NEW HAVEN, Conn. - An independent study found that some widely available hand sanitizers in the U.S. — which were rapidly produced in an effort to prevent infection amid the COVID-19 pandemic — contain high levels of a chemical known to cause cancer.
Out of 260 hand sanitizer products tested, 44 batches (17%) contained benzene, according to Valisure, an online pharmacy that tests medications and supplements for safety and consistency.
In an open letter to the U.S. Food and Drug Administration, Valisure urges the agency to immediately recall batches of hand sanitizer they say have been contaminated with the harmful chemical. The online pharmacy said it is also urging U.S. regulators to further investigate batches of hand sanitizer it says are inconsistent with FDA guidance.
Benzene is a known human carcinogen, linked to leukemia and other cancers of blood cells. The International Agency for Research on Cancer, the World Health Organization’s cancer research arm, notes that that benzene exposure has been linked with acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), multiple myeloma, and non-Hodgkin lymphoma.
The National Institute for Occupational Safety and Health lists benzene exposure routes as "inhalation, skin absorption, ingestion, skin and/or eye contact."
But during the COVID-19 public health emergency, the FDA allowed an interim limit of 2 parts per million (ppm) for benzene in liquid hand sanitizers in order to help meet high demand.
"Based on our review of available data, we have determined these interim impurity levels can be tolerated for a relatively short period of time, given the emphasis on hand hygiene during the COVID-19 public health emergency and to avoid exacerbating access issues for alcohol-based hand sanitizer," the FDA said in June.
Among the batches of hand sanitizer tested by Valisure, the highest level of benzene detected was 16.1 parts for million, which is over eight times the FDA’s temporary limit.
"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 and 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.
Valisure says it analyzed 260 unique batches of hand sanitizer from 168 different brands. The online pharmacy said it found 21 batches of hand sanitizer which contain concerning levels of benzene that were above the 2 ppm FDA interim limit.
Additionally, 23 batches of hand sanitizer contained between 0.1 and 2 parts per million of benzene. Besides benzene, "unacceptably high" levels of methanol and acetaldehyde, another carcinogen, were detected in some of the hand sanitizer products, according to the online pharmacy.
Some batches contained up to 8680 ppm of methanol, which is 14 times the FDA interim limit, according to Valisure.
Valisure said its researchers did not detect benzene in 216 batches of hand sanitizer from 152 brands in its initial analysis.
Valisure provides a list of every batch of hand sanitizer tested in its analysis.