FDA updates guidance to allow ethanol producers to make hand sanitizer

In Washington, the Food and Drug Administration has taken additional action to help ensure widespread access to hand sanitizers during the COVID-19 public health emergency. The agency has updated its guidances 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 EPApreviously 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). 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 says it is working with industry to ensure that harmful levels of impurities are not present if ethanol is used in these products. Based on careful review and consideration of available data, the FDA is specifying interim levels of certain impurities that it has 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.