A Free Hand? Company Warns of Continued Carcinogen Risk in Sanitizers

Startup pharmacy Valisure made headlines last month for warning of  benzene found in several products from China and elsewhere. The FDA has yet to act.
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Late last month, a pharmacy startup made headlines for its study that found a dangerous, cancer-causing chemical compound in hand sanitizers. But have the germ-killing gels been pulled from store shelves by now, weeks later?

“No.” 

That was the answer of David Light, CEO of Valisure, which on March 24 notified the Food and Drug Administration that it found excessive levels of benzene, which has been linked to blood cancers, in batches of several brands of sanitizers. The products were mainly produced by Chinese companies that were unheard of before the pandemic had caused shortages of the cleaners last spring.

“We obviously are hoping that they take this seriously and that they respond expeditiously,” said Light of the FDA during a recent phone call. He told TheStreet that the FDA posted a petition the company filed, but the Connecticut-based startup has since gotten no other communication from the federal agency by last week. Valisure promotes itself as a pharmacy that tests and labels -- and screens for bad batches -- of drugs and other products it sells, standing out in an industry known to be under-regulated. 

Since the notice, a few universities such as Harvard have reportedly stopped the on-campus use of the products, but little else has changed. A reporter for TheStreet noticed gels by the company found to have the highest levels of benzene on store shelves last week and for sale online this weekend. 

The FDA has yet to act on the hand sanitizing products, though it says it’s reviewing them.

“The FDA takes seriously any safety concerns raised about products we regulate, including hand sanitizers. While the agency evaluates the submitted citizen petition, we will continue to monitor the hand sanitizer marketplace and manufacturing efforts to help ensure the availability of safe hand sanitizers for U.S. consumers,” said FDA spokesman Jeremy Kahn in an email to TheStreet on Friday.

Shortly after the pandemic panic a year ago, when stores were emptied of common brands of sanitizers like Purell, shelves were flooded with new products, many of them from China, Mexico, the U.S. and elsewhere. Amazon  (AMZN) - Get Report and other online retailers were saturated with the products, too.  

By early last year, the FDA had begun warning consumers not use hundreds of sanitizers, mostly ones produced in Mexico, because they contained dangerous levels of methanol or 1-propanol, or had other types contamination. Methanol can cause neurological harm, unlike ethanol or isopropyl, which are safe for use on the skin, and are the main ingredients of the vast majority of sanitizers. 

Because of the emergency shortage caused by the COVID crisis, however, the FDA moved to temporarily allow extremely low levels of benzene -- two parts per million -- in some types of sanitizers.

More than a dozen brands Valisure studied, however, had batches that exceeded allowed levels by several times. One brand had around 16 parts per million of the carcinogenic chemical.

Once commonly used as an industrial solvent, benzene can occur naturally, and is widely used in the making of plastics, dyes, detergents and other products. Its use is heavily restricted, however, because it’s a known carcinogen linked to the development of leukemia and other cancers of blood cells.

“All organic chemists are leery of benzene (a known carcinogen), so much so that virtually all benzene in labs has been replaced by toluene, which is very similar in properties, but is not carcinogenic,” said Josh Bloom, director of chemical and pharmaceutical science at the American Council on Science and Health, an advocacy group sometimes described as a pro-industry.

But Bloom said that minuscule amounts were of little concern to most people. Gasoline, he said, can contain far more benzene, and splashing a little on one’s hand at the gas station would expose a person to more than the sanitizers would.

“I cannot tell you that there is no risk,” said Bloom in an email to TheStreet on Sunday. “Risk depends on the amount/time of exposure and the individual. In my opinion, the risk is low, probably very low, and I would not hesitate to use alcohol with very small amounts of benzene in it.”

He also noted that COVID is almost entirely spread by air, and so in general “it can reasonably be assumed that we are probably also overusing the alcohol sanitizers.”

Still, other experts have argued that any amount of benzene in products applied to the skin poses a risk, especially because sanitizer gels may be used several times a day, over long periods of time. In addition, children may use the products.

“If it is possible to have hand sanitizers that don’t have any detectable levels, it is inexcusable that the FDA doesn’t ban any hand sanitizer that contains any detectable level,” Dr. Sidney M. Wolfe, the founder of and senior adviser for Public Citizen's Health Research Group, told Bloomberg after the letter went out in March.

Wolfe told TheStreet on Sunday by email that he still stands by that comment.

In addition, while crediting the FDA for warning consumers about more than 230 other hand sanitizer products, mainly because of methanol risk, Light said the FDA "definitely has to take more action on this – and a lot more focus of this particular (benzene) problem." 

He also noted that Valisure found several products marketed to kids, though "the FDA was very adamant about hand sanitizers being produced during the emergency to not appeal to children. But a lot of companies we saw ignored that completely."

This story has been updated. Mr. Bloom's name has been updated as well, as he goes professionally by Josh.