FDA slaps craft distilleries with fees for producing hand sanitizer at the onset of the COVID-19 pandemic

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Craft distillers just can’t catch a break this year.

Along with the hardships brought about by the pandemic — such as the closure of their tasting rooms — the Food and Drug Administration is now telling distilleries that produced hand sanitizer at the start of the pandemic that they’ll need to pay a steep fee, the San Joaquin Valley Sun reports.

The FDA is now informing the businesses that, due to a technical detail in recent pandemic relief legislation, they now owe the government more than $14,000, according to the newspaper.

And here’s the cherry on top of that shit sundae: the fee is due February 12 and will likely financially devastate many craft distillers that did nothing more than try to help out.

“I can’t believe they would seriously have us pay this fee for providing sanitizer when it was most needed,” said Dennis Rylander, a co-founder of San Antonio’s Ranger Creek Brewing & Distilling. “I guess I’m still hopeful for some kind of sanity to prevail, that they’ll decide not to move forward with this.”

Ranger Creek began producing sanitizer in its north San Antonio facility in late March, donating hundreds of cases to first responders and providing nearly 200 local organizations with the needed product. The distillery also sold the sanitizer, but — like many other craft distillers across the nation — those profits were middling, at best.

“We definitely lost money on this program,” Rylander said. “Raw materials, packaging, man hours, production — it definitely wasn’t a moneymaker for us. but that wasn’t our goal. We saw a need in our community.”

The FDA is levying the fee under a provision of the CARES Act that allowed distilleries that produced sanitizer to be classified as “over-the-counter drug monograph facilities.”

“The new user fee program, which we refer to as the Over-the-Counter Monograph User Fee Act (or “OMUFA”), is modeled after the successful Prescription Drug User Fee Act (PDUFA),” the FDA stated in a Federal Register Notice published Tuesday.

“As with PDUFA, FDA anticipates that this user fee program will provide additional resources to help the agency conduct these important regulatory activities in a timely manner and ultimately help provide the public with access to innovative OTC monograph drugs.”

The FDA will require each distillery to pay the same flat “facility fee” it imposed on Tuesday. The fee applies no matter how much sanitizer each distiller produced — or even if the distillers gave it all away.

San Antonio-area distillers that produced and sold hand sanitizer include Seersucker Southern Style Gin, Ranger Creek Brewing & Distilling, Maverick Whiskey and Rebecca Creek Whiskey.

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