Earlier this month, in a step toward implementing the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), FDA issued a draft guidance document titled “Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry.” For those who may be new to MoCRA, this legislation significantly overhauled FDA oversight of the cosmetics industry by requiring manufacturers, packers, and distributors, to comply with a range of new standards, including mandatory product and facility registration, creation of safety substantiation information, and adverse event reporting subject to a December 2023 deadline (per the one-year timeframe set per statute). Additional compliance measures, including issuance of good manufacturing practices regulations, updated fragrance allergen disclosures, and domestic contact labeling are expected in 2024 and thereafter.
https://www.adlawaccess.com/2023/08/articles/fdas-draft-guidance-on-cosmetics-registration-and-listing-a-good-reminder-of-end-of-year-deadlines/
Kristi Wolff
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