August 7, 2023
The US Food and Drug Administration has issued draft guidance on cosmetic product facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
When finalized, the draft guidance will assist stakeholders with cosmetic product facility registration and product listing submissions to FDA, by describing who is responsible for making the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.
A “responsible person” is a manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of the product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.
Some small companies are exempt 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.
There are also exemptions for certain products and facilities that are subject to requirements for drugs and devices.
As per the draft guidance, FDA intends to use the FDA Establishment Identifier (FEI) as the required facility registration number.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.
For more information, including how to request an FEI number or determine if an entity already has an FEI number, please refer to the FEI Search Portal.
Companies should plan to register and list well in advance of the December 29, 2023, statutory deadline.
FDA also 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.
The pilot program is intended to provide input to inform evaluation of this new electronic submission portal. For more information, visit Federal Register Notice: Pilot Program for Cosmetic Product Facility Registration and Listing Electronic Submissions User Acceptance Testing.
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