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

Page 668 TITLE 21—FOOD AND DRUGS § 387a marketing, and distribution of tobacco products as provided for in this division; ‘‘(2) to ensure that the Food and Drug Administra- tion has the authority to address issues of particular concern to public health officials, especially the use of tobacco by young people and dependence on to- bacco; ‘‘(3) to authorize the Food and Drug Administration to set national standards controlling the manufac- ture of tobacco products and the identity, public dis- closure, and amount of ingredients used in such prod- ucts; ‘‘(4) to provide new and flexible enforcement au- thority to ensure that there is effective oversight of the tobacco industry’s efforts to develop, introduce, and promote less harmful tobacco products; ‘‘(5) to vest the Food and Drug Administration with the authority to regulate the levels of tar, nicotine, and other harmful components of tobacco products; ‘‘(6) in order to ensure that consumers are better informed, to require tobacco product manufacturers to disclose research which has not previously been made available, as well as research generated in the future, relating to the health and dependency effects or safety of tobacco products; ‘‘(7) to continue to permit the sale of tobacco prod- ucts to adults in conjunction with measures to ensure that they are not sold or accessible to underage pur- chasers; ‘‘(8) to impose appropriate regulatory controls on the tobacco industry; ‘‘(9) to promote cessation to reduce disease risk and the social costs associated with tobacco-related dis- eases; and ‘‘(10) to strengthen legislation against illicit trade in tobacco products.’’ MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION Pub. L. 111–31, div. A, § 6, June 22, 2009, 123 Stat. 1783, provided that: ‘‘(a) DELAYED COMMENCEMENT OF DATES FOR SECRE- TARIAL ACTION.— ‘‘(1) IN GENERAL.—Except as provided in subsection (c), with respect to any time periods specified in this division [see Short Title of 2009 Amendment note set out under section 301 of this title] (or in an amend- ment made by this division) that begin on the date of enactment of this Act [June 22, 2009], within which the Secretary of Health and Human Services is re- quired to carry out and complete specified activities, the calculation of such time periods shall commence on the date described in subsection (b). ‘‘(2) LIMITATION.—Subsection (a) shall only apply with respect to obligations of the Secretary of Health and Human Services that must be completed within a specified time period and shall not apply to the ob- ligations of any other person or to any other provi- sion of this division (including the amendments made by this division) that do not create such obligations of the Secretary and are not contingent on actions by the Secretary. ‘‘(b) DATE DESCRIBED.—The date described in this sub- section is the first day of the first fiscal quarter fol- lowing the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary of Health and Human Services has collected fees under section 919 of the Fed- eral Food, Drug, and Cosmetic Act [21 U.S.C. 387s] (as added by section 101). ‘‘(c) EXCEPTION.—Subsection (a) shall not apply to any time period (or date) contained— ‘‘(1) in section 102 [21 U.S.C. 387a–1], except that the reference to ‘180 days’ in subsection (a)(1) of such sec- tion shall be deemed to be ‘270 days’; and ‘‘(2) in sections 201 through 204 [amending sections 1333, 1334, and 4402 of Title 15, Commerce and Trade, and enacting provisions set out as notes under sec- tions 1333 and 4402 of Title 15] (or the amendments made by any such sections). ‘‘(d) ADJUSTMENT.—The Secretary of Health and Human Services may extend or reduce the duration of one or more time periods to which subsection (a) ap- plies if the Secretary determines appropriate [sic], ex- cept that no such period shall be extended for more than 90 days.’’ § 387a. FDA authority over tobacco products (a) In general Tobacco products, including modified risk to- bacco 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 con- taining nicotine that is not made or derived from tobacco. (c) Scope (1) In general 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 Preven- tion and Tobacco Control Act, shall be con- strued to affect, expand, or limit the Sec- retary’s authority over (including the author- ity to determine whether products may be reg- ulated), or the regulation of, products under this chapter that are not tobacco products under subchapter V or any other subchapter. (2) Limitation of authority (A) In general The provisions of this subchapter shall not apply to tobacco leaf that is not in the pos- session of a manufacturer of tobacco prod- ucts, or to the