box warning label: Topics by Science.gov

Sample records for box warning label

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.
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.
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.
Timing of new black box warnings and withdrawals for prescription medications.

PubMed

Lasser, Karen E; Allen, Paul D; Woolhandler, Steffie J; Himmelstein, David U; Wolfe, Sidney M; Bor, David H

2002-05-01

Recently approved drugs may be more likely to have unrecognized adverse drug reactions (ADRs) than established drugs, but no recent studies have examined how frequently postmarketing surveillance identifies important ADRs. To determine the frequency and timing of discovery of new ADRs described in black box warnings or necessitating withdrawal of the drug from the market. Examination of the Physicians' Desk Reference for all new chemical entities approved by the US Food and Drug Administration between 1975 and 1999, and all drugs withdrawn from the market between 1975 and 2000 (with or without a prior black box warning). Frequency of and time to a new black box warning or drug withdrawal. A total of 548 new chemical entities were approved in 1975-1999; 56 (10.2%) acquired a new black box warning or were withdrawn. Forty-five drugs (8.2%) acquired 1 or more black box warnings and 16 (2.9%) were withdrawn from the market. In Kaplan-Meier analyses, the estimated probability of acquiring a new black box warning or being withdrawn from the market over 25 years was 20%. Eighty-one major changes to drug labeling in the Physicians' Desk Reference occurred including the addition of 1 or more black box warnings per drug, or drug withdrawal. In Kaplan-Meier analyses, half of these changes occurred within 7 years of drug introduction; half of the withdrawals occurred within 2 years. Serious ADRs commonly emerge after Food and Drug Administration approval. The safety of new agents cannot be known with certainty until a drug has been on the market for many years.
Graphic warnings and text warning labels on cigarette packages in Riyadh Kingdom of Saudi Arabia: Awareness and perceptions

PubMed Central

Jradi, Hoda; Saddik, Basema

2018-01-01

BACKGROUND: Graphic warning labels have been shown to be effective in smoking initiation and cessation and were implemented in Saudi Arabia in 2012. To date, no study has assessed the effectiveness of these labels and the Saudi population's perceptions on the effectiveness of cigarette health warning labels. METHODS: We used a cross-sectional qualitative study comprising of nine focus groups among 3 different community group members including health-care workers, adult women and adult men. We conducted in-depth interviews among community leaders. Both focus groups and interviews assessed awareness levels and elicited perceptions about health warning labels on cigarette boxes currently used in the Kingdom of Saudi Arabia. RESULTS: While most participants in the study were aware and supported the use of graphic warning labels on cigarette packages, the awareness of the specific details on the labels was low. Participants perceived the effectiveness of current labels somewhat vague in smoking cessation and advocated for stronger and more aggressive graphics. Community leaders, however, preferred text-only labels and did not support aggressive labels which were deemed culturally and religiously inappropriate. CONCLUSIONS: The study suggests that while graphic warning labels are perceived as necessary on cigarette packages the currently used messages are not clear and therefore do not serve their intended purposes. Measures should be undertaken to ensure that pictorial cigarette labels used in Saudi Arabia are culturally and ethnically appropriate and are rotated on a regular basis to ensure salience among smokers and nonsmokers alike. PMID:29387252
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.
21 CFR 866.6050 - Ovarian adnexal mass assessment score test system.

Code of Federal Regulations, 2012 CFR

2012-04-01

... ovarian/adnexal mass assessment test system is a device that measures one or more proteins in serum or... § 866.1(e). (c) Black box warning. Under section 520(e) of the Federal Food, Drug, and Cosmetic Act... box and must appear in all advertising, labeling, and promotional material for these devices. That...
21 CFR 866.6050 - Ovarian adnexal mass assessment score test system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... ovarian/adnexal mass assessment test system is a device that measures one or more proteins in serum or... § 866.1(e). (c) Black box warning. Under section 520(e) of the Federal Food, Drug, and Cosmetic Act... box and must appear in all advertising, labeling, and promotional material for these devices. That...
Off-Label Prescribing, Polypharmacy, and Black-Box Warnings: A Primer for School Psychologists

ERIC Educational Resources Information Center

Shahidullah, Jeffrey D.

2012-01-01

Psychotropic medications are increasingly used to treat children and adolescents with mental health conditions. Between the years 1994 and 2001, there was a 191.7% increase in number of office visits resulting in a psychotropic medication prescription among children and adolescents. Many drugs are prescribed to children "off-label", whereby they…
Prediction of black box warning by mining patterns of Convergent Focus Shift in clinical trial study populations using linked public data.

PubMed

Ma, Handong; Weng, Chunhua

2016-04-01

To link public data resources for predicting post-marketing drug safety label changes by analyzing the Convergent Focus Shift patterns among drug testing trials. We identified 256 top-selling prescription drugs between 2003 and 2013 and divided them into 83 BBW drugs (drugs with at least one black box warning label) and 173 ROBUST drugs (drugs without any black box warning label) based on their FDA black box warning (BBW) records. We retrieved 7499 clinical trials that each had at least one of these drugs for intervention from the ClinicalTrials.gov. We stratified all the trials by pre-marketing or post-marketing status, study phase, and study start date. For each trial, we retrieved drug and disease concepts from clinical trial summaries to model its study population using medParser and SNOMED-CT. Convergent Focus Shift (CFS) pattern was calculated and used to assess the temporal changes in study populations from pre-marketing to post-marketing trials for each drug. Then we selected 68 candidate drugs, 18 with BBW warning and 50 without, that each had at least nine pre-marketing trials and nine post-marketing trials for predictive modeling. A random forest predictive model was developed to predict BBW acquisition incidents based on CFS patterns among these drugs. Pre- and post-marketing trials of BBW and ROBUST drugs were compared to look for their differences in CFS patterns. Among the 18 BBW drugs, we consistently observed that the post-marketing trials focused more on recruiting patients with medical conditions previously unconsidered in the pre-marketing trials. In contrast, among the 50 ROBUST drugs, the post-marketing trials involved a variety of medications for testing their associations with target intervention(s). We found it feasible to predict BBW acquisitions using different CFS patterns between the two groups of drugs. Our random forest predictor achieved an AUC of 0.77. We also demonstrated the feasibility of the predictor for identifying long-term BBW acquisition events without compromising prediction accuracy. This study contributes a method for post-marketing pharmacovigilance using Convergent Focus Shift (CFS) patterns in clinical trial study populations mined from linked public data resources. These signals are otherwise unavailable from individual data resources. We demonstrated the added value of linked public data and the feasibility of integrating ClinicalTrials.gov summaries and drug safety labels for post-marketing surveillance. Future research is needed to ensure better accessibility and linkage of heterogeneous drug safety data for efficient pharmacovigilance. Copyright © 2016 Elsevier Inc. All rights reserved.
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.
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.
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.
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.
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.
Warnings on alcohol containers and advertisements: international experience and evidence on effects.

PubMed

Wilkinson, Claire; Room, Robin

2009-07-01

In light of possible introduction of alcohol warning labels in Australia and New Zealand, this paper discusses the international experience with and evidence of effects of alcohol warning labels. The report describes international experience with providing information and warnings concerning the promotion or sale of alcoholic beverages, and considers the evidence on the effects of such information and warnings. The experience with and evaluations of the effects of tobacco warning labels are also considered. The most methodologically sound evaluations of alcohol warning labels are based on the US experience. Although these evaluations find little evidence that the introduction of the warning label in the USA had an impact on drinking behaviour, there is evidence that they led to an increase in awareness of the message they contained. In contrast, evaluations of tobacco warning labels find clear evidence of effects on behaviour. There is a need and opportunity for a rigorous evaluation of the impacts of introducing alcohol warning labels to add to the published work on their effectiveness. The experience with tobacco labels might guide the way for more effective alcohol warning labels. Alcohol warning labels are an increasingly popular alcohol policy initiative. It is clear that warning labels can be ineffective, but the tobacco experience suggests that effective warning labels are possible. Any introduction of alcohol warning labels should be evaluated in terms of effects on attitudes and behaviour.
Inside the black box: current policies and concerns with the United States Food and Drug Administration's highest drug safety warning system.

PubMed

Halloran, Kylene; Barash, Paul G

2010-06-01

To evaluate the United States Food and Drug Administration use of the black-box warning system to promote drug safety and to examine the droperidol black-box warning as a case study. Scientific studies report that there is no basis to issue a black-box warning for perioperative administration of droperidol for postoperative nausea and vomiting on the basis of the potential of adverse cardiac events (prolongation of the QT interval and/or development of torsades de pointes). Rather than relying on well conducted clinical investigations, the Food and Drug Administration subjectively issued a black-box warning to droperidol, which effectively removed droperidol from clinical practice for the indication of postoperative nausea and vomiting. Newer data suggest that the incidence of prolongation of the QT interval and the occurrence of torsades de pointes is similar to more expensive alternative medications used to treat postoperative nausea and vomiting.
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 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.
[Impact of cigarette packages warning labels in relation to tobacco-smoking dependence and motivation to quit].

PubMed

Mannocci, Alice; Antici, Daniele; Boccia, Antonio; La Torre, Giuseppe

2012-01-01

the principal aim was to assess the impact of health warnings on cigarette packages in Italy, the reduction of daily number of cigarette smoked, in relationship to the tobacco-smoking dependence and motivation to quit. The second aim was to compare the impact of text warnings versus graphi depictions. cross-sectional study (survey). the study was conducted through interviews to an opportunistic sample of smokers.The subject enrolled were adult smokers (years ≥ 18), living in the province of Rome. Data were collected in two outpatient clinics located in Morlupo and Rome. Interviews were administered in the waiting rooms, to patients or to their relatives/ helpers. The survey was conducted in June-September 2010. The sample size (266 participants) was computed using a power of 80%, a confidence level of 95%, an expected frequency of smokers with a low motivation to quit who reduced number of cigarettes due to warnings of 15%, and a frequency of smokers with a higher motivation to quit who reduced number of cigarettes due to warnings of 30%. the effect of the health warnings used in Italy on smoking reduction was measured with the following self-reported items: "Are you or have you been influenced by the health warnings on cigarettes packages (in relation to the daily number of cigarettes smoked)?"; "Have you changed your smoking habits due to the warnings (for example: don't smoking after a coffee.)?"; "Have you ever stopped smoking due to the warnings?" The effect of labels that used shock images on cigarette boxes was measured using followed self-reported questions: "If shocking images were used on cigarette boxes, would they have greater effect than simple warning text currently used?"; "If your favourite cigarettes brand decide to change the look of its cigarette boxes with shocking images on smoking health damages, would you be driven to change it?" thanks to the health warnings, 95% of the 270 participants were informed on smoking damages, 14% (34 smokers) reduced the number cigarettes per day, and 5% (12 smokers) attempted to quit. Forty-five percent of smokers did not know the real impact of light cigarettes on their health, and 49% decided to smoke light cigarettes after having read the warnings. Women were more susceptible to immediate consequences of smoking (appearance of wrinkles; p<0.001), and were more prone to switch to light cigarettes (p=0.002). Smoking dependence, computed with Fagerstrom's test, showed significant differences by age groups (higher in smokers aged 30-45 years; p=0.001), and in smokers who were not interested to deepen knowledge of smoking effects (p=0.009). Individuals more motivated to quit were younger smokers (p=0.012). Smokers aged ≥ 45 years (OR=2.54; 95%CI 1.05-6.17), more motivated to quit (OR=2.92; 95%CI 1.17-7.30), those who reported they do not like the smoking smell on their own clothes (OR=3.6; 95%CI 1.4-9.0), those who reported warning messages are important (OR=4.93; 95%CI 1.55-15.71), those who changed their own smoking behavior due the warnings (OR=3.31; 95%CI 1.10-9.99) were more likely to reduce daily number of cigarettes due the health warnings. Forty-seven percent thought that health warnings with text and images could have a higher impact in comparison to text-only warnings. Moreover, women were more motivated to change cigarette brand if a brand should introduce pictorial warnings (OR=2.54; 95%CI 1.41-4.56). our study showed some positive effects of the introduction of health warnings on cigarette packages. In fact, almost all were informed on tobacco effects, 14% of them reduced the amount of daily smoking, and 5% attempted to quit. Many smokers still believe that switching to lighter cigarettes (e.g. those with less nicotine and tar contents) reduces smoking-related diseases. More than 50% of smokers recognized the importance of health warnings in communicating health risks of smoking, while women were more impressed than men by shocking pictorial warnings.

The Influence of Sugar-Sweetened Beverage Health Warning Labels on Parents' Choices.

PubMed

Roberto, Christina A; Wong, Diandra; Musicus, Aviva; Hammond, David

2016-02-01

US states have introduced bills requiring sugar-sweetened beverages (SSBs) to display health warning labels. This study examined how such labels may influence parents and which labels are most impactful. In this study, 2381 demographically and educationally diverse parents participated in an online survey. Parents were randomly assigned to 1 of 6 conditions: (1) no warning label (control); (2) calorie label; or (3-6) 1 of 4 text versions of a warning label (eg, Safety Warning: Drinking beverages with added sugar[s] contributes to obesity, diabetes, and tooth decay). Parents chose a beverage for their child in a vending machine choice task, rated perceptions of different beverages, and indicated interest in receiving beverage coupons. Regression analyses controlling for frequency of beverage purchases were used to compare the no warning label group, calorie label group, and all warning label groups combined. Significantly fewer parents chose an SSB for their child in the warning label condition (40%) versus the no label (60%) and calorie label conditions (53%). Parents in the warning label condition also chose significantly fewer SSB coupons, believed that SSBs were less healthy for their child, and were less likely to intend to purchase SSBs. All P values <.05 after correcting for multiple comparisons. There were no consistent differences among different versions of the warning labels. Health warning labels on SSBs improved parents' understanding of health harms associated with overconsumption of such beverages and may reduce parents' purchase of SSBs for their children. Copyright © 2016 by the American Academy of Pediatrics.
An analysis of legal warnings after drug approval in Thailand.

PubMed

Sriphiromya, Pakawadee; Theeraroungchaisri, Anuchai

2015-02-01

Drug risk management has many tools for minimizing risk and black-boxed warnings (BBWs) are one of those tools. Some serious adverse drug reactions (ADRs) emerge only after a drug is marketed and used in a larger population. In Thailand, additional legal warnings after drug approval, in the form of black-boxed warnings, may be applied. Review of their characteristics can assist in the development of effective risk mitigation. This study was a cross sectional review of all legal warnings imposed in Thailand after drug approval (2003-2012). Any boxed warnings for biological products and revised warnings which were not related to safety were excluded. Nine legal warnings were evaluated. Seven related to drugs classes and two to individual drugs. The warnings involved four main types of predictable ADRs: drug-disease interactions, side effects, overdose and drug-drug interactions. The average time from first ADRs reported to legal warnings implementation was 12 years. The triggers were from both safety signals in Thailand and regulatory measures in other countries outside Thailand. Copyright © 2014 Elsevier Inc. All rights reserved.
21 CFR 501.17 - Animal food labeling warning statements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Animal food labeling warning statements. 501.17... food labeling warning statements. (a) Self-pressurized containers. (1) The label of a food packaged in... the following warning: Warning Avoid spraying in eyes. Contents under pressure. Do not puncture or...
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.
40 CFR 82.110 - Form of label bearing warning statement.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 18 2014-07-01 2014-07-01 false Form of label bearing warning... Substances § 82.110 Form of label bearing warning statement. (a) Conspicuousness and contrast. The warning... matter on the label. The warning statement shall appear in sharp contrast to any background upon which it...
40 CFR 82.110 - Form of label bearing warning statement.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 17 2011-07-01 2011-07-01 false Form of label bearing warning... Substances § 82.110 Form of label bearing warning statement. (a) Conspicuousness and contrast. The warning... matter on the label. The warning statement shall appear in sharp contrast to any background upon which it...
Enhancing the effectiveness of tobacco package warning labels: a social psychological perspective

PubMed Central

Strahan, E; White, K; Fong, G; Fabrigar, L; Zanna, M; Cameron, R

2002-01-01

Objective: To outline social psychological principles that could influence the psychosocial and behavioural effects of tobacco warning labels, and to inform the development of more effective tobacco warning labels. Data sources: PsycInfo and Medline literature searches and expert guided selection of principles and theories in social psychology and of tobacco warning labels, including articles, books, and reports. Conclusions: Tobacco warning labels represent a potentially effective method of influencing attitudes and behaviours. This review describes social psychological principles that could be used to guide the creation of more effective warning labels. The potential value of incorporating warning labels into a broader public health education campaign is discussed, and directions for future research are suggested. PMID:12198266
Cigarette pack warning labels in Russia: how graphic should they be?

PubMed

Wade, Benjamin; Merrill, Ray M; Lindsay, Gordon B

2011-06-01

Tobacco warning labels on cigarette packs have been shown to reduce cigarette consumption. The current study measures the Russian population's acceptance and preference of graphic (picture + text) tobacco warning labels. Nationally representative data were collected from 1778 participants in the Russian Federation in October 2009. A cross-sectional survey was conducted through person-to-person household interviews with respondents aged ≥ 14 years. Survey questions included standard demographic queries and three study-specific questions. Participants rated the strength of 13 cigarette warning labels according to their effectiveness to deter from smoking. Smoking status and the population's acceptance of similar warning labels was also measured. A dose-response pattern is apparent between the degree of graphic content of cigarette warning labels and the public's perception regarding the warning label's ability to discourage smoking. Approximately 87% of all respondents thought Russian authorities should require tobacco manufacturers to place graphic warning labels on cigarette packs, while 80% of current smokers wanted their government to enact such enforcement. The Russian population would strongly support government policy that would require graphic warning labels to be placed on cigarette packs in their country. In order to best deter from smoking, future cigarette warning labels in Russia should be as graphic as possible.
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
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
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
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.
Smokers' responses toward cigarette pack warning labels in predicting quit intention, stage of change, and self-efficacy.

PubMed

Fathelrahman, Ahmed I; Omar, Maizurah; Awang, Rahmat; Borland, Ron; Fong, Geoffrey T; Hammond, David; Zain, Zarihah

2009-03-01

This paper is concerned with the effects of cigarette pack warning labels on quitting intentions. We examined whether different responses among smokers toward cigarette pack warning labels could predict quit intentions and self-efficacy in quitting. Variables studied were "noticing warning labels during last month," "reading or looking closely at warning labels," "avoiding looking at labels during last month," "thinking about health risks of smoking because of the warning labels, "more likely to quit because of the warning labels," and "stopping from having a cigarette when about to smoke one because of the labels." A total of 2,006 adult smokers in Malaysia were surveyed in face-to-face interviews using a standardized questionnaire. Of those, 1,919 male smokers were included in the analyses. The responses "more likely to quit because of the warning labels" and "stopped from having a cigarette when about to smoke one" significantly predicted all stages of change and self-efficacy, independent of the other measures. In addition, thinking about the health risks and reading the warnings more often added extra predictive capacity but only in the early stages of contemplating change. Less intense processing of the information may be important in initiating thoughts, but cognitions about quitting and foregoing cigarettes are the key mechanisms by which warnings stimulate quitting intentions and help smokers feel capable of succeeding. Malaysian smokers appear to respond to warnings in ways comparable with those from developed countries.
The Effects of Varying Electronic Cigarette Warning Label Design Features On Attention, Recall, and Product Perceptions Among Young Adults.

PubMed

Mays, Darren; Villanti, Andrea; Niaura, Raymond S; Lindblom, Eric N; Strasser, Andrew A

2017-12-13

This study was a 3 (Brand: Blu, MarkTen, Vuse) by 3 (Warning Size: 20%, 30%, or 50% of advertisement surface) by 2 (Warning Background: White, Red) experimental investigation of the effects of electronic cigarette (e-cigarette) warning label design features. Young adults aged 18-30 years (n = 544) were recruited online, completed demographic and tobacco use history measures, and randomized to view e-cigarette advertisements with warning labels that varied by the experimental conditions. Participants completed a task assessing self-reported visual attention to advertisements with a-priori regions of interest defined around warning labels. Warning message recall and perceived addictiveness of e-cigarettes were assessed post-exposure. Approximately half of participants reported attending to warning labels and reported attention was greater for warnings on red versus white backgrounds. Recall of the warning message content was also greater among those reporting attention to the warning label. Overall, those who viewed warnings on red backgrounds reported lower perceived addictiveness than those who viewed warnings on white backgrounds, and e-cigarette users reported lower perceived addictiveness than non-users. Among e-cigarette users, viewing warnings on white backgrounds produced perceptions more similar to non-users. Greater recall was significantly correlated with greater perceived addictiveness. This study provides some of the first evidence that e-cigarette warning label design features including size and coloring affect self-reported attention and content recall.
29 CFR 1915.16 - Warning signs and labels.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 29 Labor 7 2012-07-01 2012-07-01 false Warning signs and labels. 1915.16 Section 1915.16 Labor... Other Dangerous Atmospheres in Shipyard Employment § 1915.16 Warning signs and labels. (a) Employee...) Posting of large work areas. A warning sign or label required by paragraph (a) of this section need not be...
29 CFR 1915.16 - Warning signs and labels.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 29 Labor 7 2011-07-01 2011-07-01 false Warning signs and labels. 1915.16 Section 1915.16 Labor... Other Dangerous Atmospheres in Shipyard Employment § 1915.16 Warning signs and labels. (a) Employee...) Posting of large work areas. A warning sign or label required by paragraph (a) of this section need not be...
29 CFR 1915.16 - Warning signs and labels.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 7 2010-07-01 2010-07-01 false Warning signs and labels. 1915.16 Section 1915.16 Labor... Other Dangerous Atmospheres in Shipyard Employment § 1915.16 Warning signs and labels. (a) Employee...) Posting of large work areas. A warning sign or label required by paragraph (a) of this section need not be...
29 CFR 1915.16 - Warning signs and labels.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 29 Labor 7 2014-07-01 2014-07-01 false Warning signs and labels. 1915.16 Section 1915.16 Labor... Other Dangerous Atmospheres in Shipyard Employment § 1915.16 Warning signs and labels. (a) Employee...) Posting of large work areas. A warning sign or label required by paragraph (a) of this section need not be...
29 CFR 1915.16 - Warning signs and labels.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 29 Labor 7 2013-07-01 2013-07-01 false Warning signs and labels. 1915.16 Section 1915.16 Labor... Other Dangerous Atmospheres in Shipyard Employment § 1915.16 Warning signs and labels. (a) Employee...) Posting of large work areas. A warning sign or label required by paragraph (a) of this section need not be...

Do graphic health warning labels have an impact on adolescents' smoking-related beliefs and behaviours?

PubMed

White, Victoria; Webster, Bernice; Wakefield, Melanie

2008-09-01

To assess the impact of the introduction of graphic health warning labels on cigarette packets on adolescents at different smoking uptake stages. School-based surveys conducted in the year prior to (2005) and approximately 6 months after (2006) the introduction of the graphic health warnings. The 2006 survey was conducted after a TV advertising campaign promoting two new health warnings. Secondary schools in greater metropolitan Melbourne, Australia. Students in year levels 8-12: 2432 students in 2005, and 2050 in 2006, participated. Smoking uptake stage, intention to smoke, reported exposure to cigarette packs, knowledge of health effects of smoking, cognitive processing of warning labels and perceptions of cigarette pack image. At baseline, 72% of students had seen cigarette packs in the previous 6 months, while at follow-up 77% had seen packs and 88% of these had seen the new warning labels. Cognitive processing of warning labels increased, with students more frequently reading, attending to, thinking and talking about warning labels at follow-up. Experimental and established smokers thought about quitting and forgoing cigarettes more at follow-up. At follow-up intention to smoke was lower among those students who had talked about the warning labels and had forgone cigarettes. Graphic warning labels on cigarette packs are noticed by the majority of adolescents, increase adolescents' cognitive processing of these messages and have the potential to lower smoking intentions. Our findings suggest that the introduction of graphic warning labels may help to reduce smoking among adolescents.
Graphic warning labels on plain cigarette packs: will they make a difference to adolescents?

PubMed

McCool, Judith; Webb, Lisa; Cameron, Linda D; Hoek, Janet

2012-04-01

Graphic warning labels and plain cigarette packaging are two initiatives developed to increase quit behaviour among smokers. Although a little is known about how adolescents interpret graphic warning labels, very few studies have examined how plain cigarette packaging would affect adolescents' perceptions of cigarette smoking and smoking behaviour. We explored how teens interpret and respond to graphic warning labels and the plain packaging of cigarettes, to assess the potential these strategies may offer in deterring smoking initiation. Twelve focus group interviews with a sample of 80 14-16 year old students from a diverse range of schools in Auckland, New Zealand were undertaken between June and August 2009. Textual analysis revealed that graphic warning labels may influence adolescents by reiterating a negative image of smokers. Graphic warning on a plain cigarette pack increased the attention paid to graphic warning labels and the overall perceptions of harm caused by cigarette smoking, and reduced the social appeal of cigarette smoking. This research offers evidence on how adolescents are appraising and interpreting graphic warning labels, and explores how dominant appraisals may affect the role graphic warning labels play in preventing smoking. Not only would plain cigarette packaging enhance the salience and impact of graphic warning labels, but it would potentially bolster the overall message that cigarette smoking is harmful. In the context of a comprehensive tobacco control programme, graphic warning labels on plain cigarette packaging present an explicit message about the risks (to health and image) associated with cigarette smoking. Copyright © 2012 Elsevier Ltd. All rights reserved.
Cigarette Warning Label Policy Alternatives and Smoking-Related Health Disparities

PubMed Central

Thrasher, James F.; Carpenter, Matthew J.; Andrews, Jeannette O.; Gray, Kevin M.; Alberg, Anthony J.; Navarro, Ashley; Friedman, Daniela B.; Cummings, K. Michael

2012-01-01

Background Pictorial health warning labels on cigarette packaging have been proposed for the U.S., but their potential influences among populations that suffer tobacco-related health disparities are unknown. Purpose To evaluate pictorial health warning labels, including moderation of their influences by health literacy and race. Methods From July 2011 to January 2012, field experiments were conducted with 981 adult smokers who were randomized to control (i.e., text-only labels, n=207) and experimental conditions (i.e., pictorial labels, n=774). The experimental condition systematically varied health warning label stimuli by health topic and image type. Linear mixed effects (LME) models estimated the influence of health warning label characteristics and participant characteristics on label ratings. Data were analyzed from January 2012 to April 2012. Results Compared to text-only warning labels, pictorial warning labels were rated as more personally relevant (5.7 vs 6.8, p<0.001) and effective (5.4 vs 6.8, p<0.001), and as more credible, but only among participants with low health literacy (7.6 vs 8.2, p<0.001). Within the experimental condition, pictorial health warning labels with graphic imagery had significantly higher ratings of credibility, personal relevance, and effectiveness than imagery of human suffering and symbolic imagery. Significant interactions indicated that labels with graphic imagery produced minimal differences in ratings across racial groups and levels of health literacy, whereas other imagery produced greater group differences. Conclusions Pictorial health warning labels with graphic images have the most-pronounced short-term impacts on adult smokers, including smokers from groups that have in the past been hard to reach. PMID:23159254
The Influence of Sugar-Sweetened Beverage Warnings

PubMed Central

VanEpps, Eric M.; Roberto, Christina A.

2017-01-01

Introduction California, New York, and the cities of San Francisco and Baltimore have introduced bills requiring health-related warning labels for sugar-sweetened beverages. This study measures the extent to which these warning labels influence adolescents’ beliefs and hypothetical choices. Design Participants completed an online survey in which they chose a beverage in a hypothetical vending machine task, rated perceptions of different beverages, and indicated interest in coupons for beverages. Data were collected and analyzed in 2015. Setting/participants A total of 2,202 demographically diverse adolescents aged 12–18 years completed the online survey. Intervention Participants were randomly assigned to one of six conditions: (1) no warning label; (2) calorie label; (3–6) one of four text versions of a warning label (e.g., SAFETY WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay). Main outcome measures Hypothetical choices, perceptions of beverages, interest in coupons, and endorsement of warning label policies were assessed. Results Controlling for frequency of beverage purchases, significantly fewer adolescents chose a sugar-sweetened beverage in three of the four warning label conditions (65%, 63%, and 61%) than in the no label (77%) condition. Adolescents in the four warning label conditions chose fewer sugar-sweetened beverage coupons and believed that sugar-sweetened beverages were less likely to help them lead a healthy life and had more added sugar compared with the no label condition. Conclusions Health-related warning labels on sugar-sweetened beverages improved adolescents’ recognition of the sugar content of such beverages and reduced hypothetical choices to buy sugar-sweetened beverages. PMID:27617366
Reactions of Chinese adults to warning labels on cigarette packages: A survey in Jiangsu Province

PubMed Central

2011-01-01

Background To compare reactions to warning labels presented on cigarette packages with a specific focus on whether the new Chinese warning labels are better than the old labels and international labels. Methods Participants aged 18 and over were recruited in two cities of Jiangsu Province in 2008, and 876 face-to-face interviews were completed. Participants were shown six types of warning labels found on cigarette packages. They comprised one old Chinese label, one new label used within the Chinese market, and one Chinese overseas label and three foreign brand labels. Participants were asked about the impact of the warning labels on: their knowledge of harm from smoking, giving cigarettes as a gift, and quitting smoking. Results Compared with the old Chinese label, a higher proportion of participants said the new label provided clear information on harm caused by smoking (31.2% vs 18.3%). Participants were less likely to give cigarettes with the new label on the package compared with the old label (25.2% vs 20.8%). These proportions were higher when compared to the international labels. Overall, 26.8% of participants would quit smoking based on information from the old label and 31.5% from the new label. When comparing the Chinese overseas label and other foreign labels to the new Chinese label with regard to providing knowledge of harm warning, impact of quitting smoking and giving cigarettes as a gift, the overseas labels were more effective. Conclusion Both the old and the new Chinese warning label are not effective in this target population. PMID:21349205
Trends in antidepressant prescribing to children and adolescents in Canadian primary care: A time-series analysis.

PubMed

Morkem, Rachael; Williamson, Tyler; Patten, Scott; Queenan, John A; Wong, Sabrina T; Manca, Donna; Barber, David

2017-09-01

The purpose of this study was to describe the trends and patterns of antidepressant (AD) prescribing to children and adolescents in Canadian primary care before and after the black-box warning in 2004. Prescription data from the Canadian Primary Care Sentinel Surveillance Network, a repository of primary care data on over 1 million patients, was used to analyze AD prescribing to children (8-11 y) and adolescents (12-18 y) between 2000 and 2014. Interrupted time series analyses were used to assess the impact of the 2004 black-box warning on the prescribing levels of ADs. The 2004 black-box warning had a significant and immediate effect on the prescribing of AD. However, this drop was not sustained, and 5 years after the advisory AD prescribing rates reversed direction and started to rise. Selective serotonin reuptake inhibitors dominated as the most common AD prescribed throughout the study period, increasing from 66% prior to the black-box warning to 83.12% after 2009. The black-box warning effectively reduced AD prescribing in primary care for approximately 5 years before a reversal back to a positive rate of prescribing. This rebounding could reflect an emerging consensus about the trade-off in risks and benefits. Copyright © 2017 John Wiley & Sons, Ltd.
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.
Cigarette warning label policy alternatives and smoking-related health disparities.

PubMed

Thrasher, James F; Carpenter, Matthew J; Andrews, Jeannette O; Gray, Kevin M; Alberg, Anthony J; Navarro, Ashley; Friedman, Daniela B; Cummings, K Michael

2012-12-01

Pictorial health warning labels on cigarette packaging have been proposed for the U.S., but their potential influences among populations that suffer tobacco-related health disparities are unknown. To evaluate pictorial health warning labels, including moderation of their influences by health literacy and race. From July 2011 to January 2012, field experiments were conducted with 981 adult smokers who were randomized to control (i.e., text-only labels, n=207) and experimental conditions (i.e., pictorial labels, n=774). The experimental condition systematically varied health warning label stimuli by health topic and image type. Linear mixed effects (LME) models estimated the influence of health warning label characteristics and participant characteristics on label ratings. Data were analyzed from January 2012 to April 2012. Compared to text-only warning labels, pictorial warning labels were rated as more personally relevant (5.7 vs 6.8, p<0.001) and effective (5.4 vs 6.8, p<0.001), and as more credible, but only among participants with low health literacy (7.6 vs 8.2, p<0.001). Within the experimental condition, pictorial health warning labels with graphic imagery had significantly higher ratings of credibility, personal relevance, and effectiveness than imagery of human suffering and symbolic imagery. Significant interactions indicated that labels with graphic imagery produced minimal differences in ratings across racial groups and levels of health literacy, whereas other imagery produced greater group differences. Pictorial health warning labels with graphic images have the most-pronounced short-term impacts on adult smokers, including smokers from groups that have in the past been hard to reach. Copyright © 2012 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.
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.
The Influence of Sugar-Sweetened Beverage Warnings: A Randomized Trial of Adolescents' Choices and Beliefs.

PubMed

VanEpps, Eric M; Roberto, Christina A

2016-11-01

California, New York, and the cities of San Francisco and Baltimore have introduced bills requiring health-related warning labels for sugar-sweetened beverages. This study measures the extent to which these warning labels influence adolescents' beliefs and hypothetical choices. Participants completed an online survey in which they chose a beverage in a hypothetical vending machine task, rated perceptions of different beverages, and indicated interest in coupons for beverages. Data were collected and analyzed in 2015. A total of 2,202 demographically diverse adolescents aged 12-18 years completed the online survey. Participants were randomly assigned to one of six conditions: (1) no warning label; (2) calorie label; (3-6) one of four text versions of a warning label (e.g. Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay). Hypothetical choices, perceptions of beverages, interest in coupons, and endorsement of warning label policies were assessed. Controlling for frequency of beverage purchases, significantly fewer adolescents chose a sugar-sweetened beverage in three of the four warning label conditions (65%, 63%, and 61%) than in the no label (77%) condition. Adolescents in the four warning label conditions chose fewer sugar-sweetened beverage coupons and believed that sugar-sweetened beverages were less likely to help them lead a healthy life and had more added sugar compared with the no label condition. Health-related warning labels on sugar-sweetened beverages improved adolescents' recognition of the sugar content of such beverages and reduced hypothetical choices to buy sugar-sweetened beverages. Published by Elsevier Inc.
Self-reported exposure to tobacco warning labels among U.S. middle and high school students.

PubMed

Johnson, Sarah E; Wu, Charles C; Coleman, Blair N; Choiniere, Conrad J

2014-08-01

Warning labels on tobacco products are a means to communicate information about the negative health effects of tobacco use to current and potential users. Most tobacco use begins in early adolescence, making it particularly important to understand the degree to which warning labels reach adolescents. To examine the extent to which youth report (1) seeing the current warnings on cigarettes and smokeless tobacco (SLT) products in the U.S. and (2) that seeing warnings makes them think about the health risks associated with tobacco use. Exposure to warning labels on cigarettes and SLT, as well as the degree to which adolescents report thinking about health risks in response to warnings, was examined among U.S. middle and high school students using data from the 2012 National Youth Tobacco Survey (NYTS) and analyzed in 2013. Current data suggest that less than half of adolescents who saw a cigarette pack (46.9%) or SLT product (40.3%) reported seeing the warning label "most of the time" or "always." Among adolescents who reported seeing a warning, less than one third reported that cigarette (30.4%) or SLT (25.2%) warning labels made them think about health risks "a lot." These rates were even lower among current tobacco users (<14%). Current warning labels for cigarettes and SLT could be improved by implementing warnings that incorporate features that make them salient and more likely to evoke thoughts about health risks. Published by Elsevier Inc.
Adolescents perceived effectiveness of the proposed European graphic tobacco warning labels.

PubMed

Vardavas, Constantine I; Connolly, Gregory; Karamanolis, Kostas; Kafatos, Anthony

2009-04-01

Graphical tobacco product labelling is a prominent source of health information and has an important position among tobacco control initiatives. However, little is known about its effectiveness among adolescents. With this above in mind, we aimed to research into how adolescents perceive the proposed EU graphic tobacco product warning labels as an effective means of preventing smoking initiation in comparison to the current EU text-only warning labels. Five hundred seventy four adolescents (13-18, 54% male) from Greece were privately interviewed, with the use of a digital questionnaire and randomly shown seven existing EU text-only and proposed EU graphic warning labels. Non-smoking respondents were asked to compare and rate the warnings effectiveness in regard to preventing them from smoking on a 1-5 Likert type scale. Irrespective of the warning category shown, on all occasions, non-smoking adolescents rated the suggested EU graphic labels as more effective in preventing them from smoking in comparison to the existing EU text-only warnings. Controlling for gender, age, current smoking status and number of cigarettes smoked per month, younger adolescents were found to opt for graphic warnings more often, and also perceive graphic warning labels as a more effective means of preventing them from smoking, in comparison to their elder peers (P < 0.001). The proposed EU graphic warning labels may play an important role in preventing of smoking initiation during the crucial years of early adolescence when smoking experimentation and early addiction usually take place.
Disclaimer labels on fashion magazine advertisements: effects on social comparison and body dissatisfaction.

PubMed

Tiggemann, Marika; Slater, Amy; Bury, Belinda; Hawkins, Kimberley; Firth, Bonny

2013-01-01

Recent proposals across a number of Western countries have suggested that idealised media images should carry some sort of disclaimer informing readers when these images have been digitally enhanced. The present studies aimed to experimentally investigate the impact on women's body dissatisfaction of the addition of such warning labels to fashion magazine advertisements. Participants were 120 and 114 female undergraduate students in Experiment 1 and Experiment 2 respectively. In both experiments, participants viewed fashion magazine advertisements with either no warning label, a generic warning label, or a specific more detailed warning label. In neither experiment was there a significant effect of type of label. However, state appearance comparison was found to predict change in body dissatisfaction irrespective of condition. Unexpectedly, trait appearance comparison moderated the effect of label on body dissatisfaction, such that for women high on trait appearance comparison, exposure to specific warning labels actually resulted in increased body dissatisfaction. In sum, the present results showed no benefit of warning labels in ameliorating the known negative effect of viewing thin-ideal media images, and even suggested that one form of warning (specific) might be harmful for some individuals. Accordingly, it was concluded that more extensive research is required to guide the most effective use of disclaimer labels. Copyright © 2012 Elsevier Ltd. All rights reserved.
Alcohol Warning Label Awareness and Attention: A Multi-method Study.

PubMed

Pham, Cuong; Rundle-Thiele, Sharyn; Parkinson, Joy; Li, Shanshi

2018-01-01

Evaluation of alcohol warning labels requires careful consideration ensuring that research captures more than awareness given that labels may not be prominent enough to attract attention. This study investigates attention of current in market alcohol warning labels and examines whether attention can be enhanced through theoretically informed design. Attention scores obtained through self-report methods are compared to objective measures (eye-tracking). A multi-method experimental design was used delivering four conditions, namely control, colour, size and colour and size. The first study (n = 559) involved a self-report survey to measure attention. The second study (n = 87) utilized eye-tracking to measure fixation count and duration and time to first fixation. Analysis of Variance (ANOVA) was utilized. Eye-tracking identified that 60% of participants looked at the current in market alcohol warning label while 81% looked at the optimized design (larger and red). In line with observed attention self-reported attention increased for the optimized design. The current study casts doubt on dominant practices (largely self-report), which have been used to evaluate alcohol warning labels. Awareness cannot be used to assess warning label effectiveness in isolation in cases where attention does not occur 100% of the time. Mixed methods permit objective data collection methodologies to be triangulated with surveys to assess warning label effectiveness. Attention should be incorporated as a measure in warning label effectiveness evaluations. Colour and size changes to the existing Australian warning labels aided by theoretically informed design increased attention. © The Author 2017. Medical Council on Alcohol and Oxford University Press. All rights reserved.
40 CFR 82.112 - Removal of label bearing warning statement.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 18 2014-07-01 2014-07-01 false Removal of label bearing warning... Substances § 82.112 Removal of label bearing warning statement. (a) Prohibition on removal. Except as described in paragraph (b) or (c) of this section, any warning statement that accompanies a product or...
40 CFR 82.112 - Removal of label bearing warning statement.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 17 2011-07-01 2011-07-01 false Removal of label bearing warning... Substances § 82.112 Removal of label bearing warning statement. (a) Prohibition on removal. Except as described in paragraph (b) or (c) of this section, any warning statement that accompanies a product or...
Impact of Tobacco-Related Health Warning Labels across Socioeconomic, Race and Ethnic Groups: Results from a Randomized Web-Based Experiment

PubMed Central

Cantrell, Jennifer; Vallone, Donna M.; Thrasher, James F.; Nagler, Rebekah H.; Feirman, Shari P.; Muenz, Larry R.; He, David Y.; Viswanath, Kasisomayajula

2013-01-01

Background The U.S. Family Smoking Prevention and Tobacco Control Act of 2009 requires updating of the existing text-only health warning labels on tobacco packaging with nine new warning statements accompanied by pictorial images. Survey and experimental research in the U.S. and other countries supports the effectiveness of pictorial health warning labels compared with text-only warnings for informing smokers about the risks of smoking and encouraging cessation. Yet very little research has examined differences in reactions to warning labels by race/ethnicity, education or income despite evidence that population subgroups may differ in their ability to process health information. The purpose of the present study was to evaluate the potential impact of pictorial warning labels compared with text-only labels among U.S. adult smokers from diverse racial/ethnic and socioeconomic subgroups. Methods/Findings Participants were adult smokers recruited from two online research panels (n = 3,371) into a web-based experimental study to view either the new pictorial warnings or text-only warnings. Participants viewed the labels and reported their reactions. Adjusted regression models demonstrated significantly stronger reactions for the pictorial condition for each outcome salience (b = 0.62, p<.001); perceived impact (b = 0.44, p<.001); credibility (OR = 1.41, 95% CI = 1.22−1.62), and intention to quit (OR = 1.30, 95% CI = 1.10−1.53). No significant results were found for interactions between condition and race/ethnicity, education, or income. The only exception concerned the intention to quit outcome, where the condition-by-education interaction was nearly significant (p = 0.057). Conclusions Findings suggest that the greater impact of the pictorial warning label compared to the text-only warning is consistent across diverse racial/ethnic and socioeconomic populations. Given their great reach, pictorial health warning labels may be one of the few tobacco control policies that have the potential to reduce communication inequalities across groups. Policies that establish strong pictorial warning labels on tobacco packaging may be instrumental in reducing the toll of the tobacco epidemic, particularly within vulnerable communities. PMID:23341895
Health warning labels for alcoholic beverages in Canada.

PubMed

Smart, R G

1990-01-01

This paper reviews the background and rationale for health warning labels for alcoholic beverages. They have been recently approved for the United States. Mexico and Colombia already have such labels. However, Canadian health officials seem reluctant to require them unless the alcohol industry agrees. Arguments against labels (i.e. that they detract from other efforts, are misguided or ineffective) are not convincing. Evidence from research on health warnings on cigarettes and prescription and non-prescription drugs shows that labels can be effective if well designed. Special problems in having bilingual labels may exist but could be overcome. Canada should have health warning labels on alcoholic beverages as soon as possible.
ASW Reach-Back Cell Oceanography Analysis System (ARCOAS) Version 3 User’s Guide

DTIC Science & Technology

2012-02-24

65 Table of Figures Figure 2.1: Warning dialog box indicating ActiveX ...Click OK in response to the message box indicating that ActiveX controls are being used by the application (Figure 2.1). Figure 2.1: Warning...dialog box indicating ActiveX controls could be unsafe. 3. Open an existing map or create a new empty map. 4. Start ARCOAS by clicking the ARCOAS
Educational differences in the impact of pictorial cigarette warning labels on smokers: findings from the International Tobacco Control (ITC) Europe surveys.

PubMed

Nagelhout, Gera E; Willemsen, Marc C; de Vries, Hein; Mons, Ute; Hitchman, Sara C; Kunst, Anton E; Guignard, Romain; Siahpush, Mohammad; Yong, Hua-Hie; van den Putte, Bas; Fong, Geoffrey T; Thrasher, James F

2016-05-01

To examine (1) the impact of pictorial cigarette warning labels on changes in self-reported warning label responses: warning salience, cognitive responses, forgoing cigarettes and avoiding warnings, and (2) whether these changes differed by smokers' educational level. Longitudinal data of smokers from two survey waves of the International Tobacco Control (ITC) Europe Surveys were used. In France and the UK, pictorial warning labels were implemented on the back of cigarette packages between the two survey waves. In Germany and the Netherlands, the text warning labels did not change. Warning salience decreased between the surveys in France (OR=0.81, p=0.046) and showed a non-significant increase in the UK (OR=1.30, p=0.058), cognitive responses increased in the UK (OR=1.34, p<0.001) and decreased in France (OR=0.70, p=0.002), forgoing cigarettes increased in the UK (OR=1.65, p<0.001) and decreased in France (OR=0.83, p=0.047), and avoiding warnings increased in France (OR=2.93, p<0.001) and the UK (OR=2.19, p<0.001). Warning salience and cognitive responses decreased in Germany and the Netherlands, forgoing did not change in these countries and avoidance increased in Germany. In general, these changes in warning label responses did not differ by education. However, in the UK, avoidance increased especially among low (OR=2.25, p=0.001) and moderate educated smokers (OR=3.21, p<0.001). The warning labels implemented in France in 2010 and in the UK in 2008 with pictures on one side of the cigarette package did not succeed in increasing warning salience, but did increase avoidance. The labels did not increase educational inequalities among continuing 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/

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.
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.
The evolution of health warning labels on cigarette packs: the role of precedents, and tobacco industry strategies to block diffusion

PubMed Central

Hiilamo, Heikki; Crosbie, Eric; Glantz, Stanton A

2013-01-01

Objective To analyse the evolution and diffusion of health warnings on cigarette packs around the world, including tobacco industry attempts to block this diffusion. Methods We analysed tobacco industry documents and public sources to construct a database on the global evolution and diffusion of health warning labels from 1966 to 2012, and also analysed industry strategies. Results Health warning labels, especially labels with graphic elements, threaten the tobacco industry because they are a low-cost, effective measure to reduce smoking. Multinational tobacco companies did not object to voluntary innocuous warnings with ambiguous health messages, in part because they saw them as offering protection from lawsuits and local packaging regulations. The companies worked systematically at the international level to block or weaken warnings once stronger more specific warnings began to appear in the 1970s. Since 1985 in Iceland, the tobacco industry has been aware of the effectiveness of graphic health warning labels (GWHL). The industry launched an all-out attack in the early 1990s to prevent GHWLs, and was successful in delaying GHWLs internationally for nearly 10 years. Conclusions Beginning in 2005, as a result of the World Health Organisation Framework Convention on Tobacco Control (FCTC), GHWLs began to spread. Effective implementation of FCTC labelling provisions has stimulated diffusion of strong health warning labels despite industry opposition. PMID:23092884
The evolution of health warning labels on cigarette packs: the role of precedents, and tobacco industry strategies to block diffusion.

