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.

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.

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.

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.

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

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.

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.

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.

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

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.

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.…

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.

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.

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.

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 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.

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

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.

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

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.

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

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 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

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.

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.

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.

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.

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.

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...

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

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.

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...

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

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.

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.

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...

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.

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.

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

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.

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.

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 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.

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.

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

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

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

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.

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.

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...

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…

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.

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.

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

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.

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/

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/

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.

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.

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…

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/

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.

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.

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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/

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.

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.

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.

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...

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.

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

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

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

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.

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.

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

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.

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.

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.

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.

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.

[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.

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.

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.

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.

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.

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 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...

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.

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.

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.

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.

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.

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.

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.

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/

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.

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…

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...

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.

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.

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...

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.

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.

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 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.

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.

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...

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...

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...

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.

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.

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/

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

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...

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

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.

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.

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

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.

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.

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.

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.

"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.

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

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.

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

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

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...

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.

"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.

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

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.

"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.

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...

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…

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…

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.

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…

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.

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...

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.

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.

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.

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

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

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

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...

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.

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.

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.

The role of negative affect and message credibility in perceived effectiveness of smokeless tobacco health warning labels in Navi Mumbai, India and Dhaka, Bangladesh: A moderated-mediation analysis.

PubMed

Mutti-Packer, Seema; Reid, Jessica L; Thrasher, James F; Romer, Daniel; Fong, Geoffrey T; Gupta, Prakash C; Pednekar, Mangesh S; Nargis, Nigar; Hammond, David

2017-10-01

There is strong evidence showing that pictorial health warnings are more effective than text-only warnings. However, much of this evidence comes from high-income countries and is limited to cigarette packaging. Moreover, few studies have identified mechanisms that might explain the impact of warnings. The current study examined the potential mediating role of negative affect and the moderating influence of message credibility in perceived effectiveness of smokeless tobacco warnings in two low- and middle-income countries (LMICs). Field interviews were conducted in India and Bangladesh, with adult (19+ years) smokeless tobacco users (n=1053), and youth (16-18years) users (n=304) and non-users (n=687). Respondents were randomly assigned to view warnings in one of four conditions: (1) Text-only, (2) pictorial with symbolic imagery, (3) pictorial with graphic images of health effects, or (4) pictorial with personalized graphic images plus a personal testimonial. The findings provide support for the mediating influence of negative affect in perceived effectiveness, for adult and youth smokeless tobacco users who viewed pictorial warnings (vs. text-only), and graphic health warnings (vs. personal testimonials). Among adults, message credibility moderated the indirect effect; the association was stronger when credibility was high and weaker when it was low. Among youth users and non-users, message credibility did not moderate the indirect effect. Consistent with research from high-income countries, these findings highlight the importance of selecting imagery that will elicit negative emotional reactions and be perceived as credible. Differential effects among adults and youth highlight the importance of pre-testing images. Copyright © 2017 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.

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

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.

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...

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.

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...

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

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...

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

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 ...

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

PubMed

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

2018-02-01

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

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...

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

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…

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.

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.

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.

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.

Testing of Candidate Icons to Identify Acetaminophen-Containing Medicines

PubMed Central

Shiffman, Saul; Cotton, Helene; Jessurun, Christina; Sembower, Mark A.; Pype, Steve; Phillips, Jerry

2016-01-01

Adding icons on labels of acetaminophen-containing medicines could help users identify the active ingredient and avoid concomitant use of multiple medicines containing acetaminophen. We evaluated five icons for communication effectiveness. Adults (n = 300) were randomized to view a prescription container label or over-the-counter labels with either one or two icons. Participants saw two icon candidates, and reported their interpretation; experts judged whether these reflected critical confusions that might cause harm. Participants rated how effectively each icon communicated key messages. Icons based on abbreviations of “acetaminophen” (“Ac”, “Ace”, “Acm”) were rated less confusing and more effective in communicating the active ingredient than icons based on “APAP” or an abstract symbol. Icons did not result in critical confusion when seen on a readable medicine label. Icon implementation on prescription labels was more effective at communicating the warning against concomitant use than implementation on over-the-counter (OTC) labels. Adding an icon to a second location on OTC labels did not consistently enhance this communication, but reduced rated effectiveness of acetaminophen ingredient communication among participants with limited health literacy. The abbreviation-based icons seem most suitable for labeling acetaminophen-containing medications to enable users to identify acetaminophen-containing products. PMID:28970383

[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.

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.

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.

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.

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.

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...

Validation of a Poison Prevention Program.

ERIC Educational Resources Information Center

Gill, Noel C.; Braden, Barbara T.

Two way analyses of variance and cross-group descriptive comparisons assessed the effectiveness of the Siop Poison Prevention Program, which included an educational program and the use of warning labels, on improving verbal and visual discrimination of poisonous and nonpoisonous products for preschool children. The study sample consisted of 156…

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.

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.

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.

Tobacco health warning messages on plain cigarette packs and in television campaigns: a qualitative study with Australian socioeconomically disadvantaged smokers.

PubMed

Guillaumier, Ashleigh; Bonevski, Billie; Paul, Christine

2015-02-01

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 risk and cessation benefit messages. Six focus groups were conducted over September 2012-April 2013 with adult clients of welfare organizations in regional New South Wales, Australia who were current smokers (n = 51). Participants discussed HWLs, plain packaging and anti-smoking television advertisements. Discussions were audio-taped, transcribed verbatim and analysed using thematic analysis. Highly emotive warnings delivering messages of negative health effects were most likely to capture the attention of the study participants; however, these warning messages did not prompt quit attempts and participants were sceptical about the effectiveness of cessation programmes such as telephone quitlines. Active avoidance of health warning messages was common, and many expressed false and self-exempting beliefs towards the harms of tobacco. Careful consideration of message content and medium is required to communicate the anti-smoking message to disadvantaged smokers who consider themselves desensitized to warnings. Health communication strategies should continue to address false beliefs about smoking and educate on cessation services that are currently underutilized. © The Author 2014. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

The Moderating Effects of Self-Esteem and Self-Efficacy on Responses to Graphic Health Warnings on Cigarette Packages: A Comparison of Smokers and Nonsmokers.

PubMed

Chun, Seungwoo; Park, Joon Woo; Heflick, Nathan; Lee, Seon Min; Kim, Daejin; Kwon, Kyenghee

2018-08-01

Do graphic pictorial health warnings (GPHWs) on cigarette packaging work better for some people than others? According to the Extended Parallel Process Model (EPPM), fear appeals should heighten positive change only if a person believes he or she is capable of change (i.e., self-efficacy). We exposed 242 smokers and 241 nonsmokers (aged 18-29) in the Republic of Korea to either a GPHW or a text-only warning in a between-subjects experiment. Results indicated that the GPHW increased intentions and motivations to quit smoking (for smokers) and intentions and motivations to not start smoking (for nonsmokers). However, these effects were moderated by self-efficacy related to quitting or not starting smoking. For smokers, a GPHW was especially effective in increasing desires and intentions to quit for people high in self-efficacy and high in self-esteem. However, for nonsmokers, a GPHW was effective only when self-efficacy was high, regardless of self-esteem level. For smokers and nonsmokers, results were mediated by heightened perceived health estimation. Implications for understanding the effectiveness of warning labels on cigarettes, for the introduction of GPHWs in the Republic of Korea, and for the Extended Parallel Process Model, are discussed.

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.

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

PubMed

Rodwin, Marc A

2013-01-01

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

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

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.

Early warning systems for the management of chronic heart failure: a systematic literature review of cost-effectiveness models.

PubMed

Albuquerque De Almeida, Fernando; Al, Maiwenn; Koymans, Ron; Caliskan, Kadir; Kerstens, Ankie; Severens, Johan L

2018-04-01

Describing the general and methodological characteristics of decision-analytical models used in the economic evaluation of early warning systems for the management of chronic heart failure patients and performing a quality assessment of their methodological characteristics is expected to provide concise and useful insight to inform the future development of decision-analytical models in the field of heart failure management. Areas covered: The literature on decision-analytical models for the economic evaluation of early warning systems for the management of chronic heart failure patients was systematically reviewed. Nine electronic databases were searched through the combination of synonyms for heart failure and sensitive filters for cost-effectiveness and early warning systems. Expert commentary: The retrieved models show some variability with regards to their general study characteristics. Overall, they display satisfactory methodological quality, even though some points could be improved, namely on the consideration and discussion of any competing theories regarding model structure and disease progression, identification of key parameters and the use of expert opinion, and uncertainty analyses. A comprehensive definition of early warning systems and further research under this label should be pursued. To improve the transparency of economic evaluation publications, authors should make available detailed technical information regarding the published models.

Graphic Health Warnings on Cigarette Packs: How Long Before the Effects on Adolescents Wear Out?

PubMed

White, Victoria; Bariola, Emily; Faulkner, Agatha; Coomber, Kerri; Wakefield, Melanie

2015-07-01

To examine the long-term impact of graphic health-warning labels (GHWL) on adolescents' cognitive processing of warning labels and cigarette pack perceptions. Cross-sectional school-based surveys of students aged 13-17 years residing in urban centers, conducted prior to GHWL introduction (2005) and 6 months (2006), 2 years (2008), and 5 years (2011) post-GHWL introduction. Students who had seen a cigarette pack in the previous 6 months or in 2006, who had seen GHWL were included in analyses (2005 n = 2,560; 2006 n = 1,306; 2008 n = 2,303; 2011 n = 2,716). Smoking stage, reported exposure to cigarette packs, cognitive processing of GHWL, and positive and negative perceptions of pack image were assessed. While cognitive processing of GHWL in 2006 and 2008 was greater than 2005 (p < .01), by 2011 scores had returned to 2005 levels. This pattern of change was consistent across smoking status groups. Pack image perceptions became more negative over time among all students, irrespective of smoking experience. While positive pack image ratings were lower in all subsequent years than 2005, the 2008 rating was higher than 2006 (p < .01). A significant interaction between survey time and smoking status (p < .01) showed that significant increases in positive pack ratings after 2006 only occurred among current and experimental smokers. When novel, GHWL on cigarette packs increase cognitive processing among adolescents. However, this effect diminishes after 5 years, suggesting more regular message refreshment is needed. Australia's adoption of plain packaging is intended to undermine positive pack appeal and increase warning salience. © The Author 2014. 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.

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

76 FR 43119 - Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-20

... and it is identified as a device using focused ultrasound to produce localized, mechanical motion... labeling includes warnings related to patient reaction in terms of pain and information to user in terms of observable skin reactions that are known to be precursors to the potential thermal adverse effects...

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

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...

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

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...

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.

"Plain packaging" regulations for tobacco products: the impact of standardizing the color and design of cigarette packs.

PubMed

Hammond, David

2010-01-01

Tobacco packaging and labeling policies have emerged as prominent and cost-effective tobacco control measures. Although packaging policies have primarily focused on health warnings, there is growing recognition of the importance of packaging as a marketing tool for the tobacco industry. The current paper reviews evidence on the potential impact of standardizing the color and design of tobacco packages -so called "plain" packaging. The evidence indicates three primary benefits of plain packaging: increasing the effectiveness of health warnings, reducing false health beliefs about cigarettes, and reducing brand appeal especially among youth and young adults. Overall, the research to date suggests that "plain" packaging regulations would be an effective tobacco control measure, particularly in jurisdictions with comprehensive restrictions on other forms of marketing.

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...

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

Is Disgust the Driver behind the Selection of Images for UK Tobacco Packets?

ERIC Educational Resources Information Center

Humphris, Gerry; Williams, Brian

2014-01-01

Objective: The use of pictorial warning labels on tobacco packets has gained almost universal international acceptance. In a public consultation exercise in 2006, the Department of Health in England, through a web-based answering system, asked people's preferences of 42 images, asking which images might be effective to encourage tobacco cessation…

Influence of Price and Labeling on Energy Drink Purchasing in an Experimental Convenience Store.

