Food and Drug Administration Regulation of Tobacco: Integrating Science, Law, Policy, and Advocacy

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The Family Smoking Prevention and Tobacco Control Act (hereafter referred to as “the Act”) became law in 2009. One of its key provisions grants the Food and Drug Administration (FDA) authority to regulate tobacco products “for the protection of the public health.”1 Recognizing that the traditional “safe and effective” standard governing drugs and devices was inappropriate for tobacco products, which are inherently lethal, Congress designed the “public health standard … to be a flexible standard that focuses on the overall goal of reducing the number of individuals who die or are harmed by tobacco products.”2 The language is intentionally broad, focusing on protecting the health of the population as a whole. Before the FDA can adopt a tobacco product standard, it must consider the scientific evidence regarding: (1) the risks and benefits of the proposed standard to the entire population, including both users and nonusers of tobacco products; (2) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (3) the increased or decreased likelihood that those who do not currently use tobacco products, most notably youth, will start to use tobacco products.1 To assist the FDA with these determinations, a Tobacco Products Scientific Advisory Committee (TPSAC) was established, comprising individuals with expertise ranging from basic to population science. Congress mandated the TPSAC to issue its first report and set of recommendations to the FDA by March 2011 on the impact of menthol on public health, especially on “children, African-Americans, Hispanics, and other racial and ethnic minorities.” The FDA is empowered to ban or reduce menthol in cigarettes if it determines such action would satisfy the public health standard. Given the likely complex impact of product standards on patterns of tobacco use, a transdisciplinary perspective is needed to fully understand how the population will adapt to changes in the regulatory environment. This editorial explores the meaning of the new standard, and specifically how scientific evidence, including 3 articles in this month's Journal,3–5 can help to inform the FDA's consideration of the menthol question.