7 ms·

FDA suspends Juul ban as company appeals

24 points by kdamica 4y ago

Clubber 4y ago
The basic premise that Juul didn't, "submit sufficient evidence that they are safe," seem suspect in and of itself. How do you prove something isn't dangerous? I can prove it is dangerous with studies, but to prove it isn't dangerous seems like an impossible task.
- exabrial 4y ago
  What blows my mind is cigarettes are on the market but are _definitely_ not safe. They even say it on the box. And they REMAIN on the market! I think if people went at this with rational minds: * Discover side effects (via actual science, not the "vaping is melting your brains" commercials on TV) * List them on the box * Let people decide
  - namlem 4y ago
    If rational minds were allowed to prevail at the FDA, we would have had an Omicron booster months ago.
    - seper8 4y ago
      Who is stopping you getting an omicron booster? (I'm not aware of the current situation in the US btw, just know that it's perfectly possible to get a booster in the NL)
      - mikeyouse 4y ago
        OP is more interested in the reformulated vaccines from Pfizer/Moderna more specifically tailored to the Omicron variants rather than another shot with the original formulation which has showed waning efficacy against the newest strains.
      - coryrc 4y ago
        The FDA.
      - xyzzyz 4y ago
        The OP’s point is that in US (and also almost certainly in Netherlands), you’re not getting the omicron booster, you’re getting original Covid strain booster.
      - namlem 4y ago
        It hasn't been approved, no one is making it.
        ugjka 4y ago
        Moderna has a candidate that'll probably land on the market sometime around september
        Tostino 4y ago
        Which is a pathetic turnaround for what was supposed to be a technology quick to iterate with. I'd love to know where the holdup actually is.
        namlem 4y ago
        The hold up is with the FDA. The variant booster had been ready for months, it just takes a long time to approve.
    - mherdeg 4y ago
      I am fairly grumpy that we didn't get the Moderna SARS-CoV-2 vaccine for 2-5yos months ago. Waiting for Pfizer's data was such a strange policy choice. There may be something going on under the hood here I don't understand, but the behavior of VRBPAC has felt very strange to me.
      - bananapear 4y ago
        Are you not concerned that a lot of European countries stopped giving that one to people under 30 for safety reasons? (https://www.bmj.com/content/375/bmj.n2477 https://www.bmj.com/content/375/bmj.n2477)
        whizzter 4y ago
        If you look at the FDA press release it does seem like they seem to have mostly narrowed down the at-risk groups since, I guess they might've also tweaked dosages at this point. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children https://www.fda.gov/news-events/press-announcements/coronavi...
        vkou 4y ago
        The risk was very minor, and was in hindsight not worth waiting for. But now that the data is in, though, when your option is two vaccines, one with very minor risk, and one with even less risk, and they are both equally effective, it's obvious that you should prefer the latter.
      - whizzter 4y ago
        Not entirely sure about what this refers to, but.. 1: The Moderna vaccine is separate from Pfizer/Biontech even if they share technological base. 2: Moderna was discontinued for younger people (below 30yos) in at least some European countries due to slightly higher risk of myocarditis (even if the Pfizer vaccine had slightly lower efficiancy). Seems like both vaccines are allowed for smaller children in the US now. Over here they put the cutoff for the vaccine at 12-13yos iirc (my older kid got it but not my younger one).
    - vkou 4y ago
      It's only been two and a half years, we're still very early in this pandemic. I'm sure that a few more years, maybe a decade, when everyone who understands vaccines are confident that the entire category of COVID vaccines is safe and effective, we'll have a flu-like assembly line producing new vaccines for the deluge of new variants we'll be facing.
  - HWR_14 4y ago
    > What blows my mind is cigarettes are on the market but are _definitely_ not safe The FDA is allowed by law to regulate vapes. The Supreme Court ruled that the FDA wasn't allowed to regulate tobacco. Congress fixed the SC's complaint and since then the FDA has been moving slowly to prevent another (harder to overcome) legal issue from the SC or to lead to prohibition. That's why the FDA is suddenly proposing rules limiting nicotine and menthol flavoring in cigarettes.
  - BitwiseFool 4y ago
    Cigarettes and other tobacco products predate the FDA by hundreds of years and despite the harm they are known to cause, they're essentially 'grandfathered in' because of cultural inertia.
- HarryHirsch 4y ago
  Come off it, please. Juul took out patents showing that their vape had a psychopharmacology similar to cigarettes, which everyone knows are hugely addictive. Juul needs to be killed dead.
  - atestu 4y ago
    If the effects are similar to cigarettes that's an argument to keep it legal imo... otherwise you'd have to ban cigarettes too.
  - elmerfud 4y ago
    I would support this conclusion only if cigarettes, and other tobacco products were similarly banned. Since they're not, Juul should be treated the same. What it really comes down to is not equal protection under the law, it's big tobacco wants Juul gone.
    - mikeyouse 4y ago
      > What it really comes down to is not equal protection under the law, it's big tobacco wants Juul gone. This is nonsensical. "Big tobacco" owns Juul. And couching the shutting down of a company addicting kids to nicotine in terms of equal protection is.. bleh. https://www.cnn.com/2018/12/19/business/altria-juul/index.html https://www.cnn.com/2018/12/19/business/altria-juul/index.ht...
