FDA Extends MoCRA Enforcement Deadline: Cosmetics Industry Gets Additional 6 Months

In a recent development, the U.S. Food and Drug Administration (FDA) has announced a six-month extension of the enforcement deadline for cosmetic product facility registration and product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The previous deadline of December 29, 2023, has been pushed back to July 1, 2024, providing the cosmetics industry with additional time to comply with these regulatory obligations.

This decision comes in the wake of the FDA's commitment to facilitating a smooth transition for industry stakeholders in complying with the new regulatory landscape mandated by MoCRA. The Agency recognizes the importance of ensuring that cosmetic manufacturers and processors have adequate time to submit facility registration and product listing information.

Background and Timeline:

1. Suspension of Voluntary Cosmetic Registration Program (VCRP): In March 2023, the FDA announced the suspension of submissions to the Voluntary Cosmetic Registration Program (VCRP) due to the imminent implementation of the facility registration and product listing authorities mandated by MoCRA.
2. Draft Guidance on Cosmetic Product Regulations: By August 2023, the FDA issued draft guidance on cosmetic product facility registration and product listing, aligning with the requirements set forth by MoCRA. This draft, once finalized, will offer crucial recommendations and instructions for individuals submitting cosmetic product facility registrations and product listings to the FDA.
3. Introduction of Electronic Submission Portal: In September 2023, the FDA introduced an opportunity for public comment on its newly developed draft electronic submission portal named "Cosmetics Direct," along with the paper forms (Forms FDA 5066 and 5067). Emphasizing the importance of electronic submissions for efficiency, the Agency anticipates the availability of electronic submission options and supporting documentation in early December 2023.

Details of the Delayed Enforcement:

The FDA's decision to delay enforcement aims to provide regulated industries with the necessary time to comply with MoCRA's new authorities, which include facility registration and product listing requirements. Specifically, the delay extends to July 1, 2024, for both the statutory deadline of December 29, 2023, and specific registration and listing requirements.

This extension also includes a grace period for owners or operators of facilities that commenced manufacturing or processing a cosmetic product after December 29, 2022, and for cosmetic products first marketed after that date.

MoCRA Authorities and Exemptions:

Cosmetic product manufacturers and processors are required to register their facilities, update information promptly, and renew registrations every two years. Responsible persons, such as manufacturers, packers, or distributors, must list each cosmetic product marketed, including ingredients, and provide annual updates.

Exemptions are granted to certain small businesses. However, such exemptions do not apply to facilities that manufacture or process, or to responsible persons for, the following cosmetic products:

• Products that regularly come into contact with the mucus membranes 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. 

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

As the FDA extends the MoCRA implementation deadline, industry stakeholders are encouraged to take advantage of the additional time granted to ensure a seamless transition to compliance with the new regulations.