for an FDA-approved medication for the treatment of severe, persistent or recurrent dementia-related symptoms of agitation and aggression (even in the absence of psychosis), that are unresponsive to nonpharmacologic intervention. The authors have outlined methodological enhancements to better evaluate treatment approaches in future registration trials, and they provided an algorithm for improving the treatment of these patients in nursing home and non-nursing home settings. PMID:18494535

Mycophenolate fetal toxicity and risk evaluation and mitigation strategies.

PubMed

Kim, M; Rostas, S; Gabardi, S

2013-06-01

The mycophenolic acid (MPA) preparations are one of the most commonly used immunosuppressants in the United States. However, these agents carry a black box warning regarding their use during pregnancy due to an association with increased risk of miscarriage and congenital defects. To ensure that the benefits of MPA outweigh the risks, the Food and Drug Administration (FDA) required all manufacturers of MPA products to propose risk evaluation and mitigation strategies (REMS). Four years after initially calling for proposals, the FDA approved a single shared REMS system in September 2012. The elements of the MPA REMS include a medication guide and elements to assure safe use (ETASU). The medication guide, which was previously FDA-approved in 2008, should continue to be distributed to patients, and the ETASU requires physicians to complete training and obtain patient signatures on the "Patient-Prescriber Acknowledgement Form." A single, national, voluntary pregnancy registry is available, and pregnant patients should be encouraged to participate. Although the impact of the MPA REMS on clinical practice is not clear, it is a step toward increasing the understanding of fetal risks with MPA products among patients and possibly practitioners. © Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons.

Differences in reproductive toxicology between alopecia drugs: an analysis on adverse events among female and male cases

PubMed Central

Li, Qingfeng

2016-01-01

Alopecia is a dermatological condition with limited therapeutic options. Only two drugs, finasteride and minoxidil, are approved by FDA for alopecia treatment. However, little is known about the differences in adverse effects between these two drugs. We examined the clinical reports submitted to the FDA Adverse Event Reporting System (FAERS) from 2004 to 2014. For both female and males, finasteride was found to be more associated with reproductive toxicity as compared to minoxidil. Among male alopecia cases, finasteride was significantly more concurrent with several forms of sexual dysfunction. Among female alopecia cases, finasteride was significantly more concurrent with harm to fetus and disorder of uterus. In addition, drug-gene network analysis indicated that finasteride could profoundly disturb pathways related to sex hormone signaling and oocyte maturation. These findings could provide clues for subsequent toxicological research. Taken together, this analysis suggested that finasteride could be more liable to various reproductive adverse effects. Some of these adverse effects have yet to be warned in FDA-approved drug label. This information can help improve the treatment regimen of alopecia and post-marketing regulation of drug products. PMID:27738338

Rooting out institutional corruption to manage inappropriate off-label drug use.

PubMed

Rodwin, Marc A

2013-01-01

Prescribing drugs for uses that the FDA has not approved - off-label drug use - can sometimes be justified but is typically not supported by substantial evidence of effectiveness. At the root of inappropriate off-label drug use lie perverse incentives for pharmaceutical firms and flawed oversight of prescribing physicians. Typical reform proposals such as increased sanctions for manufacturers might reduce the incidence of unjustified off-label use, but they do not remove the source of the problem. Public policy should address the cause and control the practice. To manage inappropriate off-label drug use, off-label prescriptions must be tracked in order to monitor the risks and benefits and the manufacturers' conduct. Even more important, reimbursement rules should be changed so that manufacturers cannot profit from off-label sales. When off-label sales pass a critical threshold, manufacturers should also be required to pay for independent testing of the safety and effectiveness of off-label drug uses and for the FDA to review the evidence. Manufacturers should also finance, under FDA supervision, programs designed to warn physicians and the public about the risks of off-label drug use. © 2013 American Society of Law, Medicine & Ethics, Inc.

Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies.

PubMed

Nguyen, Diane; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Montagne, Michael

2013-01-22

The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA's first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA.This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997-2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997-2000) the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001-2008) it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009-2011) it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3 ± 36.4), Bush (29.5 ± 16.2) and Obama (41.7 ± 11.1). Most regulatory letters released by FDA headquarters were related to marketing and advertising activities of pharmaceutical companies. The number of regulatory letters was highest during the second Clinton administration, diminished during the Bush administrations, and increased again during the Obama administration. A further assessment of the impact of changes in federal administration on the enforcement activities of the FDA is required.

Right to experimental treatment: FDA new drug approval, constitutional rights, and the public's health.

PubMed

Leonard, Elizabeth Weeks

2009-01-01

On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have lawmakers on both sides of the aisle in Congress. But proponents of expanded access fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the study's outcome and the health of patients who might benefit from the deliberate, careful process of new drug approval as it currently operates under FDA's auspices.

Oats

MedlinePlus

... saturated fat. For each gram of soluble fiber (beta-glucan) consumed, total cholesterol decreases by about 1.42 ... total cholesterol than foods containing oat bran plus beta-glucan soluble fiber. The FDA recommends that approximately 3 ...

Adverse drug events and the Freedom of Information Act: an apple in Eden.

PubMed

Stang, P E; Fox, J L

1992-02-01

To review some of the abuses and proper uses of the Food and Drug Administration's (FDA's) spontaneous adverse-reaction reporting system, as a way of educating the reader to its strengths and limitations. Published literature and reports based on information obtained from the FDA's database of spontaneous adverse drug-event reports. The Freedom of Information Act has increased public access to the FDA's database of spontaneous adverse drug reaction reports. As these reports are voluntarily received and reported to the FDA, their use for comparisons of drug safety is severely limited. Despite these limitations and the FDA's caveats for use of these data, consumer advocacy groups, researchers, and various pharmaceutical marketing groups have used this source to project the incidence of adverse drug reactions. The FDA's spontaneous adverse-event reporting system is designed to generate signals of unexpected adverse drug events. Use of the data gathered by this system to make drug safety comparisons is beyond their credible scope because many factors influence the reporting of adverse events. Researchers and peer reviewers should place these data in the proper perspective and support sound research into questions of drug safety.

Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines.

PubMed

Klara, Kristina; Kim, Jeanie; Ross, Joseph S

2018-05-01

Direct-to-consumer (DTC) advertisements for prescription drugs in the United States are regulated by the Food and Drug Administration (FDA). Off-label promotion, or the advertisement of a drug for an indication not approved by the FDA, is prohibited. Our objective was to examine the presence of off-label promotion in broadcast DTC ads and to assess their adherence to FDA guidelines mandating fair balance in presentation of risks and benefits and prohibiting misleading advertisement claims. All English-language broadcast DTC ads for prescription drugs that aired in the United States from January 2015 to July 2016 were obtained from AdPharm, an online collection of healthcare advertisements. Ad length was measured and adherence to FDA guidelines was assessed for several categories: key regulatory items, indicators of false or misleading ads, and indicators of fair balance in presentation of risks and benefits. Our sample included 97 unique DTC ads, representing 60 unique drugs and 67 unique drug-indication combinations. No ads described drug risks quantitatively, whereas drug efficacy was presented quantitatively in 25 (26%) ads. Thirteen (13%) ads, all for diabetes medications, suggested off-label uses for weight loss and blood pressure reduction. The most commonly advertised drugs were indicated for the treatment of inflammatory conditions (n = 12; 18%), diabetes or diabetic neuropathy (n = 11; 16%), bowel or bladder dysfunction (n = 6; 9%), and infections or allergic reaction (n = 6; 9%). More than three-quarters (n = 51; 76%) advertised drugs to treat chronic conditions. Few broadcast DTC ads were fully compliant with FDA guidelines. The overall quality of information provided in ads was low, and suggestions of off-label promotion were common for diabetes medications. The impact of current DTC ads and off-label marketing on patient and prescriber decisions merits further scrutiny.

Cigarette packaging and health warnings: the impact of plain packaging and message framing on young smokers

PubMed Central

Mays, Darren; Niaura, Raymond S.; Evans, W. Douglas; Hammond, David; Luta, George; Tercyak, Kenneth P.

2014-01-01

Objective This study examined the impact of pictorial cigarette warning labels, warning label message framing, and plain cigarette packaging on young adult smokers’ motivation to quit. Methods Smokers ages 18–30 (n=740) from a consumer research panel were randomized to one of four experimental conditions where they viewed online images of 4 cigarette packs with warnings about lung disease, cancer, stroke/heart disease, and death, respectively. Packs differed across conditions by warning message framing (gain versus loss) and packaging (branded versus plain). Measures captured demographics, smoking behavior, covariates, and motivation to quit in response to cigarette packs. Results Pictorial warnings about lung disease and cancer generated the strongest motivation to quit across conditions. Adjusting for pre-test motivation and covariates, a message framing by packaging interaction revealed gain-framed warnings on plain packs generated greater motivation to quit for lung disease, cancer, and mortality warnings (p < 0.05), compared with loss-framed warnings on plain packs. Conclusions Warnings combining pictorial depictions of smoking-related health risks with text-based messages about how quitting reduces risks may achieve better outcomes among young adults, especially in countries considering or implementing plain packaging regulations. PMID:24420310

The Role of Adverse Event Reporting in the FDA Response to a Multistate Outbreak of Liver Disease Associated with a Dietary Supplement

PubMed Central

DeBeck, Heidi J.; LeBlanc, Pamela; Mogen, Kathryn M.; Wolpert, Beverly J.; Sabo, Jonathan L.; Salter, Monique; Seelman, Sharon L.; Lance, Susan E.; Monahan, Caitlin; Steigman, David S.; Gensheimer, Kathleen

2015-01-01

Objective Liver disease is a potential complication from using dietary supplements. This study investigated an outbreak of non-viral liver disease associated with the use of OxyELITE ProTM, a dietary supplement used for weight loss and/or muscle building. Methods Illness details were ascertained from MedWatch reports submitted to the U.S. Food and Drug Administration (FDA) describing consumers who ingested OxyELITE Pro alone or in combination with other dietary supplements. FDA's Forensic Chemistry Center analyzed samples of OxyELITE Pro. Results From February 2012 to February 2014, FDA received 114 reports of adverse events of all kinds involving consumers who ingested OxyELITE Pro. The onset of illness for the first report was December 2010 and for the last report was January 2014. Thirty-three states, two foreign nations, and Puerto Rico submitted reports. Fifty-five of the reports (48%) described liver disease in the absence of viral infection, gallbladder disease, autoimmune disease, or other known causes of liver damage. A total of 33 (60%) of these patients were hospitalized, and three underwent liver transplantation. In early 2013, OxyELITE Pro products entered the market with a formulation distinct from products sold previously. The new formulation replaced 1,3-dimethylamylamine with aegeline. However, the manufacturer failed to submit to FDA a required “new dietary ingredient” notice for the use of aegeline in OxyELITE Pro products. Laboratory analysis identified no drugs, poisons, pharmaceuticals, toxic metals, usnic acid, N-Nitroso-fenfluramine, pyrrolizidine alkaloids, aristocholic acid, or phenethylamines in the products. Conclusions Vigilant surveillance is required for adverse events linked to the use of dietary supplements. PMID:26327730

The legal and economic forces that will shape the international market for cybersurgery.

PubMed

McLean, Thomas R

2006-12-01

Despite the common use of medical devices most health care providers have little understanding how a device alters medical malpractice litigation. Such knowledge will be increasingly valuable as cybersurgery (i.e. remote robotic surgery) becomes routine. Review of the laws governing products and telecommunication liability. Litigation after cybersurgery will be complex. In addition to being able to sue physicians and hospitals, patients who sustain an adverse outcome after cybersurgery will have the potential to sue the robotic manufacturer and telecommunication company. Robotics manufacturers can obtain virtual immunity from liability if they elected to place their devices on the market after obtaining [see text]360 per-market approval from the FDA. However, because [see text]360 pre-market approval is expensive and time consuming most medical devices on the market (including the robotic surgical instruments) do not have immunity to products liability. Consequently, after an adverse cybersurgical outcome a manufacturer of a robotic surgical instrument faces liability for failure to warn, design defects, and failure to properly manufacture. As for telecommunication providers, existing law provides them with immunity from liability. Litigation following cybersurgery will involve multiple defendants who are likely to use "finger pointing" defenses. Accordingly, there will be liability traps associated with providing cybersurgery. Copyright 2006 John Wiley & Sons, Ltd.

Refuting the ticagrelor-aspirin black box warning: and proposing a ticagrelor early-PCI black box warning.

PubMed

DiNicolantonio, James J; Serebruany, Victor L; Tomek, Ales

2013-10-03

Ticagrelor, a novel reversible antiplatelet agent, has a black box warning to avoid maintenance doses of aspirin>100mg. However, a significant ticagrelor-early percutaneous coronary intervention (PCI) interaction exists. To discuss the inappropriateness of the black box warning for aspirin doses>100mg with ticagrelor and the appropriateness (and need) for a black box warning for ticagrelor patients needing early (within 24 hours of randomization) PCI. The FDA Complete Response Review for ticagrelor indicates that aspirin doses ≥ 300 mg/daily was not a significant interaction. In the ticagrelor-aspirin ≥ 300 mg cohort, all-cause mortality (through study end) and cardiovascular (CV) mortality (through study end) were not significantly increased (HR=1.27; 95% CI, 0.84-1.93, p=0.262 and HR=1.39; 95% CI:0.87-2.2, p=0.170), respectively. However, in patients treated with early (within 24 hours) PCI, ticagrelor significantly increased all-cause mortality (30 day: HR=1.89; 95% CI: 1.26-2.81, p=0.002, and through study end, HR=1.41; 95% CI,1.08-1.84, p=0.012) and increased CV mortality (30 day: HR=1.31; 95% CI: 0.97-1.77, p=0.075, and through study end, HR=1.35; 95% CI, 0.995-1.82, p=0.054) compared to clopidogrel. Early-PCI was more prevalent in the US versus outside-US regions (61% versus 49%). The black box warning for the use of maintenance aspirin doses over 100mg/daily with ticagrelor is inappropriate and ignores the more important, credible, and highly significant ticagrelor-early PCI adverse interaction in PLATO. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Use of the chloroplast gene ycf1 for the genetic differentiation of pine nuts obtained from consumers experiencing dysgeusia.

PubMed

Handy, Sara M; Parks, Matthew B; Deeds, Jonathan R; Liston, Aaron; de Jager, Lowri S; Luccioli, Stefano; Kwegyir-Afful, Ernest; Fardin-Kia, Ali R; Begley, Timothy H; Rader, Jeanne I; Diachenko, Gregory W

2011-10-26

Pine nuts are a part of traditional cooking in many parts of the world and have seen a significant increase in availability/use in the United States over the past 10 years. The U.S. Food and Drug Administration (US FDA) field offices received 411 complaints from U.S. consumers over the past three years regarding taste disturbances following the consumption of pine nuts. Using analysis of fatty acids by gas chromatography with flame ionization detection, previous reports have implicated nuts from Pinus armandii (Armand Pine) as the causative species for similar taste disturbances. This method was found to provide insufficient species resolution to link FDA consumer complaint samples to a single species of pine, particularly when samples contained species mixtures of pine nuts. Here we describe a DNA based method for differentiating pine nut samples using the ycf1 chloroplast gene. Although the exact cause of pine nut associated dysgeusia is still not known, we found that 15 of 15 samples from consumer complaints contained at least some Pinus armandii, confirming the apparent association of this species with taste disturbances.

Reversal of oxycodone and hydrocodone tolerance by diazepam.

PubMed

Gonek, Maciej; Akbarali, Hamid I; Henderson, Graeme; Dewey, William L

2017-11-01

The Centers for Disease Control has declared opioid abuse to be an epidemic. Overdose deaths are largely assumed to be the result of excessive opioid consumption. In many of these cases, however, opioid abusers are often polydrug abusers. Benzodiazepines are one of the most commonly co-abused substances and pose a significant risk to opioid users. In 2016, the FDA required boxed warnings - the FDA's strongest warning - for prescription opioid analgesics and benzodiazepines about the serious risks associated with using these medications at the same time. The point of our studies was to evaluate the interactions between these two classes of drugs. We investigated whether diazepam adds to the depressant effects of opioids or do they alter the levels of tolerance to opioids. In the present study, we have found that the antinociceptive tolerance that developed to repeated administration of oxycodone was reversed by an acute dose of diazepam. Antinociceptive tolerance to hydrocodone was also reversed by acute injection of diazepam; however, a fourfold higher dose of diazepam was required when compared to reversal of oxycodone-induced tolerance. These doses of diazepam did not potentiate the acute antinociceptive effect of either opioid. The same dose of diazepam that reversed oxycodone antinociceptive tolerance also reversed oxycodone locomotor tolerance while having no potentiating effects. These studies show that diazepam does not potentiate the acute effect of prescription opioids but reverses the tolerance developed after chronic administration of the drugs. Copyright © 2017 Elsevier B.V. All rights reserved.

Analyzing temozolomide medication errors: potentially fatal.

PubMed

Letarte, Nathalie; Gabay, Michael P; Bressler, Linda R; Long, Katie E; Stachnik, Joan M; Villano, J Lee

2014-10-01

The EORTC-NCIC regimen for glioblastoma requires different dosing of temozolomide (TMZ) during radiation and maintenance therapy. This complexity is exacerbated by the availability of multiple TMZ capsule strengths. TMZ is an alkylating agent and the major toxicity of this class is dose-related myelosuppression. Inadvertent overdose can be fatal. The websites of the Institute for Safe Medication Practices (ISMP), and the Food and Drug Administration (FDA) MedWatch database were reviewed. We searched the MedWatch database for adverse events associated with TMZ and obtained all reports including hematologic toxicity submitted from 1st November 1997 to 30th May 2012. The ISMP describes errors with TMZ resulting from the positioning of information on the label of the commercial product. The strength and quantity of capsules on the label were in close proximity to each other, and this has been changed by the manufacturer. MedWatch identified 45 medication errors. Patient errors were the most common, accounting for 21 or 47% of errors, followed by dispensing errors, which accounted for 13 or 29%. Seven reports or 16% were errors in the prescribing of TMZ. Reported outcomes ranged from reversible hematological adverse events (13%), to hospitalization for other adverse events (13%) or death (18%). Four error reports lacked detail and could not be categorized. Although the FDA issued a warning in 2003 regarding fatal medication errors and the product label warns of overdosing, errors in TMZ dosing occur for various reasons and involve both healthcare professionals and patients. Overdosing errors can be fatal.

Promotion of prescription drugs to consumers.

PubMed

Rosenthal, Meredith B; Berndt, Ernst R; Donohue, Julie M; Frank, Richard G; Epstein, Arnold M

2002-02-14

Spending on prescription drugs is the fastest growing component of the health care budget. There is public concern about the possibility that direct-to-consumer advertising of prescription drugs will result in inappropriate prescribing and higher costs of care. Guidelines issued in 1997 by the Food and Drug Administration (FDA) regarding advertising to consumers through electronic media are considered by some to be responsible for unleashing a flood of direct-to-consumer advertising. Using data on spending for promotional purposes and sales of prescription drugs, we examined industrywide trends for various types of promotion. We also tracked the relation between promotional efforts and sales over time. Finally, we documented the variation in direct-to-consumer advertising among and within five therapeutic classes of drugs and compared the variation in the intensity of such advertising with variation in the intensity of promotion to health care professionals. Annual spending on direct-to-consumer advertising for prescription drugs tripled between 1996 and 2000, when it reached nearly $2.5 billion. Despite this increase, such advertising accounts for only 15 percent of the money spent on drug promotion and is highly concentrated on a subgroup of products. Within a therapeutic class, there is marked variation in the intensity of direct-to-consumer advertising, and the amount of such advertising for specific products fluctuates over time. The initial surge in direct-to-consumer advertising preceded the 1997 FDA guidelines that clarified the rules for electronic direct-to-consumer advertising, and thus the 1997 guidelines may not have been the most important reason for the overall increase. Although the use of direct-to-consumer advertising has grown disproportionately to other forms of promotion, it continues to account for a small proportion of total promotional efforts. Nevertheless, physicians must assist patients in evaluating health-related information obtained through direct advertising.

Fair Balance and Adequate Provision in Direct-to-Consumer Prescription Drug Online Banner Advertisements: A Content Analysis.

PubMed

Adams, Crystal

2016-02-18

The current direct-to-consumer advertising (DTCA) guidelines were developed with print, television, and radio media in mind, and there are no specific guidelines for online banner advertisements. This study evaluates how well Internet banner ads comply with existing Food and Drug Administration (FDA) guidelines for DTCA in other media. A content analysis was performed of 68 banner advertisements. A coding sheet was developed based on (1) FDA guidance documents for consumer-directed prescription drug advertisements and (2) previous DTCA content analyses. Specifically, the presence of a brief summary detailing the drug's risks and side effects or of a "major statement" identifying the drug's major risks, and the number and type of provisions made available to consumers for comprehensive information about the drug were coded. In addition, the criterion of "fair balance," the FDA's requirement that prescription drug ads balance information relating to the drug's risks with information relating to its benefits, was measured by numbering the benefit and risk facts identified in the ads and by examining the presentation of risk and benefit information. Every ad in the sample included a brief summary of risk information and at least one form of adequate provision as required by the FDA for broadcast ads that do not give audiences a brief summary of a drug's risks. No ads included a major statement. There were approximately 7.18 risk facts for every benefit fact. Most of the risks (98.85%, 1292/1307) were presented in the scroll portion of the ad, whereas most of the benefits (66.5%, 121/182) were presented in the main part of the ad. Out of 1307 risk facts, 1292 were qualitative and 15 were quantitative. Out of 182 benefit facts, 181 were qualitative and 1 was quantitative. The majority of ads showed neutral images during the disclosure of benefit and risk facts. Only 9% (6/68) of the ads displayed positive images and none displayed negative images when presenting risks facts. When benefit facts were being presented, 7% (5/68) showed only positive images. No ads showed negative images when the benefit facts were being presented. In the face of ambiguous regulatory guidelines for online banner promotion, drug companies appear to make an attempt to adapt to regulatory guidelines designed for traditional media. However, banner ads use various techniques of presentation to present the advertised drug in the best possible light. The FDA should formalize requirements that drug companies provide a brief summary and include multiple forms of adequate provision in banner ads.

FDA actions against health economic promotions, 2002-2011.

PubMed

Neumann, Peter J; Bliss, Sarah K

2012-01-01

To investigate Food and Drug Administration (FDA) regulatory actions against drug companies' health economic promotions from 2002 through 2011 to understand how frequently and in what circumstances the agency has considered such promotions false or misleading. We reviewed all warning letters and notices of violation ("untitled letters") issued by the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) to pharmaceutical companies from January 2002 through December 2011. We analyzed letters containing a violation related to "health economic promotion," defined according to one of several categories (e.g., implied claims of cost savings due to work productivity or economic claims containing unsupported statements about effectiveness or safety). We also collected information on factors such as the indication and type of media involved and whether the letter referenced Section 114 of the Food and Drug Administration Modernization Act. Of 291 DDMAC letters sent to pharmaceutical companies during the study period, 35 (12%) cited a health economic violation. The most common type of violation cited was an implied claim of cost savings due to work productivity or functioning (found in 20 letters) and economic claims containing unsubstantiated comparative claims of effectiveness, safety, or interchangeability (7 letters). The violations covered various indications, mostly commonly psychiatric disorders (6 letters) and pain (6 letters). No DDMAC letter pertained to Food and Drug Administration Modernization Act Section 114. The FDA has cited inappropriate health economic promotions in roughly 12% of the letters issued by the DDMAC. The letters highlight drug companies' interest in promoting the value of their products and the FDA's concerns in certain cases about the lack of supporting evidence. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Impact of the 2011 FDA transvaginal mesh safety update on AUGS members' use of synthetic mesh and biologic grafts in pelvic reconstructive surgery.

PubMed

Clemons, Jeffrey L; Weinstein, Milena; Guess, Marsha K; Alperin, Marianna; Moalli, Pamela; Gregory, William Thomas; Lukacz, Emily S; Sung, Vivian W; Chen, Bertha H; Bradley, Catherine S

2013-01-01

To describe the frequency of use and recent change in use of synthetic mesh and biologic grafts in pelvic organ prolapse (POP) and stress urinary incontinence surgery by American Urogynecology Society (AUGS) members. An electronic survey of AUGS members was conducted between December 2011 and January 2012. Frequency of graft use in POP (overall and by transvaginal and transabdominal approaches) and stress urinary incontinence surgery was queried relative to the timing of the 2011 Food and Drug Administration (FDA) safety update. Rates of materials' use before and after the statement were compared using Wilcoxon signed rank test. Fifty-three percent (507/962) of AUGS members responded and were included in analysis; 79% were urogynecologists. Before the FDA warning, in POP surgery, most (90%) used synthetic mesh and fewer (34%) used biologic grafts; 99% used synthetic mesh slings. After the FDA statement, respondents reported an overall decrease in the percent of POP cases in which they used synthetic mesh (P < 0.001) but no change in biologic graft use for POP (P = 0.37) or synthetic mesh sling use (P = 0.10). Specifically, transvaginal mesh use decreased: 40% reported decreased use and 12% stopped use. However, transvaginal mesh was still used by 61% of respondents in at least some cases. No change (62%) or increased use (12%) of mesh was reported for transabdominal POP procedures. Synthetic mesh use in transvaginal POP surgery decreased after the 2011 FDA safety update, but synthetic mesh use for transabdominal POP repair and sling procedures and overall biologic graft use in POP surgery did not decrease.

Pictorial Health Warning Label Content and Smokers' Understanding of Smoking-Related Risks--A Cross-Country Comparison

ERIC Educational Resources Information Center

Swayampakala, Kamala; Thrasher, James F.; Hammond, David; Yong, Hua-Hie; Bansal-Travers, Maansi; Krugman, Dean; Brown, Abraham; Borland, Ron; Hardin, James

2015-01-01

The aim of the present study was to assess smokers' level of agreement with smoking-related risks and toxic tobacco constituents relative to inclusion of these topics on health warning labels (HWLs). 1000 adult smokers were interviewed between 2012 and 2013 from online consumer panels of adult smokers from each of the three countries: Australia…

Reactions to Graphic Health Warnings in the United States

ERIC Educational Resources Information Center

Nonnemaker, James M.; Choiniere, Conrad J.; Farrelly, Matthew C.; Kamyab, Kian; Davis, Kevin C.

2015-01-01

This study reports consumer reactions to the graphic health warnings selected by the Food and Drug Administration to be placed on cigarette packs in the United States. We recruited three sets of respondents for an experimental study from a national opt-in e-mail list sample: (i) current smokers aged 25 or older, (ii) young adult smokers aged 18-24…

Diet pills and the cataract outbreak of 1935: reflections on the evolution of consumer protection legislation.

PubMed

Margo, Curtis E; Harman, Lynn E

2014-01-01

An outbreak of cataracts in 1935 caused by dinitrophenol (DNP), the active ingredient of popular diet pills, highlighted the inability of the U.S. Food and Drug Administration (FDA) to prevent harmful drugs from entering the marketplace. Just two years earlier, the FDA used horrific images of ocular surface injury caused by cosmetics at the World's Fair in Chicago to garner public support for legislative reform. The FDA had to walk a fine line between a public awareness campaign and lobbying Congress while lawmakers debated the need for consumer protection. The cataract outbreak of 1935 was conspicuous in the medical literature during the height of New Deal legislation, but questions persist as to how much it affected passage of the proposed Food, Drug, and Cosmetic Act (of 1938). The legislation languished in committee for years. The cataract outbreak probably had little impact on the eventual outcome, but medical opinion concerning the safety of DNP may have contributed to the voluntary withdrawal of the diet drug from the market. We review the DNP cataract outbreak and examine it in context of the challenges facing regulatory reform at that time. Copyright © 2014 Elsevier Inc. All rights reserved.

Regulatory Challenges for Cartilage Repair Technologies.

PubMed

McGowan, Kevin B; Stiegman, Glenn

2013-01-01

In the United States, few Food and Drug Administration (FDA)-approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product's attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible.

Regulatory Challenges for Cartilage Repair Technologies

PubMed Central

Stiegman, Glenn

2013-01-01

In the United States, few Food and Drug Administration (FDA)–approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product’s attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible. PMID:26069647

Scouting For Approval: Lessons on Medical Device Regulation in an Era of Crowdfunding from Scanadu's "Scout".

PubMed

Smith, Colleen

2015-01-01

Internet crowdfunding, a new and increasingly popular method of raising capital to develop products and businesses, has recently come into conflict with the Food and Drug Administration's (FDA's) regulation of medical devices. This Article examines the issues that arise when companies pre-sell medical devices via crowdfunding campaigns before gaining FDA approval of the devices. Because Internet crowdfunding has only been in use for a few years, little has been written about it academically, particularly about its interaction with FDA regulations. The rising interest in crowdfunding, coupled with the downturn in investment in the American medical device industry, make this a salient issue that is ripe for FDA review. This Article uses the crowdfunding campaign Scanadu, a medical device company, conducted in 2013 to raise money to develop its in-home diagnostic device, the "Scout," as a starting point for this analysis. Because it is extremely costly to develop a device and obtain FDA approval, medical device companies should be able to utilize crowdfunding to raise the necessary capital. However, because of the possible dangers medical devices pose, FDA needs to review the risks created by allowing companies to crowdfund medical devices and should issue guidance to help companies comply with FDA regulations while still allowing them to take advantage of the benefits of crowdfunding. This guidance should ensure the continued commitment to consumer safety that is at the core of FDA regulation.

Patient autonomy and the regulation of direct-to-consumer advertising.

PubMed

Zachry, W M; Ginsburg, D B

2001-12-01

The current direction of the US Food and Drug Administration (FDA) policy on direct-to-consumer advertising (DTCA) of pharmaceuticals is a subject of debate. The literature addresses the benefits and drawbacks of DTCA, but the foundations for such policies have not been investigated in detail. This paper explores the most recent FDA guidance on broadcast DTCA based on a critical examination of the principle of autonomy. Autonomy is determined not by the ability to choose a therapy, but by the ability to actively participate in choices about health care. DTCA can be an effective tool to increase patient awareness of their therapeutic choices, encourage patients to seek more information, and help them draw closer to autonomous choices, but only if the presentations provide fair and balanced information on the benefits and risks of therapy.