PubMed

Temple, Jennifer L; Ziegler, Amanda M; Epstein, Leonard H

2016-01-01

To examine the impact of energy drink (ED) pricing and labeling on the purchase of EDs. Participants visited a laboratory-based convenience store 3 times and purchased a beverage under different ED labeling (none, caffeine content, and warning labels) and pricing conditions. The 36 participants (aged 15-30 years) were classified as energy drink consumers (≥ 2 energy drinks/wk) and nonconsumers (< 1 energy drink/mo). Data were log transformed to generate elasticity coefficients. The authors analyzed changes in elasticity as a function of price and labeling using mixed-effects regression models. Increasing the price of EDs reduced ED purchases and increased purchasing of other caffeinated beverages among ED consumers. Energy drink labels affected ED sales in adolescents. These data suggest that ED pricing and labeling may influence the purchasing of ED, especially in adolescent consumers. Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

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...

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...

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.

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…

Potential Impact of Graphic Health Warnings on Cigarette Packages in Reducing Cigarette Demand and Smoking-Related Deaths in Vietnam.

PubMed

Minh, Hoang Van; Chung, Le Hong; Giang, Kim Bao; Duc, Duong Minh; Hinh, Nguyen Duc; Mai, Vu Quynh; Cuong, Nguyen Manh; Manh, Pham Duc; Duc, Ha Anh; Yang, Jui-Chen

2016-01-01

Two years after implementation of the graphic health warning intervention in Vietnam, it is very important to evaluate the intervention's potential impact. The objective of this paper was to predict effects of graphic health warnings on cigarette packages, particularly in reducing cigarette demand and smoking-associated deaths in Vietnam. In this study, a discrete choice experiment (DCE) method was used to evaluate the potential impact of graphic tobacco health warnings on smoking demand. To predict the impact of GHWs on reducing premature deaths associated with smoking, we constructed different static models. We adapted the method developed by University of Toronto, Canada and found that GHWs had statistically significant impact on reducing cigarette demand (up to 10.1% through images of lung damage), resulting in an overall decrease of smoking prevalence in Vietnam. We also found that between 428,417- 646,098 premature deaths would be prevented as a result of the GHW intervention. The potential impact of the GHW labels on reducing premature smoking-associated deaths in Vietnam were shown to be stronger among lower socio-economic groups.

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...

Global Evidence on the Association between Cigarette Graphic Warning Labels and Cigarette Smoking Prevalence and Consumption

PubMed Central

Ngo, Anh; Cheng, Kai-Wen; Huang, Jidong; Chaloupka, Frank J.

2018-01-01

Background: In 2011, the courts ruled in favor of tobacco companies in preventing the implementation of graphic warning labels (GWLs) in the US, stating that FDA had not established the effectiveness of GWLs in reducing smoking. Methods: Data came from various sources: the WHO MPOWER package (GWLs, MPOWER policy measures, cigarette prices), Euromonitor International (smoking prevalence, cigarette consumption), and the World Bank database (countries’ demographic characteristics). The datasets were aggregated and linked using country and year identifiers. Fractional logit regressions and OLS regressions were applied to examine the associations between GWLs and smoking prevalence and cigarette consumption, controlling for MPOWER policy scores, cigarette prices, GDP per capita, unemployment, population aged 15–64 (%), aged 65 and over (%), year indicators, and country fixed effects. Results: GWLs were associated with a 0.9–3 percentage point decrease in adult smoking prevalence and were significantly associated with a reduction of 230–287 sticks in per capita cigarette consumption, compared to countries without GWLs. However, the association between GWLs and cigarette consumption became statistically insignificant once country indicators were included in the models. Conclusions: The implementation of GWLs may be associated with reduced cigarette smoking. PMID:29495581

Global Evidence on the Association between Cigarette Graphic Warning Labels and Cigarette Smoking Prevalence and Consumption.

PubMed

Ngo, Anh; Cheng, Kai-Wen; Shang, Ce; Huang, Jidong; Chaloupka, Frank J

2018-02-28

Background : In 2011, the courts ruled in favor of tobacco companies in preventing the implementation of graphic warning labels (GWLs) in the US, stating that FDA had not established the effectiveness of GWLs in reducing smoking. Methods : Data came from various sources: the WHO MPOWER package (GWLs, MPOWER policy measures, cigarette prices), Euromonitor International (smoking prevalence, cigarette consumption), and the World Bank database (countries' demographic characteristics). The datasets were aggregated and linked using country and year identifiers. Fractional logit regressions and OLS regressions were applied to examine the associations between GWLs and smoking prevalence and cigarette consumption, controlling for MPOWER policy scores, cigarette prices, GDP per capita, unemployment, population aged 15-64 (%), aged 65 and over (%), year indicators, and country fixed effects. Results : GWLs were associated with a 0.9-3 percentage point decrease in adult smoking prevalence and were significantly associated with a reduction of 230-287 sticks in per capita cigarette consumption, compared to countries without GWLs. However, the association between GWLs and cigarette consumption became statistically insignificant once country indicators were included in the models. Conclusions : The implementation of GWLs may be associated with reduced cigarette smoking.

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.

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.

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.

Responses to tobacco control policies among youth.

PubMed

Crawford, M A; Balch, G I; Mermelstein, R

2002-03-01

Explore adolescents' response to current and potential tobacco control policy issues. The 13 site Tobacco Control Network (TCN), sponsored by the Centers for Disease Control and Prevention, conducted 129 sex and ethnic homogeneous focus groups. 785 white, African American, Asian American/Pacific Islander, American Indian, and Hispanic adolescents who were primarily smokers from rural, urban, and suburban locations across the USA. Awareness, knowledge, opinions, and behaviour regarding laws and rules, prices, cigarette ingredients, and warning labels. Teenagers were generally familiar with laws and rules about access and possession for minors, but believed them ineffective. They were knowledgeable about prices, and reported that a sharp and sudden increase could lead them to adjust their smoking patterns but could also have negative consequences. They found a list of chemical names of cigarette ingredients largely meaningless, but believed that disclosing and publicising their common uses could be an effective deterrent, especially for those who were not yet smoking. They were aware of current warning labels, but considered them uninformative and irrelevant. Understanding teenagers' attitudes and behaviours before implementing policies that will affect them will likely increase their effectiveness. Disclosing and publicising the chemical contents of cigarettes, and increasing prices quickly and sharply, are potentially effective areas for policy change to impact adolescent tobacco use.

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...

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

PubMed

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

2016-10-01

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

Graphic warning labels and the demand for cigarettes.

PubMed

Starr, Martha A; Drake, Keith

2017-03-01

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

Children's misunderstandings of hazard warning signs in the new globally harmonized system for classification and labeling.

PubMed

Latham, Garry; Long, Tony; Devitt, Patric

2013-12-01

Accidental chemical poisoning causes more than 35 000 child deaths every year across the world, and it leads to disease, disability, and suffering for many more children. Children's ignorance of dangers and their failure to interpret hazard warning signs as intended contribute significantly to this problem. A new Globally Harmonized System for Classification and Labeling is being implemented internationally with a view to unifying the current multiple and disparate national systems. This study was designed to establish a productive, effective means of teaching the new GHS warning signs to primary school children (aged 7-11 years). A pre-test, post-test, follow-up test design was employed, with a teaching intervention informed by a Delphi survey of expert opinion. Children from one school formed the experimental group (n = 49) and a second school provided a control group (n = 23). Both groups showed a gain in knowledge from pre-test to post-test, the experimental group with a larger gain but which was not statistically significant. However, longer-term retention of knowledge, as shown by the follow-up test, was statistically significantly greater in the experimental group (p = 0.001). The employment of teaching to match children's preferred learning styles, and the use of active learning were found to be related to improved retention of knowledge. Part of the study involved eliciting children's interpretation of standard hazard warning symbols, and this provoked considerable concern over the potential for dangerous misinterpretation with disastrous consequences. This article focuses on the reasons for such misconception and the action required to address this successfully in testing the intervention.

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

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.

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 ...

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…

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...

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…

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

Associations between coherent neural activity in the brain's value system during antismoking messages and reductions in smoking.

PubMed

Cooper, Nicole; Tompson, Steven; O'Donnell, Matthew B; Vettel, Jean M; Bassett, Danielle S; Falk, Emily B

2018-04-01

Worldwide, tobacco use is the leading cause of preventable death and illness. One common strategy for reducing the prevalence of cigarette smoking and other health risk behaviors is the use of graphic warning labels (GWLs). This has led to widespread interest from the perspective of health psychology in understanding the mechanisms of GWL effectiveness. Here we investigated differences in how the brain responds to negative, graphic warning label-inspired antismoking ads and neutral control ads, and we probed how this response related to future behavior. A group of smokers (N = 45) viewed GWL-inspired and control antismoking ads while undergoing fMRI, and their smoking behavior was assessed before and one month after the scan. We examined neural coherence between two regions in the brain's valuation network, the medial prefrontal cortex (MPFC) and ventral striatum (VS). We found that greater neural coherence in the brain's valuation network during GWL ads (relative to control ads) preceded later smoking reduction. Our results suggest that the integration of information about message value may be key for message influence. Understanding how the brain responds to health messaging and relates to future behavior could ultimately contribute to the design of effective messaging campaigns, as well as more broadly to theories of message effects and persuasion across domains. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

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

PubMed Central

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

2015-01-01

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

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

PubMed

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

2016-11-01

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

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.

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...

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.

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.

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...

Examining the relationship between psychosocial and behavioral proxies for future consumption behavior: self-reported impact and bidding behavior in an experimental auction study on cigarette labeling

PubMed Central

Rousu, Matthew C.; Thrasher, James F.

2014-01-01

Experimental and observational research often involves asking consumers to self-report the impact of some proposed option. Because self-reported responses involve no consequence to the respondent for falsely revealing how he or she feels about an issue, self-reports may be subject to social desirability and other influences that bias responses in important ways. In this article, we analyzed data from an experiment on the impact of cigarette packaging and pack warnings, comparing smokers’ self-reported impact (four-item scale) and the bids they placed in experimental auctions to estimate differences in demand. The results were consistent across methods; however, the estimated effect size associated with different warning labels was two times greater for the four-item self-reported response scale when compared to the change in demand as indicated by auction bids. Our study provides evidence that self-reported psychosocial responses provide a valid proxy for behavioral change as reflected by experimental auction bidding behavior. More research is needed to better understand the advantages and disadvantages of behavioral economic methods and traditional self-report approaches to evaluating health behavior change interventions. PMID:24399267

Car radiator burns: a prevention issue.

PubMed

Rabbitts, Angela; Alden, Nicole E; Conlin, Tara; Yurt, Roger W

2004-01-01

Scald burns continue to be the major cause of injury to patients admitted to the burn center. Scald burns occurring from car radiator fluid comprise a significant subgroup. Although manufacturer warning labels have been placed on car radiators, these burns continue to occur. This retrospective review looks at all patients admitted to our burn center who suffered scald burns from car radiator fluid to assess the extent of this problem. During the study period, 86 patients were identified as having suffered scald burns as a result of contact with car radiator fluid. Seventy-one percent of the burn injuries occurred in the summer months. The areas most commonly burned were the head and upper extremities. Burn prevention efforts have improved greatly over the years; however, this study demonstrates that scald burns from car radiator fluid continue to cause physical, emotional, and financial devastation. The current radiator warning labels alone are not effective. The National Highway Traffic Safety Administration has proposed a new federal motor vehicle safety standard to aid in decreasing the number of scald burns from car radiators. The results of this study were submitted to the United States Department of Transportation for inclusion in a docket for federal legislation supporting these safety measures.

Cigarette graphic health warning labels and information avoidance among individuals from low socioeconomic position in the U.S.

PubMed

McCloud, Rachel Faulkenberry; Okechukwu, Cassandra; Sorensen, Glorian; Viswanath, K

2017-04-01

Although graphic health warning labels (GHWs) on cigarette packs have influenced cessation behaviors in other countries, no U.S. studies have explored the impact of avoidance of GHW content among individuals from low socioeconomic position (SEP). The purpose of this study was to determine the predictors of intention to avoid GHWs, and how avoidance impacts cessation intention, in a low SEP sample in the U.S. Data come from low SEP smokers (n = 541) involved in a field experiment. The participants responded to questions pre- and post viewing of GHWs assessing SEP, intention to avoid them, emotional reactions, and intention to seek health information or quit smoking. Backwards stepwise logistic regression determined the predictors for intention to avoid GHWs. Simple and adjusted logistic regression analyzed the association between avoidance and its main predictors and outcomes of intentions to seek information or quit smoking. Predictors for avoidance included being somewhat addicted to cigarettes (OR 2.3, p = 0.002), younger than 25 (OR 2.6, p = 0.008), and having medium (OR 3.4, p < 0.001) or high (OR 4.7, p < 0.001) levels of negative emotional reaction to the labels. Intention to avoid GHWs was positively associated with the intent to look for health information about smoking (OR 2.2, p = 0.002). Higher levels of negative emotional reaction were positively associated with cessation behaviors, with high negative emotional reaction associated with nine times the odds of quitting (p < 0.001). Results indicate avoidance of GHWs does not detract from the labels' benefit and that GHWs are an effective means of communicating smoking risk information among low SEP groups.

