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Judge Gives E-Cigarette Makers 10 Months To Seek FDA Review (bloomberg.com) 89

Posted by BeauHD from the time-is-ticking dept.
An anonymous reader quotes a report from Bloomberg: E-cigarette companies such as Juul must submit applications to U.S. regulators by May 2020 to keep their vaping products on the market, a federal judge ruled Friday. The ruling was the result of a court case brought by anti-tobacco and public-health groups after the FDA had delayed an earlier application deadline. The groups argued that the agency had abdicated its duty to regulate the products, which have been blamed for a rise of youth use of vaping products. A company's e-cigarettes will be able to stay on the market for up to one year while the FDA considers its application, according to the order. In anticipation of having to move more quickly, the FDA issued a guideline last month to help e-cigarette makers craft their applications. "Given the uncertainty in the efficacy of e-cigarettes as smoking cessation devices, the overstated effects that a shorter deadline may have on manufacturers, the industry's recalcitrance, the continued availability of e-cigarettes and their acknowledged appeal to youth, and the clear public health emergency, I find that a deadline is necessary," U.S. District Judge Paul Grimm wrote in his order.

Juul said it was supportive of the application process and had been preparing research on its products and how they're used by smokers. "We're confident in the content and quality of the materials we will submit with our application," said spokeswoman Lindsay Andrews.
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Judge Gives E-Cigarette Makers 10 Months To Seek FDA Review More

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

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  • I'm all for regulating e-cigs so long as tobacco cigarettes are held to the same standard.

    • Re: Can we get the same standards for tobacco? (Score:4, Insightful)

      by jdawgnoonan ( 718294 ) on Saturday July 13, 2019 @09:31AM (#58918938)
      No doubt. What is annoying are the Prohibitionists who want to protect everyone from themselves and treat e-cigarettes like they are the same as combustible cigarettes vs the tobacco industry which is attempting to shut out the smaller players in the ecig market by playing off the Prohibitionists. I am a 20 year cigarette smoker who quit and I know plain well based on my own body that e-cigarettes did not harm my body like cigarettes did, as my body felt like it does as a non-smoker within a few weeks of switching. I used e-cigarettes for about a year. It was also much easier to quit the e-cigarettes than it was to switch from analogues.

      • Re: Can we get the same standards for tobacco? (Score:5, Insightful)

        by sjames ( 1099 ) on Saturday July 13, 2019 @10:36AM (#58919182) Homepage Journal

        There is a significant faction of prohibitionists for whom the e-cig is their worst nightmare. The e-cig lets smokers give up the nasty health effects of smoking without giving up the enjoyment of niicotine! What an unspeakable horror for the faction that really just wanted to spoil people's enjoyment and wield power over them using the health effects as an excuse!

        For the people who were genuinely concerned about the health effects of smoking, the e-cig is a big win. Perhaps a total victory, perhaps it falls a bit short of that (the research on that is far from complete) , but certainly the e-cig has done more than patches and gum to get people to stop smoking.

        As for the moral panic over teens using Juul, surely that's better than having them smoke to be 'cool'. For the rest, stricter enforcement of the restrictions on sales to minors would seem the way to go, including requiring any credit card purchace to clearly identify the product as an e-cig so parents can act (or not) as they deem appropriate.

        As for Juul itself, it's pretty much the bottom of the barrel as e-cigs go.

        • Re: (Score:2, Informative)

          by Anonymous Coward

          The argument is rarely that E-Cigs are as bad as regular cigs. It i pretty well assumed they aren't nearly as bad, but that doesn't make them OK. Certainly as a smoking cessation aid they can be a big positive. But we've achieved a great reduction in young people ever even starting smoking cigarettes, and it appears some of them who wouldn't smoke a cigarette are now choosing to smoke E-Cigs. That's a bad thing given that E-Cigs do appear to have legitimate health risks, not a 'moral panic' and therefore s

          • Re: (Score:2)

            by sjames ( 1099 )

            It *IS* a moral panic given that the number of teens ACTUALLY vaping is rather small. You'll note that I did suggest tighter regulation of sales to minors as a way to address those issues. It is true that less teens are smoking these days, but where's the evidence that the teens vaping wouldn't have otherwise chosen to smoke? Or, the more realistic question, the evidence that more teens who would never smoke are using e-cigs that teens who would smoke if they couldn't vape?

