The US Food and Drug Administration receives about 5,000 reports each year about health problems related to the use of cosmetic products, and under a new law, the agency has issued updated instructions for reporting these types of serious adverse events.
The FDA’s authority to regulate cosmetics has expanded under the Modernization of Cosmetics Regulation Act or MoCRA, which went into effect December 29. The agency now requires manufacturers and distributors to submit reports of serious adverse events related to cosmetic products directly to the FDA – and to do so within 15 business days.
Reports of these events, “until MoCRA, were only voluntary. So even if a serious adverse event was found, it was submitted to the agency on a voluntary basis,” Dr. Linda Katz, director of the FDA’s Office of Cosmetics and Colors, said Tuesday.
“If you look at, in general, the amount of adverse events that we get for cosmetics, they range,” she said. “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 the new act, such an event can be considered “serious” if it results in death, a life-threatening experience, hospitalization, a persistent disability, medical or surgical interventions, a birth defect, infection or significant disfigurement, including second- or third-degree burns or significant hair loss.
“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,” Dr. Namandjé Bumpus, the FDA’s chief scientist and soon-to-be principal deputy commissioner, said Tuesday. “So these data will be beneficial to us and really help us advance public health as far as our regulation of cosmetics.”
The updated instructions require a manufacturer, packer or distributor whose name appears on the label of the cosmetic product to report serious adverse events within 15 business days.
That report must include a copy of the label that was on or within the retail packaging, and any new information about the adverse event that emerges within a year of the initial report must also be submitted to the FDA within 15 business days.
“Over the course of the next several months, we will have an electronic way that industry can submit these reports to us directly rather than having to use the paper forms,” Katz said. “In addition, we expect that consumers will also be able to file online.”
Currently, the FDA has a website instructing consumers and health care professionals on how to report a cosmetic-related complaint via phone, online or in the mail.
FDA looks at ‘forever chemicals’ in cosmetics
With the implementation of MoCRA, the FDA is also assessing the use of per- and polyfluoroalkyl substances, or PFAS, in cosmetic products and the potential risks from PFAS exposure. The act requires the FDA to publish a report summarizing its safety assessment on PFAS in cosmetics before December 29, 2025.
PFAS, commonly called “forever chemicals,” are a group of widely used and long-lasting synthetic chemicals that linger in the environment and the human body because they break down very slowly over time. In July, a study from the US Geological Survey found that nearly half of the tap water in the United States is contaminated with these chemicals.
PFAS exposure has been linked to health effects including an increased risk of some cancers, obesity, high cholesterol, decreased fertility and developmental effects in children.
“PFAS, when it’s present in a cosmetic product, may appear in two ways. It may be intentionally added to go ahead and make a product appear glossier or shinier than it would be without it. That’s one of its uses. But it may also be a byproduct of the manufacturing of the cosmetic,” Katz said Tuesday.
Both Katz and Bumpus added that there is not much data or published research available on PFAS in cosmetics.
“We’ll be looking at the sum of the data that are there in the literature, but one of the great things about FDA being a scientific agency is that we can actually, very strategically, try to fill certain scientific gaps through our own research,” Bumpus said.
“As a scientific agency, we also can generate data as needed through doing our own experimentation and we have really exceptional scientists who can do that,” she said. “So that will be part of what we leverage as we are trying to understand the potential impacts or science of PFAS for this report.”