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FDA Denies Authorization to Market JUUL Products (fda.gov)
62 points by kdamica 9 days ago | hide | past | favorite | 97 comments





Yesterday:

FDA to order Juul e-cigarettes off U.S. market(wsj.com)

https://news.ycombinator.com/item?id=31835843

Submitted by kgwgk | 389 points | 662 comments


I don't think this was a good merge, as this is the full official statement. The original post should at least be re-upped, as it's currently not on the front page.

Yeah the first article reports that the FDA "is preparing" to order Juul take its e-cigarettes off market, "according to people familiar with the matter."

This article is the FDA doing that.


Yeah, I wonder if we can get these threads merged.

Monoamine oxidase inhibitors (MAOIs) in tobacco smoke increase the effectiveness and addictiveness of nicotine, which practically means tobacco is dramatically more addictive than nicotine alone [0]. By switching to an alternative that contains nicotine while keeping physical sensations essentially unchanged, tobacco users can remove MAOIs from their system and then focus on the behavior (hand fiddling, inhaling) and chemical addiction (gradually reduce dosage) separately.

Beyond that, vaping is so obviously safer than smoking. It strikes me as profoundly hypocritical to ban the less dangerous alternative, while keeping the unbelievably deadly cigarettes on the market.

[0]: https://www.jneurosci.org/content/25/38/8593


This is frustrating for smokers who jumped to the vaping lesser evil. Vaping did help a lot of people wean their habit to a halt. It's clearly a much better alternative to cigs. Imho FDA is pushing it by doing this, we all know what dirty shenanigans FDA is up to, I'm inclined to believe it's a move meant to make some competitor a lot of money under the guise of caring for people's health.

I quit smoking cigarettes ten years ago and only because I switched to vaping. If they banned it I'd go back to tobacco. In an ideal world I'd do neither, but I've been doing it for so long and I just get a lot of satisfaction out of it that's hard to replace. If we want to discuss banning things that are unhealthy, destructive, or unsightly; there's a very long list of things we should tackle first. There's a nickel plant next to my house that's been fined about 8 times in the past few years for excessive emissions and that's just an example within a mile of where I live. Don't even get me started on phthalates or plastics.

I think it's the opposite: Vaping is keeping people who want to quit smoking addicted to nicotine.

For most people I know the problem aren't the physical effects of addiction (those are over in a few weeks) but the peer pressure from all your friends who are still smoking.

Since they banned smoking in bars and restaurants in Austria, I saw A LOT of people quit smoking. It's really not that hard when everybody looks at you in disgust when you suck on your cigarette outside a bar.

If you offer vaping as a socially acceptable form of smoking, these people have a lot less incentive to give up nicotine, and will stick with it.

So I think that vaping is slowing the decline of nicotine, and it absolutely should be banned. (At some point cigarettes should probably be banned as well, but it's probably too early for that)


Nicotine doesn't kill you. It doesn't make everything you own smell like burnt asshole. It doesn't make you cough up black goo when you lay on an inversion table or gasp for breath after a flight of stairs. Vaping is the greatest weapon ever created in the fight against smoking-related health damage.

You make the assumption that people who vape would smoke if they couldn't vape. If vaping was the only way to quit smoking I would agree with you.

But when I look around me, I see that a lot of people have managed to quit smoking without vaping.

Marketing vaping as a way to give up smoking is very disingenious, because you are just trading one addiction for another.

I know that you can give up smoking without starting another addiction. I did it, my girlfriend did it, my sisters did it, my best friend from high school did it. It took a few attempts, but we all managed to kick the habit. All of us used to smoke a pack a day, and now we're free.

Juul was a last ditch attempt by tobacco companies to keep everyone addicted so they keep paying their idiot tax for their daily dose of nicotine. I'm glad someone is doing something against it.


You make the assumption that people who vape would smoke if they couldn't vape.

No, I'm saying that enough people have switched from smoking to vaping to more than make up for the health damage caused by people who only started vaping.


Yes, but what I'm saying is that most of the people who switched to vaping would have given up smoking altogether if they couldn't vape.

Now they’ll have to quit completely. They’ll live.

huh? Did I misunderstand or did they ban cigarettes too?

Unsurprisingly, this is out of touch. Juul has been dead among teenagers for years, basically immediately after the FDA banned flavors. Its now been replaced by, as far as I can tell, completely unregulated disposable e-cigarettes which have been growing in price, size, and strength. Ask your interns when the last time they saw a Juul at their college was.

Also why don't FDA just pull cigarettes off the market if they can do something like this?

Because the FDA wants the public to support big tobacco. I realize this sounds sarcastic, but how could anyone possibly refute?

