FDA Issues Final Guidance on Registration and Listing of Cosmetic Product Facilities and Products
Cosmetics Constituent Update
December 18, 2023
The U.S. Food and Drug Administration, today, issued a final guidance for industry on cosmetic product facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
The guidance assists 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, when to submit, and certain exemptions to the registration and listing requirements.
The guidance also contains information about a new electronic registration and listing submission portal. Today, FDA is announcing that the new electronic submission portal, Cosmetics Direct, is available. FDA is also developing paper forms, Form FDA 5066 and Form FDA 5067 for cosmetic product registration and cosmetic product listing as an alternative submission tool that are anticipated to be available soon at Registration & Listing of Cosmetic Product Facilities and Products.
As described in the guidance, FDA will be using 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.
Commenting
This guidance also includes a new draft guidance section, Appendix B, for comment purposes only, that describes frequently asked questions and answers about cosmetic product facility registrations and product listing submissions. Aside from that section, this guidance finalizes the draft guidance that was published on August 8, 2023. To ensure that the Agency considers your comment on Appendix B before it begins work on the final version of this section of the guidance, submit either electronic or written comments on this section as described in the Federal Register Notice: Registration and Listing of Cosmetic Product Facilities and Products; Guidance for Industry; Availability.
Exemptions
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 in 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.
Delayed Enforcement
On November 8, 2023, FDA issued guidance on its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements under MoCRA for six months to help ensure that industry has sufficient time to submit such facility registration and product listing information.
FDA does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements.
In addition, FDA does not intend to enforce the registration requirement for owners or operators of facilities that first engaged in manufacturing or processing a cosmetic product after December 29, 2022, or the listing requirement for cosmetic products first marketed after December 29, 2022, until July 1, 2024.