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Volume XI, Number 168

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FDA Places All Alcohol-Based Hand Sanitizers from Mexico on Import Alert

On January 26, FDA placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert in an effort to stop violative products from entering the US market until the Agency is able to review the products’ safety. See FDA’s Press Release. Under the import alert, FDA may detain shipments of the alcohol-based hand sanitizers from Mexico, and as part of the entry review, FDA will consider any specific evidence offered by importers or manufacturers that the hand sanitizers were manufactured in accordance with US current good manufacturing practices (cGMPs). This is the first time the FDA has issued a countrywide import alert for any category of drug product.

Over the course of the ongoing COVID pandemic, the FDA has seen an increase in hand sanitizer products from Mexico that were labeled to contain ethanol, but tested positive for methanol. Methanol, or wood alcohol, can be toxic when absorbed through the skin and life-threatening when ingested and is not an acceptable ingredient in hand sanitizer or other drugs. The FDA is aware of methanol-contaminated hand sanitizer adverse events, including blindness, cardiac effects, effects on the central nervous system, hospitalizations, and death.

From April to December 2020, the FDA analyzed alcohol-based hand sanitizers imported from Mexico and found that 84% of the samples were not in compliance with FDA regulations. More than half were found to contain toxic ingredients, including methanol and/or 1-propanol.

Methanol-contaminated hand sanitizers are a serious safety concern for the FDA, and the Agency has been proactively working with companies to recall products and encourage retailers to remove violative products. Further, since July 2020, the FDA has issued 14 warning letters to manufacturers for distributing hand sanitizers with undeclared methanol, inappropriate ethanol content, and misleading claims.

 

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 27
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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