Hysteroscopic Sterilization With Essure: Summary of the U.S. Food and Drug Administration Actions and Policy Implications for Postmarketing Surveillance.

PubMed

Walter, Jessica R; Ghobadi, Comeron W; Hayman, Emily; Xu, Shuai

2017-01-01

In September 2015, the U.S. Food and Drug Administration (FDA) convened a meeting of the Obstetrics and Gynecology Advisory Board Committee to address the sudden increase of patient-reported adverse events surrounding Essure, a Class III device offering a less invasive method for permanent female sterilization. After a review of the premarketing and postmarketing data and existing scientific literature, the FDA concluded there was insufficient evidence to remove the device from the market. However, the FDA did release a new guidance document requiring a black box warning for the device and ordered a new postmarketing study comparing Essure's safety and efficacy with laparoscopic tubal sterilization. The device was first approved in 2002 based on nonrandomized, single-arm prospective clinical studies. Since its approval, the device has grown in popularity, particularly in the United States. The driving forces for the sudden increase in adverse event reporting starting in 2013 related to the device remain unclear. Until completion of the new postmarketing study, there will continue to be significant uncertainty of the technology's risk-benefit profile. The controversy with Essure underscores the need for obstetricians and gynecologists to be actively involved in the lifecycle of medical devices. This includes actively reporting adverse events associated with devices to the FDA, supporting the implementation of unique device identifiers enriched with clinical records and paired with insurance claims, and stewarding robust device-specific registries.

Comprehending product warning information: age-related effects and the roles of memory, inferencing, and knowledge.

PubMed

Hancock, Holly E; Fisk, Arthur D; Rogers, Wendy A

2005-01-01

Two experiments were conducted to determine if age affects comprehension for explicit and implied warning information and, if so, to reveal the nature of such effects. Experiment 1 measured younger (18-23 years) and older (65-75 years) adults' comprehension for real-world warnings via a verification test presented immediately after reading the warnings or after a delay. In Experiment 2, younger (18-22 years) and older (64-76 years) participants also read fabricated warnings that were inconsistent with real-world knowledge. In both experiments, older adults frequently failed to infer the correct hazard and safety information. The older adults also had trouble understanding warning information even when it was explicitly stated (when no inferences were required), especially when memory demands were high and product-specific knowledge could not be used. That many of the older adults did not understand commonly used product warnings indicates that the wording on many household products is not conducive to being understood by everyone who uses them. Actual or potential applications of this research include the recommendation that designers of product labels, warnings, and instructions should consider minimizing memory load and maximizing opportunities for knowledge application when designing consumer warnings.

Warnings as a directive front-of-pack nutrition labelling scheme: comparison with the Guideline Daily Amount and traffic-light systems.

PubMed

Arrúa, Alejandra; Machín, Leandro; Curutchet, María Rosa; Martínez, Joseline; Antúnez, Lucía; Alcaire, Florencia; Giménez, Ana; Ares, Gastón

2017-09-01

Warnings have recently been proposed as a new type of directive front-of-pack (FOP) nutrition labelling scheme to flag products with high content of key nutrients. In the present work, this system was compared with the two most common FOP nutrition labelling schemes (Guideline Daily Amounts (GDA) and traffic-light system) in terms of goal-directed attention, influence on perceived healthfulness and ability to differentiate between products. Design/Setting/Subjects Goal-directed attention to FOP labels was evaluated using a visual search task in which participants were presented with labels on a computer screen and were asked to indicate whether labels with high sodium content were present or absent. A survey with 387 participants was also carried out, in which the influence of FOP labels on perceived healthfulness and ability to identify the healthful alternative were evaluated. Warnings improved consumers' ability to correctly identify a product with high content of a key nutrient within a set of labels compared with GDA and received the highest goal-directed attention. In addition, products with high energy, saturated fat, sugar and/or sodium content that featured warnings on the label were perceived as less healthful than those featuring the GDA or traffic-light system. Warnings and the traffic-light system performed equally well in the identification of the most healthful product. Results from the present work suggest that warnings have potential as directive FOP nutrition labels to improve consumer ability to identify unhealthful products and highlight advantages compared with the traffic-light system.

Effects of plain packaging, warning labels, and taxes on young people's predicted sugar-sweetened beverage preferences: an experimental study.

PubMed

Bollard, Tessa; Maubach, Ninya; Walker, Natalie; Ni Mhurchu, Cliona

2016-09-01

Consumption of sugar-sweetened beverages (SSBs) is associated with increased risk of obesity, diabetes, heart disease and dental caries. Our aim was to assess the effects of plain packaging, warning labels, and a 20 % tax on predicted SSB preferences, beliefs and purchase probabilities amongst young people. A 2 × 3 × 2 between-group experimental study was conducted over a one-week period in August 2014. Intervention scenarios were delivered, and outcome data collected, via an anonymous online survey. Participants were 604 New Zealand young people aged 13-24 years who consumed soft drinks regularly. Participants were randomly allocated using a computer-generated algorithm to view one of 12 experimental conditions, specifically images of branded versus plain packaged SSBs, with either no warning, a text warning, or a graphic warning, and with or without a 20 % tax. Participant perceptions of the allocated SSB product and of those who might consume the product were measured using seven-point Likert scales. Purchase probabilities were measured using 11-point Juster scales. Six hundred and four young people completed the survey (51 % female, mean age 18 (SD 3.4) years). All three intervention scenarios had a significant negative effect on preferences for SSBs (plain packaging: F (6, 587) = 54.4, p <0.001; warning label: F (6, 588) = 19.8, p <0.001; 20 % tax: F (6, 587) = 11.3, p <0.001). Plain packaging and warning labels also had a significant negative impact on reported likelihood of purchasing SSB's (p = <0.001). A 20 % tax reduced participants' purchase probability but the difference was not statistically significant (p = 0.2). Plain packaging and warning labels significantly reduce young people's predicted preferences for, and reported probability of purchasing, SSBs.

Recall of health warnings in smokeless tobacco ads.

PubMed

Truitt, Linda; Hamilton, William L; Johnston, P R; Bacani, C P; Crawford, S O; Hozik, L; Celebucki, Carolyn

2002-06-01

To determine the effects of health warning characteristics in smokeless tobacco magazine print ads on warning recall, and the implications for current US Federal regulations. Subjects examined two distracter ads and one of nine randomly assigned smokeless tobacco ads varying in health warning presence, size (8 to 18 point font), and contrast (low versus high)-including no health warning. They were then interviewed about ad content using recall and recognition questions. A convenience sample of 895 English speaking males aged 16-24 years old who were intercepted at seven shopping malls throughout Massachusetts during May 2000. Proven aided recall, or recall of a health warning and correct recognition of the warning message among distracters, and false recall. Controlling for covariates such as education, employment/student status, and Hispanic background, proven aided recall increased significantly with font size; doubling size from 10 to 20 point font would increase recall from 63% to 76%. Although not statistically significant, recall was somewhat better for high contrast warnings. Ten per cent of the sample mistakenly recalled the warning where none existed. As demonstrated by substantially greater recall among ads that included health warnings over ads that had none, health warnings retained their value to consumers despite years of exposure (that can produce false recall). Larger health warnings would enhance recall, and the proposed model can be used to estimate potential recall that affects communication, perceived health risk, and behaviour modification.

The history and contemporary challenges of the US Food and Drug Administration.

PubMed

Borchers, Andrea T; Hagie, Frank; Keen, Carl L; Gershwin, M Eric

2007-01-01

The year 2006 marks the 100th anniversary of the regulatory agency now known as the US Food and Drug Administration (FDA), the first consumer protection agency of the federal government and arguably the most influential regulatory agency in the world. The FDA thus plays an integral role in the use of pharmaceuticals, not only in the United States but worldwide. The goal of this review was to present an overview of the FDA and place its current role in the perspectives of history and contemporary needs. Relevant materials for this review were identified through a search of the English-language literature indexed on MEDLINE (through 2006) using the main search terms United States Food and Drug Administration, FDA, history of the FDA, drug approvals, drug legislation, and FDA legislation. Results from the initial searches were then explored further. The statute that created the bureau which later became the FDA established this agency to prohibit interstate commerce of adulterated foods, drinks, and drugs. The Food, Drug, and Cosmetic Act that replaced it in 1938, and subsequent food and drug laws and amendments, expanded the FDA's responsibilities to cosmetics, medical devices, biological products, and radiation-emitting products. These amendments have also established the FDA as a mainly preventive regulatory agency that relies chiefly on pre-market control. As such, the FDA has played an important role in shaping the modern pharmaceutical industry by making the scientific approach and the clinical trial process the standard for establishing safety and efficacy and by making rigorous scientific analysis the predominant component of the process for pharmaceutical regulation. As shown in this review, the evolution of the FDA can be described as a series of "crisis-legislation-adaptation" cycles: a public health crisis promoted the passage of congressional legislation, which was then followed by implementation of the law by the FDA. However, the crises the FDA faces currently are likely to be overcome only under strong and permanent leadership willing to redefine the role and procedures of the FDA with an open mind.

Consumers' preferences for the communication of risk information in drug advertising.

PubMed

Davis, Joel J

2007-01-01

Research was conducted to identify consumers' preferences regarding the form, content, and placement of drug side-effect information in direct-to-consumer (DTC) advertising. Specific questions explored preferences for the presence or absence of numeric information, the use of placebo and discontinuation groups as a context for understanding drug risk, the sequence in which side effects are presented, and the placement of side-effect statements on DTC Web sites. Consumers prefer detailed, readily accessible risk information--preferences that are a major departure from current advertiser practices and from what current and proposed Food and Drug Administration (FDA) regulations require.

77 FR 4329 - Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-27

..., challenging FDA's 2009 petition response under the First Amendment. On cross-motions for summary judgment, the... examine consumer reactions to health claims using those phrases, with and without various disclaimers...

Recall of health warnings in smokeless tobacco ads

PubMed Central

Truitt, L; Hamilton, W; Johnston, P; Bacani, C; Crawford, S; Hozik, L; Celebucki, C

2002-01-01

Design: Subjects examined two distracter ads and one of nine randomly assigned smokeless tobacco ads varying in health warning presence, size (8 to 18 point font), and contrast (low versus high)—including no health warning. They were then interviewed about ad content using recall and recognition questions. Subjects: A convenience sample of 895 English speaking males aged 16–24 years old who were intercepted at seven shopping malls throughout Massachusetts during May 2000. Main outcome measures: Proven aided recall, or recall of a health warning and correct recognition of the warning message among distracters, and false recall. Results: Controlling for covariates such as education, employment/student status, and Hispanic background, proven aided recall increased significantly with font size; doubling size from 10 to 20 point font would increase recall from 63% to 76%. Although not statistically significant, recall was somewhat better for high contrast warnings. Ten per cent of the sample mistakenly recalled the warning where none existed. Conclusions: As demonstrated by substantially greater recall among ads that included health warnings over ads that had none, health warnings retained their value to consumers despite years of exposure (that can produce false recall). Larger health warnings would enhance recall, and the proposed model can be used to estimate potential recall that affects communication, perceived health risk, and behaviour modification. PMID:12034984

Problems associated with direct-to-consumer advertising (DTCA) of restricted, implantable medical devices: should the current regulatory approach be changed?

PubMed

Patsner, Bruce

2009-01-01

Advertising and promotion of Food and Drug Administration (FDA)-approved medical products has been one of the most controversial and bitterly litigated areas in food and drug law in the U.S. for more than a decade. Hundreds of newspaper articles and dozens of law review articles have been written on the subject of the risks and benefits of direct to consumer advertising (DTCA) of medical products, but until very recently virtually all of this literature and commentary has focused exclusively on prescription and over-the-counter drugs. Even when FDA has sponsored public hearings to address the issue of DTCA of all medical products, as it did in 2005, review of the content of the speakers' presentations reveals that almost all of the subject matter, nearly all of the data, and the majority of comments concerned DTCA of drugs. Not a single law review article has ever been devoted exclusively to the subject of advertising and promotion of medical devices to consumers--until now.

A wonderful life or diarrhea and dry mouth? Policy issues of direct-to-consumer drug advertising on television.

PubMed

Macias, Wendy; Pashupati, Kartik; Lewis, Liza Stavchansky

2007-01-01

Over $4 billion is being spent on direct-to-consumer advertising (DTCA) of prescription drugs. Although the greatest proportion of this media budget is spent on television, relatively few studies have investigated the key issues of DTCA on television (DTCA-TV), including fair balance, FDA regulations and if information or appeals is focused on more. This study found that emotional and rational appeals were used to a similar degree in DTCA-TV. Print tends to be more informative than TV. After developing a four-tiered classification scheme (lawbreakers, bare minimums, DTC main pack/peloton and proactives), this study found that DTCA-TV ads are not doing a good job of meeting the FDA's fair balance requirement, particularly in presenting risk information in a comprehensible manner. Today's new active healthcare consumers often want to learn what issues are important to consider when investigating drugs and how to evaluate alternative courses of treatment. Given the proportion of money spent on television, the medical industry is correct to be concerned that education does not appear more important to DTCA advertisers.

Does front-of-pack nutrition information improve consumer ability to make healthful choices? Performance of warnings and the traffic light system in a simulated shopping experiment.

PubMed

Machín, Leandro; Aschemann-Witzel, Jessica; Curutchet, María Rosa; Giménez, Ana; Ares, Gastón

2018-02-01

The inclusion of more attention-grabbing and easily interpretable front-of-pack (FOP) nutrition information is one of the public policies that can be implemented to empower consumers to identify unhealthful food products and to make more informed food choices. The aim of the present work was to evaluate the influence of two FOP nutrition labelling schemes - the traffic light labelling and the warning scheme - on consumer food purchases when facing a health goal. The study was conducted with 1182 people from Montevideo (Uruguay), recruited using a Facebook advertisement. Participants were randomly allocated to one of three between-subjects experimental conditions: (i) a control condition with no FOP nutrition information, (ii) FOP nutrition information using a modified version of the traffic light system including information about calorie, saturated fat, sugars and sodium content per portion, and (iii) FOP nutrition information using the Chilean warning system including separate signs for high calorie, saturated fat, sugars and sodium content. Respondents were asked to imagine that they had to purchase food in order to prepare a healthy dinner for themselves and their family, using the website of an online grocery store. Results showed that FOP nutrition information effectively improved the average healthfulness of participants' choices compared to the control condition, both in terms of the average nutritional composition of the purchased products and expenditure in specific product categories. No relevant differences between the effect of the traffic light and the warning system were found. Copyright © 2017 Elsevier Ltd. All rights reserved.

ClinicalTrials.gov, stem cells and 'pay-to-participate' clinical studies.

PubMed

Turner, Leigh

2017-09-01

Numerous US businesses that engage in direct-to-consumer advertising of stem cell interventions that are not US FDA-approved also recruit clients by listing 'pay-to-participate' studies listed on ClinicalTrials.gov . Individuals considering enrolling in such studies and NIH officials responsible for overseeing the database need to be aware that some businesses are using the registry to promote unapproved stem cell interventions that study subjects are charged to receive. Inclusion of such studies in ClinicalTrials.gov reveals that the database needs better screening tools. In particular, screening should evaluate whether studies submitted to the registry have been reviewed and permitted to proceed by the FDA in the case of clinical studies requiring FDA clearance in addition to institutional review board approval.

Visual gut punch: persuasion, emotion, and the constitutional meaning of graphic disclosure.

PubMed

Goodman, Ellen P

2014-01-01

The ability of government to "nudge" with information mandates, or merely to inform consumers of risks, is circumscribed by First Amendment interests that have been poorly articulated. New graphic cigarette warning labels supplied courts with the first opportunity to assess the informational interests attending novel forms of product disclosures. The D.C. Circuit enjoined them as unconstitutional, compelled by a narrative that the graphic labels converted government from objective informer to ideological persuader, shouting its warning to manipulate consumer decisions. This interpretation will leave little room for graphic disclosure and is already being used to challenge textual disclosure requirements (such as county-of-origin labeling) as unconstitutional. Graphic warning and the increasing reliance on regulation-by-disclosure present new free speech quandaries related to consumer autonomy, state normativity, and speaker liberty. This Article examines the distinct goals of product disclosure requirements and how those goals may serve to vindicate, or to frustrate, listener interests. I argue that many disclosures, and especially warnings, are necessarily both normative and informative, expressing value along with fact. It is not the existence of a norm that raises constitutional concern but rather the insistence on a controversial norm. Turning to the means of disclosure, this Article examines how emotional and graphic communication might change the constitutional calculus. Using autonomy theory and the communications research on speech processing, I conclude that disclosures do not bypass reason simply by reaching for the heart. If large graphic labels are unconstitutional, it will be because of undue burden on the speaker, not because they are emotionally powerful. This Article makes the following distinct contributions to the compelled commercial speech literature: critiques the leading precedent, Zauderer v. Office of Disciplinary Counsel, from a consumer autonomy standpoint; brings to bear empirical communications research on questions of facticity and rationality in emotional and graphic communications; and teases apart and distinguishes among various free speech dangers and contributions of commercial disclosure mandates with a view towards informing policy, law, and research.

Barbecue Basics: Tips to Prevent Foodborne Illness

MedlinePlus Videos and Cool Tools

... Pin it Email Print Subscribe: FDA Consumer Health Information Español It’s the season for picnics, cookouts, and ... 13/2017 Note: If you need help accessing information in different file formats, see Instructions for Downloading ...

Hearing Aids and Personal Sound Amplifiers: Know the Difference

MedlinePlus

... Devices and Personal Sound Amplification Products - Guidance for Industry and FDA Staff (PDF - 42KB) More in Consumer Updates Animal & Veterinary Children's Health Cosmetics Dietary Supplements Drugs Food Medical Devices Nutrition Radiation-Emitting Products Tobacco Products ...

Eye Tracking Outcomes in Tobacco Control Regulation and Communication: A Systematic Review.

PubMed

Meernik, Clare; Jarman, Kristen; Wright, Sarah Towner; Klein, Elizabeth G; Goldstein, Adam O; Ranney, Leah

2016-10-01

In this paper we synthesize the evidence from eye tracking research in tobacco control to inform tobacco regulatory strategies and tobacco communication campaigns. We systematically searched 11 databases for studies that reported eye tracking outcomes in regards to tobacco regulation and communication. Two coders independently reviewed studies for inclusion and abstracted study characteristics and findings. Eighteen studies met full criteria for inclusion. Eye tracking studies on health warnings consistently showed these warnings often were ignored, though eye tracking demonstrated that novel warnings, graphic warnings, and plain packaging can increase attention toward warnings. Eye tracking also revealed that greater visual attention to warnings on advertisements and packages consistently was associated with cognitive processing as measured by warning recall. Eye tracking is a valid indicator of attention, cognitive processing, and memory. The use of this technology in tobacco control research complements existing methods in tobacco regulatory and communication science; it also can be used to examine the effects of health warnings and other tobacco product communications on consumer behavior in experimental settings prior to the implementation of novel health communication policies. However, the utility of eye tracking will be enhanced by the standardization of methodology and reporting metrics.

Eye Tracking Outcomes in Tobacco Control Regulation and Communication: A Systematic Review

PubMed Central

Meernik, Clare; Jarman, Kristen; Wright, Sarah Towner; Klein, Elizabeth G.; Goldstein, Adam O.; Ranney, Leah

2016-01-01

Objective In this paper we synthesize the evidence from eye tracking research in tobacco control to inform tobacco regulatory strategies and tobacco communication campaigns. Methods We systematically searched 11 databases for studies that reported eye tracking outcomes in regards to tobacco regulation and communication. Two coders independently reviewed studies for inclusion and abstracted study characteristics and findings. Results Eighteen studies met full criteria for inclusion. Eye tracking studies on health warnings consistently showed these warnings often were ignored, though eye tracking demonstrated that novel warnings, graphic warnings, and plain packaging can increase attention toward warnings. Eye tracking also revealed that greater visual attention to warnings on advertisements and packages consistently was associated with cognitive processing as measured by warning recall. Conclusions Eye tracking is a valid indicator of attention, cognitive processing, and memory. The use of this technology in tobacco control research complements existing methods in tobacco regulatory and communication science; it also can be used to examine the effects of health warnings and other tobacco product communications on consumer behavior in experimental settings prior to the implementation of novel health communication policies. However, the utility of eye tracking will be enhanced by the standardization of methodology and reporting metrics. PMID:27668270

Evaluating the Impact of U.S. Food and Drug Administration-Proposed Nutrition Facts Label Changes on Young Adults' Visual Attention and Purchase Intentions

ERIC Educational Resources Information Center

Graham, Dan J.; Roberto, Christina A.

2016-01-01

Background: The U.S. Food and Drug Administration (FDA) has proposed modifying the Nutrition Facts Label (NFL) on food packages to increase consumer attention to this resource and to promote healthier dietary choices. Aims: The present study sought to determine whether the proposed NFL changes will affect consumer attention to the NFL or purchase…

Health warnings promote healthier dietary decision making: Effects of positive versus negative message framing and graphic versus text-based warnings.

PubMed

Rosenblatt, Daniel H; Bode, Stefan; Dixon, Helen; Murawski, Carsten; Summerell, Patrick; Ng, Alyssa; Wakefield, Melanie

2018-08-01

Food product health warnings have been proposed as a potential obesity prevention strategy. This study examined the effects of text-only and text-and-graphic, negatively and positively framed health warnings on dietary choice behavior. In a 2 × 5 mixed experimental design, 96 participants completed a dietary self-control task. After providing health and taste ratings of snack foods, participants completed a baseline measure of dietary self-control, operationalized as participants' frequency of choosing healthy but not tasty items and rejecting unhealthy yet tasty items to consume at the end of the experiment. Participants were then randomly assigned to one of five health warning groups and presented with 10 health warnings of a given form: text-based, negative framing; graphic, negative framing; text, positive framing; graphic, positive framing; or a no warning control. Participants then completed a second dietary decision making session to determine whether health warnings influenced dietary self-control. Linear mixed effects modeling revealed a significant interaction between health warning group and decision stage (pre- and post-health warning presentation) on dietary self-control. Negatively framed graphic health warnings promoted greater dietary self-control than other health warnings. Negatively framed text health warnings and positively framed graphic health warnings promoted greater dietary self-control than positively framed text health warnings and control images, which did not increase dietary self-control. Overall, HWs primed healthier dietary decision making behavior, with negatively framed graphic HWs being most effective. Health warnings have potential to become an important element of obesity prevention. Copyright © 2018 Elsevier Ltd. All rights reserved.

Concerns regarding a new culture method for Borrelia burgdorferi not approved for the diagnosis of Lyme disease.

PubMed

Nelson, Christina; Hojvat, Sally; Johnson, Barbara; Petersen, Jeannine; Schriefer, Marty; Beard, C Ben; Petersen, Lyle; Mead, Paul

2014-04-18

In 2005, CDC and the Food and Drug Administration (FDA) issued a warning regarding the use of Lyme disease tests whose accuracy and clinical usefulness have not been adequately established. Often these are laboratory-developed tests (also known as "home brew" tests) that are manufactured and used within a single laboratory and have not been cleared or approved by FDA. Recently, CDC has received inquiries regarding a laboratory-developed test that uses a novel culture method to identify Borrelia burgdorferi, the spirochete that causes Lyme disease. Patient specimens reportedly are incubated using a two-step pre-enrichment process, followed by immunostaining with or without polymerase chain reaction (PCR) analysis. Specimens that test positive by immunostaining or PCR are deemed "culture positive". Published methods and results for this laboratory-developed test have been reviewed by CDC. The review raised serious concerns about false-positive results caused by laboratory contamination and the potential for misdiagnosis.

Triptans, serotonin agonists, and serotonin syndrome (serotonin toxicity): a review.

PubMed

Gillman, P Ken

2010-02-01

The US Food and Drug Administration (FDA) have suggested that fatal serotonin syndrome (SS) is possible with selective serotonin reuptake inhibitors (SSRIs) and triptans: this warning affects millions of patients as these drugs are frequently given simultaneously. SS is a complex topic about which there is much misinformation. The misconception that 5-HT1A receptors can cause serious SS is still widely perpetuated, despite quality evidence that it is activation of the 5-HT2A receptor that is required for serious SS. This review considers SS involving serotonin agonists: ergotamine, lysergic acid diethylamide, bromocriptine, and buspirone, as well as triptans, and reviews the experimental foundation underpinning the latest understanding of SS. It is concluded that there is neither significant clinical evidence, nor theoretical reason, to entertain speculation about serious SS from triptans and SSRIs. The misunderstandings about SS exhibited by the FDA, and shared by the UK Medicines and Healthcare products Regulatory Agency (in relation to methylene blue), are an important issue with wide ramifications.

A rare cause of drug-induced hepatitis in an immunocompromised patient and the role of glutathione.

PubMed

Senadhi, Viplove; Arora, Deepika; Arora, Manish; Marsh, Franklin

2012-08-27

The Food and Drug Administration (FDA) has issued a warning on numerous herbal drugs, including many popular products at General Nutrition Centers (GNC), regarding unstudied hepatotoxicity. There have been recent reports of GNC products such as hydroxycut and herbalife, causing drug-induced hepatitis. Herbal medications are over-the-counter products and are not investigated thoroughly by the FDA. Given that the most common outpatient laboratory abnormality is elevated liver transaminases, a sign of hepatocellular toxicity; it is not surprising that some of these products end up causing hepatic dysfunction, especially when taken in large volume. There are numerous herbal supplements that are hepatotoxic, however, these medications have a much more significant effect in human immunodeficiency virus (HIV)/ acquired immune deficiency syndrome patients, which is secondary to depleted glutathione. We present a rare case of drug induced hepatitis secondary to herbal medications used to treat HIV and elucidate the role of glutathione depletion in immunocompromised patients.

A rare cause of drug-induced hepatitis in an immunocompromised patient and the role of glutathione

PubMed Central

Senadhi, Viplove; Arora, Deepika; Arora, Manish; Marsh, Franklin

2012-01-01

The Food and Drug Administration (FDA) has issued a warning on numerous herbal drugs, including many popular products at General Nutrition Centers (GNC), regarding unstudied hepatotoxicity. There have been recent reports of GNC products such as hydroxycut and herbalife, causing drug-induced hepatitis. Herbal medications are over-the-counter products and are not investigated thoroughly by the FDA. Given that the most common outpatient laboratory abnormality is elevated liver transaminases, a sign of hepatocellular toxicity; it is not surprising that some of these products end up causing hepatic dysfunction, especially when taken in large volume. There are numerous herbal supplements that are hepatotoxic, however, these medications have a much more significant effect in human immunodeficiency virus (HIV)/ acquired immune deficiency syndrome patients, which is secondary to depleted glutathione. We present a rare case of drug induced hepatitis secondary to herbal medications used to treat HIV and elucidate the role of glutathione depletion in immunocompromised patients. PMID:22993667

77 FR 25371 - Transportation of Household Goods in Interstate Commerce; Consumer Protection Regulations...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-30

... services when the shipper agrees to release the carrier from full liability for potential loss and damage... implemented a congressional directive to enhance consumer protection in cases of loss or damage that occur... the estimates they provide to prospective shippers: WARNING: If a moving company loses or damages your...

Policy implications of drug importation.

PubMed

Palumbo, Francis B; Mullins, C Daniel; Slagle, Ashley F; Rizer, Jessica

2007-12-01

Importation of prescription drugs into the United States has been a major health policy issue for some time. The original objective of personal importation was to allow patients to have access to drugs that were not available to them in the United States either for continuation of therapy begun in another country or when all US Food and Drug Administration (FDA)-approved drug options for their condition had been exhausted. An increasing proportion of personally imported drugs are currently marketed in the United States, but imported drugs are presumably available at a lower cost to the consumer. As US consumers opt for importation through Internet sites and other means of purchase from other countries, potential risks of exposure to counterfeit products have increased, presenting challenges to both the US regulatory system and pharmaceutical companies. This commentary summarizes the current state of importation of prescription drugs into the United States. Regulators and policymakers are under increasing pressure to address the high cost of branded drugs in the United States and the desires of many US patients to purchase less expensive formulations of these products through importation. In many cases, the historical policies surrounding personal importation of prescription drugs that are not sold in the United States have been blatantly ignored, leaving the FDA in a quandary. While current legislative proposals would allow for greater access to drugs directly to consumers from other countries, they do not address the fact that the FDA has no ability to monitor the safety and efficacy of imported products. As such, the possibility of the entry of counterfeit medications and the related potential harm remain concerns.

CYP2C19 variation, not citalopram dose nor serum level, is associated with QTc prolongation.

PubMed

Kumar, Yingying; Kung, Simon; Shinozaki, Gen

2014-12-01

Recently, a FDA Safety Communication warned of a dose-dependent risk for QTc prolongation with citalopram, which is metabolized by CYP2C19 of the cytochrome P450 system. We investigate associations between citalopram and escitalopram dose, serum concentration, CYP2C19 phenotype, and QTc. We undertook a retrospective chart review of citalopram or escitalopram patients with the inclusion criteria of consistent medication dose, CYP2C19 phenotype (extensive metabolizers [EM], intermediate metabolizers [IM], poor metabolizers [PM]), and QTc interval on ECG. We further identified 42 citalopram users with citalopram serum concentration measurements and ECG. Regression and one-way ANOVA were used to examine the relationship between citalopram dose, citalopram serum concentration, CYP2C19 phenotype, and QTc interval. Of 75 citalopram patients, the EM group had significantly shorter QTc intervals than a combined IM+PM group (427.1±23.6 ms vs. 440.1±26.6 ms, one-tailed t-test, p=0.029). In the 80 escitalopram cohort, there was no significant difference in QTc between phenotype groups. There was no statistical correlation between citalopram (p=0.62) or escitalopram (p=0.30) dose and QTc. QTc was not associated with citalopram serum level (p=0.45). In contrast to the FDA warning, this study found no association between citalopram/escitalopram dose and QTc. However, PM of the drug tended to have longer QTc intervals. Our findings suggest cytochrome P450 genotyping in select patients may be helpful to guide medication optimization while limiting harmful effects. © The Author(s) 2014.

