Contributor Post Created with Sketch. Recommended by Ricochet Members Created with Sketch. Deep State Normal: FDA edition

 

distillery hand sanitizerThe FDA appeared to be forced off of its normal politics position. This banal evil institution sought to act on behalf of big corporations and the global elite uniparty in Washington DC by crippling small businesses, driving them out of competition with the big corporations. The pretense was a fee to be assessed for “over-the-counter (OTC) monograph drug” alcohol production. The alcohol was not turned into profitable booze by small distilleries. It was turned into supposedly life-saving hand sanitizer, which has almost no profit margin, if any. The fee was published and then suspended, for 2020, a day or two later. This was no mistake. Rather, it was the administrative state reasserting itself and then temporarily feigning magnanimity.

The salaried bureaucratic denizens on the surface of the Swamp, highly paid by American taxpayers at the point of federal government guns, at best did not consider the enormous human cost. After all, these forgotten Americans, from entry-level worker hauling sacks of grain, to entrepreneur owners operating with the thinnest net of credit and personal assets, are the deplorable creatures who must be broken to make a new omelet in the Great (Socialist) Reset. Crushing small businesses and their employees is entirely beneficial to normal Capital Hill politics and the RepubliCan’t Party’s paymasters.

This is why the globalist left’s Democratic Party fought for and got what it wanted in the latest federal appropriations monstrosities, while the con men and women of the RepubliCan’t party ensured that repeal of Section 230 was kept out of the must-pass bills. The rogues’ gallery, from the “Freedom Caucus” to Ted Cruz, all are on board with allowing Mitch and the California loser party leader to remain in their “leadership” positions while the enemies of our constitutional republic, Alphabet (Google/YouTube), Facebook, and Twitter, are kept in power to ensure the wrong kind of Republican is never again able to win the presidency or the Senate majority.

This latest attack on deplorables was enabled by the Republican’ts allowing language in the falsely named “CARES Act.”

The federal CARES Act included a change to how nonprescription, over-the-counter drugs are regulated by the FDA and allowed for the agency to collect fees from businesses registered to make those products, such as hand sanitizer.

On December 29, 2020, Alex Azar‘s subordinates at the Federal Drug Administration officially announced they would punish small distilleries for producing hand sanitizer, assessing these barely surviving small businesses and their employees a $14,000 annual fee. The excuse was that Congress (thanks to the RepubliCan’t Party) had defined the change to hand sanitizer production as OTC medicine. The professional staff and their lobbyist patrons knew exactly what this would allow the FDA to do. Alex Azar, who colluded with Fraudster* Fauci in crushing the deplorables and reasserting the dominance of normal political elites, is personally responsible for the conduct of his agency, including the FDA.

Struggling Distillers Hit With Surprise $14,000 FDA Fee for Producing Hand Sanitizer During Pandemic

WASHINGTON, DC — In a shocking turn of events, the FDA announced Dec. 29 without any advance notice that it is imposing fees on distilleries and other facilities that produced hand sanitizer during the pandemic.

“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. “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.”

[. . . ]

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 FDA has acted consistently against America on behalf of the medical-industrial complex, only partially limited by direct orders from President Trump. The New Year’s Eve publication in the Federal Register came with the full knowledge of Azar, who has full responsibility for his entire agency’s regulatory decisions. This was not a low-level employee operating in a cave, isolated from the past year’s news. This was consistent conduct. The reversal is not creditable to a morally upright HHS Secretary correcting a misguided or rogue subordinate. It is, at best, a directly ordered correction by President Trump, and more likely a bit of kabuki theater, showing the Deep State’s muscle while providing a media story of Azar being the good guy.

Azar fired nobody. Azar had the regulation published and did not force withdrawal of the regulation, instead only “forgiving” the fine/”fee” for 2020. Here is how the hand sanitizer fee works in the real world, here is what normal politics looks like for deplorable flyover country Americans being shoved back down the memory hole and told by “conservative” corporatist mouthpieces to “get a U-Haul” trailer and “learn to code:”

[Peg] Hays, the owner of Casey Jones Distillery in Hopkinsville, Kentucky, was among the many distilleries around the country that began producing hand sanitizer during the coronavirus pandemic as many communities dealt with shortages.

