Underutilisation of no-tobacco-sale orders against retailers that repeatedly sell to minors, 2015-2019, USA.

IMPORTANCE: Research demonstrates that policies aimed at retailers who sell to minors must be strongly enforced to have an impact on youth usage rates. OBJECTIVES: In 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. METHODS: We 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. RESULTS: Among 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. CONCLUSIONS: The 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.

Closing the Regulatory Gap for Synthetic Nicotine Products.

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, and less-harmful, nicotine-containing products. 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, resulting in roughly 480,000 deaths per year. But a new consumer 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 products satisfy the FDCA's definition of a drug. It concludes with a discussion of the policy benefits of categorizing synthetic nicotine products as drugs.

Evidentiary Support in Public Comments to the FDA's Center for Tobacco Products.

Electronic Nicotine Delivery Systems (ENDS) were introduced into the US market in 2007, and until recently these devices were unregulated at the federal level. In 2014, the US Food and Drug Administration (FDA) published a Notice of Proposed Rulemaking asserting its intention to regulate ENDS and requesting public comments on numerous related issues, including potential limits on the sale of flavored ENDS. This article analyzes key comments submitted to the FDA on the issue of flavor regulation in ENDS and examines the weight and credibility of the evidence presented by both supporters and opponents of regulation. It also describes the final deeming rule, published in May 2016, and the FDA's response to the evidence submitted. This is the first study to examine public comments submitted to the FDA's Center for Tobacco Products, and it concludes that opponents of regulation were more likely to rely on sources that were not peer reviewed and that were affected by conflicts of interest. In light of these findings, the FDA and the research community should develop processes to carefully and critically analyze public comments submitted to the FDA on issues of tobacco regulation.

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.

Online E-cigarette Marketing Claims: A Systematic Content and Legal Analysis.

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.

Emotion in the Law and the Lab: The Case of Graphic Cigarette Warnings.

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.