麻豆传媒

Two months after finding benzene in hand sanitizer products, the online pharmacy Valisure has detected the carcinogen in several sun care products and is again calling for the FDA to intervene to protect public health.

The New Haven, Connecticut-based company announced in a that it found benzene in 78 sunscreen and after-sun care products, including -- 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."

Benzene, which has been found to be a cause of blood cancers, was found in sprays, gels, and lotions featuring both chemical- and mineral-based formulations.

"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, Valisure's co-founder and CEO, in the release.

"There is not a safe level of benzene that can exist in sunscreen products," noted Christopher Bunick, MD, PhD, associate professor of dermatology at Yale University in New Haven.

Valisure is asking the FDA to encourage the recall of the batches containing benzene and to "better define limits for benzene contamination in drug and cosmetic products." The 2-ppm limit, for example, only applies in special circumstances -- not including sunscreen manufacturing. "Therefore, in addition to recalls, Valisure is also 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. The company has also released a public petition to the FDA.

"Benzene contamination is a broad and very concerning issue in the American consumer product supply chain," Light said, requiring "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."

Valisure examined 294 unique batches of sun products from 69 different companies.

"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."

In late March, Valisure detected benzene and other contaminants that are potentially harmful in several batches of multiple brands of hand sanitizer, asking the FDA to push the recall of the affected batches and include a benzene exposure limit in its guidance.

Then in late April, Scentsational Soaps & Candles issued a voluntary national recall of scented hand sanitizers, 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.

Valisure was founded in 2015 on the premise of independently testing the medications it sells.

Comment