“March 15, we had actually planning to close the distillery to get through COVID,” she said. “And then in less than two weeks, we’re out producing sanitizer.”

[. . .]

Hays said Casey Jones Distillery is a small operation expected to produce 12,000 gallons of alcohol this year and only employs a handful of employees.

“We are not just a small craft distillery. We are a nano-small craft distillery,” she said. “We’d probably have sat down and had a big talk and said, ‘Look, how are we going to cut hours here?'”

The Department of Health and Human Services reversed course Thursday and withdrew the fee for producing hand sanitizer in 2020.

[. . .]

Hays said she is grateful and relieved she will not have to pay the fee, but she is also seeking clarity about whether she can continue selling the hand sanitizer that is in her inventory without incurring another fee next year.

“We’ll lose the money we have invested in our inventory, plus if we ship a bottle, we’ve got that 14,060 bucks ahead of us.”

This is largely the fault of the passive aggressive RepubliCan’t Party’s subversion of our constitutional republic for the past four years, from enabling Putin’s “Russian collusion” disinformation campaign, to enabling the crippling of policy control through letting Schumer blockade hundreds of administration appointments from being made, to using the blue slip excuse to keep much of the federal judiciary solidly leftist, to ensuring there would be no real election security reform in 2017 (ensuring that each vote is cast by just one actual eligible American citizen).


* Fauci knew the initial model he used to scare President Trump and the nation into submission was a fraud, created by a serial hype artist in Britain whose projections over the decades show a need for very steep discounting. His supposed medical expert recommendation was not based on any peer reviewed study or experiment. His supposed “public health” prescriptions deliberately excluded the vast majority of real medical expertise, keeping out all the equally qualified experts that any real doctor would be obligated to consult for medical side effects (heart, cancer, circulatory, diabetes, mental health, child brain development . . .).

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  1. DrewInEastHillQuarantineZone Coolidge

    Is there no tar? Have we run out of feathers?

    • #1
    • January 1, 2021, at 7:45 PM PST
    • 15 likes
  2. Clifford A. Brown Contributor
    Clifford A. Brown

    DrewInEastHillQuarantineZone (View Comment):

    Is there no tar? Have we run out of feathers?

    Tar will shortly be regulated out of reach as a carbon culprit. Feathers imply transgression of animal rights.

    • #2
    • January 1, 2021, at 7:53 PM PST
    • 12 likes
  3. DonG (2+2=5. Say it!) Coolidge

    Clifford A. Brown: The FDA has acted consistently against America on behalf of the medical-industrial complex

    Sacrificing lives to boost profits! Nice edgy post. Keep up the ire!

    • #3
    • January 1, 2021, at 8:28 PM PST
    • 6 likes
  4. RushBabe49 Thatcher

    May I publish with attribution on my blog?

    • #4
    • January 1, 2021, at 9:05 PM PST
    • 4 likes
  5. JennaStocker Member

    Motto of the government bureaucracy: “No good deed goes unpunished.”

    • #5
    • January 1, 2021, at 9:11 PM PST
    • 8 likes
  6. JustmeinAZ Member

    I have never used hand sanitizer. If I knew which labels were produced by the small companies I would buy some.

    • #6
    • January 1, 2021, at 9:23 PM PST
    • 5 likes
  7. Flicker Coolidge

    Clifford A. Brown: This banal evil institution sought to act on behalf of global corporations and the global elite uniparty in Washington D.C. by crippling small distilleries, driving them out of business competition with the big corporations.

    Reminiscent of the Whiskey rebellion.

    • #7
    • January 1, 2021, at 10:08 PM PST
    • 7 likes
  8. Rodin Member

    (Sigh) 

    • #8
    • January 2, 2021, at 4:09 AM PST
    • 3 likes
  9. Gazpacho Grande' Coolidge

    So much for rights being inherent in our being, as recognized in the Declaration. Now we must all seek approval and financial relief from faceless administrative policies, built out over decades. Like barnacles on a ship, they need to be scraped off, roughly, on a regular cadence.

    Or instead of scraped, scrapped, thrown off, and replaced with a new form of drug approval government.

