In a letter sent to FDA Administrator Stephen Hahn, Spanberger and 86 of her colleagues requested that the agency update its guidance to recognize the use of undenatured alcohol in sanitizers. Undenatured alcohol—which distillers in Central Virginia and across the country have readily available—is compliant with the World Health Organization’s (WHO’s) hand sanitizer formula and has the same effectiveness as denatured alcohol.
Although the use of undenatured alcohol is consistent with the WHO’s formula for hand sanitizer, the FDA only allows denatured alcohol to be used in the production of American hand sanitizer. Spanberger requested clarification of the guidance that would allow distilled spirits producers to continue their charitable efforts to help meet the pressing needs of healthcare workers, public servants, and others on the front lines of this public health crisis.
“Through the current guidance, the FDA is standing in the way of hundreds of thousands of gallons of hand sanitizer from being produced and given to those on the front lines battling this pandemic. We have a responsibility to provide more resources to help flatten the curve and alleviating this burden would allow distilleries the opportunity to step up and help their communities,” said Spanberger and her colleagues. “We strongly urge the agency to update its guidance to recognize the use of undenatured alcohol in the production of hand sanitizer during the COVID-19 health crisis and work with industry on reasonable safeguards to keep hand sanitizer out of the hands of children. This will ensure distillers do not face a tax bill for filling a vital need in their communities.”
The United States largely differentiates between undenatured and denatured alcohol for tax purposes, with undenatured alcohol incurring the distilled spirits Federal Excise Tax (FET) paid to the federal government. A provision was included in the recently-passed Coronavirus Aid, Relief, and Economic Security Act signed into law by President Trump that would temporarily remove FET on hand sanitizer production, as long as a distiller has followed FDA guidance.
The bipartisan letter is led by U.S. Reps. John Yarmuth (D-KY-03) and Andy Barr (R-KY-06).
This effort builds on Spanberger’s work to provide personal protective equipment (PPE) and hand sanitizer to healthcare professionals. On Friday, Spanberger urged the U.S. Department of Health and Human Services to use its authorities under the Defense Production Act (DPA) to provide immediate, additional supplies of PPE to nursing homes and long-term care facilities in Central Virginia and across the country.
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