MoCRA Updates: U.S. FDA Updates the Guidance on Cosmetic Facility Registration and Product Listing

On December 11, 2024, the U.S. Food and Drug Administration (FDA) released an updated Guidance on the Registration and Listing of Cosmetic Product Facilities and Products (the Guidance). Originally issued on December 18, 2023, this updated Guidance provides crucial information on terminology, responsible entities for application submissions, required documentation, submission methods, deadlines, and more. It aims to assist stakeholders in navigating the process of registering cosmetic facilities and listing products with the FDA.

The 2023 version of the Guidance included a request for public comments on 19 frequently asked questions (FAQs) in Appendix B (Q1-19). This latest update finalizes the content of these FAQs and introduces three new FAQs (Q20-22), which are open for public comment until January 13, 2025. 

The three newly added FAQs cover the following topics:

• Responsibilities of the US Agent;

• Situations where one Facility Establishment Identifier (FEI) number may be linked to multiple buildings involved in the manufacture or processing of cosmetic products;

• Product listings for free samples and gifts.