The Food and Drug Administration has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert. It is the first time the FDA has issued a countrywide import alert for any category of drug products.
The FDA’s analyses of alcohol-based hand sanitizers imported from Mexico found 84% of the samples analyzed by the agency 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 and/or 1-propanol, at dangerous levels.
Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin and can be deadly when ingested, the FDA said. Methanol is not an acceptable ingredient in hand sanitizer or other drugs.
“Today’s actions are necessary to protect the safe supply of alcohol-based hand sanitizers. 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,” said Judy McMeekin, FDA associate commissioner for regulatory affairs.
The symptoms from exposure can include vomiting, seizures, blindness, effects on the central nervous system, and hospitalizations and death, with young children being most at risk, the agency said. The FDA urged consumers who think they’ve been exposed to contaminated hand sanitizer and are experiencing symptoms to seek immediate medical attention.
Under the import alert, alcohol-based hand sanitizers from Mexico offered for import are subject to heightened FDA scrutiny, and FDA staff may detain the shipment. As part of their entry review, FDA staff will consider any specific evidence offered by importers or manufacturers that the hand sanitizers were manufactured according to U.S. current good manufacturing practice requirements. This marks the first time the FDA has issued a countrywide import alert for any category of the drug product.
The FDA has posted and regularly updates a list of hand sanitizer products that consumers should not use, which include those that the FDA has found to contain methanol and/or 1-propanol. In most cases, methanol does not appear as an ingredient on the 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," said Judy McMeekin, Pharm.D., FDA Associate Commissioner for Regulatory Affairs.