On December 29, 2022, the President enacted the Consolidated Appropriations Act, 2023 (Pub. L. 117-328), which included the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Among its provisions, MoCRA introduced section 607 to the Federal Food, Drug, and Cosmetic Act (FD&C Act), establishing rigorous requirements for the registration of facilities engaged in the manufacturing or processing of cosmetic products distributed within the United States. Moreover, it mandated the responsible person to submit a “cosmetic product listing” for each cosmetic product to the Food and Drug Administration (FDA).
The previous voluntary cosmetics registration program, outlined in 21 CFR Parts 710 and 720, ceased to operate as of March 27, 2023, as the FDA is actively working on implementing an updated system in alignment with MoCRA’s demands for cosmetic product facility registrations and product listings. Notably, data from the former voluntary program will not transition to this new system, given the significant disparities in information requirements. In an effort to enhance efficiency and the timely submission and management of data, FDA intends to launch an electronic submission portal for registration and product listing under section 607 of the FD&C Act in October 2023, alongside the development of an alternative paper-based submission method. Additionally, it’s important to note that certain small businesses, as defined in section 612 of the FD&C Act, are exempt from the requirement to register their facilities and list their cosmetic products. Non-compliance with the registration and listing mandates as specified in section 607 of the FD&C Act is deemed a prohibited act under section 301(hhh) of the FD&C Act (21 U.S.C. 331(hhh)).
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