For many American craft distillers, 2020 was already one of their worst years ever. The COVID-19-related closure of tasting rooms and cocktail bars, loss of tourism, and inability to offer in-store sampling slashed their sales revenue and cut them off from their customers. Then this week, just as it seemed they’d made it through the worst of a terrible year, the Food and Drug Administration (FDA) had one more surprise in store: The agency delivered notice to distilleries that had produced hand sanitizer in the early days of the pandemic that they now owe an unexpected fee to the government of more than $14,000.
Since the foundation of this country, Distillers and Government have been at odds; sometimes lightly and sometimes all the way trampling with constitutional rights and creating long-lasting agencies that kill citizens because they can and need to prance in front of TV cameras.
And, goes without saying, government understand pretty well that a populace that can provide for themselves, does not need them and can make them shrink or disappear. This is not being mean, this is punishment for Attempted Murder of a Bureaucratic Office in the First Degree.
Never let a good deed to unpunished, as the old maxim goes. It would not surprise me for clothing (or other) companies that switched to mask/medical gear production, to be penalized as well.
There was a time when the FDA did good work for the good of the country. Now? One has to wonder.
“Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021”
From reading the notice, dated 12/22/20202, this is applicable to 2021 and not an ex-post-facto fee. It is also nice to know the FDA funds itself, self-licking icecream cone style, by imposing fees on companies it regulates. So much for Congress funding things.
I’m an engineer in the chemical industry and I’ve been involved in compliance with federal regulations before. 99% of compliance depends on the private companies reading the regulations and acting appropriately. While the govt can audit at will, in point of fact there’s very little auditing performed. Again, compliance really depends on companies self-auditing and self-reporting. It is unheard of for the various 3 and 4 letter agencies to send out a letter like this.
Which means some govt office drone thought this out, presented it to his manager, and he in turn ran it up the flagpole. This was deliberate. Not an over-sight, not a regular form letter, but a deliberate intent BFYTW letter.
No govt agency should be self-supporting based on fines and fees. We see what happens when small town police depts get to keep ticket revenue, the same thing happens on a big scale too.
The ‘career professionals’ think Trump’s gone on the 20th and they can double down on the BFYTW actions.
“HHS officials said after many conversations with Legislators and the key agencies, they have withdrawn the Notice published in the Federal Register re OTC Monograph Drug Facility Fees and directed FDA to cease enforcement of these fees.“
Translation, “Oops. We got caught and don’t want Whiskey Rebellion 2.0.”
https://whnt.com/news/alabama-news/if-its-left-untouched-its-not-going-to-be-pleasant-distillers-face-14k-fee-for-producing-hand-sanitizer/
This reminds me of NY telling all the volunteer nurses who came to the state to help out with the early surge to remember to pay their NY state non-resident income taxes.
Oops.
Yep that’s one reason why my response, as an RN, when they were all, “ZOMG! New York, The Capitol Of The World, is falling! Nurses, everywhere, come save us!”, was “FUNY!”. (and not as in amusing. Rather, as in “Go worship at the altar of the patron saint of fertility. With yourself.)