producers of tobacco leaf, in- cluding tobacco growers, tobacco ware- houses, and tobacco grower cooperatives, nor shall any employee of the Food and Drug Ad- ministration have any authority to enter onto a farm owned by a producer of tobacco leaf without the written consent of such pro- ducer. (B) Exception Notwithstanding subparagraph (A), if a producer of tobacco leaf is also a tobacco product manufacturer or controlled by a to- bacco 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 to- bacco product manufacturer and who is not otherwise engaged in the manufacturing process. (C) Rule of construction Nothing in this subchapter shall be con- strued 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. Page 669 TITLE 21—FOOD AND DRUGS § 387a–1 1 So in original. Probably should be ‘‘chapter IX’’. 2 So in original. The comma probably should not appear. (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 Con- trol 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 Commis- sioner of Food and Drugs in the same manner as the other agency centers within the Food and Drug Administration. The Center shall be re- sponsible for the implementation of this sub- chapter and related matters assigned by the Commissioner. (f) Office to assist small tobacco product manu- facturers The Secretary shall establish within the Food and Drug Administration an identifiable office to provide technical and other nonfinancial as- sistance to small tobacco product manufactur- ers to assist them in complying with the re- quirements of this chapter. (g) Consultation prior to rulemaking Prior to promulgating rules under this sub- chapter, the Secretary shall endeavor to consult with other Federal agencies as appropriate. (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 REFERENCES IN TEXT The Family Smoking Prevention and Tobacco Con- trol 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. Sec- tion 102 of title I of the Act enacted section 387a–1 of this title. Section 103 of title I of the Act amended sec- tions 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 pro- visions 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 renum- bered 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 prod- uct 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. § 387a–1. Final rule (a) Cigarettes and smokeless tobacco (1) In general On the first day of publication of the Federal Register that is 180 days or more after June 22, 2009, the Secretary of Health and Human Serv- ices shall publish in the Federal Register a final rule regarding cigarettes and smokeless tobacco, which— (A) is deemed to be issued under chapter 9 1 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387 et seq.], as added by section 101 of this division; and (B) shall be deemed to be in compliance with all applicable provisions of chapter 5 of title 5 and all other provisions of law relat- ing to rulemaking procedures. (2) Contents of rule Except as provided in this subsection, the final rule published under paragraph (1),2 shall be identical in its provisions to part 897 of the regulations promulgated by the Secretary of Health and Human Services in the August 28, 1996, issue of the Federal Register (61 Fed. Reg. 44615–44618). Such rule shall— (A) provide for the designation of jurisdic- tional authority that is in accordance with this subsection in accordance with this divi- sion and the amendments made by this divi- sion; (B) strike Subpart C—Labels and section 897.32(c); (C) strike paragraphs (a), (b), and (i) of sec- tion 897.3 and insert definitions of the terms ‘‘cigarette’’, ‘‘cigarette tobacco’’, and ‘‘smokeless tobacco’’ as defined in section 900 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387]; (D) insert ‘‘or roll-your-own paper’’ in sec- tion 897.34(a) after ‘‘other than cigarettes or smokeless tobacco’’; (E) include such modifications to section 897.30(b), if any, that the Secretary deter- mines are appropriate in light of governing First Amendment case law, including the de- cision of the Supreme Court of the United States in Lorillard Tobacco Co. v. Reilly (533 U.S. 525 (2001)); (F) become effective on the date that is 1 year after June 22, 2009; and (G) amend paragraph (d) of section 897.16 to read as follows: ‘‘(d)(1) Except as provided in subparagraph (2), no manufacturer, distributor, or retailer may distribute or cause to be distributed any free samples of cigarettes, smokeless tobacco, or other tobacco products (as such term is defined in section 201 of the Federal Food, Drug, and Cosmetic Act). ‘‘(2)(A) Subparagraph (1) does not prohibit a manufacturer, distributor, or retailer from dis- tributing or causing to be distributed free sam- ples of smokeless tobacco in a qualified adult- only facility.