Alcohol

The FDA Is Making It Much, Much Harder for Distilleries To Produce Hand Sanitizer

Rules designed to keep alcohol safe for children are slowing down production of a product that’s in short supply.

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In the midst of the COVID-19 pandemic, hand sanitizer has become an incredibly scarce resource. It's practically impossible to find any at a grocery or drug store, or to order it online. But in Washington, D.C., at least, anyone who wants a bottle can get one. All you have to do is buy a bottle of booze. 

That's what I did yesterday when I ordered delivery of a pre-bottled cocktail—the delicious rye-apple brand blend, the American Trilogy—from Restorative Republic, a local distiller that makes bourbon, vodka, rye, and apple brandy. A few hours later, the bottle was delivered to my front gate—along with a smaller bottle labeled "hand cleaner." 

Local distilleries like Restorative Republic and rum-maker Cotton & Reed are making artisanal hand cleaner, the primary ingredient in which is high-proof alcohol. And anyone who buys a bottle of their booze also gets a small bottle of what you might call hipster Purell. They're not alone. Distilleries across the country have begun producing hand cleaners, and many more have said they'd like to, with more than 500 producers reportedly indicating they'd like to convert some of their production. 

But there's a problem: The Food and Drug Administration (FDA) currently won't let them do so in an efficient way. 

"We are ready willing and able to produce massive amounts of hand sanitizer," says Matt Dogali, the President and CEO of the American Distilled Spirits Alliance. The FDA, along with the Alcohol Tax and Trade Bureau, he says, "have guidance documents about how we make our hand sanitizer." And that guidance requires a denaturant—an additive meant to make the alcohol unpalatable if, say, a child tried to drink it. 

But the denaturant the FDA currently requires would temporarily wreck their production lines. "We make consumable alcohol products," he says. "And if we introduce a denaturant into our lines, it renders them useless for future alcohol production barring extreme cleaning measures, because we cannot have any remnant of the denaturant in our lines, and then sell a consumable product." Deep cleaning could take down lines, which in many distilleries run either continuously or the majority of every day, for days if not longer, costing distilleries precious time and money in the process. 

Some distilleries, he said, initially began producing sanitizer with ethanol, which is used to produce consumable alcohol, and food-safe ingredients. But the FDA released follow-up guidance saying those food-safe formulas were only allowable with types of alcohol that most liquor producers don't use. The March guidance document says that, given the emergency circumstances surrounding the spread of COVID-19, the FDA "does not intend to take action" against alcohol producers who make alcohol for hand sanitizer—so long as a lengthy list of requirements is met. 

The FDA's requirements have nothing to do with making hand sanitizer work; hand sanitizer doesn't require a denaturant to be effective at killing germs. In fact, the World Health Organization's (WHO) guidelines for producing it don't include a denaturant. 

Those guidelines are what some distilleries, like Republic Restoratives, have reportedly followed—and why they are labeling it "hand cleaner" instead of sanitizer. "I don't really know what the FDA thinks about things like this," owner Pia Carusone told Washingtonian in March. Regulations governing the production of sanitizer are also why they can't sell it. 

Nor are the FDA's approved denaturing agents the only options. Dogali says there are other substances that could be added that would ward off drinking without affecting production lines. And he'd like to see direct sales to medical facilities approved as well. 

Distillers, Dogali says, have proposed to the FDA that "they should allow us to make a commercial-grade hand sanitizer, that is, a hand sanitizer that would never end up for public sale." It would never reach store shelves to which children might have access, and that way, it wouldn't need to be denatured to discourage consumption. The goal, he says, would be to "put our products in the hands of professionals. That allows conventional labs to restock grocery stores." 

"If we can alleviate the demands of the hospitals and first responders," he says, then other producers can restock the grocery stores. 

The Distilled Spirits Council of the United States (DISCUS), another industry group, has set up a portal for distillers hoping to produce sanitizer. Among other things, producing sanitizer allows "craft distilleries to keep their stills going, maintain their employees and stay afloat during this crisis," said CEO Chris Swonger, in a statement.

