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FDA puts some hand sanitizers from Mexico on import alert

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The U.S. Food and Drug Administration has placed all alcohol-based hand sanitizers from Mexico on a country-wide import alert.

The move is meant to “help stop products that appear to be in violation from entering the U.S. until the agency is able to review the products’ safety,” according to a press release from the agency.

“Over the course of the ongoing pandemic, the agency has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol (also known as ethyl alcohol) but tested positive for methanol contamination,” the alert states. “Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin and life-threatening when ingested.”

Under the import alert, alcohol-based hand sanitizers from Mexico are subject to heightened FDA scrutiny, and FDA staff may detain shipments.

“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.

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The FDA’s analyses of alcohol-based hand sanitizers imported from Mexico found 84% of the samples from April through December 2020 were not in compliance with the FDA’s regulations. More than half of the samples were found to contain toxic ingredients, including methanol, according to the news release.

In most cases, methanol does not appear as an ingredient on the product label.

Methanol-contaminated hand sanitizers are a serious safety concern, according to the release, and the FDA is aware of “adverse events including blindness, cardiac effects, effects on the central nervous system and hospitalizations and death … Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.

“Although people using these products on their hands are at risk for methanol poisoning, young children who ingest these products, and adolescents and adults who drink these products as an alcohol substitute are most at risk.”

Consumers who have been exposed to hand sanitizer contaminated with methanol and are experiencing symptoms should contact their local poison control center and seek immediate medical treatment.

For more information — including a link to the FDA’s “do-not-use list” — consumers should refer to the FDA’s guidelines on hand sanitizers at https://www.fda.gov/consumers/consumer-updates/safely-using-hand-sanitizer.