Juul Violated Federal Rules by Marketing Vaping Products as Safer Than Cigarettes, FDA Says (nytimes.com) 95
Juul Labs, the dominant e-cigarette company, violated federal regulations by selling its vaping products as a safe alternative to traditional tobacco cigarettes without approval from the Food and Drug Administration, the agency said in a warning letter on Monday. From a report: The F.D.A. issued its warning amid a public health crisis over more than 400 cases of vaping-related lung illnesses that have hospitalized many young teenagers and adults, and possibly five deaths. Public health investigators have yet to determine a specific cause, but have cited the use of both cannabis-related and nicotine vaping products from a number of companies as possible suspects. The agency's warning letter to Juul follows a lengthy inquiry into the company's marketing and sales practices, as well as a review of congressional testimony from Juul executives, consumers -- including students and parents -- and antismoking advocates. Under federal law, companies are not permitted to market products as safer than cigarettes or a safe alternative without proving those claims to the F.D.A.
lolz the summary proves the claim (Score:4, Interesting)
400 lung illnesses and 5 suspected deaths linked to vaping.
7 to 8 million dead and tens of millions maimed do to smoking.
Conclusion: Vaping can't be claimed to be safer than cigarettes!
Obviously government and media are being agenda driven in all this mindless railing against vaping which is provably safer than smoking. Sure, I'd agree it's bad to vape, but it's over a million times safer than smoking (based on body count and diseases)
So, a handful of people got bad product, and maybe some people even had weakened lungs....
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You didn't factor in how long people have been smoking (decades and decades) and how long people have been regularly vaping (one decade tops).
Two very different sample sizes.
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15 years of vaping; still a laughable situation, smoking provably much more deadly than vaping. Tens of millions of vapers are not having problems. Six percent of the smokers who dropped dead were smoking for less than 15 years.
Re:lolz the summary proves the claim (Score:4, Insightful)
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Studies have been done, vaping is safer than smoking. It's not safer than breathing air.
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I mean hell, you see people smoking for real in the movies, not vaping....
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Then juul merely needs to send those studies to the FDA and show how those studies back up their claims.
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Then juul merely needs to send those studies to the FDA and show how those studies back up their claims.
The FDA is run by a bunch of bureaucratic political hacks who start with a range of "politically acceptable" conclusions and select only that which backs their conclusions.
Note that most news articles concerning vaping and Juul as well as new vaping regulations target *all* vaping with their "think of the children!" BS, not just the specific troublemakers. This is because Big Tobacco can afford the costs of heavy regulatory compliance burdens including onerous fines which the much smaller vape industry comp
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As someone who has actually had to work on an FDA submission I can tell you don't know what you are talking about. The FDA is a scientific organization who evaluates studies and claims. The fact that the science doesn't back-up your political ideology doesn't mean that the FDA is being political, it means you are.
Anti-vaping hysteria is propaganda
Why are you equating anti-vaping hysteria with the FDA? Did you read the article? The FDA isn't anti-vaping. The FDA merely enforced the same rules they enforce everywhere: If you are going to
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[From parent post] "Vaping is provably safer than smoking."
There is thing called proof, you don't get to make medical claims without it.
And there's the issue. I have no doubt vaping is safer than smoking, or could be. But apparently the FDA hasn't seen the actual proof. Neither have I, for that matter. If it's provably safer, it should be easy enough for Juul to do so.
(Never mind that the FDA could enforce a more neutral position: until we see some evidence one way or the other, you can sell it but you can't make health claims one way or the other. Or that you can make claims but have to mention this claim is unsupported. Or, that you could
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Isnt it fucking obvious, pure smoke is bad. I cant imagine anything worse than cig smoke , apart from Chernobyl reactor smoke, or unfiltered cig smoke, or damn direct fumes from a car exhaust.
Seriously its fucking obvious, nothing IS WORSE than cigarettes.
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I've wondered how the taxes on e-cigarettes compares to regular ones, not to mention the Tobacco Industry has a huge stake in either co-opting the vaping companies by purchase or attrition (through suits and government pressure).
My guess is somewhere in the middle. All new technology is met with huge resistance from established industries, and those established industries will fight tooth and nail (and use government coercion) to keep their market. (See: automobiles, radio, cassettes, VCRs, etc. etc. etc.)
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e-cigarettes do not currently have any sin-taxes applied to them, and anti-tobacco activists are seeing their tobacco sin-tax money reduced as people move from cigarettes to vaping
It makes me wonder if all of the kerfuffle over vaping is really just anti-tobacco activists looking to get their piece of the action
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You're basically pimping a nicotine delivery system. How proud you must be. And teenage smoking is on the rise due to vaping. Moron.
