August 7, 2023
The U.S. Food and Drug Administration, today, issued draft guidance on cosmetic product facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
When finalized, the draft guidance will assist stakeholders with cosmetic product facility registration and product listing submissions to FDA, by describing who is responsible for making the registration and listing submissions, what information to include, how to submit, and when to submit, as well as certain exemptions to the registration and listing requirements.
MoCRA provided new authorities to FDA including:
- Facility Registration: Cosmetic product manufacturers and processors must register their facilities with FDA, update content within 60 days of any changes, and renew their registration every two years.
- Product Listing: A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
Responsible person means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.
MoCRA exempts certain small businesses from facility registration and product listing requirements.
However, such exemptions do not apply to facilities that manufacture or process, or responsible persons for, the following cosmetic products:
- Products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use.
- Products that are injected.
- Products that are intended for internal use.
- Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use.
Exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices.
In March 2023, FDA issued a Constituent Update FDA Has Stopped Accepting Submissions to the Voluntary Cosmetic Registration Program (VCRP) as a result of the facility registration and product listing authorities mandated by MoCRA.
The draft guidance also contains information about a new electronic registration and listing submission portal. FDA intends to make the new electronic submission portal available in October 2023. FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency. FDA is also developing a paper form as an alternative submission tool to the electronic submission portal.
As described in the draft guidance, FDA intends to use the FDA Establishment Identifier (FEI) as the required facility registration number. To facilitate the registration process, the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration. To determine if an entity already has an FEI number, please refer to the FEI Search Portal. If your firm does not have an FEI number assigned by FDA, see How can I request an FEI? at FEI Search Portal (fda.gov).
The responsible person will need to obtain the relevant facility registration (FEI) number(s) for each facility where their cosmetic products are manufactured or processed, because the facility registration number(s) is required for the product listing submission. If the facility is a small business that is exempt from registration and has no facility registration number, then facility name/address can be provided instead for the product listing.
Stakeholders should plan to register and list well in advance of the December 29, 2023, statutory deadline.
In addition, FDA is soliciting applications from members of the cosmetic product industry interested in participating in a voluntary pilot program to conduct User Acceptance Testing (UAT) to help evaluate a potential new electronic submissions portal for cosmetic product facility registration and listing. This electronic submission portal is being implemented pursuant to MoCRA. FDA plans to accept up to nine participants for the pilot program. The pilot program is intended to provide input to inform evaluation of this new electronic submission portal. For more information, please refer to: Federal Register Notice: Pilot Program for Cosmetic Product Facility Registration and Listing Electronic Submissions User Acceptance Testing.
To Submit Comments on the Draft Guidance:
Comments on the draft guidance should be submitted by 9/7/2023. You may submit electronic comments to Regulations.gov. All written comments should be identified with the docket number FDA-2023-D-1716 and title of the guidance document.