Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the U.S. FDA now requires mandatory registration and listing for cosmetic facilities and cosmetic products marketed in the United States. These requirements represent a significant shift from the prior voluntary program and apply to most cosmetic manufacturers and responsible persons.
Facility Registration
Cosmetic manufacturers and processors are required to register each facility where cosmetic products are manufactured or processed for U.S. distribution. This registration must be submitted to FDA and maintained with timely updates when facility information changes.
FDA provides Form FDA-5066 (Cosmetic Product Facility Registration) as one method to submit facility registration information. Facility registration may also be completed electronically through FDA’s cosmetics registration and listing system.
Cosmetic Product Listing
Each cosmetic product placed on the U.S. market must be listed with FDA by the responsible person. Product listings include key information such as product category, ingredients, and facility identifiers.
FDA provides Form FDA-5067 (Cosmetic Product Listing) as a submission tool for product listing. As with facility registration, product listings may also be submitted electronically using FDA-supported systems.
Important Regulatory Context
MoCRA establishes the legal obligation to register facilities and list cosmetic products; the use of specific FDA forms is not itself the requirement, but one of several submission mechanisms provided by FDA. Companies remain responsible for ensuring that registrations and listings are accurate, current, and compliant with MoCRA timelines and FDA guidance.
