Judge Gives E-Cigarette Makers 10 Months to Seek FDA Review | Hacker News Reader

Judge Gives E-Cigarette Makers 10 Months to Seek FDA Review

bloomberg.com

96 pointsJumpCrisscross117 comments

I hope this doesn't result in e-cigs getting banned in the US because that would be terrible. I live in the same house with someone who has been smoking since they were a teenager (quite common where we're from) and e-cigs has allowed them to stop smoking cigarettes which may or may not benefit them that much but it most certainly benefits me (no smell of smoke in the house, no second hand smoking, etc). They have tried quitting multiple times before and nicotine patches, gum, etc.

The article mentions that the group which filed a lawsuit is disputing the effectiveness of e-cigs as "smoking cessation" devices. From my personal experience they most definitely function.

> I hope this doesn't result in e-cigs getting banned in the US because that would be terrible.

If there is unequivocal, unhacked evidence that e-cigarettes reduce mortality by a sensible comparison in adults, obviously nothing will be banned, but you ought to be able to see why this is a high bar to meet for children.

> obviously nothing will be banned

Tobacco: 500,000

Alcohol Deaths: 88,000

All Non Alcohol Drug Overdoses (including prescriptions): 64,000

Marijuana Deaths: 0

Yearly statistics for the USA. Seems your 'obvious' might not be so obvious for the rest of us.

But then again, I think many 'obvious' things for you are not obvious to the rest of us. Like the muddled thinking related to children: 1st, it's already illegal to sell them to kids 2nd, will kids get them less if they are removed from local retail locations that check ID? Will driving it underground reduce consumption or only increase the dangers of use?

For some, it's obvious that they see it obviously. Others... we see nuance and no clear cut answers. Though many of us dislike such strong and rash positions backed by emotive, reactionary, broad stroke arguments and so little data.

Nobody dies from Marijuana overdoses but having smoke in your lungs is having smoke in your lungs whether it comes form a cigarette or a joint or a campfire and it's pretty much equally bad each way. Users tend to spend less time smoking joints than cigarettes but I'd be very surprised if the incidence of lung cancer from marijuana was zero.

Because there definitely isn't any other way to consume marijuana other than smoking it.

There are alternative ways to consume tobacco too

But Tobacco and it's components, regardless of how they are consumed, are carcinogens.

My post with statistics, while downvoted, is correct.

The largest studies of lung-cancer–marijuana-use association were also very surprised to find that the incidence of lung cancer from marijuana was, apparently, statistically indistinguishable from zero.

What you say is common sense. Like the earth being flat and the sun revolving around the earth, though, it just happens to be completely wrong.

> having smoke in your lungs is having smoke in your lungs whether it comes form a cigarette or a joint

This is not a thing that's true, it's a thing you assume. Having different smokes or vapors in your lungs can have different effects, just as drinking different liquids can have different effects. Tobacco smoke causes cancers. The more elements in another smoke that are shared with tobacco (or other plants that cause disease) the more the new smoke should be suspect, and it suggests a direction for initial testing. We can't just treat all odors as cancer-causing; vaping doesn't even involve burning vegetable matter, so even if burning some chemicals common to all plants causes cancer, that wouldn't make vaping suspect.

From what I have read any type of smoke you put in your lungs is carcinogenic, Marijuana included. https://www.ncbi.nlm.nih.gov/pubmed/23846283?dopt=Abstract

Yes, but some types of smoke are much more carcinogenic than others.

Incredible how the same people who denounce edibles also then go ahead and assume all weed is smoked.

It's like they want it both ways.

> Vaping doesn’t even involve burning vegetable matter

Actually the substrates are PG or (more popularly) VG. That’s propylene glycol or vegetable glycerin. The latter is obviously plant based and studies have even measured the concentration vapers breathe as meeting OSHA standards.

The real dangers of vaping are: the vasoconstriction of nicotine, the flavoring (which famously caused issues when a substance that was safe to consume but not inhale was used), and the free radicals from burning cotton or oxidizing metal in the coils.

