FDA Denies Authorization To Market JUUL Products (fda.gov) 93
Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to JUUL Labs for all of their products currently marketed in the United States. From a report: As a result, the company must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or risk enforcement action. The products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%. Retailers should contact JUUL with any questions about products in their inventory.
"Today's action is further progress on the FDA's commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards," said FDA Commissioner Robert M. Califf, M.D. "The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping." Further reading: Biden Administration Targets Removal of Most Nicotine From Cigarettes.
"Today's action is further progress on the FDA's commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards," said FDA Commissioner Robert M. Califf, M.D. "The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping." Further reading: Biden Administration Targets Removal of Most Nicotine From Cigarettes.
Must be serious if they did it twice. (Score:2)
Re: (Score:2)
Re: (Score:2)
The dupes on slashdot are the result of parallel dimensions occasionally intersecting.
sigh (Score:2, Informative)
dupe of story still on front page, only like three stories down [slashdot.org]
This is why nobody respects the Slashdot "editors"
or Slashdot
Re: (Score:1)
Re: (Score:2)
Yep. Just update the story with the link.
Bring Back Youth Smoking! (Score:2, Troll)
Now it will be easier for teens to get cigarettes than vapes, which most people find more offensive smelling and cause more problems, both health and to others such as the litter of cigarette butts.
This feels like two steps backward since the "TRUTH" kids have now come of age and are lobbying for the ban of anything that has any relation to tobacco; and ma
Comment removed (Score:4)
Re: (Score:3)
Re: (Score:3)
But they were advertising to kids, which the other brands are not. Despite repeated warnings and fines, they continued advertising to kids because it was profitable. Now they don't get to sell their products at all, but the other companies' products are still on the shelves.
Why are you defending the one company that's gotten smacked down because of their flagrant violation of advertising practices? What makes you think kids will ask for cigarettes due to this one company's products being banned when so m
Re: (Score:2)
What makes me think they'll ask for cigarettes? Most of the other vape products taste really bad in comparison, there's a reason why Juul was successful, they offered the most palatable vape product.
Nobody is paying me, I own no interest in any companies selling Juul, no stock in Altria or
Re: Bring Back Youth Smoking! (Score:2)
Are you dense? They haven't banned vaping. They've banned one particular manufacturer from selling vaping products. So there's no slippery slope here. Vaping can continue to be a fine alternative. You'll just need to buy a different brand of vape. You know, just like how If Kelloggs kept putting lead in their cereals and got banned, you could continue to buy cereal from Post, General Mills, etc without there being any sort of slippery slope.
Re: (Score:2)
Re: (Score:2)
Yes you mentioned camel...a company that stopped it's marketing decades ago, and dropped it mascot 25 years ago in response. They no longer do that. Should they have been banned at that time? Probably, as it would've set a great precedent that would hopefully prevent other companies (possibly even Juul) from doing the same. But that's in the past. Are you suggesting that because we didn't take action in the past we shouldn't do it now? That would be a ridiculous assertion that would prevent any form of soci
Re: (Score:2)
Note my other comments about other manufacturer's products being generally poor tasting and inferior, and Juul having a plurality of market share. And yes, this is part of an "anti-vaping" push, with vaping now being banned in numerous places. Flavors were restricted, I as an adult cannot buy a refillable vape with a mango flavor anymore, one has to go t
Re: (Score:2)
Juul also dropped its advertising campaigns that were far more subtle/less clearly targeted to kids than Joe Camel. Three years later, they're banned.
My lord, that is one of the most clueless comments I've ever seen. Far more subtle? LOL. For crying out loud, they paid schools $10k to let representatives come into the school and show kids how to smoke a Juul. Really fucking subtle! And they took out ads on websites for helping middle and high school kids with their homework. No, that's not clearly targetted to kids. I'm sure they thought those schools and websites were full of adults, not kids.
And 3 years? If I punch you in the face, you have 5 or more y
Re: (Score:2)
For crying out loud, they paid schools $10k to let representatives come into the school and show kids how to smoke a Juul..
