FDA Delays MoCRA Enforcement: A Reprieve for Industry Compliance

15 Nov FDA Delays MoCRA Enforcement: A Reprieve for Industry Compliance

In a recent development, the U.S. Food and Drug Administration (FDA) has made a strategic move by announcing the postponement of the enforcement of certain provisions under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This decision, aimed at offering the cosmetic industry a grace period, underscores the FDA’s commitment to ensuring a smooth transition toward compliance with the new regulatory landscape.

Understanding MoCRA

MoCRA, enacted in 2022, bestowed the FDA with enhanced authority, particularly in the realms of facility registration and product listing for cosmetic products. The key provisions under MoCRA include:

Facility Registration

Cosmetic product manufacturers and processors are now required to register their facilities with the FDA. This involves periodic updates within 60 days of any changes and a mandatory renewal every two years.

Product Listing

A responsible person, such as the manufacturer, packer, or distributor, must provide the FDA with a comprehensive list of each marketed cosmetic product. This list should include detailed information about product ingredients, with updates required annually.

Navigating Exemptions

MoCRA acknowledges exemptions for certain small businesses, but these do not cover cosmetic products that:

• Regularly come into contact with the mucus membrane of the eye under customary conditions.
• Are intended for injection, internal use, or alter appearance for more than 24 hours without consumer removal.

Additionally, exemptions are not applicable to products and facilities subject to requirements for drugs and devices.

Regulatory Milestones

The regulatory journey began in March 2023 when the FDA ceased accepting submissions to the Voluntary Cosmetic Registration Program (VCRP) in response to MoCRA mandates. Subsequently, in August 2023, the FDA released draft guidance on cosmetic product facility registrations and product listings. This guidance, upon finalization, will serve as a valuable resource for those navigating compliance.

September 2023 marked another milestone with the FDA opening an opportunity for public comments on the draft electronic submission portal, Cosmetics Direct, and accompanying paper forms. The push towards electronic submissions reflects the FDA’s commitment to enhancing efficiency and timeliness in data management.

Delayed Enforcement: A Strategic Move

In the latest announcement, the FDA has declared a six-month delay in enforcing the cosmetic product facility registration and product listing requirements. This extension, beyond the statutory deadline of December 29, 2023, extends the grace period until July 1, 2024. The FDA has also clarified that the registration and listing requirements will not be enforced for facilities or products initiated after December 29, 2022, until the revised enforcement date.

Future Forwarding: Staying Ahead of Regulatory Changes

As the regulatory landscape evolves, it is imperative for industry stakeholders, including Future Forwarding, to stay informed about policy changes. Keeping abreast of developments ensures a proactive approach to compliance, reducing the risk of disruptions and ensuring the seamless flow of cargo.

Future Forwarding, with its commitment to staying informed and adapting to regulatory changes, stands as a trusted partner in handling cargo. In this dynamic environment, the ability to navigate evolving regulations is crucial, and Future Forwarding’s dedication to compliance positions us as a reliable choice for businesses seeking a forward-thinking logistics partner. Reach out today.