21 U.S.C. § 387a — FDA authority over tobacco products

(a) In general. Tobacco products — including modified-risk tobacco products approved under section 387k — are regulated by the Secretary under this subchapter, not under the drug and device rules of subchapter V. (b) Applicability. This subchapter covers all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, plus any other tobacco products the Secretary decides by rule to include. It also covers any nicotine-containing product that isn't made from tobacco at all. (c) Scope. (1) Nothing in this subchapter, or in specific parts of the Family Smoking Prevention and Tobacco Control Act, changes the Secretary's authority over products under this chapter that are not tobacco products — that authority stays exactly as it was. (2) This subchapter does NOT apply to tobacco leaf that a tobacco product manufacturer doesn't yet possess, or to leaf producers — tobacco growers, tobacco warehouses, and grower cooperatives. No FDA employee can enter a tobacco farm without the grower's written permission. However, if a tobacco leaf producer is also a tobacco product manufacturer, or is controlled by one, that producer is covered by this subchapter in its role as a manufacturer — except this exception doesn't apply to a grower who simply grows tobacco under contract for a manufacturer and isn't otherwise involved in manufacturing. Nothing in this subchapter lets the Secretary make rules about growing tobacco leaf itself, or about leaf producers, beyond regulating a manufacturer's own actions that affect production. (d) Rulemaking procedures. Every rule made under this subchapter must follow chapter 5 of title 5 (the standard federal rulemaking process). This doesn't change the separate rulemaking rules in section 102(a) of the Family Smoking Prevention and Tobacco Control Act. (e) Center for tobacco products. Within 90 days of June 22, 2009, the Secretary must create a Center for Tobacco Products inside the FDA, reporting to the FDA Commissioner the same way other FDA centers do. This Center is responsible for carrying out this subchapter and related tasks the Commissioner assigns. (f) Office to assist small tobacco product manufacturers. The Secretary must create an identifiable FDA office to give small tobacco manufacturers technical and other non-financial help in following this chapter's requirements. (g) Consultation prior to rulemaking. Before making rules under this subchapter, the Secretary must try to consult with other relevant federal agencies.