FDA updates cosmetics regulations to focus on ‘serious adverse effects’

Cosmetics manufacturers and distributors are now required to report serious adverse reactions to their products, following updated requirements from the US Food and Drug Administration.

The Modernization of Cosmetics Regulation Act (MoCRA) went into effect on Dec. 29, 2023, requiring the manufacturers, packers and distributors of cosmetic goods to file reports of serious adverse events related to their products within 15 business days. Under former FDA regulations, reporting these reactions was fully voluntary.

What is a serious adverse event?

A “serious adverse event” is defined by the FDA as a reaction to a product that results in a person’s death, near-death experience, hospitalization, disability, birth defect, infection, significant disfigurement or surgical or medical intervention to prevent said complications.

Dr. Linda Katz, director of the FDA’s Office of Cosmetics and Colors, said Tuesday that approximately one quarter of previously reported adverse events due to cosmetic products would be categorized as serious.

“If you look at, in general, the amount of adverse events that we get for cosmetics, they range,” she said, per CNN. “They’re about a little over 5,000 total per year. Not all of those are serious. In fact, it used to be that, when we’d look at them, about 25% would meet a definition previously of ‘serious.’”

Under MoCRA, responsible parties must report any instances of serious adverse events to the FDA within 15 days. The required report includes a form the responsible party must fill out, as well as a copy of the product’s retail label. If the responsible party receives additional information about the serious adverse event within one year of filing their report, they must submit that new information in an additional FDA report within 15 days.

Why did the FDA update cosmetics regulations?

One purpose of MoCRA is to enable the FDA to gather better data on public health, according to Dr. Namandjé Bumpus, Chief Scientist of the FDA.

“The serious adverse event reporting is really a key provision because it allows us to just understand a lot more about what’s out there and what people are experiencing,” Bumpus said, per CNN. “So these data will be beneficial to us and really help us advance public health as far as our regulation of cosmetics.”

MoCRA will also help the FDA study cosmetics with per- and polyfluoroalkyl substances (PFAS), also known as “forever chemicals,” which the FDA has linked to serious adverse health effects.

How do you check if cosmetics are FDA approved?

Although all drugs and pharmaceuticals must receive FDA approval before being sold in the U.S., cosmetics do not fall under those same requirements. According to the FDA, color additives are the only product that must receive approval before they go on the market. However, the FDA can take action against a product if they find it violates the law.

To check whether a specific product or ingredient has been reviewed by the FDA, consult the Cosmetics Products & Ingredients page on the FDA website. Additional information on labeling guides and cosmetics laws and regulations are also available on the site.