The Food & Drug Administration needs to update its guidance to allow the use of undenatured alcohol in producing hand sanitizer during the Covid-19 health crisis. And it needs to update it now, not next week and certainly not next month.
That was the message 87 Members of Congress sent to Commissioner Stephen Hahn in a letter. The letter was co-authored by Reps. John Yarmuth (R-Ky.) and Andy Barr (D-Ky.)
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.
“Distillers across the country are jumping in to produce hand sanitizer for first responders, hospitals and those in need in their communities,” said Chris Swonger, president/CEO, Distilled Spirits Council of the U.S. in a statement. “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.”
“Through the current guidance, the FDA is standing in the way of hundreds of thousands of gallons of hand sanitizer being produced and given to those on the front lines battling this pandemic,” the Congressmen state in their letter. “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,” they say.
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 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.
Meanwhile, Dr. Anthony Fauci, director of the National Institute of Allergy & Infectious Diseases, said projections he has examined showed the disease would kill between 100,000 and 200,000 Americans. Worst-case projections of more than 1 million U.S. deaths are “very, very unlikely” he said, adding an estimate is an estimate and could well be wrong.
As of publication time, the Johns Hopkins University has confirmed 143,055 cases and 2,513 deaths in the United States.
Trump Backs Off: President Trump had threatened to put a quarantine zone around the New York Metro area but backed off after Gov. Cuomo had a hissy-fit. Instead, CDC urged “residents of New York, New Jersey, and Connecticut to refrain from non-essential domestic travel for 14 days effective immediately.
‘This Domestic Travel Advisory does not apply to employees of critical infrastructure industries, including but not limited to trucking, public health professionals, financial services, and food supply. These employees of critical infrastructure, as defined by the Department of Homeland Security (https://www.cisa.gov/publication/guidance-essential-critical-infrastructure-workforce), have a special responsibility to maintain normal work schedules,” CDC said.