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

# §387e. Annual registration

- (a) **Definitions—** In this section:
  - (1) **Manufacture, preparation, compounding, or processing—** The term “manufacture, preparation, compounding, or processing” shall include repackaging or otherwise changing the container, wrapper, or [labeling](/usc/21/321.md?p=m) of any [tobacco product](/usc/21/321.md?p=rr-1) [package](/usc/21/387.md?p=13) in furtherance of the [distribution](/usc/21/360eee.md?p=5) of the [tobacco product](/usc/21/321.md?p=rr-1) from the original place of manufacture to the [person](/usc/21/321.md?p=e) who makes final delivery or sale to the ultimate consumer or user.
  - (2) **Name—** The term “name” shall include in the case of a partnership the name of each partner and, in the case of a corporation, the name of each corporate officer and director, and the [State](/usc/21/387.md?p=19) of incorporation.
- (b) **Registration by owners and operators—** On or before December 31 of each year, every [person](/usc/21/321.md?p=e) who owns or operates any establishment in any [State](/usc/21/387.md?p=19) engaged in the manufacture, preparation, compounding, or processing of a [tobacco product](/usc/21/321.md?p=rr-1) or [tobacco products](/usc/21/321.md?p=rr-1) shall register with the [Secretary](/usc/21/321.md?p=d) the name, places of business, and all such establishments of that [person](/usc/21/321.md?p=e). If enactment of the Family Smoking Prevention and Tobacco Control Act occurs in the second half of the calendar year, the [Secretary](/usc/21/321.md?p=d) shall designate a date no later than 6 months into the subsequent calendar year by which registration pursuant to this subsection shall occur.
- (c) **Registration by new owners and operators—** Every [person](/usc/21/321.md?p=e) upon first engaging in the manufacture, preparation, compounding, or processing of a [tobacco product](/usc/21/321.md?p=rr-1) or [tobacco products](/usc/21/321.md?p=rr-1) in any establishment owned or operated in any [State](/usc/21/387.md?p=19) by that [person](/usc/21/321.md?p=e) shall immediately register with the [Secretary](/usc/21/321.md?p=d) that [person](/usc/21/321.md?p=e)’s name, place of business, and such establishment.
- (d) **Registration of added establishments—** Every [person](/usc/21/321.md?p=e) required to register under subsection [(b)](#b) or [(c)](#c) shall immediately register with the [Secretary](/usc/21/321.md?p=d) any additional establishment which that [person](/usc/21/321.md?p=e) owns or operates in any [State](/usc/21/387.md?p=19) and in which that [person](/usc/21/321.md?p=e) begins the manufacture, preparation, compounding, or processing of a [tobacco product](/usc/21/321.md?p=rr-1) or [tobacco products](/usc/21/321.md?p=rr-1).
- (e) **Uniform product identification system—** The [Secretary](/usc/21/321.md?p=d) may by regulation prescribe a uniform system for the identification of [tobacco products](/usc/21/321.md?p=rr-1) and may require that [persons](/usc/21/321.md?p=e) who are required to list such [tobacco products](/usc/21/321.md?p=rr-1) under [subsection (i)](#i) shall list such [tobacco products](/usc/21/321.md?p=rr-1) in accordance with such system.
- (f) **Public access to registration information—** The [Secretary](/usc/21/321.md?p=d) shall make available for inspection, to any [person](/usc/21/321.md?p=e) so requesting, any registration filed under this section.
- (g) **Biennial inspection of registered establishments—** Every establishment registered with the [Secretary](/usc/21/321.md?p=d) under this section shall be subject to inspection under [section 374 of this title](/usc/21/374.md) or [subsection (h)](#h), and every such establishment engaged in the manufacture, compounding, or processing of a [tobacco product](/usc/21/321.md?p=rr-1) or [tobacco products](/usc/21/321.md?p=rr-1) shall be so inspected by 1 or more officers or employees duly designated by the [Secretary](/usc/21/321.md?p=d) at least once in the 2-year period beginning with the date of registration of such establishment under this section and at least once in every successive 2-year period thereafter.
- (h) **Registration by foreign establishments—** Any establishment within any foreign country engaged in the manufacture, preparation, compounding, or processing of a [tobacco product](/usc/21/321.md?p=rr-1) or [tobacco products](/usc/21/321.md?p=rr-1), shall register under this section under regulations promulgated by the [Secretary](/usc/21/321.md?p=d). Such regulations shall require such establishment to provide the information required by [subsection (i)](#i) and shall include provisions for registration of any such establishment upon condition that adequate and effective means are available, by arrangement with the government of such foreign country or otherwise, to enable the [Secretary](/usc/21/321.md?p=d) to determine from time to time whether [tobacco products](/usc/21/321.md?p=rr-1) manufactured, prepared, compounded, or processed in such establishment, if imported or offered for import into the [United States](/usc/21/387.md?p=22), shall be refused admission on any of the grounds set forth in [section 381(a) of this title](/usc/21/381.md?p=a).
