乌鸦传媒

Online pharmacy Valisure is sounding the alarm over what it says are contaminated batches of a pandemic staple.

The New Haven, Connecticut-based company announced Wednesday that it had , a , in several batches across multiple brands of hand sanitizer.

Valisure to the FDA, asking the agency to request an immediate recall of the affected batches and update guidance to include an exposure limit for benzene. The FDA regulates hand sanitizer as a drug product.

"The presence of benzene, a known human carcinogen, and multiple other contaminants, in products widely recommended for the prevention of spreading the SARS-CoV-2 virus causing COVID-19 and regularly used by adults and children in large volumes makes these findings especially troubling," the company wrote in its citizen petition.

That's in part because the National Institute for Occupational Safety and Health lists "'inhalation, skin absorption, ingestion, skin and/or eye contact'" as exposure routes for benzene, the company wrote.

Valisure -- which was founded in 2015 on the premise of independently testing the medications it sells -- noted that the FDA has said benzene should not be used in drug products because of its toxicity. (Benzene is a widely used industrial solvent, is present in substances such as gasoline, cigarette smoke, and forest fires, and is also a feedstock for other chemicals.)

However, during the current public health emergency, FDA has set an interim limit of 2 parts per million for the chemical only in liquid hand sanitizers.

Valisure said a good portion of the batches of hand sanitizer it tested missed FDA's mark.

The company analyzed 260 unique batches of hand sanitizer from 168 brands, according to its citizen petition. Of those batches, 44 -- or 17% -- contained benzene levels of at least 0.1 ppm, the company's testing found. Twenty-one batches (8%) -- which included liquid and gel hand sanitizers -- contained benzene above the 2 ppm interim limit. The highest level of benzene detected was 16.1 ppm, more than eight times the limit.

Valisure noted in its FDA petition that, in addition to benzene, it also found sanitizer batches with high levels of methanol and acetaldehyde -- categorized by leading health organizations as "possibly carcinogenic to humans." The FDA has issued in hand sanitizers.

In the general course of business, Valisure regularly checks thousands of products, said David Light, the company's founder and CEO. Another member of the team recently suggested adding benzene to the list of chemicals Valisure tests for since it's a general area of concern and the company continues to expand what it looks for in drugs.

Given the known toxicity of benzene, Light said he wasn't expecting to find much.

However, he said, "As we've been scanning more hand sanitizer-type products, we started seeing some signals there." As a result, the company decided to undertake what Light called a broader market sweep.

Light said that Valisure's hand sanitizer findings indicate contamination with benzene is "a batch-to-batch problem." At this point, he said the company can't specify whether buying a certain brand of hand sanitizer over another prevents the problem from affecting purchasers.

It's hard to know whether the presence of benzene in these products emerged before the pandemic, Light said. As part of addressing that question, the company has opened a crowdsourcing study for hand sanitizer through which individuals and organizations can send their own products or packages to be tested.

There may be things to be learned about distribution or expiration dates, Light said. "I think there's going to be a lot more information that comes out as time goes on."

Valisure said it's also asking the FDA to further investigate batches of hand sanitizer that, in addition to containing benzene, are inconsistent with agency guidance not to add inactive ingredients -- such as those that improve smell, taste, or appearance -- that can increase the risk of ingestion by children.

The FDA said in a statement to 乌鸦传媒 that it "continues to test hand sanitizer products and proactively work with companies, when appropriate, to recall products and encourage retailers to remove products from store shelves and online marketplaces when quality issues arise."

The agency added that it "reminds manufacturers, distributors, repackagers and importers they are responsible for the quality of their products and urges manufacturers to test their ingredients to ensure they meet specifications and are free from harmful contamination."

The FDA is currently reviewing Valisure's petition on benzene.

Previously, Valisure has identified quality issues that led to global recalls of the antacid medication ranitidine and the diabetes drug metformin.

Comment