US FDA Updates Guidance for Industry on Registration and Listing of Cosmetic Product Facilities and Products

In December 11, 2024, the U.S. Food and Drug Administration (FDA) issued updated guidance for industry on registration and listing of cosmetic product facilities and products. The guidance finalizes the frequently asked questions and answers (FAQ) in Appendix B (Q1-19). In addition, three new FAQs (Q20-22) in Appendix B of the guidance are marked as “for comment purposes only”. These three FAQs are available for comments before January 13, 2025.

The three new FAQ address the following topics:

• responsibilities of a U.S. Agent
• situations when one FEI number may be associated with multiple buildings that manufacture or process cosmetic products
• product listing for free samples/gifts

The FDA first issued a final guidance for industry on cosmetic product facility registrations and product listings in December, 2023, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The guidance assists stakeholders with requirements for cosmetic product facility registration and product listing submissions to the FDA by describing who is responsible for making the registration and listing submissions, what information to include, how to submit, when to submit and certain exemptions to the registrations and listing.

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Further Information

FDA Notices