In August 2023, The Food and Drug Administration (FDA) issued a draft guidance for cosmetic product facility registrations and cosmetic product listings, including ingredients. 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 (MoCRA) of 2022’s requirements for facility registration and product listing as well as the exemptions for certain small businesses.
MoCRA Requirements:
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
For a cosmetic product marketed as of Dec. 29, 2022, a cosmetic product listing must be submitted no later than Dec. 29, 2023
For a cosmetic product that is first marketed after Dec. 29, 2022, a cosmetic product listing must be submitted within 120 days of marketing such product in interstate commerce, 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
Any updates to a product listing, such as a change in product ingredients, are to be provided annually
For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.
To learn more: click here