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

# §387r. Drug products used to treat tobacco dependence

- (a) **In general—** The [Secretary](/usc/21/321.md?p=d) shall—
  - (1) at the request of the applicant, consider designating [products](/usc/21/360eee.md?p=13) for smoking cessation, including [nicotine](/usc/21/387.md?p=12) replacement [products](/usc/21/360eee.md?p=13) as fast track research and approval [products](/usc/21/360eee.md?p=13) within the meaning of [section 356 of this title](/usc/21/356.md);
  - (2) consider approving the extended use of [nicotine](/usc/21/387.md?p=12) replacement [products](/usc/21/360eee.md?p=13) (such as [nicotine](/usc/21/387.md?p=12) patches, [nicotine](/usc/21/387.md?p=12) gum, and [nicotine](/usc/21/387.md?p=12) lozenges) for the treatment of tobacco dependence; and
  - (3) review and consider the evidence for additional indications for [nicotine](/usc/21/387.md?p=12) replacement [products](/usc/21/360eee.md?p=13), such as for craving relief or relapse prevention.
- (b) **Report on innovative products—**
  - (1) **In general—** Not later than 3 years after June 22, 2009, the [Secretary](/usc/21/321.md?p=d), after consultation with recognized scientific, medical, and public health experts (including both Federal agencies and nongovernmental entities, the Institute of Medicine of the National Academy of Sciences, and the Society for Research on [Nicotine](/usc/21/387.md?p=12) and Tobacco), shall submit to the Congress a report that examines how best to regulate, promote, and encourage the development of innovative [products](/usc/21/360eee.md?p=13) and treatments (including [nicotine](/usc/21/387.md?p=12)-based and non-[nicotine](/usc/21/387.md?p=12)-based [products](/usc/21/360eee.md?p=13) and treatments) to better achieve, in a manner that best protects and promotes the public health—
    - (A) total abstinence from tobacco use;
    - (B) reductions in consumption of tobacco; and
    - (C) reductions in the harm associated with continued tobacco use.
  - (2) **Recommendations—** The report under [paragraph (1)](#b-1) shall include the recommendations of the [Secretary](/usc/21/321.md?p=d) on how the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration should coordinate and facilitate the exchange of information on such innovative [products](/usc/21/360eee.md?p=13) and treatments among relevant offices and centers within the Administration and within the National Institutes of Health, the Centers for Disease Control and Prevention, and other relevant agencies.

## Source credit

(June 25, 1938, ch. 675, § 918, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1825.)

## Notes

### Statutory Notes and Related Subsidiaries

### 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.