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Sure, if you want to believe a website that is supported by tobacco sin-taxes, which also is aiming to get money from the sin taxes they are want applied to vaping products
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What business is it of yours if people like nicotine? No different than you liking caffeine. Or would you ban that too?
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Poor choice for comparison. Caffeine is the only widely used drug that actually makes you healthier (even if no one seems to be able to figure out why).
Now, comparing it to alcohol might be smarter.
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The point is you busybodies need to learn to mind your own business. Like it or not freedom means the freedom to make unhealthy choices if someone wishes.
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Alcohol is damaging even if you don't drink to excess or get addicted. Yes there are some minor health benefits to wines but otherwise any consumption of alcohol has negative impacts to the liver and the brain. T
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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4363846/
Nicotine is a poison.
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What's their interest, killing their customers or selling an addictive product for as much as possible ? Surely all cigarette companies should switch to being vaping companies to prolong the lives of their victims ( *cough*, I mean customers) ?
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"Tens of millions of vapers are not having problems"
Um, what?
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"how long people have been regularly vaping (one decade tops)."
Try a couple millennia. Hookah is vaping, when you're doing it right.
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Re:lolz the summary proves the claim (Score:4, Insightful)
Of course this recent spate of vaping injuries is the result of VITAMIN E OIL being added to illicit THC concentrate
The Vitamin E results in lung inflammation and injury, BUT only a few news outlets have started to report it since they have all bought into the VAPING IS BAD FOR THE CHILDREN narrative
The real lesson here is the CRIMINALIZING things makes them more DANGEROUS
If THC vaping is illegal, the CRIMINALS will produce it with no testing and they will HURT people
If all vaping is made illegal then there will be even more injuries do to dangerous products in the black market
It is far past time for all of these vaping/cannabis PROHIBITIONISTS to grow the fuck up and realize that their efforts are HURTING people more than helping them
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Of course this recent spate of vaping injuries is the result of VITAMIN E OIL being added to illicit THC concentrate
Do you think those people just one day picked up a THC pen and started puffing away? They were probably all either already smokers of traditional marijuana, or were vapers. If they're vapers and they've been trained that vaping isn't bad for you and, as any stoner will tell you, marijuana is good for you, then why wouldn't they assume that THC vaping is bad for you? How can safe + safe = bad?
That being said, I'm all for promoting vaping over traditional cigarettes as I do believe they are safer than ciga
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... However, they need to emphasize that "safer" =/= "good" and that they are really just "less bad" than cigarettes.
Less bad is better than bad tho, so there is that.
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... However, they need to emphasize that "safer" =/= "good" and that they are really just "less bad" than cigarettes.
Less bad is better than bad tho, so there is that.
True, less bad is better than bad, but safer than sounds better than less bad, because less bad still implies bad. Safer implies good.
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I'm pretty sure that vaping IS bad for children. Is everyone left on Slashdot a complete douchebag (other than me of course)?
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No, you really ARE a douchebag if you want to promote public policy for adults based on your concern 'FOR THE CHILDREN', which has been used to promote all sorts of horrible public policy in the past
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Re:lolz the summary proves the claim (Score:4, Insightful)
1) We don't know the sample size of the *three* populations
' a) smokers
' b) vapers
' c) random control group
2) We don't know how long / how many uses of the new product it takes to achieve a health failure of some sort
3) Severity of the health problem should be weighted heavily in the context of time it takes to become ill Item 2 should really scare the crap out of users. It may be true that we're seeing only a handful of cases, but we also see that the severity is quite high despite vaping products being on the market for only a few short years. Given the limited evidence so far, I'd rather poison myself with cigarettes for a short period of time than poison myself with vaporizers. I'm not aware the cigarettes have put people in the hospital as an immediate, acute health risk as vaporizers have. Of course cigarettes have know, long-term damage, but Philip Morris and gang gave up on passing their product off as safe a long time ago.
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vaping around for 15 years. Your FUD attempt is laughable. Tens of millions of vapers have NOT being going to the hospital. Instead a handful of problem cases known after a decade and a half. Raw veggies have caused more problems than vaping.
You'd be a fool to take up the deadly habit of smoking, 70 chemicals in tobacco smoke are known to cause cancer. Zero chemicals in vaping mainstream commercial products are known to cause cancer.
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vaping around for 15 years.
Lol, the vegans of the tobacco world.
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vaping around for 15 years
Which is not long enough for any real conclusion to be made. The 1964 report was based on information obtained from 1920-1960, a forty year study on a product that had been around for centuries. That information was then reevaluated and ultimately didn't result in real regulation until 1990s so about 70 years after evidence was beginning to be collected. So I think we're done here with whatever meaningless argument you were trying to put out there for everyone.