    - mrtranscendence 4y ago
      Juul is big tobacco; it's owned by Philip Morris.
    - HarryHirsch 4y ago
      Philip Morris has a 35 % stake in Juul, so they are at least "medium tobacco". Practically speaking, you can't ban cigarettes right yet, you'll have another Prohibition problem, but sooner or later the cigarette problem will solve itself, everybody agrees that cigarettes are disgusting. Juul on the other hand marketed itself to schoolchildren as a hip and safe alternative. That problem must be addressed.
- victorclf 4y ago
  Drugs and vaccines must have sufficient evidence that they are safe before being released to the public. If you want to know more about how they go about doing this, just read some of those studies.
- HWR_14 4y ago
  > I can prove it is dangerous with studies, but to prove it isn't dangerous seems like an impossible task. You don't see that you run the same damn studies but get a negative effect? You can even do it solely off p-value (but instead should do a more complex calculation based on the harms discovered, etc.) If your "is it dangerous" study shows it is with p < 0.05 = dangerous, p > 0.10 = safe, 0.05 <= p <= 0.10 = more study needed.
hoofhearted 4y ago
http://archive.today/E2mZs http://archive.today/E2mZs
photochemsyn 4y ago
This decision is hard to justify on the basis of scientific evidence of harm. Despite the tobacco industry's decades-long effort to deny the link between lung cancer and smoking tobacco, it seems well-understood that the combustion product benzo[alpha]pyrene plays a major role. This is one of the polycyclic aromatic hydrocarbons (5 rings in this case) which, after being processed by lung cytochrome p450 enzymes, will form mutagenic DNA adducts. Adducts that form in regions of the genome that control the cell life cycle can result in cancers, particularly if defects exist in normal DNA repair mechanisms. For example: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3268909/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3268909/ Some of the enzymatic activity resulting in conversion of PAHs to activated PAHs capable of binding to DNA appears to be promoted by nicotine and inhibited by THC, curiously enough, i.e. the cannabis-vs-tobacco smoke issue: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1277837/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1277837/ However, there's no benzo[a]pyrene or similar PAHs generated via vaping, it's just nicotine in an aerosolizable liquid (propylene glycol + glycerine) which doesn't seem to have any medical negatives. Juul also includes benzoic acid as a preservative to avoid microbial growth, however, which is something I'd avoid inhaling personally. Nicotine is indeed a highly addictive substance, but there seems to be no scientific reason to allow smoking plain tobacco while banning vaporized nicotine. I'd suggest removing the benzoic acid, which would of course shorten shelf life and perhaps require refrigeration, if anything.
- CarbonCycles 4y ago
  I agree with you...it's the additional factors that appear to be more muta/carcinogenic than the nicotine itself. Granted (as you said) nicotine isn't ideal. The amount of sugar and its related health effects IMO completely outweigh the impacts of nicotine. The large food corps are finding ways to make sugary food more addictive so you have populations of sugar addicts starting at a very early age...the entire picture is so very distorted.
- hash07e 4y ago
  [dead]
zzixp 4y ago
I'm honestly not sure at this point why Juul is on the chopping block. I'm a college student, and Juul took off during my sophomore year of high school. They absolutely marketed to teenagers and created a dangerous product, but they're no longer the biggest player in the game. By my senior year of high school, most kids had moved on to disposable vapes. From what I know, they're about the same price, you don't have to worry about recharging them (and having a teacher/parent ask you about your "usb stick"), and have the same number of hits Juul should absolutely be fined/etc for marketing to children and starting the vaping epidemic in high schools, but the FDA is years too late on that front
CarbonCycles 4y ago
Juul was especially targeted by the FDA as Juul's advertising and marketing was specifically targeting the younger crowd. There are other products on the market that are similar to Juul (i.e., RJ Reynolds vape products), but the marketing appears to be different in tone than Juul. On another note but relevant, there is an interesting conversation that is yet to be had with the Supreme Courts recent ruling on the EPAs overreach of executive power...the same argument could be made with the FDA.
mimikatz 4y ago
People have consumed Tobacco (I assume in the search of Nicotine) for centuries. There is obviously some human enjoyment and satisfaction in doing so. Transitioning from more harmful smoking to less harmful 'smoking' is good. Letting people choose unhealthy things to enjoy is good (assuming a decent risk calculation). The antivape movement seems so weird amongst the general social themes in the US to open up weed and in more fringe cases decriminalize more drugs.
andiareso 4y ago
It seems like FDA overreach. I mean I get that we don't want teens to get hooked on a bad habit, but.... sugar is marketed like crazy to toddlers, kids, teens etc. in a much more aggressive way and is by far more harmful in the long run. I don't vape anymore, but it was fun and passed the time. I'd much rather see FDA approved vape formulas than random suppliers with who knows what inside them.

