In the early days of the epidemic, more than 800 kilns stopped making their usual whiskey, gin, vodka and other alcoholic beverages. They instead started making hand sanitizers, which were in short supply at the time. This often required withdrawing their equipment and stopping production of their main products, but said they were happy to help their communities.
Now they are getting an unpleasant reward for their trouble: the FDA is charging them $ 14,060 or more.
“It’s a surprise for our community of small distillers,” says Becky Harris, co-owner of Cactactin Creek Distilling in Virginia and president of the American Craft Spirits Association.
The fee is the result of these furnaces temporarily classified as a non-prescription drug manufacturer. In normal times, the FDA charges this fee to offset the costs of oversight and regulation of over-the-counter drug manufacturers to ensure public health and safety. But it has blinded many small, often family-owned furnaces that are already struggling to manage the 2020 economic impact.
When the furnaces started producing hand sanitizers in the spring, their effort was highly systematic. As head of his industry association, Harris held nearly daily meetings for the week to ensure that the distilleries’ sanitizers meet strict guidelines for safety and efficacy.
It also meant working with the federal government, as many laws regulating the beverage alcohol industry were to be temporarily set aside. Before the epidemic, it would be illegal to manufacture sanitizers for these facilities. “We worked with the FDA to register companies and clarify the rules,” says Harris. “At no point was the audience of the forthcoming fee exposed under his guidance, particularly one of the announced scale.”
Now the industry is asking the FDA to waive the fee.
“This unexpected charge serves to punish already struggling furnaces, who jumped at the time of needing to do the right thing,” says Chris Swonger, president and CEO of the Distilled Spirits Council of the United States, in a statement issued on December 31. . ” 2020. “While this charge may be a goalscoring error for a large pharmaceutical company, it would be disastrous for smaller furnaces who stepped in to help produce this important product.”
Meanwhile, the recipients of that hand sanitizer are showing their appreciation. Back in March and April, many distilleries shifted their production, with medical facilities running dangerously low to life-saving prisons.
“When our hospital went out of hand sanitizer, we were grateful to the distilleries,” says a nurse in Southern Indiana, who spoke to The Entrepreneur, but told her to remain anonymous because her hospital told her to talk to the press Did not authorize for “Starlight [Distillery] Also donated different bottles for us and even set up a station where we could bring our container from home and fill it. We were very grateful. ”
But it was not just hospitals that benefited from the distillery’s efforts. Businesses needed hand sanitizers and other cleaning solutions as a condition of reopening their businesses.
“When we were told that we could finally reopen during phase one, we were given new cleanliness and hygiene guidelines and had to come up with PPE and supplies to ensure the safety of both staff and our patients Could, “Dr. Andrew Harvey, owner of Harvey Eye Optometry in Kentucky. “We actually took an extra week off because masks, thermometers and cleaning supplies were sold everywhere at that time. One thing we could easily find, and in ample supply, was the sanitizer made by local furnaces. I feel very fortunate to live in an area with very amazing distilleries, such as the Gifa Creed, which really made the move to meet the epidemic’s new demand. ”
Now that the furnaces are aware of the fees, they will have to work faster. The distillery had to register with the FDA to make hand sanitizers, and if they do not cancel their registration with the FDA by the end of 2020, they are told they will be on the hook again in 2021 for this fee Will stay
Harris says, “I’m sure the FDA is already in question with pleas from small companies.” “We would love to help them by working with them to resolve this issue and then working to bring this information to the community.”