The FDA is called upon to protect public health after benzene is found in sun care products.
Two months ago, New Haven, Connecticut-based Valisure, an online pharmacy, found benzene in hand sanitizer products. Now, the company is saying that it has detected the cancer-causing chemical in sun care products and is asking the Food and Drug Administration (FDA) to recall these products from store shelves.
The Centers for Disease Control and Prevention (CDC), warns that benzene is colorless (or light-yellow liquid at room temperature), has a sweet odor and is highly flammable. The agency states, “The seriousness of poisoning caused by benzene depends on the amount, route, and length of time of exposure, as well as the age and preexisting medical condition of the exposed person.” Benzene is considered a carcinogen and has been linked to blood cancers.
Vailsure said in a release that benzene was discovered in “78 sunscreen and after-sun care products, including 14 lots across four different brands — Neutrogena, Sun Bum, CVS Health, Fruit of the Earth — that contained 2.78 to 6.26 parts per million (ppm) of benzene. More than one-quarter of the products tested featured detectable levels of benzene; some batches had as much as three times the conditionally restricted FDA concentration limit of 2 ppm.”
David Light, Valisure’s co-founder and CEO, explained, “The presence of this known human carcinogen in products widely recommended for the prevention of skin cancer and that are regularly used by adults and children is very troubling,” Christopher Bunick, MD, PhD, associate professor of dermatology at Yale University in New Haven, also noted, “There is not a safe level of benzene that can exist in sunscreen products.”
Valisure would like to see a recall and is asking the FDA to “better define limits for benzene contamination in drug and cosmetic products.” In addition, the company is “petitioning the FDA to create a concentration limit for standard drug products, including sunscreen, and to also set a daily exposure limit,” the release explained.
“Benzene contamination is a broad and very concerning issue in the American consumer product supply chain,” Light said. He added this is why there is “the critical need for independent testing. It is imperative for FDA to expeditiously address current regulatory gaps regarding benzene in both drug and cosmetic products.”
“Any significant detection of benzene should be deemed unacceptable,” according to Valisure’s release. “Being that many of the tested sunscreen and after-sun care products did not contain detectable levels of benzene, it does not appear that benzene use is unavoidable for their manufacture and considering the long history of widespread use of these products, it also does not appear that they currently constitute a significant therapeutic advance.”
Scentsational Soaps & Candles issued a voluntary national recall of scented hand sanitizers in April, citing the presence of benzene, methanol, and acetaldehyde. That recall “further underscores the necessity to better regulate benzene and its apparent prevalence in the drug and consumer product supply chains,” Valisure argued. There were not any reported adverse reactions to Scentsational’s recalled products. However, company spokesperson Steve Morrison said at the time that it “is doing everything possible to carry out the recall and make sure this doesn’t happen again.”