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FDA Issues Guidance on Cosmetic Facility Registration
Tuesday, February 20, 2024

The Food and Drug Administration (FDA) issued new guidance in January 2024 on facility registration requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Under MoCRA, cosmetic manufacturers and processors must register their facilities with the FDA and renew the registration every two years. If any such facility fails to register, that facility may not distribute or sell cosmetic products in the United States. Although MoCRA is now in effect, the FDA announced it does not intend to enforce the facility registration and cosmetic product listing requirements until July 1, 2024.

To help facilities decide whether they need to register with the FDA, the FDA published a decision tool which walks through a series of yes/no questions that will determine whether registration with the FDA is required.

Additionally, the FDA announced a set of facility registration and cosmetic product listing tools for cosmetic firms to use in electronically registering and listing products with the FDA. Alternatively, the FDA published two paper forms for FDA cosmetic facility registration and cosmetic product listing. The electronic tools and paper forms are available at the FDA’s website.

Please see the FDA’s guidance document for additional information.

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