Cosmetic products and ingredients, other than color additives, are not required to have Food and Drug Administration (FDA) approval before they go on the market. However, there are laws and regulations that apply to cosmetics that are distributed in the United States.
In December 2022, President Biden signed into law the Consolidated Appropriations Act, which included the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Among other provisions, MoCRA established requirements for cosmetic product facility registration and product listing. These requirements are coming into effect as early as October 2023.
FDA Solutions Group Cosmetic Services
Our cosmetic regulatory specialists can answer any questions you may have to help your company comply with the new registration and listing requirements of MoCRA. The FDA is finalizing the information needed to register cosmetic products and will make that available on or after October 1, 2023, and the below products will be available once that information is finalized. Please contact us if you would like to speak to a regulatory specialist now.
- Domestic Cosmetic Facility Registration and Product Listing: for establishments located in the United States that are involved in manufacturing or processing of a cosmetic product for distribution in the United States.
- Foreign Cosmetic Facility Registration, U.S. Agent Service and Product Listing: for establishments located outside of the United States that are involved in manufacturing or processing of a cosmetic product for distribution in the United States.