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FDA Issues Final Guidance Document on MoCRA Requirements for Cosmetic Facility Registration and Cosmetic Product Listing, Also Opens Electronic Portal for Submissions

December 19, 2023

On December 18, 2023, the U.S. Food and Drug Administration (FDA) made two announcements concerning the cosmetic facility registration and cosmetic product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). First, the Agency launched its “Cosmetics Direct” electronic submissions portal to receive cosmetic facility registration and product listing information. Second, FDA released its final guidance on the information to be included with registration and listing submissions. As noted in a compliance policy issued on November 8, 2023, the Agency is not enforcing the facility registration or product listing requirements until July 1, 2024. Nevertheless, companies should begin taking steps to comply with the new provisions. The December 18 developments are discussed in more detail below.

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