June 16, 2021

FDA Places All Hand Sanitizers Imported From Mexico on Import Alert

The FDA has placed all hand sanitizers imported from Mexico on import alert to help stop products that are in violation of U.S. law from entering the country until the agency can ascertain the product’s safety. Many hand sanitizers imported from that country have tested positive for methanol contamination since the coronavirus pandemic began last year.

FDA Places All Hand Sanitizers Imported From Mexico on Import Alert

Methanol, or wood alcohol, is toxic when absorbed through the skin and it is life-threatening when ingested. Methanol is not allowed in hand sanitizers.

Under the import alert, the alcohol-based hand sanitizers imported from Mexico are subject to heightened FDA scrutiny. FDA staff can detain the shipment.

FDA Associate Commissioner for Regulatory Affairs Judy McMeekin, Pharm.D., said in a statement, “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. 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.”

FDA analysis of alcohol-based hand sanitizers imported from Mexico found that 84% of the samples tested from April 2020 through December 2020 were not in compliance with FDA regulations. More than half the samples contained toxic ingredients, including methanol and/or 1-propanol, at dangerous levels. The list of recalled hand sanitizers are available at the FDA web site.

The FDA has also issued fourteen warning letters since July 2020 for distributing hand sanitizer with undeclared methanol, inappropriate ethanol content, misleading claims which include incorrectly stating FDA approval, and improper manufacturing practices. FDA is working with Mexican government authorities, manufacturers, and retailers to make sure these potentially dangerous products are not sold to consumers.

FDA is aware of adverse events connected to hand sanitizers, which include blindness, cardiac effects, effects on the central nervous system, and hospitalizations and death. Methanol exposure can cause nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, and death. Around 900 children have been accidentally poisoned by these types of hand sanitizer in January 2021 alone.

Anyone who has experienced any adverse effects after using hand sanitizer should see a doctor and contact their local poison control center. Then report the event to the FDA’s MedWatch Adverse Event Reporting Program.

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