Evaluation of Radiation Doses Due to Consumption of Contaminated Food Items and Calculation of Food Class-Specific Derived Intervention Levels

DOE Office of Scientific and Technical Information (OSTI.GOV)

Heinzelman, K M; Mansfield, W G

This document evaluates the expected radiation dose due to the consumption of several specific food classes (dairy, meat, produce, etc.) contaminated with specific radionuclides, and relates concentration levels in food to the detection abilities of typical aboratory analysis/measurement methods. The attached charts present the limiting organ dose as a function of the radionuclide concentration in a particular food class, and allow the user to compare these concentrations and doses to typical analytical detection apabilities. The expected radiation dose depends on several factors: the age of the individual; the radionuclide present in the food; the concentration of the radionuclide in themore » food; and the amount of food consumed. Food consumption rates for individuals of various ges were taken from the 1998 United States Food and Drug Administration (FDA) document, Accidental Radioactive Contamination of HUman Food and Animal Feeds: Recommendations for State and Local Agencies. In that document, the FDA defines the erived Intervention Level (DIL), which is the concentration of a particular radionuclide in food that if consumed could result in an individual receiving a radiation dose exceeding the Protection Action Guide (PAG) thresholds for intervention. This document also resents odified, food class specific DIL, which is calculated using a somewhat modified version of the FDA's procedure. This document begins with an overview of the FDA's DIL calculation, followed by a description of the food class specific DIL calculations, and finally charts of the radiation dose per radioactivity concentration for several food class/radionuclide combinations.« less

Cigarette packaging and health warnings: the impact of plain packaging and message framing on young smokers.

PubMed

Mays, Darren; Niaura, Raymond S; Evans, W Douglas; Hammond, David; Luta, George; Tercyak, Kenneth P

2015-03-01

This study examined the impact of pictorial cigarette-warning labels, warning-label message framing and plain cigarette packaging, on young adult smokers' motivation to quit. Smokers aged 18-30 years (n=740) from a consumer research panel were randomised to one of four experimental conditions where they viewed online images of four cigarette packs with warnings about lung disease, cancer, stroke/heart disease and death, respectively. Packs differed across conditions by warning-message framing (gain vs loss) and packaging (branded vs plain). Measures captured demographics, smoking behaviour, covariates and motivation to quit in response to cigarette packs. Pictorial warnings about lung disease and cancer generated the strongest motivation to quit across conditions. Adjusting for pretest motivation and covariates, a message framing by packaging interaction revealed gain-framed warnings on plain packs generated greater motivation to quit for lung disease, cancer and mortality warnings (p<0.05), compared with loss-framed warnings on plain packs. Warnings combining pictorial depictions of smoking-related health risks with text-based messages about how quitting reduces risks, may achieve better outcomes among young adults, especially in countries considering or implementing plain packaging regulations. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Balancing consumer protection and scientific integrity in the face of uncertainty: the example of gluten-free foods.

PubMed

McCabe, Margaret Sova

2010-01-01

In 2009, gluten-free foods were not only "hot" in the marketplace, several countries, including the United States, continued efforts to define gluten-free and appropriate labeling parameters. The regulatory process illuminates how difficult regulations based on safe scientific thresholds can be for regulators, manufacturers and consumers. This article analyzes the gluten-free regulatory landscape, challenges to defining a safe gluten threshold, and how consumers might need more label information beyond the term "gluten-free." The article includes an overview of international gluten-free regulations, the Food and Drug Administration (FDA) rulemaking process, and issues for consumers.

College student reactions to health warning labels: sociodemographic and psychosocial factors related to perceived effectiveness of different approaches.

PubMed

Berg, Carla J; Thrasher, James F; Westmaas, J Lee; Buchanan, Taneisha; Pinsker, Erika A; Ahluwalia, Jasjit S

2011-12-01

To examine factors associated with perceiving different types of pictorial cigarette health warning labels as most effective in motivating smokers to quit or preventing smoking initiation among college students. We administered an online survey to 24,055 students attending six Southeast colleges in Fall, 2010. We obtained complete data for the current analyses from 2600. Current smoking prevalence was 23.5%. The largest majority (78.6%) consistently rated gruesome images as most effective, 19.5% rated testimonial images as most effective, and only a small proportion rated either standard (1.6%) or human suffering images (0.3%) as most effective. Subsequent analyses focused on differences between those endorsing gruesome images or testimonials as most effective. Factors related to ranking testimonials versus gruesome images as most effective included being female (p<0.01), White (p<0.01), and nonsmokers (p=0.04), lower perceived smoking prevalence (p<0.01), and greater receptivity to laws/restrictions around smoking (p<0.01) and tobacco marketing (p=0.01). Among smokers, factors related to ranking testimonials as most effective versus gruesome images included being female (p=0.03), being White (p=0.03), higher autonomous motivation (p=0.03), and greater extrinsic self-efficacy (p=0.02). Understanding factors related to perceived effectiveness of different pictorial warnings among subpopulations should inform health warning labels released by the FDA. Copyright © 2011 Elsevier Inc. All rights reserved.

College student reactions to health warning labels: Sociodemographic and psychosocial factors related to perceived effectiveness of different approaches

PubMed Central

Berg, Carla J.; Thrasher, James F.; Westmaas, J. Lee; Buchanan, Taneisha; Pinsker, Erika A.; Ahluwalia, Jasjit S.

2011-01-01

Objective To examine factors associated with perceiving different types of pictorial cigarette health warning labels as most effective in motivating smokers to quit or preventing smoking initiation among college students. Method We administered an online survey to 24,055 students attending six Southeast colleges in Fall, 2010. We obtained complete data for the current analyses from 2,600. Results Current smoking prevalence was 23.5%. The largest majority (78.6%) consistently rated gruesome images as most effective, 19.5% rated testimonial images as most effective, and only a small proportion rated either standard (1.6%) or human suffering images (0.3%) as most effective. Subsequent analyses focused on differences between those endorsing gruesome images or testimonials as most effective. Factors related to ranking testimonials versus gruesome images as most effective included being female (p<0.01), White (p<0.01), and nonsmokers (p=0.04), lower perceived smoking prevalence (p<0.01), and greater receptivity to laws/restrictions around smoking (p<0.01) and tobacco marketing (p=0.01). Among smokers, factors related to ranking testimonials as most effective versus gruesome images included being female (p=0.03), being White (p=0.03), higher autonomous motivation (p=0.03), and greater extrinsic self-efficacy (p=0.02). Conclusions Understanding factors related to perceived effectiveness of different pictorial warnings among subpopulations should inform health warning labels released by the FDA. PMID:21945706

Factual text and emotional pictures: overcoming a false dichotomy of cigarette warning labels.

PubMed

Popova, Lucy; Owusu, Daniel; Jenson, Desmond; Neilands, Torsten B

2017-04-20

In reviewing the first set of pictorial warning labels in the USA, the courts equated textual labels with facts and information, and images with emotion. This study tested the differences in perceived informativeness and emotion between textual and pictorial cigarette warning labels. An online study with 1838 US adults who were non-smokers (n=764), transitioning smokers (quit smoking in the past 2 years or currently trying to quit, n=505) or current smokers (n=569). Each participant evaluated 9 out of 81 text and pictorial cigarette warning labels. Participants reported to what extent they perceived the label as informative and factual and the negative emotions they felt while looking at each label. We used linear mixed models to account for the nesting of multiple observations within each participant. There were no significant differences in perceived informativeness between textual (mean 6.15 on a 9-point scale) and pictorial labels (6.14, p=0.80, Cohen's d=0.003). Textual labels evoked slightly less emotion (4.21 on a 9-point scale) than pictorial labels (4.42, p<0.001, Cohen's d=0.08). Perceived informativeness and emotion were strongly correlated (Pearson r=0.53, p<0.001). Our findings contradict courts' conclusions that pictorial messages are emotional and not factual. Pictorial labels are rated as informative and factual, textual labels evoke emotion, and emotionality and informativeness are strongly correlated. These findings serve as evidence for the Food and Drug Administration (FDA) to counteract the claim that pictorial warning labels, by definition, are not 'purely factual and uncontroversial'. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Information for Consumers (Drugs)

MedlinePlus

... Evaluation and Mitigation Strategies (REMS) REMS is a risk management plan required by FDA for certain prescription drugs, that uses tools beyond routine professional labeling to ensure that the benefits of the drug outweigh its risks. Index to Drug - Specific Information List of drugs ...

40 CFR 80.572 - What labeling requirements apply to retailers and wholesale purchaser-consumers of Motor Vehicle...

Code of Federal Regulations, 2013 CFR

2013-07-01

... engines. Recommended for use in all diesel vehicles and engines. (b) From June 1, 2010, through September... and later nonroad diesel engines. Recommended for use in all other non-highway diesel engines. WARNING... retailers and wholesale purchaser-consumers of Motor Vehicle, NR, LM and NRLM diesel fuel and heating oil...

40 CFR 80.572 - What labeling requirements apply to retailers and wholesale purchaser-consumers of Motor Vehicle...

Code of Federal Regulations, 2014 CFR

2014-07-01

... engines. Recommended for use in all diesel vehicles and engines. (b) From June 1, 2010, through September... and later nonroad diesel engines. Recommended for use in all other non-highway diesel engines. WARNING... retailers and wholesale purchaser-consumers of Motor Vehicle, NR, LM and NRLM diesel fuel and heating oil...

American Council on Consumer Interests Annual Conference (35th, Baltimore, Maryland, March 29-April 1, 1989). The Proceedings.

ERIC Educational Resources Information Center

Carsky, Mary L., Ed.

Among the 90 papers in this volume, education-related titles are as follows: "The Colston Warne Legacy" (Peterson); "Keeping a File on Survey Respondents" (Huang); "Aging-in-Place: Are Responses in the Best Interest of Elderly Consumers?" (Stum); "Low-Income Elderly in Health Maintenance Organizations:…

Testosterone replacement therapy and voiding dysfunction

PubMed Central

Baas, Wesley

2016-01-01

Testosterone replacement therapy (TRT) represents an increasing popular treatment option for men with late-onset hypogonadism (LOH). Because of unsubstantiated beliefs of testosterone’s effect on the prostate, the FDA has recently placed a warning on testosterone products, stating that TRT may worsen benign prostatic hyperplasia (BPH). Within this review article we have demonstrated the current understanding of the physiology of testosterone and its relationship with prostatic and lower urinary tract physiology. The current evidence suggests that not only does TRT not worsen lower urinary tract symptoms (LUTS), but that hypogonadism itself is an important risk factor for LUTS/BPH. PMID:28078221

POISON POLITICS: A Contentious History of Consumer Protection Against Dangerous Household Chemicals in the United States

PubMed Central

Benrubi, Isidore Daniel

2013-01-01

The history of consumer protection against household poisons presents a key case study of the uniquely American struggle to balance public health and safety with the interests of business. By the late 19th century, package designs, warning labels, and state statutes had formed an uneven patchwork of protective mechanisms against accidental poisonings. As household chemicals proliferated in the early 20th century, physicians concerned with childhood poisonings pressured the federal government to enact legislation mandating warning labels on packaging for these substances. Manufacturers of household chemicals agreed to labeling requirements for caustic poisons but resisted broader regulation. Accidental poisonings of children continued to increase until the enactment of broad labeling and packaging legislation in the 1960s and 1970s. This history suggests that voluntary agreements between government agencies and manufacturers are inadequate to protect consumers against household poisonings and that, in the United States, protective household chemical regulation proceeds in a reactive rather than a precautionary manner. PMID:23488510

Poison politics: a contentious history of consumer protection against dangerous household chemicals in the United States.

PubMed

Jones, Marian Moser; Benrubi, Isidore Daniel

2013-05-01

The history of consumer protection against household poisons presents a key case study of the uniquely American struggle to balance public health and safety with the interests of business. By the late 19th century, package designs, warning labels, and state statutes had formed an uneven patchwork of protective mechanisms against accidental poisonings. As household chemicals proliferated in the early 20th century, physicians concerned with childhood poisonings pressured the federal government to enact legislation mandating warning labels on packaging for these substances. Manufacturers of household chemicals agreed to labeling requirements for caustic poisons but resisted broader regulation. Accidental poisonings of children continued to increase until the enactment of broad labeling and packaging legislation in the 1960s and 1970s. This history suggests that voluntary agreements between government agencies and manufacturers are inadequate to protect consumers against household poisonings and that, in the United States, protective household chemical regulation proceeds in a reactive rather than a precautionary manner.

Concomitant use of opioid medications with triptans or serotonergic antidepressants in US office-based physician visits.

PubMed

Molina, Kyle C; Fairman, Kathleen A; Sclar, David A

2018-01-01

Opioids are not recommended for routine treatment of migraine because their benefits are outweighed by risks of medication overuse headache and abuse/dependence. A March 2016 US Food and Drug Administration (FDA) safety communication warned of the risk of serotonin syndrome from using opioids concomitantly with 5-hydroxytryptamine receptor agonists (triptans) or serotonergic antidepressants: selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). Epidemiological information about co-prescribing of these medications is limited. The objective of this study was to estimate the nationwide prevalence of co-prescribing of an opioid with a serotonergic antidepressant and/or triptan in US office-based physician visits made by 1) all patients and 2) patients diagnosed with migraine. National Ambulatory Medical Care Survey (NAMCS) data were obtained for 2013 and 2014. Physician office visits that included the new or continued prescribing of ≥1 opioid medication with a triptan or an SSRI/SNRI were identified. Co-prescribed opioids were stratified by agent to determine the proportion of co-prescriptions with opioids posing a higher risk of serotonergic agonism (meperidine, tapentadol, and tramadol). Of an annualized mean 903.6 million office-based physician visits in 2013-2014, 17.7 million (2.0% of all US visits) resulted in the prescribing of ≥1 opioid medication with a triptan or an SSRI/SNRI. Opioid-SSRI/SNRI was co-prescribed in 16,044,721 visits, while opioid-triptan was co-prescribed in 1,622,827 visits. One-fifth of opioid co-prescribing was attributable to higher-risk opioids, predominantly tramadol (18.6% of opioid-SSRI/SNRI, 21.8% of opioid-triptan). Of 7,672,193 visits for patients diagnosed with migraine, 16.3% included opioid prescribing and 2.0% included co-prescribed opioid-triptan. During a period approximately 2 years prior to an FDA warning about the risk of serotonin syndrome from opioid-SSRI/SNRI or opioid-triptan co-prescribing, use of these combinations was common in the USA. Studies on prescribing patterns following the March 2016 warning, and on the risk of serotonin syndrome associated with these co-prescriptions, are needed.

Self-reported awareness of the presence of product warning messages and signs by Hispanics in San Francisco.

PubMed Central

Marín, G

1994-01-01

This study investigated the self-reported awareness of the presence of product warning messages and signs among random samples of Hispanics in San Francisco surveyed in 1990 and in 1991. The messages that were tested related to cigarettes, alcoholic beverages, and other consumer products. A random sample of 1,204 Hispanics (43.5 percent males) were interviewed by telephone in 1990. The corresponding figure for the second survey in 1991 was 1,569 Hispanics (41.1 percent males). In general, respondents reported low levels of awareness of the presence of product warning messages and signs. The exception was warning messages on cigarette packets which approximately 70 percent of the respondents reported having seen within the 12 months before the survey. There was an increase from 1990 to 1991 in the reported awareness of warning messages for wine, beer, and cigarettes. Smokers and drinkers of alcoholic beverages reported the highest levels of awareness of the relevant warning messages and signs. Length of exposure to warning messages and multiplicity of sources (for example, advertisements and products) seem to produce greater levels of awareness of the presence of product warning messages. Less acculturated, Spanish-speaking Hispanics are less likely to report being aware of the warnings, particularly those that appear only in English (for example, alcoholic beverages). PMID:8153279

Giving Medicine to Children

MedlinePlus

... visit FDA's videos for consumers on YouTube Administrando Medicina a los Niños Cuando los niños pequeños están ... ser difícil que ellos llegen a tomar su medicina. Vea este vídeo para obtener consejos de un ...

Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice.

PubMed

Deyo, Richard A

2004-01-01

Despite many successes, drug approval at the Food and Drug Administration (FDA) is subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs and devices and studies demonstrating advantages of older drugs over newer ones highlight the importance of these limitations. The FDA does not compare competing drugs and rarely requires tests of clinical efficacy for new devices. It does not review advertisements before use, assess cost-effectiveness, or regulate surgery (except for devices). Many believe postmarketing surveillance of drugs and devices is inadequate. A source of tension within the agency is pressure for speedy approvals. This may have resulted in "burn-out" among medical officers and has prompted criticism that safety is ignored. Others argue, however, that the agency is unnecessarily slow and bureaucratic. Recent reports identify conflicts of interest (stock ownership, consulting fees, research grants) among some members of the FDA's advisory committees. FDA review serves a critical function, but physicians should be aware that new drugs may not be as effective as old ones; that new drugs are likely to have undiscovered side effects at the time of marketing; that direct-to-consumer ads are sometimes misleading; that new devices generally have less rigorous evidence of efficacy than new drugs; and that value for money is not considered in approval.

Laboratory-based testing to evaluate abuse-deterrent formulations and satisfy the Food and Drug Administration's recommendation for Category 1 Testing.

PubMed

Altomare, Christopher; Kinzler, Eric R; Buchhalter, August R; Cone, Edward J; Costantino, Anthony

The US Food and Drug Administration (FDA) considers the development of abuse-deterrent formulations of solid oral dosage forms a public health priority and has outlined a series of premarket studies that should be performed prior to submitting an application to the Agency. Category 1 studies are performed to characterize whether the abuse-deterrent properties of a new formulation can be easily defeated. Study protocols are designed to evaluate common abuse patterns of prescription medications as well as more advanced methods that have been reported on drug abuse websites and forums. Because FDA believes Category 1 testing should fully characterize the abuse-deterrent characteristics of an investigational formulation, Category 1 testing is time consuming and requires specialized laboratory resources as well as advanced knowledge of prescription medication abuse. Recent Advisory Committee meetings at FDA have shown that Category 1 tests play a critical role in FDA's evaluation of an investigational formulation. In this article, we will provide a general overview of the methods of manipulation and routes of administration commonly utilized by prescription drug abusers, how those methods and routes are evaluated in a laboratory setting, and discuss data intake, analysis, and reporting to satisfy FDA's Category 1 testing requirements.

Consumer and health literacy: The need to better design tobacco-cessation product packaging, labels, and inserts.

PubMed

Weiss, Stephanie M; Smith-Simone, Stephanie Y

2010-03-01

Tobacco-cessation product packaging and instruction materials may not be appropriate for some smokers and may contribute to the underuse and misuse of evidence-based treatments. The dual goals of this project are to analyze literacy levels of Food and Drug Administration (FDA)-approved and non-approved tobacco-cessation product packaging, directions, and claims, and to identify and categorize claims found on product packaging. The Campaign for Tobacco Free Kids (CTFK) maintains the Quitting and Reducing Tobacco Use Inventory of Products (QuiTIP) database, which catalogs products marketed and sold to consumers to reduce or quit use of tobacco products. It also includes all medications approved by the FDA for tobacco cessation as well as a sample of non-approved products such as homeopathic, herbal, nutritional, or dietary supplements commonly marketed as either cessation aids or alternative tobacco/nicotine products. This paper assesses the reading levels required to understand product packaging, labeling, and instructions using the Simple Measure of Gobbledygook (SMOG) and identifies claims on the product package labels using standard qualitative methods. Key findings show that the average reading levels needed to understand instructions for both FDA-approved and non-approved cessation products are above the reading levels recommended to ensure maximum comprehension. Improving the packaging and directions of evidence-based tobacco-cessation products so that they are preferably at or below a fifth-grade reading level, along with using consumer-based design principles to develop packaging, may help smokers take advantage of and correctly use products that will greatly increase their chances of successful quitting. 2010 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Can claims, misleading information, and manufacturing issues regarding dietary supplements be improved in the United States?

PubMed

Gibson, James E; Taylor, David A

2005-09-01

The safety and effectiveness of over-the-counter (OTC) drugs are assessed through the Food and Drug Administration's (FDA's) OTC drug review. Prescription drugs are approved through the rigorous new drug application (NDA) process. In contrast, dietary supplements are regulated as foods, and the FDA must determine that a dietary supplement ingredient poses a "significant or unreasonable risk of illness or injury" instead of requiring the manufacturer to provide safety data. According to the FDA, there are more than 29,000 different dietary supplements available to consumers today. This momentum has its roots in consumer interest in health and self-care and suggests that Americans are searching for alternatives to conventional foods for physical and mental well being. The Committee on the Framework for Evaluating the Safety of Dietary Supplements was formed under the auspices of the Food and Nutrition Board that produced a report entitled Dietary Supplements: A Framework for Evaluating Safety. Categories of specific information identified for use are 1) human data, 2) animal studies, 3) in vitro experiments, and 4) information on related substances. Several factors were identified to guide the FDA in applying the framework. Two of these factors are expressed as follows: 1) "the appropriate scientific standard to be used to overturn this basic assumption of safety is to demonstrate significant or unreasonable risk, not prove that an ingredient is unsafe"; and 2) "approaches taken by diverse organizations and governmental bodies, both within and outside the United States, which evaluate the safety and at times efficacy of dietary supplement ingredients, vary in their relevance to the protection of the American public from risks associated with consumption of dietary supplement ingredients".

Influence of attitudes on pharmacists' intention to report serious adverse drug events to the Food and Drug Administration

PubMed Central

Gavaza, Paul; Brown, Carolyn M; Lawson, Kenneth A; Rascati, Karen L; Wilson, James P; Steinhardt, Mary

2011-01-01

AIM To investigate the influence of pharmacists' attitudes on intention to report serious adverse drug events (ADEs) to the Food and Drug Administration (FDA). METHODS This cross-sectional study used a mail survey to collect data from hospital and community pharmacists practicing in Texas, United States. Three and 16 items were used to measure intention and attitudes, respectively, using a seven-point bipolar scale. Pharmacists' demographic and practice characteristics, and past reporting were also measured. RESULTS The response rate was 26.4% (n = 377/1500 pharmacists). Most pharmacists intended (n = 297, 78.8%) to report serious ADEs that they will encounter to the FDA through MedWatch. Overall, pharmacists held favourable attitudes towards reporting serious ADEs (mean = 24.5, SD = 6.7, possible range 1–49, neutral = 16). Pharmacists intending to report serious ADEs had more favourable attitudes than those who did not (P < 0.001). About 90% of the pharmacists believed that reporting serious ADEs would improve patient safety. However, 72.6% indicated that reporting serious ADEs was time consuming and over half (55.5%) of the respondents believed that reporting serious ADEs disrupted the normal workflow. Non-intenders held stronger beliefs that ADE reporting would disrupt the normal workflow and was time consuming compared with intenders. Years of experience, number of hours worked and practice setting were associated with pharmacists' attitudes towards reporting (P < 0.05). CONCLUSIONS Most pharmacists held moderately favourable attitudes and high intentions toward reporting serious ADEs to the FDA. This study's findings contribute to an increased understanding of individual factors that influence pharmacists' attitude and intention towards reporting serious ADEs to the FDA. PMID:21332572

U.S. consumers attitudes toward farm animal cloning.

PubMed

Brooks, Kathleen R; Lusk, Jayson L

2011-10-01

In January 2008, the United States Food and Drug Administration concluded "meat and milk from cattle, swine, and goat clones or their offspring are as safe to eat as food we eat from those species now" (U.S. FDA, 2010). However, cloning remains a very controversial topic. A web-based survey administered by Knowledge Networks was used to determine U.S. consumers' awareness of and attitudes toward meat and milk from cloned cattle. Findings reveal consumers do not differentiate much between products from cloned animals and products from non-cloned animals. Overall consumers are concerned that animal cloning is an unnatural process and that it will lead to human cloning. Copyright © 2011 Elsevier Ltd. All rights reserved.

An extensive review of commercial product labels the good, bad and ugly.

PubMed

Mrvos, R; Dean, B S; Krenzelok, E P

1986-02-01

Cautions and warnings on consumer products play an important role in the prevention and treatment of poison exposures. Frequently those exposed will follow the directions before calling the poison center, physician or emergency room. An extensive label review of 200 commercial products was conducted to determine if medical treatment advice was correct, if the general public was able to comprehend warning statements, and if warnings were adequate. We conclude there are products available that provide precise, correct information. However, there are many that contain incorrect, misleading, and often dangerous information to an unsuspecting public. Various examples of both types are given to make the poison information specialist aware of what information is presented.

40 CFR 80.573 - What labeling requirements apply to retailers and wholesale purchaser-consumers of NRLM diesel...

Code of Federal Regulations, 2014 CFR

2014-07-01

... Maximum) Required for use in all model year 2011 and later nonroad diesel engines. Recommended for use in all other non-highway diesel engines. WARNING Federal law prohibits use in highway vehicles or engines... retailers and wholesale purchaser-consumers of NRLM diesel fuel and heating oil beginning June 1, 2012? 80...

40 CFR 80.573 - What labeling requirements apply to retailers and wholesale purchaser-consumers of NRLM diesel...

Code of Federal Regulations, 2013 CFR

2013-07-01

... Maximum) Required for use in all model year 2011 and later nonroad diesel engines. Recommended for use in all other non-highway diesel engines. WARNING Federal law prohibits use in highway vehicles or engines... retailers and wholesale purchaser-consumers of NRLM diesel fuel and heating oil beginning June 1, 2012? 80...

40 CFR 80.573 - What labeling requirements apply to retailers and wholesale purchaser-consumers of NRLM diesel...

Code of Federal Regulations, 2011 CFR

2011-07-01

... Maximum) Required for use in all model year 2011 and later nonroad diesel engines. Recommended for use in all other non-highway diesel engines. WARNING Federal law prohibits use in highway vehicles or engines... retailers and wholesale purchaser-consumers of NRLM diesel fuel and heating oil beginning June 1, 2012? 80...

40 CFR 80.573 - What labeling requirements apply to retailers and wholesale purchaser-consumers of NRLM diesel...

Code of Federal Regulations, 2012 CFR

2012-07-01

... Maximum) Required for use in all model year 2011 and later nonroad diesel engines. Recommended for use in all other non-highway diesel engines. WARNING Federal law prohibits use in highway vehicles or engines... retailers and wholesale purchaser-consumers of NRLM diesel fuel and heating oil beginning June 1, 2012? 80...

77 FR 12063 - Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Nonprescription Drugs...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-28

... consumer studies needed to assess proper use of a MedKit containing doxycycline to be taken in the event of... doxycycline hyclate. FDA intends to make background material available to the public no later than 2 business...

Mini Lessons from FDA.

ERIC Educational Resources Information Center

Food and Drug Administration (DHEW), Washington, DC.

Eight self-contained lessons present information about topics of current interest in the Food and Drug Administration. Multidisciplinary in nature, the lessons can be integrated into ongoing activities in elementary or secondary level reading, math, language arts, social studies, science, art, health, consumer education, and home economics. The…

Cyberpharmacies and the role of the US Food And Drug Administration

PubMed Central

2001-01-01

The sale of consumer products over the Internet has grown rapidly, including the sale of drugs. While the growth in online drug sales by reputable pharmacies is a trend that may provide benefits to consumers, online drug sales also present risks to purchasers and some unique challenges to regulators, law enforcement officials and policy makers. The Food and Drug Administration (FDA or the Agency) is concerned about the public health implications of Internet drug sales, and we are responding to these concerns as part of our overall goal of developing and implementing risk-based strategies to protect public health and safety. Although other products regulated by the Agency, such as medical devices, medical test products, foods, dietary supplements and animal drugs also are sold online, this paper focuses on online drug sales. We discuss the advantages and risks of online drug sales, outline FDA's authority and enforcement activities in this area, and describe new initiatives we are taking to better respond to the regulatory challenges we face. PMID:11720945

Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; revision of certain labeling controls. Final rule.

PubMed

2012-03-20

The Food and Drug Administration (FDA) is amending the packaging and labeling control provisions of the current good manufacturing practice (CGMP) regulations for human and veterinary drug products by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons. FDA is also permitting the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment when cut labeling is used. This action is intended to protect consumers from labeling errors more likely to cause adverse health consequences, while eliminating the regulatory burden of applying the rule to labeling unlikely to reach or adversely affect consumers. This action is also intended to permit manufacturers to use a broader range of error prevention and labeling control techniques than permitted by current CGMPs.

Consumer Sleep Technology: An American Academy of Sleep Medicine Position Statement.

PubMed

Khosla, Seema; Deak, Maryann C; Gault, Dominic; Goldstein, Cathy A; Hwang, Dennis; Kwon, Younghoon; O'Hearn, Daniel; Schutte-Rodin, Sharon; Yurcheshen, Michael; Rosen, Ilene M; Kirsch, Douglas B; Chervin, Ronald D; Carden, Kelly A; Ramar, Kannan; Aurora, R Nisha; Kristo, David A; Malhotra, Raman K; Martin, Jennifer L; Olson, Eric J; Rosen, Carol L; Rowley, James A

2018-05-15

Consumer sleep technologies (CSTs) are widespread applications and devices that purport to measure and even improve sleep. Sleep clinicians may frequently encounter CST in practice and, despite lack of validation against gold standard polysomnography, familiarity with these devices has become a patient expectation. This American Academy of Sleep Medicine position statement details the disadvantages and potential benefits of CSTs and provides guidance when approaching patient-generated health data from CSTs in a clinical setting. Given the lack of validation and United States Food and Drug Administration (FDA) clearance, CSTs cannot be utilized for the diagnosis and/or treatment of sleep disorders at this time. However, CSTs may be utilized to enhance the patient-clinician interaction when presented in the context of an appropriate clinical evaluation. The ubiquitous nature of CSTs may further sleep research and practice. However, future validation, access to raw data and algorithms, and FDA oversight are needed. © 2018 American Academy of Sleep Medicine.

