Modernization of Cosmetics Regulation Act (MoCRA) Creates Regulatory Framework for Stronger FDA Enforcement of Cosmetics
On December 23 Congress passed legislation to significantly expand the regulatory authority of the Food and Drug Administration (FDA) over cosmetics. The Modernization of Cosmetics Regulation Act (MoCRA) was included as part of its year-end Consolidated Appropriations Act of 2023 and many of the key provisions will take effect a year from the enactment date on December 29, 2023. The measure has been in the making for more than a decade and represents the first major update to FDA’s cosmetic authorities since 1938. The Act calls on FDA to begin a rulemaking process to implement the new law and a final rule is required within three years.
In addition to expanding the FDA’s regulatory and enforcement authority, MoCRA imposes a number of significant new requirements on a “responsible person” – defined as cosmetics manufacturers, packers, and distributors – in accordance with Section 609(a) of the Federal Food, Drug, and Cosmetic Act or Section 4(a) of the Fair Packaging and Labeling Act. These include:
- FDA will establish Cosmetic Good Manufacturing Practice (CGMP) regulations consistent with national and international standards.
- Facility registration for any facility that manufactures, processes, or imports cosmetic products intended for sale in the U.S. Registration applies to both U.S. and non-U.S. facilities.
- Product and ingredient listing, including manufacturing location.
- Updated cosmetic labeling requirements, including identification of contact information for adverse events on product labels; identification of fragrance allergens on product labels consistent with the FDA’s new regulations; and updated labeling requirements for products intended for professional use.
- Maintenance of records to “adequately substantiate” product safety.
- Reporting of adverse events to FDA and maintenance of records documenting these events.
For the first time FDA will have mandatory recall authority if they reasonably believe that a cosmetic has been adulterated or misbranded and could result in serious adverse health consequences or death.
Cosmetic companies have the opportunity to participate in the FDA’s solicitation of public comments on the Current Good Manufacturing Practice Requirements, fragrance allergens, and testing for talc-containing cosmetics and to provide feedback on the use and safety of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products.
Responsible persons should begin planning for facility registration and product listing ahead of the December 2023 deadline. Additionally, cosmetic companies should also review MoCRA's requirements related to CGMP, labeling, product safety substantiation, adverse events reporting and record keeping. As the FDA is scheduled to initiate rule making and implementation on these key areas of compliance cosmetic companies should expect more guidance and specific regulations in the coming years.