---
kind: "section"
citation: "21 U.S.C. § 387f"
title: "21"
title_heading: "Food and Drugs"
number: "387f"
heading: "General provisions respecting control of tobacco products"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/387f"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter IX — Tobacco Products"
---

# §387f. General provisions respecting control of tobacco products

- (a) **In general—** Any requirement established by or under section [387b](/usc/21/387b.md), [387c](/usc/21/387c.md), [387e](/usc/21/387e.md), or [387i](/usc/21/387i.md) of this title applicable to a [tobacco product](/usc/21/321.md?p=rr-1) shall apply to such [tobacco product](/usc/21/321.md?p=rr-1) until the applicability of the requirement to the [tobacco product](/usc/21/321.md?p=rr-1) has been changed by action taken under [section 387g of this title](/usc/21/387g.md), [section 387j of this title](/usc/21/387j.md), [section 387k of this title](/usc/21/387k.md), or [subsection (d)](#d) of this section, and any requirement established by or under section [387b](/usc/21/387b.md), [387c](/usc/21/387c.md), [387e](/usc/21/387e.md), or [387i](/usc/21/387i.md) of this title which is inconsistent with a requirement imposed on such [tobacco product](/usc/21/321.md?p=rr-1) under [section 387g of this title](/usc/21/387g.md), [section 387j of this title](/usc/21/387j.md), [section 387k of this title](/usc/21/387k.md), or [subsection (d)](#d) of this section shall not apply to such [tobacco product](/usc/21/321.md?p=rr-1).
- (b) **Information on public access and comment—** Each notice of proposed rulemaking or other notification under section [387g](/usc/21/387g.md), [387h](/usc/21/387h.md), [387i](/usc/21/387i.md), [387j](/usc/21/387j.md), or [387k](/usc/21/387k.md) of this title or under this section, any other notice which is published in the Federal Register with respect to any other action taken under any such section and which [states](/usc/21/387.md?p=19) the reasons for such action, and each publication of findings required to be made in connection with rulemaking under any such section shall set forth—
  - (1) the manner in which interested [persons](/usc/21/321.md?p=e) may examine data and other information on which the notice or findings is[^1] based; and
  - (2) the period within which interested [persons](/usc/21/321.md?p=e) may present their comments on the notice or findings (including the need therefore) orally or in writing, which period shall be at least 60 days but may not exceed 90 days unless the time is extended by the [Secretary](/usc/21/321.md?p=d) by a notice published in the Federal Register stating good cause therefore.
- (c) **Limited confidentiality of information—** Any information reported to or otherwise obtained by the [Secretary](/usc/21/321.md?p=d) or the [Secretary](/usc/21/321.md?p=d)’s representative under section [387c](/usc/21/387c.md), [387d](/usc/21/387d.md), [387g](/usc/21/387g.md), [387h](/usc/21/387h.md), [387i](/usc/21/387i.md), [387j](/usc/21/387j.md), [387k](/usc/21/387k.md), or [374](/usc/21/374.md) of this title, or under subsection [(e)](#e) or [(f)](#f) of this section, which is exempt from disclosure under subsection (a) of [section 552 of title 5](/usc/5/552.md) by reason of [subsection (b)(4)](/usc/5/552.md?p=b-4) of that section shall be considered confidential and shall not be disclosed, except that the information may be disclosed to other officers or employees concerned with carrying out this subchapter, or when relevant in any proceeding under this subchapter.
- (d) **Restrictions—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) may by regulation require restrictions on the sale and [distribution](/usc/21/360eee.md?p=5) of a [tobacco product](/usc/21/321.md?p=rr-1), including restrictions on the access to, and the advertising and promotion of, the [tobacco product](/usc/21/321.md?p=rr-1), if the [Secretary](/usc/21/321.md?p=d) determines that such regulation would be appropriate for the protection of the public health. The [Secretary](/usc/21/321.md?p=d) may by regulation impose restrictions on the advertising and promotion of a [tobacco product](/usc/21/321.md?p=rr-1) consistent with and to full extent permitted by the first amendment to the Constitution. The finding as to whether such regulation would be appropriate for the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the [tobacco product](/usc/21/321.md?p=rr-1), and taking into account—
    - (A) the increased or decreased likelihood that existing users of [tobacco products](/usc/21/321.md?p=rr-1) will stop using such [products](/usc/21/360eee.md?p=13); and
    - (B) the increased or decreased likelihood that those who do not use [tobacco products](/usc/21/321.md?p=rr-1) will start using such [products](/usc/21/360eee.md?p=13).

