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Comment by pope_meat | Hacker News Reader

Fun fact, if you claim to be a smoking cessation product you get the FDA at your door going "oh, so this is a medical product" and you're now obligated to prove that your product works as a medical cessation product, and requires a doctor's note to pick up. You can't market yourself as a smoking cessation product without getting the hounds of hell being unleashed on you by the regulators.

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> you're now obligated to prove that your product works

And that's a bad thing?

For business? Absolutely

Also bad for the people who might benefit from the product even though it didn't help a statistically significant portion of people in an expensive clinical trial.

I wonder how many non smokers we have in this thread making decisions for others. If only we’d think of the children! Screw the adults struggling with nicotine addiction, they should go back to cigarettes or just quit (like they’ve been trying to for years).

Why do people have to stick their noses in things that don’t affect them?

> And that's a bad thing?

If your product causes harm in any way—regardless of the benefits—you're going to have a difficult time getting regulatory approval. It will also greatly affect access to the product, as not everyone has access to good doctors, and most items that are FDA-regulated requires prescriptions.

For a product which is a superior, healthier option to cigarettes, it's a massive regulatory burden that could kill the business. I can't imagine anyone would defend that as preferable to the status quo.

> If your product causes harm in any way—regardless of the benefits—you're going to have a difficult time getting regulatory approval

Question stands, is that a bad thing?

Besides not everything FDA approved becomes a prescription medication. On topic; nicotine gums and patches as smoke cessation products are widely available as OTC.

I think the implication is that a product can do some harm, while reducing the overall harm in the system. In this case, vaping might cause some harm, but it potentially reduces the overall harm by doing much less harm than cigarettes. I believe the comment is saying that, by pushing for regulatory approval, the product may never enter the market and would thus not be able to reduce the overall harm being done.

In this case, we would certainly have to consider the potentially increased harm of non-smokers taking up vaping to assess the overall harm being done, but I see the merits of the basic argument at least.

> Nicotine gums and patches as smoke cessation products are widely available as OTC.

The first nicotine gum, Nicorette, began as a prescription-only product in the US.

See marijuana if you believe regulators will actually listen to a preponderance of evidence. FDA/pharma executives are a revolving door, and therefore concerned chiefly with the health of pharma rather than humans.

Recent developments (see aducanumab) have shown that the FDA mainly cares about safety but much less so about efficacy.

There are (AFAIK) 3 cannabis derived products that the FDA has approved. Given the large cost required to get a new patentable drug through the FDA, it doesn't come as a surprise that no one's willing to foot that bill.

What the DEA (a totally different governmental organization with different motivations and biases) thinks about marijuana is reprehensible, however.

https://www.fda.gov/news-events/public-health-focus/fda-and-...

Exactly. They have approved 3 niche pharmaceutical industry replacements. Meanwhile they have kept their head in the sand regulating the 26 state cannabis industry, and we have no universal standards for contaminants, potency, etc. beyond state imposed regulations.

The CBD industry, which has been commercialized in most states, is also totally unregulated.

There's an interesting tradeoff there. Getting through clinical trials to prove it works is expensive, though that's realistically more an annoyance to the company than a problem for the public. But once you have gone through all of that, you're probably looking at the product now being sold for a higher price (increased barriers to entry means more competition), and possibly only by prescription. Which might severely reduce availability to less-wealthy smokers. Which, I think at this point, is most smokers. On the other hand, that would also severely reduce availability to kids who aren't already addicted to some other tobacco product. So there's that.

Long story short, I can imagine a lot of valid arguments pointing in every which way here.

But… you get to charge 10x more and make the insurance companies or government pay.

*these statements have not been validated by the FDA

There are countless products from weight loss to joint pain to "improve your memory" that sidestep the issue with those 9 simple words. I don't see why it would be any different for Juul.

Because that language is for dietary supplements which have a specific legislative carve out from falling under FDA regulation.

These products can do that because they contain no substances that need approval in any way, so they are likely just food supplements without any active ingredients.

Nicotine will count as an active ingredient, you can't just slap these 9 words to any random drug and just sell it over the counter.

> requires a doctor's note to pick up.

I don’t think this is true. I can buy Nicolette all over the place without a doctors note. In the US at least.

