The U.S. Food and Drug Administration (FDA) has released a draft guidance detailing its plans for the registration of cosmetic product facilities and listing of cosmetic products, two new regulatory requirements applicable to many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There are no fees associated with product listing or facility registration, the draft guidance states. Additionally, “small businesses” (i.e., those whose average gross annual U.S. sales of cosmetics for the previous three-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such combined products (and do not also manufacture solely cosmetic products) are similarly exempt, according to the draft guidance.
Among other elements, the draft guidance includes a list of cosmetic product categories and codes for industry use in registration/listing, and FDA seeks feedback and suggestions for improvements.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 U.S. on Dec. 29, 2022, must be registered by Dec. 29, 2023. The same deadline applies to the listing of cosmetic products marketed on Dec. 29, 2022. A facility that commenced operations after Dec. 29, 2022, must submit a registration by the later of 60 days after the commencement of operations or Feb. 27, 2024. An existing facility that introduced a new product after Dec. 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 Dec. 29, 2023, the guidance states.
Facility registrations must be renewed biannually and 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, according to the guidance.
FDA stated that it will consider all comments received on the guidance by September 7, 2023.
For more information, visit www.fda.gov.
