Dataset Information

Warning Statements and Safety Practices Among Manufacturers and Distributors of Electronic Cigarette Liquids in the United States.

ABSTRACT: Introduction:Prior to the US Food and Drug Administration's (FDA) regulation of electronic cigarettes and warning statements related to nicotine addiction, there was no critical examination of manufacturer/distributor voluntary practices that could potentially inform FDA actions aimed to protect consumers. This study examined the content of warning statements and safety characteristics of electronic cigarette liquid bottles using a national sample. Methods:Research staff randomly selected four electronic cigarette liquid manufacturers/distributors from four US geographic regions. Staff documented the characteristics of product packaging and content of warning statements on 147 electronic cigarette liquids (0-30 mg/ml of nicotine) purchased online from 16 manufacturers/distributors in April of 2016. Results:Data showed that 97.9% of the electronic cigarette liquid bottles included a warning statement, most of which focused on nicotine exposure rather than health. Only 22.4% of bottles used a warning statement that indicated the product "contained nicotine." Of bottles that advertised a nicotine-based concentration of 12 mg/ml, 26% had a warning statements stated that the product "contains nicotine." None of the statements that indicated that the product "contained nicotine" stated that nicotine was "addictive." All bottles had a safety cap and 12% were in plastic shrink-wrap. Fifty-six percent of the websites had a minimum age requirement barrier that prevented under-aged persons from entering. Conclusions:Most manufacturers/distributors printed a warning statement on electronic cigarette liquid bottles, but avoided warning consumers about the presence and the addictiveness of nicotine. Studies are needed to examine manufacturer/distributor modifications to product packaging and how packaging affects consumer behaviors. Implications:These data can inform future FDA requirements related to the packaging and advertising of e-cigarette liquids; regulation related to the content of warning statements, including exposure warning statements, which are not currently mandated; and requirements on websites or language on packaging to help manufacturers adhere to the minimum age of purchase regulation. The data can also be used to help FDA develop additional guidance on the framing of statements on packaging that helps consumers make informed decisions about purchasing the product or protecting young people from use or unintentional exposure to the product.

SUBMITTER: Fagan P

PROVIDER: S-EPMC6037121 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Warning Statements and Safety Practices Among Manufacturers and Distributors of Electronic Cigarette Liquids in the United States.

Fagan Pebbles P Pokhrel Pallav P Herzog Thaddeus A TA Guy Mignonne C MC Sakuma Kari-Lyn K KK Trinidad Dennis R DR Cassel Kevin D KD Jorgensen Dorothy D Lynch Tania T Felicitas-Perkins Jamie Q JQ Palafox Sherilyn S Hamamura Faith D FD Maloney Sarah S Degree Kaylah K Sterling Kymberle K Moolchan Eric T ET Clanton Mark S MS Eissenberg Thomas E TE

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco 20180701 8

<h4>Introduction</h4>Prior to the US Food and Drug Administration's (FDA) regulation of electronic cigarettes and warning statements related to nicotine addiction, there was no critical examination of manufacturer/distributor voluntary practices that could potentially inform FDA actions aimed to protect consumers. This study examined the content of warning statements and safety characteristics of electronic cigarette liquid bottles using a national sample.<h4>Methods</h4>Research staff randomly ...[more]