    No such regulation may require that the sale or [distribution](/usc/21/360eee.md?p=5) of a [tobacco product](/usc/21/321.md?p=rr-1) be limited to the written or oral authorization of a practitioner [licensed](/usc/21/360eee.md?p=9) by law to prescribe medical [products](/usc/21/360eee.md?p=13).

  - (2) **Label statements—** The [label](/usc/21/321.md?p=k) of a [tobacco product](/usc/21/321.md?p=rr-1) shall bear such appropriate statements of the restrictions required by a regulation under [subsection (a)](#a) as the [Secretary](/usc/21/321.md?p=d) may in such regulation prescribe.
  - (3) **Limitations—**
    - (A) **In general—** No restrictions under [paragraph (1)](#d-1) may—
      - (i) prohibit the sale of any [tobacco product](/usc/21/321.md?p=rr-1) in face-to-face [transactions](/usc/21/360eee.md?p=24-A) by a specific category of retail outlets; or
      - (ii) establish a minimum age of sale of [tobacco products](/usc/21/321.md?p=rr-1) to any [person](/usc/21/321.md?p=e) older than 21 years of age.
    - (B) **Matchbooks—** For purposes of any regulations issued by the [Secretary](/usc/21/321.md?p=d), matchbooks of conventional size containing not more than 20 paper matches, and which are customarily given away for free with the purchase of [tobacco products](/usc/21/321.md?p=rr-1), shall be considered as adult-written publications which shall be permitted to contain advertising. Notwithstanding the preceding sentence, if the [Secretary](/usc/21/321.md?p=d) finds that such treatment of matchbooks is not appropriate for the protection of the public health, the [Secretary](/usc/21/321.md?p=d) may determine by regulation that matchbooks shall not be considered adult-written publications.
  - (4) **Remote sales—**
    - (A) **In general—** The [Secretary](/usc/21/321.md?p=d) shall—
      - (i) within 18 months after June 22, 2009, promulgate regulations regarding the sale and [distribution](/usc/21/360eee.md?p=5) of [tobacco products](/usc/21/321.md?p=rr-1) that occur through means other than a direct, face-to-face exchange between a [retailer](/usc/21/387.md?p=14) and a consumer in order to prevent the sale and [distribution](/usc/21/360eee.md?p=5) of [tobacco products](/usc/21/321.md?p=rr-1) to individuals who have not attained the minimum age established by applicable law for the purchase of such [products](/usc/21/360eee.md?p=13), including requirements for age [verification](/usc/21/360eee.md?p=28); and
      - (ii) within 2 years after June 22, 2009, issue regulations to address the promotion and marketing of [tobacco products](/usc/21/321.md?p=rr-1) that are sold or distributed through means other than a direct, face-to-face exchange between a [retailer](/usc/21/387.md?p=14) and a consumer in order to protect individuals who have not attained the minimum age established by applicable law for the purchase of such [products](/usc/21/360eee.md?p=13).
    - (B) **Relation to other authority—** Nothing in this paragraph limits the authority of the [Secretary](/usc/21/321.md?p=d) to take additional actions under the other paragraphs of this subsection.
  - (5) **Minimum age of sale—** It shall be unlawful for any [retailer](/usc/21/387.md?p=14) to sell a [tobacco product](/usc/21/321.md?p=rr-1) to any [person](/usc/21/321.md?p=e) younger than 21 years of age.
- (e) **Good manufacturing practice requirements—**
  - (1) **Methods, facilities, and controls to conform—**
    - (A) **In general—** In applying manufacturing restrictions to tobacco, the [Secretary](/usc/21/321.md?p=d) shall, in accordance with [subparagraph (B)](#e-1-B), prescribe regulations (which may differ based on the type of [tobacco product](/usc/21/321.md?p=rr-1) involved) requiring that the methods used in, and the facilities and controls used for, the manufacture, preproduction design validation (including a process to assess the performance of a [tobacco product](/usc/21/321.md?p=rr-1)), packing, and storage of a [tobacco product](/usc/21/321.md?p=rr-1) conform to current good manufacturing practice, or hazard analysis and critical control point methodology, as prescribed in such regulations to assure that the public health is protected and that the [tobacco product](/usc/21/321.md?p=rr-1) is in compliance with this subchapter. Such regulations may provide for the testing of raw tobacco for [pesticide chemical residues](/usc/21/321.md?p=q-2) regardless of whether a tolerance for such chemical residues has been established.
