Name: The FDA Is Slapping Craft Distillers With A $14,000 Fee For Making Hand Sanitizer
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The FDA Is Slapping Craft Distillers With A $14,000 Fee For Making Hand Sanitizer

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BETAThis is a BETA experience. You may opt-out by&nbsp;Dec 31, 2020,Update: Late in the day on December 31, HHS voided the fees for distillers. .In the early days on the pandemic things like masks and hand sanitizer were hard, if not impossible to find. Thought to be essential in keeping our communities safe, amateur seamstresses across the country worked to hand-make masks for health care workers and those around them that needed them and craft distillers did what they could do to help: they made hand sanitizer.It was a feel-good story this summer, but now the FDA is making that hand sanitizer, more than many of those distillers, many of which who donated all that they made, made off the sanitizers creation in the first place.“This incredibly frustrating news comes as a complete shock to the more than 800 distilleries across the country that came to the aid of their local communities and first responders.&nbsp;This unexpected fee serves to punish already struggling distilleries who jumped in at a time of need to do the right thing,” said Distilled Spirits Council President and CEO Chris Swonger.MORE FOR YOU“While this fee may be a rounding error to a large pharmaceutical company, this will be disastrous to small distilleries who stepped up to help produce this critical product – it will quite literally bankrupt some struggling businesses. We are urging FDA to immediately waive the fees for distillers who are producing hand sanitizer on a temporary basis to help combat the pandemic, pursuant to the FDA’s temporary policy.”For many craft distillers, whose business like many others were suffering during the pandemic, making the sanitizer was not only a way to help their community, it was also a way to stay afloat.Making that sanitizer also wasn’t easy: On March 18 the TTB encouraged distillers to make sanitizer, saying they could do so without prior approval as long as they followed WHO guidelines; however, on March 29 the FDA , something distillers did not already have on hand. Denaturing agents were scarce at the time, and denaturing the alcohol, which is not recommended by the WHO, caused the cost and time associated with creating the hand sanitizer to go up.Denaturing treats an alcohol with bittering agents so it is unsuitable for human consumption and is not something typically done by distillers that are literally in the business of creating drinkable alcohol. Not only an extra cost, it also meant additional cleaning for distillers to remove the product from their equipment afterward.was announced on December 29 without providing any advance notice to the distilleries it impacts.Fees are being lived under a newly established “OTC monograph drug user fee program.” Beyond a $14,060 Monograpah Drug Facility Fee, distillers will also be responsible for a $9,373 Contract Manufacturing Organization Facility Fee.&nbsp;Those fees are also due almost immediately. Distillers are expected to hand over the cash for both by February 11, 2021.Even worse, in order to not get charged the same fee in 2022 distillers have to de-register themselves in the FDA eDRLS system and cease making and selling sanitizer by today, December 31, just 2 days after the announcement.“Everyone was totally blindsided by FDA’s announcement and as&nbsp;a result, craft distillers across the country are scrambling to&nbsp;understand and respond, says Phil McDaniel, CEO of St. Augustine Distillery and Chair of the DISCUS Craft Advisory Council.“Given all that’s happened in 2020, the timing of this news could not be worse.&nbsp;The $14,000 fee being assessed could&nbsp;certainly put many of these small family owned businesses out of business.”.&nbsp;some of my other work&nbsp;.&nbsp;

BETAThis is a BETA experience. You may opt-out by&nbsp;Dec 31, 2020,Update: Late in the day on December 31, HHS voided the fees for distillers. .In the early days on the pandemic things like masks and hand sanitizer were hard, if not impossible to find. Thought to be essential in keeping our communities safe, amateur seamstresses across the country worked to hand-make masks for health care workers and those around them that needed them and craft distillers did what they could do to help: they made hand sanitizer.It was a feel-good story this summer, but now the FDA is making that hand...

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Emily Price

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The FDA Is Slapping Craft Distillers With A $14,000 Fee For Making Hand Sanitizer

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