$14,000 FDA fee coming to distilleries who made hand sanitizer, according to trade association
By: Dan Gross (RochesterFirst - Rochester, NY)
No good deed goes unpunished by bureaucrats.
S E E D E D C O N T E N T
ROCHESTER, N.Y. (WROC) — For distilleries across the US and in Rochester, turning to producing hand sanitizer was not only a way to stay in business, many thought it was the right thing to do.
"We are doing this to help our community, to hopefully save lives and to get our employees back to work. We want to do our part in these unprecedented times," said owner of Black Button Distilling, Jason Barrett, when the company made the announcement on March 19th. "I couldn't stand by and watch this pandemic ravage my hometown of Rochester. We will work around the clock to help as many as we can."
But now, they are faced with a steep cost for making hand sanitizer. According to Distilled Sprits Council, the FDA will be charging distilleries a $14,000 fee if they produced hand sanitizers.
BREAKING NEWS: Struggling Distillers Hit w/ Surprise $14,000 @US_FDA Fee for Producing Hand Sanitizer During #COVID19
This incredibly frustrating news is a complete shock to the 800+ distillers that came to the aid of their communities & first responders https://t.co/VQt8iNSUSTpic.twitter.com/Hj00sKCRjB — Distilled Spirits Council of the United States (@DistilledSpirit) December 31, 2020
The trade association also said the announcement was made on December 29th with no preamble or warning, and they are urging the FDA to waive those fees.
"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. 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.
The association describes the fees in a press release:
These fees are being levied under a newly established "OTC monograph drug user fee program," which has established fees on OTC monograph drug facilities, as well as OTC Monograph Order Requests (OMORs) for FY 2021. The FDA has stated that these fees also apply to facilities, including distilleries, that produced hand sanitizer under the temporary policy during Covid-19.
The fees impacting distillers are a $14,060 Monograph Drug Facility Fee and $9,373 Contract Manufacturing Organization Facility Fee. The fees for FY 2021 are due on February 11, 2021.
In order for distillers to avoid the 2022 OTC Monograph Drug Facility Fee, they need to act today, December 31, 2020 to (1) cease producing and selling the product; and (2) de-register in the FDA eDRLS system.
"We stand proud that when our local community had a need this spring we leapt into action and delivered over 405,000 bottles of FDA ethanol-based hand sanitizer. That's over 300 million hand washes spread across NY state. We delivered to the Javits Field hospital when no one else could, we sent trailer loads to Hunts Point Produce Market so they could continue to feed NYC. We donated $100,000 worth to our local United Way so that regardless of someone's ability to pay, they could be safe," said Barret in a statement following the announcement of the FDA fee.
"Just a few weeks ago we worked with Cuomo's office to donate another 7,000 bottles to the NYD Board of Elections to keep New Yorkers across the state safe at the polls on Election Day. We delivered smaller orders to over 2,000 police departments, fire stations, hospitals and nursing homes, as well as thousands of private businesses and consumers. You should have seen it, men and women working seven days a week up to 20 hours a day regardless of the weather fighting for their community as if lives depended on their actions that day. Parking lots turned into staging areas, bartenders became bottlers and delivery drivers. We did all of this without regard for profit or what focusing on this new product seven days a week would do to our business."
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