            But if the problem really is under

          • Re: (Score:1)

            by Anonymous Coward

            The argument is rarely that E-Cigs are as bad as regular cigs......

            Every single Add I see or hear from the anti vapers basically does say that, and while usually not explicitly stated, it is implied by the heavy handed hyperbolic language they use.

        • As for the moral panic over teens using Juul, surely that's better than having them smoke to be 'cool'.

          That's false logic. Before the e-cigarettes specifically marketed toward teens, cigarette smoking had all but been completely wiped out among that age group. The popularity of e-cigarettes has actually increased the rate at which teens smoke regular cigarettes and use other forms of tobacco.

        • There is a significant faction of prohibitionists for whom the e-cig is their worst nightmare. The e-cig lets smokers give up the nasty health effects of smoking without giving up the enjoyment of niicotine! What an unspeakable horror for the faction that really just wanted to spoil people's enjoyment and wield power over them using the health effects as an excuse!

          The problem is that there are nasty health effects to e-cigs. They are just different than tobacco and no one should claim otherwise. The point of e-cigs originally was not to replace cigarettes with e-cigs permanently. They were to temporarily provide nicotine to a person while the person was quitting smoking (and nicotine) altogether.

          For the people who were genuinely concerned about the health effects of smoking, the e-cig is a big win. Perhaps a total victory, perhaps it falls a bit short of that (the research on that is far from complete)

          Describe total victory [lung.org]: "A recent study from the University of North Carolina found that even in small doses, inhaling the two primary ingredients found in e-cigarettes

          • Re: (Score:2)

            by sjames ( 1099 )

            I followed up on the UNC study. They exposed embryonic kidney cells to a growth medium containing 10% PG/VG mix and 1% of the pure flavoring ingrediants. That's WAY more than mature lung tissue will see from an e-cig. It's like saying water is deadly. When we force fed rats 10 gallons of water over a 5 minute period...

            I'm not claiming e-cigs are health food, but they're nowhere near as harmful as cigarettes either. Since it appears that menthol and cinnamon are commonly found to be the more harmful flavorin

        • Whatever legitimate health concerns there might me with e-cigs, the biggest losers stands to be Big-tobacco .I would be extremely surprised if much of the push-back against e-cigs is not funded directly or covertly by Big-tobacco.

        • As for the moral panic over teens using Juul, surely that's better than having them smoke to be 'cool'.

          But smoking already wasn't cool. Cigarette use in teens was down to 12% before the Juul. Now eCig use is at 20% and rising. Further, only 1 in 8 teens even know that ecigs have nicotine.

          It's not "should kids smoke cigarettes or puff a Juul", its "we've succeeded in making smoking uncool, now theres something replacing it."

          And, frankly, there's for more data that suggest ecigs keep people from quitting s

    • as a tobacco cessation device. I would assume if Juul would completely drop (and perhaps go to length to make clear in advertising) all notion that vaping can be used for that purpose then they could settle out of court and call it a day, but it's probably worth way, way more to go through FDA review.
    • [sarcasm]Maybe they should even regulate tobacco [wikipedia.org] with multiple agencies. Like the FDA and maybe another one just for tobacco and throw in alcohol and firearms in there. Let's call it Firearms, Alcohol, and Tobacco. No that's a terrible acronym. How about ATF [wikipedia.org]. [/sarcasm]
  • Let's make vaping nicotine illegal and get these people back on the obviously safer cigarettes, just as old money capitalism always wanted. If you must, think of the children.


    Did poes law strike again? Leave your thoughts in the comment section...

  • All thanks to vaping - back in the days when there were no stupid regulations. If I were to do it now with the current witchhunt on vaping products, I don't think I would've even started.

    It's complicated enough for a smoker to get used to a mod, atomizers, juices and whatnot. But with the current "tobacco products" restrictions imposed on vaping products nowadays here in Europe, you have to be really dedicated to switch to vaping.

    Thanks Big Tobacco and Big Pharma. I hope none of the extra deaths you're cau

  • Nicotine without tar ... (Score:5, Informative)

    by Rip!ey ( 599235 ) on Saturday July 13, 2019 @10:34AM (#58919176)
    I quit cigarettes in 2015. The intention was nicotine without tar, as I'd accepted that I could not quit. Cold turkey, nicotine gum, two courses of Champix, hypnotherapy, none of that worked. And so I ordered an e-cig online.