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You are ignorant of history. In 1969 the warning label on tobacco products was mandated. Tobacco ads on TV banned in USA in 1970, widely known it was bad then, massive amounts of studies in 1950s and 1960s showed it. Tobacco tar only need be painted on skin of lab animals to cause cancer. Breathing tobacco smoke gave animals cancer.
Paint an animal with vaping liquid, and you'll get a wet animal. Give an animal vaping smoke, and if nicotine in vapors might get a little buzz. Proven in studies, look 'em
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Zero chemicals in vaping mainstream commercial products are known to cause cancer.
Er what?
And those are the chemicals that are known. That doesn’t include “flavorings” which aren’t always known. The amount of each chemical may be small but that does not mean there are zero chemicals and that there is zero risk.
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er what yourself. no mainstream vape product has those as ingredients.
Why don't you look at what any cigarette has instead if you want to see 70 carcinogens.
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Conclusion: Vaping can't be claimed to be safer than cigarettes!
Due to previous history with snake oil products, the US laws on advertising "medical effectiveness" is perhaps even more stringent than in the EU.
This is the same sort of thing as General Mills getting slapped for advertising Cheerios as being "heart healthy".
You see, it isn't enough to prove that vaping, generic, is safer than cigarette smoking. Juul Labs has to prove that their exact formulation(s) are safer.
The same way that General Mills has to basically repeat the studies showing that consuming oats l
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>This is the same sort of thing as General Mills getting slapped for advertising Cheerios as being "heart healthy".
That claim was entirely false as well. Cheerios will promote heart disease through a number of mechanisms on its own and in combination with sugar and with plant based oils that no human body ever saw before the last century.
The vaping is safer than smoking claim is possibly correct given what we've seen to date, but like you say, the statistics are murky. But it's not an outright lie.
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Due to previous history with snake oil products, the US laws on advertising "medical effectiveness"...
I strongly doubt anyone who smokes or vapes is under any illusion this is good for them. It's a recreational drug, not a therapy, it's probably toxic in some way, and they're willing to pay that cost to get the nicotine high.
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And “safer than smoking” doesn’t make it safe. One JUUL pod contains 20 cigarettes worth of nicotine.*
Vaping can weaken your immune system, can damage blood vessels, and makes you significantly more likely to start smoking cigarettes.
https://www.thetruth.com/artic... [thetruth.com]
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You're the douche bag,
Eating spinach is not safe, more diseases and deaths from that than of reported vaping issues thus far. Driving to work is not safe, more deaths and maimings than that from vaping.
Most vapers changed from smoking to vaping, you're wrong about "significantly more likely to smoke". What nonsense.
Vaping is safer than smoking, studies show that.
Then you list a bunch of health issues that smoking will definitely do, without a shred of proof vaping would do.
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going this far out of your way to justify vaping...
Are you an employee of juul's PR department or something?
Re: lolz the summary proves the claim (Score:2)
It May be safter, but businesses can not legally say that unless they have submitted the proof.
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What a douche bag. Vaping is not safe.
OK, and that hits my major objection with TFA. Between the headline and the first paragraph, it switches between "Vaping is safe" and "Vaping is safer (than smoking)." That's an enormous difference. I don't know anything which I'd call "safe", where "safe" means "risk free". Water isn't safe, just ask the residents of Flint or Newark, or any drowning victim. Everything has risks and benefits and only individuals can decide for themselves whether the risk is worth the reward. So if TFA means to say "vaping i
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which is provably safer than smoking...over a million times safer than smoking
Then they need to prove it. That's all the FDA is saying.
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plenty of studies done over the years, vaping safer than smoking, if not absolutely safe. Raw greens in your salad have made the news more often with disease and death than vaping.
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plenty of studies done over the years, vaping safer than smoking, if not absolutely safe.
Then they should have no problems validating their claims to the FDA, but they still need to. The FDA isn't saying the claims are false, they are saying they haven't been properly verified.
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I don't get it (Score:2)
Public health investigators have yet to determine a specific cause, but have cited the use of both cannabis-related and nicotine vaping products from a number of companies as possible suspects.
Cannabis is a chill out drug . . . a "downer".
Nicotine is a hype up drug . . . an "upper".
Why should you mix the two? Won't they just cancel each other out, and leave you in a normal state?
Although I do remember that John Belushi died of a "Speedball"; a mix of cocaine (upper) and heroin "downer".
My drug education has been highly neglected.
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The lung injuries are due to illicit thc vaping cartridges containing Vitamin E oil
this is because the black market does not operate with any safety in mind, only profits
the only way to address this is legalization and regulation of the supply chain
fyi, anybody who has been injured, who claims they did not use the thc cartridges, are most likely lying to avoid criminal charges
Re:I don't get it (Score:5, Informative)
Also, THC is not a downer, i.e. it does not suppress the central nervous system and no quantity will suppress autonomous breathing functions like any actual downers (this is what makes them deadly).
