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

# §387o. Regulation requirement

- (a) **Testing, reporting, and disclosure—** Not later than 36 months after June 22, 2009, the [Secretary](/usc/21/321.md?p=d) shall promulgate regulations under this chapter that meet the requirements of [subsection (b)](#b).
- (b) **Contents of rules—** The regulations promulgated under [subsection (a)](#a)—
  - (1) shall require testing and reporting of [tobacco product](/usc/21/321.md?p=rr-1) constituents, ingredients, and [additives](/usc/21/387.md?p=1), including [smoke constituents](/usc/21/387.md?p=17), by [brand](/usc/21/387.md?p=2) and subbrand that the [Secretary](/usc/21/321.md?p=d) determines should be tested to protect the public health, provided that, for purposes of the testing requirements of this paragraph, [tobacco products](/usc/21/321.md?p=rr-1) manufactured and sold by a single [tobacco product manufacturer](/usc/21/387.md?p=20) that are identical in all respects except the [labels](/usc/21/321.md?p=k), packaging design, logo, trade dress, trademark, [brand](/usc/21/387.md?p=2) name, or any combination thereof, shall be considered as a single [brand](/usc/21/387.md?p=2); and
  - (2) may require that [tobacco product manufacturers](/usc/21/387.md?p=20), packagers, or importers make disclosures relating to the results of the testing of tar and [nicotine](/usc/21/387.md?p=12) through [labels](/usc/21/321.md?p=k) or advertising or other appropriate means, and make disclosures regarding the results of the testing of other constituents, including [smoke constituents](/usc/21/387.md?p=17), ingredients, or [additives](/usc/21/387.md?p=1), that the [Secretary](/usc/21/321.md?p=d) determines should be disclosed to the public to protect the public health and will not mislead consumers about the risk of tobacco-related disease.
- (c) **Authority—** The [Secretary](/usc/21/321.md?p=d) shall have the authority under this subchapter to conduct or to require the testing, reporting, or disclosure of [tobacco product](/usc/21/321.md?p=rr-1) constituents, including [smoke constituents](/usc/21/387.md?p=17).
- (d) **Small tobacco product manufacturers—**
  - (1) **First compliance date—** The initial regulations promulgated under [subsection (a)](#a) shall not impose requirements on [small tobacco product manufacturers](/usc/21/387.md?p=16) before the later of—
    - (A) the end of the 2-year period following the final promulgation of such regulations; and
    - (B) the initial date set by the [Secretary](/usc/21/321.md?p=d) for compliance with such regulations by [manufacturers](/usc/21/360hh.md?p=3) that are not [small tobacco product manufacturers](/usc/21/387.md?p=16).
  - (2) **Testing and reporting initial compliance period—**
    - (A) **4-year period—** The initial regulations promulgated under [subsection (a)](#a) shall give each [small tobacco product manufacturer](/usc/21/387.md?p=16) a 4-year period over which to conduct testing and reporting for all of its [tobacco products](/usc/21/321.md?p=rr-1). Subject to [paragraph (1)](#d-1), the end of the first year of such 4-year period shall coincide with the initial date of compliance under this section set by the [Secretary](/usc/21/321.md?p=d) with respect to [manufacturers](/usc/21/360hh.md?p=3) that are not [small tobacco product manufacturers](/usc/21/387.md?p=16) or the end of the 2-year period following the final promulgation of such regulations, as described in [paragraph (1)(A)](#d-1-A). A [small tobacco product manufacturer](/usc/21/387.md?p=16) shall be required—
      - (i) to conduct such testing and reporting for 25 percent of its [tobacco products](/usc/21/321.md?p=rr-1) during each year of such 4-year period; and
      - (ii) to conduct such testing and reporting for its largest-selling [tobacco products](/usc/21/321.md?p=rr-1) (as determined by the [Secretary](/usc/21/321.md?p=d)) before its other [tobacco products](/usc/21/321.md?p=rr-1), or in such other order of priority as determined by the [Secretary](/usc/21/321.md?p=d).
    - (B) **Case-by-case delay—** Notwithstanding [subparagraph (A)](#d-2-A), the [Secretary](/usc/21/321.md?p=d) may, on a case-by-case basis, delay the date by which an individual [small tobacco product manufacturer](/usc/21/387.md?p=16) must conduct testing and reporting for its [tobacco products](/usc/21/321.md?p=rr-1) under this section based upon a showing of undue hardship to such [manufacturer](/usc/21/360hh.md?p=3). Notwithstanding the preceding sentence, the [Secretary](/usc/21/321.md?p=d) shall not extend the deadline for a [small tobacco product manufacturer](/usc/21/387.md?p=16) to conduct testing and reporting for all of its [tobacco products](/usc/21/321.md?p=rr-1) beyond a total of 5 years after the initial date of compliance under this section set by the [Secretary](/usc/21/321.md?p=d) with respect to [manufacturers](/usc/21/360hh.md?p=3) that are not [small tobacco product manufacturers](/usc/21/387.md?p=16).
