The Food and Drug Administration (FDA) is a federal agency regulating several products, such as medical devices, drugs, food, and cosmetics. On top, the FDA is in charge of enforcing of the law. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) reinforces FDA’s authority over cosmetic products.
As in the European Union, cosmetics in the US are not subject to pre-market approval by the FDA; thus, they cannot bear the claim “FDA-approved” or similar. Only color additives must be approved before being used in cosmetics, drugs, and food. It is the responsibility of the Responsible Person to ensure cosmetic products comply with the law before entering the market. However, the FDA performs in-market controls.
To facilitate communication with the FDA, MoCRA establishes new requirements, such as product listing, facility registration, and the appointment of a US Agent for foreign facilities.
FDA’s enforcement tasks
In the context of in-market controls, MoCRA gives the FDA additional powers in case of adulterated or misbranded products or risk of serious adverse health consequences. It can:
- Check the documentation to verify compliance with the law;
- Inspect facilities worldwide;
- Suspend facility registration in case of non-compliance;
- Request the manufacturers to provide details about ingredients, fragrances, and flavors;
- Demand the manufacturer to recall the product voluntarily. The FDA can impose a mandatory withdrawal if the manufacturer does not comply.
Additionally, the FDA cooperates with the U.S. Customs and Border Protection to monitor that cosmetic products imported into the United States meet the regulatory requirements. Non-compliant products might be destroyed or re-exported.
Future tasks for the US regulator
MoCRA introduces new tasks for the FDA to establish rules on:
- Good Manufacturing Practices (GMP) — The proposed rule shall be released by December 29, 2024, and be finalized one year later, by December 29, 2025;
- Labelling of fragrance allergens — The proposal is to be released by June 29, 2024;
- Standardized testing methods for detecting and identifying asbestos in cosmetic products containing talc — The proposal shall be published by December 29, 2023.
The FDA must also assess the use and safety of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products and publish their conclusions on the topic by December 29, 2025.
Lastly, the FDA issues guidance documents for the industry, like the Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing.
Do you need help to comply with MoCRA? Obelis, with 35 years of international regulatory experience, is the ideal partner to support you in the compliance journey. Contact us today to discover our US services dedicated to manufacturers, brand owners, and producers of cosmetic products.
Francesca Santacatterina
Publications Department
22.11.2023
References:
- FDA. (2022). FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated. Retrieved on 22.11.2023
- FDA. (2022). Inspections of Cosmetics. Retrieved on 22.11.2023