21 U.S.C. § 387r — Drug products used to treat tobacco dependence

(a) The Secretary must do three things if a drug company asks. First, the Secretary must think about labeling smoking-cessation products as "fast track" products. This includes nicotine replacement products. That label can speed up research and approval under section 356. Second, the Secretary must think about letting people use nicotine replacement products longer. These include patches, gum, and lozenges, used to treat tobacco dependence. Third, the Secretary must look at proof for new uses of these products. This includes easing cravings or stopping relapse. (b) Within three years, the Secretary must send Congress a report. The report covers new products for tobacco dependence. Before writing it, the Secretary must talk with science, medical, and public health experts. This includes federal agencies and outside groups. It also includes the Institute of Medicine and the Society for Research on Nicotine and Tobacco. The report must study how to regulate and support new nicotine-based and non-nicotine products. The goal is public health, in three ways. These are helping people fully quit tobacco, cutting how much tobacco people use, and cutting harm from tobacco use that goes on. The report must also give the Secretary's ideas. These ideas should cover how the FDA can share news about these products better within its own offices. They should also cover sharing with the National Institutes of Health, the Centers for Disease Control and Prevention, and other agencies.

The record. According to the source credit, this section was added to the Federal Food, Drug, and Cosmetic Act of June 25, 1938 (ch. 675) as a new section 918, enacted by Public Law 111–31, division A, title I, § 101(b)(3), on June 22, 2009, and published at 123 Stat. 1825. The credit reflects a single enactment event, with no subsequent amendments recorded. Historical context. Public Law 111–31 is commonly known as the Family Smoking Prevention and Tobacco Control Act of 2009. That Act is generally understood to have granted the Food and Drug Administration comprehensive authority to regulate tobacco products, following decades of debate over whether and how the federal government should oversee tobacco manufacturing, marketing, and sale in light of well-documented public health harms associated with tobacco use. Within that broader framework, provisions addressing smoking-cessation drug products are typically described as reflecting Congress's parallel interest in encouraging the development, approval, and expanded use of treatments—such as nicotine replacement therapies—that could help reduce tobacco dependence and its associated health consequences. Beyond this general legislative purpose, the record does not establish the specific reasoning that led Congress to include the particular directives found in this section, such as the fast-track consideration provisions or the mandated report on innovative cessation products. Any more detailed account of legislative intent for these specific requirements would be speculative and is not supported by the materials provided.