Final Guidance on Registration and Listing of Cosmetic Product Facilities and Products

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The U.S. Food and Drug Administration, On Dec 18,2023, issued a final guidance for industry on cosmetic product facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

The guidance assists stakeholders with cosmetic product facility registration and product listing submissions to FDA, by describing who is responsible for making the registration and listing submissions, what information to include, how to submit, when to submit, and certain exemptions to the registration and listing requirements.

As described in the guidance, FDA will be using the FDA Establishment Identifier (FEI) as the required facility registration number. To facilitate the registration process, the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration.

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