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Distillers urge FDA to revisit regulations on production of hand sanitizer

3 years 10 months 2 weeks ago Thursday, April 02 2020 Apr 2, 2020 April 02, 2020 10:31 AM April 02, 2020 in News
Source: ABC News

When panicked shoppers purchased inordinate amounts of hand sanitizer, grocery store shelves across the nation were left without one of the key products needed in the fight against the spread of novel coronavirus.

But members of the booze industry came to the rescue. Distillers in various U.S. states followed a World Health Organization-approved recipe to create and sell their own hand sanitizers to the public use. 

Though members of the public are thankful for this, U.S. federal regulators have concerns.

According to ABC News, the federal government is insisting that the WHO's recipe simply isn't safe enough. 

But critics argue that the Food and Drug Administration's unbending stance is hindering the production and distribution of thousands of gallons of much-needed germ killer, though some distillers are providing their product regardless of FDA guidelines.

More than 600 distillers are involved in sanitizer production, according to industry experts, many following WHO rules.

And the new $2 trillion stimulus bill signed into law last may have presented these distillers with yet a new problem.

While the legislation waives certain excise taxes that these distillers would otherwise face, it also includes stricter FDA guidelines on how to produce hand sanitizer. 

"This would penalize distillers who jumped in to produce hand sanitizer based on the WHO guidelines when regulatory guidance was unclear," said Chris Swonger, president and CEO of the Distilled Spirits Council of the United States (DISCUS), which represents scores of large and small distillers.

Instead of utilizing products that distillers would naturally have on hand, the FDA insists they use foul-smelling, toxic agents that would deter the public from consuming hand sanitizer.

But using these agents on their equipment could make it much harder for such companies to return to their routine production of whiskey and other alcoholic beverages once the nation returns to normal.

This is why distillers are urging the federal government to relax its rules on hand sanitizer guidelines.

But the FDA is refusing to back down. 

While they did revise their guidelines to permit the use of food-grade alcohol, the agency's safety concerns remain, according to a spokesman. They require the addition of foul-tasting chemicals in the final product.

"The FDA’s guidances explain that the FDA does not intend to object to the manufacture of denatured or undenatured alcohol for use in hand sanitizers, so long as a denaturant (bitterant) is added prior to the final production of the hand sanitizer," FDA's Jeremy Kahn, said in a statement to ABC News. "Adding these denaturants to the alcohol renders the product less appealing to ingest."

Kahn said incidents of children consuming lethal sanitizer have been increasing during the COVID-19 pandemic, noting that "in an 18-month old child, it takes only a small amount to be potentially lethal."

"Consumer safety is a top priority for the FDA," Khan said, adding "To protect children, it is important to make hand sanitizers unpalatable."

As the war against the coronavirus pandemic wages on, a separate battle continues between distillers who are eager to arm consumers with life-saving sanitizer and the FDA, who aims to protect the most vulnerable members of the community from misusing the germ-cleansing product. 

It remains to be seen which side will back down before the pandemic dissolves. 

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