---
kind: "section"
citation: "21 U.S.C. § 364c"
title: "21"
title_heading: "Food and Drugs"
number: "364c"
heading: "Registration and product listing"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/364c"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter VI — Cosmetics"
---

# §364c. Registration and product listing

- (a) **Submission of registration—**
  - (1) **Initial registration—**
    - (A) **Existing facilities—** Every [person](/usc/21/321.md?p=e) that, on December 29, 2022, owns or operates a [facility](/usc/21/364.md?p=3-A) that engages in the manufacturing or processing of a [cosmetic product](/usc/21/364.md?p=2) for [distribution](/usc/21/360eee.md?p=5) in the United States shall register each [facility](/usc/21/364.md?p=3-A) with the [Secretary](/usc/21/321.md?p=d) not later than 1 year after December 29, 2022.
    - (B) **New facilities—** Every [person](/usc/21/321.md?p=e) that owns or operates a [facility](/usc/21/364.md?p=3-A) that first engages, after December 29, 2022, in manufacturing or processing of a [cosmetic product](/usc/21/364.md?p=2) for [distribution](/usc/21/360eee.md?p=5) in the United States, shall register with the [Secretary](/usc/21/321.md?p=d) such [facility](/usc/21/364.md?p=3-A) within 60 days of first engaging in such activity or 60 days after the deadline for registration under [subparagraph (A)](#a-1-A), whichever is later.
  - (2) **Biennial renewal of registration—** A [person](/usc/21/321.md?p=e) required to register a [facility](/usc/21/364.md?p=3-A) under [paragraph (1)](#a-1) shall renew such registrations with the [Secretary](/usc/21/321.md?p=d) biennially.
  - (3) **Contract manufacturers—** If a [facility](/usc/21/364.md?p=3-A) manufactures or processes [cosmetic products](/usc/21/364.md?p=2) on behalf of a [responsible person](/usc/21/364.md?p=4), the [Secretary](/usc/21/321.md?p=d) shall require only a single registration for such [facility](/usc/21/364.md?p=3-A) even if such [facility](/usc/21/364.md?p=3-A) is manufacturing or processing its own [cosmetic products](/usc/21/364.md?p=2) or [cosmetic products](/usc/21/364.md?p=2) on behalf of more than one [responsible person](/usc/21/364.md?p=4). Such single registration may be submitted to the [Secretary](/usc/21/321.md?p=d) by such [facility](/usc/21/364.md?p=3-A) or any [responsible person](/usc/21/364.md?p=4) whose [products](/usc/21/360eee.md?p=13) are manufactured or processed at such [facility](/usc/21/364.md?p=3-A).
  - (4) **Updates to content—** A [person](/usc/21/321.md?p=e) that is required to register under [subsection (a)(1)](#a-1) shall notify the [Secretary](/usc/21/321.md?p=d) within 60 days of any changes to information required under [subsection (b)(2)](#b-2).
  - (5) **Abbreviated renewal registrations—** The [Secretary](/usc/21/321.md?p=d) shall provide for an abbreviated registration renewal process for any [person](/usc/21/321.md?p=e) that owns or operates a [facility](/usc/21/364.md?p=3-A) that has not been required to submit updates under [paragraph (4)](#a-4) for a registered [facility](/usc/21/364.md?p=3-A) since submission of the most recent registration of such [facility](/usc/21/364.md?p=3-A) under paragraph [(1)](#a-1) or [(2)](#a-2).
- (b) **Format; contents of registration—**
  - (1) **In general—** Registration information under this section may be submitted at such time and in such manner as the [Secretary](/usc/21/321.md?p=d) may prescribe.
  - (2) **Contents—** The registration under [subsection (a)](#a) shall contain—
    - (A) the [facility](/usc/21/364.md?p=3-A)’s name, physical address, email address, and telephone number;
    - (B) with respect to any foreign [facility](/usc/21/364.md?p=3-A), the contact for the United States agent of the [facility](/usc/21/364.md?p=3-A), and, if available, the electronic contact information;
    - (C) the [facility](/usc/21/364.md?p=3-A) registration number, if any, previously assigned by the [Secretary](/usc/21/321.md?p=d) under [subsection (d)](#d);
    - (D) all brand names under which [cosmetic products](/usc/21/364.md?p=2) manufactured or processed in the [facility](/usc/21/364.md?p=3-A) are sold; and
    - (E) the [product](/usc/21/360eee.md?p=13) category or categories and [responsible person](/usc/21/364.md?p=4) for each [cosmetic product](/usc/21/364.md?p=2) manufactured or processed at the [facility](/usc/21/364.md?p=3-A).
