Sending Office: Honorable John A. Yarmuth
Urge the FDA to Update Guidance that Supports Hand Sanitizer Production
Current signers: Yarmuth, Barr, Neguse, Lynch, Dean, Morelle, Cooper
Chairman Yarmuth and Rep. Andy Barr are leading a letter to the FDA urging them to update their guidance on hand sanitizer production so that distilleries can use what they have on hand to make it, which is in accordance with WHO’s formula. As things are
now, the FDA is only allowing denatured alcohol to be used in the production of hand sanitizers. Distilleries have the capacity to make hundreds of thousands of gallons in a short amount of time using the undenatured alcohol they already have.
There was a provision included in the Senate bill that will allow the FET to be waived as long as a distiller has followed the FDA guidance. If the FDA updates their guidance, distillers will not be hit with a huge tax bill at the end of this for stepping
up and helping out our communities. So now we are urging the FDA to update their guidance to include undenatured alcohol for the production of hand sanitizer.
If anyone has questions or would like sign on, please email Katy Rowley (email@example.com) with Chairman Yarmuth or Michael Case (firstname.lastname@example.org) with Rep. Barr. The deadline is Friday (3/26) at 4pm.
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.
e-Dear Colleague version 2.0