PubMed

Hiilamo, Heikki; Crosbie, Eric; Glantz, Stanton A

2014-01-01

To analyse the evolution and diffusion of health warnings on cigarette packs around the world, including tobacco industry attempts to block this diffusion. We analysed tobacco industry documents and public sources to construct a database on the global evolution and diffusion of health warning labels from 1966 to 2012, and also analysed industry strategies. Health warning labels, especially labels with graphic elements, threaten the tobacco industry because they are a low-cost, effective measure to reduce smoking. Multinational tobacco companies did not object to voluntary innocuous warnings with ambiguous health messages, in part because they saw them as offering protection from lawsuits and local packaging regulations. The companies worked systematically at the international level to block or weaken warnings once stronger more specific warnings began to appear in the 1970s. Since 1985 in Iceland, the tobacco industry has been aware of the effectiveness of graphic health warning labels (GWHL). The industry launched an all-out attack in the early 1990s to prevent GHWLs, and was successful in delaying GHWLs internationally for nearly 10 years. Beginning in 2005, as a result of the World Health Organisation Framework Convention on Tobacco Control (FCTC), GHWLs began to spread. Effective implementation of FCTC labelling provisions has stimulated diffusion of strong health warning labels despite industry opposition.
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
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.
Short and Sweet: The Persuasive Effects of Message Framing and Temporal Context in Antismoking Warning Labels.

PubMed

Mollen, Saar; Engelen, Susanne; Kessels, Loes T E; van den Putte, Bas

2017-01-01

Current warning labels on cigarette packages are generally focused on long-term losses that can be incurred if one continues smoking. This study compares the effects of these labels against warning labels that stress short-term losses of smoking as well as labels that stress short- and long-term benefits that can be obtained when one quits smoking. A 2 (message frame: gain vs. loss) × 2 (temporal context: short vs. long term) between-subjects experiment was conducted among 132 smokers, with attitude toward quitting smoking and intention to quit smoking, as well as information-seeking behavior and message recall, as the dependent variables. Findings were in line with theory regarding message framing and temporal discounting, showing enhanced effects of gain over loss frames and short-term over long-term consequences on warning labels for attitudes and intentions. In addition, an interaction between message frame and temporal context was found. Especially, gain-framed messages showed stronger effects on intentions to quit smoking than loss-framed messages when warning labels concerned short-term outcomes. Findings suggest that current warning labels, with an emphasis on long-term negative health outcomes, should be reconsidered.
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
Israeli Arab and Jewish youth knowledge and opinion about alcohol warning labels: pre-intervention data.

PubMed

Weiss, S

1997-01-01

This article presents baseline data on the opinion toward alcohol beverage warning labels and on levels of knowledge of the risks discussed in the contents of the labels prior to the labels' introduction, and on levels of knowledge of additional alcohol-related hazards not included in the proposed warning labels, among a sample of 3065 adolescents of four religions living in the northern region of Israel. About 2220 Arab participants (Moslems, Christians and Druze) and 845 Jewish respondents answered in the winter of 1996 a Hebrew version of an American questionnaire, which had been used to measure levels of knowledge of the label in the United States. More respondents were in favour of warning labels on alcohol containers than on advertisements. Arabs as a group were more in favour of warning labels on alcohol containers than Jews. The initial knowledge levels among the participants were not very high, especially concerning the item 'Drinking impairs the ability to operate machinery' (74.4%) which is included on the proposed warning label, and concerning two hazards which are not included: 'Drinking increases risk of cancer' (54.6%) and 'Drinking increases risk of high blood pressure' (60.4%). Abstainers knew more than drinkers that 'Pregnant women should not drink', 'Drinking increases risk of cancer' and 'Alcohol in combination with other drugs is hazardous'. Implications for public health are discussed and alternative warning messages that might be used to inform the Israeli public of several less well-known hazards are suggested.
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
Simulating the Impact of Sugar-Sweetened Beverage Warning Labels in Three Cities.

PubMed

Lee, Bruce Y; Ferguson, Marie C; Hertenstein, Daniel L; Adam, Atif; Zenkov, Eli; Wang, Peggy I; Wong, Michelle S; Gittelsohn, Joel; Mui, Yeeli; Brown, Shawn T

2018-02-01

A number of locations have been considering sugar-sweetened beverage point-of-purchase warning label policies to help address rising adolescent overweight and obesity prevalence. To explore the impact of such policies, in 2016 detailed agent-based models of Baltimore, Philadelphia, and San Francisco were developed, representing their populations, school locations, and food sources, using data from various sources collected between 2005 and 2014. The model simulated, over a 7-year period, the mean change in BMI and obesity prevalence in each of the cities from sugar-sweetened beverage warning label policies. Data analysis conducted between 2016 and 2017 found that implementing sugar-sweetened beverage warning labels at all sugar-sweetened beverage retailers lowered obesity prevalence among adolescents in all three cities. Point-of-purchase labels with 8% efficacy (i.e., labels reducing probability of sugar-sweetened beverage consumption by 8%) resulted in the following percentage changes in obesity prevalence: Baltimore: -1.69% (95% CI= -2.75%, -0.97%, p<0.001); San Francisco: -4.08% (95% CI= -5.96%, -2.2%, p<0.001); Philadelphia: -2.17% (95% CI= -3.07%, -1.42%, p<0.001). Agent-based simulations showed how warning labels may decrease overweight and obesity prevalence in a variety of circumstances with label efficacy and literacy rate identified as potential drivers. Implementing a warning label policy may lead to a reduction in obesity prevalence. Focusing on warning label design and store compliance, especially at supermarkets, may further increase the health impact. Copyright © 2018 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.
Effectiveness of FDA's new over-the-counter acetaminophen warning label in improving consumer risk perception of liver damage.

PubMed

Goyal, R K; Rajan, S S; Essien, E J; Sansgiry, S S

2012-12-01

The Food and Drug Administration (FDA) issued new organ-specific warning label requirements for over-the-counter (OTC) analgesic products in order to make consumers aware of the risk of liver damage when using acetaminophen. However, awareness of a health risk alone cannot ensure consumers' engagement in safe and preventive behaviour. In this study, we attempted to: (i) measure consumer risk perception of liver damage due to the OTC acetaminophen products and (ii) analyse the effectiveness of the new organ-specific warning label in improving consumer risk perception of liver damage and intention to perform protective behaviours while using OTC acetaminophen products. This within-subject experimental study used a convenience sample of English-speaking adults visiting OTC segments of selected pharmacy stores in Houston. Participants were randomly exposed to the old and new warning labels and their respective risk perception (measured on a visual analogue scale, 0%, no risk, to 100%, extreme risk) and behavioural intention (measured on a 7-point Likert scale) were recorded using a validated, self-administered questionnaire. Descriptive statistics and non-parametric Wilcoxon signed-rank tests were performed using sas statistical software (v 9.2) at a priori significance level of 0.05. Majority of participants (74.4%) were not aware of the new warnings; however, majority (67.8%) had prior knowledge of the risk. The mean risk perception score for the new warning label was found to be significantly higher (72.2% vs. 65.9%, P < 0.0001) than the old warning label. Similarly, the average intention score for the new warning label was significantly higher (5.06 vs. 4.86, P < 0.0001) than the old warning label. The new warning label mandated by FDA is effective in improving consumer risk perception of potential liver damage and may encourage protective behaviour. However, future studies are essential to assess the impact of the new label on actual changes in consumer behaviour and subsequent reduction in acetaminophen-related morbidity and mortality. © 2012 Blackwell Publishing Ltd.
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.
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.
Impact of anti-tobacco warning labels on behaviour of tobacco users in one of the cities of Gujarat, India.

PubMed

Shah, V R; Dave, V R; Sonaliya, K N

2013-06-01

Tobacco use continues to be the leading global cause of preventable deaths, killing nearly 6 million people worldwide each year. Tobacco control must be given the high priority by scaling up tobacco control measures. In India under Control of Tobacco Product Act, it is mandatory to keep the warning labels over all kind of tobacco products in order to minimise the use of tobacco. Review of the knowledge regarding warning labels printed on tobacco products among its users and to evaluate the impact of them on addicting behaviour. A Cross Sectional study was carried out among the group of people using tobacco in any form. Total 776 tobacco users were enrolled in the study. Mean age of tobacco user was 41.4 years. Out of total 776 tobacco users, 561 (72.3%) had ever noticed warning signals over the tobacco products. Among those who have noticed warning labels, 64.4 % became aware about health effects and 66% have thought to quit tobacco. Tobacco users of young age group (15-45) were more aware regarding warning labels. Females were less aware. As level of education increases number of tobacco users who tried to quit or reduced the daily quantity of tobacco intake were also increases. Positive impact of warning labels has been seen among the tobacco users who have noticed them. Not all the tobacco users were aware regarding the presence of warning labels as per the findings of present study.
10 CFR 850.38 - Warning signs and labels.

Code of Federal Regulations, 2010 CFR

2010-01-01

... CANCER HAZARD AUTHORIZED PERSONNEL ONLY (b) Warning labels. (1) The responsible employer must affix... CONTAMINATED WITH BERYLLIUM DO NOT REMOVE DUST BY BLOWING OR SHAKING CANCER AND LUNG DISEASE HAZARD (c) Warning...
10 CFR 850.38 - Warning signs and labels.

Code of Federal Regulations, 2011 CFR

2011-01-01

... CANCER HAZARD AUTHORIZED PERSONNEL ONLY (b) Warning labels. (1) The responsible employer must affix... CONTAMINATED WITH BERYLLIUM DO NOT REMOVE DUST BY BLOWING OR SHAKING CANCER AND LUNG DISEASE HAZARD (c) Warning...
10 CFR 850.38 - Warning signs and labels.

Code of Federal Regulations, 2012 CFR

2012-01-01

... CANCER HAZARD AUTHORIZED PERSONNEL ONLY (b) Warning labels. (1) The responsible employer must affix... CONTAMINATED WITH BERYLLIUM DO NOT REMOVE DUST BY BLOWING OR SHAKING CANCER AND LUNG DISEASE HAZARD (c) Warning...
10 CFR 850.38 - Warning signs and labels.

Code of Federal Regulations, 2013 CFR

2013-01-01

... CANCER HAZARD AUTHORIZED PERSONNEL ONLY (b) Warning labels. (1) The responsible employer must affix... CONTAMINATED WITH BERYLLIUM DO NOT REMOVE DUST BY BLOWING OR SHAKING CANCER AND LUNG DISEASE HAZARD (c) Warning...
10 CFR 850.38 - Warning signs and labels.

Code of Federal Regulations, 2014 CFR

2014-01-01

... CANCER HAZARD AUTHORIZED PERSONNEL ONLY (b) Warning labels. (1) The responsible employer must affix... CONTAMINATED WITH BERYLLIUM DO NOT REMOVE DUST BY BLOWING OR SHAKING CANCER AND LUNG DISEASE HAZARD (c) Warning...

The impact and acceptability of Canadian-style cigarette warning labels among U.S. smokers and nonsmokers.

PubMed

Peters, Ellen; Romer, Daniel; Slovic, Paul; Jamieson, Kathleen Hall; Wharfield, Leisha; Mertz, C K; Carpenter, Stephanie M

2007-04-01

Cigarette smoking is a major source of mortality and medical costs in the United States. More graphic and salient warning labels on cigarette packs as used in Canada may help to reduce smoking initiation and increase quit attempts. However, the labels also may lead to defensive reactions among smokers. In an experimental setting, smokers and nonsmokers were exposed to Canadian or U.S. warning labels. Compared with current U.S. labels, Canadian labels produced more negative affective reactions to smoking cues and to the smoker image among both smokers and nonsmokers without signs of defensive reactions from smokers. A majority of both smokers and nonsmokers endorsed the use of Canadian labels in the United States. Canadian-style warnings should be adopted in the United States as part of the country's overall tobacco control strategy.
Comparison of Brief Summary Formats Through a Health Literacy Lens.

PubMed

Sharp, Michele L; Hall, Lori; Eleftherion, Anthony; Simpson, Katherine; Neuhauser, Linda

2018-01-01

Print pharmaceutical advertisements in the United States require inclusion of a brief summary of side effects, warnings, precautions, and contraindications from the labeling. The full package insert, which sponsors have traditionally used to fulfill the brief summary requirement, does not adhere to health literacy best practices, limiting its value to consumers. This study compared the understandability and usability of brief summaries in 3 formats designed to be more consumer friendly. Three brief summary formats were tested: (1) 2-column "Question and Answer"; (2) "Prescription Drug Facts Box," similar to current US over-the-counter drug facts labeling; and (3) "Health Literacy," based on clear communication principles. Researchers evaluated the formats using the Suitability Assessment of Materials (SAM) tool and conducted structured, scripted, one-on-one interviews (usability tests) with participants with estimated low to average education levels. This research was replicated across 2 therapeutic areas (type 2 diabetes and plaque psoriasis). SAM scores showed that the Health Literacy format outperformed the Question and Answer format and the Prescription Drug Facts Box format in both therapeutic areas, with both Health Literacy brief summaries rated on the SAM as "superior." Qualitative usability tests supported the SAM findings, with the Health Literacy format preferred consistently over the Question and Answer format, and more often than not over the Prescription Drug Facts Box format. Sponsors can employ a user-tested Health Literacy format to improve the understandability and usability of brief summaries with patients.
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.
Public attitudes toward larger cigarette pack warnings: Results from a nationally representative U.S. sample

PubMed Central

2017-01-01

A large body of evidence supports the effectiveness of larger health warnings on cigarette packages. However, there is limited research examining attitudes toward such warning labels, which has potential implications for implementation of larger warning labels. The purpose of the current study was to examine attitudes toward larger warning sizes on cigarette packages and examine variables associated with more favorable attitudes. In a nationally representative survey of U.S. adults (N = 5,014), participants were randomized to different warning size conditions, assessing attitude toward “a health warning that covered (25, 50, 75) % of a cigarette pack.” SAS logistic regression survey procedures were used to account for the complex survey design and sampling weights. Across experimental groups, nearly three-quarters (72%) of adults had attitudes supportive of larger warning labels on cigarette packs. Among the full sample and smokers only (N = 1,511), most adults had favorable attitudes toward labels that covered 25% (78.2% and 75.2%, respectively), 50% (70% and 58.4%, respectively), and 75% (67.9% and 61%, respectively) of a cigarette pack. Young adults, females, racial/ethnic minorities, and non-smokers were more likely to have favorable attitudes toward larger warning sizes. Among smokers only, females and those with higher quit intentions held more favorable attitudes toward larger warning sizes. Widespread support exists for larger warning labels on cigarette packages among U.S. adults, including among smokers. Our findings support the implementation of larger health warnings on cigarette packs in the U.S. as required by the 2009 Tobacco Control Act. PMID:28253257
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.
The Association between Warning Label Requirements and Cigarette Smoking Prevalence by Education-Findings from the Global Adult Tobacco Survey (GATS).

PubMed

Shang, Ce; Huang, Jidong; Cheng, Kai-Wen; He, Yanyun; Chaloupka, Frank J

2017-01-21

The Guidelines for the implementation of Article 11 of the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) require that cigarette health warning labels should include pictures and take up 50% or more of the principal display area. This study examined how the association between large pictorial warnings, those covering ≥50% of the front and back of the package, and the prevalence of cigarette smoking varies by educational attainment. We pooled individual-level tobacco use data from the Global Adult Tobacco Survey (GATS) in 18 countries between 2008 and 2013 and linked them with warning label requirements during the same period from the MPOWER database and reports regarding warnings. The respondents' self-reported exposure to warnings was examined according to education. Logistic regressions were further employed to analyze education-specific associations between large pictorial warnings and smoking prevalence, and whether such association differed by education was examined using an interaction test. At the time of the survey, eight out of 18 countries had imposed graphic warning labels that covered ≥50% of the package. These warnings were associated with a 10.0% (OR = 0.89; 95% CI: 0.81, 0.97; p ≤ 0.01) lower cigarette smoking prevalence among adults with less than a secondary education or no formal education, but not among respondents with at least a secondary education. Less educated respondents were also less likely to be exposed to warnings in all 18 countries. The association between strong warnings and lower smoking prevalence among less educated respondents could be greater if their exposure to warnings increases. Prominent pictorial warning labels can potentially reduce health disparities resulting from smoking across different education levels.
The Association between Warning Label Requirements and Cigarette Smoking Prevalence by Education-Findings from the Global Adult Tobacco Survey (GATS)

PubMed Central

Shang, Ce; Huang, Jidong; Cheng, Kai-Wen; He, Yanyun; Chaloupka, Frank J.

2017-01-01

Introduction: The Guidelines for the implementation of Article 11 of the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) require that cigarette health warning labels should include pictures and take up 50% or more of the principal display area. This study examined how the association between large pictorial warnings, those covering ≥50% of the front and back of the package, and the prevalence of cigarette smoking varies by educational attainment. Methods: We pooled individual-level tobacco use data from the Global Adult Tobacco Survey (GATS) in 18 countries between 2008 and 2013 and linked them with warning label requirements during the same period from the MPOWER database and reports regarding warnings. The respondents’ self-reported exposure to warnings was examined according to education. Logistic regressions were further employed to analyze education-specific associations between large pictorial warnings and smoking prevalence, and whether such association differed by education was examined using an interaction test. Results: At the time of the survey, eight out of 18 countries had imposed graphic warning labels that covered ≥50% of the package. These warnings were associated with a 10.0% (OR = 0.89; 95% CI: 0.81, 0.97; p ≤ 0.01) lower cigarette smoking prevalence among adults with less than a secondary education or no formal education, but not among respondents with at least a secondary education. Less educated respondents were also less likely to be exposed to warnings in all 18 countries. The association between strong warnings and lower smoking prevalence among less educated respondents could be greater if their exposure to warnings increases. Conclusions: Prominent pictorial warning labels can potentially reduce health disparities resulting from smoking across different education levels. PMID:28117729
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.
Disparagement of Health Warning Labels on Cigarette Packages and Cessation Attempts: Results from Four Countries

ERIC Educational Resources Information Center

Osman, Amira; Thrasher, James F.; Yong, Hua-Hie; Arillo-Santillán, Edna; Hammond, David

2017-01-01

Health warning labels (HWLs) on cigarette packs that use strong fear appeals may evoke defensive responses including acts of disparaging the warnings. Whether warning disparagement undermines HWL effectiveness remains unclear. We assessed correlates of one type of HWL disparagement and its association with subsequent cessation attempts.…
Effectiveness of text versus pictorial health warning labels and predictors of support for plain packaging of tobacco products within the European Union.

PubMed

Agaku, Israel T; Filippidis, Filippos T; Vardavas, Constantine I

2015-01-01

Tobacco product warning labels are a key health communication medium with plain packaging noted as the next step in the evolution of tobacco packaging. We assessed the self-reported impact of text versus pictorial health warnings and the determinants of support for plain packaging of tobacco products in the European Union (EU). The Special Eurobarometer 385 survey was analyzed for 26,566 adults from 27 EU countries in 2012. The self-reported impact of warning labels (text or pictorial) and determinants of EU-wide support for plain packaging were assessed using multivariate logistic regression. Current smokers in countries where cigarette pictorial warnings were implemented had higher odds of reporting that health warning labels had any effect on their smoking behavior (making a quit attempt or reducing number of cigarettes smoked per day) compared to respondents in countries with text-only warning labels (adjusted odds ratio, aOR = 1.31; 95% confidence interval, 95% CI: 1.10-1.56). Population support for plain packaging of tobacco packs was higher in countries where cigarette pictorial warnings already existed (aOR = 1.17; 95% CI: 1.07-1.28). These findings indicate that the implementation of pictorial warnings at an EU level may have a positive behavioral impact among smokers and pave the way for population support for plain packaging in the EU.
Impact of the graphic Canadian warning labels on adult smoking behaviour.

PubMed

Hammond, D; Fong, G T; McDonald, P W; Cameron, R; Brown, K S

2003-12-01

To assess the impact of graphic Canadian cigarette warning labels on current adult smokers. A random-digit-dial telephone survey was conducted with 616 adult smokers in south western Ontario, Canada in October/November 2001, with three month follow up. Smoking behaviour (quitting, quit attempts, and reduced smoking), intentions to quit, and salience of the warning labels. Virtually all smokers (91%) reported having read the warning labels and smokers demonstrated a thorough knowledge of their content. A strong positive relation was observed between a measure of cognitive processing-the extent to which smokers reported reading, thinking about, and discussing the new labels-and smokers' intentions to quit (odds ratio (OR) 1.11, 95% confidence interval (CI) 1.07 to 1.16; p < 0.001). Most important, cognitive processing predicted cessation behaviour at follow up. Smokers who had read, thought about, and discussed the new labels at baseline were more likely to have quit, made a quit attempt, or reduced their smoking three months later, after adjusting for intentions to quit and smoking status at baseline (OR 1.07, 95% CI 1.03 to 1.12; p < 0.001). Graphic cigarette warning labels serve as an effective population based smoking cessation intervention. The findings add to the growing literature on health warnings and provide strong support for the effectiveness of Canada's tobacco labelling policy.
The Age-related Positivity Effect and Tobacco Warning Labels

PubMed Central

Roberts, Megan E.; Peters, Ellen; Ferketich, Amy K.; Klein, Elizabeth G.

2016-01-01

Objectives This study tested whether age is a factor in viewing time for tobacco warning labels. The approach drew from previous work demonstrating an age-related positivity effect, whereby older adults show preferences toward positive and away from negative stimuli. Methods Participants were 295 daily smokers from Appalachian Ohio (age range: 21–68). All participants took part in an eye-tracking paradigm that captured the attention paid to elements of health warning labels in the context of magazine advertisements. Participants also reported on their past cessation attempts and their beliefs about the dangers of smoking. Results Consistent with theory on age-related positivity, older age predicted weaker beliefs about smoking risks, but only among those with no past-year quit attempts. In support of our primary hypothesis, older age was also related to a lower percentage of time spent viewing tobacco warning labels, both overall (text + image) and for the graphic image alone. These associations remained after controlling for cigarettes smoked per day. Conclusions Overall, findings suggest that age is an important consideration for the design of future graphic warning labels and other tobacco risk communications. For older adults, warning labels may need to be tailored to overcome the age-related positivity effect. PMID:27617273
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.
Examining Interpretations of Graphic Cigarette Warning Labels Among U.S. Youth and Adults.

PubMed

McQueen, Amy; Waters, Erika A; Kaphingst, Kimberly A; Caburnay, Charlene A; Sanders Thompson, Vetta L; Boyum, Sonia; Kreuter, Matthew W

2016-08-01

Few studies have examined how diverse populations interpret warning labels. This study examined interpretations of 9 graphic cigarette warning labels (image plus text) proposed by the U.S. Food and Drug Administration among a convenience sample of youth (ages 13-17) and adults (18+) across the United States. Participants (N = 1,571) completed a cross-sectional survey. Participants were asked to select 1 of 3 plausible interpretations (1 preferred vs. 2 alternative) created by the research team about the particular consequence of smoking addressed in each warning label. Participants also rated each label for novelty, counterarguing, perceived effectiveness, and harm. Smokers reported their thoughts of quitting, self-efficacy, and motivation to quit. Although at least 70% of the sample chose the preferred interpretation for 7 of 9 labels, only 13% of participants chose all 9 preferred interpretations. The odds of selecting the preferred interpretation were lower among African Americans, among those with less education, and for labels perceived as being more novel. Smokers reported greater counterarguing and less perceived effectiveness and harms than nonsmokers, but results were not consistent across all labels and interpretations. The alternative interpretations of cigarette warning labels were associated with lower perceived effectiveness and lower perceived harms of smoking, both of which are important for motivating quit attempts.
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.
Graphic Canadian Cigarette Warning Labels and Adverse Outcomes: Evidence from Canadian Smokers

PubMed Central

Hammond, David; Fong, Geoffrey T.; McDonald, Paul W.; Brown, K. Stephen; Cameron, Roy

2004-01-01

Objectives. We assessed the impact of graphic Canadian cigarette warning labels. Methods. We used a longitudinal telephone survey of 616 adult smokers. Results. Approximately one fifth of participants reported smoking less as a result of the labels; only 1% reported smoking more. Although participants reported negative emotional responses to the warnings including fear (44%) and disgust (58%), smokers who reported greater negative emotion were more likely to have quit, attempted to quit, or reduced their smoking 3 months later. Participants who attempted to avoid the warnings (30%) were no less likely to think about the warnings or engage in cessation behavior at follow-up. Conclusions. Policymakers should not be reluctant to introduce vivid or graphic warnings for fear of adverse outcomes. PMID:15284057
Cosmetic Foot Surgery: Fashion's Pandora's Box

MedlinePlus

... Fashion’s Pandora’s Box? A A A | Print | Share Cosmetic Foot Surgery: Fashion’s Pandora’s Box? Foot and ankle surgeons warn ... extreme and imprudent as it may sound, the cosmetic surgery craze is not just for faces anymore—it ...
Impact of front-of-pack nutrition information and label design on children's choice of two snack foods: Comparison of warnings and the traffic-light system.

PubMed

Arrúa, Alejandra; Curutchet, María Rosa; Rey, Natalia; Barreto, Patricia; Golovchenko, Nadya; Sellanes, Andrea; Velazco, Guillermo; Winokur, Medy; Giménez, Ana; Ares, Gastón

2017-09-01

Research on the relative influence of package features on children's perception of food products is still necessary to aid policy design and development. The aim of the present work was to evaluate the relative influence of two front-of-pack (FOP) nutrition labelling schemes, the traffic light system and Chilean warning system, and label design on children's choice of two popular snack foods in Uruguay, wafer cookies and orange juice. A total of 442 children in grades 4 to 6 from 12 primary schools in Montevideo (Uruguay) participated in the study. They were asked to complete a choice-conjoint task with wafer cookies and orange juice labels, varying in label design and the inclusion of FOP nutrition information. Half of the children completed the task with labels featuring the traffic-light system (n = 217) and the other half with labels featuring the Chilean warning system (n = 225). Children's choices of wafer cookies and juice labels was significantly influenced by both label design and FOP nutritional labels. The relative impact of FOP nutritional labelling on children's choices was higher for the warning system compared to the traffic-light system. Results from the present work stress the need to regulate the design of packages and the inclusion of nutrient claims, and provide preliminary evidence of the potential of warnings to discourage children's choice of unhealthful products. Copyright © 2017 Elsevier Ltd. 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
Implicit associations and compensatory health beliefs in smokers: exploring their role for behaviour and their change through warning labels.

PubMed

Glock, Sabine; Müller, Barbara C N; Krolak-Schwerdt, Sabine

2013-11-01

Smokers might think that the negative effects of smoking can be compensated for by other behaviours, such as doing exercise or eating healthily. This phenomenon is known as compensatory health beliefs (CHBs). Graphic warning labels on cigarette packets emphasize the negative effects of smoking, which may impact CHBs. Research so far has assessed CHBs explicitly only via questionnaires, although implicit cognition might be an important factor in continuing to smoke. This study investigated the impact of graphic warning labels on CHBs, by testing CHBs both implicitly and explicitly. The study had a three-group experimental design. ANOVAs and multiple regression analyses were run on the results. We assessed explicit CHBs among non-smokers, smokers, and smokers confronted with graphic warning labels (N = 107; 47 females, 23.89 years old, 78 daily smokers). Implicit associations between smoking and CHB-specific behaviours (e.g., eating healthy food) were measured using a Single-Target Implicit Association Test. After the experiment, participants were able to choose between a healthy and unhealthy food reward. Non-smokers and smokers differed in explicit CHBs but not in implicit cognitions. Warning labels influenced implicit associations among smokers but did not affect explicit CHBs. Most interestingly, implicit associations and explicit CHBs predicted food choice and smoking among smokers not confronted with warning labels. Graphic warning labels could be used in interventions to inhibit automatic associations between smoking and healthy behaviours. Unlearning implicit cognitions might in turn affect explicit CHBs, thus decreasing their role in reducing the negative feelings caused by smoking. © 2013 The British Psychological Society.

Lack of pregnancy warnings on over-the-counter dermatologic products containing potentially harmful hydroquinone.

PubMed

Bio, L L; Cies, J J

2017-07-01

To determine the presence of pregnancy warnings on over-the-counter (OTC) dermatologic products with hydroquinone, a potentially harmful ingredient. Data were obtained from the Food and Drug Administration National Drug Code Directory and Label Repository to identify OTC dermatologic products containing hydroquinone. Products were stratified based on pregnancy or general warning presence (WP) or absence (WA). Product characteristics were compared between groups: hydroquinone concentration, presence of external packaging, indication and warning statements. Of the 112 products studied, 21 had a pregnancy warning and 3 included a general warning against use: WP (n=24) and WA (n=88) group. External packaging was more prevalent in the WP group compared to WA (62.5% vs 29.5%, P=0.004). Majority of OTC dermatologic products containing hydroquinone did not have a pregnancy warning. This highlights the need for improved labeling and informs providers caring for pregnant women of OTC labeling limitations.
Mediational pathways of the impact of cigarette warning labels on quit attempts

PubMed Central

Yong, Hua-Hie; Borland, Ron; Thrasher, James F.; Thompson, Mary E.; Nagelhout, Gera E.; Fong, Geoffrey T.; Hammond, David; Cummings, K. Michael

2015-01-01

Objectives To test and develop, using structural equation modelling, a robust model of the mediational pathways through which health warning labels exert their influence on smokers’ subsequent quitting behaviour. Methods Data come from the International Tobacco Control Four-Country Survey, a longitudinal cohort study conducted in Australia, Canada, the UK, and the US. Waves 5–6 data (n=4988) were used to calibrate the hypothesized model of warning label impact on subsequent quit attempts via a set of policy-specific and general psychosocial mediators. The finalised model was validated using Waves 6–7 data (n=5065). Results As hypothesized, warning label salience was positively associated with thoughts about risks of smoking stimulated by the warnings (β=.58, p<.001), which in turn were positively related to increased worry about negative outcomes of smoking (β=.52, p<.001); increased worry in turn predicted stronger intention to quit (β=.39, p<.001) which was a strong predictor of subsequent quit attempts (β=.39, p<.001). This calibrated model was successfully replicated using Waves 6–7 data. Conclusions Health warning labels seem to influence future quitting attempts primarily through their ability to stimulate thoughts about the risks of smoking, which in turn help to raise smoking-related health concerns, which lead to stronger intentions to quit, a known key predictor of future quit attempts for smokers. By making warning labels more salient and engaging, they should have a greater chance to change behaviour. PMID:24977309
Mediational pathways of the impact of cigarette warning labels on quit attempts.

PubMed

Yong, Hua-Hie; Borland, Ron; Thrasher, James F; Thompson, Mary E; Nagelhout, Gera E; Fong, Geoffrey T; Hammond, David; Cummings, K Michael

2014-11-01

To test and develop, using structural equation modeling, a robust model of the mediational pathways through which health warning labels exert their influence on smokers' subsequent quitting behavior. Data come from the International Tobacco Control Four-Country Survey, a longitudinal cohort study conducted in Australia, Canada, the United Kingdom, and the United States. Waves 5-6 data (n = 4,988) were used to calibrate the hypothesized model of warning label impact on subsequent quit attempts via a set of policy-specific and general psychosocial mediators. The finalized model was validated using Waves 6-7 data (n = 5065). As hypothesized, warning label salience was positively associated with thoughts about risks of smoking stimulated by the warnings (β = .58, p < .001), which in turn were positively related to increased worry about negative outcomes of smoking (β = .52, p < .001); increased worry in turn predicted stronger intention to quit (β = .39, p < .001), which was a strong predictor of subsequent quit attempts (β = .39, p < .001). This calibrated model was successfully replicated using Waves 6-7 data. Health warning labels seem to influence future quitting attempts primarily through their ability to stimulate thoughts about the risks of smoking, which in turn help to raise smoking-related health concerns, which lead to stronger intentions to quit, a known key predictor of future quit attempts for smokers. By making warning labels more salient and engaging, they should have a greater chance to change behavior. PsycINFO Database Record (c) 2014 APA, all rights reserved.
Young children's perceptions of health warning labels on cigarette packages: a study in six countries.

PubMed

Borzekowski, Dina L G; Cohen, Joanna E

2014-01-01

Health warning labels on cigarette packages are one way to reach youth thinking about initiating tobacco use. The purpose of this study was to examine awareness and understanding of current health warning labels among 5 and 6 year old children. Researchers conducted one-on-one interviews with urban and rural 5 and 6 year olds from Brazil, China, India, Nigeria, Pakistan, and Russia. Among the 2,423 participating children, 62 % were unaware of the health warnings currently featured on cigarette packages, with the lowest levels of awareness in India and the highest levels in Brazil. When shown the messages, the same percentage of participating children (62 %) showed no level of message understanding. While youth are receiving social and informational messages promoting tobacco use, health warning labels featured on cigarette packages are not effectively reaching young children with anti-smoking messages.
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.
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.
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.
FDA Warns About Stem Cell Therapies

MedlinePlus

... For Consumers Consumer Updates FDA Warns About Stem Cell Therapies Share Tweet Linkedin Pin it More sharing ... the boxed section below for more advice. Stem Cell Uses and FDA Regulation The FDA has the ...
40 CFR 82.110 - Form of label bearing warning statement.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 17 2010-07-01 2010-07-01 false Form of label bearing warning statement. 82.110 Section 82.110 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE The Labeling of Products Using Ozone-Depleting...
40 CFR 82.112 - Removal of label bearing warning statement.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 17 2010-07-01 2010-07-01 false Removal of label bearing warning statement. 82.112 Section 82.112 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE The Labeling of Products Using Ozone-Depleting...
Speaking out about physical harms from tobacco use: response to graphic warning labels among American Indian/Alaska Native communities

PubMed Central

Patterson Silver Wolf, David A; Tovar, Molly; Thompson, Kellie; Ishcomer, Jamie; Kreuter, Matthew W; Caburnay, Charlene; Boyum, Sonia

2016-01-01

Objective This study is the first to explore the impact of graphic cigarette labels with physical harm images on members of American Indian/Alaska Native (AI/AN) communities. The aim of this article is to investigate how AI/AN respond to particular graphic warning labels. Methods The parent study recruited smokers, at-risk smokers and non-smokers from three different age groups (youths aged 13–17 years, young adults aged 18–24 years and adults aged 25+ years) and five population subgroups with high smoking prevalence or smoking risk. Using nine graphic labels, this study collected participant data in the field via an iPad-administered survey and card sorting of graphic warning labels. This paper reports on findings for AI/AN participants. Results After viewing graphic warning labels, participants rated their likelihood of talking about smoking risks to friends, parents and siblings higher than their likelihood of talking to teachers and doctors. Further, this study found that certain labels (eg, the label of the toddler in the smoke cloud) made them think about their friends and family who smoke. Conclusions Given the influence of community social networks on health beliefs and attitudes, health communication using graphic warning labels could effect change in the smoking habits of AI/AN community members. Study findings suggest that graphic labels could serve as stimuli for conversations about the risks of smoking among AI/AN community members, and could be an important element of a peer-to-peer smoking cessation effort. PMID:27009143
Adult smokers' reactions to pictorial health warning labels on cigarette packs in Thailand and moderating effects of type of cigarette smoked: findings from the international tobacco control southeast Asia survey.

PubMed

Yong, Hua-Hie; Fong, Geoffrey T; Driezen, Pete; Borland, Ron; Quah, Anne C K; Sirirassamee, Buppha; Hamann, Stephen; Omar, Maizurah

2013-08-01

In this study, we aimed to examine, in Thailand, the impact on smokers' reported awareness of and their cognitive and behavioral reactions following the change from text-only to pictorial warnings printed on cigarette packs. We also sought to explore differences by type of cigarette smoked (roll-your-own [RYO] vs. factory-made [FM] cigarettes). Data came from the International Tobacco Control Southeast Asia Survey, conducted in Thailand and Malaysia, where a representative sample of 2,000 adult smokers from each country were recruited and followed up. We analyzed data from one wave before (Wave 1) and two waves after the implementation of the new pictorial warnings (two sets introduced at Waves 2 and 3, respectively) in Thailand, with Malaysia, having text-only warnings, serving as a control. Following the warning label change in Thailand, smokers' reported awareness and their cognitive and behavioral reactions increased markedly, with the cognitive and behavioral effects sustained at the next follow-up. By contrast, no significant change was observed in Malaysia over the same period. Compared to smokers who smoke any FM cigarettes, smokers of only RYO cigarettes reported a lower salience but greater cognitive reactions to the new pictorial warnings. The new Thai pictorial health warning labels have led to a greater impact than the text-only warning labels, and refreshing the pictorial images may have helped sustain effects. This finding provides strong support for introducing pictorial warning labels in low- and middle-income countries, where the benefits may be even greater, given the lower literacy rates and generally lower levels of readily available health information on the risks of smoking.
Adult Smokers’ Reactions to Pictorial Health Warning Labels on Cigarette Packs in Thailand and Moderating Effects of Type of Cigarette Smoked: Findings From the International Tobacco Control Southeast Asia Survey

PubMed Central

2013-01-01

Introduction: In this study, we aimed to examine, in Thailand, the impact on smokers’ reported awareness of and their cognitive and behavioral reactions following the change from text-only to pictorial warnings printed on cigarette packs. We also sought to explore differences by type of cigarette smoked (roll-your-own [RYO] vs. factory-made [FM] cigarettes). Methods: Data came from the International Tobacco Control Southeast Asia Survey, conducted in Thailand and Malaysia, where a representative sample of 2,000 adult smokers from each country were recruited and followed up. We analyzed data from one wave before (Wave 1) and two waves after the implementation of the new pictorial warnings (two sets introduced at Waves 2 and 3, respectively) in Thailand, with Malaysia, having text-only warnings, serving as a control. Results: Following the warning label change in Thailand, smokers’ reported awareness and their cognitive and behavioral reactions increased markedly, with the cognitive and behavioral effects sustained at the next follow-up. By contrast, no significant change was observed in Malaysia over the same period. Compared to smokers who smoke any FM cigarettes, smokers of only RYO cigarettes reported a lower salience but greater cognitive reactions to the new pictorial warnings. Conclusions: The new Thai pictorial health warning labels have led to a greater impact than the text-only warning labels, and refreshing the pictorial images may have helped sustain effects. This finding provides strong support for introducing pictorial warning labels in low- and middle-income countries, where the benefits may be even greater, given the lower literacy rates and generally lower levels of readily available health information on the risks of smoking. PMID:23291637
Graphic Warning Labels Elicit Affective and Thoughtful Responses from Smokers: Results of a Randomized Clinical Trial.

PubMed

Evans, Abigail T; Peters, Ellen; Strasser, Andrew A; Emery, Lydia F; Sheerin, Kaitlin M; Romer, Daniel

2015-01-01

Observational research suggests that placing graphic images on cigarette warning labels can reduce smoking rates, but field studies lack experimental control. Our primary objective was to determine the psychological processes set in motion by naturalistic exposure to graphic vs. text-only warnings in a randomized clinical trial involving exposure to modified cigarette packs over a 4-week period. Theories of graphic-warning impact were tested by examining affect toward smoking, credibility of warning information, risk perceptions, quit intentions, warning label memory, and smoking risk knowledge. Adults who smoked between 5 and 40 cigarettes daily (N = 293; mean age = 33.7), did not have a contra-indicated medical condition, and did not intend to quit were recruited from Philadelphia, PA and Columbus, OH. Smokers were randomly assigned to receive their own brand of cigarettes for four weeks in one of three warning conditions: text only, graphic images plus text, or graphic images with elaborated text. Data from 244 participants who completed the trial were analyzed in structural-equation models. The presence of graphic images (compared to text-only) caused more negative affect toward smoking, a process that indirectly influenced risk perceptions and quit intentions (e.g., image->negative affect->risk perception->quit intention). Negative affect from graphic images also enhanced warning credibility including through increased scrutiny of the warnings, a process that also indirectly affected risk perceptions and quit intentions (e.g., image->negative affect->risk scrutiny->warning credibility->risk perception->quit intention). Unexpectedly, elaborated text reduced warning credibility. Finally, graphic warnings increased warning-information recall and indirectly increased smoking-risk knowledge at the end of the trial and one month later. In the first naturalistic clinical trial conducted, graphic warning labels are more effective than text-only warnings in encouraging smokers to consider quitting and in educating them about smoking's risks. Negative affective reactions to smoking, thinking about risks, and perceptions of credibility are mediators of their impact. Clinicaltrials.gov NCT01782053.
Message on a bottle: are alcohol warning labels about cancer appropriate?

PubMed

Miller, Emma R; Ramsey, Imogen J; Baratiny, Genevieve Y; Olver, Ian N

2016-02-11

Although most Australians are unaware of the risk, there is strong evidence for a direct link between alcohol consumption and many types of cancer. Warning labels on alcohol products have been proposed as a cost-effective strategy to inform the community of this health risk. We aimed to identify how Australians might respond to such an approach. We conducted a national online survey canvassing responses to four separate cancer warning messages on labels. The graphically presented messages were informed by qualitative data from a series of focus groups among self-identified 'light-to-moderate' drinkers. For each label, participants were asked their level of agreement with impact statements about raising awareness, prompting conversation, influencing drinking behaviour and educating others about cancer risk. We analysed responses according to demographic and other factors, including self-reported drinking behaviour (using the 3-item Alcohol Use Disorder Test - AUDIT-C - scores). Approximately 1600 participants completed the survey, which was open to all Australian adults over a period of 1 month in 2014. Overall, the labels were well received, with the majority (>70 %) agreeing all labels could raise awareness and prompt conversations about the cancer risk associated with alcohol. Around 50 % or less agreed that the labels could influence drinking behaviour, but larger proportions agreed that the labels would prompt them to discuss the issue with family and friends. Although sex, AUDIT-C score and age were significantly associated with agreement on bivariate analysis, multivariate analyses demonstrated that being inclined to act upon warning label recommendations in general was the most important predictor of agreement with all of the impact statements. Having a low AUDIT-C score also predicted agreement that the labels might prompt behaviour change in friends. The findings suggest that providing detailed warnings about cancer risk on alcohol products is a viable means of increasing public awareness of the health risks associated with alcohol consumption. Further research is needed to explore the ability of such warnings to influence behavioural intentions and actual drinking behaviour.
The Sound Field Around a Tuning Fork and the Role of a Resonance Box

NASA Astrophysics Data System (ADS)

Bogacz, Bogdan F.; Pedziwiatr, Antoni T.

2015-02-01

Atypical two-tine tuning fork is barely audible when held vibrating at an arm's length. It is enough, however, to touch its base to a table or, better, to a resonance box and the emitted sound becomes much louder. An inquiring student may pose questions: —Why is a bare tuning fork such a weak emitter of sound?—What is the role of the resonance box?—Where does energy connected with larger intensity of emitted acoustic waves come from?
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
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.
Public support for graphic health warning labels in the U.S.

PubMed

Kamyab, Kian; Nonnemaker, James M; Farrelly, Matthew C

2015-01-01

In 2009, the U.S. Food and Drug Administration was required to mandate that graphic health warning labels be placed on cigarette packages and advertisements. To assess public support in the U.S. for graphic health warning labels from 2007 to 2012. Data from 17,498 respondents from 13 waves of the National Adult Tobacco Survey, a list-assisted random-digit-dial survey, were used. Overall support for graphic health warning labels, as well as support by smoking status, and by sociodemographics and smoker characteristics are estimated. Analyses were conducted in 2014. Since 2007, a majority of the public overall has been in favor of labels. Support increased significantly among the public overall and among non-smokers from 2007 through 2009 (p<0.001), after which it remained flat. Among smokers, support levels increased from 2007 through 2011 (p<0.001), but decreased significantly from 2011 through 2012 (p<0.001). Support was high regardless of smoking status, although among smokers, support varied by level of smoking, interest in quitting, and whether labels were seen as an important reason to quit. Support varied by sociodemographic characteristics, particularly among smokers. Younger, less-affluent, and less-educated smokers supported labels at higher levels than their counterparts. A majority of U.S. residents support graphic health warning labels for cigarette packs, though support among smokers declined after 2011. Copyright © 2015 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.
A comparison of the impact of U.S. and Canadian cigarette pack warning label requirements on tobacco industry profitability and the public health.

PubMed

Givel, Michael

2007-10-01

Since the early 1980s, neo-liberals have argued that command and control regulation (such as modern tobacco control programs) are costly in supporting corporate markets and profits. Some recent social constructionists have also argued that weak and symbolic command and control policies are necessary to maintain corporate productivity. This paper examines whether the command and control-oriented United States cigarette warning label law is symbolic thus helping to maintain corporate profitability. This paper compares United States and Canadian requirements that promote significant smoking cessation such as color pictures or graphics on cigarette packs. This paper also provides a detailed overview of the respective cigarette pack warning label laws through an archival and content analysis of tobacco industry documents, LexisNexis, web pages, and peer reviewed journal articles. Cigarette pack warning label requirements under the command and control United States Cigarette Labeling and Advertising Act are currently fairly symbolic and weak in promoting tobacco cessation when compared with the much stronger Canadian warning label requirements. Contrary to the arguments of neo-liberals, symbolic command and control policies can actually support corporate private profit making, which for the tobacco industry occurs at the expense of the public health.

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.
Effectiveness of cigarette warning labels: examining the impact of graphics, message framing, and temporal framing.

PubMed

Nan, Xiaoli; Zhao, Xiaoquan; Yang, Bo; Iles, Irina

2015-01-01

This study examines the effectiveness of cigarette warning labels, with a specific focus on the impact of graphics, message framing (gain vs. loss), and temporal framing (present-oriented vs. future-oriented) among nonsmokers in the United States. A controlled experiment (N = 253) revealed that graphic warning labels were perceived as more effective, stronger in argument strength, and were generally liked more compared to text-only labels. In addition, loss-framed labels, compared to their gain-framed counterparts, were rated higher in perceived effectiveness, argument strength, and liking. No significant difference was observed between the present- and future-oriented frames on any of the dependent variables. Implications of the findings for antismoking communication efforts are discussed.
21 CFR 501.17 - Animal food labeling warning statements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Animal food labeling warning statements. 501.17 Section 501.17 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.17 Animal...
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.
Representation, Exemplification, and Risk: Resonance of Tobacco Graphic Health Warnings Across Diverse Populations.

