The federal government will temporarily allow some impurities in alcohol-based hand sanitizer amid the coronavirus pandemic, a reversal from tighter restrictions on such impurities imposed in April.
The new guidance from the Food and Drug Administration allows hand sanitizers to contain up to 2 parts per million (ppm) benzene and 50 ppm acetaldehyde.
“The FDA appreciates industry’s willingness to help meet the increasing demand for alcohol-based hand sanitizers during the COVID-19 pandemic,” the FDA said in a statement.
“Early on during the public health emergency, as demand for alcohol-based hand sanitizer had dramatically increased, we issued temporary policies to provide flexibility to help meet this demand and to help get supply quickly to where it was needed, whether it was for health care professionals or for individuals and their families,” the FDA added.
The agency said that numerous smaller hospital systems and outpatient facilities, as well as consumers in some areas, have said they still struggle to obtain alcohol-based hand sanitizers.
“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,” the FDA stated.
Since the beginning of the coronavirus pandemic, the ethanol industry has invested millions in increased production of corn-based alcohol sanitizer, Reuters reported Tuesday. A total of 27 plants are currently producing ethanol specifically for sanitizer production, according to the Renewable Fuels Association, which has argued the government’s restrictions are excessive.
“We do not believe the new guidance will help alleviate the hand sanitizer shortage in any meaningful way,” the group’s president, Geoff Cooper, told Reuters, saying no level of benzene is present in the ethanol the industry provides either for hand sanitizers or for other purposes.