FDA relieves cosmetics industry with six-month reprieve delaying MoCRA enforcement

09 Nov 2023 --- The US FDA has granted cosmetics manufacturers more time to prepare for the enforcement of new regulations under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). A six-month delay has been issued, allowing companies to register their cosmetic facilities and product listings in line with the new obligations.

The move aims to relieve the industry by giving sufficient time to meet the MoCRA requirements.

“The Personal Care Products Council (PCPC) supports the FDA’s announcement to exercise enforcement discretion on MoCRA facility registration and product listing compliance deadline for six months — moving the compliance date from December 29 to July, 2024,” states the association.

Additionally, the FDA will not enforce the registration requirement for cosmetics manufacturing and processing facilities that began operating after December 29, 2022. Once businesses officially register their facilities by the time MoCRA is enacted in July 2024, they must update content within 60 days and renew registration every two years.

The FDA has also delayed requiring businesses to register cosmetic products marketed after December 29, 2022, until July 1, 2024. This action involves informing the regulatory agency of all product ingredients and submitting updates annually.

As the industry adjusts to these regulatory changes, the FDA encourages stakeholders to leverage the additional time granted to ensure a smooth transition into compliance.The FDA has delayed requiring businesses to register cosmetic products marketed after December 29, 2022, until July 1, 2024.

Meanwhile, the FDA has also published a compliance policy, a guidance to aid cosmetic product facility owners or operators in meeting the Federal Food, Drug, and Cosmetic Act requirements for registration and responsible persons. 

Exceptions to the new rules
While MoCRA exempts certain small businesses from facility registration and product listing requirements, exceptions exist for specific cosmetic products and facilities. 

These exceptions include products regularly in contact with the mucus membrane of the eye, injected products, those intended for internal use and products altering appearance for more than 24 hours.

Notably, exemptions do not apply to facilities or responsible persons for products subject to drug and device requirements.

Timeline leading up to MoCRA enforcement
MoCRA was passed last December and is providing the FDA with new authorities.

Furthermore, the regulatory journey began in March this year when the FDA stopped accepting submissions to the Voluntary Cosmetic Registration Program due to the facility registration and product listing authorities mandated by MoCRA.

In August, the FDA issued its first draft guidance on MoCRA’s cosmetic product facility registrations and product listings. This includes, among other things, recommendations on what specific information to include in these submissions and how businesses can complete these necessary registrations. Once finalized, the guidance will provide recommendations and instructions for submitting essential information to the agency.The FDA encourages stakeholders to leverage the additional time granted to ensure a smooth transition into compliance. 

In September, the FDA initiated a public commentary on the draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). According to the agency, the move has promoted efficient processes within the cosmetic sector.

“PCPC provided feedback to the FDA on the development of an efficient electronic submission program and recognizes that the FDA’s development of Cosmetics Direct is ongoing. PCPC will continue to offer feedback to the FDA on the agency’s implementation of MoCRA and is encouraging member companies to prepare for registration and listing,” shares the association.

“PCPC has shared FDA’s instructions with member companies on obtaining an FDA-assigned Establishment Identifier (FEI) number for each facility that is manufacturing or processing cosmetic products, as needed. PCPC has also shared information with member companies to help facilitate communications between companies that intend to coordinate their registration and listing activities.”

The association states that it anticipates the FDA’s launch of Cosmetics Direct once the platform is complete.

By Venya Patel