More than half of hand sanitizers imported from Mexico contain dangerous levels of toxic ingredients and should not be used by consumers, according to the U.S. Food and Drug Administration. In January alone, more than 900 accidental poisonings involving hand sanitizer were reported in the U.S., the overwhelming majority involving young children.
The FDA on Tuesday issued a countrywide import alert for alcohol-based hand sanitizers from Mexico, the agency's latest attempt to address a pandemic-induced spike in products contaminated with methanol, or wood alcohol. The substance, which in most cases is not listed as an ingredient on the labels, can be toxic when absorbed through the skin, and life-threatening when ingested.
"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," the FDA noted.
The increased use of hand sanitizers has led to a surge in accidental poisonings, most involving children. According to data from the National Poison Data System, there were 938 hand-sanitizer exposure cases reported to the 55 U.S. Poison Control Centers during a 10-day period, from January 1, 2021 to January 10, a 57% increase from a year ago. Of those cases, nearly 600 involved children ages 5 and younger.
"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 FDA stated.
The FDA for months has warned consumers against using a long list of hand sanitizer products containing methanol, calling them a serious safety concern that had led to blindness, hospitalizations and death. Methanol exposure can also result in nausea, vomiting, headaches, blurred vision, seizures, coma and permanent damage to the nervous system, the agency said.
"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," Judy McMeekin, an associate commissioner for regulatory affairs at the FDA, said in the statement Tuesday.
The import alert — the agency's first for any category of a drug product, it said — follows an FDA analysis that found 84% of hand sanitizers from Mexico sampled from April through December 2020 did not comply with FDA regulations. A majority of the samples contained dangerous amounts of toxic ingredients including methanol and/or 1-propanol.
Shipments of hand sanitizers from Mexico can now be detained by the FDA, and will be subject to heightened scrutiny, the agency said.