The U.S. Food and Drug Administration ordered to place all alcohol-based hand sanitizers from Mexico on a countrywide import alert. This decision marks the first time the FDA has issued a countrywide import alert for any category of a drug product.
The FDA said in a statement that it took this action to prevent products that appear to be in violation from entering the U.S. until the agency can review the safety of hand sanitizers.
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.
Throughout 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 said.
Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin and life-threatening when ingested. Methanol is not an acceptable ingredient in hand sanitizer or other drugs.
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“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. “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.”
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. The agency 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.
The FDA has issued 14 warning letters since July 2020 for distributing hand sanitizer with undeclared methanol, inappropriate ethanol content, misleading claims, including improper FDA approval, and improper manufacturing practices. Methanol-contaminated hand sanitizers are a serious safety concern, FDA said. Poison control centers and state health departments have reported adverse reactions from methanol exposure, including nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent nervous system damage, or death.