Then ceramic coil ftw

You are absolutely correct.

Low quality coils can be very dangerous.

That is why open and free access to products consenting adults want to use is important.

Most quality vaping is done with ceramic coils.

There are facts and nuance and reason. Or reactionary emotive perspectives that only hurt everyone involved. The choice is yours.

it's not the tobacco per se, even if it's a factor, the primary cancirogens are the other shit they mix in to get it burning easily, reliably and timely

This thread's so full of FUD spread by the aptly-named Truth campaign, and this one (and its parent) takes the cake. Eventually the fight-fire-with-fire approach they took to combat big tobacco is going to bite us.

While you're probably right about primary carcinogens, the tobacco plant pulls radioactive isotopes like Po-210 and Pb-210 out of the soil and air, and those concentrations have been growing as Polonium levels rise in soil from years of fertilizer use[1]. So to say 'it's not the tobacco' is a very dangerous comment.

Moreover, cardiovascular disease is the primary cause of death for smokers, not lung cancer, and while extracting nicotine from tobacco and vaporizing it in a PG/VG solution might mitigate risk of the latter there's no reason to believe it'll do anything for CVD. If anything, without the MAOI in tobacco that increases the nicotine's effect, on average folks vaping probably have higher levels in their bloodstream than folks that smoke.

[1]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2270238/

> Moreover, cardiovascular disease is the primary cause of death for smokers

that alone tells nothing, cardiovascular disease is the primary death cause for general populace, that why you need to work out incidences, and guess which one has greater variation?

cardiovascular disease: 4x more likely

Cancer: 23x the risk compared to general populace

respiratory disease: 17x the risk

https://www.cdc.gov/tobacco/data_statistics/fact_sheets/heal...

funny how you had to cherry pick stats to present your point while accusing people of being shills.

smoking is bad, we get it. not everyone that can see a larger picture are part of God knows what conspiracy.

and I specifically did not say "tobacco without the other stuff is fine" so go grind your axe somewhere else

Juul is supportive of this -- and Juul is funded deeply enough (by Altria -- Marlboro, over 12 billion) to be able to go through the FDA review. Pretty much all the independents cannot. This means that the vaporizer business will be completely ceded to "big tobacco". Please don't say "e-cigarette", say "vaporizer" instead. Really would appreciate that.

The simple solution there seems to be making e-cigs available via a prescription as a smoking cessation/avoidance device.

The simple solution is to not do anything other than require e cigs to advertise the adverse effects of their product. As far as I can tell, they aren’t hurting anyone other than the people that use them. And as a society, I think junk food and carb heavy meals are a costlier disease.

As someone who lost 80 pounds cutting out junk food, sugar, and carb heavy foods while watching my older brother continue to struggle with his weight and accompanying health issues, I heartily agree.

Oh, dear god no. Nicotine inhalers exist, and I went to a doctor to get a prescription for them a few years before ecigs became prevalent. The doctor insisted that Chantix was the way to go. I reacted badly to Chantix.

I finally quit cigarettes by switching to ecigs, and eventually quit those as well. Actually, I just passed the 5 year mark nicotine-free a couple weeks ago.

Point is, doctors are happy prescribing Chantix, which is bad, and the better option may simply not be prescribed to folks for whom it would to a lot of good.

Not in the US, the price would go up 10x.

I think they should remain available to adults and for minors by Rx (if they got hooked on tobacco). But I certainly would like to see this better understood and regulated.

I don’t think they should be outright banned like SF is doing, but some regulation and understanding (sci studies) would be good.

Surely tobacco should only be available by prescription, by the same argument?

I mean, what argument is there for e-cigarettes to be banned or heavily regulated when anyone can go buy cigarettes?

If they ban both, fine. If they just go after e-cigarettes, this is the work of the tobacco lobby, end of.

It's the puritans, not big tobacco. Big tobacco loves ecigs, they're its future.

Right, but if the can create a regulatory environment that makes it impossible for anyone but juggernauts to compete, then they’re securing that future.

