FDA Seeks Comment on Cosmetics Direct and Forms – Update from Bergeson & Campbell, P.C.

FDA Seeks Comment on Cosmetics Direct and Forms Regarding Registration of Cosmetic Product Facility and Cosmetic Product Listing

On September 15, 2023, the U.S. Food and Drug Administration (FDA) announced that it is seeking comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). The submission portal and paper forms are part of FDA’s implementation of the new registration and listing requirements mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). FDA has provided screenshots of the draft electronic system, draft Form FDA 5066 — Registration of Cosmetic Product Facility, and draft Form FDA 5067 — Cosmetic Product Listing — for review and comment. Comments on FDA’s proposed collection of information are due October 18, 2023. 88 Fed. Reg. 63960. For more information, please read the full memorandum.

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