FDA Issues Guidelines for Incoming Beauty Regulation – WWD


As deadlines fast approach for the Modernization of Cosmetics Regulation Act, the first major statutory change to cosmetics regulation since the 1930s, the Food and Drug Administration has issued new guidelines to the beauty industry.

Known in the industry as MoCRA, the ruling essentially means that the FDA has been ordered by Congress to engage in more regulatory activity of the cosmetics industry.

While it is multifaceted, the FDA has spoken about the registration and listing components that will go into force on Dec. 29, making information about cosmetic products, including the ingredients used in products and the facilities where they are produced, readily available to the agency.

This includes nail polishes, shaving creams and other grooming products, perfumes, face and body cleansers, hair care products, moisturizers and other skin care products. Some small businesses are exempt.

“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, FDA’s chief scientist. “Passage of the MoCRA changed this.”

The guidelines state that facility registration information is to be updated within 60 days of a change and registration to be renewed every two years. Any updates to a product listing, such as a change in ingredients, are to be provided annually. The FDA is accepting comments on the draft guidance until Sept. 7.

A portal will go live in October for companies to add in the cosmetic product facility registrations and product listings. It’s also developing a paper form as an alternative submission tool. 

As for whether this will be made available to the public, some information — but not all — can be accessed through a request under the Freedom of Information Act, according to the FDA guidance.

Linda Katz, director of the FDA’s Office of Cosmetics and Colors, said: “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.”

Kelly A. Bonner, an associate at law firm Duane Morris, called the new guidelines “significant.”

“It represents FDA’s first real efforts to translate MoCRA into practice,” she said. “It is the first time FDA is mandating facility registration and product listing for an industry that is not used to that level of federal oversight in the United States, which is still the biggest market for personal care products worldwide.”



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