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

https://reason.com/2020/12/30/when-there-wasnt-enough-hand-sanitizer-distilleries-stepped-up-now-theyre-facing-14060-fda-fees/

by exolymph • 6 years ago

124 90 6 years ago

reason.com

dsukhin• 6 years ago

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?

sharken• 6 years ago

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

bryanlarsen• 6 years ago

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

cptskippy2• 6 years ago

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?

epmaybe• 6 years ago

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.

ArchD• 6 years ago

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

valuearb• 6 years ago

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.

nucleardog2• 6 years ago

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.

jaggederest• 6 years ago

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.

Lazare2• 6 years ago

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.

casefields• 6 years ago

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

starpilot• 6 years ago

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

ineedasername15• 6 years ago

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.

hooloovoo_zoo• 6 years ago

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?

compiler-guy2• 6 years ago

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.

erik_seaberg2• 6 years ago

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.

csours• 6 years ago

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.

WarOnPrivacy2• 6 years ago

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.

ImprovedSilence• 6 years ago

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.

gayprogrammer• 6 years ago

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.

Alupis2• 6 years ago

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

ineedasername15• 6 years ago

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

lostapathy• 6 years ago

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

rgbrenner• 6 years ago

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.

hirundo• 6 years ago

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.

tptacek5• 6 years ago

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.

matthewdgreen• 6 years ago

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.

bavell• 6 years ago

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

ineedasername15• 6 years ago

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

erik_seaberg2• 6 years ago

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.

ineedasername15• 6 years ago

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).

zaroth2• 6 years ago

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!

stickfigure• 6 years ago

"No good deed goes unpunished."

ineedasername15• 6 years ago

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.

rkagerer• 6 years ago

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

tptacek5• 6 years ago

It seems likely that's exactly what will happen.

dwighttk2• 6 years ago

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

perihelions• 6 years ago

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...

Guthur• 6 years ago

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?

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

Related Stories