Six-Month Delay for Registration and Listing of Cosmetic Product Facilities and Products

New requirements for cosmetics companies to submit facility registrations and product listings are being delayed for six months under a guidance document issued recently by the Food and Drug Administration. These requirements cover 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.

Under the Modernization of Cosmetics Regulation Act of 2022, cosmetic product manufacturers and processors must register their facilities with the FDA, update content within 60 days of any changes, and renew their registrations every two years. In addition, each marketed cosmetic product (including its ingredients) must be listed with the FDA and updates must be provided annually.

There are exemptions to these requirement for certain small businesses as well as certain products and facilities that are subject to requirements for drugs and medical devices.

The FDA’s new guidance states that the agency does not intend to enforce the facility registration and product listing requirements until July 1, 2024. This deadline applies to all facility registrations and product listings, regardless of when the facilities first engaged in manufacturing or processing or when the products were first marketed. (The FDA had previously set variable deadlines based on these events that began as early as Dec. 29, 2023.)

For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.

This article was originally published in the Sandler, Travis & Rosenberg Trade Report

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