On November 8th, 2023, the U.S Food and Drug Administration (FDA) announced that it will delay the enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for six months. The FDA issued guidance on its intent to delay enforcement to help ensure that the industry has sufficient time to submit such facility registration and product listing information.
According to the FDA press release, MoCRA provided new authorities to FDA including:
• Facility Registration: Cosmetic product manufacturers and processors must register their facilities with FDA, update content within 60 days of any changes, and renew their registration every two years.
• Product Listing: A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
There are certain small business that the McCRA will exempt from facility registration and product listing requirements. There will be exemptions for certain products and facilities that are subject to requirements for drugs and devices. The FDA press release explains that these exemptions do not apply to facilities that manufacture or process, or responsible persons for, the following cosmetic products:
• Products that regularly come into 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.
The FDA issued a Constituent Update in March 2023, as a result of mandates to facility registration and product listing authorities by MoCRA. The FDA issued draft guidance on cosmetic product facility registration and product listings in August 2023, as mandated by MoCRA. Once finalized, the draft guidance will provide instructions and recommendation to help assist persons submitting cosmetic product facility registration and product listings to FDA.
The FDA announced in September 2023 that it has developed a draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). In order to facilitate efficiency and timeliness of data submission and management for the agency, the FDA strongly encourages electronic submission. Electronic submission, technical assistance documents, and paper submission forms are anticipated by the FDA to be available in early December 2023.
Announced Today: Delayed Enforcement
According to the press release by the FDA, they do 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, the 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 29th 2022, or the listing requirement for cosmetic products first marketed after December 29th, 2022, until July 1, 2024.
A.N. Deringer, Inc. will continue to monitor the situation.
For more information, you can visit U.S. Food & Drug Administration.