---
kind: "section"
citation: "21 U.S.C. § 387a–1"
title: "21"
title_heading: "Food and Drugs"
number: "387a–1"
heading: "Final rule"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/387a-1"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter IX — Tobacco Products"
---

# §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](/usc/21/321.md?p=d) of Health and Human Services shall publish in the Federal Register a final rule regarding [cigarettes](/usc/21/387.md?p=3) and [smokeless tobacco](/usc/21/387.md?p=18), which—
    - (A) is deemed to be issued under [chapter 9](/usc/21/chch9.md)[^1] of the Federal [Food](/usc/21/321.md?p=f), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. 387](/usc/21/387.md) et seq.], as added by [section 101](/usc/21/101.md) of this division; and
    - (B) shall be deemed to be in compliance with all applicable provisions of [chapter 5](/usc/5/chptI/ch5.md) of title 5 and all other provisions of law relating to rulemaking procedures.
  - (2) **Contents of rule—** Except as provided in this subsection, the final rule published under [paragraph (1)](#a-1),[^2] shall be identical in its provisions to part 897 of the regulations promulgated by the [Secretary](/usc/21/321.md?p=d) 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 jurisdictional authority that is in accordance with this subsection in accordance with this division and the amendments made by this division;
    - (B) strike Subpart C—[Labels](/usc/21/321.md?p=k) and section 897.32(c);
    - (C) strike paragraphs (a), (b), and (i) of section 897.3 and insert definitions of the terms “[cigarette](/usc/21/387.md?p=3)”, “[cigarette tobacco](/usc/21/387.md?p=4)”, and “[smokeless tobacco](/usc/21/387.md?p=18)” as defined in section 900 of the Federal [Food](/usc/21/321.md?p=f), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. 387](/usc/21/387.md)];
    - (D) insert “or roll-your-own paper” in section 897.34(a) after “other than [cigarettes](/usc/21/387.md?p=3) or [smokeless tobacco](/usc/21/387.md?p=18)”;
    - (E) include such modifications to section 897.30(b), if any, that the [Secretary](/usc/21/321.md?p=d) determines are appropriate in light of governing First Amendment case law, including the decision of the Supreme Court of the [United States](/usc/21/387.md?p=22) 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](/usc/21/360hh.md?p=3), [distributor](/usc/21/387.md?p=7), or [retailer](/usc/21/387.md?p=14) may [distribute](/usc/21/360eee.md?p=5) or cause to be distributed any free samples of [cigarettes](/usc/21/387.md?p=3), [smokeless tobacco](/usc/21/387.md?p=18), or other [tobacco products](/usc/21/321.md?p=rr-1) (as such term is defined in [section 201](/usc/21/201.md) of the Federal [Food](/usc/21/321.md?p=f), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act).
  - “(2)
    - (A) Subparagraph (1) does not prohibit a [manufacturer](/usc/21/360hh.md?p=3), [distributor](/usc/21/387.md?p=7), or [retailer](/usc/21/387.md?p=14) from distributing or causing to be distributed free samples of [smokeless tobacco](/usc/21/387.md?p=18) in a qualified adult-only facility.
    - “(B) This subparagraph does not affect the authority of a [State](/usc/21/387.md?p=19) or local government to prohibit or otherwise restrict the [distribution](/usc/21/360eee.md?p=5) of free samples of [smokeless tobacco](/usc/21/387.md?p=18).
    - “(C) For purposes of this paragraph, the term ‘qualified adult-only facility’ means a facility or restricted area that—
      - “(i) requires each [person](/usc/21/321.md?p=e) present to provide to a law enforcement officer (whether on or off duty) or to a security guard [licensed](/usc/21/360eee.md?p=9) by a governmental entity government-issued identification showing a photograph and at least the minimum age established by applicable law for the purchase of [smokeless tobacco](/usc/21/387.md?p=18);
      - “(ii) does not sell, serve, or [distribute](/usc/21/360eee.md?p=5) alcohol;
      - “(iii) is not located adjacent to or immediately across from (in any direction) a space that is used primarily for youth-oriented marketing, promotional, or other activities;
      - “(iv) is a temporary structure constructed, designated, and operated as a distinct enclosed area for the purpose of distributing free samples of [smokeless tobacco](/usc/21/387.md?p=18) in accordance with this subparagraph;
      - “(v) is enclosed by a barrier that—
        - “(I) is constructed of, or covered with, an opaque material (except for entrances and exits);
        - “(II) extends from no more than 12 inches above the ground or floor (which area at the bottom of the barrier must be covered with material that restricts visibility but may allow airflow) to at least 8 feet above the ground or floor (or to the ceiling); and
        - “(III) prevents [persons](/usc/21/321.md?p=e) outside the qualified adult-only facility from seeing into the qualified adult-only facility, unless they make unreasonable efforts to do so; and
      - “(vi) does not display on its exterior—
        - “(I) any [tobacco product](/usc/21/321.md?p=rr-1) advertising;
        - “(II) a [brand](/usc/21/387.md?p=2) name other than in conjunction with words for an area or enclosure to identify an adult-only facility; or
        - “(III) any combination of words that would imply to a reasonable observer that the [manufacturer](/usc/21/360hh.md?p=3), [distributor](/usc/21/387.md?p=7), or [retailer](/usc/21/387.md?p=14) has a sponsorship that would violate section 897.34(c).
