U.S. Food and Drug Administration (FDA) Update: Registration and Listing of Cosmetic Product Facilities and Product
To all our cosmetic importers,
On August 7, 2023, the U.S. Food and Drug Administration (FDA) issued a draft guidance requiring submissions of cosmetic product facility registrations and cosmetic product listings under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
A newsletter has also been issued by Sandler, Travis, & Rosenberg explaining the details of these requirements. Please ensure that you inform your manufacturers to register their facility and that the responsible person must also list products with the FDA no later than December 29, 2023 to avoid hold and refusal upon arrival of your shipments.
The Food and Drug Administration has issued a https://www.fda.gov/media/170732/download 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 MoCRA’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.
Source to this e-blast, courtesy of ST&R, Sandler, Travis & Rosenberg: https://www.strtrade.com/trade-news-resources/str-trade-report/trade-report/august/guidance-for-registration-and-listing-of-cosmetic-product-facilities-and-products?mkt_tok=NzIzLVdPWi00NDYAAAGNyBsyZmvebUcCpTkHiPfgA-fIR4zpBR7IlkYYSudlc1nkGJuCer6IW0wWhtfqpmv5BhpknfreuIss5I6xPC24TkAdlPAljr6Eduqyl7hHFg#utm_source=tradereport&utm_medium=email