FDA Delays MoCRA Enforcement by 6 Months

Today (Nov. 8, 2023) the U.S. Food and Drug Administration (FDA) announced it will delay the enforcement of the requirements for cosmetic product facility registration and product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for an additional six months after the Dec. 29, 2023, deadline (i.e., July 1, 2024) to ensure the industry has sufficient time to submit such information.

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 Dec. 29, 2022, or the listing requirement for cosmetic products first marketed after Dec. 29, 2022, until the July 1, 2024 deadline. 

Furthermore, in response to the recent MoCRA submission portal delay, the FDA has advised it will be ready to accept registration and listing information by the statutory deadline of Dec. 29, 2023, and encourages companies to meet that deadline if they are able to do so, according to a Duane Morris blog post.

See related: A Modernization of Cosmetics Regulation Act (MoCRA) Compliance Checklist

The FDA does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the Dec. 29, 2023, deadline."

New Authority

MoCRA will provide the FDA new authorities in terms of the following:

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 the FDA, including product ingredients, and provide any updates annually.

Responsible person means the manufacturer, packer or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.

Exemptions: MoCRA exempts certain small businesses from facility registration and product listing requirements. However, such 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 membranes of the eyes under customary or usual conditions of use;
• Products that are injected;
• Products that are intended for internal use; and
• Products that are intended to alter appearance for more than 24 hr under customary or usual conditions of use and removal by the consumer is not part of such conditions of use.

Exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices.

See related: FDA to Industry: Review SLP Guides, Gather Data Until MOCRA Portal Launches

Recent MoCRA Updates

In March 2023, the FDA issued a constituent update, "FDA Has Stopped Accepting Submissions to the Voluntary Cosmetic Registration Program (VCRP)" as a result of the facility registration and product listing authorities mandated by MoCRA.

In August 2023, the FDA issued draft guidance on cosmetic product facility registrations and product listings, as mandated by MoCRA. The draft guidance, when finalized, will provide recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA.

In September 2023, the FDA announced an opportunity to comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). The FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency.

This, of course, will rely on the timely launch of the portal for digital submissions; stay tuned as we watch this develop.