Pictorial health warnings on cigarette packages in qatar: preimplementation awareness and perceptions of ever-smokers versus never-smokers.

PubMed

Awaisu, Ahmed; Hagi, Aisha; Ashour, Marwa Attia; Kheir, Nadir

2013-10-01

Studies have demonstrated that pictorial health warnings (PHWs) on cigarette packages were significantly associated with increased awareness of smoking-related health hazards and behavior change. A new legislation on PHWs was recently endorsed and PHWs have recently been introduced in Qatar. This study aims to evaluate the general public's awareness, beliefs, and perceptions on antitobacco PHW labels on cigarette packs prior to the implementation of the new regulation. A cross-sectional survey using a pretested 23-item questionnaire was conducted among randomly approached adults in Qatar. Data were analyzed using IBM SPSS(®) version 19. Demographic characteristics and other outcomes of interest were compared using chi-square or Fisher's exact tests. A total of 500 participants (59% male) responded to the survey. Most notably, ever-smokers did not significantly differ from never-smokers on awareness of PHW. About one third of the respondents had no idea about any specific text warning messages on tobacco products sold and nearly 45% of them did not know what a PHW was. Furthermore, a substantial proportion (more than 20%) of the respondents in both groups did not believe that introducing PHWs will enhance smoking behavior change. Nonsmokers generally tended to have more positive attitudes than smokers toward perceived impact of PHWs. These findings suggest the needs for increased awareness about the value of PHWs and call for further research to determine the effectiveness of PHW labels on cigarette packages in Qatar and greater Middle Eastern region, where legislations on PHWs are still at infancy.

Relative Importance of Different Attributes of Graphic Health Warnings on Tobacco Packages in Viet Nam.

PubMed

Giang, Kim Bao; Chung, Le Hong; Minh, Hoang Van; Kien, Vu Duy; Giap, Vu Van; Hinh, Nguyen Duc; Cuong, Nguyen Manh; Manh, Pham Duc; Duc, Ha Anh; Yang, Jui-Chen

2016-01-01

Graphic health warnings (GHW) on tobacco packages have proven to be effective in increasing quit attempts among smokers and reducing initial smoking among adolescents. This research aimed to examine the relative importance of different attributes of graphic health warnings on tobacco packages in Viet Nam. A discrete choice experimental (DCE) design was applied with a conditional logit model. In addition, a ranking method was used to list from the least to the most dreadful GHW labels. With the results from DCE model, graphic type was shown to be the most important attribute, followed by cost and coverage area of GHW. The least important attribute was position of the GHW. Among 5 graphic types (internal lung cancer image, external damaged teeth, abstract image, human suffering image and text), the image of lung cancer was found to have the strongest influence on both smokers and non-smokers. With ranking method, the image of throat cancer and heart diseases were considered the most dreadful images. GHWs should be designed with these attributes in mind, to maximise influence on purchase among both smokers and non-smokers.

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.

Distribution of new graphic warning labels: Are tobacco companies following regulations?

PubMed

Wilson, Nick; Peace, Jo; Li, Judy; Edwards, Richard; Hoek, Janet; Stanley, James; Thomson, George

2009-08-25

To test the hypothesis that tobacco companies would not follow a regulation that required seven new graphic health warnings (GHWs) to be evenly distributed on cigarette packs and that they would distribute fewer packs featuring warnings regarded by smokers as being more disturbing. Cross-sectional survey of purchased packs (n = 168) and street-collected discarded packs (convenience sample of New Zealand cities and towns, n = 1208 packs) with statistical analysis of seven types of new GHWs. A priori warning impact was judged using three criteria, which were tested against data from depth interviews with retailers. The GHWs on the purchased packs and street-collected packs both showed a distribution pattern that was generally consistent with the hypothesis ie, there were disproportionately more packs featuring images judged as "least disturbing" and disproportionately fewer of those with warnings judged "more disturbing". The overall patterns were statistically significant, suggesting an unequal frequency of the different warnings for both purchased (p < 0.0001) and street-collected packs (p = 0.035). One of the least disturbing images (of a "corpse with toe-tag") dominated the distribution in both samples. Further analysis of the street-collected packs revealed that this image appeared disproportionately more frequently on manufactured cigarettes made by each of the three largest New Zealand tobacco companies. Although stock clustering could explain the purchase pack result, there were no obvious reasons why the same uneven warning distribution was also evident among the street-collected packs. These results suggest that tobacco companies are not following the regulations, which requires even distribution of the seven different GHWs on cigarette packs; further monitoring is required to estimate the extent of this non-compliance. As an immediate measure, governments should strictly enforce all regulations applying to health warnings, particularly given that these are an effective tobacco control intervention that cost tax payers nothing.

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

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.

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.

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.

The impact of price and nutrition labelling on sugary drink purchases: Results from an experimental marketplace study.

PubMed

Acton, Rachel B; Hammond, David

2018-02-01

To examine the effect of front-of-package (FOP) nutrition labelling and sugary drink taxation on consumer beverage purchases. A total of 675 respondents aged 16 years and older participated in an experimental marketplace study using a 4 × 5 within-between group design. Participants were randomised to one of four labelling conditions (no label; star rating; high sugar symbol; health warning) and completed five within-subject purchase tasks. Beverage prices in each task corresponded to 'tax' conditions: 0%, 10%, 20%, 30% and a variable tax proportional to free sugar level. In each task, participants selected from 20 commercially available beverages; upon conclusion, one of five selections was randomly chosen for purchase. As price increased, participants were significantly less likely to select a sugary drink, and selected drinks with fewer calories and less free sugar (p < 0.001 for all). The overall effect of labelling was not statistically significant, although there was a trend for the 'high sugar' label to reduce the likelihood of selecting a sugary drink (p = 0.11) and encouraging participants to select drinks with less free sugar (p = 0.11). Increasing price was associated with reduced sugary drink purchases. Enhanced FOP labelling results highlight the need for further research to investigate their potential impact. The study adds empirical support for taxation to reduce sugary drink consumption. Copyright © 2017 Elsevier Ltd. All rights reserved.

Audit of manufactured products: use of allergen advisory labels and identification of labeling ambiguities.

PubMed

Pieretti, Mariah M; Chung, Danna; Pacenza, Robert; Slotkin, Todd; Sicherer, Scott H

2009-08-01

The Food Allergy Labeling and Consumer Protection Act became effective January 1, 2006, and mandates disclosure of the 8 major allergens in plain English and as a source of ingredients in the ingredient statement. It does not regulate advisory labels. We sought to determine the frequency and language used in voluntary advisory labels among commercially available products and to identify labeling ambiguities affecting consumers with allergy. Trained surveyors performed a supermarket survey of 20,241 unique manufactured food products (from an original assessment of 49,604 products) for use of advisory labels. A second detailed survey of 744 unique products evaluated additional labeling practices. Overall, 17% of 20,241 products surveyed contain advisory labels. Chocolate candy, cookies, and baking mixes were the 3 categories of 24 with the greatest frequency (> or = 40%). Categorically, advisory warnings included "may contain" (38%), "shared equipment" (33%), and "within plant" (29%). The subsurvey disclosed 25 different types of advisory terminology. Nonspecific terms, such as "natural flavors" and "spices," were found on 65% of products and were not linked to a specific ingredient for 83% of them. Additional ambiguities included unclear sources of soy (lecithin vs protein), nondisclosure of sources of gelatin and lecithin, and simultaneous disclosure of "contains" and "may contain" for the same allergen, among others. Numerous products have advisory labeling and ambiguities that present challenges to consumers with food allergy. Additional allergen labeling regulation could improve safety and quality of life for individuals with food allergy.

Predictive and External Validity of a Pre-Market Study to Determine the Most Effective Pictorial Health Warning Label Content for Cigarette Packages

PubMed Central

Thrasher, James F.; Reid, Jessica L.; Hammond, David

2016-01-01

Abstract Introduction: Studies examining cigarette package pictorial health warning label (HWL) content have primarily used designs that do not allow determination of effectiveness after repeated, naturalistic exposure. This research aimed to determine the predictive and external validity of a pre-market evaluation study of pictorial HWLs. Methods: Data were analyzed from: (1) a pre-market convenience sample of 544 adult smokers who participated in field experiments in Mexico City before pictorial HWL implementation (September 2010); and (2) a post-market population-based representative sample of 1765 adult smokers in the Mexican administration of the International Tobacco Control Policy Evaluation Survey after pictorial HWL implementation. Participants in both samples rated six HWLs that appeared on cigarette packs, and also ranked HWLs with four different themes. Mixed effects models were estimated for each sample to assess ratings of relative effectiveness for the six HWLs, and to assess which HWL themes were ranked as the most effective. Results: Pre- and post-market data showed similar relative ratings across the six HWLs, with the least and most effective HWLs consistently differentiated from other HWLs. Models predicting rankings of HWL themes in post-market sample indicated: (1) pictorial HWLs were ranked as more effective than text-only HWLs; (2) HWLs with both graphic and “lived experience” content outperformed symbolic content; and, (3) testimonial content significantly outperformed didactic content. Pre-market data showed a similar pattern of results, but with fewer statistically significant findings. Conclusions: The study suggests well-designed pre-market studies can have predictive and external validity, helping regulators select HWL content. PMID:26377516

Predictive and External Validity of a Pre-Market Study to Determine the Most Effective Pictorial Health Warning Label Content for Cigarette Packages.

PubMed

Huang, Li-Ling; Thrasher, James F; Reid, Jessica L; Hammond, David

2016-05-01

Studies examining cigarette package pictorial health warning label (HWL) content have primarily used designs that do not allow determination of effectiveness after repeated, naturalistic exposure. This research aimed to determine the predictive and external validity of a pre-market evaluation study of pictorial HWLs. Data were analyzed from: (1) a pre-market convenience sample of 544 adult smokers who participated in field experiments in Mexico City before pictorial HWL implementation (September 2010); and (2) a post-market population-based representative sample of 1765 adult smokers in the Mexican administration of the International Tobacco Control Policy Evaluation Survey after pictorial HWL implementation. Participants in both samples rated six HWLs that appeared on cigarette packs, and also ranked HWLs with four different themes. Mixed effects models were estimated for each sample to assess ratings of relative effectiveness for the six HWLs, and to assess which HWL themes were ranked as the most effective. Pre- and post-market data showed similar relative ratings across the six HWLs, with the least and most effective HWLs consistently differentiated from other HWLs. Models predicting rankings of HWL themes in post-market sample indicated: (1) pictorial HWLs were ranked as more effective than text-only HWLs; (2) HWLs with both graphic and "lived experience" content outperformed symbolic content; and, (3) testimonial content significantly outperformed didactic content. Pre-market data showed a similar pattern of results, but with fewer statistically significant findings. The study suggests well-designed pre-market studies can have predictive and external validity, helping regulators select HWL content. © 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.

Implementation of effective cigarette health warning labels among low and middle income countries: state capacity, path-dependency and tobacco industry activity.

PubMed

Hiilamo, Heikki; Glantz, Stanton A

2015-01-01

We investigates the effects of ratifying the WHO Framework Convention of Tobacco Control (FTCT), state capacity, path-dependency and tobacco industry activity on the implementation of effective health warning labels (HWL) on cigarette packs among low and middle income countries (LMIC). Using logistic regression in separate analyses for FCTC Article 11 compliant HWLs and graphic HWLs (GHWL), we found that the odds of FCTC compliance increased by a factor of 1.31 for each year after FCTC entered into force in the country (p < 0.01). The odds of passing GHWLs increased by a factor of 1.46 (p < 0.05) per year after FCTC entered into force. The weaker the capacity of the states were, the less likely they were to have implemented FCTC compliant HWLs (p < 0.05). The countries with voluntary HWLs in 1992 were less likely (OR = 0.19, p < 0.01) to comply with FCTC 21 years later (in 2013). The FCTC has promoted HWL policies among LMICs. Public health regulations require investments in broader state capacity. As the theory of path-dependency predicts voluntary agreements have long lasting influence on the direction of tobacco control in a country. Adopting voluntary HWL policies reduced likelihood of having FCTC compliant HWLs decades later. The fact that voluntary agreements delayed effective tobacco regulations suggests that policymakers must be careful of accepting industry efforts for voluntary agreements in other areas of public health as well, such as alcohol and junk food. Copyright © 2014 Elsevier Ltd. All rights reserved.