PubMed

Bigman, Cabral A; Nagler, Rebekah H; Viswanath, K

2016-08-01

As countries implement Article 11 of the World Health Organization (WHO) Framework Convention on Tobacco Control, graphic warning labels that use images of people and their body parts to illustrate the consequences of smoking are being added to cigarette packs. According to exemplification theory, these case examples-exemplars-can shape perceptions about risk and may resonate differently among demographic subpopulations. Drawing on data from eight focus groups (N = 63) with smokers and nonsmokers from vulnerable populations, this qualitative study explores whether people considered exemplars in their reactions to and evaluations of U.S. graphic health warning labels initially proposed by the Food and Drug Administration. Participants made reference to prior and concurrent mass media messages and exemplars during the focus groups and used demographic cues in making sense of the images on the warning labels. Participants were particularly sensitive to age of the exemplars and how it might affect label effectiveness and beliefs about smoking. Race and socioeconomic status also were salient for some participants. We recommend that exemplars and exemplification be considered when selecting and evaluating graphic health warnings for tobacco labels and associated media campaigns.
Attitudes and preferences of consumers toward food allergy labeling practices by diagnosis of food allergies.

PubMed

Ju, Se-Young; Park, Jong-Hwan; Kwak, Tong-Kyoung; Kim, Kyu-Earn

2015-10-01

The objective of this study was to investigate food allergens and prevalence rates of food allergies, followed by comparison of consumer attitudes and preferences regarding food allergy labeling by diagnosis of food allergies. A total of 543 individuals living in Seoul and Gyeonggi area participated in the survey from October 15 to 22 in 2013. The results show that the prevalence of doctor-diagnosed food allergies was 17.5%, whereas 6.4% of respondents self-reported food allergies. The most common allergens of doctor-diagnosed and self-reported food allergy respondents were peaches (30.3%) and eggs (33.3%), respectively, followed by peanuts, cow's milk, and crab. Regarding consumer attitudes toward food labeling, checking food allergens as an item was only significantly different between allergic and non-allergic respondents among all five items (P < 0.001). All respondents reported that all six items (bold font, font color, box frame, warning statement, front label, and addition of potential allergens) were necessary for an improved food allergen labeling system. PLSR analysis determined that the doctor-diagnosed group and checking of food allergens were positively correlated, whereas the non-allergy group was more concerned with checking product brands. An effective food labeling system is very important for health protection of allergic consumers. Additionally, government agencies must develop policies regarding prevalence of food allergies in Korea. Based on this information, the food industry and government agencies should provide clear and accurate food labeling practices for consumers.
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.
Speaking out about physical harms from tobacco use: response to graphic warning labels among American Indian/Alaska Native communities.

PubMed

Patterson Silver Wolf, David A; Tovar, Molly; Thompson, Kellie; Ishcomer, Jamie; Kreuter, Matthew W; Caburnay, Charlene; Boyum, Sonia

2016-03-23

This study is the first to explore the impact of graphic cigarette labels with physical harm images on members of American Indian/Alaska Native (AI/AN) communities. The aim of this article is to investigate how AI/AN respond to particular graphic warning labels. The parent study recruited smokers, at-risk smokers and non-smokers from three different age groups (youths aged 13-17 years, young adults aged 18-24 years and adults aged 25+ years) and five population subgroups with high smoking prevalence or smoking risk. Using nine graphic labels, this study collected participant data in the field via an iPad-administered survey and card sorting of graphic warning labels. This paper reports on findings for AI/AN participants. After viewing graphic warning labels, participants rated their likelihood of talking about smoking risks to friends, parents and siblings higher than their likelihood of talking to teachers and doctors. Further, this study found that certain labels (eg, the label of the toddler in the smoke cloud) made them think about their friends and family who smoke. Given the influence of community social networks on health beliefs and attitudes, health communication using graphic warning labels could effect change in the smoking habits of AI/AN community members. Study findings suggest that graphic labels could serve as stimuli for conversations about the risks of smoking among AI/AN community members, and could be an important element of a peer-to-peer smoking cessation effort. 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/
40 CFR 763.95 - Warning labels.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT ASBESTOS Asbestos-Containing Materials in Schools § 763.95 Warning labels. (a) The local education agency shall...: ASBESTOS. HAZARDOUS. DO NOT DISTURB WITHOUT PROPER TRAINING AND EQUIPMENT. ...
40 CFR 763.95 - Warning labels.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT ASBESTOS Asbestos-Containing Materials in Schools § 763.95 Warning labels. (a) The local education agency shall...: ASBESTOS. HAZARDOUS. DO NOT DISTURB WITHOUT PROPER TRAINING AND EQUIPMENT. ...
40 CFR 763.95 - Warning labels.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT ASBESTOS Asbestos-Containing Materials in Schools § 763.95 Warning labels. (a) The local education agency shall...: ASBESTOS. HAZARDOUS. DO NOT DISTURB WITHOUT PROPER TRAINING AND EQUIPMENT. ...
40 CFR 763.95 - Warning labels.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT ASBESTOS Asbestos-Containing Materials in Schools § 763.95 Warning labels. (a) The local education agency shall...: ASBESTOS. HAZARDOUS. DO NOT DISTURB WITHOUT PROPER TRAINING AND EQUIPMENT. ...
40 CFR 763.95 - Warning labels.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT ASBESTOS Asbestos-Containing Materials in Schools § 763.95 Warning labels. (a) The local education agency shall...: ASBESTOS. HAZARDOUS. DO NOT DISTURB WITHOUT PROPER TRAINING AND EQUIPMENT. ...
21 CFR 101.17 - Food labeling warning, notice, and safe handling statements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... any other labeling. (e) Dietary supplements containing iron or iron salts. (1) The labeling of any dietary supplement in solid oral dosage form (e.g., tablets or capsules) that contains iron or iron salts... concentrating and inhaling the contents can be harmful or fatal. (2) The warning required by paragraph (b)(1) of...
21 CFR 101.17 - Food labeling warning, notice, and safe handling statements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... any other labeling. (e) Dietary supplements containing iron or iron salts. (1) The labeling of any dietary supplement in solid oral dosage form (e.g., tablets or capsules) that contains iron or iron salts... concentrating and inhaling the contents can be harmful or fatal. (2) The warning required by paragraph (b)(1) of...
21 CFR 101.17 - Food labeling warning, notice, and safe handling statements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... any other labeling. (e) Dietary supplements containing iron or iron salts. (1) The labeling of any dietary supplement in solid oral dosage form (e.g., tablets or capsules) that contains iron or iron salts... concentrating and inhaling the contents can be harmful or fatal. (2) The warning required by paragraph (b)(1) of...
21 CFR 501.17 - Animal food labeling warning statements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Animal food labeling warning statements. 501.17... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.17 Animal... with each valve actuation. (iv) Products of a net quantity of contents of less than 1/2 oz. (c) Animal...
21 CFR 501.17 - Animal food labeling warning statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Animal food labeling warning statements. 501.17... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.17 Animal... with each valve actuation. (iv) Products of a net quantity of contents of less than 1/2 oz. (c) Animal...
21 CFR 501.17 - Animal food labeling warning statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Animal food labeling warning statements. 501.17... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.17 Animal... with each valve actuation. (iv) Products of a net quantity of contents of less than 1/2 oz. (c) Animal...
21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...
21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...
21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...
21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...
Testing warning messages on smokers’ cigarette packages: A standardized protocol

PubMed Central

Brewer, Noel T.; Hall, Marissa G.; Lee, Joseph G. L.; Peebles, Kathryn; Noar, Seth M.; Ribisl, Kurt M.

2015-01-01

Purpose Lab experiments on cigarette warnings typically use a brief one-time exposure that is not paired with the cigarette packs smokers use every day, leaving open the question of how repeated warning exposure over several weeks may affect smokers. This proof of principle study sought to develop a new protocol for testing cigarette warnings that better reflects real-world exposure by presenting them on cigarette smokers’ own packs. Methods We tested a cigarette pack labeling protocol with 76 US smokers ages 18 and older. We applied graphic warnings to the front and back of smokers’ cigarette packs. Results Most smokers reported that at least 75% of the packs of cigarettes they smoked during the study had our warnings. Nearly all said they would participate in the study again. Using cigarette packs with the study warnings increased quit intentions (p<.05). Conclusion Our findings suggest a feasible pack labeling protocol with six steps: (1) schedule appointments at brief intervals; (2) determine typical cigarette consumption; (3) ask smokers to bring a supply of cigarette packs to study appointments; (4) apply labels to smokers’ cigarette packs; (5) provide participation incentives at the end of appointments; and (6) refer smokers to cessation services at end of the study. When used in randomized controlled trials in settings with real-world message exposure over time, this protocol may help identify the true impact of warnings and thus better inform tobacco product labeling policy. PMID:25564282
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.
Cigarette graphic warning labels increase both risk perceptions and smoking myth endorsement.

PubMed

Evans, Abigail T; Peters, Ellen; Shoben, Abigail B; Meilleur, Louise R; Klein, Elizabeth G; Tompkins, Mary Kate; Tusler, Martin

2018-02-01

Cigarette graphic warning labels elicit negative emotion, which increases risk perceptions through multiple processes. We examined whether this emotion simultaneously affects motivated cognitions like smoking myth endorsement (e.g. 'exercise can undo the negative effects of smoking') and perceptions of cigarette danger versus other products. 736 adult and 469 teen smokers/vulnerable smokers viewed one of three warning label types (text-only, low emotion graphic or high emotion graphic) four times over two weeks. Emotional reactions to the warnings were reported during the first and fourth exposures. Participants reported how often they considered the warnings, smoking myth endorsement, risk perceptions and perceptions of cigarette danger relative to smokeless tobacco and electronic cigarettes. In structural equation models, emotional reactions influenced risk perceptions and smoking myth endorsement through two processes. Emotion acted as information about risk, directly increasing smoking risk perceptions and decreasing smoking myth endorsement. Emotion also acted as a spotlight, motivating consideration of the warning information. Warning consideration increased risk perceptions, but also increased smoking myth endorsement. Emotional reactions to warnings decreased perceptions of cigarette danger relative to other products. Emotional reactions to cigarette warnings increase smoking risk perceptions, but also smoking myth endorsement and misperceptions that cigarettes are less dangerous than potentially harm-reducing tobacco products.
Graphic Warning Labels Elicit Affective and Thoughtful Responses from Smokers: Results of a Randomized Clinical Trial

PubMed Central

Evans, Abigail T.; Peters, Ellen; Strasser, Andrew A.; Emery, Lydia F.; Sheerin, Kaitlin M.; Romer, Daniel

2015-01-01

Objective Observational research suggests that placing graphic images on cigarette warning labels can reduce smoking rates, but field studies lack experimental control. Our primary objective was to determine the psychological processes set in motion by naturalistic exposure to graphic vs. text-only warnings in a randomized clinical trial involving exposure to modified cigarette packs over a 4-week period. Theories of graphic-warning impact were tested by examining affect toward smoking, credibility of warning information, risk perceptions, quit intentions, warning label memory, and smoking risk knowledge. Methods Adults who smoked between 5 and 40 cigarettes daily (N = 293; mean age = 33.7), did not have a contra-indicated medical condition, and did not intend to quit were recruited from Philadelphia, PA and Columbus, OH. Smokers were randomly assigned to receive their own brand of cigarettes for four weeks in one of three warning conditions: text only, graphic images plus text, or graphic images with elaborated text. Results Data from 244 participants who completed the trial were analyzed in structural-equation models. The presence of graphic images (compared to text-only) caused more negative affect toward smoking, a process that indirectly influenced risk perceptions and quit intentions (e.g., image->negative affect->risk perception->quit intention). Negative affect from graphic images also enhanced warning credibility including through increased scrutiny of the warnings, a process that also indirectly affected risk perceptions and quit intentions (e.g., image->negative affect->risk scrutiny->warning credibility->risk perception->quit intention). Unexpectedly, elaborated text reduced warning credibility. Finally, graphic warnings increased warning-information recall and indirectly increased smoking-risk knowledge at the end of the trial and one month later. Conclusions In the first naturalistic clinical trial conducted, graphic warning labels are more effective than text-only warnings in encouraging smokers to consider quitting and in educating them about smoking’s risks. Negative affective reactions to smoking, thinking about risks, and perceptions of credibility are mediators of their impact. Trial Registration Clinicaltrials.gov NCT01782053 PMID:26672982
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.
21 CFR 201.308 - Ipecac syrup; warnings and directions for use for over-the-counter sale.

Code of Federal Regulations, 2011 CFR

2011-04-01

... following, in a prominent and conspicuous manner: (1) A statement conspicuously boxed and in red letters, to... Poison Control Center, or hospital emergency room immediately for advice.” (2) A warning to the effect...
21 CFR 201.308 - Ipecac syrup; warnings and directions for use for over-the-counter sale.

Code of Federal Regulations, 2012 CFR

2012-04-01

... following, in a prominent and conspicuous manner: (1) A statement conspicuously boxed and in red letters, to... Poison Control Center, or hospital emergency room immediately for advice.” (2) A warning to the effect...
21 CFR 201.308 - Ipecac syrup; warnings and directions for use for over-the-counter sale.

Code of Federal Regulations, 2014 CFR

2014-04-01

... following, in a prominent and conspicuous manner: (1) A statement conspicuously boxed and in red letters, to... Poison Control Center, or hospital emergency room immediately for advice.” (2) A warning to the effect...
21 CFR 201.308 - Ipecac syrup; warnings and directions for use for over-the-counter sale.

Code of Federal Regulations, 2013 CFR

2013-04-01

... following, in a prominent and conspicuous manner: (1) A statement conspicuously boxed and in red letters, to... Poison Control Center, or hospital emergency room immediately for advice.” (2) A warning to the effect...
21 CFR 201.305 - Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use...

Code of Federal Regulations, 2010 CFR

2010-04-01

... immediate container label with a statement directed to pharmacists not to remove the label or (ii) by including in the package a printed warning with instructions to pharmacists to place the warning on the...
21 CFR 201.305 - Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use...

Code of Federal Regulations, 2013 CFR

2013-04-01

... immediate container label with a statement directed to pharmacists not to remove the label or (ii) by including in the package a printed warning with instructions to pharmacists to place the warning on the...
21 CFR 201.305 - Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use...

Code of Federal Regulations, 2014 CFR

2014-04-01

... immediate container label with a statement directed to pharmacists not to remove the label or (ii) by including in the package a printed warning with instructions to pharmacists to place the warning on the...
21 CFR 201.305 - Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use...

Code of Federal Regulations, 2011 CFR

2011-04-01

... immediate container label with a statement directed to pharmacists not to remove the label or (ii) by including in the package a printed warning with instructions to pharmacists to place the warning on the...
21 CFR 201.305 - Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use...

Code of Federal Regulations, 2012 CFR

2012-04-01

... immediate container label with a statement directed to pharmacists not to remove the label or (ii) by including in the package a printed warning with instructions to pharmacists to place the warning on the...
Effects of 30% and 50% Cigarette Pack Graphic Warning Labels on Visual Attention, Negative Affect, Quit Intentions, and Smoking Susceptibility among Disadvantaged Populations in the United States.

PubMed

Skurka, Chris; Kemp, Deena; Davydova, Julie; Thrasher, James F; Byrne, Sahara; Safi, Amelia Greiner; Avery, Rosemary J; Dorf, Michael C; Mathios, Alan D; Scolere, Leah; Niederdeppe, Jeff

2018-06-07

Though the WHO Framework Convention for Tobacco Control (FCTC) calls for the implementation of large graphic warning labels (GWLs) on cigarette boxes, the courts have blocked the implementation of 50% labels in the United States. We conducted an experiment to explore whether changing the size of GWLs is associated with changes in visual attention, negative affect, risk beliefs, and behavioral intentions. We recruited adult smokers (N = 238) and middle-school youth (N = 237) throughout the state of New York in May 2016. We randomly assigned participants to one of three between-subject conditions (no GWL [control], 30% GWL, 50% GWL). Adult and youth participants looked at the GWLs longer when the GWL covered 50% versus 30% of the pack's front. Increasing GWL size from 30% to 50% did not influence negative affect or risk beliefs, though both GWL sizes increased negative affect relative to the no-GWL control group. Exposure to 50% GWLs increased adult smokers' intentions to quit compared to no-GWL, but smokers exposed to 30% GWLs did not differ from control. There were no differences between 50% GWLs, 30% GWLs, and control on youth smoking susceptibility. Findings provide some evidence of the benefits of a 50% versus 30% GWL covering the front of the pack for adult smokers and at-risk youth from socioeconomically disadvantaged backgrounds-though not on all outcomes. This research shows that 30% GWLs on cigarette packages increase negative affect relative to packages without front-of-package GWLs. Larger GWLs on cigarette packages (50% vs. 30%) increase visual attention to the warning and its pictorial content among low-SES smokers and at-risk youth but do not further increase negative affect. A 50% GWL increased adults' quit intention compared to no GWL at all, but we were underpowered to detect modest differences in quit intentions between a 50% and 30% GWL. Future work should thus continue to explore the boundary conditions under which relatively larger GWLs influence cognitive, affective, and behavioral outcomes.
Role of metabolism in drug-induced idiosyncratic hepatotoxicity.

PubMed

Walgren, Jennie L; Mitchell, Michael D; Thompson, David C

2005-01-01

Rare adverse reactions to drugs that are of unknown etiology, or idiosyncratic reactions, can produce severe medical complications or even death in patients. Current hypotheses suggest that metabolic activation of a drug to a reactive intermediate is a necessary, yet insufficient, step in the generation of an idiosyncratic reaction. We review evidence for this hypothesis with drugs that are associated with hepatotoxicity, one of the most common types of idiosyncratic reactions in humans. We identified 21 drugs that have either been withdrawn from the U.S. market due to hepatotoxicity or have a black box warning for hepatotoxicity. Evidence for the formation of reactive metabolites was found for 5 out of 6 drugs that were withdrawn, and 8 out of 15 drugs that have black box warnings. For the other drugs, either evidence was not available or suitable studies have not been carried out. We also review evidence for reactive intermediate formation from a number of additional drugs that have been associated with idiosyncratic hepatotoxicity but do not have black box warnings. Finally, we consider the potential role that high dosages may play in these adverse reactions.

Implicit motivational impact of pictorial health warning on cigarette packs.

PubMed

Volchan, Eliane; David, Isabel A; Tavares, Gisella; Nascimento, Billy M; Oliveira, Jose M; Gleiser, Sonia; Szklo, Andre; Perez, Cristina; Cavalcante, Tania; Pereira, Mirtes G; Oliveira, Leticia

2013-01-01

The use of pictorial warning labels on cigarette packages is one of the provisions included in the first ever global health treaty by the World Health Organization against the tobacco epidemic. There is substantial evidence demonstrating the effectiveness of graphic health warning labels on intention to quit, thoughts about health risks and engaging in cessation behaviors. However, studies that address the implicit emotional drives evoked by such warnings are still underexplored. Here, we provide experimental data for the use of pictorial health warnings as a reliable strategy for tobacco control. Experiment 1 pre-tested nineteen prototypes of pictorial warnings to screen for their emotional impact. Participants (n = 338) were young adults balanced in gender, smoking status and education. Experiment 2 (n = 63) tested pictorial warnings (ten) that were stamped on packs. We employed an innovative set-up to investigate the impact of the warnings on the ordinary attitude of packs' manipulation, and quantified judgments of warnings' emotional strength and efficacy against smoking. Experiment 1 revealed that women judged the warning prototypes as more aversive than men, and smokers judged them more aversive than non-smokers. Participants with lower education judged the prototypes more aversive than participants with higher education. Experiment 2 showed that stamped warnings antagonized the appeal of the brands by imposing a cost to manipulate the cigarette packs, especially for smokers. Additionally, participants' judgments revealed that the more aversive a warning, the more it is perceived as effective against smoking. Health warning labels are one of the key components of the integrated approach to control the global tobacco epidemic. The evidence presented in this study adds to the understanding of how implicit responses to pictorial warnings may contribute to behavioral change.
The impacts of fear and disgust on the perceived effectiveness of smoking warning labels: a study on Turkish university students.

PubMed

Tugrul, Tugba Orten

2015-03-01

This study investigated the perceived effectiveness of pictorial warning labels on cigarette packages on Turkish university students. In particular, the impacts of fear and disgust elicited by these labels were examined using the smoking decision process model. A survey was conducted with 344 undergraduate students at a private university in Izmir, the third largest city of Turkey. The findings showed differences in levels of fear and disgust evoked by pictorial warning labels for each stage in the smoking decision process, which in turn led to differences in the perceived effectiveness of the labels. Thus, this study underlines the importance of tailoring antismoking messages according to specific target groups and also suggests considering the smoking-decision-process model as segments and targeting groups in creating effective messages. © 2013 APJPH.
21 CFR 740.2 - Conspicuousness of warning statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Conspicuousness of warning statements. 740.2... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.2 Conspicuousness of warning statements. (a) A warning statement shall appear on the label prominently and conspicuously as compared to...
21 CFR 740.2 - Conspicuousness of warning statements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Conspicuousness of warning statements. 740.2... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.2 Conspicuousness of warning statements. (a) A warning statement shall appear on the label prominently and conspicuously as compared to...
21 CFR 740.2 - Conspicuousness of warning statements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Conspicuousness of warning statements. 740.2... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.2 Conspicuousness of warning statements. (a) A warning statement shall appear on the label prominently and conspicuously as compared to...
21 CFR 740.2 - Conspicuousness of warning statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Conspicuousness of warning statements. 740.2... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.2 Conspicuousness of warning statements. (a) A warning statement shall appear on the label prominently and conspicuously as compared to...
21 CFR 740.2 - Conspicuousness of warning statements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Conspicuousness of warning statements. 740.2... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.2 Conspicuousness of warning statements. (a) A warning statement shall appear on the label prominently and conspicuously as compared to...
Pimecrolimus in atopic dermatitis: Consensus on safety and the need to allow use in infants

PubMed Central

Luger, Thomas; Boguniewicz, Mark; Carr, Warner; Cork, Michael; Deleuran, Mette; Eichenfield, Lawrence; Eigenmann, Philippe; Fölster-Holst, Regina; Gelmetti, Carlo; Gollnick, Harald; Hamelmann, Eckard; Hebert, Adelaide A; Muraro, Antonella; Oranje, Arnold P; Paller, Amy S; Paul, Carle; Puig, Luis; Ring, Johannes; Siegfried, Elaine; Spergel, Jonathan M; Stingl, Georg; Taieb, Alain; Torrelo, Antonio; Werfel, Thomas; Wahn, Ulrich

2015-01-01

Atopic dermatitis (AD) is a distressing dermatological disease, which is highly prevalent during infancy, can persist into later life and requires long-term management with anti-inflammatory compounds. The introduction of the topical calcineurin inhibitors (TCIs), tacrolimus and pimecrolimus, more than 10 yr ago was a major breakthrough for the topical anti-inflammatory treatment of AD. Pimecrolimus 1% is approved for second-line use in children (≥2 yr old) and adults with mild-to-moderate AD. The age restriction was emphasized in a boxed warning added by the FDA in January 2006, which also highlights the lack of long-term safety data and the theoretical risk of skin malignancy and lymphoma. Since then, pimecrolimus has been extensively investigated in short- and long-term studies including over 4000 infants (<2 yr old). These studies showed that pimecrolimus effectively treats AD in infants, with sustained improvement with long-term intermittent use. Unlike topical corticosteroids, long-term TCI use does not carry the risks of skin atrophy, impaired epidermal barrier function or enhanced percutaneous absorption, and so is suitable for AD treatment especially in sensitive skin areas. Most importantly, the studies of pimecrolimus in infants provided no evidence for systemic immunosuppression, and a comprehensive body of evidence from clinical studies, post-marketing surveillance and epidemiological investigations does not support potential safety concerns. In conclusion, the authors consider that the labelling restrictions regarding the use of pimecrolimus in infants are no longer justified and recommend that the validity of the boxed warning for TCIs should be reconsidered. PMID:25557211
Associations of Proposed Relative-Risk Warning Labels for Snus With Perceptions and Behavioral Intentions Among Tobacco Users and Nonusers.

PubMed

Rodu, Brad; Plurphanswat, Nantaporn; Hughes, John R; Fagerström, Karl

2016-05-01

The US Food and Drug Administration can require changes in warning statements for modified risk tobacco products. We report an independent analysis of a consumer perception survey sponsored by Swedish Match as part of a Modified Risk Tobacco Product application to change warning labels for Swedish snus products. The survey exposed each of 4324 daily exclusive cigarette smokers, 1033 daily smokeless tobacco users, 1205 daily other tobacco users, 726 former users, and 5915 triers/never users to one of four current warnings and two proposed relative-risk labels (No tobacco product is safe, but this product presents lower risks to health than cigarettes, or No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes) for snus. Descriptive and logistic regression analyses examined four outcomes: believability, harmfulness, motivation to use, and intention to buy snus. Compared with the current not-safe-alternative warning, adult tobacco users who viewed the proposed labels perceived them as less believable, perceived snus as less harmful and were more likely to use and buy snus. The proposed labels had no impact on former smokers' likelihood to use and buy snus; triers/never users viewing the substantially lower risk label were more likely to buy snus. Tobacco users viewing the proposed labels perceived snus as less harmful than cigarettes and may be more likely to use and buy snus. If labeling changes lead to increased snus use and cigarette reduction or abstinence, public health may benefit. If the opposite occurs, public health could suffer. © 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.
The Efficacy of Cigarette Warning Labels on Health Beliefs in the United States and Mexico

PubMed Central

MUTTI, SEEMA; HAMMOND, DAVID; REID, JESSICA L.; THRASHER, JAMES F.

2013-01-01

Concern over health risks is the most common motivation for quitting smoking. Health warnings on tobacco packages are among the most prominent interventions to convey the health risks of smoking. Face-to-face surveys were conducted in Mexico (n=1,072), and a web-based survey was conducted in the US (n=1,449) to examine the efficacy of health warning labels on health beliefs. Respondents were randomly assigned to view two sets of health warnings (each with one text-only warning and 5–6 pictorial warnings) for two different health effects. Respondents were asked whether they believed smoking caused 12 different health effects. Overall, the findings indicate high levels of health knowledge in both countries for some health effects, although significant knowledge gaps remained; for example: less than half of respondents agreed that smoking causes impotence and less than one third agreed that smoking causes gangrene. Mexican respondents endorsed a greater number of correct beliefs about the health impact of smoking than the US sample. In both countries, viewing related health warning labels increased beliefs about the health risks of smoking, particularly for less well-known health effects, such as gangrene, impotence, and stroke. PMID:23905611
Testing warning messages on smokers' cigarette packages: a standardised protocol.

PubMed

Brewer, Noel T; Hall, Marissa G; Lee, Joseph G L; Peebles, Kathryn; Noar, Seth M; Ribisl, Kurt M

2016-03-01

Lab experiments on cigarette warnings typically use a brief one-time exposure that is not paired with the cigarette packs smokers use every day, leaving open the question of how repeated warning exposure over several weeks may affect smokers. This proof of principle study sought to develop a new protocol for testing cigarette warnings that better reflects real-world exposure by presenting them on cigarette smokers' own packs. We tested a cigarette pack labelling protocol with 76 US smokers ages 18 and older. We applied graphic warnings to the front and back of smokers' cigarette packs. Most smokers reported that at least 75% of the packs of cigarettes they smoked during the study had our warnings. Nearly all said they would participate in the study again. Using cigarette packs with the study warnings increased quit intentions (p<0.05). Our findings suggest a feasible pack labelling protocol with six steps: (1) schedule appointments at brief intervals; (2) determine typical cigarette consumption; (3) ask smokers to bring a supply of cigarette packs to study appointments; (4) apply labels to smokers' cigarette packs; (5) provide participation incentives at the end of appointments; and (6) refer smokers to cessation services at end of the study. When used in randomised controlled trials in settings with real-world message exposure over time, this protocol may help identify the true impact of warnings and thus better inform tobacco product labelling policy. NCT02247908. 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/
Recall of anti-tobacco advertising and information, warning labels and news stories in a national sample of Aboriginal and Torres Strait Islander smokers.

PubMed

Nicholson, Anna K; Borland, Ron; Sarin, Jasmine; Wallace, Sharon; van der Sterren, Anke E; Stevens, Matthew; Thomas, David P

2015-06-01

To describe recall of anti-tobacco advertising (mainstream and targeted), pack warning labels, and news stories among a national sample of Aboriginal and Torres Strait Islander smokers, and to assess the association of these messages with attitudes that support quitting, including wanting to quit. A quota sampling design was used to recruit participants from communities served by 34 Aboriginal community-controlled health services and one community in the Torres Strait. We surveyed 1643 Aboriginal and Torres Strait Islander smokers from April 2012 to October 2013. Frequency of recall of advertising and information, warning labels and news stories; recall of targeted and local advertising; attitudes about smoking and wanting to quit. More smokers recalled often noticing warning labels in the past month (65%) than recalled advertising and information (45%) or news stories (24%) in the past 6 months. When prompted, most (82%) recalled seeing a television advertisement. Just under half (48%) recalled advertising that featured an Aboriginal or Torres Strait Islander person or artwork (targeted advertising), and 16% recalled targeted advertising from their community (local advertising). Frequent recall of warning labels, news stories and advertising was associated with worry about health and wanting to quit, but only frequent advertising recall was associated with believing that society disapproves of smoking. The magnitude of association with relevant attitudes and wanting to quit increased for targeted and local advertising. Strategies to tackle Aboriginal and Torres Strait Islander smoking should sustain high levels of exposure to anti-tobacco advertising, news stories and warning labels. More targeted and local information may be particularly effective to influence relevant beliefs and subsequently increase quitting.
21 CFR 740.1 - Establishment of warning statements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Establishment of warning statements. 740.1 Section...) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.1 Establishment of warning statements. (a) The label of a cosmetic product shall bear a warning statement whenever necessary or appropriate to prevent...
21 CFR 740.1 - Establishment of warning statements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Establishment of warning statements. 740.1 Section...) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.1 Establishment of warning statements. (a) The label of a cosmetic product shall bear a warning statement whenever necessary or appropriate to prevent...
21 CFR 740.1 - Establishment of warning statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Establishment of warning statements. 740.1 Section...) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.1 Establishment of warning statements. (a) The label of a cosmetic product shall bear a warning statement whenever necessary or appropriate to prevent...
21 CFR 740.1 - Establishment of warning statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Establishment of warning statements. 740.1 Section...) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.1 Establishment of warning statements. (a) The label of a cosmetic product shall bear a warning statement whenever necessary or appropriate to prevent...
21 CFR 740.1 - Establishment of warning statements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Establishment of warning statements. 740.1 Section...) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.1 Establishment of warning statements. (a) The label of a cosmetic product shall bear a warning statement whenever necessary or appropriate to prevent...
Implicit Motivational Impact of Pictorial Health Warning on Cigarette Packs

PubMed Central

Volchan, Eliane; David, Isabel A.; Tavares, Gisella; Nascimento, Billy M.; Oliveira, Jose M.; Gleiser, Sonia; Szklo, Andre; Perez, Cristina; Cavalcante, Tania; Pereira, Mirtes G.; Oliveira, Leticia

2013-01-01

Objective The use of pictorial warning labels on cigarette packages is one of the provisions included in the first ever global health treaty by the World Health Organization against the tobacco epidemic. There is substantial evidence demonstrating the effectiveness of graphic health warning labels on intention to quit, thoughts about health risks and engaging in cessation behaviors. However, studies that address the implicit emotional drives evoked by such warnings are still underexplored. Here, we provide experimental data for the use of pictorial health warnings as a reliable strategy for tobacco control. Methods Experiment 1 pre-tested nineteen prototypes of pictorial warnings to screen for their emotional impact. Participants (n = 338) were young adults balanced in gender, smoking status and education. Experiment 2 (n = 63) tested pictorial warnings (ten) that were stamped on packs. We employed an innovative set-up to investigate the impact of the warnings on the ordinary attitude of packs’ manipulation, and quantified judgments of warnings’ emotional strength and efficacy against smoking. Findings Experiment 1 revealed that women judged the warning prototypes as more aversive than men, and smokers judged them more aversive than non-smokers. Participants with lower education judged the prototypes more aversive than participants with higher education. Experiment 2 showed that stamped warnings antagonized the appeal of the brands by imposing a cost to manipulate the cigarette packs, especially for smokers. Additionally, participants’ judgments revealed that the more aversive a warning, the more it is perceived as effective against smoking. Conclusions Health warning labels are one of the key components of the integrated approach to control the global tobacco epidemic. The evidence presented in this study adds to the understanding of how implicit responses to pictorial warnings may contribute to behavioral change. PMID:23977223
Analysing compliance of cigarette packaging with the FCTC and national legislation in eight former Soviet countries.

PubMed

Mir, Hassan; Roberts, Bayard; Richardson, Erica; Chow, Clara; McKee, Martin

2013-07-01

To analyse compliance of cigarette packets with the Framework Convention on Tobacco Control (FCTC) and national legislation and the policy actions that are required in eight former Soviet Union countries. We obtained cigarette packets of each of the 10 most smoked cigarette brands in Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Moldova, Russia and Ukraine. The packets were then analysed using a standardised data collection instrument. The analysis included the placing, size and content of health warning labels and deceptive labels (eg, 'Lights'). Findings were assessed for compliance with the FCTC and national legislation. Health warnings were on all packets from all countries and met the FCTC minimum recommendations on size and position except Azerbaijan and Georgia. All countries used a variety of warnings except Azerbaijan. No country had pictorial health warnings, despite them being mandatory in Georgia and Moldova. All of the countries had deceptive labels despite being banned in all countries except Russia and Azerbaijan where still no such legislation exists. Despite progress in the use of health warning messages, gaps still remain-particularly with the use of deceptive labels. Stronger surveillance and enforcement mechanisms are required to improve compliance with the FCTC and national legislation.
Attitudes and preferences of consumers toward food allergy labeling practices by diagnosis of food allergies

PubMed Central

Ju, Se-young; Park, Jong-Hwan; Kim, Kyu-earn

2015-01-01

BACKGROUND/OBJECTIVES The objective of this study was to investigate food allergens and prevalence rates of food allergies, followed by comparison of consumer attitudes and preferences regarding food allergy labeling by diagnosis of food allergies. SUBJECTS/METHODS A total of 543 individuals living in Seoul and Gyeonggi area participated in the survey from October 15 to 22 in 2013. RESULTS The results show that the prevalence of doctor-diagnosed food allergies was 17.5%, whereas 6.4% of respondents self-reported food allergies. The most common allergens of doctor-diagnosed and self-reported food allergy respondents were peaches (30.3%) and eggs (33.3%), respectively, followed by peanuts, cow's milk, and crab. Regarding consumer attitudes toward food labeling, checking food allergens as an item was only significantly different between allergic and non-allergic respondents among all five items (P < 0.001). All respondents reported that all six items (bold font, font color, box frame, warning statement, front label, and addition of potential allergens) were necessary for an improved food allergen labeling system. PLSR analysis determined that the doctor-diagnosed group and checking of food allergens were positively correlated, whereas the non-allergy group was more concerned with checking product brands. CONCLUSIONS An effective food labeling system is very important for health protection of allergic consumers. Additionally, government agencies must develop policies regarding prevalence of food allergies in Korea. Based on this information, the food industry and government agencies should provide clear and accurate food labeling practices for consumers. PMID:26425282

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.
A Qualitative Content Analysis of Cigarette Health Warning Labels in Australia, Canada, the United Kingdom, and the United States

PubMed Central

Bell, Kirsten; Dennis, Simone

2015-01-01

The legislation of health warning labels on cigarette packaging is a major focus for tobacco control internationally and is a key component of the World Health Organization’s Framework Convention on Tobacco Control. This population-level intervention is broadly supported as a vital measure for warning people about the health consequences of smoking. However, some components of this approach warrant close critical inspection. Through a qualitative content analysis of the imagery used on health warning labels from 4 countries, we consider how this imagery depicts people that smoke. By critically analyzing this aspect of the visual culture of tobacco control, we argue that this imagery has the potential for unintended consequences, and obscures the social and embodied contexts in which smoking is experienced. PMID:25521883
Can cigarette warnings counterbalance effects of smoking scenes in movies?

PubMed

Golmier, Isabelle; Chebat, Jean-Charles; Gélinas-Chebat, Claire

2007-02-01

Scenes in movies where smoking occurs have been empirically shown to influence teenagers to smoke cigarettes. The capacity of a Canadian warning label on cigarette packages to decrease the effects of smoking scenes in popular movies has been investigated. A 2 x 3 factorial design was used to test the effects of the same movie scene with or without electronic manipulation of all elements related to smoking, and cigarette pack warnings, i.e., no warning, text-only warning, and text+picture warning. Smoking-related stereotypes and intent to smoke of teenagers were measured. It was found that, in the absence of warning, and in the presence of smoking scenes, teenagers showed positive smoking-related stereotypes. However, these effects were not observed if the teenagers were first exposed to a picture and text warning. Also, smoking-related stereotypes mediated the relationship of the combined presentation of a text and picture warning and a smoking scene on teenagers' intent to smoke. Effectiveness of Canadian warning labels to prevent or to decrease cigarette smoking among teenagers is discussed, and areas of research are proposed.
The role of health consciousness in predicting attention to health warning messages.

PubMed

Kaskutas, L A; Greenfield, T K

1997-01-01

Guided by information processing theory and the health belief model, this paper considers the relationship between health consciousness among the general population and attention to environmental health warnings about alcohol consumption. Mechanisms of exposure to three dominant types of impersonal alcohol-related health messages in the environment are explored. Cross-sectional survey using telephone interview data. A representative nationwide sample of adults was interviewed in 1993 (n = 1026), with a response rate of 63%. Key variables include exposure to warning labels on alcoholic beverages, to point-of-sale posters, and to advertisements in the media, as well as respondents' alcohol consumption, health problems (indicative of salience of health warnings), and level of health consciousness assessed by items tapping concern with nutrition and seeking information on health topics. In the total sample, over a third had seen a warning label or poster and almost all had seen an advertisement about the risks associated with alcohol consumption in 1993. Survey respondents scored very high on five individual items that make up the health consciousness scale introduced here, with 69% endorsing all items. The scale demonstrated good internal reliability (alpha = .70) and was significantly correlated (p < .01) with not enjoying getting drunk and with usually reading product warning labels, suggesting construct validity. Yet the hypothesized strong relationships between health consciousness and attention to health warnings about drinking were not observed; nor was salience of messages a predictor of recall. Importantly, high proportions of underage drinkers and young adults at elevated risk for drinking problems are reached by container warning label messages. Mechanisms of exposure recall vary based on message source, with "container label recall" associated with heavier drinking, younger age, and purchasing patterns; "poster recall" associated with purchasing and health consciousness; and "advertisement recall" associated with heavy consumption and younger age. These results are contrary to predictions from skeptics of broad-based informational interventions, who argue that only the already-health conscious are attentive to health warnings about the risks of alcohol consumption. These data suggest that the label is reaching intended target audiences, especially younger people, males, and heavier alcohol consumers. Future research in predicting attention to impersonal health warnings in the environment should continue to improve the assessment of constructs such as salience and health consciousness, and should further test the applicability of available theoretical models. Subsequent research should also consider additional measures to tap mechanisms of exposure to impersonal health messages to enable a better understanding of the population that is not being reached by such public health interventions.
Looking into Generator Room, showing electromagnetic pulse (EMP) filter boxes ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

Looking into Generator Room, showing electromagnetic pulse (EMP) filter boxes mounted above door - Beale Air Force Base, Perimeter Acquisition Vehicle Entry Phased-Array Warning System, Power Plant, End of Spencer Paul Road, north of Warren Shingle Road (14th Street), Marysville, Yuba County, CA
Appalachian residents' perspectives on new U.S. cigarette warning labels.

PubMed

Reiter, Paul L; Broder-Oldach, Benjamin; Wewers, Mary Ellen; Klein, Elizabeth G; Paskett, Electra D; Katz, Mira L

2012-12-01

The U.S. Food and Drug Administration revealed new pictorial warning labels in June 2011 for cigarette packages, yet little is known about how these labels are perceived by U.S. residents. We examined the reactions to and attitudes about the new labels among residents of Appalachian Ohio, a region with a high smoking prevalence. We conducted focus groups with Appalachian Ohio residents between July and October 2011. Participants included healthcare providers (n = 30), community leaders (n = 26), parents (n = 28), and young adult men ages 18-26 (n = 18). Most participants supported the addition of the new labels to U.S. cigarette packages, though many were unaware of the labels prior to the focus groups. Participants did not think the labels would be effective in promoting smoking cessation among smokers in their communities, but they were more positive about the potential of the labels to reduce smoking initiation. Participants reported positive feedback about the more graphic labels, particularly those showing a man with a tracheal stoma or a person with severe oral disease. The labels that include a cartoon image of an ill infant and a man who quit smoking received the most negative feedback. Participants generally supported adding pictorial warning labels to U.S. cigarette packages, but only a few of labels received mostly positive feedback. Results offer early insight into how the new labels may be received if they are put into practice.
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.
77 FR 39710 - Draft Guidance for Industry on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-05

...] Draft Guidance for Industry on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and... Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use... enforcement discretion with regard to the liver warning required in the labeling. DATES: Although you can...
16 CFR 1203.6 - Labeling and instructions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... visible to the user: (1) Model designation. (2) A warning to the user that no helmet can protect against... wearer's head in accordance with the manufacturer's fitting instructions. (4) A warning to the user that... protect the head against further impacts, and that this damage may not be visible to the user. This label...
The role of theory-driven graphic warning labels in motivation to quit: a qualitative study on perceptions from low-income, urban smokers.

PubMed

Mead, Erin L; Cohen, Joanna E; Kennedy, Caitlin E; Gallo, Joseph; Latkin, Carl A

2015-02-07

Use of communication theories in the development of pictorial health warning labels (graphic warning labels) for cigarette packaging might enhance labels' impact on motivation to quit, but research has been limited, particularly among low socioeconomic status (SES) populations in the U.S. This qualitative study explored perceptions of theory-based graphic warning labels and their role in motivation to quit among low-income smokers. A cross-sectional qualitative study was conducted with 25 low-income adult smokers in Baltimore, Maryland, who were purposively sampled from a community-based source population. Semi-structured, in-depth interviews were conducted from January to February 2014. Participants were asked about the motivational impact of 12 labels falling into four content categories: negative depictions of the health effects of smoking to smokers and others, and positive depictions of the benefits of quitting to smokers and others. Data were coded using a combined inductive/deductive approach and analyzed thematically through framework analysis. Labels depicting negative health effects to smokers were identified as most motivational, followed by labels depicting negative health effects to others. Reasons included perceived severity of and susceptibility to the effects, negative emotional reactions (such as fear), and concern for children. Labels about the benefits of quitting were described as motivational because of their hopefulness, characters as role models, and desire to improve family health. Reasons why labels were described as not motivational included lack of impact on perceived severity/susceptibility, low credibility, and fatalistic attitudes regarding the inevitability of disease. Labels designed to increase risk perceptions from smoking might be significant sources of motivation for low SES smokers. Findings suggest innovative theory-driven approaches for the design of labels, such as using former smokers as role models, contrasting healthy and unhealthy characters, and socially-oriented labels, might motivate low SES smokers to quit.
Role of tobacco warning labels in informing smokers about risks of smoking among bus drivers in Mangalore, India.

PubMed

Mallikarjun, Sajjanshetty; Rao, Ashwini; Rajesh, Gururaghavendran; Shenoy, Ramya; Bh, Mithun Pai

2014-01-01

Smoking tobacco is considered as a leading cause of preventable death, mostly in developing countries like India. One of the primary goals of international tobacco control is to educate smokers about the risks associated with tobacco consumption. Tobacco warning labels (TWLs) on cigarette packages are one of the most common statutory means to communicate health risks of smoking to smokers, with the hope that once educated, they will be more likely to quit the habit. The present survey was conducted to assess the effectiveness of TWLs in communicating health risks of tobacco usage among 263 adult smokers working as bus drivers in Karnataka State Road Transport Corporation (KSRTC), Mangalore, India. Information was collected on demographic details, exposure and response to health warnings on tobacco products, intention to quit and nicotine dependency. The majority (79.5%) of the respondents revealed negative intentions towards quitting smoking. Nearly half of the participants had a 'low' nicotine dependency (47.5%) and 98.1% of the respondents had often noticed warning labels on tobacco packages. These health warnings made 71.5% of the respondents think about quitting smoking. Respondents who noticed advertisement or pictures about dangers of smoking had better knowledge, with respect to lung cancer and impotence as a consequence of tobacco. A higher exposure to warning labels was significantly associated with lower nicotine dependency levels of smokers among the present study population. A significantly higher number of respondents who noticed advertisement or pictures about the dangers of smoking thought about the risks of smoking and were more inclined to think about quitting smoking. As exposure increased, an increase in the knowledge and response of participants was also observed. Exposure to tobacco warning labels helps to educate smokers about health risks of tobacco smoking. It may be possible to promote oral health among bus drivers by developing strategies to educate them about these risk factors.
Warning about the harms of tobacco use in 22 countries: findings from a cross-sectional household survey.

PubMed

Chiosi, John J; Andes, Linda; Asma, Samira; Palipudi, Krishna; McAfee, Tim

2016-07-01

Knowledge about the harms of tobacco use deters initiation and is associated with cessation. Most studies on this knowledge in the general population have been in high-income countries, but the tobacco use burden is increasing in low-income and middle-income countries. We sought to estimate levels of knowledge about tobacco-related diseases in 22 countries and determine the factors associated with differences in knowledge. We used data from the Global Adult Tobacco Survey (GATS), a nationally representative survey of persons aged ≥15 years. GATSs were conducted from 2008 to 2013 in 22 low-income and middle-income countries. Information was gathered on tobacco-related knowledge and noticing of antismoking mass media messages and health warning labels on cigarette packages. We constructed a four-point knowledge scale and performed multivariate regression analyses. Median country values for the proportion of adults who believed smoking causes a specific illness were 95.9% for lung cancer, 82.5% for heart attack and 74.0% for stroke. Knowledge scores ranged from 2.1 to 3.8. In multivariate regressions, adults scored significantly higher on the knowledge scale if they noticed antismoking media messages (22 countries) or health warning labels (17 countries). Significantly higher knowledge scores occurred in all 9 countries with pictorial health warning labels compared with only 8 out of 13 countries with text-only warning labels. Antismoking media messages appear effective for warning the public about the harms from tobacco use in all 22 countries, while warning labels are effective in the majority of these countries. Our findings suggest opportunities to motivate smoking cessation globally. 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/
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
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.
Pimecrolimus in atopic dermatitis: consensus on safety and the need to allow use in infants.

