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

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.