Independent pharmaceutical testing company Valisure recently found that 78 lots of sunscreens and sun care products contained benzene, a known carcinogen that has been linked to blood cancer and other illnesses. Of the 78 batches with detectable levels, 40 products were found to have "significantly detected" levels of benzene. This week the lab sent off a petition to the Food and Drug Administration warning that it’s found potentially unsafe levels of 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. 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.
According to the U. S. Center for Disease Control and Prevention (CDC), the World Health Organization (WHO), U.S. Department of Health and Human Services, and various other regulatory agencies, benzene is known to cause cancer in humans. The National Institute for Occupational Safety and Health (NIOSH) also defines benzene as a carcinogen and exposure can include “inhalation, skin absorption, ingestion, and skin and/or eye contact.”
Click the following link to read the Valisure letter to the FDA with the list of 78 lots of sunscreens that it has requested the FDA recall:
“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 (the petition also contains the list of potentially contaminated products).
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.
Leukemia (cancer of blood-forming organs), anemia (a decrease in red blood cells), excessive bleeding and decreased ovary size have all been linked to long-term benzene exposure, according to information from the CDC and Department of Health and Human Services.
Valisure's findings are concerning because there is no safe amount of benzene in any product, according to the FDA, which refers to it as a Class 1 Solvent. Benzene is a known contaminant in the petroleum industry, and there are a lot of petroleum products that make their way into cosmetics, lotions and creams.
“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.
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