PubMed

Luger, Thomas; Boguniewicz, Mark; Carr, Warner; Cork, Michael; Deleuran, Mette; Eichenfield, Lawrence; Eigenmann, Philippe; Fölster-Holst, Regina; Gelmetti, Carlo; Gollnick, Harald; Hamelmann, Eckard; Hebert, Adelaide A; Muraro, Antonella; Oranje, Arnold P; Paller, Amy S; Paul, Carle; Puig, Luis; Ring, Johannes; Siegfried, Elaine; Spergel, Jonathan M; Stingl, Georg; Taieb, Alain; Torrelo, Antonio; Werfel, Thomas; Wahn, Ulrich

2015-06-01

Atopic dermatitis (AD) is a distressing dermatological disease, which is highly prevalent during infancy, can persist into later life and requires long-term management with anti-inflammatory compounds. The introduction of the topical calcineurin inhibitors (TCIs), tacrolimus and pimecrolimus, more than 10 yr ago was a major breakthrough for the topical anti-inflammatory treatment of AD. Pimecrolimus 1% is approved for second-line use in children (≥2 yr old) and adults with mild-to-moderate AD. The age restriction was emphasized in a boxed warning added by the FDA in January 2006, which also highlights the lack of long-term safety data and the theoretical risk of skin malignancy and lymphoma. Since then, pimecrolimus has been extensively investigated in short- and long-term studies including over 4000 infants (<2 yr old). These studies showed that pimecrolimus effectively treats AD in infants, with sustained improvement with long-term intermittent use. Unlike topical corticosteroids, long-term TCI use does not carry the risks of skin atrophy, impaired epidermal barrier function or enhanced percutaneous absorption, and so is suitable for AD treatment especially in sensitive skin areas. Most importantly, the studies of pimecrolimus in infants provided no evidence for systemic immunosuppression, and a comprehensive body of evidence from clinical studies, post-marketing surveillance and epidemiological investigations does not support potential safety concerns. In conclusion, the authors consider that the labelling restrictions regarding the use of pimecrolimus in infants are no longer justified and recommend that the validity of the boxed warning for TCIs should be reconsidered. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Cancer illustrations and warning labels on cigarette packs: perceptions of teenagers from high socioeconomic status in Lahore.

PubMed

Zil-E-Ali, Ahsan; Ahsen, Noor Fatima; Iqbal, Humaira

2015-06-01

Smoking is linked with adverse health outcomes and multi-organ diseases with six million deaths every year. The smoking population includes both genders and the habit is seen in minors as well. The cross-sectional study was conducted in Lahore among teenagers belonging to high socioeconomic class. A sample of 191 students was recruited by convenience sampling. The teenagers were questioned on their perceptions relating to prohibition labels, factors that led them to smoke, and ideas to make health warnings more effective. Overall, 66(34.55%) teenagers were smokers, and of them, 50(75.75%) were boys and 16(24.24%) were girls. Besides, 25(37.9%) smokers were of the view that smoking is a bad habit; 40(60.6%) said prohibition labels would not change the mindset of the smoker; 35(53%)believed that a smoker is completely uninfluenced by prohibition labels. Results suggest that the warning labels on cigarette packs should be made more comprehensible and alarming for smokers.
"Bringing a Butter Knife to a Gun Fight"? Salience, Disclosure, and FDA's Differing Approaches to the Tobacco Use and Obesity Epidemics.

PubMed

Weimholt, Josef

2015-01-01

One might expect--given the vastly different look, feel, and function of the ubiquitous (and innocuous) Nutrition Facts panel and the "inflammatory" graphic warning labels for cigarettes--that the statutes establishing such disclosure requirements would exhibit similar disparities. In fact, the relevant provisions of the Nutrition Labeling and Education Act of 1990 and the Family Smoking Prevention and Tobacco Control Act of 2009 are. quite analogous. Like other mandated disclosures, the nutrition label and the cigarette. graphic warnings seek to simultaneously inform and influence consumer decisions. Both statutes grant FDA considerable discretion in.the implementation of the labeling requirements, generally allowing the agency to alter the format and content of the labels as necessary to promote the statutory goals. Thus, the differences in the nutrition and cigarette warning labels are not the product of the statutory schemes alone; rather, they reflect important differences in FDA's interpretation and prioritization of the dual regulatory goals, and in the agency's implicit or explicit assumptions about human behavior.
Positive impact of Australian ‘blindness’ tobacco warning labels: findings from the ITC four country survey

PubMed Central

Kennedy, Ryan David; Spafford, Marlee M; Behm, Ilan; Hammond, David; Fong, Geoffrey T; Borland, Ron

2013-01-01

Background Smokers with greater knowledge of the health effects of smoking are more likely to quit and remain abstinent. Australia has communicated the causal association of smoking and blindness since the late 1990s. In March 2007, Australia became the first country to include a pictorial warning label on cigarette packages with the message that smoking causes blindness. The current study tested the hypothesis that the introduction of this warning label increased smokers’ knowledge of this important health effect. Methods Six waves of the International Tobacco Control Four Country Survey were conducted, as a telephone survey of 17,472 adult smokers in Australia, Canada, United Kingdom and the United States, with three waves before and three waves after the blindness health warning was introduced in Australia. The survey measured adult smokers’ knowledge that smoking causes blindness. Results Australian smokers were significantly more likely to report that smoking causes blindness, compared to Canadian, UK and US smokers, where there were neither health campaigns nor health warnings labels about blindness. After the introduction of the blindness warning, Australian smokers were more likely than before the blindness warning to report that they know that smoking causes blindness (62 versus 49 per cent; OR = 1.68, 95% CI: 1.03, 2.76, p = 0.04). In Australia, smokers aged over 55 years were less likely than those aged 18 to 24 to report that smoking causes blindness (OR = 0.43; 95% CI: 0.29, 0.62, p < 0.001). Conclusion While more smokers report that smoking causes blindness in Australia compared to other countries, which have not had national social marketing campaigns, further gains in knowledge were found after pictorial warning labels were introduced in Australia. Findings suggest there is still a need to educate the public about the causal association of smoking and blindness. More education may be needed to redress the knowledge gap in older Australian smokers as the incidence of age-related macular degeneration increases with age. PMID:22882362
Evaluating the effectiveness of a smoking warning label on raising patient awareness of smoking and bladder cancer.

PubMed

Johnson, B; Abouassaly, R; Ghiculete, D; Stewart, R J

2013-08-01

We assessed the knowledge of patients with regard to the association between smoking and bladder cancer, and examined the impact of a novel smoking warning label on raising awareness of this issue. We conducted a prospective cross-sectional study involving patients who presented to urology and family practice clinics. A questionnaire was used to assess knowledge regarding the association between smoking and various diseases. Participants were also asked to evaluate a novel smoking warning label for bladder cancer. A total of 291 (97%) patients responded to the questionnaire including 143 (95.3%) at urology clinics and 148 (98.7%) at family practice clinics. Overall only 45.2% of respondents were aware of the association between smoking and bladder cancer compared to 97.4% who knew that there was an association between smoking and lung cancer. There were no significant differences in knowledge between those at urology and family practice clinics. After viewing the warning label, 58.1% of respondents stated that it had changed their opinion on smoking and bladder cancer, and 74.8% felt that this label would be an effective tool to raise awareness of the issue. Patients who changed their opinion had statistically significantly less initial knowledge about the association between smoking and bladder cancer (36.7% vs 57.5% for those who did not change their opinion, p <0.001). Awareness of the link between smoking and bladder cancer remains low. The use of a smoking warning label may help raise awareness of this important public health issue. Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
Ohio Appalachian residents' views on smoke-free laws and cigarette warning labels.

PubMed

Reiter, Paul L; Wewers, Mary E; Paskett, Electra D; Klein, Elizabeth G; Katz, Mira L

2012-01-01

Smoke-free laws and the addition of graphic warning labels to cigarette packages represent public health policies that can potentially reduce smoking and smoking-related disease. The attitudes and beliefs relating to these policies were examined among residents of Ohio Appalachia, a mostly rural region with high smoking prevalence among its residents. Focus groups were conducted with participants from Ohio Appalachia during the summer of 2007. Groups included healthcare providers (n=37), community leaders (n=31), parents (n=19), and young adult women aged 18-26 years (n=27). Most participants were female (94%), non-Hispanic White (94%), and married (65%). Participants believed that most non-smokers supported Ohio's enforced statewide comprehensive smoke-free law that began in 2007, while some smokers opposed the law due to a perceived infringement of their rights. They also reported that most residents and local businesses were abiding by and enforcing the law. Participants supported the addition of graphic warning labels to cigarette packages in the USA. They believed that such warning labels could help deter adolescents and adult non-smokers from smoking initiation, particularly if the negative aesthetic effects of smoking were emphasized. However, they felt the labels would be less effective among current smokers and older individuals living in their communities. Participants generally held positive views about both the smoke-free law and the addition of graphic warning labels to cigarette packages in the USA. These tobacco-related public health policies are promising strategies for potentially reducing smoking and its associated diseases among residents living in Appalachia. Additional research is needed to further examine support for these policies among more diverse Appalachian populations.

21 CFR 347.52 - Labeling of astringent drug products.

Code of Federal Regulations, 2010 CFR

2010-04-01

... use only”. (ii) The labeling states “When using this product [bullet] avoid contact with eyes. If... affected area. Dry pencil after use.” (3) For products containing witch hazel identified in § 347.12(c... may be omitted. The second warning in § 347.52(c)(1) may state: “avoid contact with eyes”. The warning...
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.
Cigarette Graphic Warning Labels Are Not Created Equal: They Can Increase or Decrease Smokers' Quit Intentions Relative to Text-Only Warnings.

PubMed

Evans, Abigail T; Peters, Ellen; Shoben, Abigail B; Meilleur, Louise R; Klein, Elizabeth G; Tompkins, Mary Kate; Romer, Daniel; Tusler, Martin

2017-10-01

Cigarette graphic-warning labels elicit negative emotion. Research suggests negative emotion drives greater risk perceptions and quit intentions through multiple processes. The present research compares text-only warning effectiveness to that of graphic warnings eliciting more or less negative emotion. Nationally representative online panels of 736 adult smokers and 469 teen smokers/vulnerable smokers were randomly assigned to view one of three warning types (text-only, text with low-emotion images, or text with high-emotion images) four times over 2 weeks. Participants recorded their emotional reaction to the warnings (measured as arousal), smoking risk perceptions, and quit intentions. Primary analyses used structural equation modeling. Participants in the high-emotion condition reported greater emotional reaction than text-only participants (bAdult = 0.21; bTeen = 0.27, p's < .004); those in the low-emotion condition reported lower emotional reaction than text-only participants (bAdult = -0.18; bTeen = -0.22, p's < .018). Stronger emotional reaction was associated with increased risk perceptions in both samples (bAdult = 0.66; bTeen = 0.85, p's < .001) and greater quit intentions among adults (bAdult = 1.00, p < .001). Compared to text-only warnings, low-emotion warnings were associated with reduced risk perceptions and quit intentions whereas high-emotion warnings were associated with increased risk perceptions and quit intentions. Warning labels with images that elicit more negative emotional reaction are associated with increased risk perceptions and quit intentions in adults and teens relative to text-only warnings. However, graphic warnings containing images which evoke little emotional reaction can backfire and reduce risk perceptions and quit intentions versus text-only warnings. This research is the first to directly manipulate two emotion levels in sets of nine cigarette graphic warning images and compare them with text-only warnings. Among adult and teen smokers, high-emotion graphic warnings were associated with increased risk perceptions and quit intentions versus text-only warnings. Low-emotion graphic warnings backfired and tended to reduce risk perceptions and quit intentions versus text-only warnings. Policy makers should be aware that merely placing images on cigarette packaging is insufficient to increase smokers' risk perceptions and quit intentions. Low-emotion graphic warnings will not necessarily produce desired population-level benefits relative to text-only or high-emotion warnings. © 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.
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…
Teaching Generalized Reading of Product Warning Labels to Young Adults with Autism Using the Constant Time Delay Procedure

ERIC Educational Resources Information Center

Dogoe, Maud S.; Banda, Devender R.; Lock, Robin H.; Feinstein, Rita

2011-01-01

This study examined the effectiveness of the constant timed delay procedure for teaching two young adults with autism to read, define, and state the contextual meaning of keywords on product warning labels of common household products. Training sessions were conducted in the dyad format using flash cards. Results indicated that both participants…
30 CFR 47.43 - Label alternatives.

Code of Federal Regulations, 2010 CFR

2010-07-01

... COMMUNICATION (HazCom) Container Labels and Other Forms of Warning § 47.43 Label alternatives. The operator may... container to which it applies, (b) Communicates the same information as required on the label, and (c) Is...
Impact of Waterpipe Tobacco Pack Health Warnings on Waterpipe Smoking Attitudes: A Qualitative Analysis among Regular Users in London.

PubMed

Jawad, Mohammed; Bakir, Ali; Ali, Mohammed; Grant, Aimee

2015-01-01

Despite the rise in prevalence of waterpipe tobacco smoking, it has received little legislative enforcement from governing bodies, especially in the area of health warning labels. Twenty regular waterpipe tobacco smokers from London took part in five focus groups discussing the impact of waterpipe tobacco pack health warnings on their attitudes towards waterpipe smoking. We presented them with existing and mock waterpipe tobacco products, designed to be compliant with current and future UK/EU legislation. Data were analysed using thematic analysis. Participants felt packs were less attractive and health warnings were more impactful as health warnings increased in size and packaging became less branded. However, participants highlighted their lack of exposure to waterpipe tobacco pack health warnings due to the inherent nature of waterpipe smoking, that is, smoking in a café with the apparatus already prepacked by staff. Health warnings at the point of consumption had more reported impact than health warnings at the point of sale. Waterpipe tobacco pack health warnings are likely to be effective if compliant with existing laws and exposed to end-users. Legislations should be reviewed to extend health warning labels to waterpipe accessories, particularly the apparatus, and to waterpipe-serving premises.
Considerations and Future Research Directions for E-Cigarette Warnings-Findings from Expert Interviews.

PubMed

Wackowski, Olivia A; Hammond, David; O'Connor, Richard J; Strasser, Andrew A; Delnevo, Cristine D

2017-07-14

Tobacco warning labels are important sources of risk information but research historically has been cigarette-centric. This qualitative study aimed to inform future direction and research on warnings for e-cigarettes. Between June and August 2016, we conducted interviews with 10 researchers with expertise in tobacco warning label research. Interviewees were registrants of a 2016 National Cancer Institute grantee meeting on tobacco warnings. Several participants agreed that the Food and Drug Administration's new nicotine addiction warning for e-cigarettes could be informative but that it might not resonate with young people. Many agreed that more than one warning would be important as e-cigarette science evolves and that research on additional warning themes (e.g., nicotine exposure, harmful constituents) and execution styles (including use of pictorials) was important. Participants were somewhat mixed about the use of reduced-risk messages within e-cigarette warnings, but agreed that research on how to communicate about cigarette/e-cigarette relative risks was needed. Overall, more research is needed on tobacco warnings for non-cigarette products, including on the message content, placement, execution and potential impact on audiences' product knowledge, risk perceptions and use intentions. This is particularly needed for products such as e-cigarettes which may have harm-reduction potential relative to cigarettes and require unique considerations.
Impact of Waterpipe Tobacco Pack Health Warnings on Waterpipe Smoking Attitudes: A Qualitative Analysis among Regular Users in London

PubMed Central

Bakir, Ali; Ali, Mohammed; Grant, Aimee

2015-01-01

Background. Despite the rise in prevalence of waterpipe tobacco smoking, it has received little legislative enforcement from governing bodies, especially in the area of health warning labels. Methods. Twenty regular waterpipe tobacco smokers from London took part in five focus groups discussing the impact of waterpipe tobacco pack health warnings on their attitudes towards waterpipe smoking. We presented them with existing and mock waterpipe tobacco products, designed to be compliant with current and future UK/EU legislation. Data were analysed using thematic analysis. Results. Participants felt packs were less attractive and health warnings were more impactful as health warnings increased in size and packaging became less branded. However, participants highlighted their lack of exposure to waterpipe tobacco pack health warnings due to the inherent nature of waterpipe smoking, that is, smoking in a café with the apparatus already prepacked by staff. Health warnings at the point of consumption had more reported impact than health warnings at the point of sale. Conclusions. Waterpipe tobacco pack health warnings are likely to be effective if compliant with existing laws and exposed to end-users. Legislations should be reviewed to extend health warning labels to waterpipe accessories, particularly the apparatus, and to waterpipe-serving premises. PMID:26273642
Traffic Light System Can Increase Healthfulness Perception: Implications for Policy Making.

PubMed

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

2018-04-04

To evaluate how information about low nutrient content included in the traffic light labeling system influences consumers' perception of the healthfulness of products with high content of 1 key nutrient, and to compare the traffic light system with warnings in terms of the perception of healthfulness. Images of front-of-pack (FOP) nutrition labels (the traffic light labeling system with different numbers of nutrients with low content, and warnings) were evaluated in study 1, whereas product labels featuring the different FOP nutrition labels were evaluated in study 2. Online studies conducted in Montevideo, Uruguay. A total of 1,228 Uruguayan Facebook users. Perception of healthfulness. The researchers used ANOVA to evaluate the influence of FOP nutrition labels on perceived healthfulness. The inclusion of information about low nutrient content in the traffic light system statistically significantly increased the perception of the healthfulness of products with high nutrient content. Nutritional warnings showed healthfulness ratings similar to those of the simplified version of the traffic light system. Information about low nutrient content in the traffic light system might be used to infer health, and thus could raise the perception of healthfulness and decrease the traffic light system's efficacy in discouraging the consumption of unhealthful products. A simplified version of the traffic light highlighting only high-nutrient content or nutritional warnings seems to overcome this problem. Copyright © 2018 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.
The Impact of Health Warning Labels for Swedish Snus Advertisements on Young Adults' Snus Perceptions and Behavioral Intentions.

PubMed

Mays, Darren; Moran, Meghan B; Levy, David T; Niaura, Raymond S

2016-05-01

This study examined the impact of warning labels conveying the potential harms and addictiveness of Swedish snus and the potential-reduced harms of Swedish snus among young adult nonsmokers and smokers. A convenience sample of young adults aged 18-30 residing in the United States (n = 517, 56% male, 33% smokers) participated in an online experiment. Participants completed baseline measures and were randomized to 1 of 5 experimental conditions where they viewed a Swedish snus ad with warning labels that varied by condition: (1) Control-no warning; (2) Addiction-warning conveying the addictiveness of snus; (3) Harm-warning communicating the potential harms of snus; (4) Harm Reduction-warning conveying the potential-reduced harms of snus compared with cigarettes; (5) Harm Reduction Switch-warning communicating the potential-reduced harms of snus when switching completely from cigarettes to snus. Outcomes measured included perceived harms and addictiveness of snus, thoughts about not using snus, and intentions to use snus. Participants in the Harm Reduction and Harm Reduction Switch conditions perceived snus to be less harmful than cigarettes compared with the Control, Addiction, and Harm conditions. Nonsmokers in the Harm Reduction condition reported fewer thoughts about not using snus than nonsmokers in the Harm condition. Warnings conveying the potential-reduced harms of Swedish snus compared with cigarettes generate perceptions that snus is less harmful than cigarettes and produce fewer thoughts about not using snus among nonsmokers. Such perceptions have been associated with snus use in prior studies. © 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.
49. BOX STAMPING MACHINE Located in room above warehouse. The ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

49. BOX STAMPING MACHINE Located in room above warehouse. The power unit is missing, but the drive belt is seen hanging from the overhead. Printing plate of desired labeling would be attached to the lower half drum. Upon rotation, labeling would be transferred to a cardboard box which was being held around the upper drum. - Hovden Cannery, 886 Cannery Row, Monterey, Monterey County, CA
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
PRIORITIZING FUTURE RESEACH ON OFF-LABEL PRESCRIBING: RESULTS OF A QUANTITATIVE EVALUATION

PubMed Central

Walton, Surrey M.; Schumock, Glen T.; Lee, Ky-Van; Alexander, G. Caleb; Meltzer, David; Stafford, Randall S.

2015-01-01

Background Drug use for indications not approved by the Food and Drug Administration exceeds 20% of prescribing. Available compendia indicate that a minority of off-label uses are well supported by evidence. Policy makers, however, lack information to identify where systematic reviews of the evidence or other research would be most valuable. Methods We developed a quantitative model for prioritizing individual drugs for future research on off-label uses. The base model incorporated three key factors, 1) the volume of off-label use with inadequate evidence, 2) safety, and 3) cost and market considerations. Nationally representative prescribing data were used to estimate the number of off-label drug uses by indication from 1/2005 through 6/2007 in the United States, and these indications were then categorized according to the adequacy of scientific support. Black box warnings and safety alerts were used to quantify drug safety. Drug cost, date of market entry, and marketing expenditures were used to quantify cost and market considerations. Each drug was assigned a relative value for each factor, and the factors were then weighted in the final model to produce a priority score. Sensitivity analyses were conducted by varying the weightings and model parameters. Results Drugs that were consistently ranked highly in both our base model and sensitivity analyses included quetiapine, warfarin, escitalopram, risperidone, montelukast, bupropion, sertraline, venlafaxine, celecoxib, lisinopril, duloxetine, trazodone, olanzapine, and epoetin alfa. Conclusion Future research into off-label drug use should focus on drugs used frequently with inadequate supporting evidence, particularly if further concerns are raised by known safety issues, high drug cost, recent market entry, and extensive marketing. Based on quantitative measures of these factors, we have prioritized drugs where targeted research and policy activities have high potential value. PMID:19025425
Factors Affecting the Perceived Effectiveness of Pictorial Health Warnings on Cigarette Packages in Gulf Countries: A Cross-sectional Study.

PubMed

Mansour, Ameerah Y; Bakhsh, Zuhair

2017-01-01

To explore the perceived effectiveness of pictorial health warning (PHW) labels required by the Gulf Cooperation Council, to compare them with the Food and Drug Administration-approved PHW labels, and to determine factors affecting their perceived effectiveness. A cross-sectional study using a convenience sample of adult smokers and nonsmokers was conducted. The data were collected through a self-administered online questionnaire. The perceived effectiveness scores of PHW labels were calculated and compared among different subgroups using the Kruskal-Wallis test and the Dunn multiple comparison test at a .05 significance level. Of the 90 people invited to participate in the survey, 77 (86%) completed it, with 39 (50%) nonsmokers, 22 (29%) smokers, and 16 (21%) former smokers. Overall, labels having graphic images of illness or pathology are perceived to be most effective. Smokers generally perceived labels significantly less effective compared with former smokers and nonsmokers. Also, 55 respondents (71%) suggested that the presence of a telephone quit-line would be effective. Smoking status and image type had the most effect on the perceived effectiveness of the PHW labels on cigarette packs. Pictorial health warning labels with graphic images of pathology and a telephone quit-line are perceived to be most effective.
21 CFR 358.350 - Labeling of ingrown toenail relief drug products.

Code of Federal Regulations, 2010 CFR

2010-04-01

... established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter...) Warnings. The labeling of the product contains the following warnings under the heading “Warnings”: (1) “For external use only” in accord with § 201.66(c)(5)(i) of this chapter. (2) “Do not use [bullet] 1 on...
The Impact of Graphic Cigarette Warning Labels and Smoke-Free Law on Health Awareness and Thoughts of Quitting in Taiwan

ERIC Educational Resources Information Center

Chang, Fong-Ching; Chung, Chi-Hui; Yu, Po-Tswen; Chao, Kun-yu

2011-01-01

The present study evaluated the impact of Taiwan's graphic cigarette warning labels and smoke-free law on awareness of the health hazards of smoking and thoughts of quitting smoking. National representative samples of 1074 and 1094 people, respectively, were conducted successfully by telephone in July 2008 (pre-law) and March 2009 (post-law).…
Considerations and Future Research Directions for E-Cigarette Warnings—Findings from Expert Interviews

PubMed Central

Wackowski, Olivia A.; Hammond, David; O’Connor, Richard J.; Strasser, Andrew A.; Delnevo, Cristine D.

2017-01-01

Tobacco warning labels are important sources of risk information but research historically has been cigarette-centric. This qualitative study aimed to inform future direction and research on warnings for e-cigarettes. Between June and August 2016, we conducted interviews with 10 researchers with expertise in tobacco warning label research. Interviewees were registrants of a 2016 National Cancer Institute grantee meeting on tobacco warnings. Several participants agreed that the Food and Drug Administration’s new nicotine addiction warning for e-cigarettes could be informative but that it might not resonate with young people. Many agreed that more than one warning would be important as e-cigarette science evolves and that research on additional warning themes (e.g., nicotine exposure, harmful constituents) and execution styles (including use of pictorials) was important. Participants were somewhat mixed about the use of reduced-risk messages within e-cigarette warnings, but agreed that research on how to communicate about cigarette/e-cigarette relative risks was needed. Overall, more research is needed on tobacco warnings for non-cigarette products, including on the message content, placement, execution and potential impact on audiences’ product knowledge, risk perceptions and use intentions. This is particularly needed for products such as e-cigarettes which may have harm-reduction potential relative to cigarettes and require unique considerations. PMID:28708124
The influence of graphic warning labels on efficacy beliefs and risk perceptions: a qualitative study with low-income, urban smokers.

PubMed

Mead, Erin L; Cohen, Joanna E; Kennedy, Caitlin E; Gallo, Joseph; Latkin, Carl A

2016-01-01

Health communication theories indicate that messages depicting efficacy and threat might promote behavior change by enhancing individuals' efficacy beliefs and risk perceptions, but this has received little attention in graphic warning label research. We explored low socioeconomic status (SES) smokers' perceptions of theory-based graphic warning labels to inform the development of labels to promote smoking cessation. Twelve graphic warning labels were developed with self-efficacy and response efficacy messages paired with messages portraying high, low, or no threat from smoking. Self-efficacy messages were designed to promote confidence in ability to quit, while response efficacy messages were designed to promote confidence in the ability of the Quitline to aid cessation. From January - February 2014, we conducted in-depth interviews with 25 low SES adult men and women smokers in Baltimore, Maryland, U.S. Participants discussed the labels' role in their self-efficacy beliefs, response efficacy beliefs about the Quitline, and risk perceptions (including perceived severity of and susceptibility to disease). Data were analyzed through framework analysis, a type of thematic analysis. Efficacy messages in which participants vicariously experienced the characters' quit successes were reported as most influential to self-efficacy beliefs. Labels portraying a high threat were reported as most influential to participants' perceived severity of and susceptibility to smoking risks. Self-efficacy messages alone and paired with high threat were seen as most influential on self-efficacy beliefs. Labels portraying the threat from smoking were most motivational for calling the Quitline, followed by labels showing healthy role models who had successfully quit using the Quitline. Role model-based efficacy messages might enhance the effectiveness of labels by making smokers' self-efficacy beliefs about quitting most salient and enhancing the perceived efficacy of the Quitline. Threatening messages play an important role in enhancing risk perceptions, but findings suggest that efficacy messages are also important in the impact of labels on beliefs and motivation. Our findings could aid in the development of labels to address smoking disparities among low SES populations in the U.S.
Assessing the Consequences of Implementing Graphic Warning Labels on Cigarette Packs for Tobacco-Related Health Disparities.

PubMed

Gibson, Laura; Brennan, Emily; Momjian, Ani; Shapiro-Luft, Dina; Seitz, Holli; Cappella, Joseph N

2015-08-01

Population-level communication interventions, such as graphic warning labels (GWLs) on cigarette packs, have the potential to reduce or exacerbate tobacco-related health disparities depending on their effectiveness among disadvantaged sub-populations. This study evaluated the likely impact of nine GWLs proposed by the US Food and Drug Administration on (1) African American and (2) Hispanic smokers, who disproportionately bear the burden of tobacco-related illness, and (3) low education smokers, who have higher smoking rates. Data were collected online from current smokers randomly assigned to see GWLs (treatment) or the current text-only warning labels (control). Participants were stratified by age (18-25; 26+) in each of four groups: general population (n = 1246), African Americans (n = 1200), Hispanics (n = 1200), and low education (n = 1790). We tested the effectiveness of GWLs compared to text-only warning labels using eight outcomes that are predictive of quitting intentions or behaviors including negative emotion, intentions to hold back from smoking, intentions to engage in avoidance behaviors, and intentions to quit. Across all outcomes, GWLs were significantly more effective than text-only warning labels more often than expected by chance. Results suggested that African Americans, Hispanics and smokers with low education did not differ from the general population of smokers in their reactions to any of the nine individual GWLs. The nine GWLs were similarly effective for disadvantaged sub-populations and the general population of smokers. Implementation of GWLs is therefore unlikely to reduce or exacerbate existing tobacco-related health disparities, but will most likely uniformly increase intentions and behaviors predictive of smoking cessation. © 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.

Assessing the Consequences of Implementing Graphic Warning Labels on Cigarette Packs for Tobacco-Related Health Disparities

PubMed Central

Brennan, Emily; Momjian, Ani; Shapiro-Luft, Dina; Seitz, Holli; Cappella, Joseph N.

2015-01-01

Introduction: Population-level communication interventions, such as graphic warning labels (GWLs) on cigarette packs, have the potential to reduce or exacerbate tobacco-related health disparities depending on their effectiveness among disadvantaged sub-populations. This study evaluated the likely impact of nine GWLs proposed by the US Food and Drug Administration on (1) African American and (2) Hispanic smokers, who disproportionately bear the burden of tobacco-related illness, and (3) low education smokers, who have higher smoking rates. Methods: Data were collected online from current smokers randomly assigned to see GWLs (treatment) or the current text-only warning labels (control). Participants were stratified by age (18–25; 26+) in each of four groups: general population (n = 1246), African Americans (n = 1200), Hispanics (n = 1200), and low education (n = 1790). We tested the effectiveness of GWLs compared to text-only warning labels using eight outcomes that are predictive of quitting intentions or behaviors including negative emotion, intentions to hold back from smoking, intentions to engage in avoidance behaviors, and intentions to quit. Results: Across all outcomes, GWLs were significantly more effective than text-only warning labels more often than expected by chance. Results suggested that African Americans, Hispanics and smokers with low education did not differ from the general population of smokers in their reactions to any of the nine individual GWLs. Conclusions: The nine GWLs were similarly effective for disadvantaged sub-populations and the general population of smokers. Implementation of GWLs is therefore unlikely to reduce or exacerbate existing tobacco-related health disparities, but will most likely uniformly increase intentions and behaviors predictive of smoking cessation. PMID:26180214
Australia's double standard on Thailand's alcohol warning labels.

PubMed

O'Brien, Paula

2013-01-01

Since 2010, members of the World Trade Organization (WTO), including Australia, have opposed Thailand's proposal for graphic warnings on alcohol containers. This paper aims to provide an account of the arguments for/against Thailand and to examine the arguments' legal and political validity. This paper reviews primary WTO records in relation to Thailand's proposal to reveal the arguments for/against Thailand's proposal. The paper analyses these arguments in light of WTO cases to identify the legal strengths and weaknesses of Thailand's position. The paper then considers whether the attacks on Thailand by Australia are justified in light of the Australian Government's position on (i) alcohol warning labels in Australia and (ii) tobacco plain packaging. The legal arguments against Thailand are: only harmful alcohol consumption should be prevented; there is no evidence that graphic warning labels can reduce alcohol-related harm; the labels unnecessarily restrict international trade. There are some legal weaknesses in Thailand's proposal. Yet, Australia's opposition to Thailand cannot be justified whilst Australia is (i) mandating pregnancy-related alcohol warnings in Australia and (ii) defending its plain packaging law against similar WTO attacks. No WTO member is obliged to challenge another member for being non-compliant. The case tests the willingness of WTO members like Australia to respect the autonomy of other countries to pursue their public health goals and trial novel interventions. Australia's actions suggest it is willing to protect its alcohol industry at the expense of public health in Thailand. © 2012 Australasian Professional Society on Alcohol and other Drugs.
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.
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.
Advancing Tobacco Product Warning Labels Research Methods and Theory: A Summary of a Grantee Meeting Held by the US National Cancer Institute.

PubMed

Thrasher, James F; Brewer, Noel T; Niederdeppe, Jeff; Peters, Ellen; Strasser, Andrew A; Grana, Rachel; Kaufman, Annette R

2018-02-10

The World Health Organization's Framework Convention on Tobacco Control recommends prominent pictorial health warnings on tobacco products. To advance research methods, theory and understanding of how tobacco product warning labels (TPWLs) work, the US National Cancer Institute convened a grantee meeting. Our article describes the key insights that emerged from the meeting, situated within the context of the scientific literature. First, presentations confirmed that large, pictorial TPWLs motivate people to try to quit and encourage smoking cessation. Second, pictorial TPWLs increase attention, knowledge, negative affect, and thinking about the warning. Third, TPWL studies have primarily used brief-exposure laboratory studies and observational studies of sustained exposure through national policy implementation, with a few randomized trials involving several weeks of exposure-with generally consistent results found across study designs. Fourth, novel assessment methods include brain imaging, eye tracking and "best-worst" discrete choice experiments. To make TPWL even more effective, research is needed to confirm the mechanisms of their influence, their impact across vulnerable populations, and their effect on social media posts about tobacco products. Research is also needed on the effect of trial design choices, the predictive validity of new measurement approaches, and warning labels for non-cigarette tobacco products. To improve scientific understanding of TPWL effects, this grantee meeting summary describes emerging research methods, theory and study results. Directions for future research include examination of the mechanisms of how warning labels work across diverse tobacco products and across different populations and contexts. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco 2018. This work is written by (a) US Government employee(s) and is in the public domain in the US.
Hospital outpatients' responses to taking medications with driving warnings.

PubMed

Smyth, T; Sheehan, M; Siskind, V

2013-01-01

The study investigates the knowledge, intentions, and driving behavior of persons prescribed medications that display a warning about driving. It also examines their confidence that they can self-assess possible impairment, as is required by the Australian labeling system. We surveyed 358 outpatients in an Australian public hospital pharmacy, representing a well-advised group taking a range of medications including those displaying a warning label about driving. A brief telephone follow-up survey was conducted with a subgroup of the participants. The sample had a median age of 53.2 years and was 53 percent male. Nearly three quarters (73.2%) had taken a potentially impairing class of medication and more than half (56.1%) had taken more than one such medication in the past 12 months. Knowledge of the potentially impairing effects of medication was relatively high for most items; however, participants underestimated the possibility of increased impairment from exceeding the prescribed dose and at commencing treatment. Participants' responses to the safety implications of taking drugs with the highest level of warning varied. Around two thirds (62.8%) indicated that they would consult a health practitioner for advice and around half would modify their driving in some way. However, one fifth (20.9%) would drive when the traffic was thought to be less heavy and over a third (37.7%) would modify their medication regime so that they could drive. The findings from the follow-up survey of a subsample taking target drugs at the time of the first interview were also of concern. Only just over half (51%) recalled seeing the warning label on their medications and, of this group, three quarters (78%) reported following the warning label advice. These findings indicated that there remains a large proportion of people who either did not notice or did not consider the warning when deciding whether to drive. There was a very high level of confidence in this group that they could determine whether they were personally affected by the medication, which may be a problem from a safety perspective. This study involved persons who should have had a very high level of knowledge and awareness of medication warning labeling. Even in this group there was a lack of informed response to potential impairment. A review of the Australian warning system and wider dissemination of information on medication treatment effects would be useful. Clarifying the importance of potential risk in the general community context is recommended for consideration and further research.
Risk management strategies in the Physicians' Desk Reference product labels for pregnancy category X drugs.

PubMed

Uhl, Kathleen; Kennedy, Dianne L; Kweder, Sandra L

2002-01-01

Drugs that carry a concern for teratogenicity are often classified as pregnancy category X in the drug label and contraindicated for use during pregnancy. Many drug labels can be found in the Physicians' Desk Reference (PDR), a widely used source of drug information by American clinicians and patients. To review product labelling in the electronic PDR for the pregnancy category X products for pregnancy prevention risk management components in labelling. The electronic version of the 2001 and 2002 PDR was searched for 'pregnancy category X' products using the full text search feature. All product labels identified were retrieved and reviewed for trade name, generic name, manufacturer and indication. Product labels were manually searched for any pregnancy prevention risk management strategies included in labelling. Those labels that had specific pregnancy prevention risk management strategies were further evaluated. One hundred and seventeen pregnancy category X products were obtained from 2249 products searched in the 2001 PDR database and 124 pregnancy category X products were obtained from the 2150 products in the 2002 PDR database. All pregnancy category X products identified were drug products. The label/package insert for each drug was reviewed to identify risk management strategies for pregnancy prevention. The majority of the labels include as the sole risk management strategy either a black box warning and/or a contraindication for use in women who are or may become pregnant. Only 13 drugs contained specific pregnancy prevention risk management strategies in the label directing the clinician and/or patient, e.g. frequency of pregnancy testing, number and type of contraception methods. Two drugs, bexarotene capsules and gel, were only included in the 2001 PDR. Three drugs, isotretinoin, acitretin, and thalidomide, have formal pregnancy prevention risk management programmes. This study demonstrates the varied risk management approaches in labelling for pregnancy prevention for pregnancy category X drugs. There is a need for consistency in the classification of pregnancy category X products and the pregnancy prevention risk management strategies utilised in the labelling for them.
Standardised (plain) cigarette packaging increases attention to both text-based and graphical health warnings: experimental evidence.

PubMed

Shankleman, M; Sykes, C; Mandeville, K L; Di Costa, S; Yarrow, K

2015-01-01

To investigate whether standardised cigarette packaging increases the time spent looking at health warnings, regardless of the format of those warnings. A factorial (two pack styles x three warning types) within-subject experiment, with participants randomised to different orders of conditions, completed at a university in London, UK. Mock-ups of cigarette packets were presented to participants with their branded portion in either standardised (plain) or manufacturer-designed (branded) format. Health warnings were present on all packets, representing all three types currently in use in the UK: black & white text, colour text, or colour images with accompanying text. Gaze position was recorded using a specialised eye tracker, providing the main outcome measure, which was the mean proportion of a five-second viewing period spent gazing at the warning-label region of the packet. An opportunity sample of 30 (six male, mean age = 23) young adults met the following inclusion criteria: 1) not currently a smoker; 2) <100 lifetime cigarettes smoked; 3) gaze position successfully tracked for > 50% viewing time. These participants spent a greater proportion of the available time gazing at the warning-label region when the branded section of the pack was standardised (following current Australian guidelines) rather than containing the manufacturer's preferred design (mean difference in proportions = 0.078, 95% confidence interval 0.049 to 0.106, p < 0.001). There was no evidence that this effect varied based on the type of warning label (black & white text vs. colour text vs. colour image & text; interaction p = 0.295). During incidental viewing of cigarette packets, young adult never-smokers are likely to spend more time looking at health warnings if manufacturers are compelled to use standardised packaging, regardless of the warning design. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.
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.
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.
Shake Warning: Helping People Stay Safe With Lots of Small Boxes in the Ground to Warn Them About Strong Shaking

NASA Astrophysics Data System (ADS)

Reusch, M.

2017-12-01

A group of people at schools are joining with the group of people in control of making pictures of the state of rocks on the ground and water in our land. They are working on a plan to help all people be safe in the case of very big ground shaking (when ground breaks in sight or under ground). They will put many small boxes all over the states in the direction of where the sun sets to look for the first shake that might be a sign of an even bigger shake to come. They tell a big computer (with much power) in several large cities in those states. These computers will decide if the first shake is a sign of a very large and close ground shake, a far-away ground shake, a small but close ground shake, or even just a sign of a shake that people wanted to make. If it is a sign of a close and really big shake, then the computers will tell the phones and computers of many people to help them take safe steps before the big shaking arrives where they are. This warning might be several seconds or maybe a couple of minutes. People will be able to hide, take cover, and hold on under tables and desks in case things fall from walls and places up high in their home and work. Doctors will be able to pause hard work and boxes that move people up and down in homes, businesses, and stores will be able to stop on the next floor and open their doors to let people out and not get stuck. It will help slow down trains to be safe and not fly off of the track as well as it will help to shut off water and air that warms homes and is used for when you make food hot. To make this plan become real, people who work for these groups are putting more small boxes in areas where there are not enough and that there are many people. They are also putting small boxes in places where there are no boxes but the big shake might come from that direction. There are problems to get past such as needing many more small boxes, more people to help with this plan, and getting all people who live in these areas to learn what to do when the warning comes about the big shake, but this year there was good news when in month number four they were able to get all of the computers to talk to each other and run the same plan with the same news of the first shaking.
10 CFR 835.605 - Labeling items and containers.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false Labeling items and containers. 835.605 Section 835.605 Energy DEPARTMENT OF ENERGY OCCUPATIONAL RADIATION PROTECTION Posting and Labeling § 835.605 Labeling... shall bear a durable, clearly visible label bearing the standard radiation warning trefoil and the words...
10 CFR 835.605 - Labeling items and containers.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false Labeling items and containers. 835.605 Section 835.605 Energy DEPARTMENT OF ENERGY OCCUPATIONAL RADIATION PROTECTION Posting and Labeling § 835.605 Labeling... shall bear a durable, clearly visible label bearing the standard radiation warning trefoil and the words...
10 CFR 835.605 - Labeling items and containers.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Labeling items and containers. 835.605 Section 835.605 Energy DEPARTMENT OF ENERGY OCCUPATIONAL RADIATION PROTECTION Posting and Labeling § 835.605 Labeling... shall bear a durable, clearly visible label bearing the standard radiation warning trefoil and the words...
10 CFR 835.605 - Labeling items and containers.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 4 2013-01-01 2013-01-01 false Labeling items and containers. 835.605 Section 835.605 Energy DEPARTMENT OF ENERGY OCCUPATIONAL RADIATION PROTECTION Posting and Labeling § 835.605 Labeling... shall bear a durable, clearly visible label bearing the standard radiation warning trefoil and the words...
16 CFR 307.5 - Language requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... regulations shall be set out in the English language. If the label of a smokeless tobacco product contains a required warning in a language other than English, the required warning must also appear in English. In the... publication that is not in English, the warning statement shall appear in the predominant language of the...
The Effect of Cancer Warning Statements on Alcohol Consumption Intentions

ERIC Educational Resources Information Center

Pettigrew, Simone; Jongenelis, Michelle I.; Glance, David; Chikritzhs, Tanya; Pratt, Iain S.; Slevin, Terry; Liang, Wenbin; Wakefield, Melanie

2016-01-01

In response to increasing calls to introduce warning labels on alcoholic beverages, this study investigated the potential effectiveness of alcohol warning statements designed to increase awareness of the alcohol-cancer link. A national online survey was administered to a diverse sample of Australian adult drinkers (n = 1,680). Along with…
The impacts of cigarette packaging pictorial warning labels on smokers in the city of tehran.

PubMed

Heydari, Gholam Reza; Ramezankhani, Ali; Talischi, Firoozeh

2011-01-01

Cigarette smoking is considered the first preventable cause of death in the world. Social, familial, and personal factors play an important role in prevention or cessation of smoking. Educating the public in order to enhance their knowledge, change their attitude and improve their habits is also effective in this respect. In 2007, the executive protocol of the Comprehensive Law on Smoking Control was compiled in the Ministry of Health and according to the Article 5 of this law pictorial health warning labels had to be applied on cigarette packaging. This study was designed and conducted in 2 phases of before and 9 months after the implementation of this law and evaluated the effect of it on smokers' knowledge, attitude and pattern of smoking. This was a cross-sectional descriptive study conducted to evaluate the effect of cigarette packs' pictorial health warning labels on the knowledge, attitude and smoking pattern of smokers residing in Tehran. After calculating the size of understudy population and estimation of the exclusions, 1731 subjects were randomly selected using the multiphase cluster method from the 22 districts of Tehran. Data were collected using a questionnaire designed according to the standard questionnaire of the World Health Organization (WHO) and International Union Against Tuberculosis and Lung Disease (IUATLD). Qualitative and quantitative value and reliability of the variables including cigarette consumption, knowledge about the law, and pattern of smoking were evaluated in 2 phases and the quality of pictures and their effects on the mentioned variables were assessed in the 2(nd) phase. Before adopting the pictorial warning labels in the first phase of the study, 1731 respondents were evaluated out of which 71.8% were males and 28.2% were females. These cases had an average of 17.6±12.3 years history of smoking. A total of 38% (675 subjects) used Iranian cigarette brands and 39.5% were aware of the implementation of pictorial health warning labels on cigarette packs. In terms of smokers' attitude towards the implementation of this law, they mostly had no opinion about it. A total of 33.3% stated that they may cut down on smoking as the result of this law. Men had a higher percentage of smoking a cigarette first thing in the morning before breakfast and women had a higher rate of consuming foreign cigarette brands (P < 0.001). In the second phase of the study, 1590 cases of the phase 1 subjects participated. Subjects had a significantly higher knowledge about the implementation of pictorial health warning labels on cigarette packs (P < 0.001). Attitude towards this law did not change significantly compared to the first phase although the mean score improved by 0.07%. Enforcement of this law resulted in decreased consumption in 7.6% of the participants. However, the Wilcoxon test did not show any significant difference. In terms of the quality of pictures, 61.6% had no opinion, and 28.7% expressed that the pictures had poor quality. No significant difference was observed between the Iranian or foreign brands in terms of smoking rate after applying the pictorial warning labels. We believed that the smoking rate would decrease after applying the pictorial health warning labels on cigarette packs. However, it did not happen. Also, adopting these labels did not have a significant effect on smokers changing their favorite brand from Iranian to foreign brands or vice versa. Type and quality of pictures require major revision and corrections.
The lower effectiveness of text-only health warnings in China compared to pictorial health warnings in Malaysia.

