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GUIDANCE DOCUMENT

Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products December 2024

Download the Final Guidance Document Read the Federal Register Notice
Final

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-1716

Docket Number:
FDA-2023-D-1716
Issued by:
Guidance Issuing Office
Office of the Commissioner, Office of the Chief Scientist

This guidance provides recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA. This guidance document explains, among other things:

  • The statutory requirement to submit cosmetic product facility registrations and product listings;
  • Definitions;
  • Who is responsible for making the submissions;
  • What information to include in the submissions;
  • How to make the submissions; and
  • When to make the submissions.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

NOTE: Appendix B of this guidance describes frequently asked questions and answers. The portion of this guidance in Appendix B that describes three new frequently asked questions and answers (Q20-22), is being distributed for comment purposes only. 

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on Q20-Q22 in Appendix B before we begin work on the final version of Q20-Q22 in Appendix B, submit either electronic or written comments on this document within 30 days of publication in the Federal Register of the notice announcing the availability of the guidance. You may submit comments electronically on Regulations.gov to docket folder FDA-2023-D-1716. See the Federal Register notice for additional information on commenting. 

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