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COVID-19 UPDATE: FDA Places Import Alert on All Alcohol-Based Hand Sanitizers From Mexico

In efforts to protect consumers, the U.S. Food and Drug Administration has placed an “placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that appear to be in violation from entering the U.S. until the agency is able to review the products’ safety”. The agency has seen a large increase in hand sanitizers from Mexico that have tested positive for methanol contamination. Methanol is considered to be a toxic substance when it comes in contact with skin or when it is ingested, and is also an unacceptable ingredient in hand sanitizers.

Because of the import alert, alcohol-based hand sanitizers from Mexico offered for import will be subject to FDA scrutiny, and may be detained from shipment."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.”

According the the FDA’s analyses of alcohol based hand sanitizers imported from Mexico, more than half of the samples were discovered to contain toxic ingredients such as methanol, which does not comply with the FDA’s regulations. In most cases, methanol is not included in the product label.

“Methanol-contaminated hand sanitizers are a serious safety concern, and the FDA is aware of adverse events, including blindness, cardiac effects, effects on the central nervous system and hospitalizations and death, primarily reported to poison control centers and state departments of health. Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.” For more information, consumers should refer to the FDA’s guidelines on safe use of hand sanitizer as well as a question and answer page.

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