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Law360 (January 26, 2021, 9:47 PM EST) -- The U.S. Food and Drug Administration placed all alcohol-based hand sanitizers from Mexico on an import alert Tuesday, saying it has seen a sharp spike in toxic sanitizers coming from the country over the course of the COVID-19 pandemic.
Since the pandemic began, the FDA said there has been a rise in hand sanitizers from Mexico that test positive for methanol, otherwise known as wood alcohol. Methanol can be toxic when absorbed through the skin and life-threatening if ingested, the agency said.
Imported alcohol-based hand sanitizers from Mexico are subject to higher scrutiny from the FDA and staff may detain the shipments, the agency said.
This is the first time that the FDA has issued a countrywide import alert for any drug product category, according to the agency.
"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," FDA Associate Commissioner Judy McMeekin said in a statement.
The FDA said that its analyses of alcohol-based hand sanitizers from Mexico found that 84% of the samples tested between April and December were not in compliance with its regulations. More than half of the samples were found to have toxic ingredients, including methanol, at dangerously high levels, according to the agency.
The agency said it has sent out 14 warning letters since July over hand sanitizers that contained methanol, that were misleadingly labeled or that didn't conform to proper manufacturing standards.
"The FDA continues to proactively work with Mexican government authorities, manufacturers and retailers to ensure potentially dangerous or violative products are not distributed to consumers," the agency said.
Adverse events caused by methanol include blindness, cardiac and neurological effects, as well as hospitalizations and death, according to the FDA. Exposure to methanol can cause nausea, vomiting, headache, seizures, coma and permanent nervous system damage, the agency said.
"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 agency said.
The FDA cautioned consumers in June to avoid nine hand sanitizer products manufactured in Mexico over methanol concerns.
In that advisory, the FDA reiterated concerns about other hand sanitizer companies inaccurately promoting their products as providing prolonged protection against viruses, such as COVID-19. It said "there is no evidence to support these claims."
--Additional reporting by Hailey Konnath. Editing by Breda Lund.
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