The U.S. Food and Drug Administration (FDA) issued a flurry of Press Releases and Alerts from mid-June through the end of July warning consumers and health care professionals not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol (or wood alcohol), a substance often used to create fuel and antifreeze that can be toxic when absorbed through the skin, and life-threatening when ingested.

The FDA has posted a do-not-use list of such dangerous hand sanitizer products, which is being updated regularly by the agency.  Note that in most cases, methanol does not appear on the product label. 

 Health care providers should frequently confirm that none of their sanitizers are on the list.

Last week, the FDA issued another Press Release regarding the Agency’s effort to prevent certain hand sanitizers from entering the U.S. by placing them on an import alert. In addition, the Press Release noted that the FDA is proactively working with manufacturers to recall products and is actively encouraging retailers to remove products from store shelves and online marketplaces. As part of these actions, the FDA has issued a warning letter to Eskbiochem S.A. de C.V. regarding the distribution of its products with undeclared methanol amounts, misleading claims (including incorrectly stating that the FDA approved these products) and improper manufacturing practices.

The FDA emphasized the importance of frequent hand washing with soap and water for at least 20 seconds and, if soap and water are not readily available, that the Centers for Disease Control and Prevention (CDC) recommends consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol). The FDA further provided that no drugs, including hand sanitizers, are approved to prevent the spread of COVID-19.

On a related note, the scrutiny of hand sanitizer amid COVID-19 has been further highlighted by a newly filed suit in California federal court against hand sanitizer manufacturer, Vi-Jon Inc. The Complaint alleges that Vi-Jon Inc.’s claim “that its products can kill 99.99% of germs” is false, as there are a number of disease-causing microbes that the products are ineffective against.

If you have any questions regarding the FDA’s do-not-use list or the use of sanitizers, please do not hesitate to contact us.  To subscribe to the Health Care Law Matters Blog, click here.