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MoCRA: FDA Guidance on Facility Registration and Product Listing

Published August 22, 2023
Published August 22, 2023
Sasun Bughdaryan via Unsplash

The Modernization of Cosmetics Regulation Act (MoCRA) was passed by the U.S. Congress and signed into law by President Biden on December 29, 2022. MoCRA is the first significant amendment to FDA’s cosmetics authority since President Franklin Delano Roosevelt signed the Federal Food, Drug, and Cosmetic Act (FFDCA) into law in 1938. As deadlines for the MoCRA approach quickly, the Food and Drug Administration has issued draft guidance for cosmetic facility registration and product listing. These are two mandatory obligations under the new cosmetics regulation.

“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, PhD, 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The draft guidance, “Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry,” describes MoCRA requirements for facility registration and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. Submission of information about existing cosmetic product facilities and products is required no later than December 29, 2023. 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. 

Until March, the FDA operated a voluntary cosmetic registration program for cosmetics manufacturers that provided the agency 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, and intends to make the submission portal available in October 2023 and provide a paper form as an alternative submission tool on an unspecified date.

“The FDA is working to strengthen its oversight in regard to the safety of cosmetics,” said Linda Katz, MD, MPH, 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.”

The consultation period for this draft will run until September 7, 2023.


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