Distilleries that made hand sanitizer charged $14k surprise fee by FDA | Hacker News Reader

Distilleries that made hand sanitizer charged $14k surprise fee by FDA

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124 pointsexolymph91 comments

I wouldn't blame congress for this. Here's the CARES act: https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.p... The section begins on page 179.

It directs the FDA to set these fees to raise a certain amount... but it lets the FDA decide how they want to do that. (There are other fees set in the law, but those arent the ones the article is complaining about.) They publish these fees in the federal register, and they become effective after a short while. This is part of the normal rule making process that the executive branch is responsible for... these rules fill in the blanks in legislation passed by congress.

The FDA published these prices yesterday on Dec 29th. https://www.federalregister.gov/documents/2020/12/29/2020-28...

Theres nothing in the CARES act that requires the FDA charge distilleries.

> I wouldn't blame congress for this ... but it lets the FDA decide how they want to do that.

That's blameworthy. Congress routinely cedes what are essentially legislative powers to such agencies. It helps them dodge responsibility. IMHO it improperly transfers Article I powers to the Article II branch.

Not so much. The agencies are staffed with career professionals who are better equipped to do day-to-day and cumulative fact-finding. Congressional staff is spread thin over 535 representatives and senators and has huge turnover. I'd rather have the FAA doing line-item regulation than the Subcommittee on Aviation.

There's no reason Congress can't staff their own career professionals.

this is the general answer. Why is congress punting the "lawmaking" bureaucracy to the executive instead of it being under its own branch.

There are 2 possible reasons I see.

1) having to change the political leadership of it every 2 years (instead of 4) means it possibly wont be as effective.

2) as there is both a "lawmaking" and "enforcement" aspect to it, it makes sense for it to be under "one roof" so to speak, and it would probably be more problematic for the executive to cede that to congress than vice versa.

perhaps there are other reasons? and one can counter the above reasons?

1) Congressional leadership tends to change hands less often than presidential. 2) I'd argue that the two powers are separable. The subgroup writing the rules tends to be different from the one executing them. There's also nothing stopping these groups from consulting with one another.

is 1 really true? we have elections every 2 years for it. how many periods of time have we had no change in control of the senate or the house for 4 2 straight elections? what about fo 4 straight? vs how many times we've had dual term presidents? (serious, don't know the answer to that question, though i could probably look it up)

> is 1 really true? we have elections every 2 years for it. how many periods of time have we had no change in control of the senate or the house for 4 2 straight elections? what about fo 4 straight? vs how many times we've had dual term presidents? (serious, don't know the answer to that question, though i could probably look it up)

You can take a look here: https://en.wikipedia.org/wiki/Party_divisions_of_United_Stat.... You'll notice that the individual chambers of congress change hands less often than the presidency.

Additionally, Congress has a high incumbency rate. Even in huge swing years like 2018, the makeup of Congress remains largely the same.

Negative, agencies are staffed with career bureaucrats, who become entrenched with Federal employment protections for decades. It’s a permanent bureaucratic ruling class, with personal beliefs, philosophies, and politics. Remember, the “resistance” ? For everything Trump did, requiring the two rules be rescinded for every one rule approved, may be his greatest legacy.

I don’t think the Constitution prevents Congress from delegating precise decisionmaking to agencies of the executive branch. This seems to be a recent invention by people who want the US government to be even less effective than it is today. Because trust me, having Congressional staff micromanage regulatory agencies through a committee process is going to lead to vastly worse outcomes than what we have right now.

This isn't anything new and it's certainly not specific to this situation. It's debatable whether this is a legislative or executive function.

https://wikipedia.org/wiki/Rulemaking

The FDA first slows down the distribution of desperately needed hand sanitizer by forcing distilleries to denature the alcohol. Then it hits those trying to help with large surprise fees.

Sure glad we have those regulators protecting us from the perils of the free market and personal choice.

The free market got us methanol-laden hand sanitizer the second demand rose and the regulators looked away for a second.

Don’t mistake your broken government as an argument against government in general.

