As consumers, we often assume that our cosmetics and personal care products are safe. But did you know that the US Food and Drug Administration (FDA) receives about 5000 reports yearly about cosmetics-related health problems? These reports are known as Adverse Event Reports (AERs) and are submitted to the FDA by consumers, healthcare professionals, and manufacturers.
The Modernization of Cosmetics Regulation Act (MoCRA) has given the FDA more power to regulate cosmetics. This act became effective on December 29. Under this new law, the FDA has updated its instructions for reporting serious adverse events related to cosmetics.
The FDA now requires cosmetic product manufacturers and distributors to submit reports of serious adverse events directly within 15 business days. Reports must include a copy of the label 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.
The AERs can include a wide range of issues such as skin rashes, hair loss, allergies, and even serious health problems like cancer. While not all of these reports are necessarily related to the cosmetics themselves or considered “serious,” they do raise concerns about the safety of the ingredients used in these products.
Under the new act, 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.
Only when the new instructions were mandated did the FDA have the authority to require cosmetic companies to submit their safety data or product formulations before they were released to the market. Until then, it relied on the voluntary reporting of the industry and consumers to identify potential safety issues.
“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,” Dr. Linda Katz, director of the FDA’s Office of Cosmetics and Colors, said. “In addition, we expect that consumers will also be able to file online.”
The FDA provides instructions on its website for consumers and healthcare professionals to report cosmetic-related complaints via phone, mail, or online.
And wouldn’t you know it, with the implementation of MoCRA, the FDA is now cracking down on the use of PFAs, or “forever chemicals” in cosmetics. The act requires the FDA to publish a report summarizing its safety assessment on PFAS in cosmetics before December 29, 2025.
“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,” remarked Dr. Namandjé Bumpus, the FDA’s chief scientist, and soon-to-be principal deputy commissioner. “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 noted. “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.”
Both Katz and Bumpus added that little data or published research is available on PFAS in cosmetics.