PubMed

Elton-Marshall, Tara; Xu, Steve Shaowei; Meng, Gang; Quah, Anne C K; Sansone, Genevieve C; Feng, Guoze; Jiang, Yuan; Driezen, Pete; Omar, Maizurah; Awang, Rahmat; Fong, Geoffrey T

2015-11-01

In 2009, China changed its health warnings on cigarette packs from side-only text warnings to two text-only warnings on 30% of the bottom of the front and back of the pack. Also in 2009, Malaysia changed from similar text warnings to pictorial health warnings consistent with Framework Convention on Tobacco Control (FCTC) Article 11 Guidelines. To measure the impact of the change in health warnings in China and to compare the text-only health warnings to the impact of the pictorial health warnings introduced in Malaysia. We measured changes in key indicators of warning effectiveness among a longitudinal cohort sample of smokers from Waves 1 to 3 (2006-2009) of the International Tobacco Control (ITC) China Survey and from Waves 3 to 4 (2008-2009) of the ITC Malaysia Survey. Each cohort consisted of representative samples of adult (≥18 years) smokers from six cities in China (n=6575) and from a national sample in Malaysia (n=2883). Generalised Estimating Equations (GEE) were used to examine the impact of the health warnings on subsequent changes in salience of warnings, cognitive and behavioural outcomes. Compared to Malaysia, the weak text-only warning labels in China led to a significant change in only two of six key indicators of health warning effectiveness: forgoing cigarettes and reading the warning labels. The change to pictorial health warnings in Malaysia led to significant and substantial increases in five of six indicators (noticing, reading, forgoing, avoiding, thinking about quitting). The delay in implementing pictorial health warnings in China constitutes a lost opportunity for increasing knowledge and awareness of the harms of cigarettes, and for motivating smokers to quit. 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/
30 CFR 47.42 - Label contents.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Label contents. 47.42 Section 47.42 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR EDUCATION AND TRAINING HAZARD COMMUNICATION (HazCom) Container Labels and Other Forms of Warning § 47.42 Label contents. When an operator must make a label, the label must— (a) Be...

30 CFR 47.42 - Label contents.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Label contents. 47.42 Section 47.42 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR EDUCATION AND TRAINING HAZARD COMMUNICATION (HazCom) Container Labels and Other Forms of Warning § 47.42 Label contents. When an operator must make a label, the label must— (a) Be...
30 CFR 47.42 - Label contents.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Label contents. 47.42 Section 47.42 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR EDUCATION AND TRAINING HAZARD COMMUNICATION (HazCom) Container Labels and Other Forms of Warning § 47.42 Label contents. When an operator must make a label, the label must— (a) Be...
30 CFR 47.42 - Label contents.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Label contents. 47.42 Section 47.42 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR EDUCATION AND TRAINING HAZARD COMMUNICATION (HazCom) Container Labels and Other Forms of Warning § 47.42 Label contents. When an operator must make a label, the label must— (a) Be...
30 CFR 47.42 - Label contents.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Label contents. 47.42 Section 47.42 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR EDUCATION AND TRAINING HAZARD COMMUNICATION (HazCom) Container Labels and Other Forms of Warning § 47.42 Label contents. When an operator must make a label, the label must— (a) Be...
Current Over-the-Counter Medicine Label: Take a Look

MedlinePlus

... of OTC medicines sometimes make changes to their products or labeling (new ingredients, dosages, or warnings). Make sure to read the label each time you use the product. Always look for special "flags" or "banners" on ...
Do cigarette health warning labels comply with requirements: A 14-country study.

PubMed

Cohen, Joanna E; Brown, Jennifer; Washington, Carmen; Welding, Kevin; Ferguson, Jacqueline; Smith, Katherine C

2016-12-01

The Framework Convention on Tobacco Control, a global health treaty ratified by over 175 countries, calls on countries to ensure that tobacco packages carry health warning labels (HWLs) describing the harmful effects of tobacco use. We assessed the extent of compliance with 14 countries' HWL requirements. Unique cigarette packs were purchased in 2013 using a systematic protocol in 12 distinct neighborhoods within three of the ten most populous cities in the 14 low- and middle-income countries with the greatest number (count) of smokers. HWL compliance codebooks were developed for each country based on the details of country-specific HWL requirements, with up to four common compliance indicators assessed for each country (location, size, label elements, text size). Packs (n=1859) were double coded for compliance. Compliance was examined by country and pack characteristics, including parent company and brand family. Overall, 72% of coded cigarette packs were compliant with all relevant compliance indicators, ranging from 17% in the Philippines to 94% in Mexico. Compliance was highest for location of the warning (ranging from 75%-100%) and lowest for warning size (ranging from 46%-99%). Compliance was higher for packs bought in high SES neighborhoods, and varied by parent company and brand family. This multi-country study found at least one pack in every country - and many packs in some countries - that were not compliant with key requirements for health warning labels in the country of purchase. Non-compliance may be exacerbating health disparities. Tobacco companies should be held accountable for complying with country HWL requirements. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.
30 CFR 47.41 - Requirement for container labels.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Requirement for container labels. 47.41 Section... TRAINING HAZARD COMMUNICATION (HazCom) Container Labels and Other Forms of Warning § 47.41 Requirement for container labels. (a) The operator must ensure that each container of a hazardous chemical has a label. If a...
Pharmacists and patients feedback on empirically designed prescription warning labels: a qualitative study.

PubMed

Shiyanbola, Olayinka O; Smith, Paul D; Huang, Yen-Ming; Mansukhani, Sonal Ghura

2017-02-01

Background Recommendations call for the inclusion of both patient and provider input in the redesign of prescription labels. Pharmacist opinions on prescription warning labels are important because they are the health providers who would eventually distribute and explain the revised labels during medication counseling. They may be the first health provider to notice a patient's misunderstanding on how to safely use their prescription medications. Objectives To explore the perspectives of patients and pharmacists on five newly designed PWLs, and examine if there were similarities and differences between patients' and pharmacists' perspectives. Setting Private room in Wisconsin. Methods A descriptive study using semi-structured 60-min face-to-face individual interviews with patients and pharmacists explored patients and pharmacists' feedback on five newly designed PWLs. Patients who were 18 years and older, spoke English, and took a prescription medication and pharmacists who filled prescriptions in an ambulatory setting participated in the study. The patient and pharmacist perspectives on the words (content), picture and color (cosmetic appearance), and placement of warning instructions on the pill bottle (convenience) was based on a label redesign framework. Qualitative content analysis was done. Main outcome measure Patient and pharmacist perspectives on the newly designed PWLs. Results Twenty-one patients and eight pharmacists practicing in an academic medical center outpatient setting (n = 5) or retail pharmacy (n = 3) participated. All patients and pharmacists wanted the PWLs positioned on the front of the pill bottle but not the side of the bottle or warning instructions embedded into the main prescription label. Other similarities included participants preferring: (1) pictures closely depicting the instructions and (2) the use of yellow highlighting on the PWL to draw attention to it. There were differences in patient and pharmacist perspectives regarding the addition of 'Warning' to the instruction on the PWL with the patient preference to include the word 'Warning'. Pharmacists thought some PWL pictures had racial stereotypes, but this feedback was never mentioned by patients. Conclusions Patients and pharmacists had different preferences for PWL design changes to improve understandability. Pharmacist preferences did not always correspond with patient preferences. However, patients and pharmacists generally agreed on the preferred location of the PWL on the pill bottle and the use of color for drawing patients' attention.
Tobacco Health Warning Messages on Plain Cigarette Packs and in Television Campaigns: A Qualitative Study with Australian Socioeconomically Disadvantaged Smokers

ERIC Educational Resources Information Center

Guillaumier, Ashleigh; Bonevski, Billie; Paul, Christine

2015-01-01

Television advertisements, packaging regulations and health warning labels (HWLs) are designed to communicate anti-smoking messages to large number of smokers. However, only a few studies have examined how high smoking prevalence groups respond to these warnings. This study explored how socioeconomically disadvantaged smokers engage with health…
21 CFR 101.17 - Food labeling warning, notice, and safe handling statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... bear the following warning: WARNING—Avoid spraying in eyes. Contents under pressure. Do not puncture or... warning required by paragraph (a)(1) of this section. (4) The words “Avoid spraying in eyes” may be... containing dry or incompletely hydrated psyllium husk, also known as psyllium seed husk, and bearing a health...
PRN 96-4: Label Statements Involving Product Efficacy and Potential for Harm to Property

EPA Pesticide Factsheets

This notice explains EPA procedures in approving pesticide labels that include claims relating to the efficacy of agricultural pesticides and provides a warning to growers regarding reliance on label statements regarding pesticide efficacy.
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.
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
Young Adult Smokers' Neural Response to Graphic Cigarette Warning Labels.

PubMed

Green, Adam E; Mays, Darren; Falk, Emily B; Vallone, Donna; Gallagher, Natalie; Richardson, Amanda; Tercyak, Kenneth P; Abrams, David B; Niaura, Raymond S

2016-06-01

The study examined young adult smokers' neural response to graphic warning labels (GWLs) on cigarette packs using functional magnetic resonance imaging (fMRI). Nineteen young adult smokers ( M age 22.9, 52.6% male, 68.4% non-white, M 4.3 cigarettes/day) completed pre-scan, self-report measures of demographics, cigarette smoking behavior, and nicotine dependence, and an fMRI scanning session. During the scanning session participants viewed cigarette pack images (total 64 stimuli, viewed 4 seconds each) that varied based on the warning label (graphic or visually occluded control) and pack branding (branded or plain packaging) in an event-related experimental design. Participants reported motivation to quit (MTQ) in response to each image using a push-button control. Whole-brain blood oxygenation level-dependent (BOLD) functional images were acquired during the task. GWLs produced significantly greater self-reported MTQ than control warnings ( p < .001). Imaging data indicate stronger neural activation in response to GWLs than the control warnings at a cluster-corrected threshold p <.001 in medial prefrontal cortex, amygdala, medial temporal lobe, and occipital cortex. There were no significant differences in response to warnings on branded versus plain cigarette packages. In this sample of young adult smokers, GWLs promoted neural activation in brain regions involved in cognitive and affective decision-making and memory formation and the effects of GWLs did not differ on branded or plain cigarette packaging. These findings complement other recent neuroimaging GWL studies conducted with older adult smokers and with adolescents by demonstrating similar patterns of neural activation in response to GWLs among young adult smokers.
46 CFR 183.220 - General safety provisions.

Code of Federal Regulations, 2013 CFR

2013-10-01

... equipment and circuits must be clearly marked and identified. (e) Any cabinet, panel, box, or other enclosure containing more than one source of power must be fitted with a sign warning persons of this...
46 CFR 183.220 - General safety provisions.

Code of Federal Regulations, 2012 CFR

2012-10-01

... equipment and circuits must be clearly marked and identified. (e) Any cabinet, panel, box, or other enclosure containing more than one source of power must be fitted with a sign warning persons of this...
46 CFR 183.220 - General safety provisions.

Code of Federal Regulations, 2014 CFR

2014-10-01

... equipment and circuits must be clearly marked and identified. (e) Any cabinet, panel, box, or other enclosure containing more than one source of power must be fitted with a sign warning persons of this...
The effect of graphic cigarette warning labels on smoking behavior: evidence from the Canadian experience.

PubMed

Azagba, Sunday; Sharaf, Mesbah F

2013-03-01

There is a substantial literature that graphic tobacco warnings are effective; however, there is limited evidence based on actual smoking behavior. The objective of this paper is to assess the effect of graphic cigarette warning labels on smoking prevalence and quit attempts. A nationally representative sample of individuals aged 15 years and older from the Canadian National Population Health Survey 1998-2008 is used. The sample consists of 4,853 individuals for the smoking prevalence regression and 1,549 smokers for quit attempts. The generalized estimating equation (GEE) model was used to examine the population-averaged (marginal) effects of tobacco graphic warnings on smoking prevalence and quit attempts. To assess the effect of graphic tobacco health warnings on smoking behavior, we used a scaled variable that takes the value of 0 for the first 6 months in 2001, then increases gradually to 1 from December 2001. We found that graphic warnings had a statistically significant effect on smoking prevalence and quit attempts. In particular, the warnings decreased the odds of being a smoker (odds ratio [OR] = 0.875; 95% CI = 0.821-0.932) and increased the odds of making a quit attempt (OR = 1.330, CI = 1.187-1.490). Similar results were obtained when we allowed for more time for the warnings to appear in retail outlets. This study adds to the growing body of evidence on the effectiveness of graphic warnings. Our findings suggest that warnings had a significant effect on smoking prevalence and quit attempts in Canada.
75 FR 1274 - Implantation or Injectable Dosage Form New Animal Drugs; Hyaluronate Sodium

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-11

... safety warning for use of hyaluronate sodium injectable solution in horses. DATES: This rule is effective... human food safety warning on product labeling. The supplemental NADA is approved as of December 11, 2009...
Outstanding Questions In First Amendment Law Related To Food Labeling Disclosure Requirements For Health.

PubMed

Pomeranz, Jennifer L

2015-11-01

The federal and state governments are increasingly focusing on food labeling as a method to support good health. Many such laws are opposed by the food industry and may be challenged in court, raising the question of what is legally feasible. This article analyzes outstanding questions in First Amendment law related to commercial disclosure requirements and conducts legal analysis and policy evaluation for three current policies. These include the Food and Drug Administration's draft regulation requiring an added sugar disclosure on the Nutrition Facts panel, California's proposed sugar-sweetened beverage safety warning label bill, and Vermont's law requiring labels of genetically engineered food to disclose this information. I recommend several methods for policy makers to enact food labeling laws within First Amendment parameters, including imposing factual commercial disclosure requirements, disclosing the government entity issuing a warning, collecting evidence, and identifying legitimate governmental interests. Project HOPE—The People-to-People Health Foundation, Inc.

Arsenic content of homeopathic medicines

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

Kerr, H.D.; Saryan, L.A.

1986-01-01

In order to test the widely held assumption that homeopathic medicines contain negligible quantities of their major ingredients, six such medicines labeled in Latin as containing arsenic were purchased over the counter and by mail order and their arsenic contents measured. Values determined were similar to those expected from label information in only two of six and were markedly at variance in the remaining four. Arsenic was present in notable quantities in two preparations. Most sales personnel interviewed could not identify arsenic as being an ingredient in these preparations and were therefore incapable of warning the general public of possiblemore » dangers from ingestion. No such warnings appeared on the labels.« less
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.
Awareness of smoking risks and attitudes towards graphic health warning labels on cigarette packs: a cross-cultural study of two populations in Singapore and Scotland.

PubMed

Ng, D H L; Roxburgh, S T D; Sanjay, S; Au Eong, K G

2010-05-01

Little is known about the level of awareness of blindness as a smoking-related condition, although the relationship has been well established. To compare the awareness of smoking risks and the impact of graphic health warning labels on cigarette packs in discouraging smoking among adults in Singapore and Scotland. A cross-sectional survey using a structured interview of adults in ophthalmic, general medical, and general surgical outpatient clinics in Singapore and Scotland. One hundred and fifteen out of 163 (70.6%) outpatients in Singapore and 105 out of 112 (93.8%) outpatients in Scotland responded to the study. In both samples, awareness levels for smoking-related diseases such as lung cancer, mouth and throat cancer, heart disease, and stroke were all greater than 85%. These were found to be significantly higher than the level of awareness of blindness as a smoking-related condition (chi (2)-test, P<0.001). Although the awareness of blindness as a smoking-related condition was greater in Singapore (36.5%) than in Scotland (30.5%), this difference was not statistically significant. More than half of the respondents indicated that graphic health warning labels would be effective in discouraging them from smoking. Graphic health warning labels reading 'Smoking causes blindness' printed on cigarette packs may be useful in raising public awareness of blindness as a smoking-related condition and discouraging the habit of smoking in Singapore and Scotland.
21 CFR 101.17 - Food labeling warning, notice, and safe handling statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.17 Food labeling..., or are sold for use in food service establishments, may be provided on cartons or in labeling, e.g... the Public Health Service Act (PHS Act), any State or locality that is willing and able to assist the...
After the "At-Risk" Label: Reorienting Educational Policy and Practice. Disability, Culture, and Equity Series

ERIC Educational Resources Information Center

Brown, Keffrelyn D.

2016-01-01

This book examines how the use of the "at-risk" category and label creates problems for students and teachers. Drawing from research across various education sites, the author illustrates how educators recognize the label's potential to redress issues of equity, but warns that it can also stigmatize the students so labeled. Brown…
42 CFR 84.257 - Labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Labeling requirements. (a) A warning shall be placed on the label of each gas mask, chemical-cartridge... performance of any gas mask, chemical-cartridge respirator, or powered air-purifying respirator approved under... this subpart shall be specified as follows: Chemical-cartridge respirator 1 hour. Gas mask 4 hours...
77 FR 18250 - Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-27

... of information technology. Experimental Study of Graphic Cigarette Warning Labels--(OMB Control... graphic warnings required by the Tobacco Control Act. The experimental study data will be collected from...] Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of...
Pictorial health warning labels on cigarette packages: an investigation on opinions of male smokers.

PubMed

Shojaezadeh, Davoud; Peyman, Nooshin; Shakeri, Mohammad Taghi; Nedjat, Saharnaz; Mohaddes Hakkak, Abbas; Taghdisi, Mohammad Hossein; Mohaddes Hakkak, Hamid Reza; Shariati, Keivan; Taghipour, Ali

2014-03-01

Health warning labels on cigarette packages are among the most straightforward and important tools to communicate with smokers and various studies have illustrated their efficacy. The current study aimed to investigate the opinions of male smokers in Mashhad city about the efficacy of health warning labels printed on cigarette packages on the smoking status of smokers. This cross-sectional descriptive study was conducted in 2013 using a questionnaire. The research population included the male smokers of Mashhad. The participants were selected from the customers referring to the newsstands for cigarettes. The obtained data were analyzed employing SPSS software Version 16, and the statistical tests including Kruskal-Wallis, Spearman, and correlation coefficient of Pearson, Chi Square, Mann-Whitney, and Bonferroni correction were used in this regard. In this research, there were 500 participants with the average age of 25 years. The initiation age of smoking was eight years while the maximum age was reported as 45 years. Results of this research about the effect of these labels on decreasing cigarette consumption rate showed that almost half of the participants believed that these labels were ineffective for them (52.2%) and other smokers (53.8%).Furthermore, significant relationship was found between the age and opinion of the smokers about the influence of these labels on reducing their cigarette consumption (P < 0.001). To promote the effect of printed images on cigarette packages, it is recommended to consider the suitability of labels in the targeted culture. In addition, to be more effective consultation sites to quit smoking should be introduced under the images.
Labelling of household products and prevention of unintentional poisoning.

PubMed

de Presgrave, Rosaura Farias; Alves, Eloisa Nunes; Camacho, Luiz Antônio Bastos; Bôas, Maria Helena Simões Villas

2008-04-01

Unintentional poisoning occurs mainly in childhood due to ingestion of common household products. A decisive factor is the lack of knowledge concerning the potential toxicity of these products. A random study of 158 labels of cleaning products was conducted at the National Institute of Quality Control in Health--Brazil. Health hazard warnings, first aid in case of poisoning and storage instructions were evaluated to assess the quality of information provided to the consumer regarding the risks inherent in these products. Among these labels, 75% were considered inadequate since they did not provide all cautionary information necessary to avoid the health hazards associated with these products. First aid instructions in the case of inhalation were missing on more than 50% of labels studied and 47% did not recommend taking the label to a health professional in case of accident. Furthermore, the labels did not provide other important warnings such as "read before use" and "keep in original container': The results indicate that the labelling of cleaning products does not provide all safety information recommended for consumers.
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.
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.
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
Labeling HCFC Products Starting 2015: A More In-depth Look at What You Need to Know & Specific Guidance on Foam Products

EPA Pesticide Factsheets

Fact sheet provides information on labeling foam products. Products imported or manufactured after January 1, 2015 that contain or were manufactured with an HCFC must bear a warning label before they can be introduced into interstate commerce.
Effects of exposure to thin-ideal media images on body dissatisfaction: testing the inclusion of a disclaimer versus warning label.

PubMed

Ata, Rheanna N; Thompson, J Kevin; Small, Brent J

2013-09-01

The current study was designed to determine whether the inclusion of a disclaimer (i.e., "Retouched photograph aimed at changing a person's physical appearance.") or warning (i.e., "Warning: Trying to look as thin as this model may be dangerous to your health.") added to images of thin/attractive models would affect body dissatisfaction and intent to diet in female undergraduate students (n=342). Participants were randomly assigned to one of four groups: (a) disclaimer, (b) warning, (c) model control, or (d) car control. Results revealed a significant interaction between group and time, whereby only the car control group reported a significant change (i.e., decrease) in body dissatisfaction over time. Groups did not differ on intent to diet measured at post-exposure. The results largely replicate other findings in this area and call into question advocacy efforts to label media images as a strategy to decrease women's identification with the stimuli. Copyright © 2013 Elsevier Ltd. All rights reserved.
Marketing strategies and warning labels on children's toothpaste.

PubMed

Basch, Corey Hannah; Rajan, Sonali

2014-10-01

The overconsumption of toothpaste has negative consequences, particularly for children. This study's objectives were to describe misleading marketing strategies used in selling children's fluoridated toothpaste and identify warning label characteristics. Two researchers independently coded the packaging from 26 over-the-counter toothpastes that are specifically marketed for children. Aggressive marketing strategies targeting children were identified: every toothpaste in this sample displayed at least 1 children's animated character, 50% had at least 1 picture of a food item, 92.3% stated they were flavored and 26.9% depicted a full swirl of toothpaste, directly contradicting dentist recommendations for young children. Further, on most toothpaste tubes, warnings regarding fluoride overconsumption for young children were only listed on the back and in very small font. Misleading marketing strategies are regularly used in selling children's toothpaste as if it is a food product, while warnings regarding overconsumption among youth are minimized. Dental hygienists are in an important position to help parents of young children implement safe oral care practices. Copyright © 2014 The American Dental Hygienists’ Association.
Tsunamis: bridging science, engineering and society.

PubMed

Kânoğlu, U; Titov, V; Bernard, E; Synolakis, C

2015-10-28

Tsunamis are high-impact, long-duration disasters that in most cases allow for only minutes of warning before impact. Since the 2004 Boxing Day tsunami, there have been significant advancements in warning methodology, pre-disaster preparedness and basic understanding of related phenomena. Yet, the trail of destruction of the 2011 Japan tsunami, broadcast live to a stunned world audience, underscored the difficulties of implementing advances in applied hazard mitigation. We describe state of the art methodologies, standards for warnings and summarize recent advances in basic understanding, and identify cross-disciplinary challenges. The stage is set to bridge science, engineering and society to help build up coastal resilience and reduce losses. © 2015 The Author(s).
Labeling HCFC Products Starting 2015: What You Need to Know

EPA Pesticide Factsheets

Fact sheet explains that products imported or manufactured after January 1, 2015 that contain or were manufactured with an HCFC must bear a warning label before they can be introduced into interstate commerce.
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
75 FR 7604 - Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-22

... implement the mandatory graphic warnings required by the Tobacco Control Act. The experimental study data...] Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of... on the Experimental Study of Graphic Cigarette Warning Labels that is being conducted in support of...

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
Alcohol counter-advertising and the media. A review of recent research.

PubMed

Agostinelli, Gina; Grube, Joel W

2002-01-01

Counter-advertising commonly is used to balance the effects that alcohol advertising may have on alcohol consumption and alcohol-related problems. Such measures can take the form of print or broadcast advertisements (e.g., public service announcements [PSAs]) as well as product warning labels. The effectiveness of both types of counter-advertising is reviewed using the Elaboration Likelihood Model as a theoretical framework. For print and broadcast counter-advertisements, such factors as their emotional appeal and the credibility of the source, as well as audience factors, can influence their effectiveness. Further, brewer-sponsored counter-advertisements are evaluated and received differently than are the more conventional PSA counter-advertisements. For warning labels, both the content and design of the label influence their effectiveness, as do audience factors. The effectiveness of those labels is evaluated in terms of the extent to which they impact cognitive and affective processes as well as drinking behavior.
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.
Believability of Cigar Warning Labels Among Adolescents.

PubMed

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

2017-03-01

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. Adolescents (aged 13-17 years) 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," and "cigars are not a safe alternative to cigarettes") and one of four warning sources (Food and Drug Administration, Surgeon General, Centers for Disease Control and Prevention, and no source). Believability was assessed with "how believable is this warning," and responses were dichotomized for "not at all or somewhat" versus "very." 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. 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. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.
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
Warning Graphic Legend - Naval Oceanography Portal

Science.gov Websites

section Advanced Search... Sections Home Time Earth Orientation Astronomy Meteorology Oceanography Ice You The next radii represents 64 knot winds. Typhoon Back to top Time Labels Labels indicate the time of = universal time/Zulu Label Back to top Current Postion The current position is the black tropical cyclone
Over-the-counter vaginal contraceptive and spermicide drug products containing nonoxynol 9; required labeling. Final rule.

PubMed

2007-12-19

The Food and Drug Administration (FDA) is issuing a final rule establishing new warning statements and other labeling information for all over-the-counter (OTC) vaginal contraceptive drug products (also known as spermicides, hereinafter referred to as vaginal contraceptives or vaginal contraceptives/spermicides) containing nonoxynol 9 (N9). These warning statements will advise consumers that vaginal contraceptives/spermicides containing N9 do not protect against infection from the human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS), or against getting other sexually transmitted diseases (STDs). The warnings and labeling information will also advise consumers that use of vaginal contraceptives and spermicides containing N9 can irritate the vagina and rectum and may increase the risk of getting the AIDS virus (HIV) from an infected partner. This final rule is part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on its proposed regulation, and all relevant data and information on N9 that have come to our attention.
A Systematic Review of Fatalities Related to Acute Ingestion of Salt. A Need for Warning Labels?

PubMed Central

Campbell, Norm R. C.; Train, Emma J.

2017-01-01

There are sporadic cases of fatalities from acutely eating salt. Yet, on social media, there are “challenges to” and examples of children and some adults acutely eating salt, and recently a charity advocated eating small amounts of salt to empathize with Syrian refugees. We performed a systematic review of fatalities from ingesting salt to assess if relatively moderate doses of salt could be fatal. In 27 reports, there were 35 fatalities documented (19 in adults and 16 in children). The lethal dose was estimated to be less than 10 g of sodium (<5 teaspoons of salt) in two children, and less than 25 g sodium in four adults (<4 tablespoons of salt). The frequency of fatal ingestion of salt is not able to be discerned from our review. If investigation of the causes of hypernatremia in hospital records indicates salt overdose is relatively common, consideration could be given to placing warning labels on salt containers and shakers. Such warning labels can have the added advantage of reducing dietary salt consumption. PMID:28644412
[WHO Framework Convention on Tobacco Control (FCTC) Article 11: packaging and labelling of tobacco products].

PubMed

Bekki, Kanae; Inaba, Yohei; Kunugita, Naoki

2015-01-01

The World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) requires member countries to implement measures aimed at reducing the demand for tobacco products. FCTC article 11 describes the important forms of health communication and packaging regulations. And this article recommends on large pictorial health warnings and encourages more effective forms of disclosure on constituents and emissions. Furthermore, article 11 recognizes the importance of the package as a promotional vehicle for tobacco companies and requires the removal of potentially misleading packaging information, including the terms "light" and "mild." The Conference of the Parties (COP) adopted guidelines for implementation of article 11 on "Packaging and labelling of Tobacco Products". Some countries, such as Canada, the U.S.A., Australia, EU countries etc. positively promoted tobacco control by implementing countermeasures such as the graphic health warning labels and plain packages. These countermeasures showed the significant effects of decreasing smoking rate and preventing smoking initiation in young people. Furthermore, these warning labels were effective for the literally challenged. However, the Japanese government has not implemented these countermeasures, and only limited texts are shown on Japanese tobacco packaging. Therefore, Japan should emulate approaches taken by other countries, and promote the tobacco control policy in accordance with FCTC.
Quantifying Age-Related Differences in Information Processing Behaviors When Viewing Prescription Drug Labels

PubMed Central

Sundar, Raghav Prashant; Becker, Mark W.; Bello, Nora M.; Bix, Laura

2012-01-01

Adverse drug events (ADEs) are a significant problem in health care. While effective warnings have the potential to reduce the prevalence of ADEs, little is known about how patients access and use prescription labeling. We investigated the effectiveness of prescription warning labels (PWLs, small, colorful stickers applied at the pharmacy) in conveying warning information to two groups of patients (young adults and those 50+). We evaluated the early stages of information processing by tracking eye movements while participants interacted with prescription vials that had PWLs affixed to them. We later tested participants’ recognition memory for the PWLs. During viewing, participants often failed to attend to the PWLs; this effect was more pronounced for older than younger participants. Older participants also performed worse on the subsequent memory test. However, when memory performance was conditionalized on whether or not the participant had fixated the PWL, these age-related differences in memory were no longer significant, suggesting that the difference in memory performance between groups was attributable to differences in attention rather than differences in memory encoding or recall. This is important because older adults are recognized to be at greater risk for ADEs. These data provide a compelling case that understanding consumers’ attentive behavior is crucial to developing an effective labeling standard for prescription drugs. PMID:22719955
Pictorial Health Warning Labels on Cigarette Packages: An Investigation on Opinions of Male Smokers

PubMed Central

Shojaezadeh, Davoud; Peyman, Nooshin; Shakeri, Mohammad Taghi; Nedjat, Saharnaz; Mohaddes Hakkak, Abbas; Taghdisi, Mohammad Hossein; Mohaddes Hakkak, Hamid Reza; Shariati, Keivan; Taghipour, Ali

2014-01-01

Background: Health warning labels on cigarette packages are among the most straightforward and important tools to communicate with smokers and various studies have illustrated their efficacy. Objectives: The current study aimed to investigate the opinions of male smokers in Mashhad city about the efficacy of health warning labels printed on cigarette packages on the smoking status of smokers. Patients and Methods: This cross-sectional descriptive study was conducted in 2013 using a questionnaire. The research population included the male smokers of Mashhad. The participants were selected from the customers referring to the newsstands for cigarettes. The obtained data were analyzed employing SPSS software Version 16, and the statistical tests including Kruskal-Wallis, Spearman, and correlation coefficient of Pearson, Chi Square, Mann-Whitney, and Bonferroni correction were used in this regard. Results: In this research, there were 500 participants with the average age of 25 years. The initiation age of smoking was eight years while the maximum age was reported as 45 years. Results of this research about the effect of these labels on decreasing cigarette consumption rate showed that almost half of the participants believed that these labels were ineffective for them (52.2%) and other smokers (53.8%).Furthermore, significant relationship was found between the age and opinion of the smokers about the influence of these labels on reducing their cigarette consumption (P < 0.001). Conclusions: To promote the effect of printed images on cigarette packages, it is recommended to consider the suitability of labels in the targeted culture. In addition, to be more effective consultation sites to quit smoking should be introduced under the images. PMID:24829777
40 CFR 156.66 - Child hazard warning.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Child hazard warning. 156.66 Section... LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Human Hazard and Precautionary Statements § 156.66 Child... Out of Reach of Children.” That statement, or any alternative statement approved by EPA, must appear...
40 CFR 156.66 - Child hazard warning.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Child hazard warning. 156.66 Section... LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Human Hazard and Precautionary Statements § 156.66 Child... Out of Reach of Children.” That statement, or any alternative statement approved by EPA, must appear...
40 CFR 156.66 - Child hazard warning.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Child hazard warning. 156.66 Section... LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Human Hazard and Precautionary Statements § 156.66 Child... Out of Reach of Children.” That statement, or any alternative statement approved by EPA, must appear...
40 CFR 156.66 - Child hazard warning.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 25 2012-07-01 2012-07-01 false Child hazard warning. 156.66 Section... LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Human Hazard and Precautionary Statements § 156.66 Child... Out of Reach of Children.” That statement, or any alternative statement approved by EPA, must appear...
40 CFR 156.66 - Child hazard warning.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Child hazard warning. 156.66 Section... LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Human Hazard and Precautionary Statements § 156.66 Child... Out of Reach of Children.” That statement, or any alternative statement approved by EPA, must appear...
21 CFR 740.11 - Cosmetics in self-pressurized containers.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Cosmetics in self-pressurized containers. 740.11... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.11 Cosmetics in self-pressurized containers. (a)(1) The label of a cosmetic packaged in a self-pressurized container and intended...
21 CFR 740.11 - Cosmetics in self-pressurized containers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Cosmetics in self-pressurized containers. 740.11... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.11 Cosmetics in self-pressurized containers. (a)(1) The label of a cosmetic packaged in a self-pressurized container and intended...
21 CFR 740.11 - Cosmetics in self-pressurized containers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Cosmetics in self-pressurized containers. 740.11... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.11 Cosmetics in self-pressurized containers. (a)(1) The label of a cosmetic packaged in a self-pressurized container and intended...
21 CFR 740.11 - Cosmetics in self-pressurized containers.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Cosmetics in self-pressurized containers. 740.11... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.11 Cosmetics in self-pressurized containers. (a)(1) The label of a cosmetic packaged in a self-pressurized container and intended...

21 CFR 740.11 - Cosmetics in self-pressurized containers.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Cosmetics in self-pressurized containers. 740.11... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.11 Cosmetics in self-pressurized containers. (a)(1) The label of a cosmetic packaged in a self-pressurized container and intended...
An experimental study of the effects of electronic cigarette warnings on young adult nonsmokers' perceptions and behavioral intentions.

PubMed

Mays, Darren; Smith, Clayton; Johnson, Andrea C; Tercyak, Kenneth P; Niaura, Raymond S

2016-01-01

Electronic cigarette ("e-cigarette") manufacturers use warning labels on their advertising that vary widely in content and the U.S. Food and Drug Administration has issued a warning label requirement for e-cigarettes. There is limited data on the effects of these warnings on e-cigarette perceptions and other potential predictors of future tobacco use behavior in populations of interest to inform future regulatory requirements. This study examined the effects of e-cigarette warnings on perceptions of e-cigarettes and cigarettes and other cognitive precursors to tobacco use among young adult non-smokers. Non-smoking young adults ages 18 to 30 years (n = 436) were recruited through an internet-based crowdsourcing platform for an online experiment. Participants completed pre-exposure measures of demographics, tobacco use, and other relevant constructs and were randomized to view 1 of 9 e-cigarette stimuli in a 3 (Ad/Warning condition: Ad Only, Ad with Warning, Warning Only) x 3 (E-cigarette brand: Blu, MarkTen, Vuse) design. After viewing e-cigarette stimuli, participants reported perceptions of e-cigarettes and behavioral intentions to use e-cigarettes. Participants in the Ad Only and Ad with Warning conditions also completed a heat-mapping task assessing aspects of the ads that captured their attention. Then, participants were randomized to view cigarette ads from 1 of 3 major cigarette brands and reported perceptions of cigarettes and intentions to smoke cigarettes. Participants in the Warning Only condition reported significantly greater perceived harm and addictiveness of e-cigarettes and thoughts about not using e-cigarettes than the Ad Only and Ad with Warning conditions (p's < .05). The Ad Only and Ad with Warning conditions did not differ on these outcomes. Participants in the Warning Only condition also reported the harms of e-cigarettes were closer to those of cigarettes than the Ad Only condition (p < .05), but neither differed from the Ad with Warning condition. Visual inspection of heat-mapping task data indicate warnings drew few participants' attention. There were no significant differences across study conditions on perceptions of cigarettes or intentions to smoke. Text-based warning messages influenced young non-smokers' perceptions in a way that may dissuade e-cigarette use, but warnings appearing on advertisements had little impact.
Path analysis of warning label effects on negative emotions and quit attempts: A longitudinal study of smokers in Australia, Canada, Mexico, and the US.

PubMed

Cho, Yoo Jin; Thrasher, James F; Yong, Hua-Hie; Szklo, André Salem; O'Connor, Richard J; Bansal-Travers, Maansi; Hammond, David; Fong, Geoffrey T; Hardin, James; Borland, Ron

2018-01-01

Cigarette pack health warning labels can elicit negative emotions among smokers, yet little is known about how these negative emotions influence behavior change. Guided by psychological theories emphasizing the role of emotions on risk concern and behavior change, we investigated whether smokers who reported stronger negative emotional responses when viewing warnings reported stronger responses to warnings in daily life and were more likely to try to quit at follow-up. We analyzed data from 5439 adult smokers from Australia, Canada, Mexico, and the US, who were surveyed every four months from September 2012 to September 2014. Participants were shown warnings already implemented on packs in their country and reported negative emotional responses (i.e., fear, disgust, worry), which were averaged (range = 1 to 9). Country-stratified logistic and linear generalized estimating equations were used to analyze the effect of negative emotional responses on self-reported responses to warnings in daily life (i.e., attention, risk concern, avoidance of warnings, forgoing planned cigarettes) and quit attempts at follow-up. Models were adjusted for socio-demographic and smoking-related characteristics, survey wave, and the number of prior surveys answered. Smokers who reported stronger negative emotions were more likely to make quit attempts at follow-up (Adjusted ORs ranged from 1.09 [95% CI 1.04 to 1.14] to 1.17 [95% CI 1.12 to 1.23]; p < .001) than those who reported lower negative emotions. This relationship was mediated through attention to warnings and behavioral responses to warnings. There was no significant interaction of negative emotions with self-efficacy or nicotine dependence. Negative emotions elicited by warnings encourage behavior change, promoting attention to warnings and behavioral responses that positively predict quit attempts. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.
Effects of and attention to graphic warning labels on cigarette packages.

PubMed

Süssenbach, Philipp; Niemeier, Sarah; Glock, Sabine

2013-01-01

The present study investigates the effects of graphic cigarette warnings compared to text-only cigarette warnings on smokers' explicit (i.e. ratings of the packages, cognitions about smoking, perceived health risk, quit intentions) and implicit attitudes. In addition, participants' visual attention towards the graphic warnings was recorded using eye-tracking methodology. Sixty-three smokers participated in the present study and either viewed graphic cigarette warnings with aversive and non-aversive images or text-only warnings. Data were analysed using analysis of variance and correlation analysis. Especially, graphic cigarette warnings with aversive content drew attention and elicited high threat. However, whereas attention directed to the textual information of the graphic warnings predicted smokers' risk perceptions, attention directed to the images of the graphic warnings did not. Moreover, smokers' in the graphic warning condition reported more positive cognitions about smoking, thus revealing cognitive dissonance. Smokers employ defensive psychological mechanisms when confronted with threatening warnings. Although aversive images attract attention, they do not promote health knowledge. Implications for graphic health warnings and the importance of taking their content (i.e. aversive vs. non-aversive images) into account are discussed.
77 FR 68132 - Compliance Guidance for Small Business Entities on Labeling for Bronchodilators: Cold, Cough...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-15

... compliance guide applies to OTC bronchodilator drug products used to treat asthma that are marketed without... Asthma Alert warning), and directions that are required in the labeling of OTC bronchodilator drug...
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.
Impact of pictorial warning labels on tobacco products among patients attending outpatient department of a dental college in Bangalore city: A cross-sectional study.

PubMed

Vanishree, N; Narayan, R R; Naveen, N; Bullapa, D; Vignesh, D; P Raveendran, N M

2017-01-01

The aim of this study is to assess the knowledge, attitude, and impact of pictorial warnings present on tobacco packets among patients attending outpatient department of a dental college of Bangalore city. A cross-sectional study was conducted among 419 patients through convenience sampling, using a structured close-ended questionnaire containing 35 questions. The participants were approached and invited to participate voluntarily. The data obtained were analyzed using descriptive statistics, Chi-square test and ANOVA. Mean age of the participants was 28.1 ± 7.06 years. Out of total 419 participants, 62.8% were tobacco users. About 40.6% of the participants had average knowledge and only 22.9% had positive attitude regarding the pictorial warnings. Nearly 77.9% of tobacco users had previously attempted decreased frequency of tobacco use and 63.7% had tried quitting the habit. The difference was statistically significant (P < 0.05 Chi-square test and ANOVA). The present study revealed that most of study participants have noticed the warnings on tobacco products, and most of them believe that they could understand warning labels. This study also showed that most of study participants believed that pictorial health warnings create awareness about probable health hazards of tobacco use and that these pictorial presentations on tobacco packs positively assist in reducing or quitting tobacco smoking.
Emotional salience of the image component facilitates recall of the text of cigarette warning labels.

PubMed

Wang, An-Li; Shi, Zhenhao; Fairchild, Victoria P; Aronowitz, Catherine A; Langleben, Daniel D

2018-04-26

Graphic warning labels (GWLs) on cigarette packages, that combine textual warnings with emotionally salient images depicting the adverse health consequences of smoking, have been adopted in most European countries. In the US, the courts deemed the evidence justifying the inclusion of emotionally salient images in GWLs insufficient and put the implementation on hold. We conducted a controlled experimental study examining the effect of emotional salience of GWL's images on the recall of their text component. Seventy-three non-treatment-seeking daily smokers received cigarette packs carrying GWLs for a period of 4 weeks. Participants were randomly assigned to receive packs with GWLs previously rated as eliciting high or low level of emotional reaction (ER). The two conditions differed in respect to images but used the same textual warning statements. Participants' recognition of GWL images and statements were tested separately at baseline and again after the 4-week repetitive exposure. Textual warning statements were recognized more accurately when paired with high ER images than when paired with low ER images, both at baseline and after daily exposure to GWLs over a 4-week period. The results suggest that emotional salience of GWLs facilitates cognitive processing of the textual warnings, resulting in better remembering of the information about the health hazards of smoking. Thus, high emotional salience of the pictorial component of GWLs is essential for their overall effectiveness.
Disparagement of health warning labels on cigarette packages and cessation attempts: results from four countries.

PubMed

Osman, Amira; Thrasher, James F; Yong, Hua-Hie; Arillo-Santillán, Edna; Hammond, David

2017-12-01

Health warning labels (HWLs) on cigarette packs that use strong fear appeals may evoke defensive responses including acts of disparaging the warnings. Whether warning disparagement undermines HWL effectiveness remains unclear. We assessed correlates of one type of HWL disparagement and its association with subsequent cessation attempts. Longitudinal data (2012-14) on adult smokers from Australia, Canada, Mexico and the United States (US) were analyzed. HWL disparagement was assessed as the frequency of making fun of HWLs in the past month. Using Generalized Estimating Equation models we estimated correlates of HWL disparagement and whether HWL disparagement predicted subsequent cessation attempts. In each country, across all waves, 24-31% of smokers reported making fun of the warnings at least once in the past month. More frequent disparagement was found among males, younger participants, those with higher education and greater addiction, and those who recently attempted to quit. Attention to, avoidance of and talking to others about HWLs were all positively associated with HWL disparagement. In all countries, except the US, this type of HWL disparagement was an independent predictor of subsequent cessation attempts. HWL disparagement among smokers may indicate greater warning relevance and processing and does not result in counterproductive effects on cessation efforts. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.
14. CONTROL PANELS, EAST SIDE, MAIN FLOOR: TO LEFT (ORIGINAL ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

14. CONTROL PANELS, EAST SIDE, MAIN FLOOR: TO LEFT (ORIGINAL EQUIPMENT): UPPER FOUR GLASS BOXES ARE OVERCURRENT PROTECTIVE RELAYS; MIDDLE FOUR GLASS BOXES CONTAIN TESTING SWITCHES; LOWER TWO BOXES ARE DG1 METERING CHART RECORDERS TO RIGHT (MODERN EQUIPMENT): UPPER FOUR BLACK BOXES ARE PROTECTIVE SERVICE RELAYS; MIDDLE FOUR BOXES CONTAIN TESTING SWITCHES; LARGE BOX BELOW HOUSES REMOTE METERING SYSTEM METAL CABINETS (LABELED L-2 & L-4) BELOW CONTAIN ORIGINAL POWER CIRCUIT BREAKERS - Bonneville Power Administration South Bank Substation, I-84, South of Bonneville Dam Powerhouse, Bonneville, Multnomah County, OR
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
77 FR 14055 - Graco Children's Products Inc., Grant of Petition for Decision of Inconsequential Noncompliance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-08

... near zero. This circumstance, along with the compliant status of all other fabric and label components... 1\\1/4\\ inches. The area of the Label is insignificant with respect to the over two yards of fabric... system. Moreover, all other fabric, including other warning labels for the MyRide child restraint system...
33 CFR 150.628 - How must the operator label, tag, and mark a container of hazardous material?

Code of Federal Regulations, 2010 CFR

2010-07-01

... Workplace Safety and Health Hazard Communication Program § 150.628 How must the operator label, tag, and..., reactive and other special condition hazard warnings. The only exception is for portable containers that...
16 CFR 1205.6 - Warning label for reel-type and rotary power mowers.

Code of Federal Regulations, 2010 CFR

2010-01-01

... cutting width of the blade as possible. However, in the absence of a suitable mounting surface near the center of the cutting width, the label shall be placed on the nearest suitable mounting surface to the...
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.
Black box warning: is ketorolac safe for use after cardiac surgery?

PubMed

Oliveri, Lisa; Jerzewski, Katie; Kulik, Alexander

2014-04-01

In 2005, after the identification of cardiovascular safety concerns with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), the FDA issued a black box warning recommending against the use of NSAIDs following cardiac surgery. The goal of this study was to assess the postoperative safety of ketorolac, an intravenously administered NSAID, after cardiac surgery. Retrospective observational study. Single center, regional hospital. A total of 1,309 cardiac surgical patients (78.1% coronary bypass, 28.0% valve) treated between 2006 and 2012. A total of 488 of these patients received ketorolac for postoperative analgesia within 72 hours of surgery. Ketorolac-treated patients were younger, had better preoperative renal function, and underwent less complex operations compared with non-ketorolac patients. Ketorolac was administered, on average, 8.7 hours after surgery (mean doses: 3.1). Postoperative outcomes for ketorolac-treated patients were similar to those expected using Society of Thoracic Surgery database risk-adjusted outcomes. In unadjusted analysis, patients who received ketorolac had similar or better postoperative outcomes compared with patients who did not receive ketorolac, including gastrointestinal bleeding (1.2% v 1.3%; p = 1.0), renal failure requiring dialysis (0.4% v 3.0%; p = 0.001), perioperative myocardial infarction (1.0% v 0.6%; p = 0.51), stroke or transient ischemic attack (1.0% v 1.7%; p = 0.47), and death (0.4% v 5.8%; p<0.0001). With adjustment in a multivariate model, treatment with ketorolac was not a predictor for adverse outcome in this cohort (odds ratio: 0.72; p = 0.23). Ketorolac appears to be well-tolerated for use when administered selectively after cardiac surgery. Although a black box warning exists, the data highlights the need for further research regarding its perioperative administration. Copyright © 2014 Elsevier Inc. All rights reserved.
Disparities in knowledge about the health effects of smoking among adolescents following the release of new pictorial health warning labels.