Congress has already taken some action to make it easier for distillers to produce sanitizer by eliminating a tax on alcohol production if it's used for hand cleaner. That tax, if it had continued, would have "basically been a stop order," Dogali says, making it prohibitively expensive to produce much sanitizer. But there's a catch: The tax break only applies to sanitizer produced according to FDA guidelines. 

Personally, I'm happy to buy liquor and cleaner as a package deal: I prefer to think of it as buying a pricey bottle of hand cleaner and getting a tasty bottle of booze for free. But that's not ideal for most people, and it means that distilleries can't produce the mass quantities necessary to keep up with unprecedented demand. 

There are about 4,000 distilleries in the U.S., and many are already making some sort of hand cleaner. But Dogali says they could be making 10 times as much if the FDA were to change its rules. "At this moment in time," he says, "the amount of hand sanitizer that we're making is smaller than it could be."

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44 responses to “The FDA Is Making It Much, Much Harder for Distilleries To Produce Hand Sanitizer

  1. “I’m from the government, and I’m here to help.”

    1. Adding a poison (“denaturant”) to booze is how Government Almighty PROVES that it LOVES us, More Deeply and Dearly than we can ever Know! Also note… It is for the children!

      Scienfoology Song… GAWD = Government Almighty’s Wrath Delivers

      Government loves me, This I know,
      For the Government tells me so,
      Little ones to GAWD belong,
      We are weak, but GAWD is strong!
      Yes, Guv-Mint loves me!
      Yes, Guv-Mint loves me!
      Yes, Guv-Mint loves me!
      My Nannies tell me so!

      GAWD does love me, yes indeed,
      Keeps me safe, and gives me feed,
      Shelters me from bad drugs and weed,
      And gives me all that I might need!
      Yes, Guv-Mint loves me!
      Yes, Guv-Mint loves me!
      Yes, Guv-Mint loves me!
      My Nannies tell me so!

      DEA, CIA, KGB,
      Our protectors, they will be,
      FBI, TSA, and FDA,
      With us, astride us, in every way!
      Yes, Guv-Mint loves me!
      Yes, Guv-Mint loves me!
      Yes, Guv-Mint loves me!
      My Nannies tell me so!

    2. The FDA exists to kill Americans. It’s right there in the name. Federal Death Administration.

  2. Once again ist should be pointed out that the FDA and CDC which stand in front of progress in the name of the precautionary principle taken to the absurd have fully embraced a completely untried, untested and unproven tactic to #flattenthecurve and at the same time are putting up redtape and bureaucratic hoops on tested and already market ready drugs to be used on people dieing of this virus. They are a terrorist organization and have accomplished more damage and second order deaths in the last month than Osama bin laden could have ever dreamed of in his most elaborate plans.

    1. One of the best ways to limit government is make government fully accountable under all laws.

      Monopoly? Government itself is a monopoly, but even ignoring that, most of its unessential ungovernment functions are monopolies — TSA, meat inspectors, and so on.

      Robbery? Tax collection could be easily privatized. Eminent domain is thievery, since the “fair market price” has one buyer and no willing seller. Fines for not knowing what an eagle feather looks like. Asset forfeiture without an underlying crime.

      1. The way to limit government is to prohibit it from initiating force.

        1. Ah, then it wouldn’t be a government, would it?

          Myself, I am close to an anarchist, and agree on preventing government from initiating force. Victim prosecution, private cops, private courts, and the only crime is hurting people or taking their stuff, so no need for all those ridiculous laws describing all sorts of non-crimes.

          But given a government as a starting point, there are ways to limit it which will not be tried as long as government defines its own limits.

          1. Yes it would be because the function of government is to defend liberty. The Constitution defines the limits if government. One amendment, “Government shall not initiate force.”, would solve the problem.

            1. “the function of government is to defend liberty.”

              That’s hilarious. Government is just a highly evolved protection racket. Like any parasite, it does best if it doesn’t kill its host, so it has evolved towards being at least partially a symbiote, actually delivering some useful services and real protection, at great expense.

