FDA Issues Final Guidance on MoCRA Requirements

Posted by Timothy Miller on 12/18/23 5:00 PM

On December 18, 2023, the U.S. Food and Drug Administration (FDA) issued its final guidance on upcoming cosmetic product facility registrations and product listings that were mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).  

This guidance provides information on the statutory requirement to submit cosmetic product facility registrations and product listings, who is responsible for filing the information, when the data should be submitted and what exemptions exist for the registration and listing requirements. 

The FDA also announced new tools they have created for these requirements. The agency has an electronic registration and listing portal, Cosmetics Direct that is intended to be the primary system for providing registration and product listing information. FDA also provides two new paper forms that can be used as an alternative method for data submission to the agency.  

These new reporting requirements will become effective on July 1, 2024.  

The published guidance for registration and listing of cosmetic products can be found here:

The Cosmetics Direct portal and user guide can be found here:

Topics: FDA, MoCRA

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