The US Food and Drug Administration's Perspective on the New Antipsychotic Pimavanserin.

PubMed

Mathis, Mitchell V; Muoio, Brendan M; Andreason, Paul; Avila, Amy M; Farchione, Tiffany; Atrakchi, Aisar; Temple, Robert J

2017-06-01

To summarize the US Food and Drug Administration's (FDA's) review of the safety and effectiveness for pimavanserin, an atypical antipsychotic, for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. We describe the regulatory and clinical issues important to the FDA's approval of this New Drug Application, with special focus on the risk-benefit balance. We also describe a new labeling feature that presents additional efficacy data to clinicians. Data sets for all relevant clinical trials of pimavanserin and the Applicant's and FDA's analyses of these data were considered in this review. Data were available from 616 patients with Parkinson's disease with hallucinations and delusions who received at least 1 dose of pimavanserin, with a total exposure of 825 patient-years in the Parkinson's disease psychosis population. Pimavanserin 34 mg/d was effective in treating hallucinations and delusions associated with Parkinson's disease. In the Applicant's single pivotal trial, 80.5% of pimavanserin patients experienced at least some improvement in symptoms compared to 58.1% of patients taking placebo. Pimavanserin did not worsen motor function, an adverse effect commonly observed with other antipsychotics, probably because of a lack of consequential dopamine binding. Pimavanserin is the only FDA-approved treatment for the hallucinations and delusions seen in patients with psychosis of Parkinson's disease. Although pimavanserin appears to have a pharmacologic mechanism that is different from other atypical antipsychotics, concern remained that the increased risk of death seen with antipsychotic use in elderly demented patients, and described in all approved antipsychotic labels, would also occur with pimavanserin. Pimavanserin bears the same boxed warning about the risk of death associated with antipsychotic use in elderly patients with dementia. © Copyright 2017 Physicians Postgraduate Press, Inc.

Food and Drug Administration (FDA) postmarket reported side effects and adverse events associated with pulmonary hypertension therapy in pediatric patients.

PubMed

Maxey, Dawn M; Ivy, D Dunbar; Ogawa, Michelle T; Feinstein, Jeffrey A

2013-10-01

Because most medications for pediatric pulmonary hypertension (PH) are used off label and based on adult trials, little information is available on pediatric-specific adverse events (AEs). Although drug manufacturers are required to submit postmarket AE reports to the Food and Drug Administration (FDA), this information is rarely transmitted to practitioners. In the setting of a recent FDA warning for sildenafil, the authors sought to give a better description of the AEs associated with current therapies in pediatric PH. In January 2010, a written request was made to the Food and Drug Administration for AE records of commonly used PH medications. Reports were screened for pediatric patients, analyzed in terms of AEs, and compared with the medical literature. Arbitrarily, AEs that could be attributed to concomitant medications were not attributed to the PH medication in question. Adverse events occurring in more than 5 % of events for each drug were assumed to be associated with the targeted PH medication. Between November 1997 and December 2009, 588 pediatric AE reports (death in 257 cases) were reported for the three most commonly used therapies: bosentan, epoprostenol, and sildenafil. Many of the AEs were similar to those reported previously. However, 27 AEs not previously reported in the literature (e.g., pulmonary hemorrhage, hemoptysis, and pneumonia) were found. The FDA postmarket records for PH medications in pediatric patients show a significant number of AEs. The discovery of AEs not previously reported will better inform those caring for these complex and critically ill children, and the large number of deaths suggest they may be underreported in current literature.

[Vaginal mesh operations in the urogynecological practice after the FDA warnings. Use or not to use mesh?

PubMed

Fekete, Zoltán; Körösi, Szilvia; Németh, Gábor

2018-03-01

The prevalence of pelvic organ prolapse (POP) with aging is escalating alarmingly, and now becoming a growing epidemic among the elderly. Synthetic transvaginal mesh (TVM) has been employed with increasing popularity in the treatment of POP until the end of the last decade. After the U.S. Drug and Food Administration (FDA) warnings in the years 2008 and 2011, the number of vaginal mesh operations has decreased dramatically. The aim of the study was to evaluate and compare the anti-POP effectivity, the anti-stress incontinence (anti-SUI) efficacy, and the late (36 months) post-operative complications of the anterior vaginoplasty and the TVM operations. We analysed the clinical data from 120 patients with stage II-III anterior prolapse and concomitant SUI who had undergone surgery at a tertiary referral centre in Hungary between January 2013 and January 2014. Sixty patients underwent Kelly-Stoeckel vaginoplasty and the other 60 cases had TVM operation. The surgical complications were classified using the Clavien-Dindo (CD) classification system. The anti-POP (91.6% vs. 63.3%; p<0.001) and the anti-SUI efficacy (90% vs. 55%, p<0.001) were significantly higher in the TVM group than in the vaginoplasty group, while the overall extrusion rate was found 8.3% after a 3-year follow-up. The Clavien-Dindo score (CD) proved that the early post-operative complication profile was similar among the TVM patients as compared to the vaginoplasty group (p = 0.405). Vaginal mesh surgery represents an effective procedure for prolapse and concomitant SUI with a decreased risk of short- and long-term complications. Orv Hetil. 2018; 159(10): 397-404.

Systematic drug safety evaluation based on public genomic expression (Connectivity Map) data: Myocardial and infectious adverse reactions as application cases

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wang, Kejian, E-mail: kejian.wang.bio@gmail.com; Weng, Zuquan; Sun, Liya

Adverse drug reaction (ADR) is of great importance to both regulatory agencies and the pharmaceutical industry. Various techniques, such as quantitative structure–activity relationship (QSAR) and animal toxicology, are widely used to identify potential risks during the preclinical stage of drug development. Despite these efforts, drugs with safety liabilities can still pass through safety checkpoints and enter the market. This situation raises the concern that conventional chemical structure analysis and phenotypic screening are not sufficient to avoid all clinical adverse events. Genomic expression data following in vitro drug treatments characterize drug actions and thus have become widely used in drug repositioning. Inmore » the present study, we explored prediction of ADRs based on the drug-induced gene-expression profiles from cultured human cells in the Connectivity Map (CMap) database. The results showed that drugs inducing comparable ADRs generally lead to similar CMap expression profiles. Based on such ADR-gene expression association, we established prediction models for various ADRs, including severe myocardial and infectious events. Drugs with FDA boxed warnings of safety liability were effectively identified. We therefore suggest that drug-induced gene expression change, in combination with effective computational methods, may provide a new dimension of information to facilitate systematic drug safety evaluation. - Highlights: • Drugs causing common toxicity lead to similar in vitro gene expression changes. • We built a model to predict drug toxicity with drug-specific expression profiles. • Drugs with FDA black box warnings were effectively identified by our model. • In vitro assay can detect severe toxicity in the early stage of drug development.« less

Side effects of cytokines approved for therapy.

PubMed

Baldo, Brian A

2014-11-01

Cytokines, currently known to be more than 130 in number, are small MW (<30 kDa) key signaling proteins that modulate cellular activities in immunity, infection, inflammation and malignancy. Key to understanding their function is recognition of their pleiotropism and often overlapping and functional redundancies. Classified here into 9 main families, most of the 20 approved cytokine preparations (18 different cytokines; 3 pegylated), all in recombinant human (rh) form, are grouped in the hematopoietic growth factor, interferon, platelet-derived growth factor (PDGF) and transforming growth factor β (TGFβ) families. In the hematopoietin family, approved cytokines are aldesleukin (rhIL-2), oprelvekin (rhIL-11), filgrastim and tbo-filgrastim (rhG-CSF), sargramostim (rhGM-CSF), metreleptin (rh-leptin) and the rh-erythropoietins, epoetin and darbepoietin alfa. Anakinra, a recombinant receptor antagonist for IL-1, is in the IL-1 family; recombinant interferons alfa-1, alfa-2, beta-1 and gamma-1 make up the interferon family; palifermin (rhKGF) and becaplermin (rhPDGF) are in the PDGF family; and rhBMP-2 and rhBMP-7 represent the TGFβ family. The main physicochemical features, FDA-approved indications, modes of action and side effects of these approved cytokines are presented. Underlying each adverse events profile is their pleiotropism, potency and capacity to release other cytokines producing cytokine 'cocktails'. Side effects, some serious, occur despite cytokines being endogenous proteins, and this therefore demands caution in attempts to introduce individual members into the clinic. This caution is reflected in the relatively small number of cytokines currently approved by regulatory agencies and by the fact that 14 of the FDA-approved preparations carry warnings, with 10 being black box warnings.

A study of warning letters issued to clinical investigators and institutional review boards by the United States Food and Drug Administration.

PubMed

Gogtay, N J; Doshi, B M; Kannan, S; Thatte, U

2011-01-01

Warning letters (WLs) issued by the US FDA (United States Food and Drug Administration) mention the nature of violations by clinical investigators and institutional review boards (IRBS) and can help as training tools. WLs issued by the US FDA between January 2005 and December 2010 to clinical investigators and IRBs were reviewed for various violation themes. A total of 129 WLs were issued to investigators and 40 to IRBs. Among the WLs issued to investigators, 67 (51.95%) were issued for drug-related research and 62 (48.06%) were for device-related research. For investigators, deviation from the investigational plan was the most common violation (81%) followed by failure to maintain accurate and adequate case histories (58.1%) and then informed consent issues (48.06%). Among WLs issued to IRBs, failure to have and follow standard operating procedures (SOPs) was seen in 93.89% followed by issues pertaining to membership (59.4%). When compared to a similar study published in 2004, for clinical investigators, no improvement was seen with respect to deviation from the investigational plan and study supervision. However, a significant improvement was seen in reporting of adverse events to IRBs, and some improvement was seen in the area of informed consent. For IRBs, no improvement was seen in most areas which included maintaining and following SOPs, membership, quorum requirements, misuse of expedited review and informed consent. WLs serve as indicators of an active regulatory agency which should translate into greater safety for participants in clinical trials. For developing countries with weak regulatory systems, these can serve as useful learning tools to help improve systems and put in patient safeguards.

Regulatory and ethical issues with dietary supplements.

PubMed

Harris, I M

2000-11-01

Dietary supplements are commonly used, and many are effective or hold promise for treating various conditions. However, they do not require Food and Drug Administration (FDA) approval. Impurities and adulterants have been found in the products, mostly due to the lack of requirements for good manufacturing practices. In addition, as no standardization is required, the active ingredient may be absent or highly variable among manufacturers. The FDA published its 10-year plan for dietary supplements that addresses safety, labeling, boundaries, enforcement, research, and outreach. This endeavor, if put into place, will be instrumental in providing consumers with more confidence in the safety, composition, and labeling of dietary supplements.

No sisyphean task: how the FDA can regulate electronic cigarettes.

PubMed

Paradise, Jordan

2013-01-01

The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: "low" or "light" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the market, reaching a rapidly expanding international consumer base. Boasting nicotine delivery and the tactile feel of a traditional cigarette without the dozens of other chemical constituents that contribute to carcinogenicity, e-cigarettes are often portrayed as less risky, as a smoking reduction or even a complete smoking cessation product, and perhaps most troubling for its appeal to youth, as a flavorful, trendy, and convenient accessory. The sensationalism associated with e-cigarettes has spurred outcry from health and medical professional groups, as well as the Food and Drug Administration (FDA), because of the unknown effects on public health. Inhabiting a realm of products deemed "tobacco products" under recent 2009 legislation, e-cigarettes pose new challenges to FDA regulation because of their novel method of nicotine delivery, various mechanical and electrical parts, and nearly nonexistent safety data. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades old questions of when the FDA can assert authority over products as drugs or medical devices. Recent case law restricting FDA enforcement efforts against e-cigarettes further confounds the distinction among drugs and medical devices, emerging e-cigarette products, and traditional tobacco products such as cigarettes, cigars, and smokeless tobacco. This Article investigates the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009 (TCA). It examines the tumultuous history of attempts at tobacco regulation by reflecting on the history of Congressional activity to regulate tobacco sales and promotion. Furthermore, this Article suggests a feasible approach to strengthening regulation of e-cigarettes under the existing statutory framework. This approach includes increased scrutiny of manufacturer and distributor claims that trigger drug and medical device provisions, utilization of new tobacco product and modified risk tobacco product provisions, and promulgation of new FDA regulations and guidance specifically directed at e-cigarettes.

The Association between Potential Exposure to Magazine Ads with Voluntary Health Warnings and the Perceived Harmfulness of Electronic Nicotine Delivery Systems (ENDS)

PubMed Central

Weaver, Scott R.; Zahra, Nahleen; Huang, Jidong; Cheng, Kai-Wen; Chaloupka, Frank J.

2018-01-01

(1) Background: Several brands of electronic nicotine delivery systems (ENDS) carry voluntary health warning messages. This study examined how potential exposure to ENDS magazine ads with these voluntary health warnings were associated with the perceived harmfulness of ENDS. (2) Methods: Risk perception measures and self-reported exposure to ENDS ads were obtained from the 2014 Georgia State University (GSU) Tobacco Products and Risk Perceptions Survey of a nationally representative sample of U.S. adults. We examined the association between potential exposure to magazine ads with warnings and the perceived harms of ENDS relative to cigarettes, using binary logistic regressions and controlling for general ENDS ad exposure and socio-demographic characteristics. (3) Results: Potential exposure to ENDS magazine ads with warnings was associated with a lower probability of considering ENDS to be more or equally harmful compared to cigarettes, particularly among non-smokers (OR = 0.16; 95% CI: 0.04–0.77). In addition, ad exposure, ENDS use history, race/ethnicity, gender, education, and income were also associated with harm perceptions. (4) Conclusions: This study did not find evidence that magazine ads with warnings increased misperceptions that ENDS are equally or more harmful than cigarettes. With more ENDS advertisements carrying warnings, more research is needed to determine how the warnings in advertisements convey relative harm information to consumers and the public. PMID:29570638

The Association between Potential Exposure to Magazine Ads with Voluntary Health Warnings and the Perceived Harmfulness of Electronic Nicotine Delivery Systems (ENDS).

PubMed

Shang, Ce; Weaver, Scott R; Zahra, Nahleen; Huang, Jidong; Cheng, Kai-Wen; Chaloupka, Frank J

2018-03-23

(1) Background: Several brands of electronic nicotine delivery systems (ENDS) carry voluntary health warning messages. This study examined how potential exposure to ENDS magazine ads with these voluntary health warnings were associated with the perceived harmfulness of ENDS. (2) Methods: Risk perception measures and self-reported exposure to ENDS ads were obtained from the 2014 Georgia State University (GSU) Tobacco Products and Risk Perceptions Survey of a nationally representative sample of U.S. adults. We examined the association between potential exposure to magazine ads with warnings and the perceived harms of ENDS relative to cigarettes, using binary logistic regressions and controlling for general ENDS ad exposure and socio-demographic characteristics. (3) Results: Potential exposure to ENDS magazine ads with warnings was associated with a lower probability of considering ENDS to be more or equally harmful compared to cigarettes, particularly among non-smokers (OR = 0.16; 95% CI: 0.04-0.77). In addition, ad exposure, ENDS use history, race/ethnicity, gender, education, and income were also associated with harm perceptions. (4) Conclusions: This study did not find evidence that magazine ads with warnings increased misperceptions that ENDS are equally or more harmful than cigarettes. With more ENDS advertisements carrying warnings, more research is needed to determine how the warnings in advertisements convey relative harm information to consumers and the public.

FDA Food Safety Modernization Act

THOMAS, 111th Congress

Rep. Sutton, Betty [D-OH-13

2009-06-08

01/04/2011 Became Public Law No: 111-353. (TXT | PDF) (All Actions) Notes: H.R.2751 was introduced and first passed the House as the Consumer Assistance to Recycle and Save Act. Tracker: This bill has the status Became LawHere are the steps for Status of Legislation:

Current techniques and outcomes in hysteroscopic sterilization: current evidence, considerations, and complications with hysteroscopic sterilization micro inserts.

PubMed

Casey, James; Cedo-Cintron, Laura; Pearce, Jessica; Yunker, Amanda

2017-08-01

To describe the current data regarding effectiveness, complications, postoperative evaluation, and surgical interventions associated with Essure hysteroscopic sterilization. Hysteroscopic sterilization is a commonly performed procedure that is offered as a well tolerated, effective, outpatient method of permanent sterilization. Over the past several years, concerns have been raised regarding correct placement and postoperative complications. This has led to statements by both the Food and Drug Administration (FDA) in October, 2016 and American Association of Gynecologic Laparoscopists in February, 2017, as a significant portion of women seek removal of these devices. A current black-box warning issued by the FDA in 2016 recommends discussion of 'the probabilities of rates or events' of adverse outcomes associated with Essure placement. Although hysteroscopic sterilization is usually a safe, effective option for permanent contraception, new evidence regarding complications has emphasized the need for proper education and counseling. Appropriate patient selection and knowledge of potential complications is paramount to ensuring patients, and medical providers are well informed and have realistic expectations regarding potential placement and postoperative issues.

Drug recall: An incubus for pharmaceutical companies and most serious drug recall of history

PubMed Central

Nagaich, Upendra; Sadhna, Divya

2015-01-01

There has been an increasing trend in the number of prescribed and over-the-counter drug recall over the last few years. The recall is usually due to company's discovery, customer's complaint or Food and Drug Administration (FDA) observation. The process of recall involves a planned specific course of action, which addresses the depth of recall, need for public warning, and the extent of effectiveness checks for the recall. The FDA review and/or recommend changes to the firm's recall strategy, as appropriate. The critical recall information list includes the identity of the product; summary of the failure; amount of product produced in the distribution chain and direct account. Product recalls clashes thousands of companies every year affecting: sales, testing customer relationships and disrupting supply chains. Drug recall is incubus for pharmaceutical companies. It effects the reputation of the company. The reason for the recall can be divided into two categories: manufacturing affined and safety/efficacy affined. It is essential to follow all the guidelines related to drug development and manufacturing procedure so as to minimize drug recall. PMID:25599028

Characterizing Phage Genomes for Therapeutic Applications

PubMed Central

Philipson, Casandra W.; Voegtly, Logan J.; Lueder, Matthew R.; Long, Kyle A.; Rice, Gregory K.; Frey, Kenneth G.; Biswas, Biswajit; Cer, Regina Z.; Hamilton, Theron; Bishop-Lilly, Kimberly A.

2018-01-01

Multi-drug resistance is increasing at alarming rates. The efficacy of phage therapy, treating bacterial infections with bacteriophages alone or in combination with traditional antibiotics, has been demonstrated in emergency cases in the United States and in other countries, however remains to be approved for wide-spread use in the US. One limiting factor is a lack of guidelines for assessing the genomic safety of phage candidates. We present the phage characterization workflow used by our team to generate data for submitting phages to the Federal Drug Administration (FDA) for authorized use. Essential analysis checkpoints and warnings are detailed for obtaining high-quality genomes, excluding undesirable candidates, rigorously assessing a phage genome for safety and evaluating sequencing contamination. This workflow has been developed in accordance with community standards for high-throughput sequencing of viral genomes as well as principles for ideal phages used for therapy. The feasibility and utility of the pipeline is demonstrated on two new phage genomes that meet all safety criteria. We propose these guidelines as a minimum standard for phages being submitted to the FDA for review as investigational new drug candidates. PMID:29642590

Developing a consumer evaluation tool of weight control strategy advertisements on the Internet.

PubMed

Luevorasirikul, Kanokrat; Gray, Nicola J; Anderson, Claire W

2008-06-01

To develop two evaluation tools for weight loss and weight gain advertisements on the Internet in order to help consumers to evaluate the quality of information within these advertisements. One hundred websites identified by Internet search engines for weight loss and weight gain strategies (50 websites each) were evaluated using two specific scoring instruments, developed by adapting questions from the 'DISCERN' tool and reviewing all related weight control guidelines and advertising regulations. The validity and reliability of the adapted tools were tested. Our evaluation tools rated the information from most websites as poor quality (70%). In the case of weight loss strategies, statements about rapid (18%) and permanent (28%) weight loss caused concern as well as lack of sensible advice about dieting and a lack of product warnings (84%). Safety concerns relating to weight gain products were the lack of warnings about side effects in products containing steroids and creatine (92%). The adapted tools exhibited acceptable validity and reliability. Quality of information within weight control advertisements on the Internet was generally poor. Problems of false claims, little advice on healthy ways to modify weight and few warnings on side effects have been highlighted in this study.

76 FR 38663 - Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-01

... on the Experimental Study of Comparative Direct-to-Consumer (DTC) Advertising. This study is designed... indirect comparisons, using comparative visuals, and using vaguer language. This study is designed to apply... Effectiveness) studies designed to explore comparative effectiveness. When this large project is completed, FDA...

76 FR 76978 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-09

... comparative visuals, and using vaguer language. This study is designed to apply the existing comparative... Effectiveness) studies designed to explore comparative effectiveness. When this large project is completed, FDA... Request; Experimental Study of Comparative Direct-to-Consumer Advertising AGENCY: Food and Drug...

Focus on Food Labeling. An FDA Consumer Special Report.

ERIC Educational Resources Information Center

Food and Drug Administration (DHHS/PHS), Washington, DC.

This special issue is designed for those who want to know all they can about the new federal requirements for nutrition information on food labels. Nine articles are included. "Good Reading for Good Eating" (Paula Kurtzweil) addresses mandatory nutrition labeling, the nutrition panel, nutrient content and health claims, and ingredient…

75 FR 77647 - Medical Device User Fee Program; Meetings on Reauthorization; Request for Notification of Patient...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-13

... consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The... reauthorization negotiations with the regulated industry. ADDRESSES: Submit notification of intention to... groups at least once every month during negotiations with the regulated industry to continue discussions...

45 CFR 73a.735-101 - Principles and purpose.

Code of Federal Regulations, 2010 CFR

2010-10-01

... CONDUCT: FOOD AND DRUG ADMINISTRATION SUPPLEMENT General Provisions § 73a.735-101 Principles and purpose. (a) To assure that the business of the Food and Drug Administration (FDA) is conducted effectively... the consumer and industry, its employees must be especially alert to avoid any real or appearance of...

Counterfeit Version of Botox Found in the United States

MedlinePlus

... fax, or by phone. Health care professionals and consumers can either: Complete and submit the report online: www.fda.gov/MedWatch/report.htm , or ... Continuing Education Inspections & Compliance Federal, State & Local Officials ... Content Home Latest Recalls Report an Adverse Event MedWatch Safety Alerts News Releases ...

21 CFR 101.12 - Reference amounts customarily consumed per eating occasion.

Code of Federal Regulations, 2013 CFR

2013-04-01

... in appropriate national food consumption surveys. (2) FDA calculated the reference amounts for an... reference amounts are based on data set forth in appropriate national food consumption surveys. Such... infant or by a child under 4 years of age. (3) An appropriate national food consumption survey includes a...

21 CFR 101.12 - Reference amounts customarily consumed per eating occasion.

Code of Federal Regulations, 2012 CFR

2012-04-01

... in appropriate national food consumption surveys. (2) FDA calculated the reference amounts for an... reference amounts are based on data set forth in appropriate national food consumption surveys. Such... infant or by a child under 4 years of age. (3) An appropriate national food consumption survey includes a...

21 CFR 101.12 - Reference amounts customarily consumed per eating occasion.

Code of Federal Regulations, 2014 CFR

2014-04-01

... in appropriate national food consumption surveys. (2) FDA calculated the reference amounts for an... reference amounts are based on data set forth in appropriate national food consumption surveys. Such... infant or by a child under 4 years of age. (3) An appropriate national food consumption survey includes a...

Beta-agonists and animal welfare

USDA-ARS?s Scientific Manuscript database

The use of beta-agonists in animal feed is a high profile topic within the U.S. as consumers and activist groups continue to question its safety. The only beta-agonist currently available for use in swine is ractopamine hydrochloride (RAC). This is available as Paylean™ (Elanco Animal Health – FDA a...

Drug Advertising and the FDA.

ERIC Educational Resources Information Center

Levesque, Cynthia

With increases in consumer focused advertising for prescription drugs, the Federal Drug Administration has renewed efforts to protect the public from false advertising. In 1982, it charged that the press kits Eli Lilly and Company distributed to reporters on its new antiarthritis drug, Oraflex, misrepresented the product. It recommended that Lilly…

Characterization of medication advertisements in a popular US parenting magazine.

PubMed

Mongiovi, Jennifer; Cadorett, Valerie; Basch, Corey

2017-01-01

Background: Medication advertisements in magazines typically provide minimal educational benefit. This is of particular concern when targeted to caregivers responsible for making major medical decisions for their children. Methods: A cross-section of 72 issues from Parents magazine were collected and categorized by health condition and availability of the medication by prescription or over-the-counter (OTC).The type of medicine, dose, warning label, indication for child or adult, presence of a cartoon character, and the marketing theme used were documented. Chi-square analysis was used to determine significant differences in content. Results: Fewer than 30% (95% CI: 25.4%, 34.5%) of advertisements contained dosage information and approximately 50% (95% CI: 50.3%, 60.2%) contained side effect warnings. The greatest number of advertisements was for cold, cough and flu medications (14.7%; 95%CI: 11.6%, 18.6%). Conclusion: Medicine advertisements often do not include important information that could help consumers make informed decisions and avoid negative implications. Further research is needed to determine the attitudes of consumers to better understand and support consumers 'needs.

Consortium on Methods Evaluating Tobacco: Research Tools to Inform FDA Regulation of Snus.

PubMed

Berman, Micah L; Bickel, Warren K; Harris, Andrew C; LeSage, Mark G; O'Connor, Richard J; Stepanov, Irina; Shields, Peter G; Hatsukami, Dorothy K

2017-10-04

The U.S. Food and Drug Administration (FDA) has purview over tobacco products. To set policy, the FDA must rely on sound science, yet most existing tobacco research methods have not been designed to specifically inform regulation. The NCI and FDA-funded Consortium on Methods Evaluating Tobacco (COMET) was established to develop and assess valid and reliable methods for tobacco product evaluation. The goal of this paper is to describe these assessment methods using a U.S. manufactured "snus" as the test product. In designing studies that could inform FDA regulation, COMET has taken a multidisciplinary approach that includes experimental animal models and a range of human studies that examine tobacco product appeal, addictiveness, and toxicity. This paper integrates COMET's findings over the last 4 years. Consistency in results was observed across the various studies, lending validity to our methods. Studies showed low abuse liability for snus and low levels of consumer demand. Toxicity was less than cigarettes on some biomarkers but higher than medicinal nicotine. Using our study methods and the convergence of results, the snus that we tested as a potential modified risk tobacco product is likely to neither result in substantial public health harm nor benefit. This review describes methods that were used to assess the appeal, abuse liability, and toxicity of snus. These methods included animal, behavioral economics, and consumer perception studies, and clinical trials. Across these varied methods, study results showed low abuse-liability and appeal of the snus product we tested. In several studies, demand for snus was lower than for less toxic nicotine gum. The consistency and convergence of results across a range of multi-disciplinary studies lends validity to our methods and suggests that promotion of snus as a modified risk tobacco products is unlikely to produce substantial public health benefit or harm. © The Author 2017. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Tobacco packaging and labeling policies under the U.S. Tobacco Control Act: research needs and priorities.

PubMed

Hammond, David

2012-01-01

The Family Smoking Prevention and Tobacco Control Act (the "Act"), enacted in June 2009, gave the U.S. Food and Drug Administration authority to regulate tobacco products. The current paper reviews the provisions for packaging and labeling, including the existing evidence and research priorities. Narrative review using electronic literature search of published and unpublished sources in 3 primary areas: health warnings, constituent labeling, and prohibitions on the promotional elements of packaging. The Act requires 9 pictorial health warnings covering half of cigarette packages and 4 text warnings covering 30% of smokeless tobacco packages. The Act also prohibits potentially misleading information on packaging, including the terms "light" and "mild," and provides a mandate to require disclosure of chemical constituents on packages. Many of the specific regulatory provisions are based on the extent to which they promote "greater public understanding of the risks of tobacco." As a result, research on consumer perceptions has the potential to shape the design and renewal of health warnings and to determine what, if any, information on product constituents should appear on packages. Research on consumer perceptions of existing and novel tobacco products will also be critical to help identify potentially misleading information that should be restricted under the Act. Packaging and labeling regulations required under the Act will bring the United States in line with international standards. There is an immediate need for research to evaluate these measures to guide future regulatory action.

Can nutritional information modify purchase of ultra-processed products? Results from a simulated online shopping experiment.

PubMed

Machín, Leandro; Arrúa, Alejandra; Giménez, Ana; Curutchet, María Rosa; Martínez, Joseline; Ares, Gastón

2018-01-01

The aim of the present work was to evaluate the influence of two front-of-pack nutrition information schemes (traffic-light system and Chilean warning system) on consumer purchase of ultra-processed foods in a simulated online grocery store. Following a between-subjects design, participants completed a simulated weekly food purchase in an online grocery store under one of three experimental conditions: (i) a control condition with no nutrition information, (ii) a traffic-light system and (iii) the Chilean warning system. Information about energy (calories), sugar, saturated fats and salt content was included in the nutrition information schemes. Participants were recruited from a consumer database and a Facebook advertisement. People from Montevideo (Uruguay), aged 18-77 years (n 437; 75 % female), participated in the study. All participants were in charge of food purchase in the household, at least occasionally. No significant differences between experimental conditions were found in the mean share of ultra-processed foods purchased by participants, both in terms of number of products and expenditure, or in the mean energy, sugar, saturated fat and salt content of the purchased items. However, the Chilean warning system decreased intended purchase of sweets and desserts. Results from this online simulation provided little evidence to suggest that the traffic-light system or the Chilean warning system in isolation could be effective in reducing purchase of ultra-processed foods or improving the nutritional composition of the purchased products.