Neural response to pictorial health warning labels can predict smoking behavioral change

PubMed Central

Riddle, Philip J.; Newman-Norlund, Roger D.; Baer, Jessica; Thrasher, James F.

2016-01-01

In order to improve our understanding of how pictorial health warning labels (HWLs) influence smoking behavior, we examined whether brain activity helps to explain smoking behavior above and beyond self-reported effectiveness of HWLs. We measured the neural response in the ventromedial prefrontal cortex (vmPFC) and the amygdala while adult smokers viewed HWLs. Two weeks later, participants’ self-reported smoking behavior and biomarkers of smoking behavior were reassessed. We compared multiple models predicting change in self-reported smoking behavior (cigarettes per day [CPD]) and change in a biomarkers of smoke exposure (expired carbon monoxide [CO]). Brain activity in the vmPFC and amygdala not only predicted changes in CO, but also accounted for outcome variance above and beyond self-report data. Neural data were most useful in predicting behavioral change as quantified by the objective biomarker (CO). This pattern of activity was significantly modulated by individuals’ intention to quit. The finding that both cognitive (vmPFC) and affective (amygdala) brain areas contributed to these models supports the idea that smokers respond to HWLs in a cognitive-affective manner. Based on our findings, researchers may wish to consider using neural data from both cognitive and affective networks when attempting to predict behavioral change in certain populations (e.g. cigarette smokers). PMID:27405615

Neural response to pictorial health warning labels can predict smoking behavioral change.

PubMed

Riddle, Philip J; Newman-Norlund, Roger D; Baer, Jessica; Thrasher, James F

2016-11-01

In order to improve our understanding of how pictorial health warning labels (HWLs) influence smoking behavior, we examined whether brain activity helps to explain smoking behavior above and beyond self-reported effectiveness of HWLs. We measured the neural response in the ventromedial prefrontal cortex (vmPFC) and the amygdala while adult smokers viewed HWLs. Two weeks later, participants' self-reported smoking behavior and biomarkers of smoking behavior were reassessed. We compared multiple models predicting change in self-reported smoking behavior (cigarettes per day [CPD]) and change in a biomarkers of smoke exposure (expired carbon monoxide [CO]). Brain activity in the vmPFC and amygdala not only predicted changes in CO, but also accounted for outcome variance above and beyond self-report data. Neural data were most useful in predicting behavioral change as quantified by the objective biomarker (CO). This pattern of activity was significantly modulated by individuals' intention to quit. The finding that both cognitive (vmPFC) and affective (amygdala) brain areas contributed to these models supports the idea that smokers respond to HWLs in a cognitive-affective manner. Based on our findings, researchers may wish to consider using neural data from both cognitive and affective networks when attempting to predict behavioral change in certain populations (e.g. cigarette smokers). © The Author (2016). Published by Oxford University Press.

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.

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.

Predictors of Quitting Attempts Among Tobacco Users in Bangladesh After a Communication Campaign to Launch Graphic Warning Labels on Packaging.

PubMed

Turk, Tahir; Newton, Fiona; Choudhury, Sohel; Islam, Md Shafiqul

2018-06-01

Tobacco use contributes to an estimated 14.6% of male and 5.7% of female deaths in Bangladesh. We examine the determinants of tobacco-related quit attempts among Bangladeshis with and without awareness of the synergized "People Behind the Packs" (PBTP) communication campaign used to support the introduction of pack-based graphic warning labels (GWLs) in 2016. Data from 1,796 adults were collected using multistage sampling and a cross-sectional face-to-face survey. Analyses used a normalized design weight to ensure representativeness to the national population of smokers within Bangladesh. For the overall sample, the multivariable logistic regression model revealed quit attempts were associated with having seen the pack-based GWLs, recalling ≥1 PBTP campaign message, higher levels of self-efficacy to quit, and recognizing more potential side-effects associated with using tobacco products. Conversely, the likelihood of quitting attempts were lower among dual tobacco users (relative to smokers) and those using tobacco at least daily (vs. less than daily). The hierarchical multivariable logistic regression model among those aware of ≥1 PBTP campaign message indicated quitting attempts were positively associated with recalling more of the campaign messages and discussing them with others. This national evaluation of pack-based GWLs and accompanying PBTP campaign within Bangladesh supports the efficacy of using synergized communication messages when introducing such labels. That quit attempts are more likely among those discussing PBTP campaign messages with others and recalling more PBTP campaign messages highlights the importance of ensuring message content is both memorable and engaging.

Neural mechanisms underlying visual attention to health warnings on branded and plain cigarette packs

PubMed Central

Brooks, Jonathan C. W.; Munafò, Marcus R.; Leonards, Ute

2017-01-01

Abstract Aims To (1) test if activation in brain regions related to reward (nucleus accumbens) and emotion (amygdala) differ when branded and plain packs of cigarettes are viewed, (2) test whether these activation patterns differ by smoking status and (3) examine whether activation patterns differ as a function of visual attention to health warning labels on cigarette packs. Design Cross‐sectional observational study combining functional magnetic resonance imaging (fMRI) with eye‐tracking. Non‐smokers, weekly smokers and daily smokers performed a memory task on branded and plain cigarette packs with pictorial health warnings presented in an event‐related design. Setting Clinical Research and Imaging Centre, University of Bristol, UK. Participants Non‐smokers, weekly smokers and daily smokers (n = 72) were tested. After exclusions, data from 19 non‐smokers, 19 weekly smokers and 20 daily smokers were analysed. Measurements Brain activity was assessed in whole brain analyses and in pre‐specified masked analyses in the amygdala and nucleus accumbens. On‐line eye‐tracking during scanning recorded visual attention to health warnings. Findings There was no evidence for a main effect of pack type or smoking status in either the nucleus accumbens or amygdala, and this was unchanged when taking account of visual attention to health warnings. However, there was evidence for an interaction, such that we observed increased activation in the right amygdala when viewing branded as compared with plain packs among weekly smokers (P = 0.003). When taking into account visual attention to health warnings, we observed higher levels of activation in the visual cortex in response to plain packaging compared with branded packaging of cigarettes (P = 0.020). Conclusions Based on functional magnetic resonance imaging and eye‐tracking data, health warnings appear to be more salient on ‘plain’ cigarette packs than branded packs. PMID:27886656

Neural mechanisms underlying visual attention to health warnings on branded and plain cigarette packs.

PubMed

Maynard, Olivia M; Brooks, Jonathan C W; Munafò, Marcus R; Leonards, Ute

2017-04-01

To (1) test if activation in brain regions related to reward (nucleus accumbens) and emotion (amygdala) differ when branded and plain packs of cigarettes are viewed, (2) test whether these activation patterns differ by smoking status and (3) examine whether activation patterns differ as a function of visual attention to health warning labels on cigarette packs. Cross-sectional observational study combining functional magnetic resonance imaging (fMRI) with eye-tracking. Non-smokers, weekly smokers and daily smokers performed a memory task on branded and plain cigarette packs with pictorial health warnings presented in an event-related design. Clinical Research and Imaging Centre, University of Bristol, UK. Non-smokers, weekly smokers and daily smokers (n = 72) were tested. After exclusions, data from 19 non-smokers, 19 weekly smokers and 20 daily smokers were analysed. Brain activity was assessed in whole brain analyses and in pre-specified masked analyses in the amygdala and nucleus accumbens. On-line eye-tracking during scanning recorded visual attention to health warnings. There was no evidence for a main effect of pack type or smoking status in either the nucleus accumbens or amygdala, and this was unchanged when taking account of visual attention to health warnings. However, there was evidence for an interaction, such that we observed increased activation in the right amygdala when viewing branded as compared with plain packs among weekly smokers (P = 0.003). When taking into account visual attention to health warnings, we observed higher levels of activation in the visual cortex in response to plain packaging compared with branded packaging of cigarettes (P = 0.020). Based on functional magnetic resonance imaging and eye-tracking data, health warnings appear to be more salient on 'plain' cigarette packs than branded packs. © 2016 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

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...

Using eye-tracking to examine how embedding risk corrective statements improves cigarette risk beliefs: Implications for tobacco regulatory policy.

PubMed

Lochbuehler, Kirsten; Tang, Kathy Z; Souprountchouk, Valentina; Campetti, Dana; Cappella, Joseph N; Kozlowski, Lynn T; Strasser, Andrew A

2016-07-01

Tobacco companies have deliberately used explicit and implicit misleading information in marketing campaigns. The aim of the current study was to experimentally investigate whether the editing of explicit and implicit content of a print advertisement improves smokers' risk beliefs and smokers' knowledge of explicit and implicit information. Using a 2(explicit/implicit)×2(accurate/misleading) between-subject design, 203 smokers were randomly assigned to one of four advertisement conditions. The manipulation of graphic content was examined as an implicit factor to convey product harm. The inclusion of a text corrective in the body of the ad was defined as the manipulated explicit factor. Participants' eye movements and risk beliefs/recall were measured during and after ad exposure, respectively. Results indicate that exposure to a text corrective decreases false beliefs about the product (p<.01) and improves correct recall of information provided by the corrective (p<.05). Accurate graphic content did not alter the harmfulness of the product. Independent of condition, smokers who focused longer on the warning label made fewer false inferences about the product (p=.01) and were more likely to correctly recall the warning information (p<.01). Nonetheless, most smokers largely ignored the text warning. Embedding a corrective statement in the body of the ad is an effective strategy to convey health information to consumers, which can be mandated under the Tobacco Control Act. Eye-tracking results objectively demonstrate that text-only warnings are not viewed by smokers, thus minimizing their effectiveness for conveying risk information. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Using Eye-tracking to Examine How Embedding Risk Corrective Statements Improves Cigarette Risk Beliefs: Implications for Tobacco Regulatory Policy

PubMed Central

Lochbuehler, Kirsten; Tang, Kathy Z.; Souprountchouk, Valentina; Campetti, Dana; Cappella, Joseph N.; Kozlowski, Lynn T.; Strasser, Andrew A.

2016-01-01

Background Tobacco companies have deliberately used explicit and implicit misleading information in marketing campaigns. The aim of the current study was to experimentally investigate whether the editing of explicit and implicit content of a print advertisement improves smokers’ risk beliefs and smokers’ knowledge of explicit and implicit information. Methods Using a 2(explicit/implicit) x 2(accurate/misleading) between-subject design, 203 smokers were randomly assigned to one of four advertisement conditions. The manipulation of graphic content was examined as an implicit factor to convey product harm. The inclusion of a text corrective in the body of the ad was defined as the manipulated explicit factor. Participants’ eye movements and risk beliefs/recall were measured during and after ad exposure, respectively. Results Results indicate that exposure to a text corrective decreases false beliefs about the product (p < .01) and improves correct recall of information provided by the corrective (p < .05). Accurate graphic content did not alter the harmfulness of the product. Independent of condition, smokers who focused longer on the warning label made fewer false inferences about the product (p = .01) and were more likely to correctly recall the warning information (p < .01). Nonetheless, most smokers largely ignored the text warning. Conclusions Embedding a corrective statement in the body of the ad is an effective strategy to convey health information to consumers, which can be mandated under the Tobacco Control Act (2009). Eye-tracking results objectively demonstrate that text-only warnings are not viewed by smokers, thus minimizing their effectiveness for conveying risk information. PMID:27160034

Effect of graphic cigarette warnings on smoking intentions in young adults.