I suppose the question is where the moral outrage originates - with the puritans, or did someone plant that idea in their minds by hijacking the agenda?

I smoked for 15 years and tried all the usual quitting aids many times. E-cigs were the only thing that worked for me, but I’m a bit concerned about the long term affects of vaping.

Have you tried tapering the nicotine levels from vaping? Asking for myself..

I did.

I went from pack-a-day Newports to Vaping at 36mg/ml. Within a week I was down to 18mg/ml. Within a year I tapered all the way down to under 3mg/ml (I mixed all my own juices).

I stayed right around 3mg/ml for about a year, then I moved jobs and could no longer vape in my office. It seemed quite pointless to go outside and vape since I didnt really have the urge, I was still vaping in the evening after work for another 2-3 months. I finally reached the point where the trouble was more than it was worth, and just stopped entirely.

So yes, I'm a big fan of vaping. Is it "safe?" Probably not. Is it less harmful than cigarettes? I dont think that is even in question, at all. Vaping is, at worst, a significant harm reduction for smokers and those around them. At best, it is a method of quitting cigarettes and have proven successful for MANY former smokers.

I really hate the direction things are going with regulation, because to me it looks a lot like PM and friends are using regulatory capture to ban everything but menthol vapes that they can afford to get tested, thus perpetuating their existence and granting them a lock on the market.

I started with 25mg years ago (hard switch in April 2012 from a pack a day) and nowadays I happily vape at 3mg

Have you stopped smoking really?

To me is sounds like someone saying "I don't smoke any more, I just use cigars instead".

As in "no longer inhaling combustion products", certainly. I'll admit it's still a damned silly thing to do... unless it's compared to sticking dead plant matter into your face-hole and setting fire to it.

I started smoking at age eleven (it was perfectly legal, and I'd been buying cigarettes legally for more than half of my life by that point - it was as much a normal part of an errand as picking up a quart of milk or a loaf of bread), and can't say I put a lot of consideration into it at the time. Over then next four and a half decades, I tried quitting, unsuccessfully, dozens of times. Vaping means I haven't been inhaling burning plant matter for years. I'm happy with the harm reduction. The "quit or die" attitude is what needs to die.

I completely respect your rights to smoke whatever you feel like, and your wish for a better healthier way of doing it, or hell even suing the people who targeted you at 11, but my issue is that it hasn't been proved to my satisfaction that vaping is healthier than cigarettes.

The history of smoking is one of killing people more efficiently, ecigs feel like a continuation of that great tradition.

Are you seriously suggesting that the removal of basically every compound in tobacco found to be cancer causing and the addition of ones with a much lower likelihood of harm that have already been in use for well over a decade is going to be more dangerous?

With the exception of certain nasty flavoring agents and such, I think this is quite unlikely. There's certainly no evidence to support it.

Were they so harmless proof they they are shouldn't be hard to find. The studies I have looked at point an ambivalent picture. Unlike the case for marijuana which seems to not cause any lung cancers contrary to people looking for a link for 50 years now.

There is a fairly big practical difference between cigars and cigarettes. Cigars (like pipes) aren't traditionally inhaled into the lungs, so if you have genuinely gone from cigarettes to cigars and you aren't inhaling you're probably a lot better off.

It is a misconception that cigars are better than cigarettes. One cigar contains as much tobacco as 15-20 cigarettes and although you are not using lungs to breakdown and absorb smoke, you are using your mouth lining which can lead to all sorts of mouth cancers.

Yeah and your statistics are also misleading because who the hell smokes a full cigar in a sitting?

Most people actually. Most people who light a cigar will finish the entire thing.

In my experience most people will smoke a 1/3 or 1/2 of it and put it back. Then you clip the burnt part off and continue later. Maybe I only smoke around lightweights.

That's very much the exception than the rule, I've smoked cigars for 5 years at this point and nobody I know who also smokes does that. Usually I pencil in between 45 minutes-2 hours to smoke a cigar depending on size.