Juul is 35% owned by Altria aka Philip Morris.

That’s just basic diversification. Tobacco is still king for them.

Why does the FDA have the authority to do this ? They'd save more lives by removing all Mc Donald's from the market.

Same thing with the DEA telling me what substances I can consume.

Now instead of having a legal option, your encouraging underground, unregulated options.

How about this, slap a big label on everything from fattening foods to recreational drugs, with " This will fucking kill you, here for a good time not a long time".

Then either raise the enlistment age to 21 or drop the age of consumption to 18.

It's pretty fucking absurd you can enlist at 18 ,but can't consume recreational substances until 21.


Because the cigarette lobby is pretty strong.

But you can still buy tobacco cigarettes? How does this make any sense?

What if we start seeing teens go back to smoking cigarettes now?


Teens were already starkly dropping in picking up smoking. JUUL ended up having the opposite effect and wiping out decades worth of reductions.

Only if you consider vaping equal to smoking, which it is certainly not.

Also why is "teenagers did something" a good reason to restrict my freedom? I don't vape but teenagers also do dumb things with alcohol so I don't see how that is legal using that line of logic.

> Also why is "teenagers did something" a good reason to restrict my freedom? I don't vape but teenagers also do dumb things with alcohol so I don't see how that is legal using that line of logic.

It really depends on context and a lot of opinion and judgement where people can disagree. It's not some mechanical logic thing.

Also (at least in the US) it's actually illegal for teenagers possess or consume alcohol.


How about a simple compromise - ban all tobacco and vape marketing?

You want to smoke? Vape? Fine. But let's not create a profit motive for anyone to actively work on getting people addicted to this shit.


Because nobody thinks drinking is the same as smoking. Asking why some rules are the way they are is a fantastic idea, but consider asking more interesting questions than "Why is X not like Y". Especially when the answer is just that they are different.

Smoking bans is not about "doing something" or "doing dumb things", and if you abstract them up to that level in order to compare them you'll lose all fidelity in your question.


The short answer is that when teenagers drink alcohol, the majority don't become habitual heavy drinkers. Smoking in high school is a very strong predictor for life-long smoking, especially for heavy smoking.

(The refrain about "freedom" is a matter of settled law, as far as I'm concerned.)


I'd be ok with JUULs available via a prescription or some means of controlling access besides relying on a gas station clerk to ward off fake IDs from a mob of children.

Edit: I used the word prescription perhaps incorrectly. I believe something like a dispensary would work too. Just a higher standard than a gas station clerk.


That again holds a lower standard for alcohol, a far more dangerous drug. You want to get a prescription for a bottle of wine?

Alcohol is basically legal due to tradition.

If you were starting a fresh-slate society, with no history and all the knowledge/technology we have today, you'd probably ban alcohol and legalize marijuana.


Yet basically 100% of the societies started post agricultural revolution made alcohol central to their cultures. If it were such a no brainer you’d think that somewhere in the last 10,000 years a society would have found alcohol-free optimality, instead attempts at prohibition have mostly proven ruinous.

The fact is that alcohol provides a huge number of social benefits to a huge number of people and it outweighs the harms. I’d probably prefer a cannabis-dominant culture myself, but it’s not for everyone.


> Yet basically 100% of the societies started post agricultural revolution made alcohol central to their cultures.

Yes, but because it provides a safer drinking supply.

We've got water purification plants now.


Tobacco use in America predates the United States. It was probably in use before alcohol.

Also since when is "it's tradition" a defense for nonsensical public health policy?


An important point here is that traditional use of nicotiana rustica was more far more widespread than nicotiana tabacum. This was a much more potent (higher concentration of nicotine), and people would smoke less and less frequently.

The other recent announcement from the administration is to reduce the amount of nicotine in cigarettes which a lot of harm reduction specialists are concerned will result in more smoking rather than less.


> Also since when is "it's tradition" a defense for nonsensical public health policy?

It doesn't make for good public health policy, but as the pandemic made quite clear, the general population gets a pretty big say in it. People get pretty grumpy when you go against traditions, even for a good reason.


Even if I agreed (I don’t), this is a solved problem with the dispensary model that weed uses. Requiring a prescription is absurd.

Yes because people don’t smoke weed and drink alcohol if they are underage. There is also no means to get weed cheaper illegally in states where it is legal

That sounds acceptable. I'd be ok with JUULs hidden behind a dispensary.

There's decent evidence that teens who start vaping are much more likely to take up tobacco later on:

https://jamanetwork.com/journals/jamanetworkopen/fullarticle...


