In a recent development, the U.S. Food and Drug Administration (FDA) has announced a delay in the enforcement of the cosmetic product facility registration and product listing requirements mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This extension, lasting for an additional six months beyond the statutory deadline of December 29, 2023, until July 1, 2024, aims to afford the industry ample time to fulfill the necessary obligations.
MoCRA conferred new authorities upon the FDA, introducing key provisions:
- Facility Registration: Manufacturers and processors of cosmetic products are required to register their facilities with the FDA, update information within 60 days of any changes, and renew their registration every two years.
- Product Listing: Responsible persons, including manufacturers, packers, or distributors whose names appear on the cosmetic product label, must list each marketed cosmetic product with the FDA. This listing should encompass product ingredients, with updates submitted annually.
Certain exemptions under MoCRA apply, particularly to small businesses. However, exemptions do not cover products that regularly contact the mucus membrane of the eye, injected products, those intended for internal use, and products designed to alter appearance for over 24 hours without consumer removal.
The FDA had previously ceased accepting submissions to the Voluntary Cosmetic Registration Program (VCRP) in March 2023, aligning with MoCRA’s mandates.
In August 2023, the FDA issued draft guidance on cosmetic product facility registrations and product listings. Once finalized, this guidance will offer recommendations and instructions to assist individuals submitting such registrations and listings to the FDA.
September 2023 saw the FDA introducing an opportunity for public comment on the newly developed draft electronic submission portal, Cosmetics Direct, and paper forms (Forms FDA 5066 and 5067). The agency strongly advocates for electronic submissions to enhance efficiency and timely data management.
The FDA emphasizes that electronic submission, technical assistance documents, and paper submission forms are expected to be available in early December 2023.
With today’s announcement, the FDA underscores its commitment to supporting industry compliance by extending the enforcement grace period for cosmetic product facility registration and product listing until July 1, 2024. Additionally, the FDA will not enforce registration requirements for facilities commencing cosmetic product manufacturing or processing after December 29, 2022, or listing requirements for products first marketed after the same date until the specified deadline. This decision aims to provide an extended window for regulated entities to adhere to the impending requirements.
