Valisure LLC, a pharmacy that also does independent product testing, has recently petitioned the FDA to adopt stronger guidelines addressing the presence of benzene in sunscreen products. The pharmacy claims to have discovered benzene in 78 sunscreen and after-tanning care products in an article published on its website.
Benzene, a known human carcinogen, can be found in petroleum, cigarette smoke and coal tar. Reports that the carcinogen has been found in many brands and batches of sunscreen, which the Food and Drug Administration (FDA) classifies as drug products, as well as after-sun care products, which are controlled by the FDA as cosmetics, has raised concerns among scientists and consumers alike.
According to the US Centers for Disease Control and Prevention, the US Department of Health and Human Services, the World Health Organization, is a cancer causing agent in humans. Valisure found detectable benzene in 27% of samples tested, with some batches containing up to three times the FDA’s conditionally limited 2 ppm maximum.
Valisure is urging a recall of the affected batches as well as a better definition of benzene contamination limits in medicine and cosmetic items from the FDA. It’s crucial to remember that not all sunscreens include benzene, and that uncontaminated sunscreens are still accessible, should be used, and are essential for guarding against potentially hazardous UV rays.
Benzene has been classified as a “Class 1 solvent” by the FDA, which means it “should not be employed in the manufacture of drug substances, excipients, and drug products because of their unacceptable toxicity. However, if their use is unavoidable in order to produce a drug product with a significant therapeutic advance, then their levels should be restricted [to 2 parts per million (ppm)].”
In the Valisure news release they explain, “the toxicity of benzene in humans has been well established for over 120 years. The hematotoxicity of benzene has been described as early as 1897. A study from 1939 on benzene stated that “exposure over a long period of time to any concentration of benzene greater than zero is not safe,” which is a comment reiterated in a 2010 review of benzene research specifically stating “There is probably no safe level of exposure to benzene, and all exposures constitute some risk in a linear, if not supralinear, and additive fashion.” Benzene is specifically associated with blood cancers such as leukemia, making absorption through the skin particularly concerning as there have been multiple studies by FDA researchers showing that chemicals in sunscreen products are found in the blood at high levels after application to the skin.”
“Benzene is one of the most studied and concerning human carcinogens known to science. Its association with forming blood cancers in humans has been shown in numerous studies at trace levels of parts per million and below. 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,” said David Light, Founder and CEO of Valisure.
Valisure has established itself as a trusted brand in product testing in recent years, having spearheaded efforts to get the carcinogen NDMA removed from heartburn drugs in 2018 and more recently leading the fight to recall benzene-containing hand sanitizers. The lab examined over 300 kinds of sunscreen and after-tanning products marketed by 69 businesses in this latest endeavor, and detected benzene in 78 of them. They point out that the products were marketed as a means to protect adults and children against skin cancer, but they also point out that several of the goods they examined had levels above the FDA’s 2 percent limit. They also point out that because many of the items they examined contained no measurable levels of benzene, it is obvious that it is not an unavoidable consequence of manufacturing. They also mention the FDA’s recent discovery that sunscreen ingredients are easily absorbed via the skin.
In the petition, they request that the FDA prohibit any quantity of benzene in sunscreen and after-tanning care products, as well as initiate a recall for those that have already been marketed and have measurable quantities of benzene. They’ve also produced a table with a list of sunscreen brands that don’t contain any benzene.