FDA Drafts Cosmetic Product Facilities and Listings Guidance

Posted By Madilyn Moeller, Friday, August 11, 2023


The US Food and Drug Administration (FDA) has announced that it has issued draft guidance for cosmetic product facilities and cosmetic product listings.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.

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.

“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 release 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.

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