Absolutely not true. They paid for schools to let them come and put in their "anti-vaping " curriculum. When I was in school, RJ reynolds paid the same to my school for their "Tobacco is Whacko, if you're a teen!" campaign. Both campaigns were so lame they made kids want to smoke or vape I"m sure, but the way you present is is false..no one was showed how to Juul.
I punch you in the face, you have 5 or more years to charge me with assault in most states..
Do you bother to Google stuff before you post it? This is totally wrong too. The multistate model penal code specifies a 1 year statute of l
Re: Bring Back Youth Smoking! (Score:3)
He is right though, vaping (regular vapes not cloud machines) was almost immediately added as something you cant do.
Yet it doesnt have the same stench or second hand smoke effects. Non smokers complained about the smell/2nd hand so smokers made a new method that had no fire risk, smell, or long lasting clouds, and STILL its immediately not allowed indoors.
As a non smoker I see the bait and switch. The complaints changed when the product changed. Now its just "cheating" any smoking bans and added to all the
Re: (Score:2)
As a non smoker I see the bait and switch. The complaints changed when the product changed. Now its just "cheating" any smoking bans and added to all the restrictions.
Nothing will placate the "we must ban it!" people. They are mentally ill.
Re: (Score:2)
Are you dense? They haven't banned vaping. They've banned one particular manufacturer from selling vaping products. So there's no slippery slope here.
Absolutely. Anyone who wants to vape will continue to do so with the many alternatives. Even kids who wanted a Juul but will now have to use something else.
Good thing they solved the problem. Whatever it was.
Re: (Score:2)
Re: (Score:3)
Camel does not have a cartoon mascot. He was retired 25 years ago because of backlash because people saw it as marketing to kids. RJR took the right steps and stopped using it. [corporatea...bility.org]
Juul was/is doing the same thing, but rather than stop marketing to kids, they just keep on doing it. Now the FDA is taking action.
Re: (Score:3)
Re: Bring Back Youth Smoking! (Score:3)
In my experience the store owners who knew me and my mom were less like to sell tobacco to me and more likely to tell on me for trying. Nice try Fox News.
Re: (Score:2)
Re: (Score:2)
Then stop living in a fake Fox News reality where evil brown bodega owners get innocent young children hooked on tobacco.
Re: (Score:2)
Re: (Score:2)
Re: (Score:2)
Yup. Legitimate businesses can have their licenses revoked and, if that fails, be shut down entirely. I never took up smoking. But when I was under 21, it was easier to get pot, shrooms, acid, ecstasy, and even (If I'd been able to afford it.) cocaine than it was to get alcohol. That's one of the things that convinced me... very early on... of the absolute utter stupidity and uselessness of the war on drugs and all of its actors and proponents.
Re: (Score:1)
They actively tried NOT to market to teens, and this will do nothing to stop teens from consuming nicotine. It will just drive them back to less-healthy alternatives that are more readily available, like cigarettes or one of the other dozen disposable vape manufacturers. Or non-disposable vapes, which have even better flavors but are harder to control dosing.
This is stupid theater by stupid people who stupidly like to pretend they're making a difference.
Re: (Score:3)
No, it's being banned because the FDA won't accept their safety tests. Really this is the only way government can ban vaping, with ridiculous research requirements. No fucking way can a party get a ban through congress without hurting themselves.
Hurray for regulatory agencies making political decisions and media standing around pretending that's not what is happening ... when I agree with them.
Re: (Score:2)
They're just busy pushing everyone to do cannabis and proceed to abuse of prescription drugs.
Cigarettes are so 20th century, you have to soma harder, citizen!
Re:Bring Back Youth Smoking! (Score:4, Funny)
They're just busy pushing everyone to do cannabis and proceed to abuse of prescription drugs.
I forget, does it go Pot > Pills > Heroin > Pedophilia > Murder? Or is Pot > Pedophilia > Heroin > Pills > Murder? I can never remember which comes first.
Also, piss off with this "gateway drug" bullshit. The only crime that is preceded by pot is the willful destruction of a Cheeto bag.
Re: (Score:1)
For my late friend, it was Pot > Meth > Death.
It may or may not be a gateway drug for you, but piss off with your BS. Not everybody ends at pot and a Cheeto bag. For some, the end result is a body bag.