    It was a basic model, and as a West Australian, I can't buy liquids with nicotine locally, so everything came from Europe and the U.S. The basic model soon became something bigger, and the nicotine was soon arriving as 10% 1 litre solution bottles, watered down according to my preferences via phone apps like Steam Engine. I went through a lot of mods and tanks until I settled on a 5 Pawns Kayfun Light tank with a Joytech mod with my own rolled coils and wicks.

    In short, rather than chasing clouds, I sought out an experience that matched my cigarette draw. And over the course of a year, I dropped the nicotine levels towards zero until I was puffing like mad on an e-cig with no nicotine. By that time I had broken the physical habit of pulling out a cig, lighting it, and smoking. E-cigs are different. Rather than puffing like mad for 3 minutes, you puff a little, often and always.

    I puffed like mad on an e-cig with no nicotine for 7 months after I hit 0%, before I put it down one day and forgot about it. It's been 3 years since and in that time I've had a pleurectomy via a thoracotomy, due to burst bullae on my lungs, that comes from emphysema as a result of my smoking. Thankfully, the shadow on my right lung turned out to not be cancerous. I can't smile enough.

    And so I have a few thoughts to share ...

    1. There's a lot of people taking up vaping who were never smokers. It needs to stop. Why?
    2. My time trialing different tanks and mods demonstrated to me that the PG/VG mix in high enough concentrations has an obstructive effect on the lungs. There's a reason I settled on a Kayfun light with a light draw at low amps.
    3. Youngsters definitely need to be prevented from taking up the habit, just as they need to be kept from starting smoking cigarettes.
    4. Smokers definitely need to be allowed access to e-cigs as a "quit aid" or replacement as a "nicotine without tar" aid.
    5. The health authorities in my home country need to stop denying the existance of people like myself who used e-cigs to successfully quit. They, just like the e-cig manufacturers themselves, have a financial interest in keeping things going. Both cigs and e-cigs.

    • Re: (Score:2)

      by Kiralan ( 765796 )
      Definitely needs a +5 Informative Mod!

    • There's a lot of people taking up vaping who were never smokers. It needs to stop. Why?

      For the same reasons that people become tobacco smokers.

      The health authorities in my home country need to stop denying the existance of people like myself who used e-cigs to successfully quit. They, just like the e-cig manufacturers themselves, have a financial interest in keeping things going. Both cigs and e-cigs.

      The tobacco industry knowingly lied for decades about the impact of their products, and yet they're still around... and effectively lobbying against e-cigs on one hand, while buying them up with the other. They want an expensive regulatory environment, to keep small new players out of the market.

    • Re: (Score:1)

      by Nexion ( 1064 )

      I had tried several, if not as many, quitting strategies and none had been as effective as a vape. You really hit it on the head how it changes the ritual of smoking, and I believe it is that coupled with slowly lowering the amount of nicotine that brings success. Eventually it becomes a real drag (heh) going out to puff on this thing that is doing little more than dehydrating you in the end. Sure, the exercise is good, but eventually it becomes a bother and you just drop it altogether.

      People who push again

  • From TFA:

    âoeGiven the uncertainty in the efficacy of e-cigarettes as smoking cessation devices, the overstated effects that a shorter deadline may have on manufacturers, the industryâ(TM)s recalcitrance, the continued availability of e-cigarettes and their acknowledged appeal to youth, and the clear public health emergency, I find that a deadline is necessary,â U.S. District Judge Paul Grimm wrote in his order.

    I'm trying to figure out what the "public health emergency" that the Judge sees ac

    • Re: (Score:2, Informative)

      by UnknowingFool ( 672806 )

      I'm trying to figure out what the "public health emergency" that the Judge sees actually is. E-cigs were invented more than fifty years ago,

      The judge is referring to the rising use of e-cigs today, not when the technology was created.

      smoking rates have been declining since well before their invention, and there's been no mysterious increase that can be blamed on e-cigs.

      Smoking cigarette rates have gone down. Vaping especially among teens is at record numbers. [drugabuse.gov] Essentially vaping has replaced smoking tobacco among teens.

      In other words, what's suddenly changed to make it a "clear public health emergency"?