One of the primary ways to denature is by adding methanol. The free market had nothing to do with methylating the alcohol used in hand sanitizer.

The FDA does a lot of stuff that is great, but the institutional paranoia about someone, somewhere being able to recreationally consume alcohol isn't one of them.

Downthread someone has managed to cite the FDA specifically telling manufacturers not to include methanol.

To be fair, if it wasn't denatured then it wouldn't just be someone, somewhere. It would be hoards of underage kids. Heck if I use the self-checkout lane at the supermarket to buy cough medicine the attendant has to come over and approve the purchase because that's abused by underage kids as well.

That said, I won't claim to know precisely where the line should be drawn, but would say that in a sanitizing product shortage during a pandemic the line should be somewhere in the area of "hey how about we make it easier to make more sanitizing products right now"

Would it? Would it be hoards of teenage kids? Perhaps we should try to figure out why hoards of teenage kids would drink cough syrup or hand sanitizer. Perhaps the problem is that we pay to much attention to underage kids. Maybe if there wasn't an age limit, underage drinking wouldn't be so taboo. And underage drinking would not be a problem and binge drinking might go down.

I agree with everything you said, but in our society as it is right now, I still believe it would be hoards of teenage kids. Maybe it's a local problem, but there are stores near me that put cough medicine behind the counter for this reason. So you're right, there are underlying dynamics that contribute to this behavior, but the behavior does exist.

That's likely less to do with alcohol and more to do with the fact that it's pretty easy to "make" other psychoactive substances using it.

In particular, you can spin robitussin rapidly to separate the dextromethorphan.

https://erowid.org/chemicals/dxm/

Unrealistic, teenagers can still get trashed on vanilla extract from the grocery store but very few do

Maybe this reflects a lot more on the environment & social circle I grew up in? In that context though:

I think if the alcoholic nature of extracts were more widely known to teenagers, more would take advantage. But it also doesn't come in a convenient "party" format. If you could walk into Walmart, buy a half-gallon of sanitizer for $10 (well, pre-covid you could get those sizes for cheap, now not so much) and mix it with a gallon of fruit punch, then you've basically got the ingredients for a typical small 4-8 person Everclear & Fruitpunch highschool basement party without the hassle of tracking down that >= 21 friend.

An accident vs the government purposely poisoning American’s alcohol: https://slate.com/technology/2010/02/the-little-told-story-o...

The FDA forced distilleries to add methanol to the hand sanitiser, despite that causing significantly higher costs and delays.

I'm not sure you could have have this story more backwards.

I don't think this is correct. While it's accurate that the FDA requires industrial alcohol to be denatured, they specifically said "methanol cannot safely be used as an ingredient, or as a denaturant, in hand sanitizer"[1]. A few alternative alcohols are allowed to be used as denaturants under the emergency sanitizer guidance instead, e.g. isopropyl, tert-butyl. I don't think those are safe to drink, but I think they are safe for skin unlike methyl.

[1] https://www.fda.gov/media/136118/download

I replied in haste, and was incorrect. Mea culpa.

Having bought multiple hand sanitizers made by distilleries, I can report all of them used isopropyl, not methanol -- which certainly suggests the FDA did not require them to use methanol. And, someone else replied to you with the chapter and verse from the FDA explicitly saying the opposite of what you are.

Somebody may have this story backwards, but I don't think it's the person you're replying to. Where did you get your information?

I said nothing of the FDA or the US.

I'm in Canada. Health Canada not only did not require methanol to be added to sanitizers, it explicitly forbids it and forced recalls on many products that manufacturers tried to sell containing it.

> Don’t mistake your broken government as an argument against government in general.

I'm sure you would have taken a free market, non-FDA approved vaccine as well.

If you died of the unregulated vaccine then the market would correct the situation by incentivizing grieving families to choose a more reliable vaccine from a competitor.

I really wonder if I'm getting downvoted by free-market enthusiasts, the poor attempt at humor, or because it wasn't completely clear it was meant in sarcasm. Or maybe all three? I don't really care about internet points, but I'm always curious about such things.

