CLARKSVILLE, Tenn. (CLARKSVILLENOW) – Distilleries across the country that stepped up and began producing hand sanitizer in the face of a pandemic-induced shortage were recently surprised with a fee from the Food and Drug Administration of $14,060, including Clarksville’s Old Glory Distillery.
But late Thursday, in the wake of news reports about the fee nationwide, the Department of Health and Human Services announced in a pair of tweets that it was directing the FDA to cancel the fee.
“I’m pleased to announce we have directed FDA to cease enforcement of these arbitrary, surprise user fees. Happy New Year, distilleries, and cheers to you for helping keep us safe!” (2/2)
— ARCHIVED: HHS Office of Public Affairs (@SpoxHHS) December 31, 2020
“Small businesses who stepped up to fight COVID-19 should be applauded by their government, not taxed for doing so,” Brian Harrison, HHS Chief of Staff, said in a tweet at 5:07 p.m. Thursday.
“I’m pleased to announce we have directed FDA to cease enforcement of these arbitrary, surprise user fees. Happy New Year, distilleries, and cheers to you for helping keep us safe!”
The issue started with a facet of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) legislation that overhauled the process of getting FDA approval for manufacturing and selling over-the-counter, non-prescription products such as hand sanitizer.
However, expediting the process of securing approval for what the FDA calls “over-the-counter monograph drug,” required over 800 distilleries like Old Glory to pay the large fee, which the FDA is now being directed to cancel.
“What a relief,” Old Glory owner Matt Cunningham said Friday. “We’re thankful for what everyone did with their quick work to get this resolved.”
He said Rep. Mark Green and state Sen. Bill Powers had contacted him to see what they could do to get it resolved, prior to the HHS action.
Now Cunningham can enjoy the new year, looking forward to planning “some exciting stuff” when Old Glory Distillery fully resumes hosting events in 2021.