FDA Drafts Cosmetic Product Facilities and Listings Guidance

The US Food and Drug Administration (FDA) has announced¹ that it has issued draft guidance for cosmetic product facilities and cosmetic product listings. Once finalized, the guidance will allow the FDA to have increased oversight of cosmetic safety.

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In 2022, the Modernization of Cosmetics Regulation Act (MoCRA) served as the broadest expansion of FDA cosmetics regulation and oversight since the passage of the 1938 Federal Food, Drug, and Cosmetic Act. The law allowed the FDA to access records, including those related to safety, relevant to cosmetics products while also establishing mandatory recall authority, required adverse event reporting, facility registration, product listing, and safety substantiation.²

“On average, consumers in the US use 6 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, in a press release¹ from the FDA. Bumpus is the FDA’s chief scientist.

“Passage of the 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,” Bumpus said.

The draft guidance,³ called “Registration and Listing Cosmetic Product Facilities and Products,” further describes MoCRA requirements for facility registration, product listing, and small business exemptions. The guidance details the following:

• The statutory requirement to submit cosmetic product facility registrations and product listings
• Definitions
• Who is responsible for making the submissions
• What information to include in the submissions
• How to make the submissions
• When to make the submissions

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

The draft guidance is open for comments until September 7, 2023.

References

1. FDA issues draft guidance for registration and listing of cosmetic product facilities and products. U.S. Food and Drug Administration. August 7, 2023. Accessed August 7, 2023. https://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-registration-and-listing-cosmetic-product-facilities-and-products.
2. Center for Food Safety and Applied Nutrition. Modernization of Cosmetics Regulation Act of 2022. U.S. Food and Drug Administration. Accessed August 7, 2023. https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022#:~:text=The%20Modernization%20of%20Cosmetics%20Regulation%20Act%20of%202022%20(MoCRA)%20is,products%20many%20consumers%20use%20daily.
3. Center for Food Safety and Applied Nutrition. Draft guidance: Registration and listing of Cosmetics. U.S. Food and Drug Administration. Accessed August 7, 2023. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-registration-and-listing-cosmetic-product-facilities-and-products.