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Distilleries that made hand sanitizer charged $14k surprise fee by FDA
- dsukhin 6y agoThe 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 6y agoIf Biden stops this nonsense, then he might become a good president. But wouldn't put my money on it.
- bryanlarsen 6y agoPresidential orders are powerful but cannot override Congress. Not much Biden can do without Mitch's approval.
- jhfdbkofdcho 6y agoIf it’s an executive agency discretion thing then Biden will waive it. Check back in a couple months, they’ll do it quietly.
- jhfdbkofdcho 6y agoAnd 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-distilleries-that-made-hand-sanitizer-with-surprise-14k-fee https://thehill.com/homenews/administration/532271-fda-hits-...
- miked85 6y agodeleted
- darkwizard42 6y agowhat... 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_States_Senate https://en.wikipedia.org/wiki/Party_leaders_of_the_United_St... [1]https://en.wikipedia.org/wiki/Mitch_McConnell https://en.wikipedia.org/wiki/Mitch_McConnell
- Alupis 6y agoYes he is. Congress encompasses both the House of Representatives, and the Senate, of which Mitch McConnell is a Senator.
- cptskippy 6y 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?
- the8472 6y agoVeto everything that's not sufficiently limited in scope? And say so in advance.
- compiler-guy 6y agoMany presidents have tried such things. Non have really succeeded. It is political suicide to veto a giant spending bill over most forms of pork.
- wallacoloo 6y agoIf 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.
- loopz 6y agoIt seems bullying, lying, bribes, hookers and conspiracy theories is the bling today!
- cptskippy 6y agoThen 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.
- epmaybe 6y agoI 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 6y agoA large distillery might be happy that small competitors suffer death by regulation and thus do nothing to oppose this regulatory action.
- valuearb 6y agoThe 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.
- nucleardog 6y agoThe 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 6y agoOne 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.
- ineedasername 6y agoTo 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"
- chrismcb 6y agoWould 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.
- deleted 6y ago[deleted]
- hooloovoo_zoo 6y agoIgnoring 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-guy 6y agoBoth 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_seaberg 6y agoThe 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.
- petertodd 6y agoSARS-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/ 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/PIIS1473-3099(20)30678-2/fulltext 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.
- csours 6y agoSanitizer is much more convenient if you don't have access to a sink. Also, stores did run out of soap due to panic buying.
- rgbrenner 6y agoI wouldn't blame congress for this. Here's the CARES act: https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf 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/2020/12/29/2020-28714/fee-rates-under-the-over-the-counter-monograph-drug-user-fee-program-for-fiscal-year-2021 https://www.federalregister.gov/documents/2020/12/29/2020-28... Theres nothing in the CARES act that requires the FDA charge distilleries.
- hirundo 6y 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.
- tptacek 6y agoNot 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.
- biggermike 6y agoThere's no reason Congress can't staff their own career professionals.
- 6y ago
- ineedasername 6y agoResponse 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_seaberg 6y agoUnfortunately 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.
- ineedasername 6y ago120 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).
- wombatpm 6y ago190 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.
- zaroth 6y agoAs 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!
- stevespang 6y agoProves again that "no good deed goes unpunished"
- stickfigure 6y ago"No good deed goes unpunished."
- ineedasername 6y agoSorry, 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.
- beamatronic 6y agoBetter yet Section 230 will be repealed and dang will get sued
- rkagerer 6y agoIn a sensible world the FDA simply says "we're going to waive these fees this year and last".
- tptacek 6y agoIt seems likely that's exactly what will happen.
- dwighttk 6y agoThey seem to have just announced these fees... why would they then not charge them instead of just not creating them?
- zaroth 6y agoGiven sufficient blowback this published rule will be changed.
- tptacek 6y agoAs was easily predicted: the fees have been waived. https://twitter.com/josh_wingrove/status/1344783964926578689 https://twitter.com/josh_wingrove/status/1344783964926578689
- dwighttk 6y agoGood. I would love to see the rationale for the fee.
- tptacek 6y agoI 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.
- perihelions 6y agoI 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-guidance-documents/guidance-industry-temporary-policy-preparation-certain-alcohol-based-hand-sanitizer-products-during https://www.fda.gov/regulatory-information/search-fda-guidan...
- Guthur 6y agoAs 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?