Dangerous hand sanitizers need immediate FDA attention

Leading the charge in the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) was tasked with ensuring consumers were well equipped with safe, germ-fighting products that can keep them safe. However, we would be remiss not to note the missteps along the way.

Responding to pandemic panic, consumers rushed to stores to arm themselves with hand sanitizing products. This soaring demand prompted the FDA to lower standards for the production of alcohol-based hand sanitizer products, a move that has subsequently resulted in a list of over 200 hand sanitizer products deemed dangerous for consumer health. With trusted brands back on store shelves, it’s time for FDA to withdraw the temporary guidance that significantly lowered the standards for alcohol-based hand-sanitizers which prompted dangerous products on the market and begin enforcing higher standards.

That is why we sent a letter to the FDA to encourage the agency to rescind the emergency guidance, raise standards to pre-pandemic levels, and get toxic and ineffective products off the shelves.

The FDA first warned consumers in June 2020 about hand sanitizers containing methanol, which can be toxic when absorbed through the skin and life-threatening when ingested. Since then, the FDA updated its warning multiple times based on evidence showing “concerningly low levels of ethyl alcohol or isopropyl alcohol, which are active ingredients in hand sanitizer products.” Unfortunately, the list does not stop there.

We have seen consistent cases of toxic hand sanitizers that are still on store shelves. One study found 17 percent of studied samples contained high levels of benzene, a known carcinogen. More concerning, the products in the study were mainly produced by companies in China and Mexico that were unheard of before the pandemic.

To make matters even worse, in its latest updated warning, dated March 25, 2021, the FDA published findings of products containing microbial contamination, “which can lead to serious infections, including infection of the skin, soft tissues, lungs or bloodstream,” putting consumers with compromised immune systems at increased risk.

As we wrote in our letter, it is clear from this warning that “the root of the problem is the persistent supply of toxic hand sanitizers, but the FDA has yet to rescind the emergency guidance and take these products off the market.” Although several such products have been recalled by manufacturers and pulled from store shelves, the risk is still high, and the FDA has yet to act.

Health professionals and education institutions have voiced concerns and urged FDA to act. In a recent op-ed, Dr. Marion Mass, a pediatrician at the Children’s Hospital of Philadelphia aptly said, “The responsibility to monitor these products does not, and should not, rest solely on the shoulders of teachers and school staff… It is up to regulatory bodies like the CDC, FDA and Department of Education to provide schools with the necessary tools to keep these kids healthy and as free from dangerous carcinogens as possible.”

According to FDA spokesman Jeremy Kahn, “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.”

Unfortunately monitoring efforts of the situation alone are not enough. With numbers of consumer poisoning cases still occurring, including many children, and schools reopening, this issue rests on the shoulders of school faculties, small businesses, and consumers. The FDA needs to fulfill its consumer protection duty and urgently retract the current guidance and prioritize releasing new standards to ensure consumers are protected from unsafe products.

How much longer must we subject consumers to these unregulated, potential harmful products before the FDA takes action?

Steve Pociask and Krisztina Pusok are with the American Consumer Institute, a nonprofit educational and research organization. For more information about the Institute, visit www.TheAmericanConsumer.org or follow us on Twitter @ConsumerPal.