Company Calls on FDA to Examine Sanitizers After Carcinogen Concerns

A pharmaceuticals quality control company is calling on the Food and Drug Administration to examine the presence of a known human carcinogen in 44 sanitizers.

Valisure says it has tested and detected benzene, a known human carcinogen, in several batches across multiple brands of hand sanitizer, which are considered drug products regulated by the FDA.

From their press release:

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. The National Institute for Occupational Safety and Health (NIOSH) defines benzene as a carcinogen and lists “inhalation, skin absorption, ingestion, skin and/or eye contact” as exposure routes. 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, to meet the high demand for hand sanitizer during the COVID-19 public health emergency, FDA has allowed an interim limit of 2 parts per million (ppm) for benzene only in aqueous solution (liquid) hand sanitizers. Of the 260 hand sanitizer products tested by Valisure, including liquid and non-liquid products, 44 batches (17%) contained benzene with the highest level of benzene detected of 16.1ppm, which is over eight times this interim limit.

Valisure is asking FDA to request an immediate recall of the contaminated batches and to update its guidance to include an exposure limit for benzene in addition to a concentration. Also, Valisure is requesting FDA further investigate batches of hand sanitizer that, in addition to being  contaminated, 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.

The press release goes on:

In June 2020, FDA updated their guidelines for the production of liquid hand sanitizer to temporarily allow for the presence of benzene of up to 2.0 ppm “to reflect data submitted by fuel ethanol manufacturers producing ethanol via fermentation and distillation, indicating that at least some of their fuel ethanol products have harmful chemicals, including gasoline and benzene, which are known human carcinogens (cancer-causing agents).”

Although hand sanitizers with unacceptable levels of benzene have not previously been identified, since mid-2020, FDA has issued warnings on hand sanitizer products that have been contaminated with methanol, which can lead to serious adverse events if the contaminated products are swallowed. The CDC has issued warnings regarding individuals ingesting hand sanitizer and has stated that, “Young children might unintentionally swallow these products [hand sanitizers], whereas adolescents or adults with history of alcohol use disorder might intentionally swallow these products as an alcohol (ethanol) substitute.”

The FDA also recognizes the danger of children ingesting hand sanitizer, and, in FDA’s guidance for the manufacture of hand sanitizer during the declared COVID-19 Public Health Emergency, the agency states that firms producing hand sanitizer should “not add other active or inactive ingredients, such as ingredients to improve the smell or taste, due to the risk of accidental ingestion in children.” Out of the 44 batches of hand sanitizer containing benzene, at least 20 (45%) have product labels that indicate the use of additional ingredients to improve the smell, taste, or appearance, which do not adhere to FDA guidance, and could make such products more appealing to children, thereby increasing the risk of ingestion of specifically contaminated products.

Although considerations for ingestion of hand sanitizer should be undertaken, hand sanitizer products are not intended to be swallowed and are labeled only for topical use. Therefore, a contaminant such as benzene that can harm individuals through dermal absorption or inhalation is of great concern for public health as it can potentially affect individuals that properly use hand sanitizer on exposed skin or breath its fumes.

Beginning in January of this year, 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. As of March 9, 2021, 83% of the 231 FDA product warnings are for products manufactured in Mexico, 7% in China, and 3% in the United States. Of the 44 hand sanitizer products Valisure independently sourced and are contaminated with benzene, 2% are manufactured in Mexico, 50% in China, and 34% in the United States. This underscores the need for further action from FDA beyond the current import alerts.

“Consumer use of hand sanitizers has increased significantly during the coronavirus pandemic and while it is important that consumers have access to products that help ensure personal and public safety, it is of utmost importance that consumers have access to products that are safe and not contaminated,” stated David Light, Founder & CEO of Valisure. “The detection of hand sanitizer products that contain high levels of benzene is cause for significant concern as these products are potentially being used in high volumes several times daily by adults and children alike. We urge FDA and manufacturers to act expeditiously to remove the contaminated lots from the market. It is also important for consumers to understand that uncontaminated hand sanitizer products are available and should continue to be used.”

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