PubMed

Blanton, Hart; Snyder, Leslie B; Strauts, Erin; Larson, Joy G

2014-01-01

Graphic warnings (GWs) on cigarette packs are widely used internationally and perhaps will be in the US but their impact is not well understood. This study tested support for competing hypotheses in different subgroups of young adults defined by their history of cigarette smoking and individual difference variables (e.g., psychological reactance). One hypothesis predicted adaptive responding (GWs would lower smoking-related intentions) and another predicted defensive responding (GWs would raise smoking-related intentions). Participants were an online sample of 1,169 Americans ages 18-24, who were randomly assigned either to view nine GWs designed by the FDA or to a no-label control. Both the intention to smoke in the future and the intention to quit smoking (among smokers) were assessed before and after message exposure. GWs lowered intention to smoke in the future among those with a moderate lifetime smoking history (between 1 and 100 cigarettes), and they increased intention to quit smoking among those with a heavy lifetime smoking history (more than 100 cigarettes). Both effects were limited to individuals who had smoked in some but not all of the prior 30 days (i.e., occasional smokers). No evidence of defensive "boomerang effects" on intention was observed in any subgroup. Graphic warnings can reduce interest in smoking among occasional smokers, a finding that supports the adaptive-change hypothesis. GWs that target occasional smokers might be more effective at reducing cigarette smoking in young adults.

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.

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.

Linking mass media campaigns to pictorial warning labels on cigarette packages: a cross-sectional study to evaluate effects among Mexican smokers.

PubMed

Thrasher, James F; Murukutla, Nandita; Pérez-Hernández, Rosaura; Alday, Jorge; Arillo-Santillán, Edna; Cedillo, Claudia; Gutierrez, Juan Pablo

2013-05-01

This study assessed the effects of pictorial health warning labels (HWLs) and a linked media campaign in Mexico. Cross-sectional data were collected from a population-based sample of 1756 adult smokers, aged 18-55 years, during the initial implementation of pictorial HWLs, which some smokers had seen on cigarette packages while others had seen only the text-based HWLs. Exposure to the campaign and pictorial HWLs was assessed with aided recall methods, and other questions addressed attention and cognitive impact of HWLs, knowledge related to HWL and campaign content, and quit-related thoughts and behaviours. Logistic and linear regression models were estimated to determine associations between key outcomes and intervention exposure. In bivariate and multivariate adjusted models, recall of pictorial HWLs and of the campaign were positively associated with greater attention to and cognitive impact of HWLs, whereas only pictorial HWL exposure was associated with having refrained from smoking due to HWLs. Both recall of pictorial HWLs and of the campaign were independently associated with greater knowledge of secondhand smoke harms and toxic tobacco constituents. Smokers who recalled only the pictorial HWLs were more likely to try to quit than smokers who recalled neither the pictorial HWLs nor the campaign (17% vs 6%, p<0.001). Consistent with other studies, adult smokers' exposure to new pictorial HWLs in Mexico was associated with psychosocial and behavioural responses related to quit behaviour. Exposure to the complementary media campaign was associated with independent additive effects on campaign-related knowledge, and it enhanced psychosocial responses to pictorial HWLs.

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.

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.

Are the Public Health Responsibility Deal alcohol pledges likely to improve public health? An evidence synthesis.

PubMed

Knai, Cécile; Petticrew, Mark; Durand, Mary Alison; Eastmure, Elizabeth; Mays, Nicholas

2015-08-01

The English Public Health Responsibility Deal (RD) is a public-private partnership involving voluntary pledges between industry, government and other actors in various areas including alcohol, and designed to improve public health. This paper reviews systematically the evidence underpinning four RD alcohol pledges. We conducted a systematic review of reviews of the evidence underpinning interventions proposed in four RD alcohol pledges, namely alcohol labelling, tackling underage alcohol sales, advertising and marketing alcohol, and alcohol unit reduction. In addition, we included relevant studies of interventions where these had not been covered by a recent review. We synthesized the evidence from 14 reviews published between 2002 and 2013. Overall, alcohol labelling is likely to be of limited effect on consumption: alcohol unit content labels can help consumers assess the alcohol content of drinks; however, labels promoting drinking guidelines and pregnancy warning labels are unlikely to influence drinking behaviour. Responsible drinking messages are found to be ambiguous, and industry-funded alcohol prevention campaigns can promote drinking instead of dissuading consumption. Removing advertising near schools can contribute to reducing underage drinking; however, community mobilization and law enforcement are most effective. Finally, reducing alcohol consumption is more likely to occur if there are incentives such as making lower-strength alcohol products cheaper. The most effective evidence-based strategies to reduce alcohol-related harm are not reflected consistently in the RD alcohol pledges. The evidence is clear that an alcohol control strategy should support effective interventions to make alcohol less available and more expensive. © 2015 Society for the Study of Addiction.

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.

Hand washing and use of gloves while managing patients receiving mechanical ventilation in the ICU.

PubMed

Khatib, M; Jamaleddine, G; Abdallah, A; Ibrahim, Y

1999-07-01

To evaluate the effectiveness of warning labels permanently attached to mechanical ventilators in improving the practice of hand washing and use of gloves by respiratory care practitioners (RCPs) in the ICU. The study consisted of two 4-week periods. Daily observations of hand washing and use of gloves by RCPs were made over four 1-h observation periods. Prior to the first 4-week period, the importance of hand washing and use of gloves was presented to all staff. At the end of the first period, "Wash Hands Use Gloves" labels were permanently placed on all ventilators in the ICU. The RCPs were not aware they were being observed for hand washing and use of gloves in either period. The total number of encounters between the RCPs and patients as well as the rates of hand washing and use of gloves were obtained during the study. The rates of hand washing and use of gloves were significantly higher during the second period when labels were attached to the ventilators, as compared to the rates during the first period: hand washing, 92% vs 46% (p < 0.05); use of gloves, 92% vs 43% (p < 0.05), respectively. During the first period, the rates of pre-encounter hand washing (78%, 48%, 27%, and 29% in weeks 1 through 4, respectively) and the use of gloves (56%, 37%, 32%, and 45% in weeks 1 through 4, respectively) were primarily declining. This was not observed during the second period of the study (94%, 88%, 95%, and 92% in weeks 1 through 4, respectively) for the rates of pre-encounter hand washing and the use of gloves. Simple measures such as the placement of warning labels on mechanical ventilators can significantly improve hand washing and use of gloves by RCPs in the ICU.

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...

Effect of Graphic Cigarette Warnings on Smoking Intentions in Young Adults

PubMed Central

Blanton, Hart; Snyder, Leslie B.; Strauts, Erin; Larson, Joy G.

2014-01-01

Introduction Graphic warnings (GWs) on cigarette packs are widely used internationally and perhaps will be in the US but their impact is not well understood. This study tested support for competing hypotheses in different subgroups of young adults defined by their history of cigarette smoking and individual difference variables (e.g., psychological reactance). One hypothesis predicted adaptive responding (GWs would lower smoking-related intentions) and another predicted defensive responding (GWs would raise smoking-related intentions). Methods Participants were an online sample of 1,169 Americans ages 18–24, who were randomly assigned either to view nine GWs designed by the FDA or to a no-label control. Both the intention to smoke in the future and the intention to quit smoking (among smokers) were assessed before and after message exposure. Results GWs lowered intention to smoke in the future among those with a moderate lifetime smoking history (between 1 and 100 cigarettes), and they increased intention to quit smoking among those with a heavy lifetime smoking history (more than 100 cigarettes). Both effects were limited to individuals who had smoked in some but not all of the prior 30 days (i.e., occasional smokers). No evidence of defensive “boomerang effects” on intention was observed in any subgroup. Conclusion Graphic warnings can reduce interest in smoking among occasional smokers, a finding that supports the adaptive-change hypothesis. GWs that target occasional smokers might be more effective at reducing cigarette smoking in young adults. PMID:24806481

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.

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.

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

Stronger pack warnings predict quitting more than weaker ones: finding from the ITC Malaysia and Thailand surveys

PubMed Central

2013-01-01

Background We examined the impact of cigarette pack warning labels on interest in quitting and subsequent quit attempts among adult smokers in Malaysia and Thailand. Methods Two overlapping cohorts of adults who reported smoking factory- made cigarettes from Malaysia and Thailand were interviewed face-to-face (3189 were surveyed at baseline and 1781 re-contacted at Wave 2; 2361 current smokers were surveyed at Wave 2 and 1586 re-contacted at Wave 3). In Thailand at baseline, large text only warnings were assessed, while at Wave 2 new large graphic warnings were assessed. In Malaysia, during both waves small text only warnings were in effect. Reactions were used to predict interest in quitting, and to predict making quit attempts over the following inter-wave interval. Results Multivariate predictors of “interest in quitting” were comparable across countries, but predictors of quit attempts varied. In both countries, cognitive reactions to warnings (adjusted ORs; 1.57 & 1.69 for Malaysia at wave 1 and wave 2 respectively and 1.29 & 1.19 for Thailand at wave 1 and wave 2 respectively), forgoing a cigarette (except Wave 2 in Malaysia) (adjusted ORs; 1.77 for Malaysia at wave 1 and 1.54 & 2.32 for Thailand at wave 1 and wave 2 respectively), and baseline knowledge (except wave 2 in both countries) (adjusted ORs; 1.71 & 1.51 for Malaysia and Thailand respectively) were positively associated with interest in quitting at that wave. In Thailand only, “cognitive reactions to warnings” (adjusted ORs; 1.12 & 1.23 at wave 1 and wave 2 respectively), “forgoing a cigarette” (adjusted OR = 1.55 at wave 2 only) and “an interest in quitting” (adjusted ORs; 1.61 & 2.85 at wave 1 and wave 2 respectively) were positively associated with quit attempts over the following inter-wave interval. Salience was negatively associated with subsequent quit attempts in both Malaysia and Thailand, but at Wave 2 only (adjusted ORs; 0.89 & 0.88 for Malaysia and Thailand respectively). Conclusion Warnings appear to have common mechanisms for influencing quitting regardless of warning strength. The larger and more informative Thai warnings were associated with higher levels of reactions predictive of quitting and stronger associations with subsequent quitting, demonstrating their greater potency. PMID:24330614

Systematic review on international practices in controlling waterpipe tobacco smoking.

PubMed

Tee, Guat Hiong; Hairi, Noran N; Nordin, Fauziah; Choo, Wan Yuen; Chan, Ying Ying; Kaur, Gurpreet; Veerasingam, Pathma Devi; Bulgiba, Awang

2015-01-01

Waterpipe tobacco smoking has becoming popular especially among young people worldwide. Smokers are attracted by its sweeter, smoother smoke, social ambience and the misconception of reduced harm. The objective of this study was to systematically review the effects of waterpipe tobacco policies and practices in reducing its prevalence. A systematic review was conducted electronically using the PubMed, OVID, Science Direct, Proquest and Embase databases. All possible studies from 1980 to 2013 were initially screened based on titles and abstracts. The selected articles were subjected to data extraction and quality rating. Three studies met the inclusion criteria and were eligible for this review. Almost all of the waterpipe tobacco products and its accessories did not comply with the regulations on health warning labelling practices as stipulated under Article 11 of WHO FCTC. In addition, the grisly new warning labels for cigarettes introduced by Food and Drug Administration did not affect hookah tobacco smoking generally. Indoor air quality in smoking lounges was found to be poor and some hookah lounges were operated without smoke shop certification. Our findings revealed the availability of minimal information on the practices in controlling waterpipe smoking in reducing its prevalence. The lack of comprehensive legislations or practices in controlling waterpipe smoking warrants further research and policy initiatives to curb this burgeoning global epidemic, especially among the vulnerable younger population.

Implementation of the framework convention on tobacco control in Africa: current status of legislation.

PubMed

Tumwine, Jacqueline

2011-11-01

To describe, as of July 2011, the status of tobacco control legislation in Africa in three key areas of the Framework Convention on Tobacco Control (FCTC)-(1) Protection from exposure to tobacco smoke, (2) Packaging and labelling of tobacco products, and (3) Tobacco advertising, promotion and sponsorship. Review and analysis of tobacco control legislation in Africa, media reports, journal articles, tobacco industry documents and data published in the 2011 WHO Report on the Global Tobacco Epidemic. Modest progress in FCTC implementation in Africa with many countries having legislation or policies on the protection from exposure to tobacco smoke, however, only a handful of countries meet the standards of the FCTC Article 8 and its Guidelines particularly with regards to designated smoking areas. Little progress on packaging and labelling of tobacco products, with few countries having legislation meeting the minimum standards of the FCTC Article 11 and its Guidelines. Mauritius is the only African country with graphic or pictorial health warnings in place and has the largest warning labels in Africa. Slightly better progress in banning tobacco advertising, promotion and sponsorship has been shown by African countries, although the majority of legislation falls short of the standards of the FCTC Article 13 and its Guidelines. Despite their efforts, African countries' FCTC implementation at national level has not matched the strong regional commitment demonstrated during the FCTC treaty negotiations. This study highlights the need for Africa to step up efforts to adopt and implement effective tobacco control legislation that is fully compliant with the FCTC. In order to achieve this, countries should prioritise resources for capacity building for drafting strong FCTC compliant legislation, research to inform policy and boost political will, and countering the tobacco industry which is a major obstacle to FCTC implementation in Africa.

