FDA Issues Draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products

FDA News Release

• For Immediate Release: August 07, 2023

Today, the U.S. Food and Drug Administration issued a draft guidance which, once finalized, will assist cosmetics companies submitting cosmetic product facility registrations and cosmetic product listings, including ingredients, to the FDA. This includes a wide range of products such as makeup products, nail polishes, shaving creams and other grooming products, perfumes, face and body cleansers, haircare products, moisturizers, and other skincare products.

“On average, consumers in the U.S. use six to 12 cosmetics products daily. But, until recently the FDA didn’t have the authority to require manufacturers to submit cosmetic product listings, including a list of ingredients used in these products, or register the facilities where they were produced,” said Namandjé Bumpus, Ph.D., FDA’s Chief Scientist. “Passage of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) changed this. Later this year, registration and listing of cosmetic product facilities and products will become a requirement, making information about cosmetic products, including the ingredients used in products and the facilities where they are produced, readily available to the agency.”

The draft guidance, “Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry,” describes MoCRA requirements for facility registration and product listing, and the exemptions under MoCRA for certain small businesses. Under MoCRA, submission of information about existing cosmetic product facilities and products is required no later than Dec. 29. Facility registration information is to be updated within 60 days of a change and registration to be renewed every two years. Additionally, any updates to a product listing, such as a change in product ingredients, are to be provided annually.

“The FDA is working to strengthen its oversight in regard to the safety of cosmetics,” said Linda Katz, M.D., M.P.H., director of the FDA's Office of Cosmetics and Colors. “The agency will rely on registration and listing information to accomplish several objectives, such as identifying facilities producing products potentially causing adverse events, facilitating the recall of unsanitary products, administering product testing and surveillance programs, planning inspections and identifying products marketed in violation of the law.”

Until March, the FDA operated a Voluntary Cosmetic Registration Program for cosmetics manufacturers that provided the agency with only a snapshot of the information available about cosmetic products and ingredients, their frequency of use and businesses engaged in their manufacture and distribution. The FDA is developing a new system for receiving registration and listing information required by MoCRA.

Today’s draft guidance is intended to play a critical role in helping to ensure the safety of cosmetic products that many consumers use day-to-day. It also serves as a milestone within the agency’s continued efforts to protect the public health. The FDA is accepting comments on the draft guidance until Sept. 7.