Obviously, but if they're adults they're free to make that choice. 140,000 people die of excessive alcohol use in the US every year. This doesn't include violence, drunk driving deaths, or other deaths or crimes committed from alcohol use. I don't drink, but I don't think banning it is the solution, although it wouldn't affect me personally.

Can we agree that no vaping is a better option than vaping from a public health standpoint?

Edit: I'll also add that JUUL didn't reducing smoking in teens. Smoking was already on the way out. It was conquered culturally in the US, but JUUL et all has brought at all back.


It’s complicated, because of the two-way relationship with cigarettes. If cigarettes were not anywhere in the picture, sure, but that’s not the real world.

It's not that complicated though. You're thinking JUUL replaces cigarettes but many of the teens that would have never picked up smoking ended up smoking JUULs in droves. Especially teen girls who enjoy the feminine designs and flavors that are marketed directly to them.

Yes, and can we agree that not eating sugar is better than eating sugar? I think we all can.

I would gladly support a major/complete reduction in added sugar to our food system. It would make life a lot easier than having to read labels.

Nicotine is a systemic toxin. I don’t think there’s really an ethical high ground to being pro-vape and anti-tobacco. It’s all bad.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4363846/


Nicotine is being used as a treatment for cognitive decline and dementia. One example of a large on-going study:

https://www.alzheimers.gov/clinical-trials/memory-improvemen...

In the end we don’t really know if it makes more sense to be in favour of vape prohibition than alcohol prohibition. But pretending that vaping is in the same category as smoking in terms of potential harms is ignorant.


Kids aren’t using nicotine to treat dementia — am I missing something?

I was simply pointing out that your absolute statement that it’s “a systemic toxin” has holes in it since there are valid medical uses.

I wasn’t claiming that nicotine use is appropriate for kids, although there are likely medical uses of small doses to provide sensory gating, and it’s also not at all uncommon for wizened psych nurses to tacitly encourage schizophrenics to smoke/vape since it can provide such a rapid self-administered de-escalation of symptoms. In cases like that and many which are less dramatic than full blown schizophrenia, it’s definitely preferable that vapes are more or as accessible than cigarettes.

More to the point, most people use some sort of psychoactive drugs from time to time as methods of changing state or mood, and all have preferences for some over others. All too often we assume that other neurotypes don’t exist and that everyone else should be fine with our own preferred mixes of caffeine, alcohol, cannabis, research chemicals, plant medicines, etc.. Recognizing that if your own preferences are valid, that it’s likely others are too is a good forward step, and it’s arguable that vapes are less addictive and far less harmful than smoking, and are a win from a harm reduction perspective.

We made a huge shift as a society from nicotine-dominant workforces to caffeine-dominant workforces. There’s no indication that the availability of vaping products is reversing that secular trend in any meaningful way.


That’s a lot of text to try and convince me that the most addictive substance on earth is anything but awful for society as a whole.

Edit: Removing some snark, you’re arguing for some therapeutic benefit to nicotine.

So surely you’d be for a blanket ban on the sale of all nicotine products with the exception of a highly regulated prescription market and subsequent labeling of nicotine as a controlled substance, right?


> That’s a lot of text to try and convince me

I type and think fast, sorry. I’m also not trying to convince you as much as provide counters to bad arguments. You’re right to speak is important to me, but I’m practising harm reduction.

> surely you’d be for a blanket ban on the sale of all nicotine products

No. Age restrictions or sin taxes are one thing given the negative externalities, but if someone prefers a light vaping habit over a Frappuccino habit it’s not up to me to push them onto the black market.

Prohibition very often leads to worse outcomes.


All bad does not mean equally bad.

Yes, I suppose an ounce of Draino is better to drink than a gallon.

I can’t believe my original comment is being downvoted; I enjoy nicotine. I spent most of my early 20s smoking.

It’s pure fantasy and intellectual dishonesty to label vaping as a healthier alternative to smoking. Either way you’re a slave to nicotine. Acknowledge it and be okay with it and the adverse health effects likely to strike you — heart disease, high blood pressure, stroke, kidney disease — or quit.

But don’t lie to yourself that there’s any modicum of an argument to be made about healthy alternatives.


>I can’t believe my original comment is being downvoted

I didn't downvote you, so I don't know, but if I were to hazard a guess as to why it's being downvoted it's the absolutist stance you are taking. Like most things in life, healthiness is a spectrum and your refusal to acknowledge that is frustrating.

>It’s pure fantasy and intellectual dishonesty to label vaping as a healthier alternative to smoking.

The current medical understanding disagrees. A few chemicals inhaled is better than a few thousand chemicals. John Hopkins Medicine, for example, explicitly agrees that vaping is less harmful than smoking [1], but both are still obviously worse than not inhaling anything and if you have the willpower to drop nicotine all-together, that is very obviously the best choice.

