FDA authority over tobacco products

21 U.S.C. § 387a

• Title: 21 — Food and Drugs
• Chapter: SUBCHAPTER IX—TOBACCO PRODUCTS

Text

(a) In general
Tobacco products, including modified risk tobacco products for which an order has been issued in accordance with section 387k of this title, shall be regulated by the Secretary under this subchapter and shall not be subject to the provisions of subchapter V.
(b) Applicability
This subchapter shall apply to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other tobacco products that the Secretary by regulation deems to be subject to this subchapter. This subchapter shall also apply to any tobacco product containing nicotine that is not made or derived from tobacco.
(c) Scope
Nothing in this subchapter, or any policy issued or regulation promulgated thereunder, or in sections 101(a), 102, or 103 of title I, title II, or title III of the Family Smoking Prevention and Tobacco Control Act, shall be construed to affect, expand, or limit the Secretary's authority over (including the authority to determine whether products may be regulated), or the regulation of, products under this chapter that are not tobacco products under subchapter V or any other subchapter.
The provisions of this subchapter shall not apply to tobacco leaf that is not in the possession of a manufacturer of tobacco products, or to the producers of tobacco leaf, including tobacco growers, tobacco warehouses, and tobacco grower cooperatives, nor shall any employee of the Food and Drug Administration have any authority to enter onto a farm owned by a producer of tobacco leaf without the written consent of such producer.
Notwithstanding subparagraph (A), if a producer of tobacco leaf is also a tobacco product manufacturer or controlled by a tobacco product manufacturer, the producer shall be subject to this subchapter in the producer's capacity as a manufacturer. The exception in this subparagraph shall not apply to a producer of tobacco leaf who grows tobacco under a contract with a tobacco product manufacturer and who is not otherwise engaged in the manufacturing process.
Nothing in this subchapter shall be construed to grant the Secretary authority to promulgate regulations on any matter that involves the production of tobacco leaf or a producer thereof, other than activities by a manufacturer affecting production.
(d) Rulemaking procedures
Each rulemaking under this subchapter shall be in accordance with chapter 5 of title 5. This subsection shall not be construed to affect the rulemaking provisions of section 102(a) of the Family Smoking Prevention and Tobacco Control Act [21 U.S.C. 387a–1(a)].
(e) Center for tobacco products
Not later than 90 days after June 22, 2009, the Secretary shall establish within the Food and Drug Administration the Center for Tobacco Products, which shall report to the Commissioner of Food and Drugs in the same manner as the other agency centers within the Food and Drug Administration. The Center shall be responsible for the implementation of this subchapter and related matters assigned by the Commissioner.
(f) Office to assist small tobacco product manufacturers
The Secretary shall establish within the Food and Drug Administration an identifiable office to provide technical and other nonfinancial assistance to small tobacco product manufacturers to assist them in complying with the requirements of this chapter.
(g) Consultation prior to rulemaking
Prior to promulgating rules under this subchapter, the Secretary shall endeavor to consult with other Federal agencies as appropriate.

History

(June 25, 1938, ch. 675, §901, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1786; amended Pub. L. 117–103, div. P, title I, §111(b), Mar. 15, 2022, 136 Stat. 789.)

Editorial Notes

Editorial Notes

References in Text
The Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (c)(1), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776. Section 101(a) of title I of the Act amended section 321 of this title. Section 102 of title I of the Act enacted section 387a–1 of this title. Section 103 of title I of the Act amended sections 331, 333, 334, 355, 360m, 372 to 374, 375, 379a, 381, 393, 399, and 679 of this title and enacted provisions set out as notes under sections 331, 333, and 387c of this title. Title II of the Act amended sections 1333, 1334, 4402, and 4406 of Title 15, Commerce and Trade, and enacted provisions set out as notes under sections 1333 and 4402 of Title 15. Title III of the Act enacted section 387t of this title. For complete classification of this Act to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables.

Prior Provisions
A prior section 901 of act June 25, 1938, was renumbered section 1001 and is classified to section 391 of this title.

Amendments
2022—Subsec. (b). Pub. L. 117–103 inserted at end "This subchapter shall also apply to any tobacco product containing nicotine that is not made or derived from tobacco."

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment
Amendment by Pub. L. 117–103 effective 30 days after Mar. 15, 2022, see section 111(c) of Pub. L. 117–103, div. P, title I, Mar. 15, 2022, 136 Stat. 789, set out as a note under section 321 of this title.