Some impurities allowed in hand sanitizers due to shortages, FDA says. Does it matter?
Some impurities will be allowed in hand sanitizer to combat product shortages during the coronavirus pandemic.
The U.S. Food and Drug Administration on Monday announced it updated its guidelines on some alcohol-based hand sanitizers to increase their availability during the ongoing COVID-19 crisis while preventing inclusion of harmful levels of impurities.
This comes after the FDA in April increased restrictions on the products based on data submitted by manufacturers of fuel ethanol that showed at least some of their products contained harmful chemicals, including carcinogens benzene and gasoline.
Many of these manufacturers began helping make hand sanitizers in response to increased demand for the product and a decrease in demand for fuel, Reuters reports.
The impurities mentioned by the FDA wouldn’t normally be present in a typical fermentation or distillation process of alcohol found in hand sanitizer but may be found when making fuel or technical-grade ethanol because of the use of certain chemicals, containers or equipment, the FDA says.
But the FDA said on Monday it was still hearing of smaller hospital systems and facilities, along with consumers, having trouble finding hand sanitizer or keeping stock of it.
“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 said in the release.
Both benzene and gasoline are known cancer-causing agents, the FDA says.
Benzene, which is a “natural part” of gasoline, crude oil and cigarettes, is widely used in the U.S., according to the Centers for Disease Control and Prevention. The major effect from long-term exposure is to the blood, as the CDC says it can cause leukemia.
Gasoline, also widely used, can also cause cancer and targets the liver and kidneys among other organs, according to the CDC.
The FDA says it’s working with the industry to make sure harmful levels of impurities are not present in ethanol if it’s used in hand sanitizer.
“As with everything we do, the FDA is committed to ensuring that we appropriately balance risk and benefit,” the release says. “We believe that our temporary guidance sets the proper level of flexibility at the current time to help protect Americans during this public health emergency.”
But the Renewable Fuels Association, a trade association for the U.S. ethanol industry, released a statement Tuesday saying the new guidelines won’t help the shortage.
“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,” it said in the statement.
The association said it will continue working 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.”
The FDA plans to continue to “update, modify or withdraw” its guidelines as the situation evolves.
It also said in the release that washing hands with soap and warm water for 20 seconds is still best but that hand sanitizer with at least 60% alcohol can be used when that’s not possible.
This story was originally published June 2, 2020 at 4:10 PM with the headline "Some impurities allowed in hand sanitizers due to shortages, FDA says. Does it matter?."
