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FDA Advises Consumers to Avoid Hand Sanitizers Found to Contain Methanol

June 23, 2020

On June 19, the U.S. Food and Drug Administration (FDA) issued an advisory to consumers to stop using any hand sanitizer manufactured by a Mexican company called Eskbiochem SA de CV due to the presence of methanol, also known as wood alcohol.

FDA has demonstrated flexibility throughout the pandemic, as we discussed in a prior client alert, and even recently expanded the types of alcohol that can be used in hand sanitizers under its temporary enforcement policy. But those alternatives must still meet detailed toxicity requirements. Methanol, which can be lethal, does not pass muster.

Methanol was found in nine types of hand sanitizer products made in Eskbiochem’s facility. Methanol, according to FDA, can be toxic when absorbed through the skin or ingested. Substantial exposure can cause everything from vomiting to permanent blindness to seizures, and even death. Although FDA warns that all persons using these products on their hands are at risk and should seek immediate treatment, the agency is particularly concerned about those who ingest the product, such as young children who may do so by mistake. FDA recommends consumers dispose of the nine products immediately in appropriate hazardous waste containers. It specifically advises that consumers should not flush them or pour them down drains.

Although FDA has relaxed its prohibition of technical grade alcohol in hand sanitizers—at least those manufactured under its COVID-19 enforcement policies—manufacturers should remain vigilant in ensuring that their products meet toxicity standards and avoid harmful ingredients.

For more information, please contact the professional(s) listed below, or your regular Crowell & Moring contact.

John Fuson
Partner – Washington, D.C.
Phone: +1.202.624.2910