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21 U.S.C. § 387a — FDA authority over tobacco products
Federal law — U.S. Code and appendices · legal_authorities
**(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387k&num=0&edition=prelim), 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**
(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 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.
(2) **Limitation of authority**
(A) *In general* — 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.
(B) *Exception* — Notwithstanding subpa
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Stable record: federal_law:legal_authorities:record_usc_61b15a16cb8092babcf91de1
Source file: Laws/federal/codes/united-states-code/title-21/section-387a-fda-authority-over-tobacco-products--0a01ce1322.md
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Source location: Title 21, Chapter 9, § 387a; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387k&num=0&edition=prelim), 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**
(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 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.
(2) **Limitation of authority**
(A) *In general* — 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.
(B) *Exception* — 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.
(C) *Rule of construction* — 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)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387a–1/a&num=0&edition=prelim)].
**(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.
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Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Origin labeling**
(1) **Requirement** — Beginning 1 year after June 22, 2009, the label, packaging, and shipping containers of tobacco products other than cigarettes for introduction or delivery for introduction into interstate commerce in the United States shall bear the statement “sale only allowed in the United States”. Beginning 15 months after the issuance of the regulations required by [section 1333(d) of title 15](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1333/d&num=0&edition=prelim), as amended by section 201 of Family 11 So in original. Probably should be “the Family”. Smoking Prevention and Tobacco Control Act, the label, packaging, and shipping containers of cigarettes for introduction or delivery for introduction into interstate commerce in the United States shall bear the statement “Sale only allowed in the United States”.
(2) **Effective date** — The effective date specified in paragraph (1) shall be with respect to the date of manufacture, provided that, in any case, beginning 30 days after such effective date, a manufacturer shall not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with such paragraph.
**(b) Regulations concerning recordkeeping for tracking and tracing**
(1) **In general** — The Secretary shall promulgate regulations regarding the establishment and maintenance of records by any person who manufactures, processes, transports, distributes, receives, packages, holds, exports, or imports tobacco products.
(2) **Inspection** — In promulgating the regulations described in paragraph (1), the Secretary shall consider which records are needed for inspection to monitor the movement of tobacco products from the poi
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 387t
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Federal law — U.S. Code and appendices · legal_authorities
If any provision of this chapter is declared unconstitutional, or the applicability thereof to any person or circumstances is held invalid, the constitutionality of the remainder of the chapter and the applicability thereof to other persons and circumstances shall not be affected thereby.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 391
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** No person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product unless an order issued pursuant to subsection (g) is effective with respect to such product.
**(b) Definitions** In this section:
(1) **Modified risk tobacco product** — The term “modified risk tobacco product” means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.
(2) **Sold or distributed**
(A) *In general* — With respect to a tobacco product, the term “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products” means a tobacco product—
(i) the label, labeling, or advertising of which represents explicitly or implicitly that—
(I) the tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products;
(II) the tobacco product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or
(III) the tobacco product or its smoke does not contain or is free of a substance;
(ii) the label, labeling, or advertising of which uses the descriptors “light”, “mild”, or “low” or similar descriptors; or
(iii) the tobacco product manufacturer of which has taken any action directed to consumers through the media or otherwise, other than by means of the tobacco product’s label, labeling, or advertising, after June 22, 2009, respecting the product that would be reasonably expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful than
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 387k
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Federal law — U.S. Code and appendices · legal_authorities
For the purposes of this chapter—
**(a)**
(1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.
(2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.
**(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.
**(c)** The term “Department” means Department of Health and Human Services.
**(d)** The term “Secretary” means the Secretary of Health and Human Services.
**(e)** The term “person” includes individual, partnership, corporation, and association.
**(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
**(g)**
(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif
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Federal law — U.S. Code and appendices · legal_authorities
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:
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 387a
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