On December 29, 2022 U.S. President Joe Biden signed into law the Modernization of Cosmetics Regulation Act (MoCRA), setting in motion the requirement for most cosmetics facilities (foreign and domestic) to register with the Food and Drug Administration (FDA) by the end of 2023. The FDA posted draft guidance regarding the registration of cosmetics facilities on their website in August. On October 1, 2023, the Food and Drug Administration updated their web portal, FDA Direct, allowing those affected to begin to register and list their facilities and products in compliance with MoCRA regulations. In addition to registration and listing, foreign facilities will need to submit a U.S. Agent, a party located in the United States, as part of the process. A.N. Deringer, Inc. does not currently provide this service to importers.
The FDA 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”. This includes articles such as “skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product”. You may find the FDA’s guide Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) helpful in determining if your products are subject to the new MoCRA guidelines.
You may also access an overview of the registration and listing process here.
Please forward any questions regarding the MoCRA to email@example.com .