      According to link:

      Reported use of vaping nicotine specifically in the 30 days prior to the survey nearly doubled among high school seniors from 11 percent in 2017 to 20.9 percent in 2018. More than 1 in 10 eighth graders (10.9 percent) say they vaped nicotine in the past year, and use is up significantly in virtually all vaping measures among eighth, 10th and 12th graders. Reports of past year marijuana vaping also increased this year, at 13.1 percent for 12th graders, up from 9.5 percent last year.

      • Smoking cigarette rates have gone down. Vaping especially among teens is at record numbers. [drugabuse.gov] Essentially vaping has replaced smoking tobacco among teens.

        Actually, if you read past the scary headline in your link and look at the underlying data [monitoringthefuture.org], you see that vaping nicotine is displacing use of tobacco, alcohol, narcotics of all types, and abused prescription drugs of all types.

        That seems like a net win to me, given the immense breadth of known problems with the above substances compared to what are generally murky conjectures about vaping nicotine.

        • That seems like a net win to me, given the immense breadth of known problems with the above substances compared to what are generally murky conjectures about vaping nicotine.

          And no one is saying that people should smoke tobacco, drink, or use narcotics instead of vaping. It is not a black or white choice. All things being equal, I'm pretty sure that doctors prefer you do none of the above including vaping. There are not merely murky conjectures about vaping: vaping puts chemicals into the body. There are no long term side effects known at this time.

          • All things being equal, I'm pretty sure that doctors prefer you do none of the above including vaping.

            That's nice and all, but we're not talking about doctors -- we're talking about teenagers. They're going to experiment, just like they always have. If you think you're going to kill/crush/destroy that experimentation through legislation, I suppose nearly 100 years [wikipedia.org] is about enough time to forget how that worked out. (Oh, except it hasn't been 100 years at all [wikipedia.org].)

            I for one am happy to see that they're gravitating away from stuff that's massively dangerous to stuff that's only debatably so.

            • That's nice and all, but we're not talking about doctors -- we're talking about teenagers.

              In this specific chain you brought up "you see that vaping nicotine is displacing use of tobacco, alcohol, narcotics of all types, and abused prescription drugs of all types." to which the data shows the emergency is specifically that teens are replacing one form of chemical use with another.

              They're going to experiment, just like they always have. If you think you're going to kill/crush/destroy that experimentation through legislation,

              Society (especially within regulations) doesn't have to allow a product that essentially has no regulations and may be the next potential harm to teenagers as well as adults

              I suppose nearly 100 years [wikipedia.org] is about enough time to forget how that worked out. (Oh, except it hasn't been 100 years at all [wikipedia.org].)

              Except that no part of the judge's order is an

  • They are attacking the lesser of two evils.
  • I guess originally the idea of vaping was to provide nicotine to cigarette smokers who needed some levels of nicotine while quitting. Nicotine without the other ingredients like tar should be healthier. The key is that quitting both was supposed to be the goal, not replacement of one addiction with another. Somewhere along the way some in the vaping industry realized that they could sell to brand new markets like youth who had never smoked cigarettes.

    • even if not quitting it is safer.

      as far as peer reviewed proper studies there is not one shred of evidence of vaping linked to cancer or other disease, only a bunch of "may"s

      • even if not quitting it is safer.

        The problem is that we don't know for sure that is entirely true. The effects of tobacco are not there but there may be still health risks.

        as far as peer reviewed proper studies there is not one shred of evidence of vaping linked to cancer or other disease, only a bunch of "may"s

        There are not many studies so far but I would not say there is zero evidence of health risks [lung.org].

        • A study from the University of North Carolina found that the two primary ingredients found in e-cigarettes—propylene glycol and vegetable glycerin—are toxic to cells and that the more ingredients in an e-liquid, the greater the toxicity
        • E-cigarettes produce a number o
  • Comment removed based on user account deletion

  • It doesn't seem very clear to me. The only reason any e-cigs are even half as damaging as regular ones is when they want to adhere to an established brand's flavor to the point that they add all the same unnecessarily toxic garbage the real ones have. It's pretty likely that e-cigs without that shit don't contribute to lung cancer *at all.* What you have left after that is handwringing about the nicotine, which is addictive, but doesn't really do much by itself that is harmful beyond the addiction itself. I

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