That's not my experience. Relighting a cigar tastes awful, and half-smoking it can dry out the other half. Most folks smoke at least one full cigar in a single sitting.

I used vaping to quit smoking. Then I quit vaping, and found quitting vaping easier than quitting smoking. Now I just breathe deep when I feel like taking a hit from something. The feeling of filling my lungs with some bulls--it is what is missed most, I notice.

Quiting vaping is quite likely to be easier for actual chemical reasons - Tobacco contains not only nicotine but an MAOI which seems to add quite a bit to it's addictive effects.

https://www.ncbi.nlm.nih.gov/pubmed/16177026

I'm happy for you, and those who've stopped smoking. That said, for me personally, ECigs have been a detriment. My city basically outlawed smoking, which was generally great. Then ECig users started smoking everywhere in place of cigarettes, and even less respectfully. I had people in my office constantly smoking them, even. My thoughts on both are the same - do what you want as long as it doesn't bother me. ECig users seem to ignore that here. As long as they are treated and regulated like cigarettes, I'm on board.

That's much more a cultural and location thing. For a lot of purposes ECigs are treated like tobacco, most public smoking laws apply to ECigs ( and cannabis, etc). The reason people get away with ECigs is its less offensive in a lot of places but what can the fed. Gov due about local policing and attitude toward ECigs?

Where I live they're socially and legally treated exactly like any other form of smoked tobacco.

Nicotine has a very non-linear impact on health. While ecigs are about 10x better in terms of the amount of 2nd hand nicotine, I wouldn't call them safe. IIRC it takes extremely low nicotine levels to cause (temporary) circulatory problems.

My main issue with e-cigs is that they are heavily marketed to kids, for example with young sponsored influencers doing smoke tricks and other shit.

Thanks to e-cigs, teen cigarette (not e-cig) smoking has started increasing after decreasing for years. Teens that would have never started smoking are introduced to it with e-cigs.

I don't know how these 2 phenomenons balance out. Does the number of cigarette smokers moving to e-cigs counterbalance the number of younger people starting to smoke cigarettes because of it ?

In all cases, I have no issue with more studies on the direct impact on e-cigs themselves.

> the number of younger people starting to smoke cigarettes because of it ?

Just ban cigarettes if that is the problem.

Kids really shouldn't be smoking e-cigs either. E-cigs are only better than cigarettes because "cigarettes are so legendarily bad for you".

I can accept them as cessation devices, but all their value in this realm should be weighted against the new users they introduce, chief among them: Kids.

They shouldn’t be eating chips, breads, candy, soda, and sitting around watching garbage YouTube/Netflix media and superhero shows. Solution isn’t always to ban something. They shouldn’t be marketed to kids, just like sugary snacks in my opinion, but education is better than banning it for all adults. Just slap the same 21 year old restriction as alcohol and move on.

I don't see the argument. Bad effect from things that are relatively non-addictive (at least physically) suggest that things that are addictive needs to be even more controlled. If anything there is now a disparity between what science tells us about "junk food" and digital media, and what how we treat them. The idea that you can teach people faster than dangers can appear without boundaries doesn't seem to be supported these days.

Considering 70% of US population is overweight, and 30% is obese, I would say the foods I listed are addictive. Regardless of definitions of addictiveness, I still think education is a better force than prohibition for most vices.

Banning alcohol, marijuana, and other drugs have all been unsuccessful. Why would it work with cigarettes?

The aggressive taxation, cultural shaming, disallowing smoking in public places, health warnings etc. seem to be more effective than most blanket prohibitions, even against the addictive properties of nicotine.

> number of younger people starting to smoke cigarettes because of it ?

Where is this fear coming from? The reason you pick up cigarettes is being around other people who smoke. I have seen zero evidence that cigarettes are on the rise among kids or that vaping somehow acts as a gateway drug. Using this to justify restriction of access to a cessation aid has always struck me as myopic, ineffective, and killing people. Granted it hasn’t happened quite yet, even in SF, so maybe there’s still hope. I’m certainly not looking forward to buying juul pods at extreme prices on the street.

