FDA Finalizes MoCRA Registration & Listing FAQs and Issues New Draft FAQs

On December 11, 2024, the United States Food and Drug Administration (“FDA”) finalized the FAQs in its guidance (“Guidance”) on the cosmetic product facility registration and listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) (see our prior alerts here and here). The Guidance finalizes draft FAQs that that FDA released in December 2023 and adds three draft FAQs on which FDA has now requested comment. FDA largely finalized the draft FAQs it published last year with minor, non-substantive modifications. While FDA will accept comments on any guidance document at any time, it has requested comment on the three new draft FAQs by January 13, 2025.

The three draft FAQs address the following:

• U.S. Agent. Foreign establishments must designate a U.S. Agent. FDA clarified that the U.S. Agent is responsible for serving as the communications link between FDA and the foreign establishment. FDA expects the U.S. Agent to respond to FDA questions about the foreign establishment’s products, help schedule inspections, and receive information or documents from FDA on behalf of the foreign establishment. FDA considers providing information or documents to a U.S. Agent equivalent to providing the same information or documents to the foreign establishment.
• Facilities with Multiple Buildings. FDA provided that a single cosmetic product facility may include multiple buildings as part of the same establishment with the same FDA Establishment Identifier (“FEI”) number if the buildings are within three miles of each other, closely related to the same business, under the same management, and capable of being inspected by FDA in a single inspection.
• Free Samples and Gifts. FDA highlighted that a responsible person must submit to FDA a cosmetic product listing for each cosmetic product—even if the product is provided as a free sample or gift. But FDA does not expect product listings for products that are “provided within industry for the purposes of research and development” and not for consumer use.

[1] For more information on MoCRA, please see our comprehensive client alert here: https://www.cov.com/en/news-and-insights/insights/2022/12/years-in-the-making-congress-modernizes-fdas-cosmetics-authorities.