  - (3) **Subsequent and additional testing and reporting—** The regulations promulgated under [subsection (a)](#a) shall provide that, with respect to any subsequent or additional testing and reporting of [tobacco products](/usc/21/321.md?p=rr-1) required under this section, such testing and reporting by a [small tobacco product manufacturer](/usc/21/387.md?p=16) shall be conducted in accordance with the timeframes described in [paragraph (2)(A)](#d-2-A), except that, in the case of a new [product](/usc/21/360eee.md?p=13), or if there has been a modification described in [section 387j(a)(1)(B) of this title](/usc/21/387j.md?p=a-1-B) of any [product](/usc/21/360eee.md?p=13) of a [small tobacco product manufacturer](/usc/21/387.md?p=16) since the last testing and reporting required under this section, the [Secretary](/usc/21/321.md?p=d) shall require that any subsequent or additional testing and reporting be conducted in accordance with the same timeframe applicable to [manufacturers](/usc/21/360hh.md?p=3) that are not [small tobacco product manufacturers](/usc/21/387.md?p=16).
  - (4) **Joint laboratory testing services—** The [Secretary](/usc/21/321.md?p=d) shall allow any 2 or more [small tobacco product manufacturers](/usc/21/387.md?p=16) to join together to purchase laboratory testing services required by this section on a group basis in order to ensure that such [manufacturers](/usc/21/360hh.md?p=3) receive access to, and fair pricing of, such testing services.
- (e) **Extensions for limited laboratory capacity—**
  - (1) **In general—** The regulations promulgated under [subsection (a)](#a) shall provide that a [small tobacco product manufacturer](/usc/21/387.md?p=16) shall not be considered to be in violation of this section before the deadline applicable under paragraphs [(3)](#e-3) and [(4)](#e-4), if—
    - (A) the [tobacco products](/usc/21/321.md?p=rr-1) of such [manufacturer](/usc/21/360hh.md?p=3) are in compliance with all other requirements of this subchapter; and
    - (B) the conditions described in [paragraph (2)](#e-2) are met.
  - (2) **Conditions—** Notwithstanding the requirements of this section, the [Secretary](/usc/21/321.md?p=d) may delay the date by which a [small tobacco product manufacturer](/usc/21/387.md?p=16) must be in compliance with the testing and reporting required by this section until such time as the testing is reported if, not later than 90 days before the deadline for reporting in accordance with this section, a [small tobacco product manufacturer](/usc/21/387.md?p=16) provides evidence to the [Secretary](/usc/21/321.md?p=d) demonstrating that—
    - (A) the [manufacturer](/usc/21/360hh.md?p=3) has submitted the required [products](/usc/21/360eee.md?p=13) for testing to a laboratory and has done so sufficiently in advance of the deadline to create a reasonable expectation of completion by the deadline;
    - (B) the [products](/usc/21/360eee.md?p=13) currently are awaiting testing by the laboratory; and
    - (C) neither that laboratory nor any other laboratory is able to complete testing by the deadline at customary, nonexpedited testing fees.
  - (3) **Extension—** The [Secretary](/usc/21/321.md?p=d), taking into account the laboratory testing capacity that is available to [tobacco product manufacturers](/usc/21/387.md?p=20), shall review and [verify](/usc/21/360eee.md?p=28) the evidence submitted by a [small tobacco product manufacturer](/usc/21/387.md?p=16) in accordance with [paragraph (2)](#e-2). If the [Secretary](/usc/21/321.md?p=d) finds that the conditions described in such paragraph are met, the [Secretary](/usc/21/321.md?p=d) shall notify the [small tobacco product manufacturer](/usc/21/387.md?p=16) that the [manufacturer](/usc/21/360hh.md?p=3) shall not be considered to be in violation of the testing and reporting requirements of this section until the testing is reported or until 1 year after the reporting deadline has passed, whichever occurs sooner. If, however, the [Secretary](/usc/21/321.md?p=d) has not made a finding before the reporting deadline, the [manufacturer](/usc/21/360hh.md?p=3) shall not be considered to be in violation of such requirements until the [Secretary](/usc/21/321.md?p=d) finds that the conditions described in [paragraph (2)](#e-2) have not been met, or until 1 year after the reporting deadline, whichever occurs sooner.
  - (4) **Additional extension—** In addition to the time that may be provided under [paragraph (3)](#e-3), the [Secretary](/usc/21/321.md?p=d) may provide further extensions of time, in increments of no more than 1 year, for required testing and reporting to occur if the [Secretary](/usc/21/321.md?p=d) determines, based on evidence properly and timely submitted by a [small tobacco product manufacturer](/usc/21/387.md?p=16) in accordance with [paragraph (2)](#e-2), that a lack of available laboratory capacity prevents the [manufacturer](/usc/21/360hh.md?p=3) from completing the required testing during the period described in [paragraph (3)](#e-3).
- (f) **Rule of construction—** Nothing in subsection [(d)](#d) or [(e)](#e) shall be construed to authorize the extension of any deadline, or to otherwise affect any timeframe, under any provision of this chapter or the Family Smoking Prevention and Tobacco Control Act other than this section.

## Source credit

(June 25, 1938, ch. 675, § 915, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1820.)

## Notes

### Editorial Notes

### References in Text

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

### 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.