FDA Bills Distilleries For Making Hand Sanitizer; HHS Strikes It Down

SALT LAKE CITY, Utah – At the beginning of the pandemic, local distilleries stepped up to help mend the shortage of hand sanitizer. Now, at the end of the year, the U.S. Food & Drug Administration tried hitting them with a $14,000 fee for their generosity.

When it came time to help his community with a hand sanitizer shortage, Outlaw Distillery owner Kirk Sedgwick said it was an easy choice.

“We couldn’t keep that stuff in stock,” Sedgwick said.

The value of selling the sanitizer was about 80% less of the normal value he would get from alcohol sales, but he felt he was doing his part to help people in Utah.

Asked to pay the price for helping!

The @US_FDA sent a bill to craft distilleries that made hand sanitizer. They might be called Outlaw Distillery but they followed all the rules. @KSL5TV pic.twitter.com/q9SLIow5YQ

— Morgan Wolfe (@MorganWolfeKSL) January 1, 2021

However, after getting a bill from the FDA for $14,060 on Tuesday, he felt no good deed goes unpunished.

“We followed all the rules – and got us in more than if we didn’t follow the rules at all,” Sedgwick claimed.

Why Did The FDA Send The Fee To Distilleries?

Any company that decided to help make hand sanitizer during the shortage at the start of the pandemic had to register and pay a fee for a license through the FDA. It was a license that was needed to make the product, which was considered an over-the-counter drug regulated by the FDA.

In the CARES Act, there was a provision that allowed the FDA to charge companies for the added regulatory work the FDA had to do.

The FDA decided to send a fee out to the companies making hand sanitizer, which included a large number of small craft distilleries across the country. They asked them to pay the $14,060 fee by Jan. 11.

However, officials with the U.S. Health & Human Services overruled the decision to charge distilleries on 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!” (2/2)

— HHS Office of Public Affairs (@SpoxHHS) December 31, 2020

“That’s more than what I made selling hand sanitizer,” Sedgwick said.

He and many other distilleries have another dilemma on their hands — an extra supply of the product.

“I still have 800 gallons of sanitizer sitting around. We sold maybe one gallon total last month,” Sedgwick explained as he hopes to sell the rest of his product.

He even marked down a deal offering a free bottle for anyone who buys four travel-size spray hand sanitizers.

If distilleries still have questions, they can email sanitizer@americancraftspirits.org.