Clarifying Cosmetics Reform: FDA Issues Draft Guidance on Registration and Product Listings
Heralding the significant changes coming to the U.S. cosmetics industry starting in 2023, the U.S. Food and Drug Administration ("FDA") has issued draft guidance to companies regarding cosmetic facility registrations and product listings.
Cosmetic facility registration and product listing requirements, authorized by the Modernization of Cosmetics Regulation Act of 2022 ("MoCRA"), become effective December 29, 2023. On August 7, FDA issued draft guidance regarding these obligations, including:
- Cosmetic product manufacturers and processors must register facilities with FDA, update content within 60 days of any changes, and renew registrations every two years; and
- A responsible person, defined as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of the product, must list each marketed cosmetic product with FDA, including product ingredients, and provide updates annually.
The draft guidance provides FDA's thinking on the applicable definition of "facility" and identifies a number of entities excluded from the definition, such as retailers and establishments solely involved in the labeling, relabeling, packaging, repackaging, holding, and distributing of cosmetic products. Certain small businesses, as well as certain products and facilities subject to drug and device requirements, are also exempt from registration and listing requirements.
FDA details what information must be provided, noting that brand name information and product listing numbers will not be publicly disclosed, but all other registration and listing information will be available for public disclosure consistent with applicable laws.
FDA intends to use the FDA Establishment Identifier ("FEI") as the required facility registration number. For those unfamiliar with FEI, this requires the owner or operator of a facility to obtain an FEI number before submitting facility and product information. The responsible person will need to obtain the FEI for each facility manufacturing or processing its cosmetic products.
Registration and listing will be electronic, with the portal becoming available in October 2023. Significantly, information previously submitted to FDA's voluntary cosmetics registration program will not be transferred to the new system and FDA will not consider previous submissions to satisfy the MoCRA registration and listing requirements.
Comments on the draft guidance should be submitted by September 7, 2023.