FDA updates hand sanitizer guidance

By Erin Voegele | June 02, 2020

The U.S. Food and Drug Administration on June 1 updated guidance to provide additional clarification on the manufacturing and compounding of certain alcohol-based hand sanitizer products to help ensure that harmful levels of impurities are not present in ethanol used in hand sanitizer. The Renewable Fuels Association said the guidance provides clarity, but won’t resolve the shortage of hand sanitizer products.

In its announcement, the FDA said it appreciates industry’s willingness to help meet the increasing demand for alcohol-based hand sanitizers during the COVID-19 pandemic. Early on during the public health emergency, the FDA said it issued temporarily policies to provide flexibility to help meet increased demand for alcohol-based hand sanitizers.

“We previously updated these temporary guidances in April to reflect data submitted by fuel ethanol manufacturers producing ethanol via fermentation and distillation, indicating that at least some of their fuel ethanol products have harmful chemicals, including gasoline and benzene, which are known human carcinogens (cancer-causing agents),” said the FDA in a statement released June 1. “These impurities would not be expected from a typical fermentation and distillation process but may be present in the manufacturing environment of fuel or technical-grade ethanol, due to the use of certain chemicals, equipment or containers.

“The FDA is working with industry to ensure that harmful levels of impurities are not present if ethanol is used in these products,” the agency continued. “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.”

FDA’s updated guidance comes roughly a week after Sens. Joni Ernst, R-Iowa, and Chuck Grassley, R-Iowa, sent a letter to FDA Commissioner Stephen Hahn on May 26 urging the agency to clarify its temporary policy for the manufacture of alcohol-based hand sanitizer products during the COVID-19 pandemic. In that letter, Ernst and Grassley addressed concerns by the agency that gasoline or other fuel additives come into contact with ethanol during the ethanol production process. That concern, they said, “appears to reflect a misunderstanding of how ethanol plants operate.” The senators stressed that “gasoline is not present at ethanol plants, and alcohol for hand sanitizer that is produced at ethanol plants does not come in contact with gasoline, benzene, or other petroleum contaminants.”

Following the FDA’s June 1 announcement, the RFA issued a statement indicating the updated guidance provides clarity to ethanol producers, but said it won’t resolve current shortages of hand sanitizer products.

“While we appreciate that FDA responded to RFA’s request for more clarity and specific interim impurity limits, we do not believe the new guidance will help alleviate the hand sanitizer shortage in any meaningful way,” said Geoff Cooper, president and CEO of the RFA. “We welcome the specificity in the new guidance, but the new interim limits for certain impurities are overly restrictive and create a roadblock for producers who could otherwise supply huge volumes of safe, clean, high-quality ethyl alcohol to hand sanitizer manufacturers. For example, FDA’s new limits for certain impurities are eight times more restrictive than what is typically found in a glass of red wine and twenty times more restrictive than what has been allowed in hand sanitizer by other countries, including Canada, during the COVID-19 pandemic.

“Meanwhile, as hospitals, first responders, nursing homes, restaurants, retail stores, churches, and other public and private spaces seek out new sources of hand sanitizer to address the shortage, the U.S. continues to significantly ramp up imports of hand sanitizer from China and other countries,” Cooper added. “It is unfortunate that we are importing this product from China, when abundant supplies of high-purity American-made ethanol could be used instead. Still, we will continue to work with the FDA to ensure ethanol producers can do their part to combat COVID-19 and provide larger quantities of ethyl alcohol for hand sanitizer.”

Additional information is available on the FDA website