FDA is pushed to further loosen hand sanitizer guidelines

87 lawmakers urge agency to recognize use of undenatured alcohol

An employee fills up bottles with a hand sanitizer mix on March 20 at the Claremont Distillery in Fairfield, N.J., which is now producing sanitizer and providing it to the general public for free.  (Kena Betancur/Getty Images)
An employee fills up bottles with a hand sanitizer mix on March 20 at the Claremont Distillery in Fairfield, N.J., which is now producing sanitizer and providing it to the general public for free. (Kena Betancur/Getty Images)
Posted March 30, 2020 at 3:18pm

It’s kind of like they’re making bootleg hand sanitizer.

Although the Food and Drug Administration has loosened its guidance for the second time in a week regarding the liquor industry’s rush to produce hand sanitizer, which is in short supply across the country, the industry says it still has concerns.

And those concerns were backed up in a letter Friday from 87 members of Congress urging FDA Commissioner Stephen Hahn to allow the liquor industry to use its undenatured alcohol in the emergency production of hand sanitizer.

Unlike the World Health Organization, the FDA requires alcohol used in hand sanitizer to be denatured, that is, to have chemicals added to the formulation to make it more or less undrinkable. Distillers have a ready supply of extremely drinkable alcohol that they want to use.

“We strongly urge the agency to update its guidance to recognize the use of undenatured alcohol … and work with industry on reasonable safeguards to keep hand sanitizer out of the hands of children,” the members’ letter said, citing the FDA’s chief concern with making changes.

The Distilled Spirits Council, which has been lobbying on this issue, said the loosening of the regulations “does not go far enough to meet the needs of the hundreds of distillers making hand sanitizer.”

The council suggested in a statement that to address concerns of possible abuse of alcoholic sanitizer, its distribution could be limited to non-consumer channels. For instance, rum-maker Bacardi said last week that its facilities in Louisville, Kentucky, Jacksonville, Florida, and Puerto Rico are already providing emergency workers with free hand sanitizer.

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“The United States largely differentiates between the two types of alcohol for tax purposes,” the lawmakers wrote in their letter, noting that products made with denatured alcohol aren’t subject to the federal excise tax on alcohol while undenatured products, like liquor, are.

On Friday, Congress cleared and President Donald Trump signed into law the $2.3 trillion coronavirus rescue package. The law includes an excise tax waiver through Jan. 1, 2021 for alcohol used in making hand sanitizer, so long as it follows FDA guidance.

Democrat John Yarmuth and Republican Andy Barr, both House members from the bourbon-producing state of Kentucky, authored Friday’s letter. That same day, the FDA made final an update it had issued earlier in the week to its temporary guidance on emergency production of hand sanitizers by unlicensed facilities.

The update loosened the rules further, but with a warning. In its new guidance, the FDA noted: “Denaturing is critical because there have been reports of adverse events, including deaths, from unintentional ingestion of hand sanitizer, particularly in young children.”

In its updated guidance, the FDA still requires that before the final product is made, a bitter denaturant be added to make it even less appetizing to drink.

As for the letter from Yarmuth and Barr, an FDA spokesman wrote: “The FDA will review the letter and will respond directly to the Congressmen.”

Children and the homeless, in particular, have abused alcohol-based products in the past. The heating product Sterno, which at the time contained undenatured alcohol, was blamed for dozens of deaths in Philadelphia among the homeless in the 1960s.