The FDA completes Health Hazard Evaluations to assess the safety risk of a contaminated product that is being recalled.
#Benzene in sunscreen recall skin
He notes 2 ppm is many times higher than what is allowed in drinking water. “And remember,” he says, “these sunscreens are aerosols, so users are exposed not only when they rub it onto their skin but possibly also if they inhale it while it is being applied.” Michael Hansen, PhD, a senior scientist at CR, agrees that the levels of benzene found are alarming. “Research clearly shows that regular exposure to benzene at levels above 2 ppm increases the risk of cancer, and the amount detected in these products was well above that,” he says.
Pharmacopeia (USP), a nonprofit organization that publishes guidelines for contaminants in consumer products and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).Īt that high level, the FDA’s internal report said that serious adverse effects “were likely to occur,” including the potential for life-threatening issues or “permanent impairment of a body function.” The report (PDF), called a Health Hazard Evaluation, said that Johnson & Johnson’s tests detected levels of benzene 5 to 12 times above recommended limits set by two independent organizations: the U.S. The FDA published Johnson & Johnson’s statement on the agency’s website without providing any additional information about the matter.īut an internal FDA report-completed prior to the announcement and obtained by CR through the Freedom of Information Act-reached a different conclusion. The recall, Johnson & Johnson said, was being conducted “out of an abundance of caution.” The company declined to provide CR with a copy of its safety analysis. The company said its analysis found that the levels of benzene detected “would not be expected to cause adverse health effects,” even with daily exposure. In a July statement announcing the recall, Johnson & Johnson advised consumers to avoid using the affected products. The FDA confirmed Thursday that it was investigating the issue and directed manufacturers to test their products for the contaminant. Multiple aerosol personal care products from other manufacturers have since been recalled over the presence of benzene, but a broader explanation for how benzene contamination became so widespread is, for now, a mystery. At the time of the recall, Johnson & Johnson said it was investigating the matter, and a spokesperson last week provided no new information. It’s still unclear why benzene was found in the aerosol products. That’s based on independent standards organizations that say daily exposure above that threshold is associated with increased cancer risks. The FDA advises that manufacturers should limit benzene levels in consumer products and drugs to no more than 2 parts per million. The Johnson & Johnson products were the first to be recalled after the findings were released.
Short-term exposure to benzene can cause dizziness and headaches, while long-term exposure causes certain types of cancer and blood disorders.Ĭoncerns about benzene in aerosol sunscreen emerged in the spring of 2021 when an independent testing organization, Valisure, released a study that detected the contaminant in dozens of those products.
The products-including several of Johnson & Johnson’s Neutrogena and Aveeno aerosol sunscreens-were recalled in July after tests by the company detected benzene in multiple samples. And while Johnson & Johnson says that the levels found would not be expected to pose a health risk to consumers, the FDA report and scientists CR spoke with say otherwise. The Food and Drug Administration misled the public earlier this year about the risks posed by aerosol sunscreen products made by Johnson & Johnson that were found to be contaminated with benzene, a known carcinogen, an agency report obtained by Consumer Reports suggests.
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