I wasn’t sure it was sarcasm to be honest! I’ve seen more insane comments on HN posted with 100% seriousness and conviction.

I tried to keep it right on the edge... I find that provokes more critical thought than letting people "off the hook" with a more obvious comment they can automatically agree/disagree with. It's easy to dismiss examples as "absurd" when a concept is taken to its logical conclusion. It's the ones that walk right up to the edge, to the gray area boundaries of someone's conceptual framework, that make them consider what those boundaries are or should be.

Your comment is the same superficial “hey I’m just asking questions!” deflection that a lot of lazy intellectualism resorts to. “Maybe eugenics is a good idea because we can create a biologically superior human, we should at least discuss it!”

Considering it's a form of economics that a sizeable portion of HN think is best, it is not at all equivalent to randomly bringing up a topic that has long been held by most of society to be a bad idea and saying "just asking the question!".

It is broaching the topic in a way that doesn't automatically get upvoted by people who agree with it, or automatically downvoted by those who disagree.

I also wasn't asking a question. I was giving an actual example of the consequences of the economic system many HN'ers believe in.

No, his post require thought, which is not immediately obvious. Thus it gets ignored or dv.

It's just a reaction to the free market magical chimp thinking out there.

as another aside, this seems to be a problem with modern discourse in general. In multiple arenas I see pendulums swinging so far to one side or another that what might have been seen as satire or parody not long ago now has to be considered as someone's serious commentary on a topic.

Pendulums can't keep swinging further & further without destabilizing the entire fulcrum & structure. To stretch the metaphor further, I hope as they're on the down stroke this time around we can put a little bit of equal & opposite force against their inertia.

People post comments like yours and mean it, so sarcasm like that does not work in many places on the internet.

So yeah I'd guess that the reason is mainly 1 and 3.

Do people post comments worded that way and mean it?

"incentivizing grieving families"

It's usually dehumanized into something like "the market will adjust its behavior to reward manufacturers of higher quality products"

I did not try to say that it's impossible to identify the sarcastic nature of the comment, of course :)

You could add a /sarcasm to it for clarity, instead of posting a follow up comment

I think /sarcasm takes something away from it. If I put that there, people don't have to actually think about the comment and what I meant, or their own reaction to it. Using /s tells them automatically, and allows a reflexive response for/against the comment that short-circuits actually thinking about it. I'll risk the downvotes, they don't bother me.

But I am curious about why people downvote, hence my follow up. Clearly some people will downvote a thing they disagree with, or is flame bait. But will they downvote a thing they might agree with, but it also worded as flame bait? That sort of thing. I really am curious about the various behavioral patterns involved in awarding internet points.

/sarcasm is needed on the internet. Not everyone is a native English speaker, and even those who are have very different ideas around humor and written verbal queues.

Good points! I'll keep that in mind in what I hope is already a relatively cautious approach to that sort of comment. On the other hand, ditching all/most idiomatic English and subtleties is probably not the right approach either, or avoiding all cultural references because others might not understand-- I don't think you're suggesting that, it's just my observation that this issue exists on a spectrum and not a binary.

Edit: You're in AI-- what's the landscape look like for improving automated translation to detect sarcasm? As a problem domain, it seems like it would be a subset/cross-section of sentiment analysis & word-sense-disambiguation.

These days the biggest issue is getting a decent labelled dataset.

Once you have that you just fine-tune a BERT-dervived transformer neural network.

See https://paperswithcode.com/task/sarcasm-detection/codeless for some examples and datasets.

I think it's remarkable that the FDA issued this non-binding guidance on hand sanitizer manufacturers, in March of 2020:

"In response to the demand for alcohol-based sanitizers, certain entities that are not currently regulated by FDA as drug manufacturers have requested guidance on the preparation and distribution of hand sanitizer products for the public’s use."

