Youth-appealing features in popular e-cigarette brand advertising in the USA after heightened scrutiny in 2018.

PURPOSE: Youth 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. METHODS: Using 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. RESULTS: Of 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). CONCLUSION: Even 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.

E-Cigarettes and the Multiple Responsibilities of the FDA.

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.

Beyond Strong Enforcement: Understanding the Factors Related to Retailer Compliance With Tobacco 21.

INTRODUCTION: Tobacco 21 (T21), which sets the minimum legal sales age for tobacco to age 21, is now a national law in the United States. Although T21 is expected to help curb youth tobacco use, its impact may be dampened due to poor retailer compliance. Even within environments where enforcement is strong (ie, compliance checks are conducted with tough sanctions for violations), compliance might vary due to other factors. AIMS AND METHODS: Three studies were conducted in Columbus, OH, where T21 became strongly enforced in 2018. These studies examined how retailer compliance related to features of the neighborhood in which a retailer was located (Study 1), features of the retailer (Study 2), and features of the retail cashier (Study 3). RESULTS: Study 1 found that, after controlling for race- and age-based factors, retailers located in high (vs. low)-poverty neighborhoods had a lower likelihood of conducting identification (ID) checks. Study 2 found that ID checks were related to whether retailers displayed signage about T21, as required by the city law. Study 3 found that, among cashiers, T21 awareness (which was high) and perceptions about T21 (which were moderate) were not generally related to their retailer's compliance; having (vs. not having) scanners for ID checks was related to a higher likelihood of compliance. CONCLUSIONS: These studies emphasize the many, multilevel factors influencing T21 outcomes. Findings also indicate the potential for T21 to widen disparities in tobacco use, indicating the need for strategies to equitably improve T21 compliance. IMPLICATIONS: T21, which sets the minimum legal sales age for all tobacco products to age 21, is now a national law in the United States. Despite optimistic projections about what T21 could achieve, the ultimate impact may be dampened when it is applied in real-world settings. Our project revealed the many, multilevel factors influencing T21 compliance. Findings also indicate the potential for T21 to widen disparities in tobacco use if gaps in compliance persist. Strategies for equitably improving T21 compliance are discussed. This article is of relevance to areas interested in implementing or improving their local T21 enforcement.

Nicotine Reduction in Cigarettes: Literature Review and Gap Analysis.

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.

Consortium on Methods Evaluating Tobacco: Research Tools to Inform US Food and Drug Administration Regulation of Snus.

Introduction: The US Food and Drug Administration (FDA) has purview over tobacco products. To set policy, the FDA must rely on sound science, yet most existing tobacco research methods have not been designed to specifically inform regulation. The NCI and FDA-funded Consortium on Methods Evaluating Tobacco (COMET) was established to develop and assess valid and reliable methods for tobacco product evaluation. The goal of this article is to describe these assessment methods using a US manufactured "snus" as the test product. Methods: In designing studies that could inform FDA regulation, COMET has taken a multidisciplinary approach that includes experimental animal models and a range of human studies that examine tobacco product appeal, addictiveness, and toxicity. This article integrates COMET's findings over the last 4 years. Results: Consistency in results was observed across the various studies, lending validity to our methods. Studies showed low abuse liability for snus and low levels of consumer demand. Toxicity was less than cigarettes on some biomarkers but higher than medicinal nicotine. Conclusions: Using our study methods and the convergence of results, the snus that we tested as a potential modified risk tobacco product is likely to neither result in substantial public health harm nor benefit. Implications: This review describes methods that were used to assess the appeal, abuse liability, and toxicity of snus. These methods included animal, behavioral economics, consumer perception studies, and clinical trials. Across these varied methods, study results showed low abuse-liability and appeal of the snus product we tested. In several studies, demand for snus was lower than for less toxic nicotine gum. The consistency and convergence of results across a range of multi-disciplinary studies lends validity to our methods and suggests that promotion of snus as a modified risk tobacco products is unlikely to produce substantial public health benefit or harm.

Reducing tobacco-related harm: FDA's proposed product standard for smokeless tobacco.

