On December 11, 2024, the U.S. FDA released updated guidance on cosmetic registration, facility registration, and product listing.
The updated guidelines provide guidance on who is responsible for facility registration and product listing, what information needs to be submitted, and how to submit it.
The updated content includes three new questions and answers (Q20-Q22) in Appendix B of the FAQ:
Q20. Responsibilities of a U.S. Agent
- Assist with communication between FDA authorities and foreign manufacturing facilities.
- Respond to questions regarding products from foreign facilities that are imported into or offered for import into the U.S.
- Support FDA inspection scheduling for foreign facilities.
- Receive information and documents from FDA on behalf of foreign facilities when FDA cannot directly or quickly contact the foreign facility.
* FDA does not recommend or endorse specific U.S. Agents.
Q21. Multiple Buildings Associated with One Facility Establishment Identifier (FEI) for Cosmetic Manufacturing or Processing
- Multiple buildings with different physical addresses (within 3 miles of each other) may be managed under one FEI number if they are closely related to the same business, under the same local management, and FDA can conduct a single inspection.
- Therefore, one cosmetic facility registration can be submitted for multiple buildings connected by the same FEI number, and the physical address listed in the facility registration must match the “Physical Address” listed in the FEI Search Portal.
* FEI registration and facility registration are separate processes; FEI number registration and acquisition must be completed before submitting a facility registration.
Q22. Product Listing for Free Samples and Gifts
- According to Section 604(3) of the FD&C Act, facilities that provide free cosmetic samples at trade shows and other events as an incidental service are exempt from cosmetic facility registration, but the product listing requirement still applies.
The FDA is accepting public comments on these updates until January 31, 2025.
Please refer to the attached document below.
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