- (c) **Cosmetic product listing—**
  - (1) **In general—** For each [cosmetic product](/usc/21/364.md?p=2), the [responsible person](/usc/21/364.md?p=4) shall submit to the [Secretary](/usc/21/321.md?p=d) a [cosmetic product](/usc/21/364.md?p=2) listing, or ensure that such submission is made, at such time and in such manner as the [Secretary](/usc/21/321.md?p=d) may prescribe.
  - (2) **Cosmetic product listing—** The [responsible person](/usc/21/364.md?p=4) of a [cosmetic product](/usc/21/364.md?p=2) that is marketed on December 29, 2022, shall submit to the [Secretary](/usc/21/321.md?p=d) a [cosmetic product](/usc/21/364.md?p=2) listing not later than 1 year after December 29, 2022, or for a [cosmetic product](/usc/21/364.md?p=2) that is first marketed after December 29, 2022, within 120 days of marketing such [product](/usc/21/360eee.md?p=13) in [interstate commerce](/usc/21/321.md?p=b). Thereafter, any updates to such listing shall be made annually, consistent with paragraphs [(4)](#c-4) and [(5)](#c-5).
  - (3) **Abbreviated renewal—** The [Secretary](/usc/21/321.md?p=d) shall provide for an abbreviated process for the renewal of any [cosmetic product](/usc/21/364.md?p=2) listing under this subsection with respect to which there has been no change since the [responsible person](/usc/21/364.md?p=4) submitted the previous listing.
  - (4) **Contents of listing—**
    - (A) **In general—** Each such [cosmetic product](/usc/21/364.md?p=2) listing shall include—
      - (i) the [facility](/usc/21/364.md?p=3-A) registration number of each [facility](/usc/21/364.md?p=3-A) where the [cosmetic product](/usc/21/364.md?p=2) is manufactured or processed;
      - (ii) the name and contact number of the [responsible person](/usc/21/364.md?p=4) and the name for the [cosmetic product](/usc/21/364.md?p=2), as such name appears on the [label](/usc/21/321.md?p=k);
      - (iii) the applicable [cosmetic](/usc/21/321.md?p=i) category or categories for the [cosmetic product](/usc/21/364.md?p=2);
      - (iv) a list of ingredients in the [cosmetic product](/usc/21/364.md?p=2), including any fragrances, flavors, or [colors](/usc/21/321.md?p=t-2), with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), or by the common or usual name of the ingredient; and
      - (v) the [product](/usc/21/360eee.md?p=13) listing number, if any previously assigned by the [Secretary](/usc/21/321.md?p=d) under [subsection (d)](#d).
    - (B) **Flexible listings—** A single listing submission for a [cosmetic product](/usc/21/364.md?p=2) may include multiple [cosmetic products](/usc/21/364.md?p=2) with identical formulations, or formulations that differ only with respect to [colors](/usc/21/321.md?p=t-2), fragrances or flavors, or quantity of contents.
  - (5) **Updates to content—** A [responsible person](/usc/21/364.md?p=4) that is required to submit a [cosmetic product](/usc/21/364.md?p=2) listing shall submit any updates to such [cosmetic product](/usc/21/364.md?p=2) listing annually.
  - (6) **Submission—** A [responsible person](/usc/21/364.md?p=4) may submit [product](/usc/21/360eee.md?p=13) listing information as part of a [facility](/usc/21/364.md?p=3-A) registration or separately.
- (d) **Facility registration and product listing numbers—** At the time of the initial registration of any [facility](/usc/21/364.md?p=3-A) under [subsection (a)(1)](#a-1) or initial listing of any [cosmetic product](/usc/21/364.md?p=2) under (c)(1),[^1] the [Secretary](/usc/21/321.md?p=d) shall assign a [facility](/usc/21/364.md?p=3-A) registration number to the [facility](/usc/21/364.md?p=3-A) and a [product](/usc/21/360eee.md?p=13) listing number to each [cosmetic product](/usc/21/364.md?p=2). The [Secretary](/usc/21/321.md?p=d) shall not make such [product](/usc/21/360eee.md?p=13) listing number publicly available.
- (e) **Confidentiality—** In response to a request under [section 552 of title 5](/usc/5/552.md), information described in subsection [(b)(2)(D)](#b-2-D) or [(c)(4)(A)(i)](#c-4-A-i) that is derived from a registration or listing under this section shall be withheld under [section 552(b)(3) of title 5](/usc/5/552.md?p=b-3).
- (f) **Suspensions—**
