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FDA 'Roadblock' Slows Hand Sanitizer Production

Ethanol industry want rules to be relaxed
By Newser Editors and Wire Services
Posted Mar 27, 2020 3:07 AM CDT

(Newser) – As hospitals and nursing homes desperately search for hand sanitizer amid the coronavirus outbreak, federal regulators are preventing ethanol producers from providing millions of gallons of alcohol that could be transformed into the germ-killing mixture. The US Food and Drug Administration's roadblock has been frustrating the health care and ethanol industries, which have been calling for a relaxed regulation to deal with the public health care emergency, the AP reports. "Hand sanitizer is a big part of our lives," says Eric Barber, CEO of Mary Lanning Healthcare, a hospital in Hastings, Nebraska. "We can’t get any. We order it and it’s just not available." Facing a nationwide shortage, Barber says the FDA should temporarily relax regulations to allow alternative production.

The problem for the ethanol industry is that most plants make food-grade ethanol, one step below the highest pharmaceutical grade. Since the plants aren't certified to comply with stringent production standards designed to protect quality of medicines, food ingredients, and dietary supplements, the FDA doesn't want the alcohol used for a product to be applied to the skin. In addition, the alcohol is not denatured or mixed with a bitter additive to make it undrinkable. The FDA insists this step is "critical” because of cases of poisoning, sometimes fatal, among young children who have accidentally ingested hand sanitizers. An FDA spokesman says regulators have already seen a rise in poisonings linked to hand sanitizers in recent weeks, “heightening this public concern.”

(Read more ethanol stories.)

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