This Special Communication discusses the Food and Drug Administration's (FDA's) proposed rule that would limit N-nitrosonornicotine (NNN) levels in smokeless tobacco products. It argues that finalising and implementing this first 'product standard' would mark a significant step forward in the FDA's efforts to reduce tobacco-related harms.

Attitudes toward Tobacco, Alcohol, and Non-Alcoholic Beverage Advertisement Themes among Adolescent Boys.

BACKGROUND: Previous studies have examined what adolescents find appealing in tobacco and alcohol advertisements and how different themes in advertisements are used to manipulate consumer behaviors. Yet, we know little about the relationship between the themes portrayed in advertisements and youth attitudes towards those themes. OBJECTIVES: This study compared attitudes towards advertisements for different consumer products in a sample of urban and rural adolescent boys in order to examine how key marketing themes impact adolescent attitudes towards those advertisements. METHODS: Participants were 11- to 16-year-old boys (N = 1220) residing in either urban or rural Ohio Appalachian counties. Each participant viewed five print advertisements (one each for cigarettes, electronic cigarettes (e-cigarettes), smokeless tobacco (SLT), non-alcoholic beverages, and alcohol), presented in a random order, for eight seconds each. All advertisements had appeared in magazines that adolescent males commonly read. Attitudes towards each of the five advertisements were assessed. The advertisements were then coded for the presence of various themes, including social acceptance and masculinity. Analyses were conducted to determine associations between advertisement type and the attitude measure, and between the presence of a theme and the attitude measure. RESULTS: Overall, participants preferred non-tobacco advertisements to tobacco advertisements, rural participants had less positive attitudes and participants who had peers who used tobacco had more positive attitudes. Social acceptance and entertainment themes increased the appeal of SLT advertisements, and sex appeal increased the appeal of e-cigarette advertisements. Conclusions/Importance: Findings suggest that advertisements that promote the social nature of use in SLT advertisements may be of particular concern for their influence on adolescent boys.

Medicaid Expansion and ACA Repeal: Evidence From Ohio.

OBJECTIVES: To examine the health insurance coverage options for Medicaid expansion enrollees if the Affordable Care Act (ACA) is repealed, using evidence from Ohio, where more than half a million adults have enrolled in the state's Medicaid program through the ACA expansion. METHODS: The Ohio Medicaid Assessment Survey interviewed 42 000 households in 2015. We report data from a unique battery of questions designed to identify insurance coverage immediately prior to Medicaid enrollment. RESULTS: Ninety-five percent of new Medicaid enrollees in Ohio did not have a private health insurance option immediately before enrollment. These new enrollees are predominantly older, low-income Whites with a high school education or less. Only 5% of new Medicaid enrollees were eligible for an employer-sponsored insurance plan to which they could potentially return in the case of repeal of the ACA. CONCLUSIONS: The vast majority of Medicaid expansion enrollees would have no plausible pathway to obtaining private-sector insurance if the ACA were repealed. Demographic similarities between the expansion population and 2016 exit polls suggest that coverage losses would fall disproportionately on members of the winning Republican coalition.

FDA-Required Tobacco Product Inserts & Onserts­and the First Amendment.

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

Communicating Tobacco Product Information to the Public.

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

FDA's misplaced priorities: premarket review under the Family Smoking Prevention and Tobacco Control Act.

Among other key objectives, the 2009 Family Smoking Prevention and Tobacco Control Act was designed to end an era of constant product manipulation by the tobacco industry that had led to more addictive and attractive products. The law requires new tobacco products to undergo premarket review by the US Food and Drug Administration (FDA) before they can be sold. To assess FDA's implementation of its premarket review authorities, we reviewed FDA actions on new product applications, publicly available data on industry applications to market new products, and related FDA guidance documents and public statements. We conclude that FDA has not implemented the premarket review process in a manner that prioritises the protection of public health. In particular, FDA has (1) prioritised the review of premarket applications that allow for the introduction of new tobacco products over the review of potentially non-compliant products that are already on the market; (2) misallocated resources by accommodating the industry's repeated submissions of deficient premarket applications and (3) weakened the premarket review process by allowing the tobacco industry to market new and modified products that have not completed the required review process.