Adding sodium information to casual dining restaurant menus: Beneficial or detrimental for consumers?

PubMed

Byrd, Karen; Almanza, Barbara; Ghiselli, Richard F; Behnke, Carl; Eicher-Miller, Heather A

2018-06-01

High sodium levels in restaurant food have prompted Philadelphia and New York City to require inclusion of sodium content in addition to calories on menus to "nudge" consumers toward lower sodium foods. However, taste perceptions may impact the effectiveness of this intervention. An online survey tested whether sodium and calorie menu nutrition information (MNI) influenced consumer choices from a casual dining restaurant menu, accounting for consumers' intuition about taste of food relative to sodium, calories, and healthiness. Consumer choices were assessed based on calorie and sodium content of the menu items they selected. Participants were randomized to a menu with (1) calorie MNI only, (2) calorie plus numeric sodium MNI, (3) calorie MNI plus a sodium warning symbol for foods with 2300 mg of sodium or more, or (4) no MNI. Calorie plus numeric sodium MNI was associated with selection of meals lower in sodium compared to meals from the calorie MNI only menu or no MNI menu, but only for consumers with a taste intuition that (relatively) lower sodium, lower calorie, healthy foods were tasty. Consumers with the opposite taste intuition *(foods with these characteristics are not tasty) ordered meals higher in sodium. Inclusion of the sodium warning symbol did not result in a significantly different meal sodium content compared to the other menu conditions, regardless of taste intuition. However, differing levels of taste intuition alone, without consideration of MNI, was associated with ordering meals of significantly different calorie content. Overall, findings suggest adding calorie plus numeric sodium MNI may lead to beneficial outcomes (i.e., selecting meals lower in sodium) for some consumers and detrimental outcomes (i.e., selecting meals higher in sodium) for others, depending on their taste intuition. Copyright © 2018 Elsevier Ltd. All rights reserved.

Analysis of U.S. Food and Drug Administration food allergen recalls after implementation of the food allergen labeling and consumer protection act.

PubMed

Gendel, Steven M; Zhu, Jianmei

2013-11-01

To avoid potentially life-threatening reactions, food allergic consumers rely on information on food labels to help them avoid exposure to a food or ingredient that could trigger a reaction. To help consumers in the United States obtain the information that they need, the Food Allergen Labeling and Consumer Protection Act of 2004 defined a major food allergen as being one of eight foods or food groups and any ingredient that contains protein from one of these foods or food groups. A food that contains an undeclared major food allergen is misbranded under the U.S. Food, Drug, and Cosmetic Act and is subject to recall. Food allergen labeling problems are the most common cause of recalls for U.S. Food and Drug Administration (FDA)-regulated food products. To help understand why food allergen recalls continue to occur at a high rate, information on each food allergen recall that occurred in fiscal years 2007 through 2012 was obtained from the FDA recall database. This information was analyzed to identify the food, allergen, root cause, and mode of discovery for each food allergen recall. Bakery products were the most frequently recalled food type, and milk was the most frequently undeclared major food allergen. Use of the wrong package or label was the most frequent problem leading to food allergen recalls. These data are the first reported that indicate the importance of label and package controls as public health measures.

Direct-to-consumer advertising of pharmaceuticals.

PubMed

Gellad, Ziad F; Lyles, Kenneth W

2007-06-01

Since the US Food and Drug Administration (FDA) released new guidelines on broadcast direct-to-consumer advertising in 1997, the prevalence of direct-to-consumer advertising of prescription drugs has increased exponentially. The impact on providers, patients, and the health care system is varied and dynamic, and the rapid changes in the last several years have markedly altered the health care landscape. To continue providing optimal medical care, physicians and other health care providers must be able to manage this influence on their practice, and a more thorough understanding of this phenomenon is an integral step toward this goal. This review will summarize the history of direct-to-consumer drug advertisements and the current regulations governing them. It will summarize the evidence concerning the impact of direct-to-consumer advertising on the public, providers, and the health care system, and conclude with observations regarding the future of direct-to-consumer advertising.

Consumer friendly or reader hostile? An evaluation of the readability of DTC print ads.

PubMed

Sheehan, Kim

2008-01-01

The Food and Drug Administration requires advertisements promoting prescription drugs to be written in "consumer friendly" language. The purpose of this study is to examine the language of Direct-to-Consumer prescription drug advertisements to determine if such language is easy for consumers to read and understand. A series of advertisements for a variety of products, appearing in popular consumer magazines, were analyzed using the Flesch and Gunning-Fogg formulas to determine if DTC advertisements are more or less complex than other advertisements that consumers read today. Results indicate that DTC ads are among the most difficult print ads to read. Additionally, certain types of information contained in these print ads (such as information discussing a drug's risks and contraindications) are significantly more difficult to read than information in any other type of ad copy in magazines today. Implications for DTC marketers and the FDA are included.

Direct-to-Consumer Advertising of Pharmaceuticals

PubMed Central

Gellad, Ziad F.; Lyles, Kenneth W.

2014-01-01

Since the FDA released new guidelines on broadcast direct-to-consumer advertising in 1997, the prevalence of direct-to-consumer advertising of prescription drugs has increased exponentially. The impact on providers, patients and the health care system is varied and dynamic, and the rapid changes in the last several years have markedly altered the health care landscape. To continue providing optimal medical care, physicians and other health-care providers must be able to manage this influence on their practice, and a more thorough understanding of this phenomenon is an integral step toward this goal. This review will summarize the history of direct-to-consumer drug advertisements and the current regulations governing them. It will summarize the evidence concerning the impact of direct-to-consumer advertising on the public, providers and the health care system and conclude with observations regarding the future of direct-to-consumer advertising. PMID:17524744

Perceptions and acceptability of pictorial health warning labels vs text only--a cross-sectional study in Lao PDR.

PubMed

Sychareun, Vanphanom; Hansana, Visanou; Phengsavanh, Alongkone; Chaleunvong, Kongmany; Tomson, Tanja

2015-10-28

In Lao PDR, health warnings were first introduced with printed warning messages on the side of the cigarette package in 1993 and again in 2004. Lao PDR same year ratified the Framework Convention on Tobacco Control (WHO FCTC) but has not yet implemented pictorial health warnings. This paper aims to examine the perception and opinion of policymakers on "text-only" and "pictorial" health warnings and to understand lay people's perceptions on current health warnings and their opinions on the recommended types of health warnings. A combination of quantitative and qualitative methods were used in this cross-sectional study conducted in 2008. A purposive sample of 15 policymakers, and a representative sample of 1360 smokers and non-smokers were recruited. A range of different areas were covered including consumer attitudes towards current and proposed cigarette package design, views on health warning messages on the flip/slide and inserts, and views on the relative importance of the size, content and pictures of health warning messages. Descriptive statistics and content analysis were used. Policy makers and survey respondents said that the current health warning messages were inappropriate, ineffective, and too small in size. All respondents perceived pictorial health warnings as a potentially powerful element that could be added to the messages that can communicate quickly, and dramatically. The majority of policymakers and survey respondents strongly supported the implementation of pictorial health warnings. The non-smokers agreed that the graphic pictorial health warnings were generally more likely than written health warnings to stimulate thinking about the health risks of smoking, by conveying potential health effects, increasing and reinforcing awareness of the negative health effect of smoking, aiding memorability of the health effects and arousing fear of smoking among smokers. The study suggested that current warnings are too small and that content is inadequate and designed to be hidden on the side pack. These findings are in line with FCTC's requirements and provide strong support for introducing pictorial warning labels also in Lao PDR. Furthermore, the awareness of Members of Parliament about tobacco control measures holds promise at the highest political level.

Zohydro approval by food and drug administration: controversial or frightening?

PubMed

Manchikanti, Laxmaiah; Atluri, Sairam; Candido, Kenneth D; Boswell, Mark V; Simopoulos, Thomas T; Grider, Jay S; Falco, Frank J E; Hirsch, Joshua A

2014-01-01

The actions and regulations of the Food and Drug Administration (FDA) are crucial to the entire population of the U.S., specifically the public who take a multitude of drugs and providers who prescribe drugs and devices. Further, the FDA is relevant to investors, specifically in regards to biotech and pharmaceutical companies involved in developing new drugs. The FDA has been criticized for a lack of independence on the one hand and excessive regulatory and expanding authority without evidence and consistency of the actions on the other hand. The FDA approved a single-entity, long-acting, hydrocodone product (Zohydro, Zogenix, San Diego, CA) on October 25, 2013, against the recommendation of the FDA's own appointed scientific advisory panel, which voted 11 to 2 against the approval of Zohydro. Subsequent to the approval, multiple consumer safety organizations, health care agencies, addiction treatment providers, professional organizations, and other groups on the frontline of the opioid addiction epidemic have expressed concern. In addition, the US Congress and various state attorneys general raised serious concerns about the approval of Zohydro, which is highly addictive and may enhance the opioid addiction epidemic. Supporters of Zohydro contend that it is necessary and essential to manage chronic pain and improve functional status with no additional risk. Over the past 15 years, prescriptions for opioids have skyrocketed with the United States consuming more than 84% of the global oxycodone and more than 99% of the hydrocodone supply. The sharp increase in opioid prescribing has led to parallel increases in opioid addiction and overdose deaths, surpassing motor vehicle injuries in the U.S. Recent studies assessing the trends of medical use and misuse of opioid analgesics from 2000 to 2011 have concluded that the present trend of the continued increase in the medical use of opioid analgesics appears to contribute to increasing misuse, resulting in multiple health consequences, despite numerous regulations enforced by multiple organizations. The approval of Zohydro and its defense from the FDA were based on a misunderstanding of the prevalence of chronic severe disabling pain. Based on inaccurate data from the Institute of Medicine, in part caused by conflicts of interest, 100 million persons have been described to suffer from severe pain - the correct number is 22.6 million. This manuscript analyzes 3 important principles of drug approval and utilization based on safety, efficacy, and medical necessity. Based on the limited literature that the authors were able to review including that which was submitted to the FDA by the manufacturers, it appears the safety, efficacy, and medical necessity were not demonstrated. In fact, the study submitted to the FDA showed a 50% pain improvement in only 48% of the patients in the treatment group and 21% of the patients in the placebo group at 85 day follow-up. This is a statistically significant result but its clinical relevance is unknown. The FDA approval decision occurring against the backdrop of the advisory panel recommendation is concerning and may result in serious consequences in the future.

Bisphosphonates and Nonhealing Femoral Fractures: Analysis of the FDA Adverse Event Reporting System (FAERS) and International Safety Efforts

PubMed Central

Edwards, Beatrice J.; Bunta, Andrew D.; Lane, Joseph; Odvina, Clarita; Rao, D. Sudhaker; Raisch, Dennis W.; McKoy, June M.; Omar, Imran; Belknap, Steven M.; Garg, Vishvas; Hahr, Allison J.; Samaras, Athena T.; Fisher, Matthew J.; West, Dennis P.; Langman, Craig B.; Stern, Paula H.

2013-01-01

Background: In the United States, hip fracture rates have declined by 30% coincident with bisphosphonate use. However, bisphosphonates are associated with sporadic cases of atypical femoral fracture. Atypical femoral fractures are usually atraumatic, may be bilateral, are occasionally preceded by prodromal thigh pain, and may have delayed fracture-healing. This study assessed the occurrence of bisphosphonate-associated nonhealing femoral fractures through a review of data from the U.S. FDA (Food and Drug Administration) Adverse Event Reporting System (FAERS) (1996 to 2011), published case reports, and international safety efforts. Methods: We analyzed the FAERS database with use of the proportional reporting ratio (PRR) and empiric Bayesian geometric mean (EBGM) techniques to assess whether a safety signal existed. Additionally, we conducted a systematic literature review (1990 to February 2012). Results: The analysis of the FAERS database indicated a PRR of 4.51 (95% confidence interval [CI], 3.44 to 5.92) for bisphosphonate use and nonhealing femoral fractures. Most cases (n = 317) were attributed to use of alendronate (PRR = 3.32; 95% CI, 2.71 to 4.17). In 2008, international safety agencies issued warnings and required label changes. In 2010, the FDA issued a safety notification, and the American Society for Bone and Mineral Research (ASBMR) issued recommendations about bisphosphonate-associated atypical femoral fractures. Conclusions: Nonhealing femoral fractures are unusual adverse drug reactions associated with bisphosphonate use, as up to 26% of published cases of atypical femoral fractures exhibited delayed healing or nonhealing. PMID:23426763

Research on the cognitively impaired: lessons and warnings from the emergency research debate.

PubMed

Karlawish, J H; Sachs, G A

1997-04-01

To demonstrate that the recent events in emergency research have broad implications for the conduct of human subjects research with the cognitively impaired. This essay illustrates the similarities between the two kinds of research and suggests how understanding these similarities might help to resolve issues in human subjects research on the cognitively impaired. A review of pertinent journal articles, books, regulations, and court cases. The emergency research controversy resulted in large part because of conflicting interpretations of arguably inadequate research regulations. The proposed Food and Drug Administration (FDA) regulations include advance informed consent, a broad role for family in approving a subject's participation, replacement of a threshold of permissible risk, called minimal risk, with a more sensible balancing of risks and benefits, and a role for the community in research approval. The current state of research on the cognitively impaired suggests that many of the same problems exist now that existed in emergency research before the FDA issued its proposed regulations. The ongoing case of T.D. et al. vs N.Y. State Office of Mental Health suggest that unless steps are taken similar to those taken in emergency research, much of clinical research on the cognitively impaired could cease. Representatives of the government, medicine, and the public must recognize the unresolved issues and inadequate regulations relating to research on the cognitively impaired. The proposed FDA regulations for emergency research may provide guidance for a settlement of these issues.

Lomitapide and mipomersen: novel lipid-lowering agents for the management of familial hypercholesterolemia.

PubMed

Dixon, Dave L; Sisson, Evan M; Butler, Michael; Higbea, Ashley; Muoio, Brendan; Turner, Brandy

2014-01-01

Familial hypercholesterolemia (FH) is an autosomal dominant disorder caused primarily by mutations in the low-density lipoprotein receptor gene. Familial hypercholesterolemia is characterized by exceedingly high levels of low-density lipoprotein cholesterol (LDL-C) and subsequent premature coronary heart disease. Homozygous FH (HoFH) is less prevalent, but more severe, than heterozygous FH. Current treatment options include dietary therapy, lipid-lowering agents (eg, statins), and/or LDL-C apheresis. Despite the available treatment options, patients with FH rarely attain treatment goals. This review will focus on 2 novel agents, lomitapide and mipomersen, with recently approved US Food and Drug Administration (FDA) labeling for use in patients with HoFH. Lomitapide and mipomersen are 2 agents with novel mechanisms of action and the ability to significantly lower LDL-C, apolipoprotein B, and non-high-density lipoprotein cholesterol levels. A black box warning exists for lomitapide and mipomersen regarding the risk for transaminase elevations and hepatic steatosis. Furthermore, these agents are currently restricted for use only in patients with HoFH and have been required by the FDA to participate in a Risk Evaluation and Mitigation Strategy. These new agents offer additional treatment options for clinicians managing patients with HoFH, but it remains uncertain whether lomitapide and mipomersen will gain FDA approval for use in patients with heterozygous FH or in the general population. Cost and concern for the risk for hepatotoxicity will remain limiting factors to these agents being more widely used.

Avoiding Service Station Fraud.

ERIC Educational Resources Information Center

Burton, Grace M.; Burton, John R.

1982-01-01

High school students are warned against service station fraud. A problem-solving section is designed to help students calculate consumer costs for various fraudulent transactions. Several ways of reducing fraud or of lessening the chances of problems are noted. (MP)

Weighting Statistical Inputs for Data Used to Support Effective Decision Making During Severe Emergency Weather and Environmental Events

NASA Technical Reports Server (NTRS)

Gardner, Adrian

2010-01-01

National Aeronautical and Space Administration (NASA) weather and atmospheric environmental organizations are insatiable consumers of geophysical, hydrometeorological and solar weather statistics. The expanding array of internet-worked sensors producing targeted physical measurements has generated an almost factorial explosion of near real-time inputs to topical statistical datasets. Normalizing and value-based parsing of such statistical datasets in support of time-constrained weather and environmental alerts and warnings is essential, even with dedicated high-performance computational capabilities. What are the optimal indicators for advanced decision making? How do we recognize the line between sufficient statistical sampling and excessive, mission destructive sampling ? How do we assure that the normalization and parsing process, when interpolated through numerical models, yields accurate and actionable alerts and warnings? This presentation will address the integrated means and methods to achieve desired outputs for NASA and consumers of its data.

Gore offers to help drug companies pursue research.

PubMed

1996-03-08

A meeting convened between Vice President Al Gore and executives of leading pharmaceutical companies to determine means of accelerating efforts to develop vaccines, therapeutics, and microbicides for people with HIV. Gore explained that the administration will work with pharmaceutical companies to determine the long-term effectiveness of drugs approved by the Food and Drug Administration (FDA), work with international groups to increase investment in vaccine development, help develop new microbicides for women with HIV, and identify promising areas of AIDS research. According to advocates, the Clinton Administration has made great strides in improving and accelerating the FDA's drug approval process. The next goal of the pharmaceutical research agenda should be to include consumer advocates in the decision-making process.

Safety assessments and public concern for genetically modified food products: the American view.

PubMed

Harlander, Susan K

2002-01-01

In the relatively short time since their commercial introduction in 1996, genetically modified (GM) crops have been rapidly adopted in the United States GM crops are regulated through a coordinated framework developed in 1992 and administered by three agencies-the US Department of Agriculture (USDA) that ensures the products are safe to grow, the Environmental Protection Agency (EPA) that ensures the products are safe for the environment, and the Food and Drug Administration (FDA) that ensures the products are safe to eat. Rigorous food and environmental safety assessments must be completed before GM crops can be commercialized. Fifty-one products have been reviewed by the FDA, including several varieties of corn, soybeans, canola, cotton, rice, sugar beets, potatoes, tomatoes, squash, papaya, and flax. Because FDA considers these crops "substantially equivalent" to their conventional counterparts, no special labeling is required for GM crops in the United States and they are managed as commodities with no segregation or identity preservation. GM crops have thus made their way through commodity distribution channels into thousands of ingredients used in processed foods. It has been estimated that 70% to 85% of processed foods on supermarket shelves in the United States today contain one or more ingredients potentially derived from GM crops. The food industry and retail industry have been monitoring the opinions of their consumers on the GM issue for the past several years. Numerous independent groups have also surveyed consumer concerns about GM foods. The results of these surveys are shared and discussed here.

Nutrition warnings as front-of-pack labels: influence of design features on healthfulness perception and attentional capture.

PubMed

Cabrera, Manuel; Machín, Leandro; Arrúa, Alejandra; Antúnez, Lucía; Curutchet, María Rosa; Giménez, Ana; Ares, Gastón

2017-12-01

Warnings are a new directive front-of-pack (FOP) nutrition labelling scheme that highlights products with high content of key nutrients. The design of warnings influences their ability to catch consumers' attention and to clearly communicate their intended meaning, which are key determinants of their effectiveness. The aim of the present work was to evaluate the influence of design features of warnings as a FOP nutrition labelling scheme on perceived healthfulness and attentional capture. Five studies with a total of 496 people were carried out. In the first study, the association of colour and perceived healthfulness was evaluated in an online survey in which participants had to rate their perceived healthfulness of eight colours. In the second study, the influence of colour, shape and textual information on perceived healthfulness was evaluated using choice-conjoint analysis. The third study focused on implicit associations between two design features (shape and colour) on perceived healthfulness. The fourth and fifth studies used visual search to evaluate the influence of colour, size and position of the warnings on attentional capture. Perceived healthfulness was significantly influenced by shape, colour and textual information. Colour was the variable with the largest contribution to perceived healthfulness. Colour, size and position of the warnings on the labels affected attentional capture. Results from the experiments provide recommendations for the design of warnings to identify products with unfavourable nutrient profile.

The national and international regulatory environment in tobacco control.

PubMed

Warner, Kenneth E

2015-07-09

Despite their lethality, cigarettes are subject to little regulation that directly restricts their contents or their legality. This may change in the near future with the Framework Convention on Tobacco Control (FCTC), the world's first global health treaty, now in force, as well as developments in a few individual countries. Cigarettes are subject to a substantial number of country-specific regulations regarding their conditions of sale: their price (mostly through taxation), the places where they can be consumed (clean indoor air laws), who can smoke them (prohibitions on their use by or sales to minors), how they can be advertised or promoted (if at all), and how they must be packaged (minimum pack sizes, warning labels, plain packaging). Such policies constitute the core of successful tobacco control. The FCTC has been ratified by 180 countries representing 90% of the world's population. The FCTC requires compliance with numerous provisions relating to the kinds of regulations noted above. The treaty also mandates explicit attention to direct product regulation. Several countries have such authority, at least in limited forms. In the US, for example, the Food and Drug Administration (FDA) now has the legal authority to regulate tobacco products, including their contents. The possibility exists that, in the foreseeable future, a country will mandate product standards that will substantially reduce the appeal of cigarettes and other combusted tobacco products, which are by far the leading sources of the death and disease associated with tobacco.

NIEHS/FDA CLARITY-BPA research program update.

PubMed

Heindel, Jerrold J; Newbold, Retha R; Bucher, John R; Camacho, Luísa; Delclos, K Barry; Lewis, Sherry M; Vanlandingham, Michelle; Churchwell, Mona I; Twaddle, Nathan C; McLellen, Michelle; Chidambaram, Mani; Bryant, Matthew; Woodling, Kellie; Gamboa da Costa, Gonçalo; Ferguson, Sherry A; Flaws, Jodi; Howard, Paul C; Walker, Nigel J; Zoeller, R Thomas; Fostel, Jennifer; Favaro, Carolyn; Schug, Thaddeus T

2015-12-01

Bisphenol A (BPA) is a chemical used in the production of numerous consumer products resulting in potential daily human exposure to this chemical. The FDA previously evaluated the body of BPA toxicology data and determined that BPA is safe at current exposure levels. Although consistent with the assessment of some other regulatory agencies around the world, this determination of BPA safety continues to be debated in scientific and popular publications, resulting in conflicting messages to the public. Thus, the National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), and U.S. Food and Drug Administration (FDA) developed a consortium-based research program to link more effectively a variety of hypothesis-based research investigations and guideline-compliant safety testing with BPA. This collaboration is known as the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA). This paper provides a detailed description of the conduct of the study and a midterm update on progress of the CLARITY-BPA research program. Published by Elsevier Inc.

NIEHS/FDA CLARITY-BPA research program update

PubMed Central

Heindel, Jerrold J.; Newbold, Retha R.; Bucher, John R.; Camacho, Luísa; Delclos, K. Barry; Lewis, Sherry M.; Vanlandingham, Michelle; Churchwell, Mona I.; Twaddle, Nathan C.; McLellen, Michelle; Chidambaram, Mani; Bryant, Matthew; Woodling, Kellie; Gamboa da Costa, Gonçalo; Ferguson, Sherry A.; Flaws, Jodi; Howard, Paul C.; Walker, Nigel J.; Zoeller, R. Thomas; Fostel, Jennifer; Favaro, Carolyn; Schug, Thaddeus T.

2016-01-01

Bisphenol A (BPA) is a chemical used in the production of numerous consumer products resulting in potential daily human exposure to this chemical. The FDA previously evaluated the body of BPA toxicology data and determined that BPA is safe at current exposure levels. Although consistent with the assessment of some other regulatory agencies around the world, this determination of BPA safety continues to be debated in scientific and popular publications, resulting in conflicting messages to the public. Thus, the National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), and U.S Food and Drug Administration (FDA) developed a consortium-based research program to link more effectively a variety of hypothesis-based research investigations and guideline-compliant safety testing with BPA. This collaboration is known as the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA). This paper provides a detailed description of the conduct of the study and a midterm update on progress of the CLARITY-BPA research program. PMID:26232693

Prescription Drug Promotion from 2001-2014: Data from the U.S. Food and Drug Administration

PubMed Central

Sullivan, Helen W.; Aikin, Kathryn J.; Chung-Davies, Eunice; Wade, Michael

2016-01-01

The volume of prescription drug promotion over time is often measured by assessing changes in ad spending. However, this method obscures the fact that some types of advertising are more expensive than others. Another way to measure the changes in prescription drug promotion over time is to assess the number of promotional pieces submitted to the U.S. Food and Drug Administration (FDA). Form FDA 2253 collects information such as the date submitted and the type of material submitted. We analyzed data from Forms FDA 2253 received from 2001–2014. We examined the frequency of submissions by audience (consumer and healthcare professional) and type of promotional material. There was a noted increase in prescription drug promotion submissions across all media in the early 2000s. Although non-Internet promotion submissions have since plateaued, Internet promotion continued to increase. These results can help public health advocates and regulators focus attention and resources. PMID:27149513

76 FR 10607 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-25

... retail sales for consumption by individuals. Professional products used in salons, and free samples are not available through retail sale to consumers, so they are not considered to be in ``commercial... cosmetic industry personnel and FDA experience entering data submitted on paper Forms 2511, 2512, 2512a...

75 FR 53312 - Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-31

..., this method may not be the most ideal. Research has shown that while many consumers will make the... and Behaviors Associated with DTC Promotion of Prescription Drugs: Summary of FDA Survey Research... it is presented will impact comprehension. For instance, research with the format of over-the-counter...

Evaluation of Modified Risk Claim Advertising Formats for Camel Snus

ERIC Educational Resources Information Center

Fix, Brian V.; Adkison, Sarah E.; O'Connor, Richard J.; Bansal-Travers, Maansi; Cummings, K. Michael; Rees, Vaughan W.; Hatsukami, Dorothy K.

2017-01-01

Objectives: The US Food and Drug Administration (FDA) has regulatory authority for modified risk tobacco product advertising claims. To guide future regulatory efforts, we investigated how variations in modified risk claim advertisements influence consumer perceptions of product risk claims for Camel Snus. Methods: Young people and adults (15-65),…

75 FR 15376 - Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-29

... already published by FDA in 2004 summarizing its survey research results on the public health impacts of... and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3238, Silver... Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401...

77 FR 20030 - Draft Guidance for Industry: Reporting Harmful and Potentially Harmful Constituents in Tobacco...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-03

... products for consumer use--cigarettes, smokeless tobacco, and roll-your-own tobacco--and not with respect...: Cigarette smoke, smokeless tobacco products, and roll-your- own tobacco and cigarette filler. To facilitate... for cigarette smoke and filler, smokeless tobacco, and roll-your-own tobacco. FDA has created forms to...

Food labeling; calorie labeling of articles of food in vending machines. Final rule.

PubMed

2014-12-01

To implement the vending machine food labeling provisions of the Patient Protection and Affordable Care Act of 2010 (ACA), the Food and Drug Administration (FDA or we) is establishing requirements for providing calorie declarations for food sold from certain vending machines. This final rule will ensure that calorie information is available for certain food sold from a vending machine that does not permit a prospective purchaser to examine the Nutrition Facts Panel before purchasing the article, or does not otherwise provide visible nutrition information at the point of purchase. The declaration of accurate and clear calorie information for food sold from vending machines will make calorie information available to consumers in a direct and accessible manner to enable consumers to make informed and healthful dietary choices. This final rule applies to certain food from vending machines operated by a person engaged in the business of owning or operating 20 or more vending machines. Vending machine operators not subject to the rules may elect to be subject to the Federal requirements by registering with FDA.

Caffeine Content Labeling: A Missed Opportunity for Promoting Personal and Public Health

PubMed Central

Kole, Jon

2013-01-01

Current regulation of caffeine-containing products is incoherent, fails to protect consumers' interests, and should be modified in multiple ways. We make the case for one of the regulatory reforms that are needed: all consumable products containing added caffeine should be required by the Food and Drug Administration (FDA) to include caffeine quantity on their labels. Currently, no foods or beverages that contain caffeine are required to include caffeine content on their labels. Strengthening these lax labeling requirements could prevent direct caffeine-induced harm, protect those most vulnerable to caffeine-related side effects, and enhance consumer autonomy and effective caffeine use. Consumers have an interest in regulating their intake of caffeine and thus, ought to know how much caffeine their foods and beverages contain. PMID:24761278

"We Have a Right to Know": Exploring Consumer Opinions on Content, Design and Acceptability of Enhanced Alcohol Labels.

PubMed

Vallance, Kate; Romanovska, Inna; Stockwell, Tim; Hammond, David; Rosella, Laura; Hobin, Erin

2018-01-01

This study aimed to refine content and design of an enhanced alcohol label to provide information that best supports informed drinking and to gauge consumer acceptability of enhanced alcohol labels among a subset of consumers. Five focus groups (n = 45) were conducted with stakeholders and the general public (age 19+) across one jurisdiction in northern Canada. Interviews were transcribed and analyzed using NVivo software. The majority of participants showed strong support for enhanced alcohol labels with an emphasis on the consumers' right to know about the health risks related to alcohol. Participants preferred larger labels that included standard drink (SD) information, national low-risk drinking guidelines presented as a chart with pictograms, cancer health messaging and a pregnancy warning. Supporting introduction of the labels with a web resource and an educational campaign was also recommended. Displaying enhanced labels on alcohol containers that include SD information, low-risk drinking guidelines and other health messaging in an accessible format may be an effective way to better inform drinkers about their consumption and increase awareness of alcohol-related health risks. Introduction of enhanced labels shows potential for consumer support. Focus group findings indicate strong support for enhanced alcohol labels displaying SD information, national drinking guidelines, health messaging and a pregnancy warning. Introduction of enhanced alcohol labels in tandem with an educational campaign may be an effective way to better inform Canadian drinkers and shows potential for consumer support. © The Author 2017. Medical Council on Alcohol and Oxford University Press. All rights reserved.

American Spirit Pack Descriptors and Perceptions of Harm: A Crowdsourced Comparison of Modified Packs.

