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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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]