     

    • #9
    • January 2, 2021, at 5:32 AM PST
    • 4 likes
  10. Blondie Thatcher

    Back at the beginning of this mess, our hospital started running out of hand sanitizer. It was locked up as tight as our narcotics. One of the many distilleries delivered buckets full of sanitizer to us to use. Believe me when I say it was wonderful. We were all surprised the PTB let us have it being it wasn’t “medically approved” and all. I hate that all these guys are getting hit like this but it isn’t surprising. They couldn’t even wait until January 20th to show their true colors. Just proves what some of us have known for a while. Trump really has been standing in the breach.

    • #10
    • January 2, 2021, at 5:58 AM PST
    • 10 likes
    • This comment has been edited.
  11. Doctor Robert Member

    Alex Azar is secretary of HHS.

    He works for President Donald Trump.

    President Donald Trump can direct Mr Azar to correct this indecency.

    Mr Trump? Mr Trump? Calling Mr Trump…

    • #11
    • January 2, 2021, at 12:18 PM PST
    • 4 likes
  12. JoelB Member

    Just shows what is happening in those 5,000+ page omnibus bills that get rushed into law so quickly. When they use words like “Care”, “Affordable” and “Health” watch out. A number of years ago I was working as an engineer for PennDOT when the state passed the Local Industrial Access Roads Act. Of course the underlings referred to it as the LIAR Act which made the high muckety-mucks livid.

    • #12
    • January 2, 2021, at 12:25 PM PST
    • 4 likes
  13. The Reticulator Member

    JoelB (View Comment):

    Just shows what is happening in those 5,000+ page omnibus bills that get rushed into law so quickly. When they use words like “Care”, “Affordable” and “Health” watch out. A number of years ago I was working as an engineer for PennDOT when the state passed the Local Industrial Access Roads Act. Of course the underlings referred to it as the LIAR Act which made the high muckety-mucks livid.

    Nobody (with the possible exception of Bill Clinton) likes being called a liar. Those who are actual liars (with the possible exception of Bill Clinton) are probably extra sensitive about it. 

    • #13
    • January 2, 2021, at 1:47 PM PST
    • 1 like
  14. namlliT noD Member
    namlliT noD Joined in the first year of Ricochet Ricochet Charter Member

    Doctor Robert (View Comment):

    Alex Azar is secretary of HHS.
    He works for President Donald Trump.
    President Donald Trump can direct Mr Azar to correct this indecency.
    Mr Trump? Mr Trump? Calling Mr Trump…

    Aaand done.

    PJ Media: Trump Administration Saves Distilleries From Punitive FDA Fees for Producing Hand Sanitizer

    • #14
    • January 2, 2021, at 2:51 PM PST
    • 6 likes
    • This comment has been edited.
  15. DrewInEastHillQuarantineZone Coolidge

    namlliT noD (View Comment):

    Aaand done.

    If nobody’s been fired, it’s not done. If nobody faces any consequences, it’s not done.

    The fact that this was considered at all and had to be pulled back is evidence of evil in Washington. That EVIL must be eradicated.

    Someone needs to be fired, and not the usual “low-level staffer” either.

    • #15
    • January 2, 2021, at 3:29 PM PST
    • 8 likes
  16. RushBabe49 Thatcher

    Of course, a Biden administration would have let it stand, and pursued to the ends of the earth for payment.

    • #16
    • January 2, 2021, at 3:38 PM PST
    • 4 likes
  17. Bryan G. Stephens Thatcher
    Bryan G. Stephens Joined in the first year of Ricochet Ricochet Charter Member

    Never Trumpers who support the business as usual must be so proud. So proud.

     

    • #17
    • January 2, 2021, at 5:38 PM PST
    • 4 likes
  18. Flicker Coolidge

    Bryan G. Stephens (View Comment):

    Never Trumpers who support the business as usual must be so proud. So proud.

    They are unfortunately very deluded.

    • #18
    • January 2, 2021, at 5:41 PM PST
    • 5 likes
  19. Bryan G. Stephens Thatcher
    Bryan G. Stephens Joined in the first year of Ricochet Ricochet Charter Member

    Flicker (View Comment):

    Bryan G. Stephens (View Comment):

    Never Trumpers who support the business as usual must be so proud. So proud.

    They are unfortunately very deluded

    They are stupid. They are willingingly stupid. The refuse to connect the dots in a straight line. 

