U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products December 2023

Final
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NOTE: Appendix B of this guidance that describes frequently asked questions and answers is being distributed for comment purposes only.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 the Appendix B before we begin work on the final version of Appendix B, submit either electronic or written comments on this document by January 18, 2024. 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. 

Download the Guidance


Related Resources

Announcements 


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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.

 
Back to Top