Objectives Electronic nicotine delivery systems (ENDS), or e-cigarettes, are heavily marketed online. The purpose of our study was to perform a systematic identification and evaluation of claims made within ENDS retailer and manufacturer websites, and the legal status of such claims. Methods We employed a systematic search protocol with popular search engines using 6 terms: (1) e-cigarettes; (2) e-cigs; (3) e-juice; (4) e-liquid; (5) e-hookah; and (6) vape pen. We analyzed English-language websites where ENDS are sold for implicit and explicit health-related claims. A legal analysis determined whether such claims are permissible under the US Food and Drug Administration’s regulations. Results The vast majority of ENDS manufacturer (N = 78) and retailer (N = 32) websites made at least one health-related claim (77% and 65%, respectively). Modified risk claims and secondhand smoke-related claims were most prevalent, with an average of 2 claims per site. Conclusions Health-related claims are plentiful within ENDS manufacturer and retailer websites. Results demonstrate that these sites focus on potential benefits while minimizing or eliminating information about possible harmful effects of ENDS. These claims are subject to the current regulatory authority by the FDA, and pose a risk of misinforming consumers.

The decision in RJ Reynolds vs. FDA (2012) to invalidate FDA’s proposed graphic health warnings was based in part on the reasoning that the proposed graphic warnings cued emotional responses and therefore could not be considered “factual.” However, this reasoning demonstrated the courts’ fundamental misunderstanding of current behavioral-science research. In contrast to the courts’ artificial separation of emotions from fact, we synthesize and interpret relevant research in basic decision sciences and describe an evidence-based characterization of how emotions influence consumer decision making through multiple mechanisms. We then explore how behavioral research gets “lost in translation” in the legal process and recommend ways that behavioral scientists can work with attorneys to remedy this problem. In order for science-based tobacco regulation to survive legal challenges from the tobacco industry, courts must have access to and be able to understand and apply the relevant research. Accordingly, behavioral laboratory researchers must consider the courts as an additional audience when designing research and reporting results. Researchers wishing to influence policy should also work closely with public health lawyers to have the greatest impact on the legal system.

In July 2017 the U.S. Food and Drug Administration (FDA) announced a new "comprehensive plan for tobacco and nicotine regulation." This plan is focused on making cigarettes less addictive while facilitating the development of alternative nicotine-containing products that are far less harmful. This approach holds promise, and the public health stakes could not be higher-smoking is the leading cause of preventable death in the United States, causing roughly 480,000 deaths per year.But a new product is emerging that could upset the FDA's plans for a well-balanced regulatory scheme: synthetic nicotine. These products currently fall into a regulatory gap because they fall outside the Federal Food, Drug, and Cosmetic Act's (FDCA) definition of a tobacco product. If this gap remains in place, it is likely that more companies will exploit it in order to evade regulation, undoing the potential benefits of the FDA's plan for tobacco and nicotine regulation.This Article argues that the FDA can, and should, address this problem by regulating synthetic nicotine products as drugs. After reviewing the science of nicotine addiction and the FDA's past and present regulatory schemes for nicotine, it explains how the FDA could establish that synthetic nicotine satisfies the FDCA's definition of a drug. It concludes with a discussion of the policy benefits of categorizing synthetic nicotine as a drug.

ImportanceResearch demonstrates that policies aimed at retailers who sell to minors must be strongly enforced to have an impact on youth usage rates.ObjectivesIn the USA, the Food and Drug Administration (FDA) conducts compliance checks, issues fines, and can order retailers to stop selling tobacco products (ie, no-tobacco-sale orders (NTSOs)) to enforce the Family Smoking Prevention and Tobacco Control Act. We sought to assess FDA’s utilisation of NTSOs.MethodsWe conducted a quantitative content analysis of FDA’s enforcement actions for inspections decided between 1 October 2015 and 29 March 2019. From the 536 134 inspection records we identified 148 NTSOs and 249 720 unique retailer locations, of which 2095 had three or more violations. We randomly sampled NTSOs (n=76) and retail locations (n=152) with frequent violations. We calculated the proportion of NTSOs that could have been issued earlier by FDA. We then calculated the proportion of retailers that could have been issued an NTSO, and the proportion actually issued an NTSO using FDA’s approach and a more stringent approach.ResultsAmong NTSOs, 94.7% (95% CI: 89.8% to 97.4%) of NTSOs could have been issued earlier under a more stringent approach. On average, when an NTSO could have been issued earlier, it could have been issued 453 days earlier (95% CI: 418 to 489; range: 89–1159). Among frequently violating retail locations, 73.6% (95% CI: 66.0% to 80.0%) were eligible for an NTSO. Of those, 1.9% (95% CI: 0.5% to 7.0%) had received an NTSO.ConclusionsThe FDA’s failure to fully leverage its powers to address retailers’ underage sales of tobacco products has weakened efforts to curb the youth e-cigarette epidemic.

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