On August 7, 2023, FDA issued a draft guidance which is intended to assist industry in navigating the new facility registration and product listing requirements of the Modernization of Cosmetic Regulations Act 2022 (MOCRA) (see p. 1389 of 1653).

MOCRA requires that persons who own or operate a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the U.S. register their facility. This registration requirement is subject to a small business exception and an exception for facilities that manufacture cosmetics regulated as drugs. Furthermore, in the case of contract manufacturers, the guidance indicates that either the contract manufacturer or the person whose name appears on the label (i.e., the “responsible person”) may register and that only a single registration is required. See draft guidance for the information required to register a facility and also optional information that FDA requests but cannot require via guidance.

MOCRA also requires that the responsible person for each cosmetic product submit a product listing (also subject to the same small business and drug product exceptions referenced above). However, a single listing submission may include multiple cosmetics with identical formulations or formulations that differ only in respect to colors, fragrances or flavors, or quantity of contents. See draft guidance for the information required in a product listing and also optional information that FDA requests but cannot require via guidance.

FDA is developing an electronic portal for registration and listing submissions which will be available in October 2023 (a paper submission process will also be available but is discouraged).

Cosmetic manufacturing/processing facilities must be registered by December 29, 2023, if that facility was owned or operated by the responsible person on December 29, 2022. If the facility was not owned or operated by that date, then it must be registered by the later of: (i) within 60 days after manufacturing/processing begins or (ii) February 27, 2024. The responsible person must also submit a cosmetic product listing by December 29, 2023, unless the product was marketed after December 29, 2022, in which it must be submitted by the later of: (i) within 120 day of marketing the product or (ii) within 120 of December 29, 2023.

The product listing number, registration number, and brand names under which the cosmetic products are sold will not be publicly disclosed. All other information is available for public disclosure consistent with the Freedom of Information Act (FOIA).

FDA currently administers establishment registration and product listing requirements for drugs, medical devices, and tobacco products and registration (but not product listing) for food facilities.  If FDA implements cosmetic registration and listing only via guidance without issuing regulations (as the Agency appears to be doing), FDA will be limited to requiring only the statutory elements while asking for optional elements, such as the DUNS number and electronic submission.     

Comments to the draft guidance are due by September 7, 2023. A broader discussion of the changes to cosmetic regulation under MOCRA, including FDA’s new recall authority, the added safety substantiation requirements, and adverse event reporting requirements, can be found in this article.