24 points by kdamica 4y ago

The basic premise that Juul didn't, "submit sufficient evidence that they are safe," seem suspect in and of itself. How do you prove something isn't dangerous? I can prove it is dangerous with studies, but to prove it isn't dangerous seems like an impossible task.

exabrial 4y ago
What blows my mind is cigarettes are on the market but are _definitely_ not safe. They even say it on the box. And they REMAIN on the market! I think if people went at this with rational minds: * Discover side effects (via actual science, not the "vaping is melting your brains" commercials on TV) * List them on the box * Let people decide
- namlem 4y ago
  If rational minds were allowed to prevail at the FDA, we would have had an Omicron booster months ago.
  - seper8 4y ago
    Who is stopping you getting an omicron booster? (I'm not aware of the current situation in the US btw, just know that it's perfectly possible to get a booster in the NL)
    - mikeyouse 4y ago
      OP is more interested in the reformulated vaccines from Pfizer/Moderna more specifically tailored to the Omicron variants rather than another shot with the original formulation which has showed waning efficacy against the newest strains.
    - coryrc 4y ago
      The FDA.
    - xyzzyz 4y ago
      The OP’s point is that in US (and also almost certainly in Netherlands), you’re not getting the omicron booster, you’re getting original Covid strain booster.
    - namlem 4y ago
      It hasn't been approved, no one is making it.
      - ugjka 4y ago
        Moderna has a candidate that'll probably land on the market sometime around september
        Tostino 4y ago
        Which is a pathetic turnaround for what was supposed to be a technology quick to iterate with. I'd love to know where the holdup actually is.
        namlem 4y ago
        The hold up is with the FDA. The variant booster had been ready for months, it just takes a long time to approve.
  - mherdeg 4y ago
    I am fairly grumpy that we didn't get the Moderna SARS-CoV-2 vaccine for 2-5yos months ago. Waiting for Pfizer's data was such a strange policy choice. There may be something going on under the hood here I don't understand, but the behavior of VRBPAC has felt very strange to me.
    - bananapear 4y ago
      Are you not concerned that a lot of European countries stopped giving that one to people under 30 for safety reasons? (https://www.bmj.com/content/375/bmj.n2477 https://www.bmj.com/content/375/bmj.n2477)
      - whizzter 4y ago
        If you look at the FDA press release it does seem like they seem to have mostly narrowed down the at-risk groups since, I guess they might've also tweaked dosages at this point. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children https://www.fda.gov/news-events/press-announcements/coronavi...
      - vkou 4y ago
        The risk was very minor, and was in hindsight not worth waiting for. But now that the data is in, though, when your option is two vaccines, one with very minor risk, and one with even less risk, and they are both equally effective, it's obvious that you should prefer the latter.
    - whizzter 4y ago
      Not entirely sure about what this refers to, but.. 1: The Moderna vaccine is separate from Pfizer/Biontech even if they share technological base. 2: Moderna was discontinued for younger people (below 30yos) in at least some European countries due to slightly higher risk of myocarditis (even if the Pfizer vaccine had slightly lower efficiancy). Seems like both vaccines are allowed for smaller children in the US now. Over here they put the cutoff for the vaccine at 12-13yos iirc (my older kid got it but not my younger one).