Re: Bring Back Youth Smoking! (Score:2)
More like child abuse > pot > meth > death. That's how that cycle usually goes so fu with your bs.
Re: (Score:2)
Re: (Score:2)
Pot > Munchies > Obesity > Metabolic Syndrome > Death.
The fix I'd recommend: healthier Munchies.
Only half-joking.
Re: Bring Back Youth Smoking! (Score:2)
It goes pot > murder/suicide.
Re: (Score:2)
They're just busy pushing everyone to do cannabis and proceed to abuse of prescription drugs.
I forget, does it go Pot > Pills > Heroin > Pedophilia > Murder? Or is Pot > Pedophilia > Heroin > Pills > Murder? I can never remember which comes first.
Also, piss off with this "gateway drug" bullshit. The only crime that is preceded by pot is the willful destruction of a Cheeto bag.
The bullshit is that all the cool kids are trying to ban cigarettes - or electronic things that just sorta look like cigarettes - but at the same time somehow smoking pot is just wonderful.
Re: (Score:2)
The bullshit is that all the cool kids are trying to ban cigarettes - or electronic things that just sorta look like cigarettes
Way to change the subject. Anyway, who are these "cool kids" you're referring to? Are they the same "cool kids" from the 90s that got Joe Camel "Cancelled"? Or have we passed it on to the next generation? Getting tobacco companies to stop intentionally marketing to teenagers isn't a new concept.
but at the same time somehow smoking pot is just wonderful.
They are regulating the pot industry exactly the same. In Michigan it's illegal to have any packaging depicting food, animals, or cartoon characters. Does that sound familiar? There isn't a (serious) person on
Re: (Score:2)
Smoking tobacco has been demonized for decades. Smoking pot has been celebrated (by the hip) for decades, and now is not only legal but subsidized by the state.
And yes, it's the same political/social groups that push both stances. But you know this.
Re: (Score:2)
There is some key differences.
It is targeting a Company for bad practices, not the Vaping industry at large. Stores can get closed down if they sell Alcohol to minors, this isn't a ban on Alcohol but to the business who sell to children.
Juul basically marketed their products to kids to get them hooked on nicotine, at the worst time in development where habits that go into adult life are formed.
You can still vape, just not with Juul Products.
Re: (Score:3)
Nonsense, a good practice. Any teen would be a million times better off vaping mainstream product than smoking. There is zero evidence vaping is harmful.
I even saw some do-gooder here claiming nicotine increased cancer risk. Zero peer reviewed evidence of nicotine causing cancer.
Any of you who smoke should take up vaping instead. No known problems with major commercial vape.
(nope I don't vape nor smoke, but evidence and science is quite clear)
Re: Bring Back Youth Smoking! (Score:1)
You have to find out who is sponsoring/lobbying the FDA and the current administration. Both entities have long and old ties with both drug companies and tobacco companies.
Juul and similar vape products are a threat to both types of companies, they generally are used to bring small amounts of either or both nicotine and THC, both help with minor aches and pains, depression and other mental health. But the Feds rather have you hooked to opioids than vapes.
Re: (Score:3)
Peer reviewed studies say otherwise [nih.gov]:
"Nicotine is well known to have serious systemic side effects in addition to being highly addictive. It adversely affects the heart, reproductive system, lung, kidney etc. Many studies have consistently demonstrated its carcinogenic potential."
That said, without a doubt vaping is better than smoking.
Re: (Score:2)
Unproven "carcinogenic potential" is vague hand waving, no cancer known to have come from nicotine, ever. Zero. You'll note that solely vaping users are not having the cancers and emphysema that smokers are. I'd be more scared for someone who does charcoal grilling a lot.
Nicotine is very similar to caffeine, let's get excited about coffee or tea? Read up on what happens to body builders who high dosed on caffeine back in the day, damn that's scarier stuff than what any vaping user has had.
Vaping of main
Re: (Score:2)
You are using sophistry. As if cancer is the only bad thing that can ever happen to a person. It's a trash rhetorical technique. Learn to think.
