GUIDANCE DOCUMENT
Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products August 2023
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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
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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 OfficeOffice 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.
Related Resources
- Pilot Program for Cosmetic Product Facility Registration and Listing Electronic Submissions User Acceptance Testing (August 7, 2023)
- Constituent Update: FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products (August 7, 2023)
- Constituent Update: FDA Has Stopped Accepting Submissions to the Voluntary Cosmetic Registration Program (March 27, 2023)
- Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
- More Cosmetic Guidance & Regulations