PubMed

Pearson, Jennifer L; Richardson, Amanda; Feirman, Shari P; Villanti, Andrea C; Cantrell, Jennifer; Cohn, Amy; Tacelosky, Michael; Kirchner, Thomas R

2016-08-01

In 2015, the Food and Drug Administration issued warnings to three tobacco manufacturers who label their cigarettes as "additive-free" and/or "natural" on the grounds that they make unauthorized reduced risk claims. The goal of this study was to examine US adults' perceptions of three American Spirit (AS) pack descriptors ("Made with Organic Tobacco," "100% Additive-Free," and "100% US Grown Tobacco") to assess if they communicate reduced risk. In September 2012, three cross-sectional surveys were posted on Amazon Mechanical Turk. Adult participants evaluated the relative harm of a Marlboro Red pack versus three different AS packs with the descriptors "Made with Organic Tobacco," "100% Additive-Free," or "100% US Grown Tobacco" (Survey 1; n = 461); a Marlboro Red pack versus these AS packs modified to exclude descriptors (Survey 2; n = 857); and unmodified versus modified AS pack images (Survey 3; n = 1001). The majority of Survey 1 participants rated the unmodified AS packs as less harmful than the Marlboro Red pack; 35.4%-58.8% of Survey 2 participants also rated the modified (no claims) packs as less harmful than Marlboro Red. In these surveys, prior use of AS cigarettes was associated with reduced perceptions of risk (adjusted odds ratio [AOR] 1.59-2.40). "Made with Organic Tobacco" and "100% Additive-Free" were associated with reduced perceptions of risk when comparing the modified versus the unmodified AS packs (Survey 3). Data suggest that these AS pack descriptors communicate reduced harm messages to consumers. Findings have implications for regulatory actions related to product labeling and packaging. These findings provide additional evidence that the "Made with Organic Tobacco," "100% Additive-Free," and "100% US Grown" descriptors, as well as other aspects of the AS pack design, communicate reduced harm to non-, current, and former smokers. Additionally, they provide support for the importance of FDA's 2015 warning to Santa Fe Natural Tobacco Company on "100% Additive Free" as an unauthorized modified risk claim. © The Author 2016. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Tobacco Packaging and Labeling Policies Under the U.S. Tobacco Control Act: Research Needs and Priorities

PubMed Central

2012-01-01

Introduction: The Family Smoking Prevention and Tobacco Control Act (the “Act”), enacted in June 2009, gave the U.S. Food and Drug Administration authority to regulate tobacco products. The current paper reviews the provisions for packaging and labeling, including the existing evidence and research priorities. Methods: Narrative review using electronic literature search of published and unpublished sources in 3 primary areas: health warnings, constituent labeling, and prohibitions on the promotional elements of packaging. Results: The Act requires 9 pictorial health warnings covering half of cigarette packages and 4 text warnings covering 30% of smokeless tobacco packages. The Act also prohibits potentially misleading information on packaging, including the terms “light” and “mild,” and provides a mandate to require disclosure of chemical constituents on packages. Many of the specific regulatory provisions are based on the extent to which they promote “greater public understanding of the risks of tobacco.” As a result, research on consumer perceptions has the potential to shape the design and renewal of health warnings and to determine what, if any, information on product constituents should appear on packages. Research on consumer perceptions of existing and novel tobacco products will also be critical to help identify potentially misleading information that should be restricted under the Act. Conclusion: Packaging and labeling regulations required under the Act will bring the United States in line with international standards. There is an immediate need for research to evaluate these measures to guide future regulatory action. PMID:22039072

Fair Balance and Adequate Provision in Direct-to-Consumer Prescription Drug Online Banner Advertisements: A Content Analysis

PubMed Central

2016-01-01

Background The current direct-to-consumer advertising (DTCA) guidelines were developed with print, television, and radio media in mind, and there are no specific guidelines for online banner advertisements. Objective This study evaluates how well Internet banner ads comply with existing Food and Drug Administration (FDA) guidelines for DTCA in other media. Methods A content analysis was performed of 68 banner advertisements. A coding sheet was developed based on (1) FDA guidance documents for consumer-directed prescription drug advertisements and (2) previous DTCA content analyses. Specifically, the presence of a brief summary detailing the drug’s risks and side effects or of a “major statement” identifying the drug’s major risks, and the number and type of provisions made available to consumers for comprehensive information about the drug were coded. In addition, the criterion of “fair balance,” the FDA’s requirement that prescription drug ads balance information relating to the drug’s risks with information relating to its benefits, was measured by numbering the benefit and risk facts identified in the ads and by examining the presentation of risk and benefit information. Results Every ad in the sample included a brief summary of risk information and at least one form of adequate provision as required by the FDA for broadcast ads that do not give audiences a brief summary of a drug’s risks. No ads included a major statement. There were approximately 7.18 risk facts for every benefit fact. Most of the risks (98.85%, 1292/1307) were presented in the scroll portion of the ad, whereas most of the benefits (66.5%, 121/182) were presented in the main part of the ad. Out of 1307 risk facts, 1292 were qualitative and 15 were quantitative. Out of 182 benefit facts, 181 were qualitative and 1 was quantitative. The majority of ads showed neutral images during the disclosure of benefit and risk facts. Only 9% (6/68) of the ads displayed positive images and none displayed negative images when presenting risks facts. When benefit facts were being presented, 7% (5/68) showed only positive images. No ads showed negative images when the benefit facts were being presented. Conclusions In the face of ambiguous regulatory guidelines for online banner promotion, drug companies appear to make an attempt to adapt to regulatory guidelines designed for traditional media. However, banner ads use various techniques of presentation to present the advertised drug in the best possible light. The FDA should formalize requirements that drug companies provide a brief summary and include multiple forms of adequate provision in banner ads. PMID:26892749

Do larger graphic health warnings on standardised cigarette packs increase adolescents’ cognitive processing of consumer health information and beliefs about smoking-related harms?

PubMed Central

White, Victoria; Williams, Tahlia; Faulkner, Agatha; Wakefield, Melanie

2015-01-01

Objective To examine the impact of plain packaging of cigarettes with enhanced graphic health warnings on Australian adolescents’ cognitive processing of warnings and awareness of different health consequences of smoking. Methods Cross-sectional school-based surveys conducted in 2011 (prior to introduction of standardised packaging, n=6338) and 2013 (7–12 months afterwards, n=5915). Students indicated frequency of attending to, reading, thinking or talking about warnings. Students viewed a list of diseases or health effects and were asked to indicate whether each was caused by smoking. Two—‘kidney and bladder cancer’ and ‘damages gums and teeth’—were new while the remainder had been promoted through previous health warnings and/or television campaigns. The 60% of students seeing a cigarette pack in previous 6 months in 2011 and 65% in 2013 form the sample for analysis. Changes in responses over time are examined. Results Awareness that smoking causes bladder cancer increased between 2011 and 2013 (p=0.002). There was high agreement with statements reflecting health effects featured in previous warnings or advertisements with little change over time. Exceptions to this were increases in the proportion agreeing that smoking was a leading cause of death (p<0.001) and causes blindness (p<0.001). The frequency of students reading, attending to, thinking or talking about the health warnings on cigarette packs did not change. Conclusions Acknowledgement of negative health effects of smoking among Australian adolescents remains high. Apart from increased awareness of bladder cancer, new requirements for packaging and health warnings did not increase adolescents’ cognitive processing of warning information. PMID:28407612

Young Adult Smokers' and Prior-Smokers' Evaluations of Novel Tobacco Warning Images.

PubMed

Healey, Benjamin; Hoek, Janet

2016-01-01

On-pack warning labels represent a very cost-effective means of communicating with smokers, who potentially see warnings each time they retrieve a cigarette. Warning labels have traditionally depicted graphic health consequences of smoking but emerging evidence suggests the distal consequences shown may prove less effective in prompting cessation among young adults. We used a novel micro-survey approach to compare novel and traditional warnings, and provide an empirical foundation for a larger study. We recruited 4649 male and 2993 female participants aged 18-34 from Google Consumer Survey's Australian panel of Android mobile phone users. A screening question resulted in a sample comprising 3183 daily, non-daily, and former smokers. Twenty images corresponding to social and health risks, tobacco industry denormalization, and secondhand smoke (SHS) were tested in paired comparisons where respondents selected the image they thought most likely to prompt cessation. Irrespective of smoking status, respondents rated messages featuring harm to children as most effective and industry denormalization messages and adult SHS warnings as least effective. Within smoker groups, daily smokers rated social concerns more highly; non-daily smokers were more responsive to SHS messages, and former smokers saw intimacy and cosmetic effects warnings as more effective than other groups. While preliminary, the findings support emerging evidence that more diverse warning images may be required to promote cessation among all smoker sub-groups. Warnings depicting harm to vulnerable others appear to hold high potential and merit further investigation. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Motivation to quit smoking and acceptability of shocking warnings on cigarette packages in Lebanon

PubMed Central

Layoun, Nelly; Salameh, Pascal; Waked, Mirna; Aoun Bacha, Z; Zeenny, Rony M; El Hitti, Eric; Godin, Isabelle; Dramaix, Michèle

2017-01-01

Introduction Health warnings on tobacco packages have been considered an essential pillar in filling the gap of knowledge and communicating the health risks of tobacco use to consumers. Our primary objective was to report the perception of smokers on the textual health warnings already appearing on tobacco packages in Lebanon versus shocking pictures about the health-related smoking consequences and to evaluate their impact on smoking behaviors and motivation. Methods A pilot cross-sectional study was undertaken between 2013 and 2015 in five hospitals in Lebanon. Participants answered a questionnaire inquiring about sociodemographic characteristics, chronic respiratory symptoms, smoking behavior and motivation to quit smoking. Only-text warning versus shocking pictures was shown to the smokers during the interview. Results Exactly 66% of the participants reported that they thought shocking pictorial warnings would hypothetically be more effective tools to reduce/quit tobacco consumption compared to only textual warnings. Also, 31.9% of the smokers who were motivated to stop smoking reported that they actually had stopped smoking for at least 1 month secondary to the textual warnings effects. A higher motivation to quit cigarette smoking was seen among the following groups of smokers: males (odds ratio [OR] =1.8, P=0.02), who had stopped smoking for at least 1 month during the last year due to textual warning (OR =2.79, P<0.001), who considered it very important to report health warning on cigarette packs (OR =1.92, P=0.01), who had chronic expectoration (OR =1.81, P=0.06) and who would change their favorite cigarette pack if they found shocking images on the pack (OR =1.95, P=0.004). Conclusion Low-dependent smokers and highly motivated to quit smokers appeared to be more hypothetically susceptible to shocking pictorial warnings. Motivation to quit was associated with sensitivity to warnings, but not with the presence of all chronic respiratory symptoms. PMID:28280306

Mosai-Zines.

ERIC Educational Resources Information Center

Lagattuta, Nunzio

2000-01-01

Discusses an art project in which students, using a photograph of a favorite person as a guide, create a paper mosaic with small pieces of paper from magazines, catalogues, and brochures. Describes the process of creating the mosaics. Warns that the project is time consuming. (CMK)

Methylmercury in fish: a review of residue levels, fish consumption and regulatory action in the United States

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tollefson, L.; Cordle, F.

1986-09-01

The dangers associated with the consumption of large amounts of methylmercury in fish are well recognized, and there is some evidence to suggest that methylmercury may be the cause of subtle neurological impairments when ingested at even low to moderate levels, particularly the prenatal and early childhood periods. This concern has prompted a continuing assessment of the risk of methylmercury toxicity among fish consumers in the US as well as other countries. The toxicokinetics of methylmercury in humans are reviewed and used to estimate body burdens associated with toxic effects. To determine seafood consumption patterns among the continental US populationmore » the Food and Drug Administration (FDA) has analyzed data from a diary study commissioned by the Tuna Research Foundation. Mercury residue levels in domestic fish sampled by the FDA were used to determine the level of exposure to methylmercury. Until evidence is presented that substantially lowers the known body burden of methylmercury which causes toxicity, calculations indicate that the current 1.0 ppm regulatory level provides adequate protection for the average fish consumer, for young children, and for a significant number of consumers exceeding the acceptable daily intake. However, additional studies are being carried out in a continuing process to ensure that safe levels of prenatal exposure to mercury residues in fish are maintained.« less

Dihydroxyacetone: A Review.

PubMed

Braunberger, Taylor L; Nahhas, Amanda F; Katz, Linda M; Sadrieh, Nakissa; Lim, Henry W

2018-04-01

The sunless tanning industry has experienced rapid growth due to public education on the dangers of ultraviolet radiation on skin and improvements in products. Dihydroxyacetone (DHA) is a 3-carbon sugar allowed by the Food and Drug Administration (FDA) as a color additive in sunless tanning products. Bronzers, a product removed with soap and water, may also contain DHA. We aim to review the literature on DHA. DHA is intended for external application, not including the mucous membranes or in or around the eye area. DHA has been used in spray-tan booths and by airbrushing it onto consumers, although these are unapproved uses, as contact with the color additive is not restricted to the external part of the body. Consequently, the FDA recommends customers shield their eyes, lips, and mucous membranes, as well as refrain from ingestion or inhalation of DHA. Unlike sunscreens, products that protect against ultraviolet radiation and are regulated by the FDA as non-prescription drugs, sunless tanning products are regulated as cosmetics and cannot provide any protection from exposure to ultraviolet radiation. There are reports of non-cosmetic uses of DHA that are not FDA approved. With the wide-spread use of DHA, additional studies on its safety are warranted.

J Drugs Dermatol. 2018;17(4):387-391.

Advertising for AIDS drugs: it's everywhere lately, but is it helpful?

PubMed

Mirken, B

1998-07-01

The recent proliferation of direct to consumer (DTC) advertisements for prescription drugs, including HIV/AIDS drugs, can present a confusing and unrealistic picture of treatment options and outcomes; however, supporters claim that it stimulates awareness of treatment options and encourages dialogue between doctors and patients. The Food and Drug Administration (FDA), which regulates DTC advertising, requires that manufacturers disclose a complete description of benefits and adverse effects, similar to the information on the product's label. This balance of information applies to the written portion of the ad, but not to the visual message, which is arguably the most powerful part of the advertisement. Many of the visuals in the AIDS drugs advertisements misconstrue the effect of the virus on the patients. However, the FDA has not yet developed restrictions to more accurately control the visual component of advertisements, in order to depict the downside of disease. Additionally, manufacturers whose advertisements match the wording on their labels have an easier time getting acceptance from the FDA, but use more technical language than the typical lay person can understand. Reliance on the FDA- approved label description, restricts the drug companies from promoting off-label uses of their products, and also does not allow for the constantly changing information of a drug's effectiveness.

23andMe: a new two-sided data-banking market model.

PubMed

Stoeklé, Henri-Corto; Mamzer-Bruneel, Marie-France; Vogt, Guillaume; Hervé, Christian

2016-03-31

Since 2006, the genetic testing company 23andMe has collected biological samples, self-reported information, and consent documents for biobanking and research from more than 1,000,000 individuals (90% participating in research), through a direct-to-consumer (DTC) online genetic-testing service providing a genetic ancestry report and a genetic health report. However, on November 22, 2013, the Food and Drug Administration (FDA) halted the sale of genetic health testing, on the grounds that 23andMe was not acting in accordance with federal law, by selling tests of undemonstrated reliability as predictive tests for medical risk factors. Consumers could still obtain the genetic ancestry report, but they no longer had access to the genetic health report in the United States (US). However, this did not prevent the company from continuing its health research, with previously obtained and future samples, provided that consent had been obtained from the consumers concerned, or with health reports for individuals from other countries. Furthermore, 23andMe was granted FDA authorization on February 19, 2015, first to provide reports about Bloom syndrome carrier status, and, more recently, to provide consumers with "carrier status" information for 35 genes known (with high levels of confidence) to cause disease. In this Debate, we highlight the likelihood that the primary objective of the company was probably two-fold: promoting itself within the market for predictive testing for human genetic diseases and ancestry at a low cost to consumers, and establishing a high-value database/biobank for research (one of the largest biobanks of human deoxyribonucleic acid (DNA) and personal information). By dint of this marketing approach, a two-sided market has been established between the consumer and the research laboratories, involving the establishment of a database/DNA biobank for scientific and financial gain. We describe here the profound ethical issues raised by this setup.

Lead Content of Sindoor, a Hindu Religious Powder and Cosmetic: New Jersey and India, 2014-2015.

PubMed

Shah, Manthan P; Shendell, Derek G; Strickland, Pamela Ohman; Bogden, John D; Kemp, Francis W; Halperin, William

2017-10-01

To assess the extent of lead content of sindoor, a powder used by Hindus for religious and cultural purposes, which has been linked to childhood lead poisoning when inadvertently ingested. We purchased 95 samples of sindoor from 66 South Asian stores in New Jersey and 23 samples from India and analyzed samples with atomic absorption spectrophotometry methods for lead. Analysis determined that 79 (83.2%) sindoor samples purchased in the United States and 18 (78.3%) samples purchased in India contained 1.0 or more micrograms of lead per gram of powder. For US samples, geometric mean concentration was 5.4 micrograms per gram compared with 28.1 micrograms per gram for India samples. The maximum lead content detected in both US and India samples was more than 300 000 micrograms per gram. Of the examined US sindoor samples, 19% contained more than 20 micrograms per gram of lead (US Food and Drug Administration [FDA] limit); 43% of the India samples exceeded this limit. Results suggested continued need for lead monitoring in sindoor in the United States and in sindoor carried into the United States by travelers from India, despite FDA warnings.

After counterfeit Avastin®--what have we learned and what can be done?

PubMed

Mackey, Tim K; Cuomo, Raphael; Guerra, Camille; Liang, Bryan A

2015-05-01

Three years have passed since the FDA announced that it had detected counterfeit versions of the injectable anticancer drug bevacizumab (Avastin(®), Genentech, USA) in the US drug-supply chain. Following this discovery, almost 1,000 FDA warning letters were sent to physicians and medical practices in 48 different states and two US territories, as more batches of counterfeit Avastin were uncovered. In response, criminal prosecutions have been pursued against certain distributors and clinicians, and other individuals who trafficked, sold, purchased, and/or administered an unsafe and ineffective treatment while also defrauding the government. Although limited and targeted legal action has been taken, patients potentially affected by this seminal patient safety event have not been appropriately identified. Hence, despite the clear and documented patient-safety and public-health risks posed by the transnational criminal trade in counterfeit medicines, the case study of counterfeit bevacizumab detection in the USA demonstrates the continued lack of information, knowledge, and solutions that would be necessary to protect those who are most affected--the patients. In response, we call for greater investment in multisector, multistakeholder strategies to enhance surveillance for counterfeit medicines and enable improvements in communication of risk information, to better protect patients with cancer.

Implementation of irradiation of pork for trichina control

DOE Office of Scientific and Technical Information (OSTI.GOV)

Engel, R.E.; Post, A.R.; Post, R.C.

1988-07-01

This article describes the attempts to develop adequate regulatory framework for the use of ionizing radiations in the preservation of food. To be successful, a uniform set of guidelines are needed for the selection, calibration, and application of dosimetry systems; clearance of packaging materials; labeling information; and consumer education programs are essential. The primary regulatory agency that food processors must satisfy is the US FDA. In 1985, in response to an industry petition, the FDA amended its food additive regulations to permit the use of gamma radiation sources to irradiate fresh, non-heat processed pork cuts or carcasses to control Trichinellaspiralis.more » The regulation permits irradiation of only fresh pork within a dose range of 0.3 to 1 kGy.« less

Comparing Food Label Experiments Using Samples from Web Panels versus Mall Intercepts

ERIC Educational Resources Information Center

Chang, LinChiat; Lin, Chung-Tung Jordan

2015-01-01

To regulate health messages on food labels, the U.S. Food and Drug Administration (FDA) traditionally relied on mall intercepts to collect consumer data. In recent years, web surveys have presented a viable alternative for presenting visual stimuli with more control and efficiency in data collection. However, there is a paucity of empirical data…

Phytochemical characteristic and uterotonic effect of aqueous extract of Ficus deltoidea leaves in rats uterus.

PubMed

Amiera, Z Umi Romaizatul; Nihayah, M; Wahida, I Farah; Rajab, N F

2014-09-01

Ficus deltoidea is traditionally consumed by Malay woman to augment labour and hastening parturition. This study was to investigate the phytochemical present and uterotonic activity of F. deltoidea var. Deltoidea (FDD) and F. deltoidea var. Angustifolia (FDA) leaves aqueous extract. FDD and FDA were qualitatively analysed. In uterine contraction activity, adult female Sprague Dawley rats were pretreated with 0.2 mg kg(-1) diethylstilbestrol 24 h to induce oestrus phase. The rats then killed and uterine horns were taken out, cut into two centimetres length and put into organ bath that connected to Powerlab instrument. The uterus separately tested with cumulative concentrations of FDD (10-1280 μg mL(-1)), FDA (10-1280 μg mL(-1)), oxytocin (0.02-0.64 μg mL(-1)) and combination of oxytocin (0.08 μg mL(-1)) with FDD and FDA (10-1280 μg mL(-1)). FDD showed presence of flavonoid, saponin and tannin meanwhile FDA consist of flavonoid, tannin and terpenoid. Result showed FDD, FDA and oxytocin induced a dose-related increase in force of contraction of isolated rat uterus. The maximum uterine contraction (Emax) produced by FDD, FDA and oxytocin were at the concentration 640 μg mL(-1) (EC50, 5.903 ± 0.529 μg mL), 20 μg mL(-1) (EC50, 290.5 ± 0.158 μg mL(-1)) and 0.4 μg mL(-1) (EC50, 0.060 ± 0.011 μg mL(-1)) respectively. Combination effects of oxytocin with FDD and FDA produced Emax at the concentration 80 μg mL(-1) (EC50, 270.3 ± 0.643 μg mL(-1)) and 1280 μg mL(-1) (EC50, 26.83 ± 0.727 μg mL(-1)), respectively. Study indicated F. deltoidea possess contractile effect on uterine contraction. This plant has great potential to develop as natural uterotonic agent in inducing labour and treatment for post-partum haemorrhage.

Effect of graphic cigarette warnings on smoking intentions in young adults.

PubMed

Blanton, Hart; Snyder, Leslie B; Strauts, Erin; Larson, Joy G

2014-01-01

Graphic warnings (GWs) on cigarette packs are widely used internationally and perhaps will be in the US but their impact is not well understood. This study tested support for competing hypotheses in different subgroups of young adults defined by their history of cigarette smoking and individual difference variables (e.g., psychological reactance). One hypothesis predicted adaptive responding (GWs would lower smoking-related intentions) and another predicted defensive responding (GWs would raise smoking-related intentions). Participants were an online sample of 1,169 Americans ages 18-24, who were randomly assigned either to view nine GWs designed by the FDA or to a no-label control. Both the intention to smoke in the future and the intention to quit smoking (among smokers) were assessed before and after message exposure. GWs lowered intention to smoke in the future among those with a moderate lifetime smoking history (between 1 and 100 cigarettes), and they increased intention to quit smoking among those with a heavy lifetime smoking history (more than 100 cigarettes). Both effects were limited to individuals who had smoked in some but not all of the prior 30 days (i.e., occasional smokers). No evidence of defensive "boomerang effects" on intention was observed in any subgroup. Graphic warnings can reduce interest in smoking among occasional smokers, a finding that supports the adaptive-change hypothesis. GWs that target occasional smokers might be more effective at reducing cigarette smoking in young adults.

Effect of Graphic Cigarette Warnings on Smoking Intentions in Young Adults

PubMed Central

Blanton, Hart; Snyder, Leslie B.; Strauts, Erin; Larson, Joy G.

2014-01-01

Introduction Graphic warnings (GWs) on cigarette packs are widely used internationally and perhaps will be in the US but their impact is not well understood. This study tested support for competing hypotheses in different subgroups of young adults defined by their history of cigarette smoking and individual difference variables (e.g., psychological reactance). One hypothesis predicted adaptive responding (GWs would lower smoking-related intentions) and another predicted defensive responding (GWs would raise smoking-related intentions). Methods Participants were an online sample of 1,169 Americans ages 18–24, who were randomly assigned either to view nine GWs designed by the FDA or to a no-label control. Both the intention to smoke in the future and the intention to quit smoking (among smokers) were assessed before and after message exposure. Results GWs lowered intention to smoke in the future among those with a moderate lifetime smoking history (between 1 and 100 cigarettes), and they increased intention to quit smoking among those with a heavy lifetime smoking history (more than 100 cigarettes). Both effects were limited to individuals who had smoked in some but not all of the prior 30 days (i.e., occasional smokers). No evidence of defensive “boomerang effects” on intention was observed in any subgroup. Conclusion Graphic warnings can reduce interest in smoking among occasional smokers, a finding that supports the adaptive-change hypothesis. GWs that target occasional smokers might be more effective at reducing cigarette smoking in young adults. PMID:24806481

Advertising, computers, and pharmacy liability. A Michigan court's decision has ramifications for pharmaceutical care.

PubMed

Cacciatore, G G

1996-11-01

Arbor Drugs, Inc., advertised that its computer could detect dangerous drug interactions. A pharmacist failed to warn a patient accordingly and the patient suffered a stroke as a result of an interaction between tranylcypromine and a decongestant. The Michigan Court of Appeals held that this failure to warn was actionable under the theories of negligence and fraud as well as under the Michigan Consumer Protection Act. The court's basic message is that pharmacies may be held legally responsible for preventing harm when they represent themselves as being capable of doing so.

Evaluating the Impact of U.S. Food and Drug Administration-Proposed Nutrition Facts Label Changes on Young Adults' Visual Attention and Purchase Intentions.

PubMed

Graham, Dan J; Roberto, Christina A

2016-08-01

The U.S. Food and Drug Administration (FDA) has proposed modifying the Nutrition Facts Label (NFL) on food packages to increase consumer attention to this resource and to promote healthier dietary choices. The present study sought to determine whether the proposed NFL changes will affect consumer attention to the NFL or purchase intentions. This study compared purchase intentions (yes/no responses to "would you purchase this food?" for 64 products) and attention to NFLs (measured via high-speed eye-tracking camera) among 155 young adults randomly assigned to view products with existing versus modified NFLs. Attention to all individual components of the NFL (e.g., calories, fats, sugars) were analyzed separately to assess the impact of each proposed NFL modification on attention to that region. Data were collected in 2014; analysis was conducted in 2015. Modified NFLs did not elicit significantly more visual attention or lead to more healthful purchase intentions than did existing NFLs. Relocating the percent daily value component from the right side of the NFL to the left side, as proposed by the FDA, actually reduced participants' attention to this information. The proposed "added sugars" component was viewed on at least one label by a majority (58%) of participants. Results suggest that the proposed NFL changes may not achieve FDA's goals. Changes to nutrition labeling may need to take a different form to meaningfully influence dietary behavior. Young adults' visual attention and purchase intentions do not appear to be meaningfully affected by the proposed NFL modifications. © 2016 Society for Public Health Education.

Effect of smokeless tobacco product marketing and use on population harm from tobacco use policy perspective for tobacco-risk reduction.

PubMed

Kozlowski, Lynn T

2007-12-01

This article presents policy perspectives on the marketing of smokeless tobacco products to reduce population harm from tobacco use. Despite consensus that smokeless tobacco products as sold in the United States are less dangerous than cigarettes, there is no consensus on how to proceed. Diverse factions have different policy concerns. While the tobacco industry is exempted from U.S. Food and Drug Administration (FDA) oversight, the pharmaceutical industry whose nicotine replacement therapy (NRT) medicines compete with smokeless tobacco as noncombustible nicotine-delivery systems are regulated by the FDA. Some public health experts support smokeless tobacco use to reduce population harm from tobacco; other public health experts oppose promoting smokeless tobacco for harm reduction. Adult consumers can freely purchase currently-marketed smokeless tobacco products and even more-deadly cigarettes. Concerns with and advantages of smokeless tobacco products are discussed. In that noncombustible medicinal nicotine-delivery systems have been proven to be effective smoking-cessation aids, smokeless tobacco, as another source of psychoactive doses of nicotine, could be used similarly, in a dose-response fashion as a smoking-cessation aid (consistent with FDA principles for evaluating generic versions of drugs). Price measures should be used on tobacco products to make costs to consumers proportional to product health risks (which would make smokeless tobacco much cheaper than cigarettes), and smokeless tobacco should be encouraged as an option for smoking cessation in adult smokers, particularly for those who have failed to stop smoking using NRT or other methods.

Worldviews and trust of sources for health information on electronic nicotine delivery systems: Effects on risk perceptions and use.

PubMed

Weaver, Scott R; Jazwa, Amelia; Popova, Lucy; Slovic, Paul; Rothenberg, Richard B; Eriksen, Michael P

2017-12-01

Public health agencies, the news media, and the tobacco/vapor industry have issued contradictory statements about the health effects of electronic nicotine delivery systems (ENDS). We investigated the levels of trust that consumers place in different information sources and how trust is associated with cultural worldviews, risk perceptions, ENDS use, and sociodemographic characteristics using a nationally representative sample of 6051 U.S. adults in 2015. Seventeen percent of adults were uncertain about their trust for one or more potential sources. Among the rest, the Centers for Disease Control and Prevention (CDC), health experts, and the Food & Drug Administration (FDA) elicited the highest levels of trust. In contrast, tobacco and vapor manufacturers, vape shop employees, and, to a lesser extent, the news media were distrusted. Adults who had higher incomes and more education or espoused egalitarian and communitarian worldviews expressed more trust in health sources and the FDA, whereas those identifying as non-Hispanic Black or multiracial reported less trust. Current smokers, those who identified as non-Hispanic Black or other race, had lower incomes, and espoused hierarchy and individualism worldviews expressed less distrust toward the tobacco and vapor industry. Greater trust (or less distrust) toward the tobacco and vapor industry and an individualism worldview were associated with perceptions of lower risk of premature death from daily ENDS use, greater uncertainty about those risks, and greater odds of using ENDS. Public health and the FDA should consider consumer trust and worldviews in the design and regulation of public education campaigns regarding the potential health risks and benefits of ENDS.