    - “(D) [Distribution](/usc/21/360eee.md?p=5) of samples of [smokeless tobacco](/usc/21/387.md?p=18) under this subparagraph permitted to be taken out of the qualified adult-only facility shall be limited to 1 [package](/usc/21/387.md?p=13) per adult consumer containing no more than 0.53 ounces (15 grams) of [smokeless tobacco](/usc/21/387.md?p=18). If such [package](/usc/21/387.md?p=13) of [smokeless tobacco](/usc/21/387.md?p=18) contains individual portions of [smokeless tobacco](/usc/21/387.md?p=18), the individual portions of [smokeless tobacco](/usc/21/387.md?p=18) shall not exceed 8 individual portions and the collective weight of such individual portions shall not exceed 0.53 ounces (15 grams). Any [manufacturer](/usc/21/360hh.md?p=3), [distributor](/usc/21/387.md?p=7), or [retailer](/usc/21/387.md?p=14) who [distributes](/usc/21/360eee.md?p=5) or causes to be distributed free samples also shall take reasonable steps to ensure that the above amounts are limited to one such [package](/usc/21/387.md?p=13) per adult consumer per day.
  - “(3) Notwithstanding subparagraph (2), no [manufacturer](/usc/21/360hh.md?p=3), [distributor](/usc/21/387.md?p=7), or [retailer](/usc/21/387.md?p=14) may [distribute](/usc/21/360eee.md?p=5) or cause to be distributed any free samples of [smokeless tobacco](/usc/21/387.md?p=18)—
    - “(A) to a sports team or entertainment group; or
    - “(B) at any football, basketball, baseball, soccer, or hockey event or any other sporting or entertainment event determined by the [Secretary](/usc/21/321.md?p=d) to be covered by this subparagraph.
  - “(4) The [Secretary](/usc/21/321.md?p=d) shall implement a program to ensure compliance with this paragraph and submit a report to the Congress on such compliance not later than 18 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act.
  - “(5) Nothing in this paragraph shall be construed to authorize any [person](/usc/21/321.md?p=e) to [distribute](/usc/21/360eee.md?p=5) or cause to be distributed any sample of a [tobacco product](/usc/21/321.md?p=rr-1) to any individual who has not attained the minimum age established by applicable law for the purchase of such [product](/usc/21/360eee.md?p=13).”.
- (b) **Limitation on advisory opinions—** As of June 22, 2009, the following documents issued by the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration shall not constitute advisory opinions under section 10.85(d)(1) of title 21, Code of Federal Regulations, except as they apply to [tobacco products](/usc/21/321.md?p=rr-1), and shall not be cited by the [Secretary](/usc/21/321.md?p=d) of Health and Human Services or the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration as binding precedent:
  - (1) The preamble to the proposed rule in the document titled “Regulations Restricting the Sale and [Distribution](/usc/21/360eee.md?p=5) of [Cigarettes](/usc/21/387.md?p=3) and [Smokeless Tobacco](/usc/21/387.md?p=18) [Products](/usc/21/360eee.md?p=13) to Protect Children and Adolescents” (60 Fed. Reg. 41314–41372 (August 11, 1995)).
  - (2) The document titled “[Nicotine](/usc/21/387.md?p=12) in [Cigarettes](/usc/21/387.md?p=3) and [Smokeless Tobacco](/usc/21/387.md?p=18) [Products](/usc/21/360eee.md?p=13) is a [Drug](/usc/21/321.md?p=g-1) and These [Products](/usc/21/360eee.md?p=13) Are [Nicotine](/usc/21/387.md?p=12) Delivery [Devices](/usc/21/321.md?p=h-1) Under the Federal [Food](/usc/21/321.md?p=f), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act” (60 Fed. Reg. 41453–41787 (August 11, 1995)).
  - (3) The preamble to the final rule in the document titled “Regulations Restricting the Sale and [Distribution](/usc/21/360eee.md?p=5) of [Cigarettes](/usc/21/387.md?p=3) and [Smokeless Tobacco](/usc/21/387.md?p=18) to Protect Children and Adolescents” (61 Fed. Reg. 44396–44615 (August 28, 1996)).
  - (4) The document titled “[Nicotine](/usc/21/387.md?p=12) in [Cigarettes](/usc/21/387.md?p=3) and [Smokeless Tobacco](/usc/21/387.md?p=18) is a [Drug](/usc/21/321.md?p=g-1) and These [Products](/usc/21/360eee.md?p=13) are [Nicotine](/usc/21/387.md?p=12) Delivery [Devices](/usc/21/321.md?p=h-1) Under the Federal [Food](/usc/21/321.md?p=f), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act; Jurisdictional Determination” (61 Fed. Reg. 44619–45318 (August 28, 1996)).

## Footnotes

[^1]: So in original. Probably should be “chapter IX”.
[^2]: So in original. The comma probably should not appear.
[^3]: So in original. See References in Text note below.

## Source credit

(Pub. L. 111–31, div. A, title I, § 102, June 22, 2009, 123 Stat. 1830.)

## Notes

### Editorial Notes

### References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a)(1)(A), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of this title. Chapter 9 [IX] of the Act is classified generally to this subchapter. For complete classification of this Act to the Code, see section 301 of this title and Tables.

This division, referred to in subsec. (a)(2)(A), (5), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776, known as the Family Smoking Prevention and Tobacco Control Act. For complete classification of division A to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables.

The date of enactment of the Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (a)(2)(G), is the date of enactment of Pub. L. 111–31, which was approved June 22, 2009.

Section 103(q), referred to in subsec. (a)(6), is section 103(q) of Pub. L. 111–31, which enacted provisions set out as notes under sections 333 and 387c of this title.

### Codification

Section was enacted as part of the Family Smoking Prevention and Tobacco Control Act and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

### Statutory Notes and Related Subsidiaries

### Modification of Deadlines for Secretarial Action

For provision deeming reference to “180 days” in subsec. (a)(1) to be “270 days”, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.