The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law on December 29, 2022. It ushers in heightened regulatory oversight for cosmetic products and facilities.

MoCRA introduces provisions related to Facility Registration, Product Listing, Cosmetic GMPs, Labeling, Adverse Event Reporting, Safety Substantiation, Records, Mandatory Recall Authority, Small Businesses, Asbestos Testing in Talc-containing cosmetics and evaluating the Safety of PFAS in Cosmetics.

MoCRA mandates the inclusion of a domestic address, domestic phone number, or electronic contact information for receiving adverse event reports. It also requires labeling of fragrance allergens.

Facilities are required to adhere to Good Manufacturing Practices (GMPs) aligning with national and international standards. This regulation aims to ensure that cosmetic products are not adulterated and protect public health.

Any business whose average gross annual sales in the United States (US) of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and which does not engage in the manufacturing or processing of the cosmetic products described below, shall be considered small businesses and they are exempt from GMP, Facility Registration, and Product Listing.

• Cosmetic products that regularly come into contact with the mucus membrane of the eye under conditions of use that are customary or usual.
• Cosmetic products that are injected.
• Cosmetic products that are intended for internal use.
• Cosmetic products that are intended to alter the appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.

The term “responsible person” means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product label in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act. The “responsible person” will be responsible for:

1. Cosmetic product listing
2. Adverse events
3. Safety substantiation
4. Labeling
5. Good Manufacturing Practices (GMP)
6. Facility Registration

MoCRA allows “flexible listings”. For flexible listings, companies can submit a single listing for cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents.

A “Responsible Person” (manufacturer, packer, or distributor of a cosmetic product whose name appears on the label) must list each cosmetic product, including its ingredients, with the US FDA not later than July 1,2024. For products marketed after the enactment of MoCRA, an RP must submit the product listing by July 1, 2024. Additionally, the Responsible Person must update product listing information annually.

The MoCRA regulation has now been given legal authority to require a mandatory recall of cosmetics if the FDA determines that the cosmetic product may be adulterated or misbranded under the Food and Drug Cosmetics Act (FDCA) and exposure to the product may cause serious adverse health effects.

For facility registration, manufacturers and processors must register their facilities with the FDA and renew their registration every two (02) years. For product listing, a Responsible Person (RP) must list each marketed cosmetic product with the FDA, including product ingredients, and provide any updates annually.