---
kind: "section"
citation: "21 U.S.C. § 387d"
title: "21"
title_heading: "Food and Drugs"
number: "387d"
heading: "Submission of health information to the Secretary"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/387d"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter IX — Tobacco Products"
---

# §387d. Submission of health information to the Secretary

- (a) **Requirement—** Each [tobacco product manufacturer](/usc/21/387.md?p=20) or importer, or agents thereof, shall submit to the [Secretary](/usc/21/321.md?p=d) the following information:
  - (1) Not later than 6 months after June 22, 2009, a listing of all ingredients, including tobacco, substances, compounds, and [additives](/usc/21/387.md?p=1) that are, as of such date, added by the [manufacturer](/usc/21/360hh.md?p=3) to the tobacco, paper, filter, or other part of each [tobacco product](/usc/21/321.md?p=rr-1) by [brand](/usc/21/387.md?p=2) and by quantity in each [brand](/usc/21/387.md?p=2) and subbrand.
  - (2) A description of the content, delivery, and form of [nicotine](/usc/21/387.md?p=12) in each [tobacco product](/usc/21/321.md?p=rr-1) measured in milligrams of [nicotine](/usc/21/387.md?p=12) in accordance with regulations promulgated by the [Secretary](/usc/21/321.md?p=d) in accordance with [section 1333(e) of title 15](/usc/15/1333.md?p=e).
  - (3) Beginning 3 years after June 22, 2009, a listing of all constituents, including [smoke constituents](/usc/21/387.md?p=17) as applicable, identified by the [Secretary](/usc/21/321.md?p=d) as harmful or potentially harmful to health in each [tobacco product](/usc/21/321.md?p=rr-1), and as applicable in the smoke of each [tobacco product](/usc/21/321.md?p=rr-1), by [brand](/usc/21/387.md?p=2) and by quantity in each [brand](/usc/21/387.md?p=2) and subbrand. Effective beginning 3 years after June 22, 2009, the [manufacturer](/usc/21/360hh.md?p=3), importer, or agent shall comply with regulations promulgated under [section 387o](/usc/21/387o.md) of this title in reporting information under this paragraph, where applicable.
  - (4) Beginning 6 months after June 22, 2009, all documents developed after June 22, 2009 that relate to health, toxicological, behavioral, or physiologic effects of current or future [tobacco products](/usc/21/321.md?p=rr-1), their constituents (including [smoke constituents](/usc/21/387.md?p=17)), ingredients, components, and [additives](/usc/21/387.md?p=1).
- (b) **Data submission—** At the request of the [Secretary](/usc/21/321.md?p=d), each [tobacco product manufacturer](/usc/21/387.md?p=20) or importer of [tobacco products](/usc/21/321.md?p=rr-1), or agents thereof, shall submit the following:
  - (1) Any or all documents (including underlying scientific information) relating to research activities, and research findings, conducted, supported, or possessed by the [manufacturer](/usc/21/360hh.md?p=3) (or agents thereof) on the health, toxicological, behavioral, or physiologic effects of [tobacco products](/usc/21/321.md?p=rr-1) and their constituents (including [smoke constituents](/usc/21/387.md?p=17)), ingredients, components, and [additives](/usc/21/387.md?p=1).
  - (2) Any or all documents (including underlying scientific information) relating to research activities, and research findings, conducted, supported, or possessed by the [manufacturer](/usc/21/360hh.md?p=3) (or agents thereof) that relate to the issue of whether a reduction in risk to health from [tobacco products](/usc/21/321.md?p=rr-1) can occur upon the employment of technology available or known to the [manufacturer](/usc/21/360hh.md?p=3).
  - (3) Any or all documents (including underlying scientific or financial information) relating to marketing research involving the use of [tobacco products](/usc/21/321.md?p=rr-1) or marketing practices and the effectiveness of such practices used by tobacco [manufacturers](/usc/21/360hh.md?p=3) and [distributors](/usc/21/387.md?p=7).

  An importer of a [tobacco product](/usc/21/321.md?p=rr-1) not manufactured in the [United States](/usc/21/387.md?p=22) shall supply the information required of a [tobacco product manufacturer](/usc/21/387.md?p=20) under this subsection.

- (c) **Time for submission—**
  - (1) **In general—** At least 90 days prior to the delivery for introduction into [interstate commerce](/usc/21/321.md?p=b) of a [tobacco product](/usc/21/321.md?p=rr-1) not on the market on June 22, 2009, the [manufacturer](/usc/21/360hh.md?p=3) of such [product](/usc/21/360eee.md?p=13) shall provide the information required under [subsection (a)](#a).
  - (2) **Disclosure of additive—** If at any time a [tobacco product manufacturer](/usc/21/387.md?p=20) adds to its [tobacco products](/usc/21/321.md?p=rr-1) a new tobacco [additive](/usc/21/387.md?p=1) or increases the quantity of an existing tobacco [additive](/usc/21/387.md?p=1), the [manufacturer](/usc/21/360hh.md?p=3) shall, except as provided in [paragraph (3)](#c-3), at least 90 days prior to such action so advise the [Secretary](/usc/21/321.md?p=d) in writing.
  - (3) **Disclosure of other actions—** If at any time a [tobacco product manufacturer](/usc/21/387.md?p=20) eliminates or decreases an existing [additive](/usc/21/387.md?p=1), or adds or increases an [additive](/usc/21/387.md?p=1) that has by regulation been designated by the [Secretary](/usc/21/321.md?p=d) as an [additive](/usc/21/387.md?p=1) that is not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use, the [manufacturer](/usc/21/360hh.md?p=3) shall within 60 days of such action so advise the [Secretary](/usc/21/321.md?p=d) in writing.
- (d) **Data list—**
  - (1) **In general—** Not later than 3 years after June 22, 2009, and annually thereafter, the [Secretary](/usc/21/321.md?p=d) shall publish in a format that is understandable and not misleading to a lay [person](/usc/21/321.md?p=e), and place on public display (in a manner determined by the [Secretary](/usc/21/321.md?p=d)) the list established under [subsection (e)](#e).
  - (2) **Consumer research—** The [Secretary](/usc/21/321.md?p=d) shall conduct periodic consumer research to ensure that the list published under [paragraph (1)](#d-1) is not misleading to lay [persons](/usc/21/321.md?p=e). Not later than 5 years after June 22, 2009, the [Secretary](/usc/21/321.md?p=d) shall submit to the appropriate committees of Congress a report on the results of such research, together with recommendations on whether such publication should be continued or modified.
- (e) **Data collection—** Not later than 24 months after June 22, 2009, the [Secretary](/usc/21/321.md?p=d) shall establish, and periodically revise as appropriate, a list of harmful and potentially harmful constituents, including [smoke constituents](/usc/21/387.md?p=17), to health in each [tobacco product](/usc/21/321.md?p=rr-1) by [brand](/usc/21/387.md?p=2) and by quantity in each [brand](/usc/21/387.md?p=2) and subbrand. The [Secretary](/usc/21/321.md?p=d) shall publish a public notice requesting the submission by interested [persons](/usc/21/321.md?p=e) of scientific and other information concerning the harmful and potentially harmful constituents in [tobacco products](/usc/21/321.md?p=rr-1) and tobacco smoke.

## Source credit

(June 25, 1938, ch. 675, § 904, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1790.)

## Notes

### Editorial Notes

### Prior Provisions

A prior section 904 of act June 25, 1938, was renumbered section 1004 and is classified to section 394 of this title.

### 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.