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FOR IMMEDIATE RELEASE |
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March 29, 2020 |
Jodi Whitaker (859) 338-7917 |
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WASHINGTON, D.C. – U.S. Reps. Andy Barr (R-KY) and John Yarmuth (D-KY) are spearheading a bipartisan effort to cut red tape at the U.S. Food and Drug Administration (FDA) and allow producers of distilled spirits to continue to manufacture hand sanitizer with current supplies in response to shortages created by the ongoing COVID-19 coronavirus outbreak. This week, Barr and Yarmuth coauthored a letter—signed by 87 members of Congress in total, representing districts across the nation—that was sent to FDA Administrator Hahn urgently requesting that the agency update its guidance to recognize the use of undenatured alcohol in sanitizers. Undenatured alcohol—which distillers have readily available— is compliant with the World Health Organization’s hand sanitizer formula and has the same effectiveness as denatured alcohol. Barr and Yarmuth’s request for clarification of the guideline would allow these distilled spirits producers to continue the charitable efforts they started immediately to help meet the demands of health workers, public servants, and those on the front lines of this public health crisis. “Through the current guidance,” the members write, “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. 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.” A signed copy of the letter is available here, and full text of the letter can be found below:
March 27, 2020 The Honorable Stephen Hahn Commissioner 10903 New Hampshire Avenue Silver Spring, MD 20993
Dear Commissioner Hahn: We write regarding the U.S. Food and Drug Administration’s (FDA) guidance to manufacturers who are producing hand sanitizer as part of the COVID-19 crisis. As you know, hundreds of distilled spirits producers across the country have immediately responded to the current health crisis by halting their regular operations and quickly turning to the production of hand sanitizer. These distillers are fulfilling a critical need in their communities and providing the hand sanitizer to health care professionals, first responders, and local and state governments. They have diligently followed the guidance released by their regulator, the Alcohol, Tobacco Tax and Trade Bureau (TTB), and are producing hand sanitizer according to the World Health Organization’s (WHO) formula. Unfortunately, the FDA’s “Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19): Guidance for Industry” does not acknowledge the reality that these distillers have stepped up in a time of crisis to produce hand sanitizer using the alcohol they have readily available, which is undenatured. Undenatured alcohol is food grade alcohol that is compliant with the WHO’s hand sanitizer formula and has the same effectiveness as denatured alcohol. The United States largely differentiates between the two types of alcohol for tax purposes – with undenatured alcohol incurring the distilled spirits Federal Excise Tax (FET) and paid to the federal government. A provision was included in the recently-passed COVID-relief package that would temporarily remove the Federal Excise Tax on hand sanitizer production as long as the distiller has followed FDA guidance. 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. 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.
Sincerely,
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