  - vkou 4y ago
    It's only been two and a half years, we're still very early in this pandemic. I'm sure that a few more years, maybe a decade, when everyone who understands vaccines are confident that the entire category of COVID vaccines is safe and effective, we'll have a flu-like assembly line producing new vaccines for the deluge of new variants we'll be facing.
- HWR_14 4y ago
  > What blows my mind is cigarettes are on the market but are _definitely_ not safe The FDA is allowed by law to regulate vapes. The Supreme Court ruled that the FDA wasn't allowed to regulate tobacco. Congress fixed the SC's complaint and since then the FDA has been moving slowly to prevent another (harder to overcome) legal issue from the SC or to lead to prohibition. That's why the FDA is suddenly proposing rules limiting nicotine and menthol flavoring in cigarettes.
- BitwiseFool 4y ago
  Cigarettes and other tobacco products predate the FDA by hundreds of years and despite the harm they are known to cause, they're essentially 'grandfathered in' because of cultural inertia.
HarryHirsch 4y ago
Come off it, please. Juul took out patents showing that their vape had a psychopharmacology similar to cigarettes, which everyone knows are hugely addictive. Juul needs to be killed dead.
- atestu 4y ago
  If the effects are similar to cigarettes that's an argument to keep it legal imo... otherwise you'd have to ban cigarettes too.
- elmerfud 4y ago
  I would support this conclusion only if cigarettes, and other tobacco products were similarly banned. Since they're not, Juul should be treated the same. What it really comes down to is not equal protection under the law, it's big tobacco wants Juul gone.
  - mikeyouse 4y ago
    > What it really comes down to is not equal protection under the law, it's big tobacco wants Juul gone. This is nonsensical. "Big tobacco" owns Juul. And couching the shutting down of a company addicting kids to nicotine in terms of equal protection is.. bleh. https://www.cnn.com/2018/12/19/business/altria-juul/index.html https://www.cnn.com/2018/12/19/business/altria-juul/index.ht...
  - mrtranscendence 4y ago
    Juul is big tobacco; it's owned by Philip Morris.
  - HarryHirsch 4y ago
    Philip Morris has a 35 % stake in Juul, so they are at least "medium tobacco". Practically speaking, you can't ban cigarettes right yet, you'll have another Prohibition problem, but sooner or later the cigarette problem will solve itself, everybody agrees that cigarettes are disgusting. Juul on the other hand marketed itself to schoolchildren as a hip and safe alternative. That problem must be addressed.
victorclf 4y ago
Drugs and vaccines must have sufficient evidence that they are safe before being released to the public. If you want to know more about how they go about doing this, just read some of those studies.
HWR_14 4y ago
> I can prove it is dangerous with studies, but to prove it isn't dangerous seems like an impossible task. You don't see that you run the same damn studies but get a negative effect? You can even do it solely off p-value (but instead should do a more complex calculation based on the harms discovered, etc.) If your "is it dangerous" study shows it is with p < 0.05 = dangerous, p > 0.10 = safe, 0.05 <= p <= 0.10 = more study needed.

