FDA to delay enforcement of facility registration and product listing requirements under MoCRA

Yesterday, the US Food and Drug Administration (FDA) announced a six-month delay in enforcement of its cosmetic product facility registration and cosmetic product listing requirements issued under the Modernization of Cosmetics Regulation Act (MoCRA). The delay has been implemented to provide industry members adequate time to submit required information and comply with previously issued draft guidance​ for MoCRA’s regulatory standards.  

As CosmeticsDesign has previously reported​, MoCRA is the most significant update to US cosmetics law in over 80 years, and outlines a dramatic overhaul of the FDA’s authority to regulate cosmetics products for consumers.

These changes include mandatory adverse event reporting, as well as the requirements that cosmetics manufacturing and processing facilities must register with the FDA “and renew their registration every two years​,” and that product listings must be submitted to the FDA by designated ‘responsible person, “including product ingredients, and provide any updates annually​​.”

Prior to MoCRA’s enactment, cosmetic products were voluntarily registered with the FDA through the Voluntary Cosmetic Registration Program (VCRP), but this program was suspended by the organization in March of this year “as a result of the facility registration and product listing authorities mandated by MoCRA​​.”

Then, in August of this year, the FDA issued the above linked draft guidance for industry organizations to provide recommendations for adherence to the new facility registration and product listing requirements.