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…

Prediction and warning system of SEP events and solar flares for risk estimation in space launch operations

NASA Astrophysics Data System (ADS)

García-Rigo, Alberto; Núñez, Marlon; Qahwaji, Rami; Ashamari, Omar; Jiggens, Piers; Pérez, Gustau; Hernández-Pajares, Manuel; Hilgers, Alain

2016-07-01

A web-based prototype system for predicting solar energetic particle (SEP) events and solar flares for use by space launch operators is presented. The system has been developed as a result of the European Space Agency (ESA) project SEPsFLAREs (Solar Events Prediction system For space LAunch Risk Estimation). The system consists of several modules covering the prediction of solar flares and early SEP Warnings (labeled Warning tool), the prediction of SEP event occurrence and onset, and the prediction of SEP event peak and duration. In addition, the system acquires data for solar flare nowcasting from Global Navigation Satellite Systems (GNSS)-based techniques (GNSS Solar Flare Detector, GSFLAD and the Sunlit Ionosphere Sudden Total Electron Content Enhancement Detector, SISTED) as additional independent products that may also prove useful for space launch operators.

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.

Perceived effectiveness of pictorial health warnings among Mexican youth and adults: a population-level intervention with potential to reduce tobacco-related inequities.

PubMed

Hammond, David; Thrasher, James; Reid, Jessica L; Driezen, Pete; Boudreau, Christian; Santillán, Edna Arillo

2012-03-01

Pictorial health warnings on cigarette packages are a prominent and effective means of communicating the risks of smoking; however, there is little research on effective types of message content and socio-demographic effects. This study tested message themes and content of pictorial warnings in Mexico. Face-to-face surveys were conducted with 544 adult smokers and 528 youth in Mexico City. Participants were randomized to view 5-7 warnings for two of 15 different health effects. Warnings for each health effect included a text-only warning and pictorial warnings with various themes: "graphic" health effects, "lived experience", symbolic images, and testimonials. Pictorial health warnings were rated as more effective than text-only warnings. Pictorial warnings featuring "graphic" depictions of disease were significantly more effective than symbolic images or experiences of human suffering. Adding testimonial information to warnings increased perceived effectiveness. Adults who were female, older, had lower education, and intended to quit smoking rated warnings as more effective, although the magnitude of these differences was modest. Few interactions were observed between socio-demographics and message theme. Graphic depictions of disease were perceived by youth and adults as the most effective warning theme. Perceptions of warnings were generally similar across socio-demographic groups.

Gluten detection in foods available in the United States - a market survey.

PubMed

Sharma, Girdhari M; Pereira, Marion; Williams, Kristina M

2015-02-15

Many gluten-free (GF) food choices are now available in supermarkets. However, the unintentional presence of gluten in these foods poses a serious health risk to wheat-allergic and celiac patients. Different GF labelled foods (275) and non-GF labelled foods, without wheat/rye/barley on the ingredient label (186), were analysed for gluten content by two different enzyme linked immunosorbent assay (ELISA) kits. Considering the gluten threshold of 20ppm, GF labelled foods had 98.9% GF labelling compliance with 1.1% (3 out of 275) of foods being mislabelled/misbranded. Among the non-GF labelled foods, 19.4% (36 out of 186) of foods had >20ppm of gluten, as measured by at least one ELISA kit, of which 19 foods had >100ppm of gluten. The presence of oats in non-GF labelled foods was strongly correlated with a positive ELISA result. Gluten was also found in a significant number of foods with gluten/wheat-related advisory warnings. Published by Elsevier Ltd.

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.

77 FR 47697 - General Motors, LLC, Receipt of Petition for Decision of Inconsequential Noncompliance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-09

...; and \\3\\ Cadillac SRX and Saab 9-4X vehicles have a push button start/stop switch. (3) The crank power... ride in the back seat.'' In addition, the label on the vehicle's sun visor warns against placing a rear...

77 FR 29247 - Federal Motor Vehicle Safety Standards; Occupant Crash Protection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-17

...). ACTION: Final rule; technical amendments. SUMMARY: This final rule makes technical amendments to Federal... advanced air bag requirements. As written now, the general warning label requirements contain an explicit... equipment requirements for restraint systems. This document makes technical amendments to several of the...

Informing Workers of Chemical Hazards: The OSHA Hazard Communication Standard.

ERIC Educational Resources Information Center

American Chemical Society, Washington, DC.

Practical information on how to implement a chemical-related safety program is outlined in this publication. Highlights of the federal Occupational Safety and Health Administrations (OSHA) Hazard Communication Standard are presented and explained. These include: (1) hazard communication requirements (consisting of warning labels, material safety…

Perceived effectiveness of pictorial health warnings among Mexican youth and adults: a population-level intervention to reduce tobacco related inequities

PubMed Central

Hammond, David; Thrasher, James; Reid, Jessica L.; Driezen, Pete; Boudreau, Christian; Santillan, Edna Arillo

2015-01-01

Purpose Pictorial health warnings on cigarette packages are a prominent and effective means of communicating the risks of smoking; however, there is little research on effective types of message content and socio-demographic effects. This study tested message themes and content of pictorial warnings in Mexico. Methods Face-to-face surveys were conducted with 544 adult smokers and 528 youth in Mexico City. Participants were randomized to view 5–7 warnings for two of 15 different health effects. Warnings for each health effect included a text-only warning and pictorial warnings with various themes: “graphic” health effects, “lived experience”, symbolic images, and testimonials. Results Pictorial health warnings were rated as more effective than text-only warnings. Pictorial warnings featuring “graphic” depictions of disease were significantly more effective than symbolic images or experiences of human suffering. Adding testimonial information to warnings increased perceived effectiveness. Adults who were female, older, had lower education, and intended to quit smoking rated warnings as more effective, although the magnitude of these differences was modest. Few interactions were observed between socio-demographics and message theme. Conclusions Graphic depictions of disease were perceived by youth and adults as the most effective warning theme. Perceptions of warnings were generally similar across socio-demographic groups. PMID:22362058

Reactions to graphic health warnings in the United States.

PubMed

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

2015-02-01

This study reports consumer reactions to the graphic health warnings selected by the Food and Drug Administration to be placed on cigarette packs in the United States. We recruited three sets of respondents for an experimental study from a national opt-in e-mail list sample: (i) current smokers aged 25 or older, (ii) young adult smokers aged 18-24 and (iii) youth aged 13-17 who are current smokers or who may be susceptible to initiation of smoking. Participants were randomly assigned to be exposed to a pack of cigarettes with one of nine graphic health warnings or with a text-only warning statement. All three age groups had overall strong negative emotional (ß = 4.7, P < 0.001 for adults; ß = 4.6, P < 0.001 for young adults and ß = 4.0, P < 0.001 for youth) and cognitive (ß = 2.4, P < 0.001 for adults; ß = 3.0, P < 0.001 for young adults and ß = 4.6, P < 0.001 for youth) reactions to the proposed labels. The strong negative emotional and cognitive reactions following a single exposure to the graphic health warnings suggest that, with repeated exposures over time, graphic health warnings may influence smokers' beliefs, intentions and behaviors. © The Author 2014. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Perceptions of tobacco health warnings in China compared with picture and text-only health warnings from other countries: an experimental study.

PubMed

Fong, Geoffrey T; Hammond, David; Jiang, Yuan; Li, Qiang; Quah, Anne C K; Driezen, Pete; Yan, Mi

2010-10-01

To assess the perceived effectiveness of cigarette health warnings in China, compared with picture and text-only warnings from other countries. 1169 individuals (adult smokers, adult nonsmokers and youth) from four Chinese cities (Beijing, Shanghai, Kunming and Yinchuan) viewed 10 health warnings on cigarette packages, which included (a) the current Chinese text warnings covering 30% of the front/back of the pack (introduced October 2008); (b) the former Chinese text warning located on the side of the pack; (c) four picture warnings covering 50% of the front/back of the pack from Canada (lung cancer), Singapore (mouth disease), Hong Kong (gangrene) and European Union (clogged arteries); and (d) the same four warnings without the picture. Participants rated and ranked the 10 warnings on dimensions including how effective each would be in motivating smokers to quit and in convincing youth not to start smoking. Both Chinese warnings were consistently rated as least effective, with the new Chinese warning rated only slightly higher than the old warning. The picture warnings were consistently ranked or rated as most effective, with the text-only versions in the middle. Results were consistent across subject group, city and sex. (1) Picture warnings are rated as much more effective than the same warnings without pictures. (2) The revised health warnings in China, introduced in October 2008, are only marginally more effective than the previous warning and far less effective than even text warnings from other countries. These results, coupled with population-based evaluation studies, suggest that pictorial warnings would significantly increase the impact of health warnings in China.

Labelling and 'Dear Doctor' letters: are they noncommittal?

PubMed

van Grootheest, A C Kees; Edwards, I Ralph

2002-01-01

Over the past few years, a number of drugs have been withdrawn for safety reasons, either by drug approval authorities, or by the manufacturer. A recent example is the withdrawal of cerivastatin in connection with rhabdomyolysis. Several other drugs have also been taken off the market as a security measure, not because the nature of the risk involved was unknown but because the risk had proved apparently uncontainable. It seems that the inclusion of a warning or contraindication in the Summary of Product Characteristics (SPC) or sending a 'Dear Doctor' letter is insufficient to ensure compliant prescription behaviour. There appears to be a discrepancy between the careful use of evidence underpinning the SPC content and formal warnings and changes to the SPC and the effect they have on the prescription and dispensing of the drugs involved. This results in undue loss or damage for both the manufacturer and the patient. There are no easy solutions to tackle this problem; the ineffectiveness of labelling and 'Dear Doctor' letters has ramifications for the whole regulatory/ industrial/educational complex. We discuss briefly four possible strategies for improving the current situation, with the emphasis on the place the prescriber has in this process. The first strategy is education-based. Clinicians need to know about the comparative merits of the effectiveness and risk of drugs, as well as how they work pharmacologically, toxicologically, and what interactions they have with each other. The second strategy involves improving the information available for clinicians. Frequently, physicians do not consult the SPC for verification, leaving aside whether they have taken notice of the contents of the official SPC in the first place. It is recommended that the accessibility of SPCs is enhanced for doctors and pharmacists, drawing attention specifically to any changes. There needs to be a single body of information that covers every drug. The third strategy involves communication. There is much to be done in this area both in terms of follow-up and understanding of health professional's behaviour and how to empower best practise. The final strategy involves professional freedom. It goes without saying that doctors who issue off-label prescriptions may need to justify their actions. Deviating from the SPC should always be a considered decision and health professionals need to be aware of the additional responsibilities associated with such a decision. The dispensing pharmacist can play an important role in the implementation of warnings and contraindications.

21 CFR 510.410 - Corticosteroids for oral, injectable, and ophthalmic use in animals; warnings and labeling...

Code of Federal Regulations, 2014 CFR

2014-04-01

... resulted in premature parturition when administered during the last trimester of pregnancy. Premature..., corticosteroids used in dogs, rabbits, and rodents during pregnancy have produced cleft palate in offspring. Use... last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death...

21 CFR 510.410 - Corticosteroids for oral, injectable, and ophthalmic use in animals; warnings and labeling...

Code of Federal Regulations, 2010 CFR

2010-04-01

... resulted in premature parturition when administered during the last trimester of pregnancy. Premature..., corticosteroids used in dogs, rabbits, and rodents during pregnancy have produced cleft palate in offspring. Use... last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death...

21 CFR 510.410 - Corticosteroids for oral, injectable, and ophthalmic use in animals; warnings and labeling...

Code of Federal Regulations, 2012 CFR

2012-04-01

... resulted in premature parturition when administered during the last trimester of pregnancy. Premature..., corticosteroids used in dogs, rabbits, and rodents during pregnancy have produced cleft palate in offspring. Use... last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death...