              But it’s still a protection racket at its base, and if you ever try not paying your protection money you’ll find out just exactly who you’re paying for protection from.

              We tend to forget this, because the government enrolls most children in indoctrination camps for their formative years, but the price of actually believing government is benign can be pretty steep.

              The government is NOT your friend, and and don’t forget it.

        2. Y Y Y Y yyyyou m m m meann DISAARM them?

          Finally.. SOMEONE said it.

          that is what NEEDS to happen.

    2. “in the name of the precautionary principle taken to the absurd”

      The only approach to the precautionary principle that doesn’t end in absurdities is to ignore it.

  3. FDA really showing their value to society right now.

  4. Hey man, do you want people to die?

  5. As someone who happens to work for a company that’s shifting production to make hand sanitizer, the denaturants are also getting extremely scarce in the market. It’s now become the limiting factor on how much hand sanitizer we can make. Also our hand sanitizer won’t smell nice because the FDA won’t let us add fragrance. That would be a new recipe that would require new lengthy approvals.

    1. A few months back, I encountered a green apple–scented hand sanitizer in a hospital where I was rotating. It was oddly addictive.

  6. So they’ve decided to let people die on the off chance some kid my get a little toasty. Sounds about right.

    1. We must do everything we possibly can, you know, for the children.

  7. Don’t the denaturants make it toxic and so more dangerous than ethyl alcohol?

    1. Given that there are people crazy enough to drink pure methanol, there’s only so much a denaturant can do to ward would-be overdoses off.

    2. Yes, exactly. It makes the alcohol “safe for children” by making sure they’ll be poisoned if they drink it.

  8. is hand sanitizer more important than bourbon anyway? use soap.

  9. “By Jove, they delivered my hand sanitizer, but what is this extra bottle that’s included in the order?”

    1. It’s a double-acting internal sanitizer. First it kills the germs in your upper digestive tract, and then it kills some of those pesky brain cells.

  10. If a physician works for the World Health Organization, are they called Dr. WHO?

    1. Peter Capaldi played a physician working for the World Health Organization in World War Z. He was credited as “W.H.O. Doctor”. Two months after the release of World War Z the BBC announced he was going to play the next Doctor Who.

  11. Matt Dogali and the distillers can tell the FDA to fuck off about their guidance documents, as it clearly states in the guidance document:
    “In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.”
    Guidance documents are not law and if the distillers can come up with a solution that complies with the law as Congress wrote it, it doesn’t matter what the FDA says.

    1. Except for the potentially ruinous cost of litigating the matter when the FDA comes after them anyway. Because, regardless of whether “guidance documents” are formally legally binding, the FDA certainly means for you to treat them as legally binding, and can get quite vicious if you don’t.

  12. I don’t understand something. It appears that the producer of the alcohol must send a product to the compounding company (who presumably mix it with an emulsion with FDA approved fragrances, emulsions and colors) as the final product. Since the guidance document says that this product must have a denaturant added by the alcohol producer or, if it doesn’t, it must be labeled as such, doesn’t this mean that the denaturant can be added at the point of compounding? If the problem is that the distiller has to operate under the fiction that it is a separate operation from the compounder, that may be an unnecessary bit of extra legal accounting and paperwork, but it doesn’t seem to be a particularly insurmountable problem.

  13. Liberals: “Companies are evil and killing children.”

    Companies: “Let’s make hand sanitizer to save children.”

    Liberals: “But…but…your sanitizer will kill children.”

    1. so does fish tank cleaner IF you are stupid enough.. or wanting to murder someone and so you pass it along to that guy you’ve been wanting to divorce.