Direct-to-consumer advertising for bleeding disorders: a content analysis and expert evaluation of advertising claims.

PubMed

Abel, G A; Neufeld, E J; Sorel, M; Weeks, J C

2008-10-01

In the United States, the Food and Drug Administration (FDA) requires that all direct-to-consumer advertising (DTCA) contain both an accurate statement of a medication's effects ('truth') and an even-handed discussion of its benefits and risks/adverse effects ('fair balance'). DTCA for medications to treat rare diseases such as bleeding disorders is unlikely to be given high priority for FDA review. We reviewed all DTCA for bleeding disorder products appearing in the patient-directed magazine HemeAware from January 2004 to June 2006. We categorized the information presented in each advertisement as benefit, risk/adverse effect, or neither, and assessed the amount of text and type size devoted to each. We also assessed the readability of each type of text using the Flesch Reading Ease Score (FRES, where a score of >or=65 is considered of average readability), and assessed the accuracy of the advertising claims utilizing a panel of five bleeding disorder experts. A total of 39 unique advertisements for 12 products were found. On average, approximately twice the amount of text was devoted to benefits as compared with risks/adverse effects, and the latter was more difficult to read [FRES of 32.0 for benefits vs. 20.5 for risks/adverse effects, a difference of 11.5 (95% CI: 4.5-18.5)]. Only about two-thirds of the advertising claims were considered by a majority of the experts to be based on at least low-quality evidence. As measured by our methods, print DTCA for bleeding disorders may not reach the FDA's standards of truth and fair balance.

Guide to preemption of state-law claims against Class III PMA medical devices.

PubMed

Whitney, Daniel W

2010-01-01

There is a perception that the express preemption holding of the Supreme Court in Riegel v. Medtronic, 552 U.S. 312(2008), immunizes medical device manufacturers from common law personal injury actions involving Class III devices that received FDA clearance under a premarket approval application (PMA). In the aftermath of Riegel, many lawsuits involving Class III PMA devices have been dismissed by district courts applying the new heightened pleading standard of Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007). Other lawsuits involving Class III PMA devices premised on fraud-on-FDA have been dismissed based on the implied preemption holding of the Supreme Court in Buckman v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001). When these decisions are carefully analyzed together with Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which found no preemption regarding a Class III device receiving FDA clearance through the 510(k) mechanism, it is apparent that the preemption defense does not apply universally to Class III PMA devices. The overall methodology for framing a non-preempted claim is to first identify conduct which violated the PMA or other specific requirements related to safety or efficacy. If such conduct can also be stated in terms of a breach of a parallel common law duty (e.g, failure to warn under strict liability or negligence, manufacturing defect or breach of warranty), then it would appear the claim is not preempted. Alternatively, regardless of a specific violation, common law remedies are not preempted by general CGMP requirements.

Hemoglobin levels triggering erythropoiesis-stimulating agent therapy in patients with cancer: the shift after United States Food and Drug Administration policy changes.

PubMed

Stroupe, Kevin T; Tarlov, Elizabeth; Lee, Todd A; Weichle, Thomas W; Zhang, Qiuying L; Michaelis, Laura C; Ozer, Howard; Durazo-Arvizu, Ramon; Browning, Margaret M; Hynes, Denise M

2012-11-01

To determine whether the hemoglobin level at which health care providers prescribed erythropoiesis-stimulating agent (ESA) therapy (trigger hemoglobin level) for their patients receiving chemotherapy was lower after the United States Food and Drug Administration (FDA) mandated a black-box warning in March 2007. Retrospective analysis. U.S. Department of Veterans Affairs Healthcare System (VA) national databases. A total of 7450 patients who were diagnosed with cancer between 2002 and 2009, were undergoing chemotherapy, and who received an ESA within 12 months after their cancer diagnosis. Data were collected on patients' demographic, clinical, environmental, and treatment-related factors. After controlling for these factors, multivariable regression analyses were used to compare the trigger hemoglobin level before and after the FDA-mandated labeling change. The average trigger hemoglobin level was 0.73 g/dl lower after the labeling change (95% confidence interval [CI] -0.84 to -0.63). Moreover, the decline in trigger hemoglobin levels began in mid-2006, when the average trigger hemoglobin level fell from 10.50 g/dl in early 2006 (95% CI 10.36-10.63) to 9.30 g/dl by late 2009 (95% CI 9.10-9.49). Even before the 2007 FDA-mandated changes in ESA product labeling, hemoglobin levels that triggered ESA treatment began declining for patients receiving cancer care within the VA. This highlights the critical importance of dissemination of postmarketing safety data to impact shifts in ESA use for anemia management. © 2012 Pharmacotherapy Publications, Inc.

Evaluating the pictorial warnings on tobacco products in Arabian Gulf countries against other international pictorial warnings.

PubMed

BinDhim, Nasser F; McGeechan, Kevin; Alanazi, Anwar K T; Alanazi, Hossam M S; Alanazi, Sasoun A J; Al-Hadlaq, Solaiman M; Aljadhey, Hisham; Alhawassi, Tariq M; Alghamdi, Nadia A; Shaman, Ahmed M; Alquwayzani, Meshari S; Basyouni, Mada H

2017-05-12

Few assessments of pictorial warnings (PWs) on cigarette packs implemented in Gulf Cooperation Council (GCC) countries have been done. This article includes two cross-sectional studies. In Study 1, convenience samples of adults from the Kingdom of Saudi Arabia (n=111) and USA (n=115) participated in a consumer survey to rate a total of nine PWs from the GCC, Australia and the UK. Outcome measures were affective responses to PWs and concerns about smoking. In Study 2, tobacco control experts (n=14) from multiple countries rated the same PWs on a potential efficacy scale and completed one open-ended question about each. The PWs were altered to mask their country of origin. Analyses compared ranking on multiple outcomes and examined ratings by country of origin and by smoking status. In the consumer survey, participants from both countries rated the PWs from GCC lower than PWs from other countries on the two measures. The mixed-model analysis showed significant differences between the PWs from Australia and those from the GCC and between the PWs from the UK and those from the GCC (p<0.001) in the consumer and expert samples. The experts' comments about the PWs implemented in the GCC were negative overall and confirmed previously identified themes about effective PWs. This study shows PWs originating from the GCC had significantly lower ratings than those implemented in Australia and the UK. The GCC countries may need to re-evaluate the currently implemented PWs and update them periodically. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Reactions to graphic health warnings in the United States.

PubMed

Nonnemaker, James M; Choiniere, Conrad J; Farrelly, Matthew C; Kamyab, Kian; Davis, Kevin C

2015-02-01

This study reports consumer reactions to the graphic health warnings selected by the Food and Drug Administration to be placed on cigarette packs in the United States. We recruited three sets of respondents for an experimental study from a national opt-in e-mail list sample: (i) current smokers aged 25 or older, (ii) young adult smokers aged 18-24 and (iii) youth aged 13-17 who are current smokers or who may be susceptible to initiation of smoking. Participants were randomly assigned to be exposed to a pack of cigarettes with one of nine graphic health warnings or with a text-only warning statement. All three age groups had overall strong negative emotional (ß = 4.7, P < 0.001 for adults; ß = 4.6, P < 0.001 for young adults and ß = 4.0, P < 0.001 for youth) and cognitive (ß = 2.4, P < 0.001 for adults; ß = 3.0, P < 0.001 for young adults and ß = 4.6, P < 0.001 for youth) reactions to the proposed labels. The strong negative emotional and cognitive reactions following a single exposure to the graphic health warnings suggest that, with repeated exposures over time, graphic health warnings may influence smokers' beliefs, intentions and behaviors. © The Author 2014. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Public health benefits from pictorial health warnings on US cigarette packs: a SimSmoke simulation.

PubMed

Levy, David T; Mays, Darren; Yuan, Zhe; Hammond, David; Thrasher, James F

2017-11-01

While many countries have adopted prominent pictorial warning labels (PWLs) for cigarette packs, the USA still requires only small, text-only labels located on one side of the cigarette pack that have little effect on smoking-related outcomes. Tobacco industry litigation blocked implementation of a 2011 Food and Drug Administration's (FDA) rule requiring large PWLs. To inform FDA action on PWLs, this study provides research-based estimates of their public health impacts. Literature was reviewed to identify the impact of cigarette PWLs on smoking prevalence, cessation and initiation. Based on this analysis, the SimSmoke model was used to estimate the effect of requiring PWLs in the USA on smoking prevalence and, using standard attribution methods, on smoking-attributable deaths (SADs) and key maternal and child health outcomes. Available research consistently shows a direct association between PWLs and increased cessation and reduced smoking initiation and prevalence. The SimSmoke model projects that PWLs would reduce smoking prevalence by 5% (2.5%-9%) relative to the status quo over the short term and by 10% (4%-19%) over the long term. Over the next 50 years, PWLs are projected to avert 652 800 (327 000-1 190 500) SADs, 46 600 (17 500-92 300) low-birth-weight cases, 73 600 (27 800-145 100) preterm births and 1000 (400-2000) cases of sudden infant death syndrome. Requiring PWLs on all US cigarette packs would be appropriate for the protection of the public health, because it would substantially reduce smoking prevalence and thereby reduce SADs and the morbidity and medical costs associated with adverse smoking-attributable birth outcomes. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Suicidal Behavior and Depression in Smoking Cessation Treatments

PubMed Central

Moore, Thomas J.; Furberg, Curt D.; Glenmullen, Joseph; Maltsberger, John T.; Singh, Sonal

2011-01-01

Background Two treatments for smoking cessation—varenicline and bupropion—carry Boxed Warnings from the U.S. Food and Drug Administration (FDA) about suicidal/self-injurious behavior and depression. However, some epidemiological studies report an increased risk in smoking or smoking cessation independent of treatment, and differences between drugs are unknown. Methodology From the FDA's Adverse Event Reporting System (AERS) database from 1998 through September 2010 we selected domestic, serious case reports for varenicline (n = 9,575), bupropion for smoking cessation (n = 1,751), and nicotine replacement products (n = 1,917). A composite endpoint of suicidal/self-injurious behavior or depression was defined as a case with one or more Preferred Terms in Standardized MedDRA Query (SMQ) for those adverse effects. The main outcome measure was the ratio of reported suicide/self-injury or depression cases for each drug compared to all other serious events for that drug. Results Overall we identified 3,249 reported cases of suicidal/self-injurious behavior or depression, 2,925 (90%) for varenicline, 229 (7%) for bupropion, and 95 (3%) for nicotine replacement. Compared to nicotine replacement, the disproportionality results (OR (95% CI)) were varenicline 8.4 (6.8–10.4), and bupropion 2.9 (2.3–3.7). The disproportionality persisted after excluding reports indicating concomitant therapy with any of 58 drugs with suicidal behavior warnings or precautions in the prescribing information. An additional antibiotic comparison group showed that adverse event reports of suicidal/self-injurious behavior or depression were otherwise rare in a healthy population receiving short-term drug treatment. Conclusions Varenicline shows a substantial, statistically significant increased risk of reported depression and suicidal/self-injurious behavior. Bupropion for smoking cessation had smaller increased risks. The findings for varenicline, combined with other problems with its safety profile, render it unsuitable for first-line use in smoking cessation. PMID:22073240

21 CFR 1141.3 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... CIGARETTE PACKAGE AND ADVERTISING WARNINGS General Provisions § 1141.3 Definitions. For the purposes of this part, Cigarette means: (1) Any roll of tobacco wrapped in paper or in any substance not containing..., or purchased by, consumers as a cigarette described in paragraph (1) of this definition. Commerce...

Direct-to-consumer promotion of prescription drugs. Economic implications for patients, payers and providers.

PubMed

Findlay, S D

2001-01-01

Spending on outpatient prescription drugs in the US is accelerating rapidly. Although numerous factors are driving this trend, attention has recently focused on the role played by the marketing, promotion and advertising of pharmaceuticals, in particular direct-to-consumer (DTC) advertising. In 1997, the US Food and Drug Administration (FDA) issued a 'guidance' on such mass media promotion. The guidance altered existing FDA rules and effectively permitted pharmaceutical companies to promote prescription drugs on television and radio without giving detailed or even summary information on indications, efficacy or potential adverse effects. Since then, television commercials, in particular, and print advertisements in consumer magazines and newspapers have proliferated rapidly. Pharmaceutical companies spent $US1.8 billion on DTC advertising in 1999, a 40% increase over 1998. This spending in 1999 was heavily concentrated on about 50 drugs. Evidence is growing that DTC promotion of prescription drugs is: (i) alerting consumers to the existence of new drugs and the conditions they treat; (ii) increasing consumer demand for many drugs; (iii) contributing increasingly to the recent sharp increase in the number of prescriptions being dispensed; (iv) raising sales revenues; and, thus, (v) contributing to the higher pharmaceutical costs of health insurers, government and consumers. The public policy issues surrounding DTC advertisements centre on the following questions: (i) are the advertisements leading to the inappropriate clinical use of some drugs? (ii) are the advertisements inducing both consumers and physicians to choose more costly new brand-name drugs over less expensive, but equally effective, older brand or generic drugs? (iii) do television advertisements for prescription drugs contain a balanced amount of information on benefits versus potential adverse effects? and (iv) will the revenue benefits generated by DTC advertising cause pharmaceutical companies to focus more on developing products to treat prevalent but not life-threatening conditions, such as baldness, sexual dysfunction or memory loss? These questions are just beginning to be probed despite prescription drug spending, insurance coverage and payment policies having become major political issues in the US.

The effect of cigarillo packaging elements on young adult perceptions of product flavor, taste, smell, and appeal.

PubMed

Meernik, Clare; Ranney, Leah M; Lazard, Allison J; Kim, KyungSu; Queen, Tara L; Avishai, Aya; Boynton, Marcella H; Sheeran, Paschal J; Goldstein, Adam O

2018-01-01

Product packaging has long been used by the tobacco industry to target consumers and manipulate product perceptions. This study examines the extent to which cigarillo packaging influences perceptions of product flavor, taste, smell, and appeal. A web-based experiment was conducted among young adults. Participants viewed three randomly selected cigarillo packs, varying on pack flavor descriptor, color, type, branding, and warning-totaling 180 pack images. Mixed-effects models were used to estimate the effect of pack elements on product perceptions. A total of 2,664 current, ever, and never little cigar and cigarillo users participated. Cigarillo packs with a flavor descriptor were perceived as having a more favorable taste (β = 0.21, p < .001) and smell (β = 0.14, p < .001) compared to packs with no flavor descriptor. Compared to packs with no color, pink and purple packs were more likely to be perceived as containing a flavor (β = 0.11, p < .001), and were rated more favorably on taste (β = 0.17, p < .001), smell (β = 0.15, p < .001), and appeal (β = 0.16, p < .001). While warnings on packs decreased favorable perceptions of product taste (pictorial: β = -0.07, p = .03) and smell (text-only: β = -0.08, p = .01; pictorial: β = -0.09, p = .007), warnings did not moderate the effects of flavor descriptor or color. To our knowledge, this study provides the first quantitative evidence that cigarillo packaging alters consumers' cognitive responses, and warnings on packs do not suffice to overcome the effects of product packaging. The findings support efforts at federal, state, and local levels to prohibit flavor descriptors and their associated product flavoring in non-cigarette products such as cigarillos, along with new data that supports restrictions on flavor cues and colors.

Awareness and knowledge of methylmercury in fish in the United States

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lando, Amy M., E-mail: amy.lando@fda.hhs.gov; Zhang, Yuanting

In the 1970s several states in the Great Lakes region became concerned about mercury contamination in lakes and rivers and were the first to issue local fish consumption advisories. In 2001, the Food and Drug Administration (FDA) advised pregnant women, nursing mothers, young children, and women who may become pregnant not to consume shark, swordfish, king mackerel, and tilefish and recommended that these women not exceed 12 ounces of other fish per week. In 2004, FDA reissued this advice jointly with the U.S. Environmental Protection Agency (EPA) and modified it slightly to provide information about consumption of canned tuna andmore » more details about consumption of recreationally caught fish. Though several studies have examined consumers' awareness of the joint FDA and EPA advisory as well as different state advisories, few used representative data. We examined the changes in awareness and knowledge of mercury as a problem in fish using the pooled nationally representative 2001 and 2006 Food Safety Surveys (FSS) with sample sizes of 4482 in 2001 and 2275 in 2006. Our results indicated an increase in consumers' awareness of mercury as a problem in fish (69% in 2001 to 80% in 2006, p<.001). In our regression models, we found that in both years, parents having children less than 5 years of age were more aware of mercury in fish and knowledgeable about the information contained in the national advisories about mercury in fish (p<.01) than other adults. In both 2001 and 2006, women of childbearing age (aged 18-45) were less aware and knowledgeable about this information than other women. However, women of all age groups had larger gains in awareness and knowledge than their male counterparts during this time. Participants' race, education, income, region, fish preparation experiences, having a foodborne illness in the past year, and risk perceptions about the safety of food were significant predictors of their awareness and knowledge. - Research highlights: {yields} We examined changes in awareness and knowledge of mercury as a problem in fish. {yields} Data are from the 2001 and 2006 Food Safety Surveys (FSS). {yields} Consumers' awareness of mercury as a problem in fish increased from 2001 to 2006. {yields} Demographics were significant predictors of awareness and knowledge.« less

Global Evidence on the Association between Cigarette Graphic Warning Labels and Cigarette Smoking Prevalence and Consumption

PubMed Central

Ngo, Anh; Cheng, Kai-Wen; Huang, Jidong; Chaloupka, Frank J.

2018-01-01

Background: In 2011, the courts ruled in favor of tobacco companies in preventing the implementation of graphic warning labels (GWLs) in the US, stating that FDA had not established the effectiveness of GWLs in reducing smoking. Methods: Data came from various sources: the WHO MPOWER package (GWLs, MPOWER policy measures, cigarette prices), Euromonitor International (smoking prevalence, cigarette consumption), and the World Bank database (countries’ demographic characteristics). The datasets were aggregated and linked using country and year identifiers. Fractional logit regressions and OLS regressions were applied to examine the associations between GWLs and smoking prevalence and cigarette consumption, controlling for MPOWER policy scores, cigarette prices, GDP per capita, unemployment, population aged 15–64 (%), aged 65 and over (%), year indicators, and country fixed effects. Results: GWLs were associated with a 0.9–3 percentage point decrease in adult smoking prevalence and were significantly associated with a reduction of 230–287 sticks in per capita cigarette consumption, compared to countries without GWLs. However, the association between GWLs and cigarette consumption became statistically insignificant once country indicators were included in the models. Conclusions: The implementation of GWLs may be associated with reduced cigarette smoking. PMID:29495581

Global Evidence on the Association between Cigarette Graphic Warning Labels and Cigarette Smoking Prevalence and Consumption.

PubMed

Ngo, Anh; Cheng, Kai-Wen; Shang, Ce; Huang, Jidong; Chaloupka, Frank J

2018-02-28

Background : In 2011, the courts ruled in favor of tobacco companies in preventing the implementation of graphic warning labels (GWLs) in the US, stating that FDA had not established the effectiveness of GWLs in reducing smoking. Methods : Data came from various sources: the WHO MPOWER package (GWLs, MPOWER policy measures, cigarette prices), Euromonitor International (smoking prevalence, cigarette consumption), and the World Bank database (countries' demographic characteristics). The datasets were aggregated and linked using country and year identifiers. Fractional logit regressions and OLS regressions were applied to examine the associations between GWLs and smoking prevalence and cigarette consumption, controlling for MPOWER policy scores, cigarette prices, GDP per capita, unemployment, population aged 15-64 (%), aged 65 and over (%), year indicators, and country fixed effects. Results : GWLs were associated with a 0.9-3 percentage point decrease in adult smoking prevalence and were significantly associated with a reduction of 230-287 sticks in per capita cigarette consumption, compared to countries without GWLs. However, the association between GWLs and cigarette consumption became statistically insignificant once country indicators were included in the models. Conclusions : The implementation of GWLs may be associated with reduced cigarette smoking.

21 CFR 184.1 - Substances added directly to human food affirmed as generally recognized as safe (GRAS).

Code of Federal Regulations, 2010 CFR

2010-04-01

... with a food additive regulation. Persons seeking FDA approval of an independent determination that a... manner that may lead to deception of the consumer or to any other violation of the Federal Food, Drug, and Cosmetic Act (the Act). (d) The listing of more than one ingredient to produce the same...

21 CFR 184.1 - Substances added directly to human food affirmed as generally recognized as safe (GRAS).

Code of Federal Regulations, 2011 CFR

2011-04-01

... accordance with a food additive regulation. Persons seeking FDA approval of an independent determination that... manner that may lead to deception of the consumer or to any other violation of the Federal Food, Drug, and Cosmetic Act (the Act). (d) The listing of more than one ingredient to produce the same...

NHEXAS PHASE I ARIZONA STUDY--STANDARD OPERATING PROCEDURE FOR FOOD SAMPLE COMPARISON WITH DIARY AND SHIPMENT (UA-L-13.1)

EPA Science Inventory

The purpose of this SOP is to describe the procedures for checking the food collections with the food stated as consumed in the 24-Hour Food Diary. The sample is then packaged and shipped to the FDA for further analysis. This procedure applies to the checking of food samples an...

Food labeling; nutrition labeling of standard menu items in restaurants and similar retail food establishments. Final rule.

PubMed

2014-12-01

To implement the nutrition labeling provisions of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act or ACA), the Food and Drug Administration (FDA or we) is requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. The ACA, in part, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act), among other things, to require restaurants and similar retail food establishments that are part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items to provide calorie and other nutrition information for standard menu items, including food on display and self-service food. Under provisions of the ACA, restaurants and similar retail food establishments not otherwise covered by the law may elect to become subject to these Federal requirements by registering every other year with FDA. Providing accurate, clear, and consistent nutrition information, including the calorie content of foods, in restaurants and similar retail food establishments will make such nutrition information available to consumers in a direct and accessible manner to enable consumers to make informed and healthful dietary choices.

Progress of food irradiation in the United States

NASA Astrophysics Data System (ADS)

Derr, D. D.; Engeljohn, D. L.; Griffin, R. L.

1995-02-01

Irradiated foods have not yet made a significant impact in the United States marketplace. What progress has occurred to facilitate their commercialization? Irradiated produce has been sold in small quantities since 1992 and irradiated poultry was introduced in the marketplace in 1993. Federal inspection of irradiated commodities has settled into a regular routine. What must occur to further expand irradiated foods in the marketplace? Petitions to permit irradiation of red meats and seafood are being considered by the Food and Drug Administration (FDA) and a petition to permit the irradiation of shell eggs is being prepared for submission to FDA. In addition, the U.S. Department of Agriculture (USDA) has accelerated efforts to develop the policies and regulatory structure needed to facilitate the approval of new irradiation treatments for imported plant products regulated by quarantine. When will greater commercialization occur? More positive coverage to food irradiation in recent months by both the trade and popular press indicates a change in attitude towards irradiated foods by both consumers and the food industry. Finally, actual consumer response to available irradiated foods casts a favorable light on the potential for increased marketing of value-added irradiated foods.

Consumer concerns: motivating to action.

PubMed Central

Bruhn, C. M.

1997-01-01

Microbiologic safety is consumers' most frequently volunteered food safety concern. An increase in the level of concern in recent years suggests that consumers are more receptive to educational information. However, changing lifestyles have lessened the awareness of foodborne illness, especially among younger consumers. Failure to fully recognize the symptoms or sources of foodborne disease prevents consumers from taking corrective action. Consumer education messages should include the ubiquity of microorganisms, a comprehensive description of foodborne illnesses, and prevention strategies. Product labels should contain food-handling information and warnings for special populations, and foods processed by newer safety-enhancing technologies should be more widely available. Knowledge of the consequences of unsafe practices can enhance motivation and adherence to safety guidelines. When consumers mishandle food during preparation, the health community, food industry, regulators, and the media are ultimately responsible. Whether inappropriate temperature control, poor hygiene, or another factor, the error occurs because consumers have not been informed about how to handle food and protect themselves. The food safety message has not been delivered effectively. PMID:9366604

Interpersonal psychotherapy for depressed adolescents (IPT-A).

PubMed

Brunstein-Klomek, Anat; Zalsman, Gil; Mufson, Laura

2007-01-01

Recently the Food and Drug Administration (FDA) published a black box warning on the use of serotonin receptor reuptake inhibitors for adolescent depression. This situation makes the non-pharmacological therapeutic alternatives more relevant than ever before. The aim of this review is to introduce the theoretical formulation, practical application and efficacy studies of Interpersonal Psychotherapy for depressed adolescents (IPT-A). A review is offered of published papers in peer-reviewed journals, books and edited chapters using Medline and PsychInfo publications between 1966 and February 2005. IPT-A is an evidence-based psychotherapy for depressed adolescents in both hospital-based and community outpatient settings. IPT-A is a brief and efficient therapy for adolescent depression. Training programs for child psychologists and psychiatrists are recommended.

Evaluation of internet websites marketing herbal weight-loss supplements to consumers.

PubMed

Jordan, Melanie A; Haywood, Tasha

2007-11-01

The aim of this study was to evaluate the quality and quantity of drug information available to consumers on Internet websites marketing herbal weight-loss dietary supplements in the United States. We conducted an Internet search using the search engines Yahoo and Google and the keywords "herbal weight loss." Website content was evaluated for the presence of active/inactive ingredient names and strengths and other Food and Drug Administration (FDA) labeling requirements. Information related to drug safety for the most common herbal ingredients in the products evaluated was compared against standard herbal drug information references. Thirty-two (32) websites were evaluated for labeling requirements and safety information. All sites listed an FDA disclaimer statement and most sites (84.4%) listed active ingredients, although few listed strengths or inactive ingredients. Based on the drug information for the most common ingredients found in the weight-loss dietary supplements evaluated, potential contraindications for cardiovascular conditions, pregnancy/nursing, and high blood pressure were listed most frequently (73%, 65.5%, and 37%, respectively), whereas few websites listed potential drug interactions or adverse reactions. Potential hazards posed by dietary supplements may not be accurately, if at all, represented on Internet websites selling these products. Since consumers may not approach their physicians or pharmacists for information regarding use of dietary supplements in weight loss, it becomes necessary for health care providers to actively engage their patients in open discussion regarding the use, benefits, and hazards of dietary supplements.

The FDA role in contact lens development and safety.

PubMed

Lippman, R E

1990-01-01

The Food and Drug Administration (FDA) exercises a multifaceted role in fulfilling its mission of enforcing the Federal Food, Drug and Cosmetic Act (Act), functioning not only as industry regulator and consumer protector, but also as scientific advisor and consumer educator regarding medical devices, drugs, foods, cosmetics, and veterinary medicine. Medical devices are regulated within the Center for Devices and Radiological Health. Contact lenses are regulated under the authority of the medical device amendments. The Center is responsible for promulgating regulations, publishing guidelines, and developing written guidance in enforcing the Act, and also for guiding manufacturers of medical devices in safe and effective product development. Other components deal with the compliance of manufacturers with the marketing of medical devices within the meaning of the Act, and through labeling requirements of the Act and consumer education and informational activities. As for contact lenses, the process of updating product development regulations and guidelines is an ongoing activity. The most recent version of the Contact Lens Guideline Document, issued in April 1988, contains two major revisions involving preclinical and clinical testing. The first redefines plastics into one materials category, thus reducing testing requirements with respect to animal toxicology studies and other preclinical areas. The second revision restricts clinical testing requirements to allow confirmatory trials in applications for new daily wear lenses. The intention was to maintain the ability of studies to detect major material or design flaws in lenses, thus boosting confidence in their performance while eliminating unnecessary trials.(ABSTRACT TRUNCATED AT 250 WORDS)

Forward-looking automotive radar sensor

NASA Astrophysics Data System (ADS)

Ganci, Paul; Potts, Steven; Okurowski, Frank

1995-12-01

For intelligent cruise control (ICC) and forward looking collision warning systems to be successful products they must provide robust performance in a complex roadway environment. Inconveniences caused by dropped tracks and nuisance alarms will not be tolerated by consumers, and would likely result in rejection of these new technologies in the marketplace. The authors report on a low-cost automotive millimeter wave (MMW) radar design which addresses shortcomings associated with previously reported ICC system implementations. The importance of the sensor's ability to identify and separately track all obstacles in the field of view is discussed. The applicability of the MMW's FM-CW sensor implementation to collision warning systems is also discussed.

"When Does It Stop Being Peanut Butter?": FDA Food Standards of Identity, Ruth Desmond, and the Shifting Politics of Consumer Activism, 1960s-1970s.

PubMed

Boyce, Angie M

This article uses a historical controversy over the U.S. Food and Drug Administration's standard of identity for peanut butter as a site for investigating three topics of high importance for historians of technology, consumption, and food activism: how new industrial food-processing technologies have become regulatory problems; how government, industry, and consumer actors negotiate standards development; and how laypeople try to shape technological artifacts in spaces dominated by experts. It examines the trajectory of consumer activist Ruth Desmond, co-founder of the organization the Federation of Homemakers. By following Desmond's evolving strategies, the article shows how the broader currents of the 1960s-70s consumer movement played out in a particular case. Initially Desmond used a traditional style that heavily emphasized her gendered identity, working within a grassroots organization to promote legislative and regulatory reforms. Later, she moved to a more modern advocacy approach, using adversarial legal methods to fight for consumer protections.

An Analysis of “Natural” Food Litigation to Build a Sesame Allergy Consumer Class Action.

