New Requirement - FDA Cosmetic Facility Registration and Product Listing
Most cosmetics manufacturing and processing companies will need to register their facilities and list their products with the U.S. Food and Drug Administration (FDA), much like the requirements to register and list drugs and drug-related facilities. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requires foreign and domestic facilities to register with the FDA by December 29, 2023. Foreign-based companies are required to provide a U.S. agent in the submission.
The FDA website provides information regarding the registration and listing of cosmetic product facilities and products. Registration renewal will be required every two years. The FDA provides a guide for the use of the portal.
The Food, Drug and Cosmetic Act (FD&C Act) defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” {FD&C Act, sec.20(i)}.” Among the products included in this definition are bath products, hair products, fragrances, makeup, manicure products, toothpaste, mouthwash, cleansers, skin care preparations including shaving preparations, and deodorants, as well as any substance intended for use as a component of a cosmetic product.
The FDA has published a web page, “Is It a Cosmetic, a Drug, or Both (Or Is It Soap?),” which may be helpful to determine whether a party is subject to the new registration and listing requirements.
Failure to register or submit listing information in accordance with the FD&C Act is a prohibited act. Importers of affected products must ensure they and their foreign business partners register their facilities and list their products by December 29, 2023.