     

    • #19
    • January 3, 2021, at 7:53 AM PST
    • 2 likes
  20. Clifford A. Brown Contributor
    Clifford A. Brown

    Doctor Robert (View Comment):

    Alex Azar is secretary of HHS.

    He works for President Donald Trump.

    President Donald Trump can direct Mr Azar to correct this indecency.

    Mr Trump? Mr Trump? Calling Mr Trump…

    He did suspend the fine/fee within hours of it surfacing. Withdrawing or reversing any regulation published in the Federal Register requires a process, a process that will go well into the new presidential term.

    • #20
    • January 3, 2021, at 6:10 PM PST
    • 2 likes
  21. Clifford A. Brown Contributor
    Clifford A. Brown

    DrewInEastHillQuarantineZone (View Comment):

    namlliT noD (View Comment):

    Aaand done.

    If nobody’s been fired, it’s not done. If nobody faces any consequences, it’s not done.

    The fact that this was considered at all and had to be pulled back is evidence of evil in Washington. That EVIL must be eradicated.

    Someone needs to be fired, and not the usual “low-level staffer” either.

    Yes, as I pointed out, no one has been fired and the fees are merely suspended for 2020. We are now in 2021, so the fee may well be collected, absent an announcement that the regulation is being withdrawn/rewritten to exclude small producers of hand sanitizer so long as “COVID-19” is a “pandemic.”

    • #21
    • January 3, 2021, at 6:16 PM PST
    • 4 likes
  22. Ontheleftcoast Member

    Clifford A. Brown (View Comment):

    DrewInEastHillQuarantineZone (View Comment):

    Is there no tar? Have we run out of feathers?

    Tar will shortly be regulated out of reach as a carbon culprit. Feathers imply transgression of animal rights.

    The original tradition was to use pine tar. Plant products are a renewable resource.

    • #22
    • January 7, 2021, at 12:02 PM PST
    • 3 likes
  23. Ontheleftcoast Member

    Blondie (View Comment):

    Back at the beginning of this mess, our hospital started running out of hand sanitizer. It was locked up as tight as our narcotics. One of the many distilleries delivered buckets full of sanitizer to us to use. Believe me when I say it was wonderful. We were all surprised the PTB let us have it being it wasn’t “medically approved” and all. I hate that all these guys are getting hit like this but it isn’t surprising. They couldn’t even wait until January 20th to show their true colors. Just proves what some of us have known for a while. Trump really has been standing in the breach.

    When hand sanitizer was first running out, the pharmacies had run out of 70% rubbing alcohol but I found a couple of gallons in a hardware store. The price of hand sanitizer, when you could get it, was through the roof. I noticed that there was cheap 151 rum at BevMo; cheaper than hand sanitizer in fact. 

    I much prefer using products topically that are safe for internal use as well.

    • #23
    • January 7, 2021, at 12:07 PM PST
    • 5 likes
  24. Clifford A. Brown Contributor
    Clifford A. Brown

    Ontheleftcoast (View Comment):

    Blondie (View Comment):

    Back at the beginning of this mess, our hospital started running out of hand sanitizer. It was locked up as tight as our narcotics. One of the many distilleries delivered buckets full of sanitizer to us to use. Believe me when I say it was wonderful. We were all surprised the PTB let us have it being it wasn’t “medically approved” and all. I hate that all these guys are getting hit like this but it isn’t surprising. They couldn’t even wait until January 20th to show their true colors. Just proves what some of us have known for a while. Trump really has been standing in the breach.

    When hand sanitizer was first running out, the pharmacies had run out of 70% rubbing alcohol but I found a couple of gallons in a hardware store. The price of hand sanitizer, when you could get it, was through the roof. I noticed that there was cheap 151 rum at BevMo; cheaper than hand sanitizer in fact.

    I much prefer using products topically that are safe for internal use as well.

    Purely for medicinal purposes, of course.

    • #24
    • January 7, 2021, at 12:22 PM PST
    • 3 likes
  25. JoelB Member

    How is hand sanitizer a food or a drug? It’s a cleaning product. Nobody in his right mind takes it internally. Is dishwasher or laundry detergent regulated by the FDA?

