Though the agency doesn’t have exposure limits, it informs companies that “solvents such as benzene should not be employed in the manufacture of drug substances, excipients, or drug products because of their unacceptable toxicity.” In a statement, the FDA wrote it “continues to monitor the issue” and work with companies to recall contaminated products. In such scenarios, the FDA’s limit is two parts per million, but some products that provided no therapeutic advantage were found with levels as high as 21 ppm. Benzene can also be added in emergency situations, like the pandemic, or if it provides “significant therapeutic” advantages. The FDA’s system “really lacks independent review” because it relies on companies to self report, Light said.įederal rules allow benzene to be used in the manufacture of personal care products, and that can cause it to end up in goods, even if it’s not listed as an ingredient. Though the agency lacks the authority to order recalls and may be limited in its pre-market authority to require testing, advocates are calling on the FDA to clarify an existing benzene limit, set new exposure limits, and conduct more testing of products on store shelves to ensure they are safe, instead of leaving that up to independent labs. In a December statement, the agency said it was investigating the situation, doing its own testing and urged companies to recall contaminated products. The US banned benzene’s use as an ingredient nearly 45 years ago, and it is “somewhat unique in that it’s pretty well established to be incredibly toxic – that’s been known for decades to over a century,” said David Andrews, senior scientist at the public health advocate Environmental Working Group.Īdvocates took aim at the Food and Drug Administration for failing to do more to protect the public. The toxin has also been shown to harm the central nervous system and reproductive organs. The petroleum-based chemical “causes cancer”, especially leukemia and in blood forming organs, the US Department of Health and Human Services wrote.
Light pointed to “ decades of research” that has found no safe levels of benzene exposure because it’s so toxic at very low levels. Among the recalled hand sanitizer brands are Art Naturals, Best Brands and Natural Wunderz. Procter & Gamble, Bayer, CVS and Johnson & Johnson have issued voluntary recalls for widely distributed brands including Brut, Sure, Pantene, Herbal Essences, Old Spice, Secret, Tinactin, Lotrimin, Coppertone, Neutrogena and Aveeno. “What we’re seeing is a fundamental problem in the manufacturing of a lot of consumer products.” To date, Valisure has tested 662 items and found the chemical in 180, or about 27%, of products. “Benzene really shouldn’t be there at all,” he said. The findings suggest that benzene contamination is widespread and is probably in more products that have not yet been tested, said David Light, Valisure’s chief executive.
The contamination has been most frequently detected in aerosol or spray products, some at levels the Food and Drug Administration characterized as “life-threatening”. The lab, Valisure, last year detected benzene in hand sanitizers, sunscreens, deodorant, dry shampoos, conditioners, antiperspirants, deodorants, body sprays and anti-fungal treatments.
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