PubMed

Shaker, Dana

In a world where food allergy is still an incurable disease, law and regulation stand as necessary mechanisms to provide food-allergic consumers with the information they need to protect their health. The Food Allergen Labeling and Consumer Protection Act of 2004 provided specific labeling requirements for the “Top Eight” allergens in the U.S.: milk, soy, gluten, egg, tree nut, peanut, fish, and Crustacean shellfish. Since then, sesame has become more prevalent as an allergen and remains just as dangerous, inducing anaphylactic shock in some sesame-allergic individuals. Yet sesame remains unregulated, despite advocates and congressional members arguing for its inclusion. This note entertains one solution to this problem by exploring the most strategic way to bring a sesame allergy class action against a private food company under California’s consumer protection statutes. Because this kind of class action does not have much, if any, precedent, this note analyzes the basic, preliminary issues that any litigant would have to navigate around to certify a class, including preemption, standing, and the claim itself, by focusing on how courts have examined these issues in the recent “natural” class action litigation. It also analyzes the legal, moral, and practical aspects of choosing a type of relief, as well as whom to include in the class. Finally, this note briefly considers how FDA itself can ensure sesame is regulated on the labels of food products, given that some of the legal issues may well be insurmountable for this particular class action. This note explores the potential solutions to difficult legal hurdles in constructing a sesame allergy class action, arguing that litigating a sesame allergy class action—even if it is not ultimately successful—could start a productive conversation that might lead Congress or FDA to provide greater public health and consumer protection for those with sesame allergy.

Health claims and other health-related statements in the labeling and advertising of alcohol beverages (99R-199P). Final rule, Treasury decision.

PubMed

2003-03-03

TTB is amending the regulations to prohibit the appearance on labels or in advertisements of any health-related statement, including a specific health claim, that is untrue in any particular or tends to create a misleading impression. A specific health claim on a label or in an advertisement is considered misleading unless the claim is truthful and adequately substantiated by scientific evidence; properly detailed and qualified with respect to the categories of individuals to whom the claim applies; adequately discloses the health risks associated with both moderate and heavier levels of alcohol consumption; and outlines the categories of individuals for whom any levels of alcohol consumption may cause health risks. In addition, TTB will consult with the Food and Drug Administration (FDA), as needed, on the use of specific health claims on labels. If FDA determines that a specific health claim is a drug claim that is not in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act, TTB will not approve the use of such statement on a label. Health-related statements that are not specific health claims or health-related directional statements will be evaluated on a case-by-case basis to determine if they tend to mislead consumers. The final rule provides that health-related directional statements (statements that direct or refer consumers to a third party or other source for information regarding the effects on health of alcohol consumption) will be presumed misleading unless those statements include a brief disclaimer advising consumers that the statement should not encourage consumption of alcohol for health reasons, or some other appropriate disclaimer to avoid misleading consumers. TTB believes that the final regulations will ensure that labels and advertisements do not contain statements or claims that would tend to mislead the consumer about the significant health consequences of alcohol consumption.

Drug safety and the impact of drug warnings: An interrupted time series analysis of diabetes drug prescriptions in Germany and Denmark.

PubMed

Hostenkamp, Gisela; Fischer, Katharina Elisabeth; Borch-Johnsen, Knut

2016-12-01

To analyse the impact of drug safety warnings from the European Medicines Agency (EMA) on drug utilisation and their interaction with information released through national reimbursement bodies. Insurance claims data on anti-diabetic drug prescriptions in primary care in Germany and Denmark were analysed using interrupted time series analysis, with EMA drug warnings for thiazolidinediones (TZDs) in 2007 and 2011 as the intervention. Monthly drug utilisation data per substance in defined daily dosages (DDD) consumed per 1000 insurees were retrieved from the Danish national drug prescriptions register and one large statutory sickness fund in Germany. TZDs were generally reimbursed in Germany but restricted to individual reimbursement in Denmark. Consequently, utilisation of TZDs was much higher in Germany in 2007 compared with Denmark. For rosiglitazone, the drug warning had a significant impact on utilisation, reducing the number of DDD per 1000 insurees per day by -0.0105 in Denmark and -0.0312 in Germany (p-values<0.05). For pioglitazone, neither of the drug warnings had a significant effect on utilisation. The impact of EMA drug warnings differed across countries and might be mediated by information released through national reimbursement bodies and physician associations. Increasing complexity of new drugs and modified approval procedures require a strengthening of information exchange between drug regulation bodies and physicians to ensure patient safety. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The effect of sugar-sweetened beverage front-of-pack labels on drink selection, health knowledge and awareness: An online randomised controlled trial.

PubMed

Billich, Natassja; Blake, Miranda R; Backholer, Kathryn; Cobcroft, Megan; Li, Vincy; Peeters, Anna

2018-06-04

Sugar-sweetened beverages (SSBs) provide little nutritional value and are associated with an increased risk of diet-related diseases. Despite this, SSB consumption is high globally. One emerging strategy aimed at reducing SSB consumption involves the use of front-of-pack (FOP) labels that clearly identify the risks associated with SSB consumption. The aim of this research study was to determine whether FOP labels with a graphic warning, text warning, sugar information (with the number of teaspoons of added sugar) or Health Star Rating (HSR) reduces intended choice of a SSB in an online choice experiment with young Australian adults. 994 participants were recruited and completed the online choice experiment. Compared to the control group who were not exposed to a label, the graphic warning, text warning, sugar information and HSR labels all significantly reduced selection of a SSB in the choice scenario. The magnitude of effect was greatest for the graphic warning label (OR 0.22 95% CI 0.14-0.35). Compared to the control group, only the HSR label significantly increased selections of the high HSR drinks (OR 2.18 95% CI 1.20-3.97). FOP labels, particularly those with graphic warnings, have the potential to reduce intended SSB purchases. Labels that also identify healthier alternatives may influence consumers to substitute SSBs with healthier drinks. Copyright © 2018. Published by Elsevier Ltd.

Information on Blood Alcohol Concentration: Evaluation of Two Alcohol Nomograms.

ERIC Educational Resources Information Center

Werch, Chudley E.

1988-01-01

Compared utility of two common alcohol nomograms on impacting decisions regarding drinking, driving after drinking, knowledge of relationship between personal alcohol consumption and the legal level of intoxication, and consumer evaluation measures, to utility of alcohol information warning card. Nomograms were no more effective than cards warning…

The success of the citizen suit: protecting consumers from inaccurate food labeling by amending the Federal Food, Drug, and Cosmetic Act.

PubMed

Springer, James

2013-01-01

The Federal Food, Drug, and Cosmetic Act ("FDCA"), amended in 1990 by the Nutrition Education and Labeling Act ("NLEA"), established a national framework for the administration and promulgation of uniform food labeling standards. Specifically, the NLEA created affirmative obligations for the food--requiring detailed disclosure of food content and strict adherence to regulations governing the use of health and nutritional claims on food packaging. To accomplish these goals, Congress tasked the Food and Drug Administration ("FDA") with the sole responsibility of the enforcement of these new requirements. Under the statutory framework of the FDCA, the United States Supreme Court ("Court") has held that there is no private right of action, of which extended to the enforcement of NLEA standards. This interpretation has left individuals with no federal outlet for relief in the enforcement of federal food labeling standards. Adherence to this interpretation is especially concerning when the FDA currently faces exponential growth in administrative responsibilities while simultaneously experiencing employment reduction, a $206 million "Sequester," and a recent government-wide shutdown. As a result, the American people are left to depend on an Agency that is struggling with drastic resource reduction while being accountable for ever increasing enforcement responsibilities. To ensure consumer protection, this Article argues that Congress should amend the FDCA to include a citizen suit provision in order to provide individuals with a right of private action for the enforcement of NLEA standards. Borrowing from the successes realized under similar citizen suit provisions found in environmental legislation, this Article argues that a citizen suit provision is amendable to the FDCA and would relieve fiscal pressures, strengthen the current enforcement framework of the FDCA, encourage more robust enforcement by the FDA and states, and ensure uniform interpretation of NLEA standards.

TU-AB-204-04: Partnerships

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ochs, R.

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less

Price analysis of multiple sclerosis disease-modifying therapies marketed in the United States.

PubMed

Bin Sawad, Aseel; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Turkistani, Fatema

2016-11-01

This study assessed trends in the average wholesale price (AWP) at the market entry of disease-modifying therapies (DMTs) approved by Food and Drug Administration (FDA) in the period 1987-2014. DMT regulatory information was derived from the FDA website. The AWPs per unit at market entry data were derived from the Red Book (Truven Health Analytics Inc.). The AWP history for each DMT was collected from its date of approval to 31 December 2014. The FDA approved label defined daily dose (DDD) for adult patients was obtained from FDA approved labels. The AWP per DDD and the AWP/DDD per year of therapy were computed. Descriptive statistics, Wilcoxon tests, t-test, and multiple linear regression were performed. The statistical significance level was set at 0.05. The FDA approved 12 multiple sclerosis (MS) DMTs, including five new drug applications (NDAs) and seven biologic license applications (BLAs) as of 31 December 2014. The FDA granted orphan designation to five DMTs. There was one DMT approved by the FDA in the 1980s, three in the 1990s, three in 2000s, and five in the period 2010-2014. The market entry inflation-adjusted AWP per DDD was $10.23 for the first DMT (mitoxantrone hydrochloride) that was approved in the 1980s. The median market entry inflation-adjusted AWP per DDD was $12.41 (interquartile range [IQR] = 4.51) for DMTs approved in the 1990s, $71.26 (IQR = 58.35) in the 2000s, and $172.56 (IQR = 84.97) in the period 2010-2014. The median AWP per DDD was statistically significantly different (p = 0.011) for orphan (median = $41.82, IQR = 56.077) compared to non-orphan drugs (median = $171.32, IQR = 199.29). Year of market entry was positively associated with DMT prices at US market entry (p = 0.01). The AWP per DDD for DMTs at market entry increased substantially over time. The increase in DMTs prices exceeded the general consumer price index.

Radiation disinfestation of food and agricultural products

DOE Office of Scientific and Technical Information (OSTI.GOV)

Moy, J.H.

1985-01-01

This book presents the papers given at a conference on the radiodisinfestation of food and crops. Topics considered at the conference included food irradiation's impact of the US Agency for International Development, FDA regulations, irradiation as a quarantine treatment, quality attributes of irradiated fruits, low-dose irradiation, cesium 137 as a radiation source, radiosterilization, economic feasibility, marketing, consumer acceptance, and the packaging of irradiated products.

77 FR 72355 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-05

... also received a comment that asked FDA to provide more detail about the design of the proposed consumer... respondents respondent responses Pretest 60 1 60 0.5 (30 minutes) 30 Screener 15,000 1 15,000 0.016 (1 minute.... Sixty panel members will take part in a pretest of the study, estimated to last 30 minutes (0.5 hours...

Cognition-Enhancing Drugs and Their Appropriateness for Aviation and Ground Troops: A Meta-Analysis

DTIC Science & Technology

2010-12-01

individuals is not approved by the Food and Drug Administration (FDA). Current indications include narcolepsy, obstructive sleep apnea/hypopnea syndrome, and...to caffeine and perceived effects of caffeine in moderate and high regular caffeine consumers . Psychopharmacology. 190: 469-477...J. 2004. The effect of caffeinated tube food on cognitive performance during fatigue/circadian desynchronosis. Brooks City-Base, TX

Survival and persistence of non-pathogenic Escherichia coli and attenuated Escherichia coli O157:H7 in soils amended with animal manure in a greenhouse environment

USDA-ARS?s Scientific Manuscript database

Biological soil amendments (BSA's), including dairy cattle, poultry litter, and horse manure, play an important role in agriculture but may contain pathogens that can contaminate raw or ready-to-eat fruit and vegetable crops that are consumed raw. Proposed FDA standards include a 90- or 120-day inte...

Near-infrared Spectroscopy to Reduce the Prophylactic Fasciotomies for and Missed Cases of Acute Compartment Syndrome in Soldiers Injured in OEF/OIF

DTIC Science & Technology

2010-10-01

and Consumer Assistance at its loll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/ cdrh /industrv/support...21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH , Office of Device

Consumer Understanding, Preferences, and Responses to Different Versions of Drug Safety Messages in the United States: A Randomized Controlled Trial.

PubMed

McCormack, Lauren; Craig Lefebvre, R; Bann, Carla; Taylor, Olivia; Rausch, Paula

2016-02-01

As part of its mission, the US Food and Drug Administration (FDA) communicates with the public regularly about the benefits and risks of prescription and over-the-counter (OTC) drugs. Effectively communicating risk, however, is a significant public health challenge. To better understand how different populations understand information communicated by the FDA about drug safety, we conducted a randomized experiment to examine comprehension and other measures of effectiveness of drug safety messages that occurred in a post-market surveillance phase. We used an Internet panel survey of 1244 consumers, of whom 58% used prescription drugs in the past year. Half of the sample panel was randomized to read a previous FDA Drug Safety Communication (DSC) with the drug name changed, and the other half was randomized to read a revised version of the same DSC. We examined how making certain modifications to the way drug risk information is communicated has an impact on comprehension and behavioral intentions, including the user's likelihood of discontinuing the drug. We also studied how comprehension varied by respondent characteristics, health literacy skills, risk perceptions, and trust in the message. Based on a five-item comprehension index, the revised version of the message was associated with significantly greater comprehension of the information relative to the standard version (63 vs 52% correct, p < 0.001). Significantly more respondents found the revised version to be clear (82 vs 73%, p < 0.000), while fewer in that group reported learning something new (78% vs 84%, p = 0.015). No significant differences emerged between the two groups in terms of the message being informative, convincing, or helpful. We found no significant differences between the two groups in terms of behavioral intentions, risk perception, and trust. We found that making plain language changes to the DSC significantly increased consumers' level of comprehension of its content, providing support for ongoing use and further exploration of these strategies in pharmacovigilance communication research. The study findings have important implications for future drug safety and other communication messages related to prescription drugs.

TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.« less

Practice-based evidence: profiling the safety of cilostazol by text-mining of clinical notes.

PubMed

Leeper, Nicholas J; Bauer-Mehren, Anna; Iyer, Srinivasan V; Lependu, Paea; Olson, Cliff; Shah, Nigam H

2013-01-01

Peripheral arterial disease (PAD) is a growing problem with few available therapies. Cilostazol is the only FDA-approved medication with a class I indication for intermittent claudication, but carries a black box warning due to concerns for increased cardiovascular mortality. To assess the validity of this black box warning, we employed a novel text-analytics pipeline to quantify the adverse events associated with Cilostazol use in a clinical setting, including patients with congestive heart failure (CHF). We analyzed the electronic medical records of 1.8 million subjects from the Stanford clinical data warehouse spanning 18 years using a novel text-mining/statistical analytics pipeline. We identified 232 PAD patients taking Cilostazol and created a control group of 1,160 PAD patients not taking this drug using 1:5 propensity-score matching. Over a mean follow up of 4.2 years, we observed no association between Cilostazol use and any major adverse cardiovascular event including stroke (OR = 1.13, CI [0.82, 1.55]), myocardial infarction (OR = 1.00, CI [0.71, 1.39]), or death (OR = 0.86, CI [0.63, 1.18]). Cilostazol was not associated with an increase in any arrhythmic complication. We also identified a subset of CHF patients who were prescribed Cilostazol despite its black box warning, and found that it did not increase mortality in this high-risk group of patients. This proof of principle study shows the potential of text-analytics to mine clinical data warehouses to uncover 'natural experiments' such as the use of Cilostazol in CHF patients. We envision this method will have broad applications for examining difficult to test clinical hypotheses and to aid in post-marketing drug safety surveillance. Moreover, our observations argue for a prospective study to examine the validity of a drug safety warning that may be unnecessarily limiting the use of an efficacious therapy.

Practice-Based Evidence: Profiling the Safety of Cilostazol by Text-Mining of Clinical Notes

PubMed Central

Iyer, Srinivasan V.; LePendu, Paea; Olson, Cliff; Shah, Nigam H.

2013-01-01

Background Peripheral arterial disease (PAD) is a growing problem with few available therapies. Cilostazol is the only FDA-approved medication with a class I indication for intermittent claudication, but carries a black box warning due to concerns for increased cardiovascular mortality. To assess the validity of this black box warning, we employed a novel text-analytics pipeline to quantify the adverse events associated with Cilostazol use in a clinical setting, including patients with congestive heart failure (CHF). Methods and Results We analyzed the electronic medical records of 1.8 million subjects from the Stanford clinical data warehouse spanning 18 years using a novel text-mining/statistical analytics pipeline. We identified 232 PAD patients taking Cilostazol and created a control group of 1,160 PAD patients not taking this drug using 1∶5 propensity-score matching. Over a mean follow up of 4.2 years, we observed no association between Cilostazol use and any major adverse cardiovascular event including stroke (OR = 1.13, CI [0.82, 1.55]), myocardial infarction (OR = 1.00, CI [0.71, 1.39]), or death (OR = 0.86, CI [0.63, 1.18]). Cilostazol was not associated with an increase in any arrhythmic complication. We also identified a subset of CHF patients who were prescribed Cilostazol despite its black box warning, and found that it did not increase mortality in this high-risk group of patients. Conclusions This proof of principle study shows the potential of text-analytics to mine clinical data warehouses to uncover ‘natural experiments’ such as the use of Cilostazol in CHF patients. We envision this method will have broad applications for examining difficult to test clinical hypotheses and to aid in post-marketing drug safety surveillance. Moreover, our observations argue for a prospective study to examine the validity of a drug safety warning that may be unnecessarily limiting the use of an efficacious therapy. PMID:23717437

Petitioning the FDA to Improve Pharmaceutical, Device and Public Health Safety by Ordinary Citizens: A Descriptive Analysis

PubMed Central

Yang, Y. Tony; Cheng, Xi; Bian, John; Bennett, Charles L.

2016-01-01

The United States Constitution protects the right of citizens to petition the government for “a redress of grievances.” This right has important implications for citizens desiring to advance the public health by petitioning administrative agencies, such as the Food and Drug Administration, to take safety actions. We examined a total of 1,915 petitions filed between 2001 and 2013 to investigate the outcomes of citizen petitions that address public health concerns. We found that most petitions were filed by manufacturers against other manufacturers. Only 346 (18%) of all petitions were submitted by individuals and non-profit organizations, and 178 (87.3%) of these petitions with a final response were denied. On average, these petitions required 2.85 years for a final agency decision, and many decisions remain pending 10–13 years after their initial submission. The great majority of the approved requests included some form of risk communication, such as labeling changes, boxed warnings or placement of a drug into a Risk Evaluation and Mitigation Strategy. As a policy instrument to improve the safety of medical and food products, the citizen petition process requires sophisticated legal and scientific expertise, and may not represent a viable route for ordinary citizens to petition the FDA to “redress grievances.” PMID:27171162

Toxicological considerations for antithyroid drugs in children.

PubMed

Karras, Spiros; Tzotzas, Themistoklis; Krassas, Gerasimos E

2011-04-01

Propylthiouracil (PTU), methimazole (MMI) and carbimazole are indicated for the treatment of hyperthyroidism in adult and pediatric patients. The aim of this review is to present all the relevant information regarding the use of antithyroid drugs (ATD) in pediatric thyrotoxic cases, the pediatric toxicology of ATD and the warning which has recently been issued for PTU by the FDA. Epidemiology, diagnosis and treatment of pediatric thyrotoxicosis are all presented in this article. The authors also extensively discuss the details regarding the pharmacology, bioactivation, biodisposition, bioavailability and pharmacokinetic properties of the two main ATD (MMI and PTU). The FDA recently reported that use of PTU is associated with a higher risk for clinically serious or fatal liver injury compared to MMI in both adult and pediatric patients. They also found that congenital malformations were reported approximately three times more often with prenatal exposure to MMI compared with PTU and especially with the use of MMI during the first trimester of pregnancy. The authors believe that PTU should not be used in pediatric patients unless the patient is allergic to or intolerant of MMI, and there are no other treatment options available. That being said, PTU may be the treatment of choice during, and just before, the first trimester of pregnancy.

Petitioning the FDA to Improve Pharmaceutical, Device and Public Health Safety by Ordinary Citizens: A Descriptive Analysis.

PubMed

Chen, Brian K; Yang, Y Tony; Cheng, Xi; Bian, John; Bennett, Charles L

2016-01-01

The United States Constitution protects the right of citizens to petition the government for "a redress of grievances." This right has important implications for citizens desiring to advance the public health by petitioning administrative agencies, such as the Food and Drug Administration, to take safety actions. We examined a total of 1,915 petitions filed between 2001 and 2013 to investigate the outcomes of citizen petitions that address public health concerns. We found that most petitions were filed by manufacturers against other manufacturers. Only 346 (18%) of all petitions were submitted by individuals and non-profit organizations, and 178 (87.3%) of these petitions with a final response were denied. On average, these petitions required 2.85 years for a final agency decision, and many decisions remain pending 10-13 years after their initial submission. The great majority of the approved requests included some form of risk communication, such as labeling changes, boxed warnings or placement of a drug into a Risk Evaluation and Mitigation Strategy. As a policy instrument to improve the safety of medical and food products, the citizen petition process requires sophisticated legal and scientific expertise, and may not represent a viable route for ordinary citizens to petition the FDA to "redress grievances."

Rosiglitazone: a disappointing DREAM.

PubMed

Nissen, Steven

2007-09-01

Dr Steven Nissen is a heart specialist and currently holds the position of chairman of cardiovascular medicine at the Cleveland Clinic, OH, USA. His work has involved the development of miniaturised ultrasound imaging devices that can be threaded into a patient's heart that allow measurement of the size and composition of plaques, which indicate early artery damage. The ability to characterize and measure the size of plaques provided a novel, effective method to evaluate the efficacy of anticholesterol medications, and for the past two decades Dr Nissen has been using these and other techniques to examine the efficacy of drugs. He has also developed a strong interest in drug safety. His work linked COX-2 inhibitors such as Celebrex and Vioxx (Merck, NJ, USA) with heart attacks, and prevented Merck's similar product, Arcoxia, from being approved. He also highlighted the serious heart attack risk associated with the experimental drug Pargluva and the drug was subsequently not approved by the US FDA. More recently, Dr Nissen's work has focused on the drug rosiglitazone, which was shown to have high cardiovascular risks and has since been given a FDA warning. Here, Dr Nissen discusses the publication of the rosiglitazone meta-analysis and why he considers work in this area to be crucially important for patients.

An early warning system for groundwater pollution based on the assessment of groundwater pollution risks.

NASA Astrophysics Data System (ADS)

Zhang, Weihong.; Zhao, Yongsheng; Hong, Mei; Guo, Xiaodong

2009-04-01

Groundwater pollution usually is complex and concealed, remediation of which is difficult, high cost, time-consuming, and ineffective. An early warning system for groundwater pollution is needed that detects groundwater quality problems and gets the information necessary to make sound decisions before massive groundwater quality degradation occurs. Groundwater pollution early warning were performed by considering comprehensively the current groundwater quality, groundwater quality varying trend and groundwater pollution risk . The map of the basic quality of the groundwater was obtained by fuzzy comprehensive evaluation or BP neural network evaluation. Based on multi-annual groundwater monitoring datasets, Water quality state in sometime of the future was forecasted using time-sequenced analyzing methods. Water quality varying trend was analyzed by Spearman's rank correlative coefficient.The relative risk map of groundwater pollution was estimated through a procedure that identifies, cell by cell,the values of three factors, that is inherent vulnerability, load risk of pollution source and contamination hazard. DRASTIC method was used to assess inherent vulnerability of aquifer. Load risk of pollution source was analyzed based on the potential of contamination and pollution degree. Assessment index of load risk of pollution source which involves the variety of pollution source, quantity of contaminants, releasing potential of pollutants, and distance were determined. The load risks of all sources considered by GIS overlay technology. Early warning model of groundwater pollution combined with ComGIS technology organically, the regional groundwater pollution early-warning information system was developed, and applied it into Qiqiha'er groundwater early warning. It can be used to evaluate current water quality, to forecast water quality changing trend, and to analyze space-time influencing range of groundwater quality by natural process and human activities. Keywords: groundwater pollution, early warning, aquifer vulnerability, pollution load, pollution risk, ComGIS

Still the Great Debate – "Fair Balance" in Direct-to-Consumer Prescription Drug Advertising

PubMed Central

Rollins, Brent L.

2016-01-01

The above titled paper examined the Food and Drug Administration’s (FDA’s) warning letters and notice of violations (NOV) over a 10-year period. Findings from this content analysis reinforced what has been the primary issue for prescription direct-to-consumer advertising (DTCA) since its beginning, the fair balance of risk and benefit information. As opposed to another analysis in 2026 about this still being an issue, is there anything that can be done to prevent this problem from continuing? PMID:27239875

Food from cloned animals is part of our brave old world.

PubMed

Miller, Henry I

2007-05-01

When confronted by pressure from activists and Congress, the US Food and Drug Administration (FDA) has not always adopted policies and made decisions about individual products that accord with the scientific evidence. An example was the unnecessarily and markedly prolonged review of the veterinary drug bovine somatotropin (bST), or bovine growth hormone, during the 1980s. The FDA now faces a similar situation surrounding the question of whether meat and milk from cloned animals and their offspring are safe for human consumption. Having made a preliminary decision in the affirmative - based on an exhaustive analysis of scientific articles, health records, blood samples and studies of the composition of meat and milk - the agency has been beleaguered by criticisms. It remains to be seen whether, ultimately, science will trump anti-technology, anti-consumer activism.

Can pictorial warning labels on cigarette packages address smoking-related health disparities?: Field experiments in Mexico to assess warning label content

PubMed Central

Thrasher, James F.; Arillo-Santillán, Edna; Villalobos, Victor; Pérez-Hernández, Rosaura; Hammond, David; Carter, Jarvis; Sebrié, Ernesto; Sansores, Raul; Regalado-Piñeda, Justino

2012-01-01

Objective This study aimed to determine the most effective content of pictorial health warning labels (HWLs) and whether educational attainment moderates these effects. Methods Field experiments were conducted with 529 adult smokers and 530 young adults (258 nonsmokers; 271 smokers), wherein participants reported responses to different HWLs printed on cigarette packages. One experiment involved manipulating textual form (testimonial narrative vs didactic) and the other involved manipulating imagery type (diseased organs vs human suffering). Results Tests of mean ratings and rankings indicated that HWLs with didactic textual forms had equivalent or significantly higher credibility, relevance, and impact than HWLs with testimonial forms. Results from mixed-effects models confirmed these results. However, responses differed by participant educational attainment: didactic forms were consistently rated higher than testimonials among participants with higher education, whereas the difference between didactic and testimonial narrative forms was weaker or not statistically significant among participants with lower education. In the second experiment, with textual content held constant, greater credibility, relevance and impact was found for graphic imagery of diseased organs than imagery of human suffering. Conclusions Pictorial HWLs with didactic textual forms appear to work better than with testimonial narratives. Future research should determine which pictorial HWL content has the greatest real-world impact among consumers from disadvantaged groups, including assessment of how HWL content should change to maintain its impact as tobacco control environments strengthen and consumer awareness of smoking-related risks increases. PMID:22350859

Can pictorial warning labels on cigarette packages address smoking-related health disparities? Field experiments in Mexico to assess pictorial warning label content.

PubMed

Thrasher, James F; Arillo-Santillán, Edna; Villalobos, Victor; Pérez-Hernández, Rosaura; Hammond, David; Carter, Jarvis; Sebrié, Ernesto; Sansores, Raul; Regalado-Piñeda, Justino

2012-03-01

The objective of this study was to determine the most effective content of pictorial health warning labels (HWLs) and whether educational attainment moderates these effects. Field experiments were conducted with 529 adult smokers and 530 young adults (258 nonsmokers; 271 smokers). Participants reported responses to different pictorial HWLs printed on cigarette packages. One experiment involved manipulating textual form (testimonial narrative vs. didactic) and the other involved manipulating image type (diseased organs vs. human suffering). Tests of mean ratings and rankings indicated that pictorial HWLs with didactic textual forms had equivalent or significantly higher credibility, relevance, and impact than pictorial HWLs with testimonial forms. Results from mixed-effects models confirmed these results. However, responses differed by participant educational attainment: didactic forms were consistently rated higher than testimonials among participants with higher education, whereas the difference between didactic and testimonial narrative forms was weaker or not statistically significant among participants with lower education. In the second experiment, with textual content held constant, greater credibility, relevance, and impact was found for graphic imagery of diseased organs than imagery of human suffering. Pictorial HWLs with didactic textual forms seem to work better than those with testimonial narratives. Future research should determine which pictorial HWL content has the greatest real-world impact among consumers from disadvantaged groups, including assessment of how HWL content should change to maintain its impact as tobacco control environments strengthen and consumer awareness of smoking-related risks increases.

An exploratory study of drinkers views of health information and warning labels on alcohol containers.

PubMed

Thomson, Lisa M; Vandenberg, Brian; Fitzgerald, John L

2012-03-01

To identify general and specific features of health information warning labels on alcohol beverage containers that could potentially inform the development and implementation of a new labelling regime in Australia. Mixed methods, including a cross-sectional population survey and a qualitative study of knowledge, attitudes and behaviours regarding alcohol beverage labelling. The population survey used computer-assisted telephone interviews of 1500 persons in Victoria, Australia to gauge the level of support for health information and warning labels. The qualitative study used six focus groups to test the suitability of 12 prototype labels that were placed in situ on a variety of alcohol beverage containers. The telephone survey found 80% to 90% support for a range of information that could potentially be mandated by government authorities for inclusion on labels (nutritional information, alcohol content, health warning, images). Focus group testing of the prototype label designs found that labels should be integrated with other alcohol-related health messages, such as government social advertising campaigns, and specific labels should be matched appropriately to specific consumer groups and beverage types. There are high levels of public support for health information and warning labels on alcohol beverages. This study contributes much needed empirical guidance for developing alcohol beverage labelling strategies in an Australian context. © 2011 Australasian Professional Society on Alcohol and other Drugs.

Methods for the evaluation of alternative disaster warning systems

NASA Technical Reports Server (NTRS)

Agnew, C. E.; Anderson, R. J., Jr.; Lanen, W. N.

1977-01-01

For each of the methods identified, a theoretical basis is provided and an illustrative example is described. The example includes sufficient realism and detail to enable an analyst to conduct an evaluation of other systems. The methods discussed in the study include equal capability cost analysis, consumers' surplus, and statistical decision theory.