PubMed

Elton-Marshall, Tara; Wijesingha, Rochelle; Kennedy, Ryan David; Hammond, David

2018-06-01

This paper examined knowledge about the health effects of smoking among health equity groups following the 2012 introduction of refreshed pictorial health warning labels (HWLs) in Canada. Data are from the 2012/2013 Youth Smoking Survey a representative school-based survey of 47,203 adolescents in Grades 6-12 in nine provinces. Regression models examined overall knowledge about eight health effects of smoking included in the HWLs. Less than one-third of adolescents (32.2%) knew that smoking causes vision loss/blindness and 33.7% knew that smoking causes bladder cancer. Whereas knowledge was high for lung cancer (93.9%), knowledge about other health effects ranged from 52.9% for chronic bronchitis/emphysema to 77.6% for gum or mouth disease. Non-smoking adolescents who were: susceptible to future smoking, male, ethnic minorities, and who had less spending money were significantly less likely to be knowledgeable of the health effects of smoking. There were fewer disparities in knowledge about the health effects of smoking among smokers. Smokers who bought loose or bagged cigarettes rather than cigarettes in packages or cartons were significantly less likely to be knowledgeable about the health effects of smoking. There are significant disparities in knowledge about the health effects of smoking by health equity groups particularly among non-smoking adolescents. Warning labels have the potential to reduce disparities in knowledge about the health effects of smoking when exposure to the warning labels is universal. Complementary strategies such as mass media campaigns are needed to address disparities in knowledge. Copyright © 2017 Elsevier Inc. All rights reserved.
Implications of Graphic Cigarette Warning Labels on Smoking Behavior: An International Perspective.

PubMed

Jung, Minsoo

2016-03-01

Graphic warning labels (GWLs) have been developed as a representative non-price policy to block such marketing. This study investigated the current state and effect of the global introduction of GWLs and examines the future tasks related to GWLs. We systematically reviewed literatures on GWL and a tobacco control strategy in the past fifteen years. The policy of enforcing GWLs has spread globally based on the Framework Convention on Tobacco Control. GWLs are more effective than text warnings and are implemented in over 70 countries. The policy has showed the impact of GWLs as a preventive effect on adolescents' smoking, inducement of smoking cessation, reduction in the amount of tobacco smoked, and reduction in smoking rates. The success of an anti-smoking policy can manifests itself as an effect of individual policies, the rise of tobacco prices, and the introduction of GWLs.
21 CFR 660.45 - Labeling.

Code of Federal Regulations, 2012 CFR

2012-04-01

... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.45 Labeling. In... capable of transmitting hepatitis and should be handled accordingly. (d) The package shall include a... test methods, and (3) warnings as to possible hazards, including hepatitis transmitted in handling the...

21 CFR 660.45 - Labeling.

Code of Federal Regulations, 2014 CFR

2014-04-01

... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.45 Labeling. In... capable of transmitting hepatitis and should be handled accordingly. (d) The package shall include a... test methods, and (3) warnings as to possible hazards, including hepatitis transmitted in handling the...
21 CFR 660.45 - Labeling.

Code of Federal Regulations, 2013 CFR

2013-04-01

... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.45 Labeling. In... capable of transmitting hepatitis and should be handled accordingly. (d) The package shall include a... test methods, and (3) warnings as to possible hazards, including hepatitis transmitted in handling the...
21 CFR 660.45 - Labeling.

Code of Federal Regulations, 2011 CFR

2011-04-01

... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.45 Labeling. In... capable of transmitting hepatitis and should be handled accordingly. (d) The package shall include a... test methods, and (3) warnings as to possible hazards, including hepatitis transmitted in handling the...
21 CFR 660.45 - Labeling.

Code of Federal Regulations, 2010 CFR

2010-04-01

... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.45 Labeling. In... capable of transmitting hepatitis and should be handled accordingly. (d) The package shall include a... test methods, and (3) warnings as to possible hazards, including hepatitis transmitted in handling the...
The impact of cigarette pack design, descriptors, and warning labels on risk perception in the U.S.

PubMed

Bansal-Travers, Maansi; Hammond, David; Smith, Philip; Cummings, K Michael

2011-06-01

In the U.S., limited evidence exists on the impact of colors and brand imagery used in cigarette pack design. This study examined the impact of pack design, product descriptors, and health warnings on risk perception and brand appeal. A cross-sectional mall-intercept study was conducted with 197 adult smokers and 200 nonsmokers in Buffalo NY from June to July 2009 (data analysis from July 2009 to December 2010). Participants were shown 12 sets of packs randomly; each set varied by a particular design feature (color, descriptor) or warning label style (text versus graphic, size, attribution, message framing). Packs were rated on criteria including risk perceptions, quit motivation, and purchase interest. Participants selected larger, pictorial, and loss-framed warning labels as more likely to attract attention, encourage thoughts about health risks, motivate quitting, and be most effective. Participants were more likely to select packs with lighter color shading and descriptors such as light, silver, and smooth as delivering less tar, smoother taste, and lower health risk, compared to darker-shaded or full-flavor packs. Additionally, participants were more likely to select the branded compared to plain white pack when asked which delivered the most tar, smoothest taste, was more attractive, appealed to youth aged <18 years, and contained cigarettes of better quality. The findings support larger, graphic health warnings that convey loss-framed messages as most effective in communicating health risks to U.S. adults. The results also indicate that color and product descriptors are associated with false beliefs about risks. Plain packaging may reduce many of the erroneous misperceptions of risk communicated through pack design features. Copyright © 2011 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.
The Impact of Cigarette Pack Design, Descriptors, and Warning Labels on Risk Perception in the U.S

PubMed Central

Bansal-Travers, Maansi; Hammond, David; Smith, Philip; Cummings, K. Michael

2011-01-01

Background In the U.S., limited evidence exists on the impact of colors and brand imagery used in cigarette pack design. Purpose This study examined the impact of pack design, product descriptors, and health warnings on risk perception and brand appeal. Methods A cross-sectional mall-intercept study was conducted with 197 adult smokers and 200 nonsmokers in Buffalo, NY from June to July 2009 (data analysis from July 2009 to December 2010). Participants were shown 12 sets of packs randomly; each set varied by a particular design feature (color, descriptor) or warning label style (text vs graphic, size, attribution, message framing). Packs were rated on criteria including risk perceptions, quit motivation, and purchase interest. Results Participants selected larger, pictorial, and loss-framed warning labels as more likely to attract attention, encourage thoughts about health risks, motivate quitting, and most effective. Participants were more likely to select packs with lighter color shading and descriptors such as light, silver, and smooth as delivering less tar, smoother taste, and lower health risk, compared to darker-shaded or full flavor packs. Additionally, participants were more likely to select the branded compared to plain white pack when asked which delivered the most tar, smoothest taste, was more attractive, appealed to youth aged <18 years, and contained cigarettes of better quality. Conclusions The findings support larger, graphic health warnings that convey loss-framed messages as most effective in communicating health risks to U.S. adults. The results also indicate that color and product descriptors are associated with false beliefs about risks. Plain packaging may reduce many of the erroneous misperceptions of risk communicated through pack design features. PMID:21565661
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.
75 FR 18952 - Graco Children's Products Inc., Receipt of Petition for Decision of Inconsequential Noncompliance

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-13

... other fabric, including other warning labels for the MyRide seat, are flame resistant. The small size of... of all other fabric and label components of the MyRide seat, render the Label's noncompliance... yards of fabric that is used to make the pad and the ``soft goods'' for the MyRide seat. Proportionally...
The effect of potential electronic nicotine delivery system regulations on nicotine product selection.

PubMed

Pesko, Michael F; Kenkel, Donald S; Wang, Hua; Hughes, Jenna M

2016-04-01

To estimate the effect of potential regulations of electronic nicotine delivery systems (ENDS) among adult smokers, including increasing taxes, reducing flavor availability and adding warning labels communicating various levels of risk. We performed a discrete choice experiment (DCE) among a national sample of 1200 adult smokers. We examined heterogeneity in policy responses by age, cigarette quitting interest and current ENDS use. Our experiment overlapped January 2015 by design, providing exogenous variation in cigarette quitting interest from New Year resolutions. KnowledgePanel, an online panel of recruited respondents. A total of 1200 adult smokers from the United States. Hypothetical purchase choice of cigarettes, nicotine replacement therapy and a disposable ENDS. Increasing ENDS prices from $3 to $6 was associated with a 13.6 percentage point reduction in ENDS selection (P < 0.001). Restricting flavor availability in ENDS to tobacco and menthol was associated with a 2.1 percentage point reduction in ENDS selection (P < 0.001). The proposed Food and Drug Administration (FDA) warning label was associated with a 1.1 percentage point reduction in ENDS selection (P < 0.05) and the MarkTen warning label with a 5.1 percentage point reduction (P < 0.001). We estimated an ENDS price elasticity of -1.8 (P < 0.001) among adult smokers. Statistically significant interaction terms (P < 0.001) imply that price responsiveness was higher among adult smokers 18-24 years of age, smokers who have vaped over the last month and smokers with above the median quitting interest. Young adult smokers were 3.7 percentage points more likely to choose ENDS when multiple flavors were available than older adults (P < 0.001). Young adult smokers and those with above the median cigarette quitting interest were also more likely to reduce cigarette selection and increase ENDS selection in January 2015 (P < 0.001), potentially in response to New Year's resolutions to quit smoking. Increased taxes, a proposed US Food and Drug Administration warning label for electronic nicotine delivery systems and a more severe warning label may discourage adult smokers from switching to electronic nicotine delivery systems. Reducing the availability of flavors may reduce ENDS use by young adult smokers. © 2015 Society for the Study of Addiction.
Twelve years' experience with direct-to-consumer advertising of prescription drugs in Canada: a cautionary tale.

PubMed

Mintzes, Barbara; Morgan, Steve; Wright, James M

2009-05-27

Direct-to-consumer advertising (DTCA) of prescription drugs is illegal in Canada as a health protection measure, but is permitted in the United States. However, in 2000, Canadian policy was changed to allow 'reminder' advertising of prescription drugs. This is a form of advertising that states the brand name without health claims. 'Reminder' advertising is prohibited in the US for drugs that have 'black box' warnings of serious risks. This study examines spending on DTCA in Canada from 1995 to 2006, 12 years spanning this policy shift. We ask how annual per capita spending compares to that in the US, and whether drugs with Canadian or US regulatory safety warnings are advertised to the Canadian public in reminder advertising. Prescription drug advertising spending data were extracted from a data set on health sector spending in Canada obtained from a market research company, TNS Media Inc. Spending was adjusted for inflation and compared with US spending. Inflation-adjusted spending on branded DTCA in Canada grew from under CAD$2 million per year before 1999 to over $22 million in 2006. The major growth was in broadcast advertising, accounting for 83% of spending in 2006. US annual per capita spending was on average 24 times Canadian levels. Celebrex (celecoxib), which has a US black box and was subject to three safety advisories in Canada, was the most heavily advertised drug on Canadian television in 2005 and 2006. Of 8 brands with >$500,000 spending, which together accounted for 59% of branded DTCA in all media, 6 were subject to Canadian safety advisories, and 4 had US black box warnings. Branded 'reminder' advertising has grown rapidly in Canada since 2000, mainly due to a growth in television advertising. Although DTCA spending per capita is much lower in Canada than in the US, there is no evidence of safer content or product choice; many heavily-advertised drugs in Canada have been subject to safety advisories. For governments searching for compromise solutions to industry pressure for expanded advertising, Canada's experience stands as a stark warning.
10 CFR 835.601 - General requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... DEPARTMENT OF ENERGY OCCUPATIONAL RADIATION PROTECTION Posting and Labeling § 835.601 General requirements... include the standard radiation warning trefoil in black or magenta imposed upon a yellow background. (b... protection instructions. (c) The posting and labeling requirements in this subpart may be modified to reflect...
10 CFR 835.601 - General requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... DEPARTMENT OF ENERGY OCCUPATIONAL RADIATION PROTECTION Posting and Labeling § 835.601 General requirements... include the standard radiation warning trefoil in black or magenta imposed upon a yellow background. (b... protection instructions. (c) The posting and labeling requirements in this subpart may be modified to reflect...
10 CFR 835.601 - General requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... DEPARTMENT OF ENERGY OCCUPATIONAL RADIATION PROTECTION Posting and Labeling § 835.601 General requirements... include the standard radiation warning trefoil in black or magenta imposed upon a yellow background. (b... protection instructions. (c) The posting and labeling requirements in this subpart may be modified to reflect...
10 CFR 835.601 - General requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... DEPARTMENT OF ENERGY OCCUPATIONAL RADIATION PROTECTION Posting and Labeling § 835.601 General requirements... include the standard radiation warning trefoil in black or magenta imposed upon a yellow background. (b... protection instructions. (c) The posting and labeling requirements in this subpart may be modified to reflect...
10 CFR 835.601 - General requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... DEPARTMENT OF ENERGY OCCUPATIONAL RADIATION PROTECTION Posting and Labeling § 835.601 General requirements... include the standard radiation warning trefoil in black or magenta imposed upon a yellow background. (b... protection instructions. (c) The posting and labeling requirements in this subpart may be modified to reflect...
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.
21 CFR 349.55 - Labeling of ophthalmic astringent drug products.

Code of Federal Regulations, 2011 CFR

2011-04-01

...” (select one of the following: “eye” or “ophthalmic”) “(insert dosage form, e.g., drops).” (b) Indications... temporary relief of discomfort from minor eye irritations.” (c) Warnings. In addition to the warnings in... products containing any ingredient identified in § 349.10: (1) “If you experience eye pain, changes in...
21 CFR 349.55 - Labeling of ophthalmic astringent drug products.

Code of Federal Regulations, 2010 CFR

2010-04-01

...” (select one of the following: “eye” or “ophthalmic”) “(insert dosage form, e.g., drops).” (b) Indications... temporary relief of discomfort from minor eye irritations.” (c) Warnings. In addition to the warnings in... products containing any ingredient identified in § 349.10: (1) “If you experience eye pain, changes in...

Adolescents' Attention to Traditional and Graphic Tobacco Warning Labels: An Eye-Tracking Approach

ERIC Educational Resources Information Center

Peterson, Emily Bylund; Thomsen, Steven; Lindsay, Gordon; John, Kevin

2010-01-01

The objective of this study was determine if the inclusion of Canadian-style graphic images would improve the degree to which adolescents attend to, and subsequently are able to recall, novel warning messages in tobacco magazine advertising. Specifically, our goal was to determine if the inclusion of graphic images would 1) increase visual…
Violence in Sports.

ERIC Educational Resources Information Center

Cooper, Donald L.

Increasing violence in sports is deplored, and a warning is issued on an apparent trend toward antisocial behavior. Contact sports such as hockey and football are cited as typically engendering aggression among athletes, but spectator sports (boxing, car racing, basketball, and baseball) are also singled out as eliciting increasing violence on the…
A flexible system to capture sample vials in a storage box - the box vial scanner.

PubMed

Nowakowski, Steven E; Kressin, Kenneth R; Deick, Steven D

2009-01-01

Tracking sample vials in a research environment is a critical task and doing so efficiently can have a large impact on productivity, especially in high volume laboratories. There are several challenges to automating the capture process, including the variety of containers used to store samples. We developed a fast and robust system to capture the location of sample vials being placed in storage that allows the laboratories the flexibility to use sample containers of varying dimensions. With a single scan, this device captures the box identifier, the vial identifier and the location of each vial within a freezer storage box. The sample vials are tracked through a barcode label affixed to the cap while the boxes are tracked by a barcode label on the side of the box. Scanning units are placed at the point of use and forward data to a sever application for processing the scanned data. Scanning units consist of an industrial barcode reader mounted in a fixture positioning the box for scanning and providing lighting during the scan. The server application transforms the scan data into a list of storage locations holding vial identifiers. The list is then transferred to the laboratory database. The box vial scanner captures the IDs and location information for an entire box of sample vials into the laboratory database in a single scan. The system accommodates a wide variety of vials sizes by inserting risers under the sample box and a variety of storage box layouts are supported via the processing algorithm on the server.
Antidepressant drugs and the risk of suicide in children and adolescents.

PubMed

Isacsson, Göran; Rich, Charles L

2014-04-01

Government agencies have issued warnings about the use of antidepressant medications in children, adolescents, and young adults since 2003. The statements warn that such medications may cause de novo 'suicidality' in some people. This review explores the data on the treatment of depression that led to these warnings and subsequent data that are relevant to the warnings. It also addresses the effectiveness of antidepressant treatment in general and the relationship of suicide rates to antidepressant treatment. It concludes that the decisions for the 'black box' warnings were based on biased data and invalid assumptions. Furthermore, the decisions were unsupported by the observational data regarding suicide in young people that existed in 2003. The following recommendations would seem to follow from these observations. First, drug authorities should re-evaluate the basis for their imposed warnings on antidepressant medicines, and analyze the actual public health consequences the warnings have had. In the absence of substantial evidence supporting the warnings, they should be removed. Second, physicians and other providers with prescription privileges should continue to be educated regarding the importance of aggressively treating depression in young people, using antidepressants when indicated. Third, physicians and other professionals who treat depressed young people must always be aware of the risk of suicide (albeit quite low) and observe them closely for any signs of increased risk of suicide. This is necessary regardless of the type of treatment being provided.
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
Mirtazapine and Weight Gain in Avoidant and Restrictive Food Intake Disorder.

PubMed

Gray, Emily; Chen, Theresa; Menzel, Jessie; Schwartz, Terry; Kaye, Walter H

2018-04-01

Avoidant and restrictive food intake disorder (ARFID) is a newly classified disorder in the DSM-5 that describes a pattern of restrictive eating across the lifespan that results in significant weight loss, nutritional deficiency, dependence on enteral feeding or nutritional supplements, or marked interference in psychosocial functioning. 1 Currently, there are no evidence-based treatment approaches or medications for this disorder. 2 We have administered a range of psychoactive medications to those with ARFID in our treatment program in an attempt to find an effective medication. One medication of interest has been mirtazapine because it promotes appetite and weight gain, decreases nausea and vomiting, and improves gastric emptying. Although mirtazapine is an off-label approach in a pediatric population and carries a black box warning for an increased risk of suicide, it is an effective treatment for depression and anxiety symptoms in adults and is generally well tolerated. 3,4 There are no studies to date reporting on the use of mirtazapine in patients with ARFID. Copyright © 2018 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.
Obesity, hypertension and home sphygmomanometer cuffs.

PubMed

Akpolat, Tekin

2010-08-01

Since the increasing prevalence of obesity leads to a larger mean arm circumferences in the hypertensive population and appropriate cuff size is essential for accurate measurement of blood pressure, overweight and obese patients often require automated home sphygmomanometers with large- or extra large-sized cuffs. The aims of this study were to evaluate the information about cuff size on automated upper arm home sphygmomanometer packing boxes and compare the findings with wrist device boxes. One hundred twelve different device boxes (49 automated upper arm, 5 semi-automatic, and 58 wrist) produced by 40 manufacturers were investigated. Three different types of information were observed (written, graphical, or a combination of both). There was not any information about cuff size on 49 (44%) device boxes. Most of the information expressed on the boxes was not attractive or informative for the patients. This study showed that the information regarding cuff size on most of the device boxes was obtuse and the patients are not warned sufficiently about appropriate cuff size. Physicians and health care providers should inform and train their patients about appropriate cuff size.
Malaria rapid diagnostic kits: quality of packaging, design and labelling of boxes and components and readability and accuracy of information inserts.

PubMed

Gillet, Philippe; Maltha, Jessica; Hermans, Veerle; Ravinetto, Raffaella; Bruggeman, Cathrien; Jacobs, Jan

2011-02-13

The present study assessed malaria RDT kits for adequate and correct packaging, design and labelling of boxes and components. Information inserts were studied for readability and accuracy of information. Criteria for packaging, design, labelling and information were compiled from Directive 98/79 of the European Community (EC), relevant World Health Organization (WHO) documents and studies on end-users' performance of RDTs. Typography and readability level (Flesch-Kincaid grade level) were assessed. Forty-two RDT kits from 22 manufacturers were assessed, 35 of which had evidence of good manufacturing practice according to available information (i.e. CE-label affixed or inclusion in the WHO list of ISO13485:2003 certified manufacturers). Shortcomings in devices were (i) insufficient place for writing sample identification (n=40) and (ii) ambiguous labelling of the reading window (n=6). Buffer vial labels were lacking essential information (n=24) or were of poor quality (n=16). Information inserts had elevated readability levels (median Flesch Kincaid grade 8.9, range 7.1-12.9) and user-unfriendly typography (median font size 8, range 5-10). Inadequacies included (i) no referral to biosafety (n=18), (ii) critical differences between depicted and real devices (n=8), (iii) figures with unrealistic colours (n=4), (iv) incomplete information about RDT line interpretations (n=31) and no data on test characteristics (n=8). Other problems included (i) kit names that referred to Plasmodium vivax although targeting a pan-species Plasmodium antigen (n=4), (ii) not stating the identity of the pan-species antigen (n=2) and (iii) slight but numerous differences in names displayed on boxes, device packages and information inserts. Three CE labelled RDT kits produced outside the EC had no authorized representative affixed and the shape and relative dimensions of the CE symbol affixed did not comply with the Directive 98/79/EC. Overall, RDTs with evidence of GMP scored better compared to those without but inadequacies were observed in both groups. Overall, malaria RDTs showed shortcomings in quality of construction, design and labelling of boxes, device packages, devices and buffers. Information inserts were difficult to read and lacked relevant information.
CDL description of the CDC 6600 stunt box

NASA Technical Reports Server (NTRS)

Hertzog, J. B.

1971-01-01

The CDC 6600 central memory control (stunt box) is described utilizing CDL (Computer Design Language), block diagrams, and text. The stunt box is a clearing house for all central memory references from the 6600 central and peripheral processors. Since memory requests can be issued simultaneously, the stunt box must be capable of assigning priorities to requests, of labeling requests so that the data will be distributed correctly, and of remembering rejected addresses due to memory conflicts.
48 CFR 252.223-7001 - Hazard warning labels.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Hazardous Material Identification and Material Safety Data clause of this contract. (b) The Contractor shall label the item package (unit container) of any hazardous material to be delivered under this contract in... which hazardous material listed in the Hazardous Material Identification and Material Safety Data clause...
48 CFR 252.223-7001 - Hazard warning labels.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Hazardous Material Identification and Material Safety Data clause of this contract. (b) The Contractor shall label the item package (unit container) of any hazardous material to be delivered under this contract in... which hazardous material listed in the Hazardous Material Identification and Material Safety Data clause...
48 CFR 252.223-7001 - Hazard warning labels.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Hazardous Material Identification and Material Safety Data clause of this contract. (b) The Contractor shall label the item package (unit container) of any hazardous material to be delivered under this contract in... which hazardous material listed in the Hazardous Material Identification and Material Safety Data clause...
48 CFR 252.223-7001 - Hazard warning labels.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Hazardous Material Identification and Material Safety Data clause of this contract. (b) The Contractor shall label the item package (unit container) of any hazardous material to be delivered under this contract in... which hazardous material listed in the Hazardous Material Identification and Material Safety Data clause...
48 CFR 252.223-7001 - Hazard warning labels.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Hazardous Material Identification and Material Safety Data clause of this contract. (b) The Contractor shall label the item package (unit container) of any hazardous material to be delivered under this contract in... which hazardous material listed in the Hazardous Material Identification and Material Safety Data clause...
47 CFR 15.216 - Disclosure requirements for wireless microphones and other low power auxiliary stations capable...

Code of Federal Regulations, 2012 CFR

2012-10-01

..., conspicuous, and readily legible manner. One way to fulfill the requirement in this section is to display the consumer disclosure text in a prominent manner on the product box by using a label (either printed onto the box or otherwise affixed to the box), a sticker, or other means. Another way to fulfill this...
Negative Treatment Effects: Is It Time for a Black Box Warning?

ERIC Educational Resources Information Center

Boisvert, Charles M.

2010-01-01

Comments on Negative effects from psychological treatments: A perspective by David Barlow. The author addresses negative treatment effects in the psychotherapy field by stating that Barlow provided a historical perspective of clinical psychology's long-standing interest in studying the positive effects of psychotherapy, and he indicated that…
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.
49 CFR 172.407 - Label specifications.

Code of Federal Regulations, 2012 CFR

2012-10-01

... one color background of green, red or blue. (ii) White must be used for the text and class number for... Hazardous Materials Safety, Office of Hazardous Materials Standards, Room 8422, Nassif Building, 400 Seventh... markings and hazard warning labels and placards: (i) For Red—Use PANTONE ® 186 U (ii) For Orange—Use...
30 CFR 47.44 - Temporary, portable containers.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Temporary, portable containers. 47.44 Section... TRAINING HAZARD COMMUNICATION (HazCom) Container Labels and Other Forms of Warning § 47.44 Temporary, portable containers. (a) The operator does not have to label a temporary, portable container if he or she...

Rock Music Gets a Label.

ERIC Educational Resources Information Center

Cutietta, Robert

1986-01-01

A group called Parents Music Resource Center (PMRC) has captured the media spotlight with a proposal to have warning labels placed on music albums containing sexually explicit or violent lyrics. Major record companies have agreed to a version of the PMRC's demands for a one-year trial period, beginning in 1986. (RM)
21 CFR 314.81 - Other postmarketing reports.

Code of Federal Regulations, 2011 CFR

2011-04-01

... to safety (for example, epidemiologic studies or analyses of experience in a monitored series of... times two copies of the following reports: (1) NDA—Field alert report. The applicant shall submit... information, for example, submit a labeling supplement, add a warning to the labeling, or initiate a new study...
21 CFR 314.81 - Other postmarketing reports.

Code of Federal Regulations, 2012 CFR

2012-04-01

... to safety (for example, epidemiologic studies or analyses of experience in a monitored series of... times two copies of the following reports: (1) NDA—Field alert report. The applicant shall submit... information, for example, submit a labeling supplement, add a warning to the labeling, or initiate a new study...
21 CFR 314.81 - Other postmarketing reports.

Code of Federal Regulations, 2013 CFR

2013-04-01

... to safety (for example, epidemiologic studies or analyses of experience in a monitored series of... times two copies of the following reports: (1) NDA—Field alert report. The applicant shall submit... information, for example, submit a labeling supplement, add a warning to the labeling, or initiate a new study...
21 CFR 314.81 - Other postmarketing reports.

Code of Federal Regulations, 2014 CFR

2014-04-01

... to safety (for example, epidemiologic studies or analyses of experience in a monitored series of... times two copies of the following reports: (1) NDA—Field alert report. The applicant shall submit... information, for example, submit a labeling supplement, add a warning to the labeling, or initiate a new study...
21 CFR 201.309 - Acetophenetidin (phenacetin)-containing preparations; necessary warning statement.

Code of Federal Regulations, 2010 CFR

2010-04-01

... investigation of reports of possible toxic effects and renal damage due to misuse of the drug acetophenetidin..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Specific Labeling Requirements... Drugs, in December 1963, appointed an ad hoc Advisory Committee of Inquiry on Possible Nephrotoxicity...
Smokers' and E-Cigarette Users' Perceptions about E-Cigarette Warning Statements.

PubMed

Wackowski, Olivia A; Hammond, David; O'Connor, Richard J; Strasser, Andrew A; Delnevo, Cristine D

2016-06-30

Cigarette warning labels are important sources of risk information, but warning research for other tobacco products is limited. This study aimed to gauge perceptions about warnings that may be used for e-cigarettes. We conducted six small focus groups in late 2014/early 2015 with adult current e-cigarette users and cigarette-only smokers. Participants rated and discussed their perceptions of six e-cigarette warning statements, and warnings in two existing Vuse and MarkTen e-cigarette ads. Participants were open to e-cigarette warnings and provided the strongest reactions to statements warning that e-liquid/e-vapor or e-cigarettes can be poisonous, contain toxins, or are "not a safe alternative to smoking". However, many also noted that these statements were exaggerated, potentially misleading, and could scare smokers away from reducing their harm by switching to e-cigarettes. Opinions on the Food and Drug Administration's proposed nicotine addiction warning and warnings that e-cigarettes had not been approved for smoking cessation or had unknown health effects were mixed. Participants perceived MarkTen's advertisement warning to be stronger and more noticeable than Vuse's. Care should be taken in developing e-cigarette warnings given their relative recentness and potential for harm reduction compared to other tobacco products. Additional research, including with varied audiences, would be instructive.
Manipulating Google's Knowledge Graph Box to Counter Biased Information Processing During an Online Search on Vaccination: Application of a Technological Debiasing Strategy.

PubMed

Ludolph, Ramona; Allam, Ahmed; Schulz, Peter J

2016-06-02

One of people's major motives for going online is the search for health-related information. Most consumers start their search with a general search engine but are unaware of the fact that its sorting and ranking criteria do not mirror information quality. This misconception can lead to distorted search outcomes, especially when the information processing is characterized by heuristic principles and resulting cognitive biases instead of a systematic elaboration. As vaccination opponents are vocal on the Web, the chance of encountering their non‒evidence-based views on immunization is high. Therefore, biased information processing in this context can cause subsequent impaired judgment and decision making. A technological debiasing strategy could counter this by changing people's search environment. This study aims at testing a technological debiasing strategy to reduce the negative effects of biased information processing when using a general search engine on people's vaccination-related knowledge and attitudes. This strategy is to manipulate the content of Google's knowledge graph box, which is integrated in the search interface and provides basic information about the search topic. A full 3x2 factorial, posttest-only design was employed with availability of basic factual information (comprehensible vs hardly comprehensible vs not present) as the first factor and a warning message as the second factor of experimental manipulation. Outcome variables were the evaluation of the knowledge graph box, vaccination-related knowledge, as well as beliefs and attitudes toward vaccination, as represented by three latent variables emerged from an exploratory factor analysis. Two-way analysis of variance revealed a significant main effect of availability of basic information in the knowledge graph box on participants' vaccination knowledge scores (F2,273=4.86, P=.01), skepticism/fear of vaccination side effects (F2,273=3.5, P=.03), and perceived information quality (F2,273=3.73, P=.02). More specifically, respondents receiving comprehensible information appeared to be more knowledgeable, less skeptical of vaccination, and more critical of information quality compared to participants exposed to hardly comprehensible information. Although, there was no significant interaction effect between the availability of information and the presence of the warning, there was a dominant pattern in which the presence of the warning appeared to have a positive influence on the group receiving comprehensible information while the opposite was true for the groups exposed to hardly comprehensible information and no information at all. Participants evaluated the knowledge graph box as moderately to highly useful, with no significant differences among the experimental groups. Overall, the results suggest that comprehensible information in the knowledge graph box positively affects participants' vaccination-related knowledge and attitudes. A small change in the content retrieval procedure currently used by Google could already make a valuable difference in the pursuit of an unbiased online information search. Further research is needed to gain insights into the knowledge graph box's entire potential.
New Labeling for Neonicotinoid Pesticides

EPA Pesticide Factsheets

These documents, a graphic of the bee advisory box and letters to pesticide registrants, describe steps by EPA to change pesticide labels to better protect pollinators by being clearer and more precise in their directions for pesticide application.
Exposure to Prescription Drugs Labeled for Risk of Adverse Effects of Suicidal Behavior or Ideation among 100 Air Force Personnel Who Died by Suicide, 2006-2009

ERIC Educational Resources Information Center

Lavigne, Jill E.; McCarthy, Michael; Chapman, Richard; Petrilla, Allison; Knox, Kerry L.

2012-01-01

Prescription drugs for many indications are labeled with warnings for potential risk of suicidal ideation or behavior. Exposures to prescription drugs labeled for adverse effects of suicidal behavior or ideation among 100 Air Force personnel who died by suicide between 2006 and 2009 are described. Air Force registry data were linked to…
Waterpipe product packaging and labelling at the 3rd international Hookah Fair; does it comply with Article 11 of the Framework Convention on Tobacco Control?

PubMed

Jawad, Mohammed; Darzi, Andrea; Lotfi, Tamara; Nakkash, Rima; Hawkins, Ben; Akl, Elie A

2017-08-01

We assessed compliance of waterpipe product packaging and labelling with the Framework Convention on Tobacco Control's Article 11. We evaluated samples collected at a trade fair against ten domains: health warning location, size, use of pictorials, use of colour, and packaging information on constituents and emissions. We also evaluated waterpipe accessories (e.g., charcoal) for misleading claims. Ten of 15 tobacco products had health warnings on their principal display areas, covering a median of 22.4 per cent (interquartile range 19.4-27.4 per cent) of those areas. Three had pictorial, in-colour health warnings. We judged all packaging information on constituents and emissions to be misleading. Eight of 13 charcoal products displayed environmentally friendly descriptors and/or claims of reduced harm that we judged to be misleading. Increased compliance with waterpipe tobacco regulation is warranted. An improved policy framework for waterpipe tobacco should also consider regulation of accessories such as charcoal products.
Neural Correlates of Graphic Cigarette Warning Labels Predict Smoking Cessation Relapse

PubMed Central

Owens, Max M.; MacKillop, James; Gray, Joshua C.; Hawkshead, Brittany E.; Murphy, Cara M.; Sweet, Lawrence H.

2017-01-01

Exposure to graphic warning labels (GWLs) on cigarette packaging has been found to produce heightened activity in brain regions central to emotional processing and higher-order cognitive processes. The current study extends this literature by using functional magnetic resonance imaging (fMRI) to investigate neural activation in response to GWLs and use it to predict relapse in an evidence-based smoking cessation treatment program. Participants were 48 treatment-seeking nicotine-dependent smokers who completed an fMRI paradigm in which they were exposed to GWLs, text-only warning labels (TOLs), and matched control stimuli. Subsequently, they enrolled in smoking cessation treatment and their smoking behavior was monitored. Activation in bilateral amygdala, right dorsolateral prefrontal cortex, right inferior frontal gyrus, left medial temporal gyrus, bilateral occipital lobe, and bilateral fusiform gyrus was greater during GWLs than TOLs. Neural response in the ventromedial prefrontal cortex (vmPFC) during exposure to GWLs (relative to a visual control image) predicted relapse during treatment beyond baseline demographic and dependence severity, but response in the amygdala to GWLs did not. These findings suggest that neurocognitive processes in the vmPFC may be critical to understanding how GWL’s induce behavior change and may be useful as a predictor of smoking cessation treatment prognosis. PMID:28236714
"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.
21 CFR 201.315 - Over-the-counter drugs for minor sore throats; suggested warning.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Over-the-counter drugs for minor sore throats... Drug Products § 201.315 Over-the-counter drugs for minor sore throats; suggested warning. The Food and... counter for the relief of minor irritations of the mouth or throat. It will not object to the labeling of...
21 CFR 201.315 - Over-the-counter drugs for minor sore throats; suggested warning.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Over-the-counter drugs for minor sore throats... Drug Products § 201.315 Over-the-counter drugs for minor sore throats; suggested warning. The Food and... counter for the relief of minor irritations of the mouth or throat. It will not object to the labeling of...
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.
21 CFR 866.6050 - Ovarian adnexal mass assessment score test system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... surgery is planned, is malignant. The test is for adjunctive use, in the context of a negative primary clinical and radiological evaluation, to augment the identification of patients whose gynecologic surgery... § 866.1(e). (c) Black box warning. Under section 520(e) of the Federal Food, Drug, and Cosmetic Act...
Using Calculators in Mathematics 11. Teacher Commentary.

ERIC Educational Resources Information Center

Rising, Gerald R.; And Others

This teacher's guide is designed to aid in the incorporation of programable calculators in the school mathematics program for pupils in grade 11. Warnings include the need for care in modifying the curriculum so that students are not punished in the process. The concept of "black boxing," of letting the computer or calculator take charge…
Using Calculators in Mathematics 12. Teacher Commentary.

ERIC Educational Resources Information Center

Rising, Gerald R.; And Others

This teacher's guide is designed to aid in the incorporation of programable calculators in the school mathematics program for pupils in grade 12. Warnings are given, including the need for care in modifying the curriculum so that students are not punished in the process. The concept of "black boxing," of letting the computer or…
Detection of reactive metabolites using isotope-labeled glutathione trapping and simultaneous neutral loss and precursor ion scanning with ultra-high-pressure liquid chromatography triple quadruple mass spectrometry.

PubMed

Huang, Ke; Huang, Lingyi; van Breemen, Richard B

2015-04-07

Metabolic activation of drugs to electrophilic species is responsible for over 60% of black box warnings and drug withdrawals from the market place in the United States. Reactive metabolite trapping using glutathione (GSH) and analysis using high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) or HPLC with high resolution mass spectrometry (mass defect filtering) have enabled screening for metabolic activation to become routine during drug development. However, current MS-based approaches cannot detect all GSH conjugates present in complex mixtures, especially those present in extracts of botanical dietary supplements. To overcome these limitations, a fast triple quadrupole mass spectrometer-based approach was developed that can detect positively and negatively charged GSH conjugates in a single analysis without the need for advanced knowledge of the elemental compositions of potential conjugates and while avoiding false positives. This approach utilized UHPLC instead of HPLC to shorten separation time and enhance sensitivity, incorporated stable-isotope labeled GSH to avoid false positives, and used fast polarity switching electrospray MS/MS to detect GSH conjugates that form positive and/or negative ions. The general new method was then used to test the licorice dietary supplement Glycyrrhiza glabra, which was found to form multiple GSH conjugates upon metabolic activation. Among the GSH conjugates found in the licorice assay were conjugates with isoliquiritigenin and glabridin, which is an irreversible inhibitor of cytochrome P450 enzymes.

Clothing Flammability and Burn Injuries: Public Opinion Concerning an Overlooked, Preventable Public Health Problem.

PubMed

Frattaroli, Shannon; Spivak, Steven M; Pollack, Keshia M; Gielen, Andrea C; Salomon, Michele; Damant, Gordon H

2016-01-01

The objective of this study was to describe knowledge of clothing flammability risk, public support for clothing flammability warning labels, and stronger regulation to reduce the risk. As part of a national survey of homeowners about residential sprinkler systems, the authors included questions about clothing flammability. The authors used an online web panel to sample homeowners and descriptive methods to analyze the resulting data. The sample included 2333 homeowners. Knowledge of clothing flammability and government oversight of clothing flammability risk was low. Homeowners were evenly split about the effectiveness of current standards; however, when presented with clothing-related burn injury and death data, a majority (53%) supported stricter standards. Most homeowners (64%) supported warning labels and indicated that such labels would either have no effect on their purchasing decisions (64%) or be an incentive (24%) to purchase an item. Owners of sprinkler-equipped homes were more likely to support these interventions than owners of homes without sprinkler systems. Public knowledge about clothing flammability risks is low. Most homeowners supported clothing labels to inform consumers of this risk and increased government intervention to reduce the risk.
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.
Food Allergies: Understanding Food Labels

MedlinePlus

... Manufacturers aren't required to include warnings about food allergens accidentally introduced during manufacturing or packaging (cross-contamination). This potentially can cause trouble if you're ...
Frequency and Content of Conversations About Pictorial Warnings on Cigarette Packs.

PubMed

Morgan, Jennifer C; Southwell, Brian G; Noar, Seth M; Ribisl, Kurt M; Golden, Shelley D; Brewer, Noel T

2018-06-07

Social interactions are a key mechanism through which health communication efforts, including pictorial cigarette pack warnings, may exert their effects. We sought to better understand social interactions elicited by pictorial cigarette pack warnings. A controlled trial randomly assigned US adult smokers (n = 2149) to have their cigarette packs labeled with pictorial or text-only warnings for 4 weeks. Smokers completed surveys during the baseline visit and each of the subsequent 4 weekly visits. Smokers with pictorial warnings on their packs had more conversations throughout the trial compared to those with text-only warnings (8.2 conversations vs 5.0, p<.01). The highest number of conversations occurred during the first week. Smokers with pictorial warnings were more likely than those with text-only warnings to discuss the health effects of smoking, whether the warnings would make them want to quit and whether the warnings would make others want to quit (all p < .05). Smokers were more likely to describe pictorial warnings as scary, gross, or depressing and gloomy during conversations than text-only warnings (all p < .05). Pictorial warnings sparked more conversations about the warnings, the health effects of smoking, and quitting smoking than text-only warnings. These social interactions may extend the reach of pictorial warnings beyond the targeted smoker and may be one of the processes by which pictorial warnings have impact. Health communication can influence behavior by changing social interactions. Our trial characterized social interactions about pictorial cigarette pack warnings with a large longitudinal sample in a real-world setting. Understanding these conversations can inform the United States and other countries as they improve existing warnings and help tobacco control policy makers and health communication theorists understand how social interactions triggered by warnings affect smoking.
Assessing the Effectiveness of the International Counterproliferation Program

DTIC Science & Technology

2011-01-01

a box labeled “Ongoing needs assessment.” Within this box are the two key planning actions that contribute to this type of assessment: identification ...nation, all participating countries tend to receive a fairly standardized set of courses. This course lineup is determined largely by the ICP
Smokers’ and E-Cigarette Users’ Perceptions about E-Cigarette Warning Statements

PubMed Central

Wackowski, Olivia A.; Hammond, David; O’Connor, Richard J.; Strasser, Andrew A.; Delnevo, Cristine D.

2016-01-01

Cigarette warning labels are important sources of risk information, but warning research for other tobacco products is limited. This study aimed to gauge perceptions about warnings that may be used for e-cigarettes. We conducted six small focus groups in late 2014/early 2015 with adult current e-cigarette users and cigarette-only smokers. Participants rated and discussed their perceptions of six e-cigarette warning statements, and warnings in two existing Vuse and MarkTen e-cigarette ads. Participants were open to e-cigarette warnings and provided the strongest reactions to statements warning that e-liquid/e-vapor or e-cigarettes can be poisonous, contain toxins, or are “not a safe alternative to smoking”. However, many also noted that these statements were exaggerated, potentially misleading, and could scare smokers away from reducing their harm by switching to e-cigarettes. Opinions on the Food and Drug Administration’s proposed nicotine addiction warning and warnings that e-cigarettes had not been approved for smoking cessation or had unknown health effects were mixed. Participants perceived MarkTen’s advertisement warning to be stronger and more noticeable than Vuse’s. Care should be taken in developing e-cigarette warnings given their relative recentness and potential for harm reduction compared to other tobacco products. Additional research, including with varied audiences, would be instructive. PMID:27376310
Malaria rapid diagnostic kits: quality of packaging, design and labelling of boxes and components and readability and accuracy of information inserts

PubMed Central

2011-01-01

Background The present study assessed malaria RDT kits for adequate and correct packaging, design and labelling of boxes and components. Information inserts were studied for readability and accuracy of information. Methods Criteria for packaging, design, labelling and information were compiled from Directive 98/79 of the European Community (EC), relevant World Health Organization (WHO) documents and studies on end-users' performance of RDTs. Typography and readability level (Flesch-Kincaid grade level) were assessed. Results Forty-two RDT kits from 22 manufacturers were assessed, 35 of which had evidence of good manufacturing practice according to available information (i.e. CE-label affixed or inclusion in the WHO list of ISO13485:2003 certified manufacturers). Shortcomings in devices were (i) insufficient place for writing sample identification (n = 40) and (ii) ambiguous labelling of the reading window (n = 6). Buffer vial labels were lacking essential information (n = 24) or were of poor quality (n = 16). Information inserts had elevated readability levels (median Flesch Kincaid grade 8.9, range 7.1 - 12.9) and user-unfriendly typography (median font size 8, range 5 - 10). Inadequacies included (i) no referral to biosafety (n = 18), (ii) critical differences between depicted and real devices (n = 8), (iii) figures with unrealistic colours (n = 4), (iv) incomplete information about RDT line interpretations (n = 31) and no data on test characteristics (n = 8). Other problems included (i) kit names that referred to Plasmodium vivax although targeting a pan-species Plasmodium antigen (n = 4), (ii) not stating the identity of the pan-species antigen (n = 2) and (iii) slight but numerous differences in names displayed on boxes, device packages and information inserts. Three CE labelled RDT kits produced outside the EC had no authorized representative affixed and the shape and relative dimensions of the CE symbol affixed did not comply with the Directive 98/79/EC. Overall, RDTs with evidence of GMP scored better compared to those without but inadequacies were observed in both groups. Conclusion Overall, malaria RDTs showed shortcomings in quality of construction, design and labelling of boxes, device packages, devices and buffers. Information inserts were difficult to read and lacked relevant information. PMID:21314992
Exposure to graphic warning labels on cigarette packages: Effects on implicit and explicit attitudes towards smoking among young adults.

PubMed

Macy, Jonathan T; Chassin, Laurie; Presson, Clark C; Yeung, Ellen

2016-01-01

To test the effect of exposure to the US Food and Drug Administration's proposed graphic images with text warning statements for cigarette packages on implicit and explicit attitudes towards smoking. A two-session web-based study was conducted with 2192 young adults 18-25-years-old. During session one, demographics, smoking behaviour, and baseline implicit and explicit attitudes were assessed. Session two, completed on average 18 days later, contained random assignment to viewing one of three sets of cigarette packages, graphic images with text warnings, text warnings only, or current US Surgeon General's text warnings. Participants then completed post-exposure measures of implicit and explicit attitudes. ANCOVAs tested the effect of condition on the outcomes, controlling for baseline attitudes. Smokers who viewed packages with graphic images plus text warnings demonstrated more negative implicit attitudes compared to smokers in the other conditions (p = .004). For the entire sample, explicit attitudes were more negative for those who viewed graphic images plus text warnings compared to those who viewed current US Surgeon General's text warnings (p = .014), but there was no difference compared to those who viewed text-only warnings. Graphic health warnings on cigarette packages can influence young adult smokers' implicit attitudes towards smoking.
A qualitative exploration of young adult smokers’ responses to novel tobacco warnings

PubMed Central

2013-01-01

Background Despite reduced smoking among adolescents, smoking prevalence peaks among young adults aged 18–30, many of whom believe themselves exempt from the health risks of smoking shown in warning labels. We explored how young adult smokers perceived warnings featuring proximal risks, and whether these encouraged cessation more effectively than traditional health messages. Methods We conducted in-depth interviews with 17 young adult smokers and explored their perceptions of current warnings as well as novel warnings representing short-term health consequences; immediate social risks, and tobacco’s toxicity (denormalizing tobacco as an everyday product). We used a thematic analysis approach to explore how participants rationalized existing warnings and interpreted the novel messages. Results Participants considered the immediate social and physiological benefits they gained from smoking outweighed the distal risks shown in health warnings, which they regarded as improbable and irrelevant. Of the novel warnings, those presenting immediate social risks altered the balance of gains and losses young adults associated with smoking; however, those presenting short-term health risks or depicting tobacco as a toxin were less effective. Conclusions Participants regarded warnings featuring proximal social risks as more salient and they were less likely to rationalise these as irrelevant. Social risk messages merit further investigation to examine their potential as a complement to traditional health warnings. PMID:23800292
Does Adding Information on Toxic Constituents to Cigarette Pack Warnings Increase Smokers' Perceptions about the Health Risks of Smoking? A Longitudinal Study in Australia, Canada, Mexico, and the United States

ERIC Educational Resources Information Center

Cho, Yoo Jin; Thrasher, James F.; Swayampakala, Kamala; Lipkus, Isaac; Hammond, David; Cummings, Kenneth Michael; Borland, Ron; Yong, Hua-Hie; Hardin, James W.