Why not ban the goddamn cigarettes? People will complain and then roll their own anyway if they really need it in their life, and I certainly don’t see otherwise healthy teenagers rolling cigarettes again. It’s disgusting seeing arrays of cancerous easily smokable sticks in gas stations and corner stores.

Not a fear, a fact https://tobaccocontrol.bmj.com/content/26/e2/e106

Me and almost everyone I know who smoked quit using e-cigarettes and they are all adults. But my province (at least the prior party) is obsessed with making them harder and harder to find - at all - because 'think of the children'.

I bet the tobacco industry must love governments right now. They were getting seriously threatened for a moment there.

The tobacco industry is pivoting hard to ecigs (in the developed world at least, in more corrupt and less regulated countries they are still happily pushing it on teenagers and lobbying to take down anti-tobacco laws and education drives).

It's disgusting. In the US, you've got a massive spike in the number of 12th grade smokers, for the first time in decades. Because ecigs aren't regulated, it's a free for all. The same techniques that worked so well to them in the "golden era" of cigarettes, they're out in force again but for ecigs, amplified even more through the power of social media marketing. The playbook remains the same though: make it appealing, make it "cool" (kids love that), and target the crucial teenage demographic. Make them addicted for life.

You mean “heating”? (“we dont call it Vaping” - every big Tobacco sales rep)

If the tobacco companies have been spending hundreds of millions on R&D for over a decade on electronic cigarettes (not necessarily vaping), which is what some of them claim, then they seriously missed the boat.

I can assure you as a long time customer they don’t have much control in the market, besides trying to buy one like Juul (Juuls are overpriced garbage by the way). There’s a thousand small businesses and shops, making very good money with tons of competition which is quickly improving the products and devices. The difference bigco R&D and launching. It’s also been a boon for Shenzen/China where all the devices are made, not just for e-cigarettes but also for marijuana pens.

But the market is in its early stages I’m sure it will evolve. I’m pretty sure it’s not even close to finished in regards to optimizing the product, they get noticeably much better each year. The anti-social giant cloud thing is also fortunately being replaced by far smaller ones thanks to Nicotine Salts replacing usual e-liquids, which is 90% smaller clouds and dissipate immediately.

Regardless of your ‘think of the kids’ plight that has nothing to do with me as an adult having responsible access to my products. I can do it with alcohol, cigarettes, firearms, and weed here in Canada. These attempts to ban entire categories of products for everyone, not just kids, are dumb. Which is exactly what they are doing.

Where do you think the nicotine in any of these products comes from? The whole damn thing is the tobacco industry, not merely the parts of it wearing the legacy brands on their sleeves.

The reputation of the tobacco industry is well earned. Vigilant regulation is necessary to keep it on a leash.

>The nicotine in eliquid is the same as that used in pharmaceutical NRT. It is extracted from a member of the tobacco family but not the same plant as used for smoking tobacco as that has much less nicotine in the leaves than the rustica type of tobacco plant.

https://www.quora.com/Where-does-the-nicotine-used-in-electr...

Same industry, same shameless marketing to kids.

NRT is also used to treat people suffering (and I do mean suffering, it's a horrid burden) from ulcerative colitis. Maybe don't spend too much energy shitting on one of the only forms of relief available to them?

Doing good in other respects doesn't nullify their crimes. I'm not saying the substance should be banned; I'm saying this industry needs vigilant regulation.

If there's market demand for it, nicotine synthesis will probably get cheaper: https://www.wired.com/2016/06/vaping-industry-wants-go-post-...

It's dubious that nicotine itself is bad for you: https://www.gwern.net/Nicotine

> It's dubious that nicotine itself is bad for you

I mean, can we agree substances that enslave you - and by extension your pocketbook - are "bad for you" regardless of if they cause you to die at a sooner age?

It is likely that far more people are “enslaved” (your word) by caffeine than nicotine.