    - (B) **Requirements—** The [Secretary](/usc/21/321.md?p=d) shall—
      - (i) before promulgating any regulation under [subparagraph (A)](#e-1-A), afford the [Tobacco Products](/usc/21/321.md?p=rr-1) Scientific [Advisory Committee](/usc/21/360fff.md?p=1) an opportunity to submit recommendations with respect to the regulation proposed to be promulgated;
      - (ii) before promulgating any regulation under [subparagraph (A)](#e-1-A), afford opportunity for an oral hearing;
      - (iii) provide the [Tobacco Products](/usc/21/321.md?p=rr-1) Scientific [Advisory Committee](/usc/21/360fff.md?p=1) a reasonable time to make its recommendation with respect to proposed regulations under [subparagraph (A)](#e-1-A);
      - (iv) in establishing the effective date of a regulation promulgated under this subsection, take into account the differences in the manner in which the different types of [tobacco products](/usc/21/321.md?p=rr-1) have historically been produced, the financial resources of the different [tobacco product manufacturers](/usc/21/387.md?p=20), and the [state](/usc/21/387.md?p=19) of their existing manufacturing facilities, and shall provide for a reasonable period of time for such [manufacturers](/usc/21/360hh.md?p=3) to conform to good manufacturing practices; and
      - (v) not require any [small tobacco product manufacturer](/usc/21/387.md?p=16) to comply with a regulation under [subparagraph (A)](#e-1-A) for at least 4 years following the effective date established by the [Secretary](/usc/21/321.md?p=d) for such regulation.
  - (2) **Exemptions; variances—**
    - (A) **Petition—** Any [person](/usc/21/321.md?p=e) subject to any requirement prescribed under [paragraph (1)](#e-1) may petition the [Secretary](/usc/21/321.md?p=d) for a permanent or temporary exemption or variance from such requirement. Such a petition shall be submitted to the [Secretary](/usc/21/321.md?p=d) in such form and manner as the [Secretary](/usc/21/321.md?p=d) shall prescribe and shall—
      - (i) in the case of a petition for an exemption from a requirement, set forth the basis for the petitioner’s determination that compliance with the requirement is not required to assure that the [tobacco product](/usc/21/321.md?p=rr-1) will be in compliance with this subchapter;
      - (ii) in the case of a petition for a variance from a requirement, set forth the methods proposed to be used in, and the facilities and controls proposed to be used for, the manufacture, packing, and storage of the [tobacco product](/usc/21/321.md?p=rr-1) in lieu of the methods, facilities, and controls prescribed by the requirement; and
      - (iii) contain such other information as the [Secretary](/usc/21/321.md?p=d) shall prescribe.
    - (B) **Referral to the Tobacco Products Scientific Advisory Committee—** The [Secretary](/usc/21/321.md?p=d) may refer to the [Tobacco Products](/usc/21/321.md?p=rr-1) Scientific [Advisory Committee](/usc/21/360fff.md?p=1) any petition submitted under [subparagraph (A)](#e-2-A). The [Tobacco Products](/usc/21/321.md?p=rr-1) Scientific [Advisory Committee](/usc/21/360fff.md?p=1) shall report its recommendations to the [Secretary](/usc/21/321.md?p=d) with respect to a petition referred to it within 60 days after the date of the petition’s referral. Within 60 days after—
      - (i) the date the petition was submitted to the [Secretary](/usc/21/321.md?p=d) under [subparagraph (A)](#e-2-A); or
      - (ii) the day after the petition was referred to the [Tobacco Products](/usc/21/321.md?p=rr-1) Scientific [Advisory Committee](/usc/21/360fff.md?p=1),

      whichever occurs later, the [Secretary](/usc/21/321.md?p=d) shall by order either deny the petition or approve it.