21 CFR 510.410 - Corticosteroids for oral, injectable, and ophthalmic use in animals; warnings and labeling...

Code of Federal Regulations, 2011 CFR

2011-04-01

... resulted in premature parturition when administered during the last trimester of pregnancy. Premature..., corticosteroids used in dogs, rabbits, and rodents during pregnancy have produced cleft palate in offspring. Use... last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death...

21 CFR 510.410 - Corticosteroids for oral, injectable, and ophthalmic use in animals; warnings and labeling...

Code of Federal Regulations, 2013 CFR

2013-04-01

... resulted in premature parturition when administered during the last trimester of pregnancy. Premature..., corticosteroids used in dogs, rabbits, and rodents during pregnancy have produced cleft palate in offspring. Use... last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death...

40 CFR 747.115 - Mixed mono and diamides of an organic acid.

Code of Federal Regulations, 2010 CFR

2010-07-01

... warning statement shall be no smaller than six point type. All required label text shall be of sufficient..., commerce, importer, impurity, Inventory, manufacturer, person, process, processor, and small quantities... control of the processor. (ii) Distribution in commerce is limited to purposes of export. (iii) The...

27 CFR 16.31 - Exports.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Exports. 16.31 Section 16... TREASURY LIQUORS ALCOHOLIC BEVERAGE HEALTH WARNING STATEMENT General Provisions § 16.31 Exports. The..., bottled, or labeled for export from the United States, or for delivery to a vessel or aircraft, as...

Do Emotions Spark Interest in Alternative Tobacco Products?

ERIC Educational Resources Information Center

Popova, Lucy; So, Jiyeon; Sangalang, Angeline; Neilands, Torsten B.; Ling, Pamela M.

2017-01-01

Background: Exposure to advertisements for tobacco products and tobacco warning labels evokes emotions. This study evaluated the association of discrete positive and negative emotions with interest in alternative tobacco products. Method: In 2013, 1,226 U.S. adult nonsmokers and current smokers viewed advertisements for moist snuff, snus, and…

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-22

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

21 CFR 369.20 - Drugs; recommended warning and caution statements.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., INCLUDING ASPIRIN AND SALICYLAMIDE (EXCEPT METHYL SALICYLATE, EFFERVESCENT SALICYLATE PREPARATIONS, AND... out of reach of children.” If the article is an aspirin preparation, it should bear the first of the... aspirin tablets, but such a statement is not required on the labels of other salicylates clearly offered...

21 CFR 369.20 - Drugs; recommended warning and caution statements.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., INCLUDING ASPIRIN AND SALICYLAMIDE (EXCEPT METHYL SALICYLATE, EFFERVESCENT SALICYLATE PREPARATIONS, AND... out of reach of children.” If the article is an aspirin preparation, it should bear the first of the... aspirin tablets, but such a statement is not required on the labels of other salicylates clearly offered...

21 CFR 369.20 - Drugs; recommended warning and caution statements.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., INCLUDING ASPIRIN AND SALICYLAMIDE (EXCEPT METHYL SALICYLATE, EFFERVESCENT SALICYLATE PREPARATIONS, AND... out of reach of children.” If the article is an aspirin preparation, it should bear the first of the... aspirin tablets, but such a statement is not required on the labels of other salicylates clearly offered...

21 CFR 369.20 - Drugs; recommended warning and caution statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., INCLUDING ASPIRIN AND SALICYLAMIDE (EXCEPT METHYL SALICYLATE, EFFERVESCENT SALICYLATE PREPARATIONS, AND... out of reach of children.” If the article is an aspirin preparation, it should bear the first of the... aspirin tablets, but such a statement is not required on the labels of other salicylates clearly offered...

Augmented reality warnings in vehicles: Effects of modality and specificity on effectiveness.

PubMed

Schwarz, Felix; Fastenmeier, Wolfgang

2017-04-01

In the future, vehicles will be able to warn drivers of hidden dangers before they are visible. Specific warning information about these hazards could improve drivers' reactions and the warning effectiveness, but could also impair them, for example, by additional cognitive-processing costs. In a driving simulator study with 88 participants, we investigated the effects of modality (auditory vs. visual) and specificity (low vs. high) on warning effectiveness. For the specific warnings, we used augmented reality as an advanced technology to display the additional auditory or visual warning information. Part one of the study concentrates on the effectiveness of necessary warnings and part two on the drivers' compliance despite false alarms. For the first warning scenario, we found several positive main effects of specificity. However, subsequent effects of specificity were moderated by the modality of the warnings. The specific visual warnings were observed to have advantages over the three other warning designs concerning gaze and braking reaction times, passing speeds and collision rates. Besides the true alarms, braking reaction times as well as subjective evaluation after these warnings were still improved despite false alarms. The specific auditory warnings were revealed to have only a few advantages, but also several disadvantages. The results further indicate that the exact coding of additional information, beyond its mere amount and modality, plays an important role. Moreover, the observed advantages of the specific visual warnings highlight the potential benefit of augmented reality coding to improve future collision warnings. Copyright © 2017 Elsevier Ltd. All rights reserved.

Despite court ruling, experts insist spermicides are safe.

PubMed

1985-03-01

Recently in Atlanta, Georgia, a US District Judge, Marvin Shoob, ordered Ortho Pharmaceutical Corporation to pay US$5.1 million in damages to a 3 year old girl, born with birth defects to a women who used a spermicide, manufactured by Ortho, when the child was conceived and for 4 weeks following conception. The child was born with a missing left arm, missing fingers on the right hand, a cleft palate, and impaired hearing. The spermicide, Ortho-Gynol, contains octoxynol, which prevents pregnancy by destroying the outer layer of sperm cells. The judge maintained that Ortho was negligent for failing to attach a label to the spermicide warning users that birth defects could occur if the product was used during pregnancy. In 1983, a Food and Drug Administration (FDA) advisory committee advised drug companies that is was unnecessary to attach such a label. The chairman of the committee, Ronald W. Nelson, still maintains that a warning label is unwarrented. "Contraceptive Technology Update" spoke with a number of family planning practitioners and several experts, including some who were involved in the case, concerning their views about the case. Most of the partitioners expressed surprise about the ruling, indicated that they did not plan to alter their counseling advise concerning spermicides, and believed that a warning label was not warranted. A representative for Ortho stated that the company still believes that there is no link between birth defects and the use of spermicides. Ortho does not plan to use a warning label. A spokesman from the judge's office said that the ruling pertained only to the specific case, and that the decision was not generalizable. Robert L. Brent, an expert witness for Ortho said that studies failed to find a significant association between birth defects and spermicides; however, he noted that researchers did not rule out the possibility that there was a slightly increased risk of birth defects among infants born to women who used spermicides. Bruce Buehler, an expert witness for the plaintiff, said that there was a probable link between the spermicide and the missing arm defect and a possible link between the spermicide and the missing fingers. He said that the damage probably occurred at some crucial developmental stage during the 4 weeks following conception rather than at the time of conception. A proponent for labeling is Herschel Jick. He and his colleagues conducted a study in 1981 of 763 women, who had prescriptions for spermicides filled within 600 days of pregnancy outcome, and of 3902 nonusers. 2.2% of the users, compared to 1.1% of the nonusers gave birth to infants with birth defects. The study has been criticized by experts for failing to isolate a well-defined syndrome among infants born to spermicide users and for failing to determine if and when those identified as users actually did use the prescribed spermicides. Jose Cordero of the Center for Disease Control noted that the Center does not have an official position concerning the issue, but that he did not feel that the evidence was strong enough to support claims of an association.

Do more graphic and aversive cigarette health warning labels affect Brazilian smokers' likelihood of quitting?

PubMed

Szklo, André Salem; Volchan, Eliane; Thrasher, James F; Perez, Cristina; Szklo, Moysés; de Almeida, Liz Maria

2016-09-01

Between 2008 and 2013, Brazil experienced a large decline in smoking prevalence, with an innovative round of aversive pictorial health warnings implemented on cigarette packs and at points of sale in 2009. The objective of this study was to examine changes over time in the distribution of quitting attempts and self-reported thoughts about quitting due to health warnings among current smokers. We conducted a pre-post study to evaluate data from two nationally-representative surveys conducted in 2008 and 2013. Responses to questions on smokers' quitting attempts in the last year (yes vs. no) and whether health warnings led them to think about quitting in the last month (yes vs. no) were combined into four categories, for which the distribution of the Brazilian smoking population by year was estimated. A multinomial model was used to obtain proportions for each category, adjusted by socio-demographic variables and nicotine dependence. The proportion of smokers who reported making a quitting attempt in the last year and stated that health warnings led them think about quitting smoking statistically increased over time (from 30.0% to 33.1%; p-value=0.010). The percentage of those who answered "no" to these two questions also increased over time (from 23.5% to 32.9%; p-value≤0.001). These findings suggest that innovative warnings introduced in Brazil likely served as a "reminder" for continuing to think about cessation among those who attempted to quit in the last year. These warnings may have also triggered more avoidance of thinking about their contents than the previous warnings, which some studies have found to promote subsequent quitting activity. Copyright © 2016 Elsevier Ltd. All rights reserved.

The impact of false warnings on partial and full lane departure warnings effectiveness and acceptance in car driving.

PubMed

Navarro, Jordan; Yousfi, Elsa; Deniel, Jonathan; Jallais, Christophe; Bueno, Mercedes; Fort, Alexandra

2016-12-01

In the past, lane departure warnings (LDWs) were demonstrated to improve driving behaviours during lane departures but little is known about the effects of unreliable warnings. This experiment focused on the influence of false warnings alone or in combination with missed warnings and warning onset on assistance effectiveness and acceptance. Two assistance unreliability levels (33 and 17%) and two warning onsets (partial and full lane departure) were manipulated in order to investigate interaction. Results showed that assistance, regardless unreliability levels and warning onsets, improved driving behaviours during lane departure episodes and outside of these episodes by favouring better lane-keeping performances. Full lane departure and highly unreliable warnings, however, reduced assistance efficiency. Drivers' assistance acceptance was better for the most reliable warnings and for the subsequent warnings. The data indicate that imperfect LDWs (false warnings or false and missed warnings) further improve driving behaviours compared to no assistance. Practitioner Summary: This study revealed that imperfect lane departure warnings are able to significantly improve driving performances and that warning onset is a key element for assistance effectiveness and acceptance. The conclusion may be of particular interest for lane departure warning designers.

Graphic tobacco health warnings: which genre to choose?

PubMed

Sobani, Z; Nizami, S; Raza, E; ul Ain Baloch, N; Khan, J A

2010-03-01

Tobacco prevention studies show that graphic health warnings are more effective than text warnings, but there are no data on the effectiveness of different types of graphic health warnings in a Pakistani population. Even marginal differences in the effectiveness of genres can be of potential significance for public health. To study the effectiveness of different types of graphic tobacco warnings in a Pakistani population. We presented ten anti-smoking warnings to randomly selected volunteers (n = 170) and recorded their opinion on the effectiveness of each warning. The warnings were based on a range of images aimed at the diverse population interviewed. A grading scale based on appeal, application, educational potential and motivation towards cessation was used to produce a composite grade of perceived effectiveness of the warning. Our results indicate that graphic warnings reach a greater proportion of the population than text warnings. Those appealing to logic, and those inculcating a sense of fear by showing a deleterious outcome of smoking, were judged likely to be most effective in motivating smokers to quit and preventing experimental smokers from forming a habit.