That's the case now, initially the product was prescription only.

Oh and it tastes like shit, to save the children.

Getting licensed for vaping is easier? (really asking)

No. The only companies eligible in the PMTA License process for vape had to have been manufacturing in 2015 or 2016 when the FDA began its moratorium on new players entering the market.

They’re both incredibly expensive and laborious. Like millions of dollars per sku expensive. The fda has put all the good vape shops out of business and extortionate taxes are killing the rest as people revert back to cigarettes. The fda is actively hurting Americans by shifting these costs onto retailers which was a Coup d'état for big tobacco who had been completely blindsided by the success of startup vape companies.

Several "Citation needed" in that comment.

Here’s a good primer. I was a bit off, it’s not millions per sku, more like hundreds of thousands, but all the combinations of products also need to be accounted for and approved at great cost.

https://vaping360.com/vape-news/105656/how-will-the-pmta-dea...

If that’s not enough detail let me know, I’m happy to dig up other old articles for you. This small business destroying charade by the fda has been well documented and publicized. Though not as well as the fear mongering about children juuling.

> fear mongering about children juuling.

Why is that fear-mongering? My anecdotal evidence is that it's rampant with teens. Do you have any stats that are not anecdotal so I can educate myself?

When I was growing up all the teens were smoking and drinking. Considering how bad we know alcohol and cigarettes are for a developing brain, I'm inclined to not panic over the newest trend.

Don’t forget marijuana, it reduces blood flow to the brain. Absolutely horrible for a developing brain.

I don't know how I forgot that. It was more popular than alcohol and cigarettes at my school.

It was rampant with teens, but then we "fixed" things.

They went back to cigarettes.

Mission accomplished I guess.

Cigarettes are hard to covertly hit at school/home. They leave the person with a very distinctive stink. They are hard to buy online and damn near impossible for a minor to buy in person. With only 13% of adults smoking they aren't available to be swiped in most households and taxes in many places make those who do smoke liable to notice them walking out the door. Many places its about $10 a pack.

Furthermore it is much more socially unacceptable and awareness of the harms of cigarettes has never been higher.

Insofar as teens if eciggs were to become as hard to get as heroin tomorrow nicotine addition of teens all cause would be liable to decrease because your mom is absolutely going to know your smoking actual ciggs and have something to say in the matter.

> Cigarettes are hard to covertly hit at school/home.

I once knew an adult smoker who smoked about 1/2 a pack a day. She also didn’t want to smell like it, he had methods she employed that would leave absolutely no smell on her.

If your kid wants to hide smoking analogs then they can easily, just stand in front of a fan and wash your hands and face after.

The overwhelming majority of parents are now non smokers and no schools are accepting of smoking. Smokers on average are addicted and would need to smoke some time during the school day and during their time at home.

What you say is correct you could certainly decrease the chances of being caught but on net out of 100 smoking teens 90 will end up getting caught trying to smoke real ciggs whereas hiding a non scented vape is so extremely trivial that the situation is reversed. 90 will escape detection.

There is a distinct difference between those two circumstances.

> Smokers on average are addicted and would need to smoke some time during the school day and during their time at home.

My wife when she was smoking would go all day without smoking only to smoke at home. Also one of my school grade friends was a smoker at 13 or so, and he only smoked at home.

Also vape’s have a smell, it’s just not as pungent.

What you’re really saying is you can’t watch your kid 24/7, you don’t trust them, didn’t teach them why smoking is bad and now you want everybody else to suffer.

What I'm saying is that on net allowing juul to exist implies that the entirety of society is harmed including the people who pay taxes for the medical care required by people's vices as has been true of the industry to which they are heir. They have clearly marketed themselves to young people who otherwise wouldn't have taken up smoking. I don't think this is something we can just fine and move forward. If I walked into a school and shot several of the children I would be universally despised and strung up if the people could get their hands on me but if I market a product which leads to excess mortality of millions down the way the connection is sufficiently indirect that it is deemed somehow acceptable.

I think the entire industry ought to be taxed out of existence like boiling a frog not because I want other people to "suffer" but because I don't want people to suffer.

> What I'm saying is that on net allowing juul to exist implies that the entirety of society is harmed including the people who pay taxes for the medical care required by people's vices as has been true of the industry to which they are heir.

