FDA Takes Major Action on Hand Sanitizers from Mexico

As part of its continuing efforts to protect consumers from potentially dangerous or subpotent hand sanitizers, the US Food and Drug Administration (FDA) has 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 US until the agency is able to review the products’ safety.  This marks the first time the FDA has issued a countrywide import alert for any category of drug product.

Over the course of 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. 
 
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. 
 
“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 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 agency said it continues to take action to help prevent potentially dangerous or violative hand sanitizers from entering the United States by placing specific products on import alert, proactively working with companies to recall products and encouraging retailers to remove violative products from store shelves and online marketplaces. As part of these actions, the agency has also issued 14 warning letters since July 2020 for distributing hand sanitizer with undeclared methanol, inappropriate ethanol content, misleading claims—including incorrectly stating FDA approval—and  improper manufacturing practices. The FDA said it continues to proactively work with Mexican government authorities, manufacturers and retailers to ensure potentially dangerous or violative products are not distributed to consumers. 

On Jan. 26, the agency issued four separate warning letters to Mexican producers of hand sanitizer.