I don’t see a significant problem there either and if nicotine turns out to be roughly equally damaging (not much), is it really a problem?

Refined sugar is probably more damaging than either of them.

No. I like coffee and I don't see it as bad for me in moderation. Caffeine is addictive but it would be hard to convince me that it's carte blanche bad for me just because it's addictive.

Bingo. People that quit smoking with ecigs are transferring their addiction to something else. It may be less harmful than smoking or chewing tobacco, which inevitably leads people to compare it to caffeine.

I’ve been addicted to both. Not once has the need for a triple latte pulled me out of a movie theater at the good part, or made me duck under an eave in the freezing cold when it’s raining outside. Nicotine is first thing you think about when you wake up, when you finish a meal, when you get out of a meeting, and it’s the last thing you do before bed.

Addictions are addictions. But nicotine has demanded more of my time, money, and social and physical well-being than caffeine, for sure.

I don’t know any vaper who has to interrupt anything to feed their nicotine addiction. Nicotine alone is much much less addictive than Cigarettes and their finely tuned mix of additives designed for maximum addiction

Yes, I'm sure the ecig companies will stick to their principles and upstanding morals and not "finely tune" their products to maximum addiction. It would make them more profitable, sure, and that's the one measure we optimise for in capitalism, but I'm sure we can trust them to do the right thing.

It isn’t the nicotine that makes smoking that addictive, which is why cessation methods that focus just on nicotine fail. It is the tar and the flavor that are the big factors in both addiction and getting cancer, e-cigs are a simulated experience that recreate some of the feeling of smoking without actually shoving real smoke into your lungs.

I doubt nicotine is good for you, though. It's not like it's some micronutrient and the FDA says you should get 10mg of nicotine a day.

Nicotine reduces stress and anxiety, and stabilizes mood. In that context, nicotine may be a useful drug for some people and help them function better.

Nicotine gum may improve short-term memory. Nicotine may account for why smokers are less likely to develop Parkinson's disease.

All the 'cool' kids on Twitch vape these days, it's pretty good marketing for the activity and my guess is that alone accounts for a few percentage points at least of new vapers.

So weird. Twitch has been virtue signalling on so many superfluous things, but not vaping. Perhaps nobody noted yet?

> Because ecigs aren't regulated, it's a free for all.

They're still restricted in sale to >18 year olds, exactly the same as the definitely-worse cigarettes. The FDA approval process doesn't change who they can be sold to.

Where do you think the nicotine in ecigs comes from? For the first time in decades the industry has consumers who would rather be inhaling nicotine than be informed. Why would they be unhappy?

I'm in a country where they're banned for sale in general shops. Only licensed businesses can sell them.

Cigarettes, on the other hand, are in every corner shop.

A level of stupidity that is hard to achieve.

All I know was that I kept going back to smoking, even after quitting for a few years. I used e-cigs for 2 years, quit them 3 years ago and I have no interest in either anymore. As far as I am concerned, they are an essential tool to help people quit smoking.

I look forward to some real data on the topic though. I think some designs and chemicals (flavouring) in vaping cause harm and that with research, the risks can be mitigated.

That said, there is also a puritan no drug element to these "anti-tobacco" lobbies that have nothing to do with harm or risk, they are just the Calvinists of our day.

> That said, there is also a puritan no drug element to these "anti-tobacco" lobbies that have nothing to do with harm or risk, they are just the Calvinists of our day.

True, and what's also weird is a lot of the anti-nicotine puritans are pro-marijuana.

I think the dangerous thing is that people who have never smoked are using vapes more and more. I'm 26 and the vast majority of my friends have never been smokers, but are consistent vapers. I agree that they can help smokers, but I think the primary audience for these products never smoked.

I share your concern, but they may have become smokers if it weren't for e-cigs. I started at 15 and smoked a pack a day and some of my friends smoked double that. That's 50 cigarettes a day and not even 20. I hope the data turns out to be good news, but I really don't like how people are treating them as risk free or safe when we really don't know.