PMID: 28520985

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Project description:IntroductionIn 2018, the United States Food and Drug Administration (FDA) required that electronic cigarette (e-cigarette) manufacturers, packagers, importers, distributors, and retailers display an addictive or alternate warning statement on e-cigarette visual advertisements. Few studies have investigated the FDA-mandated and other warnings on social media. This study examined the prevalence and content of warning statements in e-cigarette-related YouTube videos.MethodsIn 2019, The Virginia Commonwealth University Center for the Study of Tobacco Products conducted bi-monthly (February-June) YouTube searches by relevance and view count to identify e-cigarette-related videos. Overall, 178 videos met the inclusion criteria. Staff coded each video for the presence of a visual/verbal warning statement, warning statement type (eg, FDA-mandated, addiction/tobacco, safety/toxic exposure, health effects), sponsorship, and tobacco product characteristics. A data extraction tool collected the video URL, title, upload date, and number of views, likes/dislikes, and comments.ResultsOnly 5.1% of videos contained FDA-mandated and 21.9% contained non-mandated warnings. All videos with FDA-mandated and 46.2% of non-mandated warnings were represented visually. Only 13.1% of industry-sponsored videos uploaded after the mandate effective date had an FDA-mandated warning statement and videos with FDA-mandated and non-mandated (v. no) warnings had significantly fewer views, likes, dislikes, and comments. Among all non-mandated warnings, 31.3% featured an addiction/tobacco, 18.8% a safety/toxic exposure, and 37.5% a health effects warning.ConclusionsThe prevalence of FDA-mandated warning statements in e-cigarette related YouTube videos was low. FDA enforcement of the warning statement mandate on YouTube could increase the public's understanding of the addictive nature of nicotine in e-cigarettes.ImplicationsThe FDA has the authority to regulate the advertisement and promotion of e-cigarettes on the Internet. These data can inform future FDA requirements related to the language content and visual representation of addiction/tobacco, safety/exposure, and health effects warning statements that appear in YouTube videos and other visual social media popular among young people. Such data would help consumers make informed decisions about purchasing e-cigarette products, using e-cigarettes, and avoiding unintentional harm related to e-cigarettes. In addition, these data may help social media platforms make decisions on whether they will prohibit advertisements that promote or facilitate the sale of tobacco products.

Project description:ImportanceMillions of Americans use electronic cigarettes (e-cigarettes). A growing number of state and local governments have started to draft and implement laws regarding the sale, marketing, and use of e-cigarettes. The association of US state regulations regarding e-cigarettes with e-cigarette use remains unknown.ObjectiveTo examine the association of US state regulations regarding e-cigarettes with current e-cigarette use among adults in the United States.Design, setting, and participantsThis cross-sectional study included adults aged 18 years or older from the 2016 and 2017 Behavioral Risk Factor Surveillance System, which is a nationwide, telephone-administered survey that collects state-representative data on health-related risk behaviors, chronic health conditions, and use of preventive services. Data analysis was performed from February 1, 2019, to April 31, 2019.ExposuresUnited States state laws regulating e-cigarette use, including prohibiting e-cigarette use in indoor areas of private workplaces, restaurants, and bars; requiring retailers to purchase a license to sell e-cigarettes; prohibiting self-service displays of e-cigarettes; prohibiting sales of tobacco products, including e-cigarettes, to persons younger than 21 years; and e-cigarette taxes.Main outcomes and measuresCurrent use of e-cigarettes.ResultsAmong 894 997 participants aged 18 years or older (503 688 women [51.3%], 679 443 non-Hispanic white [62.6%], 71 730 non-Hispanic black [16.3%], 69 823 Hispanic [11.4%], and 74 001 non-Hispanic other races [9.8%]), 28 907 (weighted prevalence, 4.4%) were currently using e-cigarettes. The age-standardized weighted prevalence of current e-cigarette use varied across US states and territories, from 1.0% in Puerto Rico to 6.2% in Guam. After adjustment for demographic, socioeconomic, and lifestyle factors, including conventional cigarette use, the odds ratios of current e-cigarette use were 0.90 (95% CI, 0.83-0.98) for state laws prohibiting e-cigarette use in indoor areas of private workplaces, restaurants, and bars; 0.90 (95% CI, 0.85-0.95) for state laws requiring retailers to purchase a license to sell e-cigarettes; 1.04 (95% CI, 0.99-1.09) for state laws prohibiting self-service displays of e-cigarettes; 0.86 (95% CI, 0.74-0.99) for state laws prohibiting sales of tobacco products, including e-cigarettes, to persons younger than 21 years; and 0.89 (95% CI, 0.83-0.96) for state laws applying taxes to e-cigarettes.Conclusions and relevanceThese findings suggest that several state regulations regarding e-cigarettes may be associated with reduced e-cigarette use among US adults.

