Are Cosmetic Manufacturers required to register with FDA? Does FDA require Cosmetic Registration of ingredients or formulas? Yes — under “Modernization of Cosmetics Regulation Act of 2022,” (or, MOCRA), FDA began requiring registration and listing.
Facilities that manufacture or process cosmetics intended for sale in the U.S. must be registered with FDA, including listing all cosmetics produced or modified at these facilities. Foreign establishments must also identify a U.S. agent and importers when registering. Cosmetic manufacturers must submit registration information for their establishments, submit listing information, and update their information every two years.
FDA also requires annual reporting by cosmetic registrants for listed cosmetic products manufactured or processed for commercial distribution in the U.S.
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