FDA releases draft guidance on cosmetics facility registration, product listing
Initial compliance date of December 29, 2023
August 7, 2023
The U.S. Food and Drug Administration (FDA) has released a draft guidance describing its plans for the registration of cosmetic product facilities and listing of cosmetic products, two new regulatory requirements applicable to many cosmetic products and their manufacturers under the Modernization of Cosmetics Regulation Act (MoCRA).
There are no fees associated with product listing or facility registration. Additionally, “small businesses” (i.e., those whose average gross annual U.S. sales of cosmetics for the previous 3-year period is less than $1,000,000) who do not engage in the manufacturing or processing of certain categories of cosmetic products (e.g., those that regularly come into contact with the mucous membrane of the eye or that are injected) are exempt from the registration and listing requirements. Cosmetic products that are also drugs and facilities that manufacture such combined products (and do not also manufacture solely cosmetic products) are similarly exempt.
Among other elements, the draft guidance includes a list of cosmetic product categories and codes for industry use in registration/listing, and FDA seeks feedback and suggestions for improvements. Of particular note, while FDA states it will not disclose information that would link particular products with particular facilities in response to requests made under the Freedom of Information Act, the agency “intends to make relevant information from cosmetic product facility registration and listing available to the public to the extent permitted by law.”
Facilities that manufactured or processed cosmetics for distribution in the United States on December 29, 2022, must be registered by December 29, 2023. The same deadline applies to the listing of cosmetic products marketed on December 29, 2022. A facility that commenced operations after December 29, 2022, must submit a registration by the later of 60 days after the commencement of operations or February 27, 2024. An existing facility that introduced a new product after December 29, 2022, must submit a listing for that product by the later of 120 days after the product's first marketing or 120 days after December 29, 2023.
Facility registrations must be renewed biannually, facility registrations must be amended within 60 days of any changes to previously submitted information, and product listings must be updated annually, including to state that a listed product is discontinued.
FDA will consider all comments received on the guidance by September 7, 2023.