Project description:INTRODUCTION:It is unclear whether warnings on electronic cigarette (e-cigarette) advertisements required by the US Food and Drug Administration (FDA) will apply to social media. Given the key role of social media in marketing e-cigarettes, we seek to inform FDA decision making by exploring how warnings on various tweet content influence perceived healthiness, nicotine harm, likelihood to try e-cigarettes, and warning recall. METHODS:In this 2 × 4 between-subjects experiment participants viewed a tweet from a fictitious e-cigarette brand. Four tweet content versions (e-cigarette product, e-cigarette use, e-cigarette in social context, unrelated content) were crossed with two warning versions (absent, present). Adult e-cigarette users (N = 994) were recruited via social media ads to complete a survey and randomized to view one of eight tweets. Multivariable regressions explored effects of tweet content and warning on perceived healthiness, perceived harm, and likelihood to try e-cigarettes, and tweet content on warning recall. Covariates were tobacco and social media use and demographics. RESULTS:Tweets with warnings elicited more negative health perceptions of the e-cigarette brand than tweets without warnings (p < .05). Tweets featuring e-cigarette products (p < .05) or use (p < .001) elicited higher warning recall than tweets featuring unrelated content. CONCLUSIONS:This is the first study to examine warning effects on perceptions of e-cigarette social media marketing. Warnings led to more negative e-cigarette health perceptions, but no effect on perceived nicotine harm or likelihood to try e-cigarettes. There were differences in warning recall by tweet content. Research should explore how varying warning content (text, size, placement) on tweets from e-cigarette brands influences health risk perceptions. IMPLICATIONS:FDA's 2016 ruling requires warnings on advertisements for nicotine-containing e-cigarettes, but does not specify whether this applies to social media. This study is the first to examine how e-cigarette warnings in tweets influence perceived healthiness and harm of e-cigarettes, which is important because e-cigarette brands are voluntarily including warnings on Twitter and Instagram. Warnings influenced perceived healthiness of the e-cigarette brand, but not perceived nicotine harm or likelihood to try e-cigarettes. We also saw higher recall of warning statements for tweets featuring e-cigarettes. Findings suggest that expanding warning requirements to e-cigarette social media marketing warrants further exploration and FDA consideration.

Project description:IntroductionSugars are major constituents and additives in traditional tobacco products, but little is known about their content or related toxins (formaldehyde, acetaldehyde, and acrolein) in electronic cigarette (e-cigarette) liquids. This study quantified levels of sugars and aldehydes in e-cigarette liquids across brands, flavors, and nicotine concentrations (n = 66).MethodsUnheated e-cigarette liquids were analyzed using liquid chromatography mass spectrometry and enzymatic test kits. Generalized linear models, Fisher's exact test, and Pearson's correlation coefficient assessed sugar, aldehyde, and nicotine concentration associations.ResultsGlucose, fructose and sucrose levels exceeded the limits of quantification in 22%, 53% and 53% of the samples. Sucrose levels were significantly higher than glucose [χ2(1) = 85.9, p < .0001] and fructose [χ2(1) = 10.6, p = .001] levels. Formaldehyde, acetaldehyde, and acrolein levels exceeded the limits of quantification in 72%, 84%, and 75% of the samples. Acetaldehyde levels were significantly higher than formaldehyde [χ2(1) = 11.7, p = .0006] and acrolein [χ2(1) = 119.5, p < .0001] levels. Differences between nicotine-based and zero-nicotine labeled e-cigarette liquids were not statistically significant for sugars or aldehydes. We found significant correlations between formaldehyde and fructose (-0.22, p = .004) and sucrose (-0.25, p = .002) and acrolein and fructose (-0.26, p = .0006) and sucrose (-0.21, p = .0006). There were no significant correlations between acetaldehyde and any of the sugars or any of the aldehydes and glucose.ConclusionsSugars and related aldehydes were identified in unheated e-cigarette liquids and their composition may influence experimentation in naïve users and their potential toxicity.ImplicationsThe data can inform the regulation of specific flavor constituents in tobacco products as a strategy to protect young people from using e-cigarettes, while balancing FDA's interest in how these emerging products could potentially benefit adult smokers who are seeking to safely quit cigarette smoking. The data can also be used to educate consumers about ingredients in products that may contain nicotine and inform future FDA regulatory policies related to product standards and accurate and comprehensible labeling of e-cigarette liquids.

Dataset Information

Warning Statements and Safety Practices Among Manufacturers and Distributors of Electronic Cigarette Liquids in the United States.

Publications

Warning Statements and Safety Practices Among Manufacturers and Distributors of Electronic Cigarette Liquids in the United States.

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