In a Bipartisan Letter to FDA Administrator Hahn, the Congresswoman and Her Colleagues Urged the FDA to Update Guidance on the Use of Undenatured Alcohol in Sanitizers, Which Meets WHO Hand Sanitizer Standards

HENRICO, V.A. - U.S. Representative Abigail Spanberger joined a bipartisan effort urging the U.S. Food and Drug Administration (FDA) to cut red tape and allow producers of distilled spirits to continue manufacturing hand sanitizer with current supplies in response to shortages caused by the ongoing coronavirus pandemic.

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. Representatives 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.

Go to: https://yarmuth.house.gov/uploads/032720-COVID-19_Hand%20Sanitizer_Letter-FINAL.pdf to read the letter, and the full letter text is also below.

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.

Read this original document at: https://spanberger.house.gov/news/documentsingle.aspx?DocumentID=2689