The U.S. Food and Drug Administration (FDA) will temporarily allow some impurities in alcohol-based hand sanitizer in an effort to expand supply during the coronavirus pandemic. The move marks a shift from increased restrictions on the products in April.
The federal agency continues to work with industry to make sure the level of impurities is safe. Concerns over data from fuel ethanol manufacturers showing some products had cancer-causing agents resulted in the tighter restrictions last month.
However, the agency wants to avoid exacerbating access issues for alcohol-based hand sanitizer during the ongoing public health crisis over COVID-19.
“The FDA appreciates industry’s willingness to help meet the increasing demand for alcohol-based hand sanitizers during the COVID-19 pandemic,” according to an agency 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 updated guidance permits up to 2 parts per million of benzene and 50 ppm of acetaldehyde.
Though the FDA says larger hospital systems were able to replenish their supply of hand sanitizer, the agency continues to hear of smaller hospital systems and outpatient facilities struggling with difficulties to access. The agency also said consumers may have difficulty finding alcohol-based hand sanitizer locally, or if they do, quantities are limited.
The importance of good hand hygiene has been emphasized throughout the pandemic, specifically washing hands often with soap and water for at least 20 seconds. Centers for Disease Control and Prevention (CDC) recommends using hand sanitizer with at least 60 percent ethanol when soap and water are not available.
However, the Renewable Fuels Association, a trade association for America’s ethanol industry, said the new guidelines bring clarity, yet doubt it will resolve supply shortages.
“We do not believe the new guidance will help alleviate the hand sanitizer shortage in any meaningful way,” Geoff Cooper, RFA president and CEO wrote in a statement. “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.”