>Blaha says “There’s almost no doubt that vaping exposes you to fewer toxic chemicals than smoking traditional cigarettes.” [1]

https://www.hopkinsmedicine.org/health/wellness-and-preventi....


You know instead of defending a toxic chemical on a message board you can just quit, right?

The only dog I have in this fight is what you have graciously pointed out — that the “very obviously best choice” is to quit nicotine altogether.

Kowtowing to nicotine pundits about health benefits of a toxic chemical ends with generations of adults slaves to said chemical, early deaths and ruined lives. I don’t do it and you shouldn’t either.


>You know instead of defending a toxic chemical on a message board you can just quit, right?

Lol. I don't vape or smoke, what a weird assumption to make solely because I pointed out that something can be healthier without being healthy.

For someone without a dog in this, you sure seem awfully eager here and elsewhere in the thread.


Ah, the only thing more addictive than nicotine — online pedantry.

I just said I do have a dog in this fight. You should too, it’s a major public health issue. Congrats on not smoking! Hope you keep it that way and encourage others to follow in your footsteps.


Atleast vaping is free from the toxic mix of combustion from smoking. So atleast part of the risk of smoking is reduced in vaping.

Nicotine has it uses and benefits.

The abuse of that or the "cigarretization" is the problem.

One thing is to get real organic tabbaco and smoke in small quantities not inhalling only getting nicotine thru gum lininings.

About the benefits in cognition [1][4] alzheimers and parkinson [2], helping with covid [3] and even testosterone [5]

Cigarretes + additives are very bad you can see the difference here [6].

Is tobbaco bad? yes. Is nicotine bad maybe.

Is cigarrete bad? Yes very

Is Cigar bad? Yes but not as cigarrete.

TlDr -> Go for pure nicotine or cigars if you need neuroprotection.

[1] - https://pubmed.ncbi.nlm.nih.gov/1579636/

[2] - https://pubmed.ncbi.nlm.nih.gov/1859921/

[3] - https://openres.ersjournals.com/content/7/2/00713-2020

[4] - https://pubmed.ncbi.nlm.nih.gov/9006184/

[5] - https://pubmed.ncbi.nlm.nih.gov/24457405/

[6] - https://pubmed.ncbi.nlm.nih.gov/29459935/



Juul didn’t lobby hard enough to achieve the same political clout.

> Juul didn’t lobby hard enough to achieve the same political clout.

Eh, probably not. The real situation is probably that they were late, and tobacco cigarettes were established before society got hostile to nicotine products.


If you want to avoid that, you probably should do something about Juul marketing their products to teenagers.

Smoking rates have been steadily dropping over years and decades, but there's recently been an explosion in teen vaping.


It amazes me how many people think marketing is the reason that teenagers use any type of drug. Weed has just become legal in the past couple of decades and wasn’t marketed. I assure you that teenagers have been smoking it before then.

> It amazes me how many people think marketing is the reason that teenagers use any type of drug.

If marketing doesn't do anything, why was Juul marketing to them? (Bonus points: Why is anyone marketing anything to anyone?)

And if it did nothing, then surely banning it would not hurt Juul in the slightest?


I know it's not the point you are trying to make, but whether or not marketing actually does anything isn't a settled question. When company A does marketing and company B doesn't in the same industry, it seems to have some effect, but when neither company does marketing sales don't necessarily go down.

Fun fact, the cigarette companies lobbied the government to ban cigarette advertising. That way, none of them would be able to market and get ahead of the others while all of them would save money on the marketing that was no longer needed. A corresponding drop in sales did not occur.


And if marketing is required for teenagers to smoke, why is weed so prevalent?

My frustration with vaping is that it's seen as "not smoking", to the point where I had a guy sitting in front of me on an airplane vaping in flight and nobody really cared.

Sitting in a cloud of someone's exhaust is really just as gross to me as sitting in a cloud of someone's smoke but it's just not nearly as obvious by smell.


> to the point where I had a guy sitting in front of me on an airplane vaping in flight and nobody really cared

For what it's worth (unless you're balling out in a private flight), that's highly illegal and a federal offense in the USA [1]. Not sure if you're in another country, but I do question the legitimacy of that comment if in the US. None the less, I do agree vaping is gross/annoying.

[1] https://www.faa.gov/newsroom/vapes-plane


Airlines and the FAA have way bigger problems than obnoxious vapers. In practice, you have to behave very poorly to merit any sort of serious response:

https://www.faa.gov/newsroom/faa-levies-161823-against-eight...

