The U.S. Food and Drug Administration (FDA) has announced a delay in enforcing the compliance requirements concerning cosmetic product facility registration and product listing, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This delay extends the deadline for six additional months, from December 29, 2023, to July 1, 2024, offering more time for the industry to adhere to these stipulations.
MoCRA granted the FDA new authorities which include:
Facility Registration: Manufacturers and processors of cosmetic products must 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 must provide the FDA with a list of each marketed cosmetic product, including its ingredients, and update this information annually.
A ‘responsible person’ is defined as the manufacturer, packer, or distributor whose name appears on the label of the cosmetic product.
However, there are exemptions for certain small businesses from the facility registration and product listing requirements, although these exemptions do not apply to specific categories of cosmetic products, such as those intended for internal use or to alter appearance for more than 24 hours without the consumer removing them.
In March 2023, the FDA stopped accepting submissions to the Voluntary Cosmetic Registration Program (VCRP) due to the implementation of the MoCRA-mandated facility registration and product listing authorities.
Following this, in August 2023, the FDA issued draft guidance for cosmetic product facility registrations and product listings. When finalized, this guidance will provide recommendations and instructions to assist individuals in submitting the required information to the FDA.
In September 2023, the FDA introduced a comment period for its new draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). The agency strongly encourages electronic submissions for efficiency and timely data management, expecting electronic submission options, technical assistance documents, and paper submission forms to be available by early December 2023.
With the delayed enforcement announcement made today, the FDA extends the grace period for an additional six months after the initial statutory deadline of December 29, 2023, aiming to ensure regulated industries have more time to comply with these regulations. The extension applies to facilities engaged in manufacturing or processing a cosmetic product after December 29, 2022, and cosmetic products first marketed after the same date. Enforcement for these entities will now begin on July 1, 2024.