Maybe, but smoking going down a lot already in the years before vaping really showed up especially iirc among younger cohorts. Antismoking efforts had worked pretty well but then vaping came in and dodged 99% of the social (at least the antismoking stigma I remember vaping being the brunt of soo many jokes and mockery when it first hit) and health stigma with no real science to back up the health claims (in absolute it's not hard to be better for your health than cigarettes after all).

>I think the dangerous thing is that people who have never smoked are using vapes more and more

I have yet to see any indication that vaping is dangerous, beyond changes in the brain from addiction. There are typically a handful of non-toxic* ingredients, and nicotine is not known to be harmful.

*For consumption, not inhalation. Still, compared to cigarettes, this seems a bit like hysteria.

If you're comparing vaping to smoking then obviously vaping is many times safer. So, if smokers convert to vaping we don't mind, we're pleased.

But if you're comparing vaping to not vaping, in young people, well vaping is going to be a bit more harmful (because everything has risks) than not vaping.

We don't know what the risks are for young non-smokers who take up vaping. We do know that there is some risk they'll become addicted to nicotine, especially because some companies have focussed on making their product more addictive.

This, combined with pre-frontal cortex development in young people, makes it harder for them to make an informed choice.

In other words, you also haven't come across any actual evidence of harm from vaping?

I really do wish people would stop citing this pre-frontal cortex development stuff as evidence against young adult's ability to make rational decisions. The actual studies do not support the claims people make using them. This is probably the worst example of the pop-sci industry run amok I've ever seen.

Who knows if they would have become smokers of vaping didn’t exist? Yes, there will be new smokers who start with vaping and never see a cigarette, but given that there were new cigarette smokers before, it still feels like we are moving in the right direction.

That's an excellent use of e-cigs. The issue is the companies that stuff enormous amounts of nicotine into their e-cigs and then claiming that it "helps people quit smoking" only because they're even more addicted to the e-cig, and then the kids who get hooked on these bad e-cigs.

I've sat in on a few court cases, and also in a jury for a murder trial. It is honestly very scary to me how a judge, a single person, can decide something that affects so many people.

To me this seems like a flaw in the US's democratic consensus algorithm. It is literally no different than if Bitcoin's algorithm allowed a single node to decide what to do with 100k BTC flowing across the network. That much decision-making power should never reside with a single person, no matter how many people voted that person to that position.

When you think about it, it's pretty scary how even something like a democracy works in practice. It's not a great system but I guess it's better than all the rest?

Well, the theory says that the judge can only apply the current law as is written. And as written his interpretation is that the FDA has regulatory jurisdiction (and therefore obligation) over E-Cigarettes. But the judge doesn't create the law. If Congress wants to change the law they can. There is nothing legally that prevents Congress from passing a law that specifically exempts E-Cigarettes from FDA approval. I am not saying that politically this is feasible - the point is only that one judge is not the only party capable of making a decision.

I think that their critique of the overall judicial system was a tangential aside and didn't - directly - apply to this specific situation.

Admittedly, I could be wrong here but that was my take-away from the OC.

You can "fix" a memory-blowup bug by just auto-restarting the server when the memory usage hits a threshold. It temporarily alleviates the problem, but it doesn't actually fix the bug. The bug is still there, and will happen again and the server will have to be restarted again, ad infinitum. The only way to solve the issue is to find out what code is not releasing memory properly.

One judge can interpret law-v1 on a whim, thereby affecting millions of people, and the only way to "fix" the bug is to get Congress to update the law to v2, which potentially takes years, which is going to leave an entire generation screwed for that time. That still doesn't solve the problem because some judge will eventually interpret law-v2 in a shifty way and this will lead to law-v3, ad infinitum. It's a bug, not a feature.

Laws are closer to guidelines. The real power seems to reside with judges who get to decide the realized consequences of violating a law, and in many cases, the nuances of what causes a law to be violated. At the end of the day, a person's life can sometimes be affected because of a decision made by a single judge.