Re: (Score:2)
Not at all, I'm using the TRUTH that zero bad health effects from vaping or nicotine gum have ever been proven.
Vague hand waving nonsense and scaremongering do not constitute proof of any harm. We can prove cigarettes are harmful, we can prove breathing charcoal smoke day after day in a job is harmful. We cannot prove nicotine use without combustion such as in vaping or nicotine gum is harmful.
Re: (Score:2)
Not at all, I'm using the TRUTH that zero bad health effects from vaping or nicotine gum have ever been proven.
Oh great, now you're even worse. I give you multiple peer reviewed studies that show there are bad health effects from vaping, and you pretend those don't exist. Seriously, turn your brain on.
Re: (Score:2)
You're an ignorant liar, nothing certain was show by any of those studies except possible link in mice and hamsters.
There is zero evidence of nictotine in humans causing cancer or any other disease in the doses normally used by vapers and smokers. The cancer from smoking is from dozens of other things.
Re: (Score:2)
If a solution is not perfect, 100% guaranteed it is as good as having absolutely no solution, correct?
Re: (Score:2)
Re: (Score:3)
Do you have anything to say about: If a solution is not perfect, 100% guaranteed it is as good as having absolutely no solution, correct?
Re: (Score:3)
Because banning things from youth has been so successful historically.
It really has. You can trend directly the successes of banning the marketing of products to children with a reduction in their uptake. And that's all Juul is in trouble for here.
Now it will be easier for teens to get cigarettes than vapes
Why would it be easier to get cigarettes than vapes just because one shitty company has been blocked for their shitty behaviour? You know Juul isn't the entire industry right? Hell they only make up a fraction of the e-cig market now compared to what they had in 2018.
Your comment is like saying people will be switching to from PCs t
Re: (Score:2)
First, you're sorely mistaken, Juul is 42% of the most recent market share data for vaping in the US. Second, You clearly have no experience with the nasty "nicotine salts" and imitation Juul vape products sold as alternatives.
Finally your analogy is a bit flawed -- This is more akin to saying now Macs are banned, and the closest alternative is a jury-rigged PC running FreeBSD within an OSX-style window manager. Or, flavors of beer are banned and you can only drink Coors Light.
More evidence that "editors" don't read... (Score:2, Flamebait)
Maybe take a scan of your own front page [slashdot.org] before accepting a submission?
Not that griping about it will change anything, since you guys have been doing the same shit for over 20 years...
Re: (Score:2)
How else is /. going to maintain comments/"engagement" with its ever-dwindling supply of forum members?
A: do stupid shit like this...constantly.
Re: (Score:2, Informative)
Re: (Score:2)
Not a good comparison (Score:1)
All I'm gonna say is that it seems wrong to compare a national security issue to a bit more flavorful vape juice as far as what should be blocked.
If there are so many other options then it wouldn't matter if JUUL stayed as one more.
Re:Resist (Sorry but you're wrong) (Score:2)
Bottom line? They *are* some "unique drug" insofar as they're the inventors of the technology and have licensed it out to all other e-cig makers/distributors. Any legal actions against Juul (the brand) can easily ripple to all other commercial brands.
Re:Resist (There's nothing to resist) (Score:3)
Second: It is the *marketing* authorizations of the products which have been revoked. In other words, they cannot be marketed and sold as-is. In the future, their inventory needs to get updated with large legal statements like, This produc
Re: (Score:3)
Re: (Score:2)
Re: bioavailability -- per Wikipedia (https://en.wikipedia.org/wiki/Fentanyl) there's a nice chart under the section heading "Pharmacokinetic (PK) data
Bioavailability 92% (transdermal) 89% (intranasal) 50% (buccal) 33% (ingestion) 100% (intramuscular) 55% (inhaled)
It's true that various methods result i
Todays headlines (Score:4, Funny)
So according to the headlines today, I can carry a Sig but not an E-cig?
Re: (Score:3)
Founders probably would've added another right to be stupid to the bill of rights if they'd only realized.
Re: (Score:3)
No, you can buy as many E-cigs as you want, you just can't buy Juul ones.
This decision doesn't affect the other E-cig manufacturers.