2018-01-01

Background: Health warning labels (HWLs) on cigarette packs in Australia, Canada, Mexico, and the United States include varying information about toxic cigarette smoke constituents and smoking-related health risks. HWL information changed more recently in Australia, Canada, and Mexico than in the United States. Aims: To investigate whether…
Conflict of interest and FCTC implementation in China.

PubMed

Wan, Xia; Ma, Shaojun; Hoek, Janet; Yang, Jie; Wu, Lanyan; Zhou, Jiushun; Yang, Gonghuan

2012-07-01

To critically review the structure of tobacco control policy making in China, examine conflicts of interest within this structure, and consider how these affected the introduction of on-pack warnings. Government policy documents and warning labels were obtained and critically reviewed. Few differences exist between the on-pack warnings formerly used in China and those introduced ostensibly to meet Framework Convention on Tobacco Control (FCTC) obligations. Comparison with tobacco manufactured for export or overseas consumption shows the new Chinese domestic on-pack warnings are demonstrably inferior to those required internationally. The inherent conflict of interest in the Chinese tobacco control agency structure, which must meet commercial and public health objectives, undermined the introduction of new health warnings. To promote more effective tobacco control policies, the conflict of interest inhibiting the public health function of the State Tobacco Monopoly Administration (STMA) must be removed. Specifically, the public health function must be separated from oversight of commercial production, and packaging must be redesigned with pictorial warnings and messages compliant with Article 11 of the FCTC.
19 CFR 18.4 - Sealing conveyances and compartments; labeling packages; warning cards.

Code of Federal Regulations, 2010 CFR

2010-04-01

... the breaking of the seals will be necessary to ventilate the hatches, or in other similar... or label to be affixed to heavy or bulky goods being so transported. If, however, he has reason to... authorized to break these seals. Car or vessel Number or name From To Notice: The merchandise in this car...
A fMRI study on the impact of advertising for flavored e-cigarettes on susceptible college-age youth*

PubMed Central

Garrison, Kathleen A.; O'Malley, Stephanie S.; Gueorguieva, Ralitza; Krishnan-Sarin, Suchitra

2018-01-01

Background E-cigarettes are sold in flavors such as “Skittles,” “strawberrylicious,” and “juicy fruit,” and no restrictions are in place on marketing e-cigarettes to youth. Sweets/fruits depicted in e-cigarette advertisements may increase their appeal to youth and interfere with health warnings. This study tested a brain biomarker of product preference for sweet/fruit versus tobacco flavor e-cigarettes, and whether advertising for flavors interfered with warning labels. Methods Participants (N=26) were college-age youth who had tried an e-cigarette and were susceptible to future e-cigarette use. They viewed advertisements in fMRI for sweet/fruit and tobacco flavor e-cigarettes, menthol and regular cigarettes, and control images of fruits/sweets/mints with no tobacco product. Cue-reactivity was measured in the nucleus accumbens, a brain biomarker of product preference. Advertisements randomly contained warning labels, and recognition of health warnings was tested post-scan. Visual attention was measured using eye-tracking. Results There was a significant effect of e-cigarette condition (sweet/tobacco/control) on nucleus accumbens activity, that was not found for cigarette condition (menthol/regular/control). Nucleus accumbens activity was greater for sweet/fruit versus tobacco flavor e-cigarette advertisements and did not differ compared with control images of sweets and fruits. Greater nucleus accumbens activity was correlated with poorer memory for health warnings. Conclusions These and exploratory eye-tracking findings suggest that advertising for sweet/fruit flavors may increase positive associations with e-cigarettes and/or override negative associations with tobacco, and interfere with health warnings, suggesting that one way to reduce the appeal of e-cigarettes to youth and educate youth about e-cigarette health risks is to regulate advertising for flavors. PMID:29626776
A fMRI study on the impact of advertising for flavored e-cigarettes on susceptible young adults.

PubMed

Garrison, Kathleen A; O'Malley, Stephanie S; Gueorguieva, Ralitza; Krishnan-Sarin, Suchitra

2018-05-01

E-cigarettes are sold in flavors such as "skittles," "strawberrylicious," and "juicy fruit," and no restrictions are in place on marketing e-cigarettes to youth. Sweets/fruits depicted in e-cigarette advertisements may increase their appeal to youth and interfere with health warnings. This study tested a brain biomarker of product preference for sweet/fruit versus tobacco flavor e-cigarettes, and whether advertising for flavors interfered with warning labels. Participants (N = 26) were college-age young adults who had tried an e-cigarette and were susceptible to future e-cigarette use. They viewed advertisements in fMRI for sweet/fruit and tobacco flavor e-cigarettes, menthol and regular cigarettes, and control images of sweets/fruits/mints with no tobacco product. Cue-reactivity was measured in the nucleus accumbens, a brain biomarker of product preference. Advertisements randomly contained warning labels, and recognition of health warnings was tested post-scan. Visual attention was measured using eye-tracking. There was a significant effect of e-cigarette condition (sweet/tobacco/control) on nucleus accumbens activity, that was not found for cigarette condition (menthol/regular/control). Nucleus accumbens activity was greater for sweet/fruit versus tobacco flavor e-cigarette advertisements and did not differ compared with control images of sweets and fruits. Greater nucleus accumbens activity was correlated with poorer memory for health warnings. These and exploratory eye-tracking findings suggest that advertising for sweet/fruit flavors may increase positive associations with e-cigarettes and/or override negative associations with tobacco, and interfere with health warnings, suggesting that one way to reduce the appeal of e-cigarettes to youth and educate youth about e-cigarette health risks is to regulate advertising for flavors. Copyright © 2018 Elsevier B.V. All rights reserved.
Perceived effectiveness of text and pictorial health warnings for smokeless tobacco packages in Navi Mumbai, India, and Dhaka, Bangladesh: findings from an experimental study.

PubMed

Mutti, Seema; Reid, Jessica L; Gupta, Prakash C; Pednekar, Mangesh S; Dhumal, Gauri; Nargis, Nigar; Hussain, Akm Ghulam; Hammond, David

2016-07-01

To examine the perceived effectiveness of text and pictorial smokeless tobacco health warnings in India and Bangladesh, including different types of message content. An experimental study was conducted in Navi Mumbai, India (n=1002), and Dhaka, Bangladesh (n=1081). Face-to-face interviews were conducted on tablets with adult (≥19 years) smokeless tobacco users and youth (16-18 years) users and non-users. Respondents viewed warnings depicting five health effects, within one of the four randomly assigned warning label conditions (or message themes): (1) text-only, (2) symbolic pictorial, (3) graphic pictorial or (4) personal testimonial pictorial messages. Text-only warnings were perceived as less effective than all of the pictorial styles (p<0.001 for all). Graphic warnings were given higher effectiveness ratings than symbolic or testimonial warnings (p<0.001). No differences were observed in levels of agreement with negative attitudes and beliefs across message themes, after respondents had viewed warnings. Pictorial warnings are more effective than text-only messages. Pictorial warnings depicting graphic health effects may have the greatest impact, consistent with research from high-income countries on cigarette warnings. 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/
A Combined Arms Approach to Defending Army Networks

DTIC Science & Technology

2012-01-01

GIG operates, through cyberspace, as a globally interconnected, end...operations from the friendly to adversary box increases the situational awareness and unity of effort the Army lacks, and creates an economy of force that...indica- tions and warnings • Present a timely and accurate estimate of technical impact result- ing from the threat activity and determine
Devising a method towards development of early warning tool for detection of malaria outbreak.

PubMed

Verma, Preeti; Sarkar, Soma; Singh, Poonam; Dhiman, Ramesh C

2017-11-01

Uncertainty often arises in differentiating seasonal variation from outbreaks of malaria. The present study was aimed to generalize the theoretical structure of sine curve for detecting an outbreak so that a tool for early warning of malaria may be developed. A 'case/mean-ratio scale' system was devised for labelling the outbreak in respect of two diverse districts of Assam and Rajasthan. A curve-based method of analysis was developed for determining outbreak and using the properties of sine curve. It could be used as an early warning tool for Plasmodium falciparum malaria outbreaks. In the present method of analysis, the critical C max (peak value of sine curve) value of seasonally adjusted curve for P. falciparum malaria outbreak was 2.3 for Karbi Anglong and 2.2 for Jaisalmer districts. On case/mean-ratio scale, the C max value of malaria curve between C max and 3.5, the outbreak could be labelled as minor while >3.5 may be labelled as major. In epidemic years, with mean of case/mean ratio of ≥1.00 and root mean square (RMS) ≥1.504 of case/mean ratio, outbreaks can be predicted 1-2 months in advance. The present study showed that in P. falciparum cases in Karbi Anglong (Assam) and Jaisalmer (Rajasthan) districts, the rise in C max value of curve was always followed by rise in average/RMS or both and hence could be used as an early warning tool. The present method provides better detection of outbreaks than the conventional method of mean plus two standard deviation (mean+2 SD). The identified tools are simple and may be adopted for preparedness of malaria outbreaks.
Perceptions and Perceived Impact of Graphic Cigarette Health Warning Labels on Smoking Behavior Among U.S. Young Adults

PubMed Central

2014-01-01

Introduction: In 2011, the Food and Drug Administration published a final rule requiring cigarette packages and advertisements to include graphic health warning labels (HWLs) with new warning statements. Implementation of this rule has been stalled by legal challenge. This study assessed correlates of smoking-related intentions related to graphic HWLs among current cigarette smokers and nonsmokers in a national sample of U.S. young adults aged 18–34. Methods: Data were collected from 4,236 participants aged 18–34 using an online panel in January 2012 for the Legacy Young Adult Cohort Study. Analyses were weighted to provide nationally representative estimates. Our main outcome was assessed with a single item: “Do you think that new warning labels with graphic pictures would make you think about not smoking?” Results: Twenty-two percent of the young adults were current cigarette smokers. Fifty-three percent endorsed that new graphic HWLs would make them think about not smoking (40% among current smokers compared with 56% among nonsmokers). Among nonsmokers, those aged 18–24, females, Hispanics, and those who were aware of graphic cigarette HWLs were more likely to report intention to not smoke related to graphic HWLs. Among current smokers, intending to quit within the next 6 months was correlated with intention resulting from graphic HWLs. Hispanic ethnicity and intention to quit within 30 days were strong correlates of intention in light, nondaily, and self-identified social/occasional smokers. Conclusions: This study supports previous findings that graphic HWLs play an important role in preventing smoking, in addition to encouraging cessation in young adults. PMID:24212476
Effect of the Framework Convention on Tobacco Control and Voluntary Industry Health Warning Labels on Passage of Mandated Cigarette Warning Labels From 1965 to 2012: Transition Probability and Event History Analyses

PubMed Central

Sanders-Jackson, Ashley N.; Song, Anna V.; Hiilamo, Heikki

2013-01-01

Objectives. We quantified the pattern and passage rate of cigarette package health warning labels (HWLs), including the effect of the Framework Convention on Tobacco Control (FCTC) and HWLs voluntarily implemented by tobacco companies. Methods. We used transition probability matrices to describe the pattern of HWL passage and change rate in 4 periods. We used event history analysis to estimate the effect of the FCTC on adoption and to compare that effect between countries with voluntary and mandatory HWLs. Results. The number of HWLs passed during each period accelerated, from a transition rate among countries that changed from 2.42 per year in 1965–1977 to 6.71 in 1977–1984, 8.42 in 1984–2003, and 22.33 in 2003–2012. The FCTC significantly accelerated passage of FCTC-compliant HWLs for countries with initially mandatory policies with a hazard of 1.27 per year (95% confidence interval = 1.11, 1.45), but only marginally increased the hazard for countries that had an industry voluntary HWL of 1.68 per year (95% confidence interval = 0.95, 2.97). Conclusions. Passage of HWLs is accelerating, and the FCTC is associated with further acceleration. Industry voluntary HWLs slowed mandated HWLs. PMID:24028248
The new weight-loss drugs, lorcaserin and phentermine-topiramate: slim pickings?

PubMed

Woloshin, Steven; Schwartz, Lisa M

2014-04-01

In 2012, the US Food and Drug Administration approved 2 drugs for long-term weight loss: lorcaserin hydrochloride (Belviq; Eisai Inc) and phentermine-topiramate (Qysmia; Vivus Inc). The approvals were based on 1-year trials showing that on top of recommendations to follow a calorie-restricted diet and to increase exercise, patients randomized to either drug lost more weight than patients randomized to placebo (3% [95% CI, 3%-4%] more weight lost with lorcaserin; 7% [95% CI, 3%-4%] more with phentermine /topiramate). The drugs have been associated with serious harms: Both drugs' labels include warnings about memory, attention, or language problems and depression; for lorcaserin, the label also warns of valvular heart disease and euphoria; and for phentermine-topiramate, the label warns of metabolic acidosis, increased heart rate, anxiety, insomnia, and elevated creatinine levels. Neither medication is marketed in Europe because of safety concerns. The manufacturer withdrew its application for lorcaserin in Europe after the European Medicines Agency (EMA) said approval was unlikely, and the EMA rejected phentermine-topiramate. In the United States, the required postmarketing safety trials are behind schedule. Until there is more convincing evidence about the cardiovascular safety of these drugs, physicians and patients should approach them cautiously. Patients who do not lose at least 5% of their body weight within 12 weeks of starting to take either drug should stop taking it, as stated in the prescribing information.

Policy-Relevant Context of Waterpipe Tobacco Smoking among University Students in Six Countries Across the Eastern Mediterranean Region: A Qualitative Study

PubMed Central

Salloum, Ramzi G; Abu-Rmeileh, Niveen; Hamadeh, Randah; Thomas, Justin; Mostafa, Aya; Yusufali, Afzalhussein; Kheirallah, Khalid A; Macauda, Mark M; Theis, Ryan P; Kadi, Lama El; Johnson, Evan J; Darawad, Muhammad W; Nakkash, Rima

2017-01-01

Background: Waterpipe tobacco smoking rates in the Eastern Mediterranean region are some of the highest worldwide, especially among young people. This study aimed to improve our knowledge of the policy-relevant context of waterpipe smoking among six countries in the Eastern Mediterranean region. Methods: In-depth interviews were conducted in Bahrain, Egypt, Jordan, Lebanon, Palestine, and the United Arab Emirates. Participants were young adult university students (18-29 years) from both genders who had ever smoked the waterpipe, recruited from universities participating in this study. Directed content analysis was used to analyze the transcripts. Results: A total of 53 in-depth interviews were conducted in Arabic in 2016. Findings were organized around 5 themes: waterpipe product characteristics; patterns of waterpipe smoking; the waterpipe café setting; perceived health consequences; and health warning labels. Waterpipe smoking was commonly perceived as a safe alternative to cigarettes. Waterpipe tobacco was reported to be widely accessible and affordable to young participants. There is a lack of knowledge among waterpipe smokers about the associated health effects. Warning labels are effective at communicating health risks associated with waterpipe smoking. Conclusions: Regulatory frameworks for waterpipe tobacco smoking should be developed and enforced, including waterpipe-specific health warning labels that elucidate the harmful effects of waterpipe smoking. PMID:28952296
Women’s Perspectives on Smoking and Pregnancy and Graphic Warning Labels

PubMed Central

Levis, Denise M.; Stone-Wiggins, Brenda; O’Hegarty, Michelle; Tong, Van T.; Polen, Kara N. D.; Cassell, Cynthia H.; Council, Mary

2015-01-01

Objectives To explore women’s knowledge, attitudes, and beliefs about adverse outcomes associated with smoking during pregnancy and which outcomes might motivate cessation; to explore reactions to graphic warnings depicting 2 adverse outcomes. Methods Twelve focus groups were conducted with women of childbearing age who were current smokers. Results Participants had low to moderate awareness of many outcomes and believed it was acceptable to smoke in the first trimester before knowledge of pregnancy. Perceived susceptibility to outcomes was low. Motivators included risk-focused information, especially serious risks to the baby (eg, stillbirth, SIDS). Graphic warnings produced strong reactions, especially the warning with a real photo. Conclusions Despite barriers to reducing rates of smoking during pregnancy, educational information and photos depicting babies’ risks could motivate women to quit. PMID:24933145
21 CFR 1002.10 - Product reports.

Code of Federal Regulations, 2010 CFR

2010-04-01

... those products which may produce increased radiation with aging, describe the methods and procedures... procedures. (j) Report for each model all warning signs, labels, and instructions for installation, operation...
21 CFR 1002.10 - Product reports.

Code of Federal Regulations, 2011 CFR

2011-04-01

... which may produce increased radiation with aging, describe the methods and procedures used, and...) Report for each model all warning signs, labels, and instructions for installation, operation, and use...
Is the Effectiveness of Tobacco Image-Based Warning Labels Likely to Vary by Socio-Demographic Variable? Findings from an Online Survey of 19,000 Members of the UK Public

ERIC Educational Resources Information Center

Styles, Maggie; Williams, Brian; Humphris, Gerry

2013-01-01

Objective: Smoking continues to be a major global cause of mortality and morbidity. Countries have increasingly adopted the use of images as warnings on cigarette packs. We aimed to investigate the likely differential impact of varied images and messages on sub-groups of the United Kingdom (UK) smoking population. Methods: Forty two images…
Women and smoking—prices and health warning messages: evidence from Spain.

PubMed

Gil-Lacruz, Ana Isabel; Gil-Lacruz, Marta; Leeder, Stephen

2015-06-01

In Spain, fewer men are smoking every year yet the number of women smokers remains relatively high. This paper examines the impact of two anti-smoking policies (increased prices and obligatory pictorial health warning labels) on womens smoking decisions; generation cohorts are used to elucidate the determinants of those decisions. We have drawn 48,755 observations of women living in Spain from the Spanish National Health Surveys of 2001, 2003, 2006 and 2011. Among the main results, we highlight that belonging to a particular generation modulates the manner in which individual characteristics and tobacco policies determine smoking decisions. For example, women's smoking was not considered as socially acceptable until the 1960s and therefore older women have lower smoking rates. However, for the younger female cohorts (generations X and Y) smoking was seen as an act of rebellion and modernity, so women belonging to these groups, irrespective of educational level, are more likely to smoke. The price of cigarettes and pictorial health warning labels on cigarette packets also influence the smoking behaviour of Spanish women. Copyright © 2015 Elsevier Ltd. All rights reserved.
Interpretations of cigarette advertisement warning labels by Philadelphia Puerto Ricans.

PubMed

Morris, Nancy; Gilpin, Dawn R; Lenos, Melissa; Hobbs, Renee

2011-09-01

This study examined Philadelphia Puerto Ricans' interpretations of the Surgeon General's warnings that appear on cigarette packaging and in advertisements. In-home family focus groups in which participants were asked to comment on magazine cigarette advertisements showed a great variety of interpretations of the legally mandated warning labels. These findings (a) corroborate and add to research in public health and communications regarding the possibility of wide variations in message interpretations and (b) support the call for public health messages to be carefully tested for effectiveness among different social groups. The article's focus on Puerto Ricans addresses the problem of misleading conclusions that can arise from aggregating all Latino subpopulations into one group. The use of a naturalistic setting to examine interpretations of messages about smoking departs from the experimental methods typically used for such research and provides new evidence that even a seemingly straightforward message can be interpreted in multiple ways. Understanding and addressing differences in message interpretation can guide public health campaigns aimed at reducing health disparities. Copyright © Taylor & Francis Group, LLC
Thyroid hormone use: trends in the United States from 1960 through 1988.

PubMed

Kaufman, S C; Gross, T P; Kennedy, D L

1991-01-01

Thyroid hormone preparations comprised over 1% of all prescriptions filled by retail pharmacies during 1988 in the conterminous United States, i.e., the 48 contiguous states. Their large market share gives the patterns of their use substantial public health importance. This article describes prescription thyroid hormone use in the United States from 1960 through 1988, using pharmaceutical marketing research data collected from panels of retail pharmacies and office-based physicians. Although the use of natural products has declined by over 50% since 1960, about one fourth of all thyroid hormone prescriptions were for natural preparations as recently as 1988. Per capita thyroid mentions (i.e., patient-physician contacts during which a thyroid agent of any kind was recommended, prescribed, dispensed, administered, ordered to be given by a hospital, or given as a sample) doubled during this period among those over 59 years old. Per capita mentions for synthetic thyroid products increased fourfold and tenfold among men and women in this age group, respectively. Use for weight loss, despite the label's boxed warning indicating it to be ineffective and potentially dangerous, has diminished but persists. Obesity was second only to hypothyroidism among the diagnoses underlying thyroid product mentions.
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.
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…
21 CFR 201.56 - Requirements on content and format of labeling for human prescription drug and biological products.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Requirements on content and format of labeling for human prescription drug and biological products. 201.56 Section 201.56 Food and Drugs FOOD AND DRUG... Contraindications Warnings and Precautions Adverse Reactions Drug Interactions Use in Specific Populations Full...
Exposure to Graphic Warning Labels on Cigarette Packages: Effects on Implicit and Explicit Attitudes toward Smoking among Young Adults

PubMed Central

Macy, Jonathan T.; Chassin, Laurie; Presson, Clark C.; Yeung, Ellen

2015-01-01

Objective Test the effect of exposure to the U.S. Food and Drug Administration’s proposed graphic images with text warning statements for cigarette packages on implicit and explicit attitudes toward smoking. Design and methods A two-session web-based study was conducted with 2192 young adults 18–25 years old. During session one, demographics, smoking behavior, and baseline implicit and explicit attitudes were assessed. Session two, completed on average 18 days later, contained random assignment to viewing one of three sets of cigarette packages, graphic images with text warnings, text warnings only, or current U.S Surgeon General’s text warnings. Participants then completed post-exposure measures of implicit and explicit attitudes. ANCOVAs tested the effect of condition on the outcomes, controlling for baseline attitudes. Results Smokers who viewed packages with graphic images plus text warnings demonstrated more negative implicit attitudes compared to smokers in the other conditions (p=.004). For the entire sample, explicit attitudes were more negative for those who viewed graphic images plus text warnings compared to those who viewed current U.S. Surgeon General’s text warnings (p=.014), but there was no difference compared to those who viewed text-only warnings. Conclusion Graphic health warnings on cigarette packages can influence young adult smokers’ implicit attitudes toward smoking. PMID:26442992
Developmental origins of recoding and decoding in memory.

PubMed

Kibbe, Melissa M; Feigenson, Lisa

2014-12-01

Working memory is severely limited in both adults and children, but one way that adults can overcome this limit is through the process of recoding. Recoding happens when representations of individual items are chunked together into a higher order representation, and the chunk is assigned a label. That label can then be decoded to retrieve the individual items from long-term memory. Whereas this ability has been extensively studied in adults (as, for example, in classic studies of memory in chess), little is known about recoding's developmental origins. Here we asked whether 2- to 3-year-old children also can recode-that is, can they restructure representations of individual objects into a higher order chunk, assign this new representation a verbal label, and then later decode the label to retrieve the represented individuals from memory. In Experiments 1 and 2, we showed children identical blocks that could be connected to make tools. Children learned a novel name for a tool that could be built from two blocks, and for a tool that could be built from three blocks. Later we told children that one of the tools was hidden in a box, with no visual information provided. Children were allowed to search the box and retrieve varying numbers of blocks. Critically, the retrieved blocks were identical and unconnected, so the only way children could know whether any blocks remained was by using the verbal label to recall how many objects comprised each tool (or chunk). We found that even children who could not yet count adjusted their searching of the box depending on the label they had heard. This suggests that they had recoded representations of individual blocks into higher-order chunks, attached labels to the chunks, and then later decoded the labels to infer how many blocks were hidden. In Experiments 3 and 4 we asked whether recoding also can expand the number of individual objects children could remember, as in the classic studies with adults. We found that when no information was provided to support recoding, children showed the standard failure to remember more than three hidden objects at once. But when provided recoding information, children successfully represented up to five individual objects in the box, thereby overcoming typical working memory limits. These results are the first demonstration of recoding by young children; we close by discussing their implications for understanding the structure of memory throughout the lifespan. Copyright © 2014 Elsevier Inc. All rights reserved.
Using fear appeals in warning labels to promote responsible gambling among VLT players: the key role of depth of information processing.

PubMed

Munoz, Yaromir; Chebat, Jean-Charles; Suissa, Jacob Amnon

2010-12-01

Video lottery terminals (VLT) are a highly lucrative gambling format, but at the same time they are among the most hazardous. Previous research has shown that threatening warnings may be an appropriate approach for promoting protective behavior. The present study explores the potential benefits of threatening warnings in the fight against compulsive gambling. A 4 × 2 factorial design experiment was used to test our model based on both Elaboration Likelihood Model and Protection Motivation Theory. 258 VLT adult players (58% males, 42% females) with various degrees of problem gambling were exposed to three threat levels (plus a control condition) from two different sources (i.e., either a medical source or a source related to the provider of VLT's). Our results show that both higher threat warnings and the medical source of warnings enhance Depth of Information Processing. It was also found that Depth of Information Processing affects positively attitude change and compliance intentions. The theoretical and managerial implications are discussed.
Influence of time orientation on food choice: Case study with cookie labels.

PubMed

Tórtora, Giuliana; Ares, Gastón

2018-04-01

Time orientation can influence health-related behaviors, including food consumption. The aim of the present work was to study the influence of time orientation on food choice, using cookie labels as case study. A choice-conjoint task was designed using labels differing in type of cookie (chocolate chips vs. granola), front-of-pack nutrition information (nutritional warnings vs. Facts Up Front system) and nutritional claim (no claim vs. "0% cholesterol. 0% trans fat"). An online study was conducted, in which 155 participants evaluated 8 pairs of cookie labels and selected the one they would buy if they were in the supermarket. Then, they were asked to complete a consideration of future consequences scale (CFC) adapted to eating habits, as well as a questionnaire about socio-demographic characteristics. Time orientation influenced participants' choices of cookies labels; particularly the importance attached to type of cookie. Participants with greater consideration of future consequences preferred the granola cookies, associated with health, while those who prioritized immediate consequences preferred chocolate chip cookies. In addition, nutritional warnings discouraged choice regardless of participants' time orientation. Results from the present work provide additional evidence of the influence of time preferences on food choices and suggest that strategies to stimulate and generate a more future-oriented perspective on eating habits could contribute to more healthful food choices. Copyright © 2018 Elsevier Ltd. All rights reserved.
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
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.
Augmented twin-nonlinear two-box behavioral models for multicarrier LTE power amplifiers.

PubMed

Hammi, Oualid

2014-01-01

A novel class of behavioral models is proposed for LTE-driven Doherty power amplifiers with strong memory effects. The proposed models, labeled augmented twin-nonlinear two-box models, are built by cascading a highly nonlinear memoryless function with a mildly nonlinear memory polynomial with cross terms. Experimental validation on gallium nitride based Doherty power amplifiers illustrates the accuracy enhancement and complexity reduction achieved by the proposed models. When strong memory effects are observed, the augmented twin-nonlinear two-box models can improve the normalized mean square error by up to 3 dB for the same number of coefficients when compared to state-of-the-art twin-nonlinear two-box models. Furthermore, the augmented twin-nonlinear two-box models lead to the same performance as previously reported twin-nonlinear two-box models while requiring up to 80% less coefficients.
GPS water level measurements for Indonesia's Tsunami Early Warning System

NASA Astrophysics Data System (ADS)

Schöne, T.; Pandoe, W.; Mudita, I.; Roemer, S.; Illigner, J.; Zech, C.; Galas, R.

2011-03-01

On Boxing Day 2004, a severe tsunami was generated by a strong earthquake in Northern Sumatra causing a large number of casualties. At this time, neither an offshore buoy network was in place to measure tsunami waves, nor a system to disseminate tsunami warnings to local governmental entities. Since then, buoys have been developed by Indonesia and Germany, complemented by NOAA's Deep-ocean Assessment and Reporting of Tsunamis (DART) buoys, and have been moored offshore Sumatra and Java. The suite of sensors for offshore tsunami detection in Indonesia has been advanced by adding GPS technology for water level measurements. The usage of GPS buoys in tsunami warning systems is a relatively new approach. The concept of the German Indonesian Tsunami Early Warning System (GITEWS) (Rudloff et al., 2009) combines GPS technology and ocean bottom pressure (OBP) measurements. Especially for near-field installations where the seismic noise may deteriorate the OBP data, GPS-derived sea level heights provide additional information. The GPS buoy technology is precise enough to detect medium to large tsunamis of amplitudes larger than 10 cm. The analysis presented here suggests that for about 68% of the time, tsunamis larger than 5 cm may be detectable.

Analysis of Local Planning Interviews.

DTIC Science & Technology

1984-04-01

Suite 121, P.O. Box 2487 Project No. 4813-D Kirkland, WA 98033 II. CONTROLLING OFFICE NAME AND ADDRESS 12. REPORT DATE Federal Emergency Management...Agency April 1984 Washington, D.C. 20472 13. NUMBER OF PAGES31 14. MONITORING AGENCY NAME & ADDRESS(If different from Controlling Office) IS. SECURITY...and Control and the basic emergency functions (Warning, RADEF, Law Enforcement, Fire, Communications, Public Information, Health, Medical, Evacuation
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.
Prescriber Compliance With Liver Monitoring Guidelines for Pazopanib in the Postapproval Setting: Results From a Distributed Research Network.

PubMed

Shantakumar, Sumitra; Nordstrom, Beth L; Hall, Susan A; Djousse, Luc; van Herk-Sukel, Myrthe P P; Fraeman, Kathy H; Gagnon, David R; Chagin, Karen; Nelson, Jeanenne J

2017-04-20

Pazopanib received US Food and Drug Administration approval in 2009 for advanced renal cell carcinoma. During clinical development, liver chemistry abnormalities and adverse hepatic events were observed, leading to a boxed warning for hepatotoxicity and detailed label prescriber guidelines for liver monitoring. As part of postapproval regulatory commitments, a cohort study was conducted to assess prescriber compliance with liver monitoring guidelines. Over a 4-year period, a distributed network approach was used across 3 databases: US Veterans Affairs Healthcare System, a US outpatient oncology community practice database, and the Dutch PHARMO Database Network. Measures of prescriber compliance were designed using the original pazopanib label guidelines for liver monitoring. Results from the VA (n = 288) and oncology databases (n = 283) indicate that prescriber liver chemistry monitoring was less than 100%: 73% to 74% compliance with baseline testing and 37% to 39% compliance with testing every 4 weeks. Compliance was highest near drug initiation and decreased over time. Among patients who should have had weekly testing, the compliance was 56% in both databases. The more serious elevations examined, including combinations of liver enzyme elevations meeting the laboratory definition of Hy's law were infrequent but always led to appropriate discontinuation of pazopanib. Only 4 patients were identified for analysis in the Dutch database; none had recorded baseline testing. In this population-based study, prescriber compliance was reasonable near pazopanib initiation but low during subsequent weeks of treatment. This study provides information from real-world community practice settings and offers feedback to regulators on the effectiveness of label monitoring guidelines.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
16 CFR 1117.5 - Information that must be reported and to whom.

Code of Federal Regulations, 2010 CFR

2010-01-01

... SAFETY ACT REGULATIONS REPORTING OF CHOKING INCIDENTS INVOLVING MARBLES, SMALL BALLS, LATEX BALLOONS AND... (including any labeling and warnings), a description of the marble, small ball, latex balloon or other small...
PRN 93-5: Labeling Requirements of the Clean Air Act

EPA Pesticide Factsheets

A regulation under the Clean Air Act requires a warning statement on products (including pesticide products) manufactured with or containing Class I ozone-depleting substances, including chlorofluorocarbons, methyl chloroform and carbon tetrachloride.
Validation of a poison prevention program.

PubMed Central

Braden, B T

1979-01-01

The effectiveness of an empirically designed poison warning label and an educational program for three and four year old children was assessed in four groups of 39 such children, with one group serving as a control. The educational program appeared to improve intellectual (verbal) awareness of poisons, the label to improve visual discrimination, and the combination of the two to have the greatest overall impact. Images p943-a PMID:474851
Photoaffinity Labeling of Ras Converting Enzyme using Peptide Substrates that Incorporate Benzoylphenylalanine (Bpa) Residues: Improved Labeling and Structural Implications

PubMed Central

Kyro, Kelly; Manandhar, Surya P.; Mullen, Daniel; Schmidt, Walter K.; Distefano, Mark D.

2012-01-01

Rce1p catalyzes the proteolytic trimming of C-terminal tripeptides from isoprenylated proteins containing CAAX-box sequences. Because Rce1p processing is a necessary component in the Ras pathway of oncogenic signal transduction, Rce1p holds promise as a potential target for therapeutic intervention. However, its mechanism of proteolysis and active site have yet to be defined. Here, we describe synthetic peptide analogues that mimic the natural lipidated Rce1p substrate and incorporate photolabile groups for photoaffinity-labeling applications. These photoactive peptides are designed to crosslink to residues in or near the Rce1p active site. By incorporating the photoactive group via p-benzoyl-L-phenylalanine (Bpa) residues directly into the peptide substrate sequence, the labeling efficiency was substantially increased relative to a previously-synthesized compound. Incorporation of biotin on the N-terminus of the peptides permitted photolabeled Rce1p to be isolated via streptavidin affinity capture. Our findings further suggest that residues outside the CAAX-box sequence are in contact with Rce1p, which has implications for future inhibitor design. PMID:22079863
Manipulating Google’s Knowledge Graph Box to Counter Biased Information Processing During an Online Search on Vaccination: Application of a Technological Debiasing Strategy

PubMed Central

Allam, Ahmed; Schulz, Peter J

2016-01-01

Background One of people’s major motives for going online is the search for health-related information. Most consumers start their search with a general search engine but are unaware of the fact that its sorting and ranking criteria do not mirror information quality. This misconception can lead to distorted search outcomes, especially when the information processing is characterized by heuristic principles and resulting cognitive biases instead of a systematic elaboration. As vaccination opponents are vocal on the Web, the chance of encountering their non‒evidence-based views on immunization is high. Therefore, biased information processing in this context can cause subsequent impaired judgment and decision making. A technological debiasing strategy could counter this by changing people’s search environment. Objective This study aims at testing a technological debiasing strategy to reduce the negative effects of biased information processing when using a general search engine on people’s vaccination-related knowledge and attitudes. This strategy is to manipulate the content of Google’s knowledge graph box, which is integrated in the search interface and provides basic information about the search topic. Methods A full 3x2 factorial, posttest-only design was employed with availability of basic factual information (comprehensible vs hardly comprehensible vs not present) as the first factor and a warning message as the second factor of experimental manipulation. Outcome variables were the evaluation of the knowledge graph box, vaccination-related knowledge, as well as beliefs and attitudes toward vaccination, as represented by three latent variables emerged from an exploratory factor analysis. Results Two-way analysis of variance revealed a significant main effect of availability of basic information in the knowledge graph box on participants’ vaccination knowledge scores (F2,273=4.86, P=.01), skepticism/fear of vaccination side effects (F2,273=3.5, P=.03), and perceived information quality (F2,273=3.73, P=.02). More specifically, respondents receiving comprehensible information appeared to be more knowledgeable, less skeptical of vaccination, and more critical of information quality compared to participants exposed to hardly comprehensible information. Although, there was no significant interaction effect between the availability of information and the presence of the warning, there was a dominant pattern in which the presence of the warning appeared to have a positive influence on the group receiving comprehensible information while the opposite was true for the groups exposed to hardly comprehensible information and no information at all. Participants evaluated the knowledge graph box as moderately to highly useful, with no significant differences among the experimental groups. Conclusion Overall, the results suggest that comprehensible information in the knowledge graph box positively affects participants’ vaccination-related knowledge and attitudes. A small change in the content retrieval procedure currently used by Google could already make a valuable difference in the pursuit of an unbiased online information search. Further research is needed to gain insights into the knowledge graph box’s entire potential. PMID:27255736
Augmented Twin-Nonlinear Two-Box Behavioral Models for Multicarrier LTE Power Amplifiers

PubMed Central

2014-01-01

A novel class of behavioral models is proposed for LTE-driven Doherty power amplifiers with strong memory effects. The proposed models, labeled augmented twin-nonlinear two-box models, are built by cascading a highly nonlinear memoryless function with a mildly nonlinear memory polynomial with cross terms. Experimental validation on gallium nitride based Doherty power amplifiers illustrates the accuracy enhancement and complexity reduction achieved by the proposed models. When strong memory effects are observed, the augmented twin-nonlinear two-box models can improve the normalized mean square error by up to 3 dB for the same number of coefficients when compared to state-of-the-art twin-nonlinear two-box models. Furthermore, the augmented twin-nonlinear two-box models lead to the same performance as previously reported twin-nonlinear two-box models while requiring up to 80% less coefficients. PMID:24624047
Graphic health warnings on tobacco packets and containers: compliance status in Bangladesh.

PubMed

Rahman, Syed Mahbubur; Alam, Md Shariful; Zubair, Abm; Shahriar, Md Hasan; Hossein, Monowar; Alam, Md Shahedul; Hefler, Marita

2018-06-12

This study describes and analyses compliance with tobacco product graphic health warning (GHW) legislation introduced in Bangladesh in March 2016. A survey based on a structured questionnaire was conducted in April 2016 (immediately following the law coming into force), and 8 months later in November 2016, in eight divisional cities in Bangladesh. Five stores from three categories of retailers of combustible and smokeless tobacco products were surveyed, providing a total of 120 completed questionnaires. The study investigated a range of measures including the image and text of GHW, their ratio and colour use, and prescribed rotation. Warning labels for 3312 tobacco items were assessed. In April 2016, 75% of tobacco products surveyed did not have GHWs. In November 2016, 19% were still found to not have the prescribed warnings. Even among products which did include GHW, there was significant non-compliance with the full range of requirements, in both survey periods. Compliance was highest for cigarette packets and lowest among smokeless tobacco products. In addition, awareness among tobacco retailers about the range of GHW requirements was low. Effective implementation of GHW labels in low-income and middle-income countries requires awareness-raising among key stakeholders, combined with focused monitoring and compliance strategies. This should take into account different product categories and manufacturers, as well as measures targeted at retailers. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
"Warning: This image has been digitally altered": The effect of disclaimer labels added to fashion magazine shoots on women's body dissatisfaction.

PubMed

Tiggemann, Marika; Brown, Zoe; Zaccardo, Mia; Thomas, Nicole

2017-06-01

The present experiment aimed to investigate the impact of the addition of disclaimer labels to fashion magazine shoots on women's body dissatisfaction. Participants were 320 female undergraduate students who viewed fashion shoots containing a thin and attractive model with no disclaimer label, or a small, large, or very large disclaimer label, or product images. Although thin-ideal fashion shoot images resulted in greater body dissatisfaction than product images, there was no significant effect of disclaimer label. Internalisation of the thin ideal was found to moderate the effect of disclaimer label, such that internalisation predicted increased body dissatisfaction in the no label and small label conditions, but not in the larger label conditions. Overall, the results showed no benefit for any size of disclaimer label in ameliorating the negative effect of viewing thin-ideal media images. It was concluded that more extensive research is required before the effective implementation of disclaimer labels. Copyright © 2017 Elsevier Ltd. All rights reserved.
21 CFR 201.310 - Phenindione; labeling of drug preparations intended for use by man.

Code of Federal Regulations, 2012 CFR

2012-04-01

... fatalities). There are also reports implicating the drug in cases of hepatitis and hypersensitivity reactions... statement to the following effect: “Warning: Agranulocytosis and hepatitis have been associated with the use...
21 CFR 201.310 - Phenindione; labeling of drug preparations intended for use by man.

Code of Federal Regulations, 2013 CFR

2013-04-01

... fatalities). There are also reports implicating the drug in cases of hepatitis and hypersensitivity reactions... statement to the following effect: “Warning: Agranulocytosis and hepatitis have been associated with the use...
16 CFR 307.6 - Requirements for disclosure on the label.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., plug of chewing tobacco, or dispenser of individual packages of smokeless tobacco that may be purchased... plug of chewing tobacco—Eight point type, provided that if the warning statement is printed in one line...
Investigating the variability of memory distortion for an analogue trauma.

PubMed

Strange, Deryn; Takarangi, Melanie K T

2015-01-01

In this paper, we examine whether source monitoring (SM) errors might be one mechanism that accounts for traumatic memory distortion. Participants watched a traumatic film with some critical (crux) and non-critical (non-crux) scenes removed. Twenty-four hours later, they completed a memory test. To increase the likelihood participants would notice the film's gaps, we inserted visual static for the length of each missing scene. We then added manipulations designed to affect people's SM behaviour. To encourage systematic SM, before watching the film, we warned half the participants that we had removed some scenes. To encourage heuristic SM some participants also saw labels describing the missing scenes. Adding static highlighting, the missing scenes did not affect false recognition of those missing scenes. However, a warning decreased, while labels increased, participants' false recognition rates. We conclude that manipulations designed to affect SM behaviour also affect the degree of memory distortion in our paradigm.
An Investigation of the Height of Embossed Braille Dots for Labels on Pharmaceutical Products

ERIC Educational Resources Information Center

Douglas, Graeme; Weston, Annette; Whittaker, Jennifer; Wilkins, Sarah Morley; Robinson, Duncan

2009-01-01

European legislation requires new pharmaceutical packaging to include both the name and strength of the drug in braille on boxes and bottles. Much of the braille on medical packaging is currently produced by an embossing process on boxes. The height of the dots that can be achieved through these methods is less than 0.3 mm. The physical dimensions…
Lockout/Tagout (LOTO) Simulator

NASA Technical Reports Server (NTRS)

Scheer, Jennifer

2011-01-01

The Lockout/Tagout (LOTO) Simulator is a portable training aid, or demonstration tool, designed to physically illustrate real-time critical-safety concepts of electrical lockout/tagout. The objective is to prevent misinterpretations of what is off and what is on during maintenance and repair of complex electrical systems. The simulator is designed in the form of a hinged box that opens up and stands on its own as an easel for demonstrations. On the outer face of the unit is a simulated circuit breaker box housing the switches. The breakers control the main power to the unit, a light bulb, and an electrical control cabinet. The light bulb is wired so that either of two breakers can provide power to it. When power is sent to the electrical control cabinet, a red indicator light illuminates. Inside the cabinet is the power supply from a personal computer. The power supply produces a 12-V dc output that is sent over to a small fan next to it, also from a computer, and an amber light on the front of the cabinet illuminates. A separate switch powers the fan on and off. The power supply is behind a plastic shield to protect against exposure to live conductors. Electrical banana jacks are mounted in the plastic shield to allow a voltmeter to be connected safely when opening the cabinet and taking a meter reading to verify de-energization as part of a simulation exercise. This LOTO simulator prototype is designed and fabricated as an all-in-one unit. All accessories can be stored inside the hinged case, and there is a handle on top for ease of transport. The circuit breaker labels attach with hook and loop fasteners so that they may be moved and changed to fit the training or demonstration scenario. The warning signs and labels on the electrical control box are magnetic, allowing for easy reconfiguration to emulate different equipment setups. A specially designed magnetic cover was made to disguise the indicator lights for demonstrations when these indicators are not used. The cover is disguised as an arc flash safety label that would typically be found on such a cabinet. One indicator light has a separate switch that can take it offline. This is to allow for demonstration to trainees on why it is important not to completely rely on indicator lights, but that they should always take a meter reading at the exposed conductors to absolutely verify de-energization before exposure. A clear plastic barrier and banana jacks inside the cabinet provide a safe way to plug in a voltmeter for demonstrations without exposure to the hazards of energized equipment. A small remote control unit is wired into the fan circuit. The remote allows the demonstrator to turn the fan on and off, provided that all of the breakers and switches leading to it are configured on as well. The remote feature was added in order to demonstrate the importance of starting the lockout/tagout task with energized equipment, then powering it down, isolating it, and locking it out to ensure that the correct breakers have been locked out.
The Fetal Alcohol Syndrome Public Awareness Campaign, 1979: Progress Report Concerning the Advance Notice of Proposed Rulemaking on Warning Labels on Containers of Alcoholic Beverages and Addendum.

ERIC Educational Resources Information Center

Department of the Treasury, Washington, DC.

This report provides expert opinion on the problems of fetal alcohol syndrome (FAS) and ways to inform the public of teratogenic risk of alcohol consumption during pregnancy. In the absence of firm evidence that moderate drinking of alcoholic beverages leads to FAS and uncertainty concerning the effectiveness of labeling of alcoholic beverages, a…
Author Correction: The F-box protein FKF1 inhibits dimerization of COP1 in the control of photoperiodic flowering.

PubMed

Lee, Byoung-Doo; Kim, Mi Ri; Kang, Min-Young; Cha, Joon-Yung; Han, Su-Hyun; Nawkar, Ganesh M; Sakuraba, Yasuhito; Lee, Sang Yeol; Imaizumi, Takato; McClung, C Robertson; Kim, Woe-Yeon; Paek, Nam-Chon

2018-02-02

The previously published version of this Article contained errors in Figure 5. In panel c, the second and fourth blot images were incorrectly labeled 'α-Myc' and should have been labelled 'α-HA'. These errors have been corrected in both the PDF and HTML versions of the Article.

Temporal Effects of Message Congruency on Attention to and Recall of Pictorial Health Warning Labels on Cigarette Packages.

