President Biden signed into law the “Consolidated Appropriations Act, 2023” on December 29, 2022. The Act includes the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”), which increased the authority of the United States Food and Drug Administration (FDA) to regulate cosmetics products and provide enhanced cosmetics protections for consumers. For insight, please see our prior blog post, Revamping of Cosmetics Regulation and Safety (January 23, 2023).
In August 2023, the FDA released draft guidance, entitled Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry, on upcoming regulatory changes pursuant to MOCRA, including guidance on cosmetic product facility registrations and product listings. For more information on this draft guidance, please see our previous blog post, Revamping Cosmetics Safety and Regulation: Updates from FDA on Regulatory Changes under MOCRA (October 17, 2023).
On November 9, 2023, the FDA published notice of final guidance entitled Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing. This guidance delays FDA’s enforcement of some facilities’ registration and product listing compliance requirements under MOCRA to July 1, 2024. This enforcement delay applies to facilities that “engaged in manufacturing or processing of a cosmetic product” or products as of MOCRA’s enactment date (December 29, 2022). Originally, MOCRA imposed a registration and listing deadline for these facilities was December 29, 2023. The FDA explains that the six-month enforcement delay is necessary to give industry more time to gather information, “including obtaining facility registration numbers to associate with cosmetic product listings, obtaining access to the electronic submissions database, and verifying accurate registration and listing information for submission.”
Electronic Submissions Database
FDA’s August 8, 2023 draft guidance announced that it plans to implement a newly developed online submission portal called “Cosmetics Direct” for facility registrations and product listings. Public comments on this system can be viewed on docket No. FDA-2023-N-1029. The FDA originally planned to have the online portal system ready sometime in October 2023, but on November 1, 2023 the FDA issued an announcement delaying the implementation date. The FDA intends to provide more information regarding the online portal system in the coming weeks.
Cosmetic Direct will use a “structured product labeling (SPL) format.” This document format will allow facilities to register and to list products in bulk under one registration ID. In October 2023, the FDA published a technical specifications document to assist facilities with properly formatting submissions to the portal.
Despite the delay in implementing the online submission portal, the FDA strongly encourages parties subject to listing and reporting requirements to prepare to use the online portal system by reviewing all available guidance documents.
Facilities regulated under MOCRA encompass any establishment that manufactures or processes cosmetics products. Under FDA regulations, a “cosmetic product” is defined as “a finished cosmetic the manufacture of which has been completed” and can include cosmetics that are also drugs, devices, or components. As a result, under MOCRA, entities that manufacture raw material inputs into cosmetics – but not final products – would not be subject to the heightened requirements.
- Downstream Establishments: MOCRA explicitly exempts establishments downstream from the manufacturing and processing of cosmetics including beauty shops, product retailers, health care entities, public health agencies, hotels and airlines that provide complimentary cosmetics, and establishments that are only involved with tasks such as labeling, packaging, or distribution.
- Small Businesses: MOCRA exempts small businesses from compliance with the GMPs and registration and listing requirements. Additionally, it provides for preemption of certain State laws with respect to registration and product listing, GMPs, records, recalls, adverse event reporting, and safety substantiation.
- Dual Products: Although dual products (i.e., a product that is both a drug and a cosmetic) fits within the definition of cosmetic product, facilities that manufacture or produce a product that is both a drug and cosmetic are exempt from the registration and listing requirements of MOCRA. However, under MOCRA, facilities that manufacture or produce these dual products and also produce products which are solely cosmetics must still register their facility and list their cosmetics with the FDA.
- Facility Registration:
- Existing facilities must register on or before July 1, 2024. MOCRA requires facilities to register within one year of MOCRA’s enactment date (December 29, 2022), so registration is required on or before December 29, 2023; however, FDA delayed enforcement of this registration requirement to July 1, 2024.
- Any new facilities, those established after the enactment date of MOCRA, must register within 60 days of engaging in such activity, or by February 27, 2024, whichever is later.
- Any facility that needs to update their registration must do so within 60 days of the change that requires an update.
- Cosmetic Product Listing:
- A listing for cosmetic products that existed on or before MOCRA’s enactment date must be submitted on or before July 1, 2024. MOCRA requires listings to be submitted within one year of MOCRA’s enactment date (on or before December 29, 2023), but FDA delayed enforcement of this listing requirement to July 1, 2024.
- Listings for new cosmetic products on the market after the enactment date (after December 29, 2022) must be submitted within 120 days of marketing the product in interstate commerce.
- Thereafter, listings must be updated annually.
Cosmetics facilities and manufacturers should review the new portal system and related guidance and technical documents. Additionally, facilities and manufacturers should watch for the FDA’s release of its final guidance to prepare to register facilities and list cosmetics in advance of July 1, 2024.