This seems like a bit of a surprise... (Score:3)
Given Phillip Morris' decades of experience tangling with the FDA I would have assumed that they would either have thrown together a product application sufficiently intimidating to buy at least a number of years of additional time on the market while lawyers thump on about regulation being 'arbitrary and capricious' or given it up as a bad job, if they thought that the data were really that unflattering, and cooked up a contingency plan of some kind.
Since that didn't happen; and they went ahead and filed the application and received a denial; I have to wonder if someone on the FDA side grew a surprise spine; or if there was share price or similar financial-engineering incentive to keep things looking externally normal even once the senior FDA-whisperers came to the conclusion that the outlook was not good.
Re: (Score:3)
Re: (Score:2)
I suppose it is possible that the loss was just an expected part of the process; since
Re: (Score:3)
Other companies who do bad things, that normally should be saved for adults to make the decision. May target children, but they will be more subtle. For example they will target the Young Adult Market, Say with Bikini clad women, buff shirtless men, all having a fun at a beach party enjoying such a product. Which kids who are aspiring to be like these young adults would be attracted to said products. However, it is still targeted toward young adults and not kids.
Most kids when they start drinking or smok
Re: (Score:2)
Were they really marketing them to kids... or to anyone else for that matter... though? I know who Juul are, of course. But the only reason I do is because of all the controversy about them in the news. And I can't recall seeing even one actual advertisement by or for them at all... anywhere... ever... over the last few years I've been aware of their existence.
The Nanny state in FULL effect (Score:1, Troll)
working with government employees (Score:3)
Checking the logic here... As a co-worker of a government employee, that would also make you a government employee, right? Are you also dumb as toast or is there possibly an exception to the stated rule?
Slashdot editors deny being competent (Score:1)
Give your job to someone who *wants* to do it.
Update the tobacco legislation (Score:3)
That is in part because e-cigs continue to lack sufficient regulation in terms of advertising (including social media), nicotine strength, nicotine delivery (nicotine salt / free nicotine), flavours & other chemicals, form factor, tax, point of sale, no-smoking law etc. Countries need to crack down hard on all this and other future tobacco products. Bring it all under one umbrella with ultimate goal of eradicating the habit entirely.
Re: (Score:1, Troll)
Ok, Boomer.
Re: (Score:2)
Ok, Boomer.
Can you please stop it with that shit? You're making our generation look like morons. If you're too dumb to actually have a comeback or a counterpoint, why not just save yourself embarrassment and simply not post.
Re: (Score:2)
Since you asked so nicely, here you go:
"The object of this Essay is to assert one very simple principle, as entitled to govern absolutely the dealings of society with the individual in the way of compulsion and control, whether the means used be physical force in the form of legal penalties, or the moral coercion of public opinion. That principle is, that the sole end for which mankind are warranted, individually or collectively, in interfering with the liberty of action of any of their number, is self-prot
Re: (Score:2)
Banning one brand of eCig does absolutely nothing to help, and pushes people back to less-healthy versions of nicotine like cigs. Until you ban actual cigarettes, this is all just bullshit theater.
Re: (Score:2)
Ban the dangerous stuff first
They are. Right now they are specifically banning a rogue actor who stands out in the industry as advertising to minors. Now that these thundercunts are banned we can go back to looking at other things which are bad for you. The fact you don't see that Juul specifically reversed the trend of decline in smoking in youths seems to be a major oversight on your behalf.
and pushes people back to less-healthy versions of nicotine like cigs
It does nothing of the sort. If Toyota recalls cars that doesn't mean people say "I'm going to buy a bicycle instead". If people are smoking e-ci
Re: (Score:2)
And cracking down won't push back people to smoking cigarettes. The issue is that e-cigarettes have spawned a new generatio
Their site emphasizes combating underage smoking (Score:2)
I know nothing about them and am not a smoker but I just looked at their site which I take it is jullabs.com. It seems they are taking it seriously.
Combating Underage Use
No one underage should use JUUL products or nicotine in any form. Data in the U.S. show rates of underage use of our products that are unacceptable. We are working to reverse this trend by focusing on restricting access to our products and limiting appeal of our products.
Over the past few years trust in our company and category has eroded.