Recently US Congress passed the Consolidated Appropriations Act, bringing changes to how cosmetic products are regulated in the US. MOCRA or the Modernization of Cosmetics Regulation Act of 2022 provides regulatory authority to US FDA over cosmetic industry. Key requirements of MOCRA are as below:
Manufacturers and processors must register their facilities with the FDA and renew such registration biennially. FDA no longer accepts VCRP registrations so Facilities that were registered under the VCRP program will have to register again under the new system.
A responsible person must list each marketed cosmetic product and ingredients with the FDA and must renew such listing annually.
- Good Manufacturing Practices (GMP)
Cosmetic manufacturing and processing facilities must comply with GMP standards.
Cosmetic product labels must adhere to new cosmetic labeling requirements.
- Adverse Event Report
A responsible person is required to report serious adverse events associated with the use of cosmetic products in the US to the FDA. FDA will have access to adverse event reports during an inspection.
- Product Safety Substantiation
A responsible person is required to ensure and maintain records supporting adequate safety substantiation for their products.
- Mandatory Recall
FDA has the authority to order a mandatory recall, if deemed necessary, if the responsible person refuses to do so voluntarily.
A responsible person means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.
Liberty Management Group Ltd. can help you with Facility Registration, Product Listing, Label compliance and other FDA regulations.
Namrata
Regulatory Consultant
support@libertymanagement.us