FDA Places All Alcohol-based Hand Sanitizers from Mexico on Import Alert

February 2, 2021

The U.S. Food and Drug Administration (FDA) has previously warned against hand sanitizer brands containing the toxic ingredient methanol. Last week, the FDA announced that all alcohol-based hand sanitizers from Mexico would be placed on a countrywide import alert over concerns of methanol contamination.

Under the import alert, hand sanitizer products from Mexico will be subject to heightened FDA scrutiny and agency staff may detain the shipments.

Methanol, or wood alcohol, is a toxic substance which harms the skin and “is not an acceptable ingredient in hand sanitizer or other drugs,” according to the FDA. The agency also lists other side effects which include blindness, nausea, headache, seizures, coma, permanent damage to the nervous system, and even death.

The FDA has issued 14 warning letters since July 2020 for distributing hand sanitizer with methanol, inappropriate ethanol content, misleading claims, and improper manufacturing practices. However, this is the first time the FDA has issued a countrywide import alert for any category of drug product. The reason for this extra caution is because hand sanitizer products from Mexico were being incorrectly labeled to contain ethanol—also known as ethyl alcohol—but tested positive for methanol. The FDA found 84% of hand sanitizers imported from Mexico from April through December 2020 were not in compliance with the agency’s regulations. More than half of the samples analyzed contained toxic ingredients including methanol and 1-propanol.

“Consumer use of hand sanitizers has increased significantly during the coronavirus pandemic, especially when soap and water are not accessible, and the availability of poor-quality products with dangerous and unacceptable ingredients will not be tolerated,” said Judy McMeekin, Pharm.D., FDA Associate Commissioner for Regulatory Affairs. “These actions are necessary to protect the safe supply of alcohol-based hand sanitizers.” 

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