- (i) **Registration information—**
  - (1) **Product list—** Every [person](/usc/21/321.md?p=e) who registers with the [Secretary](/usc/21/321.md?p=d) under subsection [(b)](#b), [(c)](#c), [(d)](#d), or [(h)](#h) shall, at the time of registration under any such subsection, file with the [Secretary](/usc/21/321.md?p=d) a list of all [tobacco products](/usc/21/321.md?p=rr-1) which are being manufactured, prepared, compounded, or processed by that [person](/usc/21/321.md?p=e) for commercial [distribution](/usc/21/360eee.md?p=5) and which have not been included in any list of [tobacco products](/usc/21/321.md?p=rr-1) filed by that [person](/usc/21/321.md?p=e) with the [Secretary](/usc/21/321.md?p=d) under this paragraph or [paragraph (2)](#i-2) before such time of registration. Such list shall be prepared in such form and manner as the [Secretary](/usc/21/321.md?p=d) may prescribe and shall be accompanied by—
    - (A) in the case of a [tobacco product](/usc/21/321.md?p=rr-1) contained in the applicable list with respect to which a [tobacco product](/usc/21/321.md?p=rr-1) standard has been established under [section 387g of this title](/usc/21/387g.md) or which is subject to [section 387j of this title](/usc/21/387j.md), a reference to the authority for the marketing of such [tobacco product](/usc/21/321.md?p=rr-1) and a copy of all [labeling](/usc/21/321.md?p=m) for such [tobacco product](/usc/21/321.md?p=rr-1);
    - (B) in the case of any other [tobacco product](/usc/21/321.md?p=rr-1) contained in an applicable list, a copy of all consumer information and other [labeling](/usc/21/321.md?p=m) for such [tobacco product](/usc/21/321.md?p=rr-1), a representative sampling of advertisements for such [tobacco product](/usc/21/321.md?p=rr-1), and, upon request made by the [Secretary](/usc/21/321.md?p=d) for good cause, a copy of all advertisements for a particular [tobacco product](/usc/21/321.md?p=rr-1); and
    - (C) if the registrant filing a list has determined that a [tobacco product](/usc/21/321.md?p=rr-1) contained in such list is not subject to a [tobacco product](/usc/21/321.md?p=rr-1) standard established under [section 387g of this title](/usc/21/387g.md), a brief statement of the basis upon which the registrant made such determination if the [Secretary](/usc/21/321.md?p=d) requests such a statement with respect to that particular [tobacco product](/usc/21/321.md?p=rr-1).
  - (2) **Consultation with respect to forms—** The [Secretary](/usc/21/321.md?p=d) shall consult with the [Secretary](/usc/21/321.md?p=d) of the Treasury in developing the forms to be used for registration under this section to minimize the burden on those [persons](/usc/21/321.md?p=e) required to register with both the [Secretary](/usc/21/321.md?p=d) and the Tax and Trade Bureau of the [Department](/usc/21/321.md?p=c) of the Treasury.
  - (3) **Biannual report of any change in product list—** Each [person](/usc/21/321.md?p=e) who registers with the [Secretary](/usc/21/321.md?p=d) under this section shall report to the [Secretary](/usc/21/321.md?p=d) once during the month of June of each year and once during the month of December of each year the following:
    - (A) A list of each [tobacco product](/usc/21/321.md?p=rr-1) introduced by the registrant for commercial [distribution](/usc/21/360eee.md?p=5) which has not been included in any list previously filed by that [person](/usc/21/321.md?p=e) with the [Secretary](/usc/21/321.md?p=d) under this subparagraph or [paragraph (1)](#i-1). A list under this subparagraph shall list a [tobacco product](/usc/21/321.md?p=rr-1) by its established name and shall be accompanied by the other information required by [paragraph (1)](#i-1).
    - (B) If since the date the registrant last made a report under this paragraph that [person](/usc/21/321.md?p=e) has discontinued the manufacture, preparation, compounding, or processing for commercial [distribution](/usc/21/360eee.md?p=5) of a [tobacco product](/usc/21/321.md?p=rr-1) included in a list filed under [subparagraph (A)](#i-3-A) or [paragraph (1)](#i-1), notice of such discontinuance, the date of such discontinuance, and the identity of its established name.
