FDA Issues Draft Guidance for MoCRA Facility Registration and Product Listing
The U.S. Food and Drug Administration (FDA) has released draft guidance, Draft Guidance for Industry: Registration and Listing of Product Facilities and Products, on the new regulatory requirements established in the Modernization of Cosmetics Regulation Act (MoCRA). Among other provisions, MoCRA added section 607 to the Federal Food, Drug, and Cosmetics Act (FFDCA), requiring cosmetic product facility registration and cosmetic product listing. The draft document details key registration and product listing requirements, including who must submit, what information is required, when registration and listings must be submitted, and how the FDA intends to accept registration and listing information.
All persons who own or operate a facility engaged in the manufacture or processing of a cosmetic product for distribution in the U.S. must register their facility. Under MoCRA, a cosmetic product “means a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.” FFDCA section 607(a)(1) provides two exceptions regarding who must register. The first exception is for small businesses that have average gross annual sales of less than $1 million in the previous three years, unless they manufacture or process cosmetics that regularly come in contact with the mucus membrane of the eye, are injected, are intended for internal use, or are intended to alter appearance for more than 24 hours (and are not meant to be removed by the customer). The second exemption is for facilities subject to the drugs and devices requirements under chapter V of the FFDCA, unless they also manufacture cosmetics that are not subject to the drug and device requirements. The same exemptions apply for submission of product listing information.
Facility registration requirements are outlined in sections 607(a) and (b) of the FFDCA. The requirements for facility registration include all brand names under which the cosmetic products manufactured or processed in the facility are sold and the product categories for each cosmetic product manufactured or processed in the facility. Registrations must be submitted by December 29, 2023, for facilities that were manufacturing or processing cosmetic products on December 29, 2022. Facilities that began manufacturing or processing after December 29, 2022, must register within 60 days of first engaging in that activity or by February 27, 2024, whichever date is later. Registrations must be updated within 60 days of any changes to the registration information and must be renewed biennially.
Product listing requirements are outlined in FFDCA section 607(c) and include the facility registration number for each facility where the cosmetic product is manufactured or processed, its applicable cosmetic category or categories, and a list of product ingredients (including fragrances, flavors, or colors). Listings must be submitted by December 29, 2023, for products that were marketed on December 29, 2022. Products that were first marketed after December 29, 2022, must be listed within 120 days of marketing the product, or within 120 days of December 29, 2023, whichever date is later. Any updates to the listing must be made annually.
Importantly, FDA clarified that any prior registrations through the Agency’s voluntary cosmetics registration programs will not be transferred to the new system; submitters will have to re-submit this information.
According to FDA, an electronic submission portal should be open for submissions beginning in October 2023, although a paper submission form is also available.