  14. “…But in Washington, D.C., at least, anyone who wants a bottle can get one. All you have to do is buy a bottle of booze…”

    As I found out this morning, buying anything, including booze. means standing in a line for 20 minutes to get into the store and then 20 minutes in the check-out line, as the woman ahead of me had to strap a cargo net over the top of the cart to keep stuff from falling out.
    The ‘social distancing’ bullshit (thanks, grease-ball Newsom) has stores limiting shoppers to 50 people in a store of 15,000 sq ft; meaning huge delays and signalling to shoppers to buy everything they possibly can, since who knows when they’ll be able to get back in the store?
    You can certainly beat on the US gov’t, but the state and local poobahs are doing their damnedest to prove that Il Duce was not an outlier.
    And you could also beat on the PANIC!!! assholes, as represented by JFree and Hihn for promoting such bullshit.

    1. If you thought Newsom is bad the unelected public health officials in the Bay Area are worse.

      They tighten restrictions “because the firt shelter order was doin so well. But the number of infections is rising at 12%, the national average.

      When I wrote to ask for their decision criteria, I got this answer:
      “Thank you for your inquiry, the Alameda County team is working to keep and provide the latest information. please visit our Alameda County Public Health for the latest information.”
      In order words, “fuck off.”

  15. There is a stupid simple solution that is already in use on another alcohol product to keep folks from buying it for drinking purposes,

    Ever thought about “cooking wine”? All it is is normal wine, with SALT added toa sifficient level no one will drink it.
    It is already being done, but for a different purpose. Just as with chloroquine, it is already being administered and has been to humans for at least four decades and is proven medically safe, OH but we CAN”T allow someone to use it to try and treat something other than what we’ve been treating i with it for fifty years. Inconceiveable…..

    eedjits. Can ANYONE point to one section, or more, wherein FedGov are given ANY authority over anything we do or do not put into our bodies? Or even ON them? What, will they regulate hats next? Oh, wait, I’ll bet some agency already does.

    FedGov have become a cancer that is taking over the whole land Nothing but a gaggle of worthless louts with too much education, too much time on their hands, never worked (I mean, spent their time making or repairing or doing something that actually PRODUCES a benefit for SOMEONE) a day in their lives, are paid FAR too much for what little they think they do.
    Maybe one benefit coming out of this panic-demonic behaviourwill be the curtain getting pulled back on the gummit dweebs so all can finally SEE what little they accomplish and how much they cost is in so many ways.

  16. FDA delenda est.

    It’s time for anyone who can offer any good or service that might help deal with COVID-19 to go right ahead and do so, and kick the shit out of any FDA twats who show up to object. If they ever bring any charges for disobeying them, we should rely on juries to tell them to go fuck themselves sideways with a full-grown Saguaro.

    -jcr

  17. so much for ‘draining the swamp’

  18. Wife: How was your day honey?
    FDA bureaucrat: It was fine. Same old, same old. Made it harder for citizens to help each other during a pandemic.
    Wife: I love you.
    FDA: Rules are rules.
    Wife: Oh, Pepe the Landscaper needs a lawyer.
    FDA: One day we’ll have open borders. You’ll see!

  19. Iran hardest hit.

    https://tinyurl.com/we77ef5

  20. Fucking big ass government agencies that operate freely independently of Congressional oversight because Congress sucks

  21. So buy the cheapest vodka you can and add some aloe vera hand cream

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  23. Recipe for bootleg (effective) hand sanitizer:

    Go to liquor store and buy cheapest bottle of pure grain spirits alcohol, 190 proof, in my neck of the woods higher priced one was called “Everclear”. 5 days ago it was sold out, so what, even cheaper at $13 per 4/5th’s bottle was Mohawk brand, 190 proof.

    You need to dilute it down so it will be most effective, around 70% alcohol and 30% aloe vera gel.

    If you can still buy it, look for aloe vera gel at supermarkets or health food stores, add about 30% aloe vera gel, if not, try for glycerin.

    The denaturant is too hard to find, so don’t use it dentatonium benzoate, used at like 5 ppm.

    Denaturant is too keep bums and kids from drinking down your hand sanitizer, maybe put habanero pepper sauce in it ?

    For the high end version add 10 drops of lavender oil.

  24. Trump needs to go to the FDA HQ and walk around the top floor and point at people and say. “You are fired”

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