They even have a small ad campaign to celebrate their leniency: "You could have spent $35k on a brand new truck, but instead you are paying a fine because you punched a flight attendant":

https://www.faa.gov/data_research/passengers_cargo/unruly_pa...


I was in business class on a United flight over the US. I was pretty sure the cabin crew was aware and my partner didn't want me to make a fuss over it.

Every flight I've ever been on in the US indicates that vaping is not allowed on-board. That's quite strange.

yeah, it's a federal crime in the US lol

Not to be pedantic, but aren't you always sitting in a cloud of someone elses exhaust? (In a confined place) with vaping it's just visual.

I'd rather deal with someone's vape than their farts. Also, I almost never have to deal with anything related to someone vaping. I can't even recall a single time.

There are different kinds of exhaust. I'd rather not be in a cloud of someone else's highly addictive chemical; I'm not gonna become dependent on CO2.

It's nearly impossible to become dependent from second hand smoke, unless you're in a gas chamber saturated with vape clouds for multiple days over and over.

I agree no one should be subjected to gross smoke against their will, but you can make a better case being accurate in it's effects.


You're not going to become dependant on someone's 2nd hand vape either.

Sure. I saw a tweet that was commenting on the normalization of weed (I know vaping isnt really talking about weed but it feels relevant) and how quickly we went from I'll take a hit of this shitty weed I got from a stranger behind this building to I guess I can rip my vape in this Target at 2pm on a Tuesday.

> My frustration with vaping is that it's seen as "not smoking", to the point where I had a guy sitting in front of me on an airplane vaping in flight and nobody really cared.

Spirit airline?


"In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data –

including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods

– that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications."


Why is Juul singled out here? Wouldn't all liquid/vapor products be equally suspect?

>company’s proprietary e-liquid pods

I'm guessing this is why it is Juul specifically. Other companies may be next, or maybe the FDA hopes using this mechanism to take down the biggest player will strike enough fear in the market that the other vendors fix the issue overall.


Because they designed and marketed specifically to teenagers and singlehandedly undid decades of progress in public health probably, if I had to guess.

They played a major part in helping me quit cigarettes when my lungs were really not feeling great, and I quickly started breathing better and am now cutting down on vaping. For that reason, I think I have a slight bias toward e-cigarette manufacturers.

This is probably a good thing though. It sounds like Juul will still be able to operate in this market but will just have to provide better data in future applications. Having high standards for FDA approval is something I'm in favor of, as long as they're not setting such a high bar that there aren't any options for people who are trying to quit cigs.


I mean honestly how many adults just decide "Im going to start smoking cigs". If I had to bet, I would say 80% of all smokers began smoking when they teenagers. Teens are still developing and cannot make proper "adult" decisions. Big tobacco whether they want to admit it or not knows they must go after teens because if they don't trying to convince a 35 year old with three kids to start doing something that they have never done is damn near impossible...

Its the same strategy that some companies use where they work with the earliest stage companies, i.e. Stripe, and they grow with them. In an extremely perverted view, big tobacco just wants to grow with their customers hahaha.


Can someone here more up to date than I on the subject give me a good jumping off place to see the real research on vaping vs smoking nicotine?

Last I heard vaping was generally considered to be safer overall because it lacked the extra carcinogens found in cigarettes, but it came out in the wash as people tend to vape far more frequently than they used to smoke and vapes are also a more direct punch of nicotine.

I’ve heard that a pipe is probably the best way to smoke if you have to do it: Tends to have a more pleasant smell to those around you, is a much purer tobacco product, and it generally isn’t inhaled. I think pipes raise the rate of various mouth cancers though.


So as I'm reading this, there are apparently other approved "electronic nicotine delivery systems (ENDS)"[1], but Juul in particular failed to provide data proving the safety of their products. Which is kind of interesting.

1. https://www.fda.gov/tobacco-products/premarket-tobacco-produ...


Wow. Pretty incredible. I don't support this industry but its pretty insane to me that a company can be regulated away in an instant like this.

Its odd that the federal govt banned a single company.

But let's keep the disposable flavored e-cigarettes from China...

This has nothing to do with public health.

Oh really? Why is that?

Think of all the more widespread public health concerns and the fact absolutely nothing is being done about them. Guns, sugar, unhealthy food in general, carbon emissions, toxic chemical emissions, car deaths, crime and deaths related to alcohol use, contaminated water supplies, etc.

Juul deliberately marketed their product toward minors. That is why their are being removed from the market and their competitors are not.

They also provided incomplete and fraudulent data about the ingredients in their liquids, which is the actual justification for the FDA revoking authorization (FTA).




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