"Because of the public health emergency posed by COVID-19, FDA does not intend to take action against firms [9] that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs [10] for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020, provided the following circumstances are present:"

"[9] Specifically, FDA does not intend to take action against firms, for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020, including any renewals made by the Secretary in accordance with section 319(a)(2) of the PHS Act (42 U.S.C. 247d(a)(2)), for violations of sections 501(a)(2)(B), 502(f)(1), 505, or 582 of the FD&C Act (21 U.S.C. 351(a)(2)(B), 352(f)(1), 355, and 360eee-1), provided circumstances described in this guidance are present. These circumstances include (but are not limited to) preparation of hand sanitizer products using only the ingredients and formulas set forth in this guidance. FDA plans to continue to sample hand sanitizer products at the border and in distribution in the U.S. for quality issues, including potential contamination and impurity levels."

https://www.fda.gov/regulatory-information/search-fda-guidan...

The most insidious part of mega bills is the surprises that get snuck into them that I'd like to believe would have been adequately thought about and debated if someone actually had a chance to read them. The article suggests the CARES act itself is to blame and the 14k charges are "fees on these facilities to fund the FDA's regulatory activities". It wasn't meant to attack distillers but that didn't stop them from getting swept up in a provision that didn't belong in this bill in the first place.

How is a logical person supposed to reconcile a bill that was meant to help the country deal with an emergency is actually penalizing the companies that stepped up to help and charging them for the extra red tape?

If Biden stops this nonsense, then he might become a good president. But wouldn't put my money on it.

Presidential orders are powerful but cannot override Congress. Not much Biden can do without Mitch's approval.

If it’s an executive agency discretion thing then Biden will waive it. Check back in a couple months, they’ll do it quietly.

And they've reversed it....

“Small businesses who stepped up to fight COVID-19 should be applauded by their government, not taxed for doing so. I’m pleased to announce we have directed FDA to cease enforcement of these arbitrary, surprise user fees. Happy New Year, distilleries, and cheers to you for helping keep us safe!” an HHS spokesman said in a statement provided to The Hill.

https://thehill.com/homenews/administration/532271-fda-hits-...

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Yes he is.

Congress encompasses both the House of Representatives, and the Senate, of which Mitch McConnell is a Senator.

what... Mitch McConnell is the Majority Leader of the Senate, one of the two bodies of representatives that makes up the Congress; he is also one of the two senators from Kentucky (and recently reelected)

[0] https://en.wikipedia.org/wiki/Party_leaders_of_the_United_St... [1]https://en.wikipedia.org/wiki/Mitch_McConnell

> If Biden stops this nonsense

Can he do it on his own? It's it Mcconnell who is rushing these bills through to avoid close scrutiny?

Veto everything that's not sufficiently limited in scope? And say so in advance.

Many presidents have tried such things. Non have really succeeded. It is political suicide to veto a giant spending bill over most forms of pork.

If many have tried, did none of them learn from their predecessors? Or why did anyone after the first guy try it again if it was so obviously political suicide?

Edit: Ugh, sorry, I know what I just said is a fallacy. I just want to believe that making systemic improvements — getting Congress to operate on a better rule set — would be the thing which gets a person re-elected.

It seems bullying, lying, bribes, hookers and conspiracy theories is the bling today!

Then nothing gets done because you need majorities to override presidential vetos and the GOP gets to call you an obstructionist to rile up it's base for the next couple elections.

I agree with what you're saying, but even without a bunch of riders there are bills that become laws and parts of those laws eventually get struck down by the court system through litigation/challenges.

I don't know enough about this provision, but if a large enough distillery (of which I know many who have deep pockets) decides to fight the charge on behalf of other smaller distilleries, it could get struck down.

A large distillery might be happy that small competitors suffer death by regulation and thus do nothing to oppose this regulatory action.

Response from distilleries should read as follows:

Dear FDA: We make alcohol legally. During the pandemic, we continued to make alcohol. We don't ask customers what sorts of cocktails they make when they buy it, but it now seems fashionable to include hand saturation of the product in the standard repertoire of mixologists and mixology enthusiasts. Aparantly a popular name for this cocktail is The Sanitizer. This does not reflect a change in our business model of making and selling alcohol. #crazycustomers #leavemealone

Unfortunately 80 proof vodka doesn’t do the job, they’d have to sell ethanol rectified well above 120 proof to leave some room for aloe.

