CLARKSVILLE, Tenn. (CLARKSVILLENOW) – Distilleries across the country that stepped up and began producing hand sanitizer in the face of a pandemic-induced shortage are now on the hook for a fee from the Food and Drug Administration of $14,060, including Clarksville’s Old Glory Distillery.

One facet of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) legislation was that it overhauled the process of getting FDA approval for manufacturing and selling over-the-counter, non-prescription products such as hand sanitizer.

However, by expediting the process of securing approval for what the FDA calls “Over-the-counter monograph drug,” distilleries like Old Glory are now footing the bill.

Unforeseen fee

In March, when the reality of the COVID-19 pandemic began to set in, the demand for hand sanitizer skyrocketed and supplies dried up across the country.

Old Glory in Clarksville saw the need, and did something about it. Not only were they making the 96% ethanol sanitizer and packaging it in March, but they did so for free. They continued to do so until September, after supply and demand stabilized.

Matt Cunningham, founder of Old Glory, said his business was alerted to the FDA fee on Tuesday.

“We’re actively following what’s going on, and hoping that the Distilled Spirits Council (of the United States), which is one of our advocacy groups, and also the American Craft Spirits Association, is able to work with the FDA and help alleviate that for us,” Cunningham told Clarksville Now.

“It’s a hefty sum of money. We switched over during that time of need, when there wasn’t any available, and we did it to help out our local community,” Cunningham said.

Additional hardships

Cunningham said the fee is being issued to all distilleries that made hand sanitizer in response to the shortage.

“It’s not just us. You know, there were over 800 distilleries across the country that switched over to (making sanitizer) too, and most of them are relatively small like us,” Cunningham said.

He added that Old Glory will have to move a lot of whiskey to make up for the expenses brought on by the fee.

“You can consider that our bottles are around $25 to $30, that’s a lot of bottles we have to sell to make up that fee for something we were unaware of and definitely weren’t expecting,” Cunningham said.

“I hope that the FDA is able to find a compromise. … It was something I felt like we were able help our community during that time, and so I hope the FDA can find a way to do the same thing for us, and maybe tell us ‘thank you.'”

According to the FDA’s website, this $14,060 user fee is due on Feb. 12, 2021.