Cosmetics Constituent Update
December 11, 2024
The U.S. Food and Drug Administration (FDA) issued updated guidance entitled Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products. In summary, the guidance finalizes the frequently asked questions and answers (FAQ) in Appendix B (Q1-19). In addition, three new FAQ in Appendix B of this guidance (Q20-22) are marked “for comment purposes only” to provide an opportunity for comment before they are finalized.
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, and product listings 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). At that time, we asked for comments on the FAQ in Appendix B (Q1-19). 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 registration and listing. For more information, including on exemptions and Cosmetics Direct, refer to the guidance and resources in the “Additional Information” section below.
Comment Period
To ensure that the agency considers your comments on the three new FAQ (Q20 – Q22) in Appendix B before it begins work on the final versions of these FAQ, submit either electronic or written comments on these FAQ, as described in the Federal Register Notice: Guidance: Registration and Listing of Cosmetic Product Facilities and Products. The comment period closes on January 13, 2025.
Additional Information
- Constituent Update: FDA Issues Final Guidance on Registration and Listing of Cosmetic Product Facilities and Products (December 2023)
- Federal Register Notice for the Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (December 2023)
- Webpage of Resources: Registration & Listing of Cosmetic Product Facilities and Products
Posted in Cosmetics, FDA and USDA Regulatory Update.