    - (C) If since the date the registrant reported under [subparagraph (B)](#i-3-B) a notice of discontinuance that [person](/usc/21/321.md?p=e) has resumed the manufacture, preparation, compounding, or processing for commercial [distribution](/usc/21/360eee.md?p=5) of the [tobacco product](/usc/21/321.md?p=rr-1) with respect to which such notice of discontinuance was reported, notice of such resumption, the date of such resumption, the identity of such [tobacco product](/usc/21/321.md?p=rr-1) by established name, and other information required by [paragraph (1)](#i-1), unless the registrant has previously reported such resumption to the [Secretary](/usc/21/321.md?p=d) under this subparagraph.
    - (D) Any material change in any information previously submitted under this paragraph or [paragraph (1)](#i-1).
- (j) **Report preceding introduction of certain substantially equivalent products into interstate commerce—**
  - (1) **In general—** Each [person](/usc/21/321.md?p=e) who is required to register under this section and who proposes to begin the introduction or delivery for introduction into [interstate commerce](/usc/21/321.md?p=b) for commercial [distribution](/usc/21/360eee.md?p=5) of a [tobacco product](/usc/21/321.md?p=rr-1) intended for human use that was not commercially marketed (other than for test marketing) in the [United States](/usc/21/387.md?p=22) as of February 15, 2007, shall, at least 90 days prior to making such introduction or delivery, report 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)—
    - (A) the basis for such [person](/usc/21/321.md?p=e)’s determination that—
      - (i) the [tobacco product](/usc/21/321.md?p=rr-1) is substantially equivalent, within the meaning of [section 387j of this title](/usc/21/387j.md), to a [tobacco product](/usc/21/321.md?p=rr-1) commercially marketed (other than for test marketing) in the [United States](/usc/21/387.md?p=22) as of February 15, 2007, or to a [tobacco product](/usc/21/321.md?p=rr-1) that the [Secretary](/usc/21/321.md?p=d) has previously determined, pursuant to subsection (a)(3) of [section 387j of this title](/usc/21/387j.md), is substantially equivalent and that is in compliance with the requirements of this chapter; or
      - (ii) the [tobacco product](/usc/21/321.md?p=rr-1) is modified within the meaning of [paragraph (3)](#j-3), the modifications are to a [product](/usc/21/360eee.md?p=13) that is commercially marketed and in compliance with the requirements of this chapter, and all of the modifications are covered by exemptions granted by the [Secretary](/usc/21/321.md?p=d) pursuant to [paragraph (3)](#j-3); and
    - (B) action taken by such [person](/usc/21/321.md?p=e) to comply with the requirements under [section 387g of this title](/usc/21/387g.md) that are applicable to the [tobacco product](/usc/21/321.md?p=rr-1).
  - (2) **Application to certain post–February 15, 2007, products—** A report under this subsection for a [tobacco product](/usc/21/321.md?p=rr-1) that was first introduced or delivered for introduction into [interstate commerce](/usc/21/321.md?p=b) for commercial [distribution](/usc/21/360eee.md?p=5) in the [United States](/usc/21/387.md?p=22) after February 15, 2007, and prior to the date that is 21 months after June 22, 2009, shall be submitted to the [Secretary](/usc/21/321.md?p=d) not later than 21 months after June 22, 2009.
  - (3) **Exemptions—**
    - (A) **In general—** The [Secretary](/usc/21/321.md?p=d) may exempt from the requirements of this subsection relating to the demonstration that a [tobacco product](/usc/21/321.md?p=rr-1) is substantially equivalent within the meaning of [section 387j of this title](/usc/21/387j.md), [tobacco products](/usc/21/321.md?p=rr-1) that are modified by adding or deleting a tobacco [additive](/usc/21/387.md?p=1), or increasing or decreasing the quantity of an existing tobacco [additive](/usc/21/387.md?p=1), if the [Secretary](/usc/21/321.md?p=d) determines that—
      - (i) such modification would be a minor modification of a [tobacco product](/usc/21/321.md?p=rr-1) that can be sold under this chapter;
      - (ii) a report under this subsection is not necessary to ensure that permitting the [tobacco product](/usc/21/321.md?p=rr-1) to be marketed would be appropriate for protection of the public health; and
      - (iii) an exemption is otherwise appropriate.
    - (B) **Regulations—** Not later than 15 months after June 22, 2009, the [Secretary](/usc/21/321.md?p=d) shall issue regulations to implement this paragraph.

## Source credit

(June 25, 1938, ch. 675, § 905, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1792.)

## Notes

### Editorial Notes

### References in Text

The Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (b), 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.

### Prior Provisions

A prior section 905 of act June 25, 1938, was renumbered section 1005 and is classified to section 395 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.