FDA Issues Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing

Today, the U.S. Food and Drug Administration (FDA) announced its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for six months to help ensure that the industry has sufficient time to submit such facility registration and product listing information. Per the Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing Guidance Document, the agency will begin enforcement 1 July 2024. This new enforcement date applies to all facilities engaged in cosmetic product manufacturing and processing regardless of when they began operations. Included in the guidance document is the anticipated release date of submission tools (both electronic and paper) in ‘early December 2023’.

Please note that the regulation has not changed. EAS recommends that all cosmetic facilities should be working toward submission of registration information by 29 December 2023 if possible. Similarly, responsible persons should also be preparing product listing information for submission to the agency by 29 December 2023 if possible.

EAS will continue to update our clients as information becomes available. Please contact Victoria Pankovich, vpankovich@easconsultinggroup.com with any questions you may have.