The US Food and Drug Administration will expand the kinds of companies that can make hand sanitizer while demand continues to outpace supply during the Covid-19 pandemic.
The agency issued temporary guidance Monday that will allow some ethanol producers to make hand sanitizers -- even if that means allowing in some small amounts of impurities, the agency said on its website.
In April, the FDA tightened restrictions on the use of ethanol in hand sanitizer.
Why it's significant: Some small hospitals are having a hard time buying supplies and consumers can only buy hand sanitizer in small quantities -- if they can find it at all -- the FDA said. Since good hand hygiene is key to preventing the spread of Covid-19, the FDA said it is working with the ethanol industry to make sure that harmful impurities aren’t introduced into the hand sanitizer during manufacturing.
What's the concern: The process to make ethanol requires fermentation and distillation. Neither process should taint the final hand sanitizer product, but if it is made in the same plant as one that makes fuel or technical-grade ethanol, the hand sanitizer could become contaminated with gasoline or benzene. Exposure to either could potentially cause cancer.
The FDA said that in looking at the data, it believes some level of certain impurities can be tolerated for a relatively short period.
What the FDA says: During the pandemic, there needs to be a “proper level of flexibility” in the rules.
“As with everything we do, the FDA is committed to ensuring that we appropriately balance risk and benefit,” the agency wrote on its website.