The Food and Drug Administration on Tuesday announced that imports of alcohol-based hand sanitizers from Mexico will be placed on an import alert after numerous samples tested positive for toxic chemicals.
According to the agency’s review of alcohol-based hand sanitizers imported from Mexico between April through December 2020, 84% of the analyzed samples during that time period were not in compliance with federal regulations. Over half of the samples contained toxic ingredients — including methanol and 1-propanol — at dangerous levels, the agency reported Tuesday.
The active ingredient that kills germs in legitimate sanitizers is ethyl alcohol, which is consumable. But some Mexican companies have been replacing it with poisonous methanol, or wood alcohol, which is used in antifreeze.
The appearance of methanol and 1-propanol are of particular concern to experts, who have seen an influx of hand sanitizer products from Mexico that tested positive for methanol contamination despite not showing the chemical on its product label.
"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, FDA Associate Commissioner for Regulatory Affairs, said in a statement.
“Today’s actions are necessary to protect the safe supply of alcohol-based hand sanitizers,” she added. “We will continue to work with our stakeholders to ensure the availability of safe products and to communicate vital information with the health and safety of U.S. consumers in mind.”
The new import alert means hand sanitizer shipments from Mexico are subject to heightened review, and FDA officials are able to detain shipments in order to ensure the supplier is adhering to U.S. manufacturing practice requirements. Tuesday’s announcement marks the first time the FDA has issued a nation-wide import alert on any one category of drug product.
Methanol exposure can create a wide host of symptoms in the patient, which range from nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, or even death.
The FDA warns that while using methanol as hand sanitizer is dangerous enough, those who are most at risk for adverse effects are “young children who ingest these products and adolescents and adults who drink these products as an alcohol substitute.”
The FDA first issued a consumer warning about the products last June, and has since issued 14 warning letters to people or companies distributing hand sanitizer with undeclared, inappropriate chemical content.
Federal agencies advise consumers looking to purchase hand sanitizers to pick products containing mostly alcohol, and little else.
The U.S. Centers for Disease Control and Prevention says hand sanitizers should be at least 60% ethyl alcohol or 70% isopropyl alcohol. Other approved ingredients may include sterile distilled water, hydrogen peroxide and glycerin, according to the U.S. Food and Drug Administration.
The FDA also warns people to watch out for hand sanitizers packaged in food and drink containers, since accidentally ingesting them could be dangerous.
The Associated Press contributed to this report.