    • #25
    • January 7, 2021, at 12:23 PM PST
    • 2 likes
  26. Ontheleftcoast Member

    Clifford A. Brown (View Comment):

    Ontheleftcoast (View Comment):

    Blondie (View Comment):

    Back at the beginning of this mess, our hospital started running out of hand sanitizer. It was locked up as tight as our narcotics. One of the many distilleries delivered buckets full of sanitizer to us to use. Believe me when I say it was wonderful. We were all surprised the PTB let us have it being it wasn’t “medically approved” and all. I hate that all these guys are getting hit like this but it isn’t surprising. They couldn’t even wait until January 20th to show their true colors. Just proves what some of us have known for a while. Trump really has been standing in the breach.

    When hand sanitizer was first running out, the pharmacies had run out of 70% rubbing alcohol but I found a couple of gallons in a hardware store. The price of hand sanitizer, when you could get it, was through the roof. I noticed that there was cheap 151 rum at BevMo; cheaper than hand sanitizer in fact.

    I much prefer using products topically that are safe for internal use as well.

    Purely for medicinal purposes, of course.

    Of course. “No, officer, that open bottle of rum is my hand sanitizer.”

    • #26
    • January 7, 2021, at 12:30 PM PST
    • 4 likes
  27. RushBabe49 Thatcher

    JoelB (View Comment):

    How is hand sanitizer a food or a drug? It’s a cleaning product. Nobody in his right mind takes it internally. Is dishwasher or laundry detergent regulated by the FDA?

    Anything used in a medical setting is FDA regulated. There are dozens of iodine-based disinfectants that are very heavily regulated for medical use. You can buy Betadine in the drugstore, and a nearly-identical product has been used for decades in surgery. It’s way more expensive, due to all the government paperwork the manufacturer must do to get it approved.

    • #27
    • January 7, 2021, at 1:09 PM PST
    • 6 likes
  28. Clifford A. Brown Contributor
    Clifford A. Brown

    RushBabe49 (View Comment):
    The federal CARES Act included a change to how nonprescription, over-the-counter drugs are regulated by the FDA and allowed for the agency to collect fees from businesses registered to make those products, such as hand sanitizer.

    Yes, what changed was an increase in scope of regulation of OTC items, accompanied by a way o supposedly make the regulations pay for themselves:

    The federal CARES Act included a change to how nonprescription, over-the-counter drugs are regulated by the FDA and allowed for the agency to collect fees from businesses registered to make those products, such as hand sanitizer.

    • #28
    • January 7, 2021, at 2:40 PM PST
    • 3 likes
  29. Matt Upton Lincoln

    This is why giant legislation is terrible. It’s a 335 page PDF, covering at least three different kinds of issues that would very loosely be joined together. If I recall correctly, this was also lumped in with the general budget omnibus. So while this may have been negotiated between between Mnuchin, Pelosi, and McConnell, there is no way it could have been deliberated. 

    As such, I’d put a decent wager that zero percent of the people negotiating or voting on this bill understood it meant a huge fee on distilleries which, in much needed service, began making hand sanitizer. The only mention of hand sanitizer directly in the bill relates to rescinding a temporary tax exemption for alcohol produced for manufacturing sanitizer starting Jan 1, 2021. (I don’t know whether or not this was known ahead of time). 

    My guess: some midlevel FDA employee tasked with figuring out who qualified for the new “OTC monograph drug facility” put the distilleries on a list, and none of the bureaucratic cogs thought “Gee, this seems unfair that distilleries which bailed the country out of a sanitizer shortage would get hit with that fee.” That is a politician’s job to make these considerations, but they outsource them all to the Administrative State with a hundred “the secretary shall” in the bill.

    • #29
    • January 7, 2021, at 4:45 PM PST
    • 3 likes
  30. Clifford A. Brown Contributor
    Clifford A. Brown

    Matt Upton (View Comment):

    This is why giant legislation is terrible. It’s a 335 page PDF, covering at least three different kinds of issues that would very loosely be joined together. If I recall correctly, this was also lumped in with the general budget omnibus. So while this may have been negotiated between between Mnuchin, Pelosi, and McConnell, there is no way it could have been deliberated.

    […]

    That is a politician’s job to make these considerations, but they outsource them all to the Administrative State with a hundred “the secretary shall” in the bill.

    Exactly so.

    AND.

    Killing off competition for big booze makers is a feature, not a bug.

    • #30
    • January 7, 2021, at 5:42 PM PST
    • 2 likes
    • This comment has been edited.