  - (1) **Suspension of registration of a facility—** The [Secretary](/usc/21/321.md?p=d) may suspend the registration of a [facility](/usc/21/364.md?p=3-A) if the [Secretary](/usc/21/321.md?p=d) determines that a [cosmetic product](/usc/21/364.md?p=2) manufactured or processed by a registered [facility](/usc/21/364.md?p=3-A) and distributed in the United States has a reasonable probability of causing serious adverse health consequences or death to humans and the [Secretary](/usc/21/321.md?p=d) has a reasonable belief that other [products](/usc/21/360eee.md?p=13) manufactured or processed by the [facility](/usc/21/364.md?p=3-A) may be similarly affected because of a failure that cannot be isolated to a [product](/usc/21/360eee.md?p=13) or [products](/usc/21/360eee.md?p=13), or is sufficiently pervasive to raise concerns about other [products](/usc/21/360eee.md?p=13) manufactured in the [facility](/usc/21/364.md?p=3-A).
  - (2) **Notice of suspension—** Before suspending a [facility](/usc/21/364.md?p=3-A) registration under this section, the [Secretary](/usc/21/321.md?p=d) shall provide—
    - (A) notice to the [facility](/usc/21/364.md?p=3-A) registrant of the [cosmetic product](/usc/21/364.md?p=2) or other [responsible person](/usc/21/364.md?p=4), as appropriate, of the intent to suspend the [facility](/usc/21/364.md?p=3-A) registration, which shall specify the basis of the determination by the [Secretary](/usc/21/321.md?p=d) that the [facility](/usc/21/364.md?p=3-A) registration should be suspended; and
    - (B) an opportunity, within 5 business days of the notice provided under [subparagraph (A)](#f-2-A), for the [responsible person](/usc/21/364.md?p=4) to provide a plan for addressing the reasons for possible suspension of the [facility](/usc/21/364.md?p=3-A) registration.
  - (3) **Hearing on suspension—** The [Secretary](/usc/21/321.md?p=d) shall provide the registrant subject to an order under paragraph [(1)](#f-1) or [(2)](#f-2) with an opportunity for an [informal hearing](/usc/21/321.md?p=x), to be held as soon as possible but not later than 5 business days after the issuance of the order, or such other time period agreed upon by the [Secretary](/usc/21/321.md?p=d) and the registrant, on the actions required for reinstatement of registration and why the registration that is subject to the suspension should be reinstated. The [Secretary](/usc/21/321.md?p=d) shall reinstate a registration if the [Secretary](/usc/21/321.md?p=d) determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration.
  - (4) **Post-hearing corrective action plan—** If, after providing opportunity for an [informal hearing](/usc/21/321.md?p=x) under [paragraph (3)](#f-3), the [Secretary](/usc/21/321.md?p=d) determines that the suspension of registration remains necessary, the [Secretary](/usc/21/321.md?p=d) shall require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by the [Secretary](/usc/21/321.md?p=d). The [Secretary](/usc/21/321.md?p=d) shall review such plan not later than 14 business days after the submission of the corrective action plan or such other time period as determined by the [Secretary](/usc/21/321.md?p=d), in consultation with the registrant.
  - (5) **Vacating of order; reinstatement—** Upon a determination by the [Secretary](/usc/21/321.md?p=d) that adequate grounds do not exist to continue the suspension actions, the [Secretary](/usc/21/321.md?p=d) shall promptly vacate the suspension and reinstate the registration of the [facility](/usc/21/364.md?p=3-A).
  - (6) **Effect of suspension—** If the registration of the [facility](/usc/21/364.md?p=3-A) is suspended under this section, no [person](/usc/21/321.md?p=e) shall introduce or deliver for introduction into [commerce](/usc/21/360hh.md?p=4) in the United States [cosmetic products](/usc/21/364.md?p=2) from such [facility](/usc/21/364.md?p=3-A).
  - (7) **No delegation—** The authority conferred by this section to issue an order to suspend a registration or vacate an order of suspension shall not be delegated to any officer or employee other than the [Commissioner](/usc/21/321.md?p=ee).

## Footnotes

[^1]: So in original. Probably should be preceded by “subsection”.

## Source credit

(June 25, 1938, ch. 675, § 607, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5851.)

## Notes

### Statutory Notes and Related Subsidiaries

### Construction; Confidentiality

Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.