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. 

Download the Draft Guidance

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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• Constituent Update: FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products (August 7, 2023) 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