120 is considered the minimum by the CDC, so that should be fine. Cask-strength whiskey, before watering down to (usually) 80 proof, is often in the 120 to 130 range anyway. (Elijah Craig has a cask-strength that clocks in around 133, but it of course depends on the batch) But I've also toured some micro-distilleries and by asking questions, it seems that distilling up around 180 proof is a pretty trivial tweaking of the equipment (combined with carful fire-safety protocols).

190 is about the highest you can get because water and alcohol form an azeotrope. To get to 200 proof you need either benzene or huge pressure swings added into the mix.

As long as you need to be 21 to buy it, and it’s taxed like alcohol, the that wouldn’t be a problem at all!

In a sensible world the FDA simply says "we're going to waive these fees this year and last".

It seems likely that's exactly what will happen.

They seem to have just announced these fees... why would they then not charge them instead of just not creating them?

Given sufficient blowback this published rule will be changed.

As was easily predicted: the fees have been waived.

https://twitter.com/josh_wingrove/status/1344783964926578689

Good. I would love to see the rationale for the fee.

I don't think there was a rationale for the fee. The FDA collects fees from OTC drug manufacturers (who operate under a standard "monograph" recipe that outlines their doses and formulations); those fees fund the FDA monograph programs. That makes economic sense! I don't think people anticipated distilleries becoming OTC drug manufacturers by dint of producing hand sanitizer.

Ignoring the silliness of this fee, wasn't regular soap more effective and always widely available? Was there any real reason to make emergency sanitizer?

There are situations where a sink and soap are not always readily available. Like... in my car after a trip to the store. Out in public, and you just touched a few too many shared use things like handrails. Pull out the bottle. Demand for this flexibility and hand cleansing has skyrocketed.

Sanitizer is much more convenient if you don't have access to a sink. Also, stores did run out of soap due to panic buying.

I'm glad whenever we stock up in prep for a hurricane we aren't accused of panic buying. Maybe that's still to come.

I prefer the German "Hamsterkauf" (lit. "hamster buying") which feels a lot less judgy

Both regular hand washing and hand sanitizer are effective. Each can be used in different places, which makes them both useful. For example, I sanitize my hands in the car after going to the grocery store. Hard to make soap and water work for that case.

The way I heard it, sanitizer seems to work (and is usable anywhere), but soap followed by running water has an advantage in not only breaking up the fatty layer protecting a coronavirus, but also sweeping it off your skin.

SARS-CoV-2 needs that outer shell to be able to infect you.

Lab tests have found that even when hand sanitizer is diluted well below recommended levels of concentration, it's still very effective at inactivating SARS-CoV-2: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7431409/

It's a relatively fragile virus. Fact is, there's very little evidence of COVID-19 spreading via surfaces, so hand hygiene and surface cleaning probably makes little if any difference: https://www.thelancet.com/journals/laninf/article/PIIS1473-3...

With some diseases surfaces certainly can be a common source of infection. But COVID-19 doesn't appear to be one of them.

Sanitizer is always first choice in hospital settings. It’s MUCH faster, and MUCH easier on the skin over repeated use than soap and water.

Hand Sanitizer, with alcohol, is far more damaging to your skin than soap.

Regular soap was hard to find near me, though I was near a hotspot.

I wasn't in a hotspot and hand soap has been hard to get all year.

Supplies sometimes were lower than usual but there has consistently been enough on hand to meet our needs - in my case unscented.

"No good deed goes unpunished."

Sorry, that phrase has been used in a song. Legal council from the RIAA will be in contact shortly with a proposal for a reasonable settlement for you infringement.

As i've said many times, expecting the government to be anything other than a hinderance is such emperically false assumption.

Here's where those beautiful taxes everyone hopes will help end up hurting industries that are trying to satisfy the market and keep themselves afloat.

What exactly does the public get for this fee, are they retroactively checking all the hand santitizer produced, that seems unlikely, or rather is this just a system built to extract wealth and doing so as effectively as possible?

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