Distilleries that pivoted in the pandemic to provide sanitizer now face FDA fees

ASHEVILLE, NC (WLOS) — Many mountain distilleries stepped up to fill a pandemic need, now they’re facing hefty fees for the work.
The FDA has reached out to many, charging them a $14,000 fee — a fee typically charged to drug manufacturer facilities — for production of hand sanitizer.
The owners of Cultivated Cocktails Distillery in Asheville had a call about the fee to end the year. They’re hopeful the FDA will grant them and others exemptions.
“This was a temporary thing for us. We do not plan on maintaining any type of sanitizer production or making this something we actually make profit off of or do on a regular basis. And we certainly prefer to make rum and gin over sanitizer,” Cultivated Cocktails Distillery owner Leah Howard said.
Cultivated Cocktails Distillery donated more than 8,500 gallons of sanitizer to health care facilities and first responders to help with the shortage. They think the FDA should waive the fee.
The FDA may not be so quick to waive the fee or offer exemptions. In a statement released they say:
“The FDA appreciates industry’s willingness to help supply alcohol-based hand sanitizer to the market to meet the increasing demand for these products during COVID-19, and we are grateful for their efforts. We understand the concern that manufacturers have about the fees they are being asked to pay, especially from small businesses during this difficult time. The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) enacted by Congress and signed into law in March 2020, imposes user fees for fiscal year 2021 (and thereafter) to be collected from over-the-counter (OTC) monograph drug facilities, such as hand sanitizer manufacturers. The statute does not provide any waiver provisions for any specific category of manufacturer or for the deadline for assessing those fees, however we stand ready to work with Congress on ways this can be addressed. The FDA has made information regarding its planned implementation of this new user fee program publicly available on the agency’s website, beginning in May 2020. As with our other user fee programs, we anticipate that these user fees will provide additional resources to help the agency conduct our important regulatory activities in a timelier manner and ultimately help provide the public with access to innovative OTC monograph drugs.”

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