Statement by Distilled Spirits Council of the United States President & CEO Chris Swonger on a letter sent by Co-chairs of the Congressional Bourbon Caucus Chairman John Yarmuth and Congressman Andy Barr and 85 members of the House of Representatives to U.S. Food and Drug Administration Commissioner Stephen Hahn urging 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:
“Distillers across the country are jumping in to produce hand sanitizer for first responders, hospitals and those in need in their communities. The recently-passed CARES Act includes an important provision to guard distillers from having to pay federal excise taxes on the alcohol used. Unfortunately, FDA must first update their guidance to permit distillers to use undenatured alcohol, which is recommended by WHO and is the type of alcohol distillers readily have on hand. We appreciate the support of Chairman Yarmuth, Congressman Barr and the 85 House members in calling on the FDA to be more flexible during this crisis so we can get hand sanitizer to those who need it most. The Distilled Spirits Council of the United States is committed to working with the FDA to explore appropriate ways to address any safety concerns.”
For weeks DISCUS has been urging FDA to update its Guidance to permit distillers to use undenatured alcohol in its hand sanitizer formula as directed by the WHO Guidance. Most beverage alcohol companies exclusively make products with undenatured alcohol and may not be able to access the required denaturing materials. Denatured spirits are those that are treated with bittering agents to make them unsuitable for human beverage consumption.
DISCUS has raised concerns with FDA regarding potential shortages of denaturing ingredients as well as the effect the denaturing materials may have on distilling equipment. Due to the highly concentrated nature and toxicity of the bittering agents, these components are very persistent and distillers may have to develop a special cleaning method to remove them before beverage grade product can be reintroduced. Requiring denaturing could also significantly increase the amount of time it takes to produce this product and get it to those who need it now.
The WHO Formula is a very high proof alcohol with hydrogen peroxide, which is less palatable than other denatured products currently on the market. Thus, further bittering should not be needed, particularly in light of the present need.