Ethanol Producers Want FDA to Ease Restrictions So They Can Supply Hand Sanitizer

(DES MOINES, Iowa) — 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 U.S. 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.

“Hand sanitizer is a big part of our lives,” said 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.”

The problem for the ethanol industry is that most plants make food-grade ethanol, one step below the highest pharmaceutical grade. But 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 said Thursday that regulators have already seen a rise in poisonings linked to hand sanitizers in recent weeks, “heightening this public concern.”

The FDA is also skeptical of industry claims that undenatured sanitizers could be distributed in a way that would keep them away from children.

“It is unclear what, if any, measure could be instituted to ensure that the product does not make its way into consumer hands, where children could have access,” FDA’s Jeremy Kahn said in an emailed statement.

Facing a nationwide shortage, Barber said the FDA should temporarily relax regulations to allow alternative production.

“You’re talking about alcohol. Does it matter if it’s fuel grade or whatever the stuff is they’re trying to price gouge now? I think its common sense,” he said.

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The American Hospital Association encouraged flexibility to help protect patients and caregivers, without directly weighing in on the sanitizer dispute.

“We may need to consider a range of possible solutions that were not on the table before the pandemic,” said Nancy Foster, a vice president with the group, in an emailed statement to the AP.

The Consumer Brands Association, formerly the Grocery Manufacturers Association, has had conversations with the FDA to push the agency to reconsider its guidelines. The group, which represents branded food, consumer products and beverage companies, said that hand sanitizer supplies are running so low that its members have had to ration it out to workers in stores, distribution centers and manufacturing plants.

“We need a temporary solution,” said Mike Gruber, vice president of regulatory and technical affairs at the trade association. “This goes toward ensuring basic food safety practices.”

Distillers that produce vodka, whisky and other alcoholic drinks have been given some regulatory waivers by the Alcohol and Tobacco Tax and Trade Bureau allowing them to produce hand sanitizer. Many have done that, but they produce …read more

Source:: Time – Business

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