Valisure Seeks FDA Action After Detecting Benzene In Hand Sanitizers

After testing and detecting human carcinogen benzene in hand sanitizers, Valisure has requested the U.S. Food and Drug Administration (FDA) for an immediate recall of the contaminated batches from the market.

The FDA states that benzene should not be used in the manufacture of any component of a drug product because of its unacceptable toxicity.

However, the FDA temporarily allowed a limit of 2 parts per million (ppm) for benzene only in aqueous solution hand sanitizers in June 2020 in order to meet the high demand for hand sanitizer during the COVID-19 public health emergency.

Benzene is known to cause cancer in humans according to the U.S. Centers for Disease Control and Prevention (CDC), the International Agency for Research on Cancer (IARC), the World Health Organization (WHO), and other regulatory agencies.

Benzene is an industrial chemical known to cause leukemia and carry other serious health risks. Out of the 260 unique batches from 168 brands tested by Valisure, 44 hand sanitizer products contained 16.1 ppm of benzene, which is over eight times the FDA’s interim limit. Hand sanitizers are considered drug products regulated by the FDA.

Of the 44 hand sanitizer products Valisure independently sourced and are contaminated with benzene, 2 percent are manufactured in Mexico, 50 percent in China, and 34 percent in the United States.

Twenty-one batches of hand sanitizer were found to contain benzene above the 2.0 ppm FDA interim limit. An additional 23 batches of hand sanitizer contained between 0.1 ppm and 2.0 ppm of benzene.

Meanwhile, benzene was not detected in an additional 216 batches of hand sanitizer from 152 brands through initial analysis of at least one sample.

Valisure’s mission is to independently check the chemical composition of medications before they reach consumers and deliver quality assurance to patients, doctors, and the broader healthcare ecosystem in partnerships with healthcare stakeholders engaged in patient care.

Valisure is requesting FDA further investigate batches of hand sanitizer that are inconsistent with FDA guidance to not add inactive ingredients, such as those that improve smell, taste or appearance, that could increase the risk of ingestion from children.

Some of the highly contaminated batches Valisure analyzed appear to be specifically formulated and marketed for children.

Since mid-2020, the FDA and CDC have issued warnings on hand sanitizer products that have been contaminated with methanol. However, a contaminant such as benzene can be more harmful to individuals through dermal absorption or inhalation and is of great concern for public health.

In its testing of hand sanitizer products, Valisure also detected unacceptably high levels of methanol, and acetaldehyde. Beginning in January, FDA placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that contain methanol from entering the U.S.

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