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For a second I read that as "died of a Spaceballs" and thought Rick Moranis was in some kind of trouble.
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Why should you mix the two? Won't they just cancel each other out, and leave you in a normal state?
Because people are idiots and make poor choices? Or, less snarky, because each drug has other effects which aren't canceled out? THC causes euphoria, among other things, not just chill. And the munchies.
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Although I do remember that John Belushi died of a "Speedball"; a mix of cocaine (upper) and heroin "downer".
My drug education has been highly neglected.
Too much of either a downer (like alcohol or opiates), or a stimulant (like nicotine or cocaine) will kill you. And no they don't cancel each other out.
It's next to impossible to overdose on THC (though most any psychoactive drug can create a level of impairment that causes you to do something else fatally stupid), so it's kind of unique in the drug world . Many would argue that is a good thing.
It's worth a smackdown (Score:3)
Under federal law, companies are not permitted to market products as safer than cigarettes or a safe alternative without proving those claims to the F.D.A.
But, the agency pointed to specific allegations that would show Juul in violation, including congressional testimony that a Juul representative spoke at a school presentation and told students that Juul "was much safer than cigarettes," and Juul was "totally safe."
\o/ (Score:1)
Carrots. Safer than cigarettes? Or receive a fine?
A suspicious-minded individual might intuit that this benefits the cigarette industry. This same individual might also wonder why it's apparently considered acceptable to prey on those individuals unable to resist expensive marketing campaigns intended to promote an addictive product which once taken up is
Perfection is the enemy of the good. (Score:1)
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That's just too much work. I prefer "Good is the enemy of I'll do it tomorrow".
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Who cares what you'll "hear out". It's none of your damned business what other people choose to do.
It should be against the law to advertise this... (Score:4, Interesting)
I would like to see, across the board, no more marketing for drugs in the United States.
If someone needs something, doctors should be recommending things to their patients. Not the other way around. Not through mass marketing.
--
America's health care system is neither healthy, caring, nor a system. - Walter Cronkite
Is Juul nicotine from tobacco? Or not? (Score:2)
If Juul's nicotine isn't from tobacco the FDA has no jurisdiction. The FDA specifically references 21 387a, which is for tobacco products only. In fact it may not even cover nicotine itself, even if it is derived from tobacco.
https://uscode.house.gov/view.... [house.gov]
'This subchapter shall apply to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other tobacco products that the Secretary by regulation deems to be subject to this subchapter.'
Re:Is Juul nicotine from tobacco? Or not? (Score:4, Interesting)
Yes, that is why, when it is currently applied to strips of cardboard with nicotine solution applied to them (Snuz) and nicotine gum, neither can claim to be safer than tobacco
The gum (for some reason) can be sold as a nicotine cessation product, although I used nicotine gum for about 5 years unsuccessfully trying to quit.
I totally kicked the nicotine habit by vaping self-mixed tapered solutions (got a big bottle of zero nicotine solution, then added it to vape as needed to thin out existing solution with nicotine in it). Quitting nicotine was totally painless, and if I felt a strong urge to smoke, I wold just vape the zero nicotine solution, thereby completely alleviating nicotine addiction as well as the habit of smoking.
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https://uscode.house.gov/view.... [house.gov]
'This subchapter shall apply to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other tobacco products that the Secretary by regulation deems to be subject to this subchapter.'
Well, if you're going to get all technical about what the statute actually says, we're never going to get anything done.
Before you know it, you'll demand Congress amend the statute so as to be clear on their actual intent. What a noob! How are they going to split their time between fundraising and grandstanding if they're bogged down with legislation and briefs and boring details?
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Interestingly enough, nicotine is present in many other plants of the 'Deadly Nightshade' family, would you suggest that the FDA regulate Tomatoes, Eggplant and Potatoes?
Re:Is Juul nicotine from tobacco? Or not? (Score:2)
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Actually, if it is already part of a widely used plant, it should be covered under the same statute as Nutraceuticals
Marketing not telling the truth? (Score:3)
Call me shocked!
What? It is. (Score:3, Interesting)
Vaping is safer than smoking. In the same way as, say, eating lead compared to eating uranium.
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Vaping may ve
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First Rule: Water Soluble (Score:4, Informative)
The two primary rules of e-cig juice...
- everything is water soluble
- everything is food save
Considering how little nicotine it take to make a person violently nauseous, in this context, nicotine is food safe (as long as some toddler doesn't drink the bottle of the juice).
Vitamin E oil AND THC are not water soluble. That is the whole fucking problem.
Is Digital Marketing really Wokrs to Grow Bussines (Score:1)