What does "seek FDA review" involve? Is 10m an appropriate lead time, or do we expect to see a lot of extension requests?

What's the likelihood that FDA in early 2020 will not again kick the can down the road?

I think the main hurdle is that you have to take a huge pile of money and light it on fire as a sacrifice to the FDA. This obviously limits the number of products and vendors that can participate in the market, although it isn't at all clear that it will reduce uptake by non-smokers.

So, the point of this is to reduce competition from smaller companies?

Expensive regulation usually benefits the organizations that can afford it to the detriment of those that can't. Regulation is certainly a two edge sword in this regard. I'm left to wonder if this is an intended or unintended consequence.

A British study recently came out finding eCigarettes 95% less harmful than cigarettes.

https://www.theguardian.com/society/2018/dec/28/vaping-is-95...

Large scale health studies are going to cost a lot of money since they use up a tremendous amount of human time and resources in short supply.

If we want the data, we have to pay for it. One option is to pay for it with tax dollars (which already happens).

I think the point is to make sure that no one dies or is hurt - the FDA takes a very strong view on preventing injury and death, not always weighting the opposite side of the coin of people who are already dying or being hurt (ex. taking years to approve drugs that have a high likelihood of helping more people than they hurt, but not doing so until being as close to totally sure as possible to try to prevent new deaths/injury)

Basically, what you're saying is that the FDA likes keeping their jobs, because the only thing that can threaten them is them screwing up. It doesn't matter if approval is expensive or takes a long time, because they have no competition or incentive to do better.

> I think the main hurdle is that you have to take a huge pile of money and light it on fire as a sacrifice to the FDA.

While the FDA is not perfect, such as medical devices regulation was in limbo and theranos, it did prevent many harmful drugs from enter market.

When I was interning at FDA NCTR, the director then was very proud that they've prevented thalidomide, that causes deformities in newly born babies, from entering market.

The e-cigarette culture is widely different in Europe. Only people that I've seen using it are 25+ year old people that want to reduce/stop smoking. Not a single kid. Let alone someone "cool". Still the European Union are regulating it and making it less attractive. Like with the recent ban of "shake n vape" for example

Tobacco is an "agricultural product" if I recall correctly. It's allowed, in part, because it predates the United States. On the other hand, e-cigs to me (IANAL) are a "drug delivery system". I've always been curious about how they were allowed even to get started - let alone turn into a 7 billion dollar market.

> I've always been curious about how they were allowed even to get started

Laws are created reactively. By default everything is legal, and it is only when there is a problem that a law is made about something.

If you go to the vitamin shop, you can see a whole isle of unregulated substances people ingest. I'm not really sure (legally) how e-cigs are different.

My friend's brother in law is a pediatrician, BIL talks about e-cig stories a lot. How young teen are using e-cig and cases where these high school boys are losing their sex drive (getting ED).

I'm not advocating for a ban but there should be independent studies conducted on the effect of e-cig and also more awareness for younger children. I'd like a long term studies on the effect of e-cig.

Treat ecigarettes like any other tobacco products. No selling to minors, inform and punish teens who use them.

Teens were smoking cigarettes two decades ago, this isn't much different.

Sometimes people wonder why progress seems to be so slow nowadays. This is an example of the kind of thing that suggests that regulation is a major brake on progress; perhaps this is why the center of gravity of world progress has shifted from Europe and the US to China.

Nicotine is a wonderful stimulant with minimal health risks. The problem with smoking is the smoke.

Wow. I think you are going to want to investigate that a bit more if you are banking your own health on that statement.

I’ve read the peer-reviewed literature. There are mild problems in rats given enormous doses, and maybe it raises your blood pressure a bit. No worse than caffeine overall.

What lobby are you working for? Nicotine has been linked with numerous heart issues. Please share this peer reviewed literature you hint at.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3755365/

Hey guess what. I didn’t use cigarettes at all for the last 10 years but used ecigs because they tasted good and were fun. It happens too. They could be harmful on balance!

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