FDA Temporarily Relaxes Ethanol Restrictions for Hand Sanitizer

By Brendan Menapace

The FDA has updated its hand sanitizer regulations to allow the use of fuel- or technical-grade ethanol that contains certain impurities up to specified limits.

Last week, the FDA updated its policies in order to “ensure widespread access to hand sanitizers during the COVID-19 public health emergency.”

In a statement from FDA Commissioner of Food and Drugs Dr. Stephen M. Hahn, the FDA stated that though carcinogens like benzene and gasoline wouldn’t be found in typical ethanol fermentation processes, they may be present on equipment or containers in facilities that manufacture technical-grade ethanol.

“The FDA is working with industry to ensure that harmful levels of impurities are not present if ethanol is used in these products,” Hahn said. “Based on careful review and consideration of available data, we are specifying interim levels of certain impurities that we have determined can be tolerated for a relatively short period of time, given the emphasis on hand hygiene during the COVID-19 public health emergency and to avoid exacerbating access issues for alcohol-based hand sanitizer.”

Consumer and health care personnel safety is a top priority for FDA. We’re working with industry to increase access to hand sanitizers and ensure that harmful levels of impurities are not present in ethanol used in these products. https://t.co/nUELuveKCF pic.twitter.com/KEtwKNB3Da

— U.S. FDA (@US_FDA) June 2, 2020

These are temporary rules aimed at increasing hand sanitizer availability while demand remains sky high. But, while there is still such a need for hand sanitizer, especially in health care environments that are working overtime to keep up with demand, the FDA has rolled back its own regulations for the sake of public health.

“Although it is our understanding that some larger hospital systems have been able to replenish their supply of hand sanitizer, we continue to hear that some smaller hospital systems and outpatient facilities are still experiencing difficulties accessing alcohol-based hand sanitizers,” Hahn said. “We also recognize that some consumers may not be able to find alcohol-based hand sanitizer in their local area, and, when they do, it is in limited quantities.”

As the COVID-19 pandemic evolves and changes, as it seems to every day, the FDA will adapt its own regulations. If we reach a point where hand sanitizer products are no longer in such high demand with low supply, expect the FDA to return to its previous stance on impurities in ethanol products.