Background

The Food and Drug Administration has issued a draft guidance to assist cosmetics companies submitting cosmetic product facility registrations and cosmetic product listings, including ingredients, to the agency. The guidance covers a broad range of items such as makeup products, nail polishes, shaving creams and other grooming products, perfumes, face and body cleansers, haircare products, moisturizers, and other skincare products.

The guidance describes the Modernization of Cosmetics Regulation Act of 2022’s requirements for facility registration and product listing as well as the exemptions for certain small businesses. Under MoCRA, every person that as of Dec. 29, 2022, owned or operated a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the U.S. must register each facility no later than Dec. 29, 2023. Every person that owns or operates a facility that first engaged, after Dec. 29, 2022, in manufacturing or processing of a cosmetic product for distribution in the U.S. must register such facility within 60 days of first engaging in such activity or by Feb. 27, 2024, whichever is later.

With regard to product listings, under MoCRA the responsible person of a cosmetic product marketed as of Dec. 29, 2022, must submit a cosmetic product listing no later than Dec. 29, 2023, or for a cosmetic product that is first marketed after Dec. 29, 2022, within 120 days of marketing such product in interstate commerce. Consistent with the approach for registration of a facility that starts manufacturing or processing cosmetic products after Dec. 29, 2022, the FDA expects the product listing for a cosmetic product first marketed after Dec 29, 2022, to be submitted within 120 days of marketing the product, or within 120 days of Dec. 29, 2023, whichever is later.

Facility registration information is to be updated within 60 days of a change and registration to be renewed every two years. Additionally, any updates to a product listing, such as a change in product ingredients, are to be provided annually.

Comments on the draft guidance may be submitted through Sept. 7. For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.

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