PubMed

Lochbuehler, Kirsten; Wileyto, E Paul; Mercincavage, Melissa; Souprountchouk, Valentina; Burdge, Jordan Z; Tang, Kathy Z; Cappella, Joseph N; Strasser, Andrew A

2018-06-16

Recent research has shown that message congruency is beneficial to recall of pictorial health warning label (PWL) content after initial exposure. Despite less attention to the text warning, smokers exposed to congruent PWLs were more likely to recall the text and the message. This study aimed to replicate these findings and to examine whether congruency also affects recall after multiple exposures over time. 320 daily smokers (39.7% female; cigarettes/day: M = 15.31, SD = 7.15) were randomized to one congruent or incongruent PWL and attended 4 laboratory sessions over 10 days. During each session, eye-movements were recorded while viewing the PWL and open-ended recall of label content was assessed after exposure. Smokers who were exposed to a congruent PWL were more likely to recall the text (p = .01) and the message (p = .02) and less likely to recall the image (p = .003) of the PWL after initial exposure. By day 4, incongruent PWLs were recalled equally well as congruent PWLs. Independent of condition, image recall was initially high and remained high while text and message recall was relatively low initially but increased over time. It was not until day 7 that about 80% of text and message recall was observed. Even when exposed to the same PWL over time, smokers require multiple exposures to recall the text and the message of a PWL. More research on the effects of congruency in the natural environment, where smokers are exposed to multiple PWLs, is needed.
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
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.
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."
Cigarette package design: opportunities for disease prevention.

PubMed

Difranza, J R; Clark, D M; Pollay, R W

2002-06-15

To learn how cigarette packages are designed and to determine to what extent cigarette packages are designed to target children. A computer search was made of all Internet websites that post tobacco industry documents using the search terms: packaging, package design, package study, box design, logo, trademark and design study. All documents were retrieved electronically and analyzed by the first author for recurrent themes. Cigarette manufacturers devote a great deal of attention and expense to package design because it is central to their efforts to create brand images. Colors, graphic elements, proportioning, texture, materials and typography are tested and used in various combinations to create the desired product and user images. Designs help to create the perceived product attributes and project a personality image of the user with the intent of fulfilling the psychological needs of the targeted type of smoker. The communication of these images and attributes is conducted through conscious and subliminal processes. Extensive testing is conducted using a variety of qualitative and quantitative research techniques. The promotion of tobacco products through appealing imagery cannot be stopped without regulating the package design. The same marketing research techniques used by the tobacco companies can be used to design generic packaging and more effective warning labels targeted at specific consumers.
Cigarette package design: opportunities for disease prevention

PubMed Central

DiFranza, JR; Clark, DM; Pollay, RW

2003-01-01

Objective To learn how cigarette packages are designed and to determine to what extent cigarette packages are designed to target children. Methods A computer search was made of all Internet websites that post tobacco industry documents using the search terms: packaging, package design, package study, box design, logo, trademark and design study. All documents were retrieved electronically and analyzed by the first author for recurrent themes. Data Synthesis Cigarette manufacturers devote a great deal of attention and expense to package design because it is central to their efforts to create brand images. Colors, graphic elements, proportioning, texture, materials and typography are tested and used in various combinations to create the desired product and user images. Designs help to create the perceived product attributes and project a personality image of the user with the intent of fulfilling the psychological needs of the targeted type of smoker. The communication of these images and attributes is conducted through conscious and subliminal processes. Extensive testing is conducted using a variety of qualitative and quantitative research techniques. Conclusion The promotion of tobacco products through appealing imagery cannot be stopped without regulating the package design. The same marketing research techniques used by the tobacco companies can be used to design generic packaging and more effective warning labels targeted at specific consumers. PMID:19570250
Cigarette package design: opportunities for disease prevention

PubMed Central

DiFranza, JR; Clark, DM; Pollay, RW

2003-01-01

Objective To learn how cigarette packages are designed and to determine to what extent cigarette packages are designed to target children. Methods A computer search was made of all Internet websites that post tobacco industry documents using the search terms: packaging, package design, package study, box design, logo, trademark and design study. All documents were retrieved electronically and analyzed by the first author for recurrent themes. Data Synthesis Cigarette manufacturers devote a great deal of attention and expense to package design because it is central to their efforts to create brand images. Colors, graphic elements, proportioning, texture, materials and typography are tested and used in various combinations to create the desired product and user images. Designs help to create the perceived product attributes and project a personality image of the user with the intent of fulfilling the psychological needs of the targeted type of smoker. The communication of these images and attributes is conducted through conscious and subliminal processes. Extensive testing is conducted using a variety of qualitative and quantitative research techniques. Conclusion The promotion of tobacco products through appealing imagery cannot be stopped without regulating the package design. The same marketing research techniques used by the tobacco companies can be used to design generic packaging and more effective warning labels targeted at specific consumers.
The Interplanetary Network II: 11 Months of Rapid, Precise GRB Localizations

NASA Astrophysics Data System (ADS)

Hurley, K.; Cline, T.; Mazets, E.; Golenetskii, S.; Trombka, J.; Feroci, M.; Kippen, R. M.; Barthelmy, S.; Frontera, F.; Guidorzi, C.; Montanari, E.

2000-10-01

Since December 1999 the 3rd Interplanetary Network has been producing small ( 10') error boxes at a rate of about one per week, and circulating them rapidly ( 24 h) via the GCN. As of June 2000, 24 such error boxes have been obtained; 18 of them have been searched in the radio and optical ranges for counterparts, resulting in four definite counterpart detections and three redshift determinations. We will review these results and explain the some of the lesser known IPN operations. In particular, we maintain an "early warning" list of potential observers with pagers and cell phones, and send messages to them to alert them to bursts for which error boxes will be obtained, allowing them to prepare for observations many hours before the complete spacecraft data are received and the GCN message is issued. As an interesting aside, now that the CGRO mission is terminated, the IPN consists entirely of non-NASA and/or non-astrophysics missions, specifically, Ulysses and Wind (Space Physics), NEAR (Planetary Physics), and BeppoSAX (ASI).
21 CFR 310.517 - Labeling for oral hypoglycemic drugs of the sulfonylurea class.

Code of Federal Regulations, 2012 CFR

2012-04-01

... cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on... vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who...
21 CFR 310.517 - Labeling for oral hypoglycemic drugs of the sulfonylurea class.

Code of Federal Regulations, 2013 CFR

2013-04-01

... cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on... vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who...
21 CFR 310.517 - Labeling for oral hypoglycemic drugs of the sulfonylurea class.

Code of Federal Regulations, 2014 CFR

2014-04-01

... cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on... vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who...
40 CFR 82.110 - Form of label bearing warning statement.

Code of Federal Regulations, 2012 CFR

2012-07-01

... contrast are: black letters on a dark blue or dark green background, dark red letters on a light red background, light red letters on a reflective silver background, and white letters on a light gray or tan...
40 CFR 82.110 - Form of label bearing warning statement.

Code of Federal Regulations, 2013 CFR

2013-07-01

... contrast are: black letters on a dark blue or dark green background, dark red letters on a light red background, light red letters on a reflective silver background, and white letters on a light gray or tan...
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.
21 CFR 310.517 - Labeling for oral hypoglycemic drugs of the sulfonylurea class.

Code of Federal Regulations, 2011 CFR

2011-04-01

... cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on... vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who...
21 CFR 310.517 - Labeling for oral hypoglycemic drugs of the sulfonylurea class.

Code of Federal Regulations, 2010 CFR

2010-04-01

... cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on... vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who...
21 CFR 201.71 - Magnesium labeling.

Code of Federal Regulations, 2014 CFR

2014-04-01

... disease [bullet] a magnesium-restricted diet”. The warnings in §§ 201.64(c), 201.70(c), 201.71(c), and 201...., a magnesium or potassium-restricted diet. 1 See § 201.66(b)(4) of this chapter for definition of...
21 CFR 201.71 - Magnesium labeling.

Code of Federal Regulations, 2012 CFR

2012-04-01

... disease [bullet] a magnesium-restricted diet”. The warnings in §§ 201.64(c), 201.70(c), 201.71(c), and 201...., a magnesium or potassium-restricted diet. 1 See § 201.66(b)(4) of this chapter for definition of...
21 CFR 201.71 - Magnesium labeling.

Code of Federal Regulations, 2013 CFR

2013-04-01

... disease [bullet] a magnesium-restricted diet”. The warnings in §§ 201.64(c), 201.70(c), 201.71(c), and 201...., a magnesium or potassium-restricted diet. 1 See § 201.66(b)(4) of this chapter for definition of...
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...

21 CFR 74.1705 - FD&C Yellow No. 5.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., nasally, vaginally, or rectally, or for use in the area of the eye, the labeling required by § 201.100(d... seen in patients who also have aspirin hypersensitivity.” This warning statement shall appear in the...
21 CFR 74.1705 - FD&C Yellow No. 5.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., nasally, vaginally, or rectally, or for use in the area of the eye, the labeling required by § 201.100(d... seen in patients who also have aspirin hypersensitivity.” This warning statement shall appear in the...
21 CFR 74.1705 - FD&C Yellow No. 5.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., nasally, vaginally, or rectally, or for use in the area of the eye, the labeling required by § 201.100(d... seen in patients who also have aspirin hypersensitivity.” This warning statement shall appear in the...
21 CFR 74.1705 - FD&C Yellow No. 5.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., nasally, vaginally, or rectally, or for use in the area of the eye, the labeling required by § 201.100(d... seen in patients who also have aspirin hypersensitivity.” This warning statement shall appear in the...
21 CFR 74.1705 - FD&C Yellow No. 5.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., nasally, vaginally, or rectally, or for use in the area of the eye, the labeling required by § 201.100(d... seen in patients who also have aspirin hypersensitivity.” This warning statement shall appear in the...
Impact of smokeless tobacco packaging on perceptions and beliefs among youth, young adults, and adults in the U.S: findings from an internet-based cross-sectional survey

PubMed Central

2014-01-01

Background Research demonstrates that tobacco packaging elements (including health warning labels, descriptive characteristics, and corporate branding) are associated with knowledge of health risks and product appeal with cigarettes. Yet, little research has assessed this with smokeless tobacco (SLT) packaging. This study evaluates the association between three SLT packaging elements with knowledge of health risks and perceptions of novelty and appeal. Additionally, we assess how effects of these messages may differ across age groups, including youth (14-17 years), young adults (18-25 years), and older adults (26-65 years). Methods 1000 participants were administered a web-based survey in 2010 and shown three sets of SLT packs in random order, varied by descriptor (flavor descriptor vs. none), warning label format (graphic vs. text), and corporate branding (branded vs. plain packaging). Participants rated the packs compared with “no difference” on appeal, novelty, and risk perceptions associated with product use. Chi-square tests were used to test for significant differences in pack selections. Multinomial regression was employed to evaluate the association between effects of packaging elements and participant age. Results More respondents selected the pack with the graphic warning label as the pack to make them consider the health risks associated with SLT use, attract their attention, and be least attractive to a smoker. The product with the text warning label was the product someone their age would want to be seen using and would appeal to peers. The SLT pack with the flavor descriptor was not associated with health risks associated with product use. The pack with corporate branding was selected as more appealing, to attract attention, and one they would want to be seen using; the plain pack was less attractive to smokers. Youth and young adults were more likely to indicate that pack elements affected their perceptions of appeal and risk associated with SLT products. Conclusion These results suggest that SLT pack characteristics have a measurable effect on perceptions of health risk and product appeal. Future research should assess these findings in the context of harm reduction. Specifically, research is needed to determine whether pack elements on SLT products can effectively convey risk and harm. PMID:24433301
Impact of smokeless tobacco packaging on perceptions and beliefs among youth, young adults, and adults in the U.S: findings from an internet-based cross-sectional survey.

PubMed

Adkison, Sarah E; Bansal-Travers, Maansi; Smith, Danielle M; O'Connor, Richard J; Hyland, Andrew J

2014-01-17

Research demonstrates that tobacco packaging elements (including health warning labels, descriptive characteristics, and corporate branding) are associated with knowledge of health risks and product appeal with cigarettes. Yet, little research has assessed this with smokeless tobacco (SLT) packaging. This study evaluates the association between three SLT packaging elements with knowledge of health risks and perceptions of novelty and appeal. Additionally, we assess how effects of these messages may differ across age groups, including youth (14-17 years), young adults (18-25 years), and older adults (26-65 years). 1000 participants were administered a web-based survey in 2010 and shown three sets of SLT packs in random order, varied by descriptor (flavor descriptor vs. none), warning label format (graphic vs. text), and corporate branding (branded vs. plain packaging). Participants rated the packs compared with "no difference" on appeal, novelty, and risk perceptions associated with product use. Chi-square tests were used to test for significant differences in pack selections. Multinomial regression was employed to evaluate the association between effects of packaging elements and participant age. More respondents selected the pack with the graphic warning label as the pack to make them consider the health risks associated with SLT use, attract their attention, and be least attractive to a smoker. The product with the text warning label was the product someone their age would want to be seen using and would appeal to peers. The SLT pack with the flavor descriptor was not associated with health risks associated with product use. The pack with corporate branding was selected as more appealing, to attract attention, and one they would want to be seen using; the plain pack was less attractive to smokers. Youth and young adults were more likely to indicate that pack elements affected their perceptions of appeal and risk associated with SLT products. These results suggest that SLT pack characteristics have a measurable effect on perceptions of health risk and product appeal. Future research should assess these findings in the context of harm reduction. Specifically, research is needed to determine whether pack elements on SLT products can effectively convey risk and harm.
Valbenazine for tardive dyskinesia: A systematic review of the efficacy and safety profile for this newly approved novel medication-What is the number needed to treat, number needed to harm and likelihood to be helped or harmed?

PubMed

Citrome, Leslie

2017-07-01

The objective of this systematic review was to describe the efficacy, tolerability, and safety of valbenazine for the treatment of tardive dyskinesia (TD). The pivotal registration trials were accessed by querying http://www.ncbi.nlm.nih.gov/pubmed/ and http://www.clinicaltrials.gov, for the search terms 'valbenazine' OR 'NBI-98854', and by also querying the EMBASE (Elsevier) commercial database for clinical poster abstracts, and by asking the manufacturer for copies of posters presented at congresses. Product labeling provided additional information. All available clinical reports of studies were identified. Descriptions of the principal results and calculation of number needed to treat (NNT) and number needed to harm (NNH) for relevant dichotomous outcomes were extracted from the available study reports and other sources of information. Valbenazine, a reversible inhibitor of Vesicular Monoamine Transporter Type 2 (VMAT2), received approval for the treatment of TD in adults based on a clinical trial development programme that included three 6-week parallel group, randomised, placebo-controlled studies, including one Phase III trial described in product labeling. The recommended dose for valbenazine is 80 mg/d. The percentage of responders in the Phase III acute study, as defined by ≥50% reduction from baseline in the Abnormal Involuntary Movement Scale dyskinesia score was 40.0% for valbenazine 80 mg/d vs 8.7% for placebo, yielding a NNT of 4 (95% CI 3-6). As pooled from available data, discontinuation rates because of an adverse event were 2.9% for valbenazine-treated patients vs 1.6% for placebo-treated patients, resulting in a NNH of 76 (ns). The only adverse event that met the threshold of incidence ≥5% for valbenazine and a rate of ≥2 times than that observed with placebo was somnolence (somnolence, fatigue, sedation), with rates of 10.9% for valbenazine (all doses) vs 4.2% for placebo, resulting in a NNH of 15 (95% CI 9-52). An additional warning and precaution is that valbenazine can prolong the ECG QT interval, however, the valbenazine product label does not contain any bolded boxed warnings or contraindications. Valbenazine is presently the only US Food and Drug Administration-approved agent specifically indicated for the treatment of TD. Valbenazine is about 15 times more likely to result in a response than in a discontinuation because of an adverse event. Head-to-head comparisons with other VMAT2 inhibitors among patients with TD in the 'real world' are needed. © 2017 John Wiley & Sons Ltd.
Does Reactance against Cigarette Warning Labels Matter? Warning Label Responses and Downstream Smoking Cessation amongst Adult Smokers in Australia, Canada, Mexico and the United States.

PubMed

Cho, Yoo Jin; Thrasher, James F; Swayampakala, Kamala; Yong, Hua-Hie; McKeever, Robert; Hammond, David; Anshari, Dien; Cummings, K Michael; Borland, Ron

2016-01-01

Some researchers have raised concerns that pictorial health warning labels (HWLs) on cigarette packages may lead to message rejection and reduced effectiveness of HWL messages. This study aimed to determine how state reactance (i.e., negative affect due to perceived manipulation) in response to both pictorial and text-only HWLs is associated with other types of HWL responses and with subsequent cessation attempts. Survey data were collected every 4 months between September 2013 and 2014 from online panels of adult smokers in Australia, Canada, Mexico, and the US were analyzed. Participants with at least one wave of follow-up were included in the analysis (n = 4,072 smokers; 7,459 observations). Surveys assessed psychological and behavioral responses to HWLs (i.e., attention to HWLs, cognitive elaboration of risks due to HWLs, avoiding HWLs, and forgoing cigarettes because of HWLs) and cessation attempts. Participants then viewed specific HWLs from their countries and were queried about affective state reactance. Logistic and linear Generalized Estimating Equation (GEE) models regressed each of the psychological and behavioral HWL responses on reactance, while controlling for socio-demographic and smoking-related variables. Logistic GEE models also regressed having attempted to quit by the subsequent survey on reactance, each of the psychological and behavioral HWL responses (analyzed separately), adjustment variables. Data from all countries were initially pooled, with interactions between country and reactance assessed; when interactions were statistically significant, country-stratified models were estimated. Interactions between country and reactance were found in all models that regressed psychological and behavioral HWL responses on study variables. In the US, stronger reactance was associated with more frequent reading of HWLs and thinking about health risks. Smokers from all four countries with stronger reactance reported greater likelihood of avoiding warnings and forgoing cigarettes due to warnings, although the association appeared stronger in the US. Both stronger HWLs responses and reactance were positively associated with subsequent cessation attempts, with no significant interaction between country and reactance. Reactance towards HWLs does not appear to interfere with quitting, which is consistent with its being an indicator of concern, not a systematic effort to avoid HWL message engagement.
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.
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.
Was the media campaign that supported Australia's new pictorial cigarette warning labels and plain packaging policy associated with more attention to and talking about warning labels?

PubMed

Nagelhout, Gera E; Osman, Amira; Yong, Hua-Hie; Huang, Li-Ling; Borland, Ron; Thrasher, James F

2015-10-01

Population-level interventions can possibly enhance each other's effects when they are implemented simultaneously. When the plain packaging policy was implemented in Australia, pictorial health warning labels (HWLs) on cigarette packages were also updated and a national mass media campaign was aired. This study examined whether smokers who recalled the media campaign reported more attention to and talking about HWLs. Longitudinal survey data was obtained among Australian adult smokers, aged 18 years and older, from an online consumer panel. One survey wave was conducted before (September 2012) and two waves were conducted after (January 2013 and May 2013) the interventions. The sample was replenished to maintain a sample size of 1000 participants at each wave. Generalized Estimating Equations analyses were performed. Compared to wave 1, attention to HWLs increased at wave 2 (b=0.32, SE=0.06, p<0.001), but not at wave 3 (b=0.10, SE=0.08, p=0.198). Talking about HWLs increased over time (IRR=1.82, 95% CI=1.58-2.09 and IRR=1.25, 95% CI=1.05-1.47, at wave 2 and wave 3 respectively). Campaign recall was significantly associated with more attention to HWLs (b=0.29, SE=0.05, p<0.001) and with more talking about HWLs (IRR=1.17, 95% CI=1.06-1.29) with similar effects across waves 2 and 3. Recall of the campaign was associated with more attention to and talking about HWLs. When adjusting for campaign recall, there was still an increasing trend in attention and talking. This suggests that the media campaign and the new packaging and labeling policies had independent and positive effects on attention to and talking about HWLs. Copyright © 2015 Elsevier Ltd. All rights reserved.
Was the media campaign that supported Australia’s new pictorial cigarette warning labels and plain packaging policy associated with more attention to and talking about warning labels?

PubMed Central

Nagelhout, Gera E.; Osman, Amira; Yong, Hua-Hie; Huang, Li-Ling; Borland, Ron; Thrasher, James F.

2016-01-01

Background Population-level interventions can possibly enhance each other’s effects when they are implemented simultaneously. When the plain packaging policy was implemented in Australia, pictorial health warning labels (HWLs) on cigarette packages were also updated and a national mass media campaign was aired. This study examined whether smokers who recalled the media campaign reported more attention to and talking about HWLs. Methods Longitudinal survey data was obtained among Australian adult smokers, aged 18 years and older, from an online consumer panel. One survey wave was conducted before (September 2012) and two waves were conducted after (January 2013 and May 2013) the interventions. The sample was replenished to maintain a sample size of 1000 participants at each wave. Generalized Estimating Equations analyses were performed. Results Compared to wave 1, attention to HWLs increased at wave 2 (b = 0.32, SE = 0.06, p < 0.001), but not at wave 3 (b = 0.10, SE = 0.08, p = 0.198). Talking about HWLs increased over time (IRR = 1.82, 95% CI = 1.58–2.09 and IRR = 1.25, 95% CI = 1.05–1.47, at wave 2 and wave 3 respectively). Campaign recall was significantly associated with more attention to HWLs (b = 0.29, SE = 0.05, p < 0.001) and with more talking about HWLs (IRR = 1.17, 95% CI = 1.06–1.29) with similar effects across waves 2 and 3. Conclusions Recall of the campaign was associated with more attention to and talking about HWLs. When adjusting for campaign recall, there was still an increasing trend in attention and talking. This suggests that the media campaign and the new packaging and labeling policies had independent and positive effects on attention to and talking about HWLs. PMID:26050643
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.
Health Warning Labels for Smokeless Tobacco: The Impact of Graphic Images on Attention, Recall, and Craving.

PubMed

Klein, Elizabeth G; Quisenberry, Amanda J; Shoben, Abigail B; Cooper, Sarah; Ferketich, Amy K; Berman, Micah; Peters, Ellen; Wewers, Mary Ellen

2017-10-01

Little research has examined the impacts of graphic health warnings on the users of smokeless tobacco products. A convenience sample of past-month, male smokeless tobacco users (n = 142; 100% male) was randomly assigned to view a smokeless tobacco advertisement with a graphic health warning (GHW) or a text-only warning. Eye-tracking equipment measured viewing time, or dwell time, in milliseconds. Following the advertisement exposure, participants self-reported smokeless tobacco craving and recalled any content in the health warning message (unaided recall). Linear and logistic regression analyses evaluated the proportion of time viewing the GHW, craving, and GHW recall. Participants who viewed a GHW spent a significantly greater proportion of their ad viewing time on GHWs (2.87 seconds or 30%), compared to those viewing a text-only warning (2.05 seconds or 24%). Although there were no significant differences by condition in total advertisement viewing duration, those participants viewing a GHW had increased recall of health warning messages compared to the text-only warning (76% had any warning message recall compared to 53%; p < .05). Self-reported craving after advertisement exposure was lower in the GHW compared to text-only condition, but the difference was not statistically significant (a rating of 4.4 vs. 5.3 on a 10-point scale; p = .08). GHWs attracted greater attention and greater recall of health warning messages compared to text-only warnings among rural male smokeless tobacco users. Among a sample of rural smokeless tobacco users, GHWs attracted more attention and recall of health warning messages compared to text-only warnings when viewed within smokeless tobacco advertising. These findings provide additional empirical support that GHWs are an effective tobacco control tool for all tobacco products and advertisements. © 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.
Comparing Alcohol Marketing and Alcohol Warning Message Policies Across Canada.

PubMed

Wettlaufer, Ashley; Cukier, Samantha N; Giesbrecht, Norman

2017-08-24

In order to reduce harms from alcohol, evidence-based policies are to be introduced and sustained. To facilitate the dissemination of policies that reduce alcohol-related harms by documenting, comparing, and sharing information on effective alcohol polices related to restrictions on alcohol marketing and alcohol warning messaging in 10 Canadian provinces. Team members developed measurable indicators to assess policies on (a) restrictions on alcohol marketing, and (b) alcohol warning messaging. Indicators were peer-reviewed by three alcohol policy experts, refined, and data were collected, submitted for validation by provincial experts, and scored independently by two team members. The national average score was 52% for restrictions on marketing policies and 18% for alcohol warning message policies. Most provinces had marketing regulations that went beyond the federal guidelines with penalties for violating marketing regulations. The provincial liquor boards' web pages focused on product promotion, and there were few restrictions on sponsorship activities. No province has implemented alcohol warning labels, and Ontario was the sole province to have legislated warning signs at all points-of-sale. Most provinces provided a variety of warning signs to be displayed voluntarily at points-of-sale; however, the quality of messages varied. Conclusions/Importance: There is extensive alcohol marketing with comparatively few messages focused on the potential harms associated with alcohol. It is recommended that governments collaborate with multiple stakeholders to maximize the preventive impact of restrictions on alcohol marketing and advertising, and a broader implementation of alcohol warning messages.
Impact of graphic pack warnings on adult smokers’ quitting activities: Findings from the ITC Southeast Asia Survey (2005–2014)

PubMed Central

Li, Lin; Fathelrahman, Ahmed I.; Borland, Ron; Omar, Maizurah; Fong, Geoffrey T.; Quah, Anne C.K.; Sirirassamee, Buppha; Yong, Hua-Hie

2016-01-01

Malaysia introduced graphic health warning labels (GHWLs) on all tobacco packages in 2009. We aimed to examine if implementing GHWLs led to stronger warning reactions (e.g., thinking about the health risks of smoking) and an increase in subsequent quitting activities; and to examine how reactions changed over time since the implementation of the GHWLs in Malaysia and Thailand where GHWL size increased from 50–55% in 2010. Data came from six waves (2005–2014) of the International Tobacco Control Southeast Asia Survey. Between 3,706 and 4,422 smokers were interviewed across these two countries at each survey wave. Measures included salience of warnings, cognitive responses (i.e., thinking about the health risks and being more likely to quit smoking), forgoing cigarettes, and avoiding warnings. The main outcome was subsequent quit attempts. Following the implementation of GHWLs in Malaysia, reactions increased, in some cases to levels similar to the larger Thai warnings, but declined over time. In Thailand, reactions increased following implementation, with no decline for several years, and no clear effect of the small increase in warning size. Reactions, mainly cognitive responses, were consistently predictive of quit attempts in Thailand, but this was only consistently so in Malaysia after the change to GHWLs. In conclusion, GHWLs are responded to more frequently, and generate more quit attempts, but warning wear-out is not consistent in these two countries, perhaps due to differences in other tobacco control efforts. PMID:27525045
Efficient organ localization using multi-label convolutional neural networks in thorax-abdomen CT scans

NASA Astrophysics Data System (ADS)

Efrain Humpire-Mamani, Gabriel; Arindra Adiyoso Setio, Arnaud; van Ginneken, Bram; Jacobs, Colin

2018-04-01

Automatic localization of organs and other structures in medical images is an important preprocessing step that can improve and speed up other algorithms such as organ segmentation, lesion detection, and registration. This work presents an efficient method for simultaneous localization of multiple structures in 3D thorax-abdomen CT scans. Our approach predicts the location of multiple structures using a single multi-label convolutional neural network for each orthogonal view. Each network takes extra slices around the current slice as input to provide extra context. A sigmoid layer is used to perform multi-label classification. The output of the three networks is subsequently combined to compute a 3D bounding box for each structure. We used our approach to locate 11 structures of interest. The neural network was trained and evaluated on a large set of 1884 thorax-abdomen CT scans from patients undergoing oncological workup. Reference bounding boxes were annotated by human observers. The performance of our method was evaluated by computing the wall distance to the reference bounding boxes. The bounding boxes annotated by the first human observer were used as the reference standard for the test set. Using the best configuration, we obtained an average wall distance of 3.20~+/-~7.33 mm in the test set. The second human observer achieved 1.23~+/-~3.39 mm. For all structures, the results were better than those reported in previously published studies. In conclusion, we proposed an efficient method for the accurate localization of multiple organs. Our method uses multiple slices as input to provide more context around the slice under analysis, and we have shown that this improves performance. This method can easily be adapted to handle more organs.
Desire versus Efficacy in Smokers’ Paradoxical Reactions to Pictorial Health Warnings for Cigarettes

PubMed Central

Romer, Daniel; Peters, Ellen; Strasser, Andrew A.; Langleben, Daniel

2013-01-01

Pictorial health warnings on cigarette packs create aversive emotional reactions to smoking and induce thoughts about quitting; however, contrary to models of health behavior change, they do not appear to alter intentions to quit smoking. We propose and test a novel model of intention to quit an addictive habit such as smoking (the efficacy-desire model) that can explain this paradoxical effect. At the core of the model is the prediction that self-efficacy and desire to quit an addictive habit are inversely related. We tested the model in an online experiment that randomly exposed smokers (N = 3297) to a cigarette pack with one of three increasing levels of warning intensity. The results supported the model’s prediction that despite the effects of warnings on aversion to smoking, intention to quit smoking is an inverted U-shape function of the smoker’s self-efficacy for quitting. In addition, smokers with greater (lesser) quit efficacy relative to smoking efficacy increase (decrease) intentions to quit. The findings show that previous failures to observe effects of pictorial warning labels on quit intentions can be explained by the contradictory individual differences that warnings produce. Thus, the model explains the paradoxical finding that quit intentions do not change at the population level, even though smokers recognize the implications of warnings. The model suggests that pictorial warnings are effective for smokers with stronger quit-efficacy beliefs and provides guidance for how cigarette warnings and tobacco control strategies can be designed to help smokers quit. PMID:23383006
Evaluating Varied Label Designs for Use with Medical Devices: Optimized Labels Outperform Existing Labels in the Correct Selection of Devices and Time to Select.

PubMed

Bix, Laura; Seo, Do Chan; Ladoni, Moslem; Brunk, Eric; Becker, Mark W

2016-01-01

Effective standardization of medical device labels requires objective study of varied designs. Insufficient empirical evidence exists regarding how practitioners utilize and view labeling. Measure the effect of graphic elements (boxing information, grouping information, symbol use and color-coding) to optimize a label for comparison with those typical of commercial medical devices. Participants viewed 54 trials on a computer screen. Trials were comprised of two labels that were identical with regard to graphics, but differed in one aspect of information (e.g., one had latex, the other did not). Participants were instructed to select the label along a given criteria (e.g., latex containing) as quickly as possible. Dependent variables were binary (correct selection) and continuous (time to correct selection). Eighty-nine healthcare professionals were recruited at Association of Surgical Technologists (AST) conferences, and using a targeted e-mail of AST members. Symbol presence, color coding and grouping critical pieces of information all significantly improved selection rates and sped time to correct selection (α = 0.05). Conversely, when critical information was graphically boxed, probability of correct selection and time to selection were impaired (α = 0.05). Subsequently, responses from trials containing optimal treatments (color coded, critical information grouped with symbols) were compared to two labels created based on a review of those commercially available. Optimal labels yielded a significant positive benefit regarding the probability of correct choice ((P<0.0001) LSM; UCL, LCL: 97.3%; 98.4%, 95.5%)), as compared to the two labels we created based on commercial designs (92.0%; 94.7%, 87.9% and 89.8%; 93.0%, 85.3%) and time to selection. Our study provides data regarding design factors, namely: color coding, symbol use and grouping of critical information that can be used to significantly enhance the performance of medical device labels.

16 CFR 316.4 - Requirement to place warning labels on commercial electronic mail that contains sexually oriented...

Code of Federal Regulations, 2010 CFR

2010-01-01

... FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CAN-SPAM RULE § 316.4 Requirement to... avoid viewing the sexually oriented material, a recipient should delete the email message without...
21 CFR 201.70 - Calcium labeling.

Code of Federal Regulations, 2013 CFR

2013-04-01

... stones [bullet] a calcium-restricted diet”. The warnings in §§ 201.64(c), 201.70(c), 201.71(c), and 201...., a calcium or sodium restricted diet. 1 See § 201.66(b)(4) of this chapter for definition of bullet...
21 CFR 201.70 - Calcium labeling.

Code of Federal Regulations, 2014 CFR

2014-04-01

... stones [bullet] a calcium-restricted diet”. The warnings in §§ 201.64(c), 201.70(c), 201.71(c), and 201...., a calcium or sodium restricted diet. 1 See § 201.66(b)(4) of this chapter for definition of bullet...
21 CFR 201.70 - Calcium labeling.

Code of Federal Regulations, 2012 CFR

2012-04-01

... stones [bullet] a calcium-restricted diet”. The warnings in §§ 201.64(c), 201.70(c), 201.71(c), and 201...., a calcium or sodium restricted diet. 1 See § 201.66(b)(4) of this chapter for definition of bullet...
21 CFR 874.3305 - Wireless air-conduction hearing aid.

Code of Federal Regulations, 2013 CFR

2013-04-01

...-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its...: (1) Appropriate analysis/testing should validate electro magnetic compatibility (EMC) and safety of... technology functions; and (3) Labeling should specify appropriate instructions, warnings, and information...
Salience and Impact of Health Warning Label on Cigarette Packs in Vietnam: Findings From the Global Adult Tobacco Survey 2015.

PubMed

Ngoc Bich, Nguyen; Thu Ngan, Tran; Bao Giang, Kim; Thi Hai, Phan; Thi Thu Huyen, Doan; Ngoc Khue, Luong; Tuan Lam, Nguyen; Van Minh, Hoang; Thi Quynh Nga, Pham; The Quan, Nguyen; Loan, Vu Hoang

2018-04-13

Viet Nam is among the countries having highest rate of male smokers in the world. The country has joined the Global Tobacco Surveillance System since 2010. Under this system, two rounds of Global Adult Tobacco Survey (GATS) were conducted in 2010 and 2015. Those two surveys provide excellent comparable data on tobacco usage and its related aspects in Vietnam. This study using the data from GATS 2015 to examine the salience and impact of cigarette pack health warnings on quitting intention in Vietnam. The Vietnam GATS 2015 was a nationally representative survey in which 9,513 households were selected using two-stage random systematic sampling method. Results of multivariate analysis showed that the strongest predictor for quit intention because of health warnings was "ever made a quit attempt in the past 12 months" followed by "believes that tobacco smoking causes serious illness". Compared to GATS 2010, GATS 2015 observed the increase in salience of cigarette health warnings. However, the current pictorial health warnings are losing their impact on motivating intention to quit. The results highlight that it is time to start the rotation cycle to refresh the current health warning set. Actions to select a new and more impressive set of pictorial health warnings should be developed as soon as possible.
Twelve Years' Experience with Direct-to-Consumer Advertising of Prescription Drugs in Canada: A Cautionary Tale

PubMed Central

Mintzes, Barbara; Morgan, Steve; Wright, James M.

2009-01-01

Background Direct-to-consumer advertising (DTCA) of prescription drugs is illegal in Canada as a health protection measure, but is permitted in the United States. However, in 2000, Canadian policy was changed to allow ‘reminder’ advertising of prescription drugs. This is a form of advertising that states the brand name without health claims. ‘Reminder’ advertising is prohibited in the US for drugs that have ‘black box’ warnings of serious risks. This study examines spending on DTCA in Canada from 1995 to 2006, 12 years spanning this policy shift. We ask how annual per capita spending compares to that in the US, and whether drugs with Canadian or US regulatory safety warnings are advertised to the Canadian public in reminder advertising. Methodology/Principal Findings Prescription drug advertising spending data were extracted from a data set on health sector spending in Canada obtained from a market research company, TNS Media Inc. Spending was adjusted for inflation and compared with US spending. Inflation-adjusted spending on branded DTCA in Canada grew from under CAD$2 million per year before 1999 to over $22 million in 2006. The major growth was in broadcast advertising, accounting for 83% of spending in 2006. US annual per capita spending was on average 24 times Canadian levels. Celebrex (celecoxib), which has a US black box and was subject to three safety advisories in Canada, was the most heavily advertised drug on Canadian television in 2005 and 2006. Of 8 brands with >$500,000 spending, which together accounted for 59% of branded DTCA in all media, 6 were subject to Canadian safety advisories, and 4 had US black box warnings. Conclusions/Significance Branded ‘reminder’ advertising has grown rapidly in Canada since 2000, mainly due to a growth in television advertising. Although DTCA spending per capita is much lower in Canada than in the US, there is no evidence of safer content or product choice; many heavily-advertised drugs in Canada have been subject to safety advisories. For governments searching for compromise solutions to industry pressure for expanded advertising, Canada's experience stands as a stark warning. PMID:19479084
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.
Suicide in pediatrics: epidemiology, risk factors, warning signs and the role of the pediatrician in detecting them.

PubMed

Dilillo, Dario; Mauri, Silvia; Mantegazza, Cecilia; Fabiano, Valentina; Mameli, Chiara; Zuccotti, Gian Vincenzo

2015-07-07

Epidemiological data suggests suicide is uncommon in childhood but becomes an extremely serious issue among adolescents.Several risk factors have been identified and include the presence of psychiatric illness, a previous suicide attempt, family factors, substance abuse, sexual and physical abuse, disorders in gender identity or bullying. Pediatricians have a primary role in searching for these risk factors, recognizing them and acting synergistically with other specialists to prevent and treat suicidal behavior.Pediatricians should also be able to identify the "warning signs" for suicide since their presence implies a need for immediate action, as attempted suicide may occur in a few hours or days.The use of antidepressant drugs and its association with suicidal risk in pediatric age is another topic of ongoing debate. Food and Drug Administration has recently introduced the so-called "black box" on antidepressants' packages with the aim of gaining attention to the possible risk of suicide among adolescents who are treated with antidepressants, with a warning that the risk of suicide is higher when starting a therapy or while adjusting its dosage.
40 CFR 82.124 - Prohibitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 17 2010-07-01 2010-07-01 false Prohibitions. 82.124 Section 82.124 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE The Labeling of Products Using Ozone-Depleting Substances § 82.124 Prohibitions. (a) Warning...
40 CFR 82.124 - Prohibitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 17 2011-07-01 2011-07-01 false Prohibitions. 82.124 Section 82.124 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE The Labeling of Products Using Ozone-Depleting Substances § 82.124 Prohibitions. (a) Warning...
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.
An examination of the effectiveness of health warning labels on smokeless tobacco products in four states in India: findings from the TCP India cohort survey.

PubMed

Gravely, Shannon; Fong, Geoffrey T; Driezen, Pete; Xu, Steve; Quah, Anne C K; Sansone, Genevieve; Gupta, Prakash C; Pednekar, Mangesh S

2016-12-13

In 2009, after many delays and changes, India introduced a single pictorial health warning label (HWL) on smokeless tobacco (SLT) packing-a symbolic image of a scorpion covering 40% of the front surface. In 2011, the scorpion was replaced with 4 graphic images. This paper tested the effectiveness of SLT HWLs in India and whether the 2011 change from symbolic to graphic images increased their effectiveness. Data were from a cohort of 4733 adult SLT users (age15+) of the Tobacco Control Project (TCP) India Survey from 4 states. The surveys included key indicators of health warning effectiveness, including warning salience, and cognitive, emotional, and behavioral responses to the warnings. The HWL change from symbolic to graphic did not result in significant increases on any of the HWL outcome indicators. A substantial minority of SLT users were unaware that SLT packages contained HWLs (27% at both waves). Noticing the warnings was also remarkably low at both waves (W1 = 34.3%, W2 = 28.1%). These effects carried over to the cognitive and behavioural measures, where among those who noticed HWLs, about one-third reported forgoing SLT at least once because of the HWLs, and fewer than 20% reported that HWLs made them think about SLT risks or about quitting SLT. Even fewer reported avoiding HWLs (8.1 to 11.6%). Among those who quit using SLT by post-policy, awareness that SLT packaging contained HWLs was significantly greater at post-policy (86.8%) compared to pre-policy (77.8%, p = 0.02). Quitters were also significantly more aware of the post-policy HWLs compared to those who continued to use SLT (p < 0.001). Health warnings on SLT packages in India are low in effectiveness, and the change from the symbolic warning (pre-policy) to graphic HWLs (post-policy) did not lead to significant increases of effectiveness on any of the HWL indicators among those who continued to use SLT products, thus suggesting that changing an image alone is not enough to have an impact. There is a critical need to implement SLT HWLs in India that are more salient (large in size and on the front and back of the package) and impactful, which following from studies of HWLs on cigarette packaging, would have strong potential to increase awareness of the harms of SLT and to motivate quitting.
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.
Trends and socioeconomic differences in policy triggers for thinking about quitting smoking: Findings from the International Tobacco Control (ITC) Europe Surveys.

PubMed

Hummel, Karin; Nagelhout, Gera E; Willemsen, Marc C; Driezen, Pete; Springvloet, Linda; Mons, Ute; Kunst, Anton E; Guignard, Romain; Allwright, Shane; van den Putte, Bas; Hoving, Ciska; Fong, Geoffrey T; McNeill, Ann; Siahpush, Mohammad; de Vries, Hein

2015-10-01

The aim of the current study is to investigate trends and socioeconomic differences in policy triggers for thinking about quitting in six European countries. Data were derived from all available survey waves of the International Tobacco Control (ITC) Europe Surveys (2003-2013). France conducted three survey waves (n=1420-1735), Germany three waves (n=515-1515), The Netherlands seven waves (n=1420-1668), Ireland three waves (n=582-1071), Scotland two waves (n=461-507), and the rest of the United Kingdom conducted seven survey waves (n=861-1737). Smokers were asked whether four different policies (cigarette price, smoking restrictions in public places, free or lower cost medication, and warning labels on cigarette packs) influenced them to think about quitting. Generalized Estimating Equation (GEE) models were estimated for each country. Cigarette price was mentioned most often in all countries and across all waves as trigger for thinking about quitting. Mentioning cigarette price and warning labels increased after the implementation of price increases and warning labels in some countries, while mentioning smoking restrictions decreased after their implementation in four countries. All studied policy triggers were mentioned more often by smokers with low and/or moderate education and income than smokers with high education and income. The education and income differences did not change significantly over time for most policies and in most countries. Tobacco control policies work as a trigger to increase thoughts about quitting, particularly in smokers with low education and low income and therefore have the potential to reduce health inequalities in smoking. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Cost effectiveness of tobacco control policies in Vietnam: the case of population-level interventions.

PubMed

Higashi, Hideki; Truong, Khoa D; Barendregt, Jan J; Nguyen, Phuong K; Vuong, Mai L; Nguyen, Thuy T; Hoang, Phuong T; Wallace, Angela L; Tran, Tien V; Le, Cuong Q; Doran, Christopher M

2011-05-01

Tobacco smoking is one of the leading public health problems in the world. It is also possible to prevent and/or reduce the harm from tobacco use through the use of cost-effective tobacco control measures. However, most of this evidence comes from developed countries and little research has been conducted on this issue in developing countries. The objective of this study was to analyse the cost effectiveness of four population-level tobacco control interventions in Vietnam. Four tobacco control interventions were evaluated: excise tax increase; graphic warning labels on cigarette packs; mass media campaigns; and smoking bans (in public or in work places). A multi-state life table model was constructed in Microsoft® Excel to examine the cost effectiveness of the tobacco control intervention options. A government perspective was adopted, with costing conducted using a bottom-up approach. Health improvement was considered in terms of disability-adjusted life-years (DALYs) averted. All assumptions were subject to sensitivity and uncertainty analysis. All the interventions fell within the definition of being very cost effective according to the threshold level suggested by the WHO (i.e.
Eliciting preferences for waterpipe tobacco smoking using a discrete choice experiment: implications for product regulation

PubMed Central

Salloum, Ramzi G; Maziak, Wasim; Hammond, David; Nakkash, Rima; Islam, Farahnaz; Cheng, Xi; Thrasher, James F

2015-01-01

Objectives Waterpipe smoking is highly prevalent among university students, and has been increasing in popularity despite mounting evidence showing it is harmful to health. The aim of this study was to measure preferences for waterpipe smoking and determine which product characteristics are most important to smokers. Setting A large university in the Southeastern USA. Participants Adult waterpipe smokers attending the university (N=367). Design Participants completed an Internet-based discrete choice experiment to reveal their preferences for, and trade-offs between, the attributes of hypothetical waterpipe smoking sessions. Participants were presented with waterpipe lounge menus, each with three fruit-flavoured options and one tobacco flavoured option, in addition to an opt out option. Nicotine content and price were provided for each choice. Participants were randomised to either receive menus with a text-only health-warning message or no message. Outcome measures Multinomial and nested logit models were used to estimate the impact on consumer choice of attributes and between-subject assignment of health warnings respectively. Results On average, participants preferred fruit-flavoured varieties to tobacco flavour. They were averse to options labelled with higher nicotine content. Females and non-smokers of cigarettes were more likely than their counterparts to prefer flavoured and nicotine-free varieties. Participants exposed to a health warning were more likely to opt out. Conclusions Fruit-flavoured tobacco and lower nicotine content labels, two strategies widely used by the industry, increase the demand for waterpipe smoking among young adults. Waterpipe-specific regulation should limit the availability of flavoured waterpipe tobacco and require accurate labelling of constituents. Waterpipe-specific tobacco control regulation, along with research to inform policy, is required to curb this emerging public health threat. PMID:26353876
Role of the Box C/D Motif in Localization of Small Nucleolar RNAs to Coiled Bodies and Nucleoli

PubMed Central

Narayanan, Aarthi; Speckmann, Wayne; Terns, Rebecca; Terns, Michael P.

1999-01-01

Small nucleolar RNAs (snoRNAs) are a large family of eukaryotic RNAs that function within the nucleolus in the biogenesis of ribosomes. One major class of snoRNAs is the box C/D snoRNAs named for their conserved box C and box D sequence elements. We have investigated the involvement of cis-acting sequences and intranuclear structures in the localization of box C/D snoRNAs to the nucleolus by assaying the intranuclear distribution of fluorescently labeled U3, U8, and U14 snoRNAs injected into Xenopus oocyte nuclei. Analysis of an extensive panel of U3 RNA variants showed that the box C/D motif, comprised of box C′, box D, and the 3′ terminal stem of U3, is necessary and sufficient for the nucleolar localization of U3 snoRNA. Disruption of the elements of the box C/D motif of U8 and U14 snoRNAs also prevented nucleolar localization, indicating that all box C/D snoRNAs use a common nucleolar-targeting mechanism. Finally, we found that wild-type box C/D snoRNAs transiently associate with coiled bodies before they localize to nucleoli and that variant RNAs that lack an intact box C/D motif are detained within coiled bodies. These results suggest that coiled bodies play a role in the biogenesis and/or intranuclear transport of box C/D snoRNAs. PMID:10397754
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
Training Requirements in OSHA Standards and Training Guidelines.

ERIC Educational Resources Information Center

Occupational Safety and Health Administration, Washington, DC.

This booklet contains Occupational Safety and Health Administration (OSHA) training requirements, excerpted from OSHA standards. The booklet is designed to help employers, safety and health professionals, training directors, and others who need to know training requirements. (Requirements for posting information, warning signs, labels, and the…

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