This paper considers the responsibilities of the FDA with regard to disseminating information about the benefits and harms of e-cigarettes. Tobacco harm reduction advocates claim that the FDA has ...been overcautious and has violated ethical obligations by failing to clearly communicate to the public that e-cigarettes are far less harmful than cigarettes. We argue, by contrast, that the FDA's obligations in this arena are more complex than they may appear at first blush. Though the FDA is accountable for informing the public about the health risks and benefits of products it regulates, it also has other roles (and attendant responsibilities) that inform when and how it should disseminate information. In addition to being a knowledge purveyor, it is also a knowledge producer, an advisor to the public, and a practical agent shaping the material conditions in which people make health-related choices. In our view, those other roles call for caution in the way the FDA interprets and communicates the available evidence.
The core structure of the 2009 Tobacco Control Act's1 regulatory framework was straightforward: tobacco products available as of2007 would be "grandfathered in" (although still subject to ...regulation), but any new tobacco product would require premarket authorization from the US Food and Drug Administration (FDA) before sale.2 Beyond being a political compromise, this structure made sense. In the absence of oversight, some e-cigarette companies copied (and updated) the tobacco industry's well-worn playbook by marketing to youths, using flavors that appeal to children, designing their products to be maximally addictive, and more.2 Without regulation or product review, the irresponsible actors had an upper hand in the marketplace. (The FDA also tries to establish that youths are not attracted to menthol e-cigarettes, a conclusion not supported by the evidence.5) Premarket review was intended to allow the FDA to proactively protect the public from new products that pose population health risks.
PurposeYouth electronic cigarette (e-cigarette) use remains high in the USA, and advertising is a contributor. The purpose of this study was to identify themes and characteristics of popular ...e-cigarette companies’ advertising after e-cigarette companies became more highly scrutinised in 2018.MethodsUsing a systematic, quantitative content analysis, three trained coders coded e-cigarette advertisements from JUUL, Puff Bar, Vuse and Blu from 2019 and 2020. Based on previous work, they coded for: type of advertisement, flavours, promotions, product cues, descriptors, claims, imagery, youth-oriented themes and sensational appeals.ResultsOf the 401 e-cigarette advertisements, the majority were emails (38.2%) and Instagram posts (30.9%). Over half (53.6%) showed flavours other than tobacco, with Puff Bar leading the brands (70.2%; p<0.001). The most frequently used product cues were showing the product (51.4%) or packaging (42.4%). The most common claim was being an alternative to smoking (14.2%). The most frequently used imagery was fruit (14.0%), employed most by Puff Bar (p<0.001). The only youth-oriented theme present was humour (4.2%). Positive sensations (eg, good taste, good smell or satisfying; 17.1%) was the most common form of appeal, with Puff Bar using it at the highest frequency (p<0.001).ConclusionEven with heightened scrutiny of e-cigarette brands, advertisements still included youth-appealing content such as flavours, fruit imagery and positive sensations. Puff Bar led in all these categories, and it rapidly gained market share after market leader JUUL limited the sales of its flavoured products. Research should continue to monitor the characteristics of e-cigarette advertisements and consider their impact on youth.
Abstract
Background
The US Food and Drug Administration (FDA) is considering reducing nicotine levels in cigarettes to “minimally or non-addictive levels.” However, important research gaps remain, ...and the FDA must determine when the available research is sufficient to support moving forward.
Methods
The authors conducted a systematic review of research articles in PubMed relating to nicotine reduction. Building on a review of risk assessment best practices, the authors also developed a risk assessment framework for tobacco regulation and used it to guide a gap analysis of nicotine reduction research.
Results
The final sample consisted of 78 articles. The majority examined either nicotine dependence on very low nicotine cigarettes (VLNCs) or markers of potential health effects of using VLNCs. One-third of the identified articles reported results from four large randomized controlled trials (RCTs). While these studies report promising results and suggest that a nicotine reduction rule would be a powerful tool to reduce cigarette smoking, our gap analysis suggests that there is a need for studies that better reflect the use and availability of a wide range of tobacco/nicotine products and the potential for dual- or multi-product use.