    - (C) **Approval—** The [Secretary](/usc/21/321.md?p=d) may approve—
      - (i) a petition for an exemption for a [tobacco product](/usc/21/321.md?p=rr-1) from a requirement if the [Secretary](/usc/21/321.md?p=d) determines that compliance with such requirement is not required to assure that the [tobacco product](/usc/21/321.md?p=rr-1) will be in compliance with this subchapter; and
      - (ii) a petition for a variance for a [tobacco product](/usc/21/321.md?p=rr-1) from a requirement if the [Secretary](/usc/21/321.md?p=d) determines that the methods to be used in, and the facilities and controls to be used for, the manufacture, packing, and storage of the [tobacco product](/usc/21/321.md?p=rr-1) in lieu of the methods, facilities, and controls prescribed by the requirement are sufficient to assure that the [tobacco product](/usc/21/321.md?p=rr-1) will be in compliance with this subchapter.
    - (D) **Conditions—** An order of the [Secretary](/usc/21/321.md?p=d) approving a petition for a variance shall prescribe such conditions respecting the methods used in, and the facilities and controls used for, the manufacture, packing, and storage of the [tobacco product](/usc/21/321.md?p=rr-1) to be granted the variance under the petition as may be necessary to assure that the [tobacco product](/usc/21/321.md?p=rr-1) will be in compliance with this subchapter.
    - (E) **Hearing—** After the issuance of an order under [subparagraph (B)](#e-2-B) respecting a petition, the petitioner shall have an opportunity for an [informal hearing](/usc/21/321.md?p=x) on such order.
  - (3) **Compliance—** Compliance with requirements under this subsection shall not be required before the end of the 3-year period following June 22, 2009.
- (f) **Research and development—** The [Secretary](/usc/21/321.md?p=d) may enter into contracts for research, testing, and demonstrations respecting [tobacco products](/usc/21/321.md?p=rr-1) and may obtain [tobacco products](/usc/21/321.md?p=rr-1) for research, testing, and demonstration purposes.

## Footnotes

[^1]: So in original. Probably should be “are”.

## Source credit

(June 25, 1938, ch. 675, § 906, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1795; amended Pub. L. 116–94, div. N, title I, § 603(a), Dec. 20, 2019, 133 Stat. 3123.)

## Notes

### Editorial Notes

### Prior Provisions

A prior section 906 of act June 25, 1938, was renumbered section 1006 and is classified to section 396 of this title.

### Amendments

2019—Subsec. (d)(3)(A)(ii). Pub. L. 116–94, § 603(a)(1), substituted “21 years” for “18 years”.

Subsec. (d)(5). Pub. L. 116–94, § 603(a)(2), added par. (5).

### Statutory Notes and Related Subsidiaries

### Regulations

Pub. L. 116–94, div. N, title I, § 603(b), Dec. 20, 2019, 133 Stat. 3123, provided that: In general.—Not later than 180 days after the date of enactment of this Act [Dec. 20, 2019], the Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) shall publish in the Federal Register a final rule to update the regulations issued under chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387 et seq.) as appropriate, only to carry out the amendments made by subsection (a) [amending this section], including to update all references to persons younger than 18 years of age in subpart B of part 1140 of title 21, Code of Federal Regulations, and to update the relevant age verification requirements under such part 1140 to require age verification for individuals under the age of 30. Such final rule shall— take full effect not later than 90 days after the date on which such final rule is published; and be deemed to be in compliance with all applicable provisions of chapter 5 of title 5, United States Code[,] and all other provisions of law relating to rulemaking procedures. Other regulations.—Prior to making amendments to part 1140 of title 21, Code of Federal Regulations[,] other than the amendments described in paragraph (1), the Secretary shall promulgate a proposed rule in accordance with chapter 5 of title 5, United States Code.”

### Modification of Deadlines for Secretarial Action

With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.