FJ Live: FDA Hand Sanitizer Rules Provide Clarity but Not Help

Shelves of a CVS pharmacy are stripped of hand sanitizer amid novel coronavirus fears in New York ( Catherine Koppel - REUTERS )



When the COVID-19 outbreak began to hit the United States, many ethanol producers turned to hand sanitizer production, both out of a sense of duty to protect their communities and to try to offset some of the losses from the sudden drop in fuel consumption.  The Food and Drug Administration later required certification of quality standards which made the sanitizer production cost prohibitive for most ethanol plants.

The FDA recently made yet another adjustment to those requirements, but Geoff Cooper of the Renewable Fuels Association told Farm Journal Live that the rules still make it quite difficult for ethanol companies to produce hand sanitizer.

"This is the fourth iteration of guidance from FDA and the agency continues to move the goalposts," Cooper said. "It is good to have finally some specific impurity limits. because we were kind of flying blind before, but we're concerned that this new guidance is not going to do anything to alleviate the shortage of hand sanitizer because those limits remain too restrictive for most us ethanol producers to meet."

Cooper said the impurity standards are inconsistent with other safety standards in the U.S. and Canada.

"The impurity that FDA appears to be most concerned about is called acid aldehyde, and that sounds like nasty stuff, but it's found in every glass of wine that you might consume," Cooper explained. "In a typical glass of white wine, you might find 500 parts per million of this acid aldehyde impurity. So it's fine. It's approved by FDA for consumption, but they have limited acid aldehyde concentrations in hand sanitizer to 50 parts per million, so eight or 10 times more restrictive than what you find in a typical glass of wine, and 20 times more restrictive than what the Canadian government allows in hand sanitizer produced in that country."