Conclusion
The current body of research on nicotine reduction is weighted towards RCTs, which is appropriate for a policy that has not yet been implemented anywhere in the world. The FDA must consider a wide range of factors that may impact a product standard’s public health impact, including those difficult to assess in RCTs, such as a nicotine reduction rule’s impact on smoking initiation and relapse.
Implications
This systematic review presents a gap analysis based on a risk assessment framework to help identify remaining research priorities to inform FDA’s potential product standard to reduce nicotine levels in cigarettes. Quickly addressing those gaps would support the FDA’s effort to develop a nicotine reduction product standard that will be effective and withstand legal challenges.
Research documents that curbing tobacco sales to adolescents through "under 21" laws represents an effective deterrent to smoking in adulthood. Despite the evidence, enacting such laws is complex and ...challenging. Here, Rosenbaum presents a reprint of an article by Michael L. Berman on raising the tobacco sales to age 21 which was originally published on Jan 14, 2016.
Objective: Examine trends in e-cigarette use, and Juul use specifically, among U.S. college students. Participants In 2016, we established a cohort of 529 incoming first-year students to a large ...Midwestern University. In 2018, these students (now third-years) were re-contacted, and a new sample of 611 incoming first-year students was enrolled. Methods: First-year students in 2016 completed a survey assessing their e-cigarette use; in 2018, first- and second-year students reported on e-cigarette use, and use of Juul specifically. Results: From 2016 to 2018, past 30-day e-cigarette use rose from 5.9% to 27.7%. In 2018, for Juul alone, ever use was above 35% and past 30-day use was above 20% for both cohorts. Juul use did not differ by gender, but was associated with higher socioeconomic status (SES) and being White. Conclusions: Findings present disturbing possibilities for long-term nicotine addiction among the next generation, and underscore the need for a rapid public health response.
•E-cigarette influencers don’t always disclose their commercial relationships.•Social media users may not recognize unlabeled posts as commercially sponsored.•Users had twice the recognition of the ...commercial disclosure #ad (vs. #sponsored).•Each second of attention on the hashtag increased the odds of recognition by 22%.
Few e-cigarette social media posts are authentic posts to friends; most come from commercially sponsored influencers. Potential disclosure strategies need to be tested to confirm whether users recognize such posts as commercially sponsored.
Between July – August 2019, young adult (ages 16–24; n = 200) participants were recruited to view their native Instagram feed on a laboratory mobile device. Posts from e-cigarette influencers were manipulated to add either #ad or #sponsored while eye tracking software measured visual attention. Participants self-reported their interpretation of the hashtags in open-ended responses. Logistic regression analyses compared recognition of commercial content by condition, and qualitative content analyses summarized the key themes related to the hashtags.
The #ad condition had nearly twice the odds of commercial recognition compared to #sponsored (OR = 1.98, CI: 1.14–3.38). Every second of attention paid to the hashtag significantly increased the odds of commercial recognition by 22% (OR: 1.22, CI: 1.00–1.33).
The #ad disclosure attracted visual attention and significantly increased recognition of commercial sponsorship from young social media users. Labeling commercially sponsored content on social media is a promising strategy to better inform users about paid social media influence.
The use of electronic cigarettes (e-cigs) is increasing rapidly, but their effects on lung toxicity are largely unknown. Smoking is a well-established cause of lung cancer and respiratory disease, in ...part through inflammation. It is plausible that e-cig use might affect similar inflammatory pathways. E-cigs are used by some smokers as an aid for quitting or smoking reduction, and by never smokers (e.g., adolescents and young adults). The relative effects for impacting disease risk may differ for these groups. Cell culture and experimental animal data indicate that e-cigs have the potential for inducing inflammation, albeit much less than smoking. Human studies show that e-cig use in smokers is associated with substantial reductions in blood or urinary biomarkers of tobacco toxicants when completely switching and somewhat for dual use. However, the extent to which these biomarkers are surrogates for potential lung toxicity remains unclear. The FDA now has regulatory authority over e-cigs and can regulate product and e-liquid design features, such as nicotine content and delivery, voltage, e-liquid formulations, and flavors. All of these factors may impact pulmonary toxicity. This review summarizes current data on pulmonary inflammation related to both smoking and e-cig use, with a focus on human lung biomarkers.
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