Implementation of graphic health warning labels on tobacco products in India: the interplay between the cigarette and the bidi industries

PubMed Central

Sankaran, Sujatha; Hiilamo, Heikki; Glantz, Stanton A

2014-01-01

Objectives To understand the competition between and among tobacco companies and health groups that led to graphical health warning labels (GHWL) on all tobacco products in India. Methods Analysis of internal tobacco industry documents in the Legacy Tobacco Document Library, documents obtained through Indias Right to Information ‘ Act, and news reports. Results Implementation of GHWLs in India reflects a complex interplay between the government and the cigarette and bidi industries, who have shared as well as conflicting interests. Joint lobbying by national-level tobacco companies (that are foreign subsidiaries of multinationals) and local producers of other forms of tobacco blocked GHWLs for decades and delayed the implementation of effective GHWLs after they were mandated in 2007. Tobacco control activists used public interest lawsuits and the Right to Information Act to win government implementation of GHWLs on cigarette, bidi and smokeless tobacco packs in May 2009 and rotating GHWLs in December 2011. Conclusions GHWLs in India illustrate how the presence of bidis and cigarettes in the same market creates a complex regulatory environment. The government imposing tobacco control on multinational cigarette companies led to the enforcement of regulation on local forms of tobacco. As other developing countries with high rates of alternate forms of tobacco use establish and enforce GHWL laws, the tobacco control advocacy community can use pressure on the multinational cigarette industry as an indirect tool to force implementation of regulations on other forms of tobacco. PMID:24950697

Tobacco industry interference for pictorial warnings.

PubMed

Oswal, K C; Pednekar, M S; Gupta, P C

2010-07-01

A study was carried out to understand the process of interference by the tobacco industry, to measure the compliance of the industry for displaying pictorial warnings on a tobacco product as per the packaging and labeling rules post 31st May, 2009, and to understand the public opinion on the messages conveyed through such warnings. A total of 60 samples of tobacco products were purchased after 31 May, 2009, from the retail vendors of tobacco sellers across the country. The government of India has from time to time, taken measures, including legislations, to control tobacco consumption. The actual implementation of these rules has been postponed repeatedly, apparently because of constant pressure exerted by the tobacco industry. The skull and bone sign hurting religious sentiments as stated by the group of ministers proved to be misleading. Later the Group of Ministers (GOM) proposed three very weak and poorly communicative pictorial health warnings to replace those recommended by the Union Health Ministry based on the inputs of the Department of Audio Visual Publicity (DAVP). The industry tried to use strategic means by displaying a dull, diluted, and watered down pictorial warning. The focus group study conducted showed that a scorpion gets associated with the product in a non-scientific manner. X-ray of the lung was hardly understood by anybody. Overall the tobacco industry has constantly flouted with the law right from the policy level to its implementation by displaying dull, diluted, and poorly informed pictorial warnings.

16 CFR 1500.14 - Products requiring special labeling under section 3(b) of the act.

Code of Federal Regulations, 2011 CFR

2011-01-01

...) Fountains. Warning (or Caution) FLAMMABLE (or EMITS SHOWERS OF SPARKS, if more descriptive). Use only under..., if More Descriptive) Use only under [close] adult supervision. (Use of the word close is optional...) Flammable (or Emits Showers of Sparks, if More Descriptive) Use only under [close] adult supervision. (Use...

16 CFR 1500.14 - Products requiring special labeling under section 3(b) of the act.

Code of Federal Regulations, 2014 CFR

2014-01-01

...) Fountains. Warning (or Caution) FLAMMABLE (or EMITS SHOWERS OF SPARKS, if more descriptive). Use only under..., if More Descriptive) Use only under [close] adult supervision. (Use of the word close is optional...) Flammable (or Emits Showers of Sparks, if More Descriptive) Use only under [close] adult supervision. (Use...

16 CFR 1500.14 - Products requiring special labeling under section 3(b) of the act.

Code of Federal Regulations, 2010 CFR

2010-01-01

...) Fountains. Warning (or Caution) FLAMMABLE (or EMITS SHOWERS OF SPARKS, if more descriptive). Use only under..., if More Descriptive) Use only under [close] adult supervision. (Use of the word close is optional...) Flammable (or Emits Showers of Sparks, if More Descriptive) Use only under [close] adult supervision. (Use...

40 CFR 156.206 - General statements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... AGRICULTURAL USE REQUIREMENTS in the labeling. (e) Spanish warning statements. If the product is classified as... appear in Spanish in addition to English followed by the statement, “Si Usted no entiende la etiqueta... some one to explain it to you in detail.)” The Spanish signal word “PELIGRO” shall be used for products...

21 CFR 201.20 - Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human...

Code of Federal Regulations, 2014 CFR

2014-04-01

..., or rectally, or for use in the area of the eye, the labeling required by § 201.100(d) shall bear the... patients who also have aspirin hypersensitivity.” This warning statement shall appear in the “Precautions...

21 CFR 201.20 - Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human...

Code of Federal Regulations, 2013 CFR

2013-04-01

..., or rectally, or for use in the area of the eye, the labeling required by § 201.100(d) shall bear the... patients who also have aspirin hypersensitivity.” This warning statement shall appear in the “Precautions...

21 CFR 201.20 - Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human...

Code of Federal Regulations, 2012 CFR

2012-04-01

..., or rectally, or for use in the area of the eye, the labeling required by § 201.100(d) shall bear the... patients who also have aspirin hypersensitivity.” This warning statement shall appear in the “Precautions...

21 CFR 201.20 - Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human...

Code of Federal Regulations, 2010 CFR

2010-04-01

..., or rectally, or for use in the area of the eye, the labeling required by § 201.100(d) shall bear the... patients who also have aspirin hypersensitivity.” This warning statement shall appear in the “Precautions...

21 CFR 201.20 - Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human...

Code of Federal Regulations, 2011 CFR

2011-04-01

..., or rectally, or for use in the area of the eye, the labeling required by § 201.100(d) shall bear the... patients who also have aspirin hypersensitivity.” This warning statement shall appear in the “Precautions...

21 CFR 201.56 - Requirements on content and format of labeling for human prescription drug and biological products.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Contraindications Warnings and Precautions Adverse Reactions Drug Interactions Use in Specific Populations Full... Adverse Reactions 7 Drug Interactions 8 Use in Specific Populations 8.1 Pregnancy 8.2 Labor and delivery 8... action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 Nonclinical Toxicology 13.1 Carcinogenesis...

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

Desensitisation to cigarette package graphic health warnings: a cohort comparison between London and Singapore

PubMed Central

Ratneswaran, Culadeeban; Chisnall, Ben; Li, Mingyue; Tan, Sarah; Douiri, Abdel; Anantham, Devanand; Steier, Joerg

2016-01-01

Objectives We compared 2 sociocultural cohorts with different duration of exposure to graphic health warning labels (GHWL), to investigate a possible desensitisation to their use. We further studied how a differing awareness and emotional impact of smoking-associated risks could be used to prevent this. Setting Structured interviews of patients from the general respiratory department were undertaken between 2012 and 2013 in 2 tertiary hospitals in Singapore and London. Participants 266 participants were studied, 163 Londoners (35% smokers, 54% male, age 52±18 years) and 103 Singaporeans (53% smokers, p=0.003; 78% male, p<0.001; age 58±15 years, p=0.012). Main outcomes and measures 50 items assessed demographics, smoking history, knowledge and the deterring impact of smoking-associated risks. After showing 10 GHWL, the impact on emotional response, cognitive processing and intended smoking behaviour was recorded. Results Singaporeans scored lower than the Londoners across all label processing constructs, and this was consistent for the smoking and non-smoking groups. Londoners experienced more ‘disgust’ and felt GHWL were more effective at preventing initiation of, or quitting, smoking. Singaporeans had a lower awareness of lung cancer (82% vs 96%, p<0.001), despite ranking it as the most deterring consequence of smoking. Overall, ‘blindness’ was the least known potential risk (28%), despite being ranked as more deterring than ‘stroke’ and ‘oral cancer’ in all participants. Conclusions The length of exposure to GHWL impacts on the effectiveness. However, acknowledging the different levels of awareness and emotional impact of smoking-associated risks within different sociocultural cohorts could be used to maintain their impact. PMID:27798017

Depressive symptoms and responses to cigarette pack warning labels among Mexican smokers

PubMed Central

Thrasher, James F.; Cayir, Ebru; Hardin, James W.; Perez-Hernandez, Rosaura; Froeliger, Brett

2016-01-01

Objective we examine whether having depressive symptoms (DS) is associated with different responses to cigarette package health warning labels (HWLs) before and after the implementation of pictorial HWLs in Mexico. Methods we analyze data from adult smokers from Wave 4 and Wave 5 (n=1340) of the International Tobacco Control Policy Evaluation Project in Mexico. Seven CES-D items assessed DS, with scores ≥ 7 indicating elevated DS. Outcomes included: attention to HWLs; cognitive responses to HWLs; tobacco constituents awareness; putting off smoking due to HWLs; avoidance of HWLs; and awareness of telephone support for cessation (i.e., quitlines). Mixed effects models were used to assess main and interactive effects of DS and time (i.e., survey wave) on each outcome. Results all HWL responses increased over time, except putting off smoking. Statistically significant interactions were found between DS and time for models of tobacco constituents awareness (b=−0.36, SE= 0.15, p=.022); putting off smoking (OR=0.41, 95% CI 0.25, 0.66); avoidance of HWLs (OR=1.84, 95% 1.03, 3.29); and quitline awareness (OR=0.35, 95% CI 0.21, 0.56). Compared to smokers with low DS, smokers with elevated DS reported stronger HWL responses at baseline; however, HWL responses increased over time among smokers with low DS, whereas HWL responses showed little or no change among smokers with elevated DS. Discussion population-level increases in HWL responses after pictorial HWLs were introduced in Mexico appeared mostly limited to smokers with low DS. In general, however, smokers with elevated DS reported equivalent or stronger HWL responses than smokers with low DS. PMID:26867043

Desensitisation to cigarette package graphic health warnings: a cohort comparison between London and Singapore.

PubMed

Ratneswaran, Culadeeban; Chisnall, Ben; Li, Mingyue; Tan, Sarah; Douiri, Abdel; Anantham, Devanand; Steier, Joerg

2016-10-24

We compared 2 sociocultural cohorts with different duration of exposure to graphic health warning labels (GHWL), to investigate a possible desensitisation to their use. We further studied how a differing awareness and emotional impact of smoking-associated risks could be used to prevent this. Structured interviews of patients from the general respiratory department were undertaken between 2012 and 2013 in 2 tertiary hospitals in Singapore and London. 266 participants were studied, 163 Londoners (35% smokers, 54% male, age 52±18 years) and 103 Singaporeans (53% smokers, p=0.003; 78% male, p<0.001; age 58±15 years, p=0.012). 50 items assessed demographics, smoking history, knowledge and the deterring impact of smoking-associated risks. After showing 10 GHWL, the impact on emotional response, cognitive processing and intended smoking behaviour was recorded. Singaporeans scored lower than the Londoners across all label processing constructs, and this was consistent for the smoking and non-smoking groups. Londoners experienced more 'disgust' and felt GHWL were more effective at preventing initiation of, or quitting, smoking. Singaporeans had a lower awareness of lung cancer (82% vs 96%, p<0.001), despite ranking it as the most deterring consequence of smoking. Overall, 'blindness' was the least known potential risk (28%), despite being ranked as more deterring than 'stroke' and 'oral cancer' in all participants. The length of exposure to GHWL impacts on the effectiveness. However, acknowledging the different levels of awareness and emotional impact of smoking-associated risks within different sociocultural cohorts could be used to maintain their impact. 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/.

[Advances in the Brazilian norm for commercialization of infant foods].

PubMed

de Fátima Moura de Araújo, Maria; Rea, Marina Ferreira; Pinheiro, Karina Aragão; de Abreu Soares Schmitz, Bethsáida

2006-06-01

To assess the advances in the Brazilian norm for commercialization of infant foods from 1988 to 2002, comparing the different texts with each other and with the International Code of Marketing of Breast-Milk Substitutes. This was a descriptive study based on data collected from documents, reports, ordinances and resolutions from the Brazilian Ministry of Health. The versions utilized in the comparison were from 1992 and 2002. Comparative analysis made it possible to identify important advances in the legislation. In 1992, liquid and powdered milk were included in the scope, along with teats and dummies (pacifiers), and also warning phrases in advertising and on product labeling. In 2002, regulations for products were published by the National Agency for Sanitary Surveillance, thereby strengthening supervisory actions and including regulations for baby foods, nutrient formulae for high-risk newborns, and nipple protectors. The phrases used in commercial advertising and on product labeling, including dummies, teats and bottles, became Ministry of Health warnings. The labeling was defined according to product types, on the basis of more restrictive rules. Significant modifications in the control over the marketing of products aimed at mothers during the lactation period. However, there are still some legislative questions that would make it possible to improve the Brazilian norm, in order to protect breastfeeding. There is also a need for the government to implement systematic monitoring routines to supervise this legislation.