Testing Lab Asks FDA to Recall 78 Sunscreens Over Carcinogen Contamination

A testing lab company called Valisure is sounding the alarm over a carcinogen that it has detected in common sun care products. This week, the lab sent off a petition to the Food and Drug Administration warning that it’s found potentially unsafe levels of a chemical called benzene in dozens of sunscreens and after-sun care lotions it tested. It’s now calling for the FDA to issue a recall of these products and conduct their own investigation into the possible contamination.

Connecticut-based Valisure is an independent testing lab company that bills itself as going above and beyond in certifying the safety of the drugs it tests, including products sold through its own pharmacy. In 2018, it notified the FDA about their discovery of a possible cancer-causing chemical called NDMA in drugs with the active ingredient ranitidine, such as the over-the-counter heartburn product Zantac. Eventually, their claims were wholly validated and both the FDA and regulatory agencies in other countries have since enacted the mandatory recall of ranitidine drugs (whether these drugs will ever return to the market is still unknown).

Earlier this March, Valisure once again reached out to the FDA, after it detected levels of benzene in hand sanitizers—a discovery that soon led to a voluntary recall of some products. And now, the lab is saying the same is true for some sunscreens and after-sun care products, like lotions used to soothe sunburns. Out of nearly 300 brands sold by 69 companies, the lab found benzene in 78 products, sometimes in much higher concentrations than conditionally allowed by the FDA.

“The presence of this known human carcinogen in sunscreen products widely recommended for the prevention of skin cancer and regularly used by adults and children in large volumes makes this finding especially troubling,” the company wrote in its citizen petition to the FDA, dated May 24.

Benzene, a colorless or slightly yellowish flammable liquid at room temperature, is naturally found in the environment and is also used as a solvent in the manufacturing of plastics and other products. But it’s acutely toxic in high doses, and it’s well established that long-term exposure can raise a person’s risk of developing cancer, often through its presence in cigarette smoke. Benzene is also suspected to raise the risk of blood cancers like leukemia. The FDA doesn’t permit the intentional introduction of benzene to drugs or consumer products it regulates, but it does set a safety threshold for its presence if unavoidable, at 2 parts per million.

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Currently, though, the FDA doesn’t recognize sunscreens as a potential source of benzene. Even if it did, Valisure claims to have detected benzene in some batches at levels higher than 2 ppm. And since most of the sunscreens the company tested didn’t contain benzene, the company argues that no amount of benzene should be tolerated by the health agency.

“There is not a safe level of benzene that can exist in sunscreen products,” said Christopher Bunick, an associate professor of dermatology at Yale University, in a statement released by Valisure. “Even benzene at 0.1 ppm in a sunscreen could expose people to excessively high nanogram amounts of benzene.”

The discovery is all the more concerning due to recent evidence collected by the FDA itself that sunscreen chemicals can be readily absorbed through the skin, possibly in levels higher than expected. So far, scientists haven’t determined whether this could be putting anyone at risk, but it’s yet another reason why the FDA should take immediate action, according to the company. In its petition, Valisure calls for the FDA to recall the products it detected benzene in, and to conduct their own investigation. The lab also asks the FDA to reevaluate how it regulates these products, a timely priority since the agency is now hammering out the latest version of their guidelines for sunscreen regulation.

As of yet, the FDA hasn’t responded to a request for comment from Gizmodo. But for those of us who regularly wear sunscreen (which should be all of us, ideally), Valisure has provided a list of sunscreen products that don’t appear to contain benzene, as well as instructions on how to dispose of products that could contain benzene, since it’s an environmental danger to marine wildlife as well.