I don't even know what to make of this. How many other things do humans do that are dangerous that we all have to pay for?

> They have clearly marketed themselves to young people who otherwise wouldn't have taken up smoking.

Why do you think this? Is it because of flavors? Do you not realize how many adults prefer flavored vape liquid? Or is it cause they ran commercials?

> I think the entire industry ought to be taxed out of existence like boiling a frog not because I want other people to "suffer" but because I don't want people to suffer.

So then you naturally try to force your opinion onto others. Why has society devolved into forcing others to do what we want? Do you think banning vapes will keep people from returning to cigarettes? Do you think addiction is just a switch one can easily turn on and off? You will cause more damage than good "taxing them out of existence like a boiling frog" (seriously wtf with that statement?) than realizing they are helping people and just minding your own business.

> Why has society devolved into forcing others to do what we want?

Because the only way to provide for the health of a society is with socialized medicine. Most of the civilized world has settled on this conclusion and even we have basically half and half.

In that context allowing people to be stupid as they want to be is ultimately allowing the stupid people to spend everyone's money.

So then this devolves into no drinking and heath police. Too much sugar in your gum? Fine. Too many carbs, fine. Overweight? Fine. Drink alcohol, fine. Light incense in your house, fine. Don’t eat the required 3 meals a day, fine. Don’t eat the menu prepared by the health and nutrition czar, fine.

Is this a country you want to live in?

Also we don’t yet have, and hopefully will never get, socialized medicine. Why do we prepare society by starting to implement the boot on the neck when we’re not even sure if it’s needed yet? Seems a bit assumptive and preemptive no?

Because the stories are pushing an agenda and ignoring the broader scope of the issue that is children using addictive substances. Conversations about children vaping should be had, but in comparison to the rate of other tobacco and nicotine use. If it’s really about the kids shouldn’t we also be looking at alcohol and other drugs like marijuana too as reference? I don’t see articles about the high school kids that start drinking, taking opiates, or smoking cigarettes and marijuana every year. These are expected behaviors, vaping is new, and the preponderance of evidence says is far less dangerous than smoking, so a lot of ignorant and easily frightened people got caught up in the rhetoric and forgot how to rationalize about new risks. The fear mongering about juul was little more than a perfect excuse to quash outcry over the ridiculous legislation against vaping products on the state and National level.

Do you have any (non-anecotal, ideally) evidence that it's dangerous?

I don't know that I buy Vaping 360, which has a banner saying "57 MILLION smokers and vaping enthusiasts reached since 2015!", as a credible source.

Below you accuse stories about harm to children of "pushing an agenda"; might this be pushing one?

Everyone’s pushing an agenda these days. I didn’t post that as an unbiased source, but as a counter argument to the unified front against vaping amongst the mainstream teleprompt readers. If you want an unbiased source for this discussion you’re going to have to have a bad time.

I'm a living citation. Was a small business owner, retail vape shop. Did fine for 5 years. Then the regulations to save the children and hit pieces in the news. All the small independent shops went under and now you can only buy the vuse, and juul, both owned by...you guessed it, the same folks who sold cigarettes.

Basically, the wrong people were making money, and the regulators fixed that. Now the money is flowing to the right people and no one gives a shit that teen smoking rates went back to higher than they were before vaping. Harm reduced, a slow clap to our regulators.

> The fda has put all the good vape shops out of business and extortionate taxes are killing the rest as people revert back to cigarettes

I'm not a conspiracy theorist, but I'll just point out the observation that there are a lot of perverse incentives to keep the tobacco money flowing, public health be damned. Hell, remember back 2019 public health officials were running made-up 'e-cigarettes are causing lung injury' scare which turned out to be entirely caused by contaminated black market THC cartriges? SF still hasn't walked back their e-cigarette ban that led to a doubling of tobacco use by high schoolers[1].

To give an idea of where priorities are, the state of California does 10x the number of checks to make sure stores are paying their cigarette taxes as they do to make sure stores aren't selling to minors.

[1] https://jamanetwork.com/journals/jamapediatrics/fullarticle/...

Philip Morris owns 35% of Juul.

Working as intended: moved to won't fix.

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