hoofhearted 4y ago

http://archive.today/E2mZs http://archive.today/E2mZs

photochemsyn 4y ago

This decision is hard to justify on the basis of scientific evidence of harm. Despite the tobacco industry's decades-long effort to deny the link between lung cancer and smoking tobacco, it seems well-understood that the combustion product benzo[alpha]pyrene plays a major role. This is one of the polycyclic aromatic hydrocarbons (5 rings in this case) which, after being processed by lung cytochrome p450 enzymes, will form mutagenic DNA adducts. Adducts that form in regions of the genome that control the cell life cycle can result in cancers, particularly if defects exist in normal DNA repair mechanisms. For example: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3268909/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3268909/ Some of the enzymatic activity resulting in conversion of PAHs to activated PAHs capable of binding to DNA appears to be promoted by nicotine and inhibited by THC, curiously enough, i.e. the cannabis-vs-tobacco smoke issue: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1277837/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1277837/ However, there's no benzo[a]pyrene or similar PAHs generated via vaping, it's just nicotine in an aerosolizable liquid (propylene glycol + glycerine) which doesn't seem to have any medical negatives. Juul also includes benzoic acid as a preservative to avoid microbial growth, however, which is something I'd avoid inhaling personally. Nicotine is indeed a highly addictive substance, but there seems to be no scientific reason to allow smoking plain tobacco while banning vaporized nicotine. I'd suggest removing the benzoic acid, which would of course shorten shelf life and perhaps require refrigeration, if anything.

CarbonCycles 4y ago
I agree with you...it's the additional factors that appear to be more muta/carcinogenic than the nicotine itself. Granted (as you said) nicotine isn't ideal. The amount of sugar and its related health effects IMO completely outweigh the impacts of nicotine. The large food corps are finding ways to make sugary food more addictive so you have populations of sugar addicts starting at a very early age...the entire picture is so very distorted.
hash07e 4y ago
[dead]

zzixp 4y ago

I'm honestly not sure at this point why Juul is on the chopping block. I'm a college student, and Juul took off during my sophomore year of high school. They absolutely marketed to teenagers and created a dangerous product, but they're no longer the biggest player in the game. By my senior year of high school, most kids had moved on to disposable vapes. From what I know, they're about the same price, you don't have to worry about recharging them (and having a teacher/parent ask you about your "usb stick"), and have the same number of hits Juul should absolutely be fined/etc for marketing to children and starting the vaping epidemic in high schools, but the FDA is years too late on that front

CarbonCycles 4y ago

Juul was especially targeted by the FDA as Juul's advertising and marketing was specifically targeting the younger crowd. There are other products on the market that are similar to Juul (i.e., RJ Reynolds vape products), but the marketing appears to be different in tone than Juul. On another note but relevant, there is an interesting conversation that is yet to be had with the Supreme Courts recent ruling on the EPAs overreach of executive power...the same argument could be made with the FDA.

mimikatz 4y ago

People have consumed Tobacco (I assume in the search of Nicotine) for centuries. There is obviously some human enjoyment and satisfaction in doing so. Transitioning from more harmful smoking to less harmful 'smoking' is good. Letting people choose unhealthy things to enjoy is good (assuming a decent risk calculation). The antivape movement seems so weird amongst the general social themes in the US to open up weed and in more fringe cases decriminalize more drugs.

andiareso 4y ago

It seems like FDA overreach. I mean I get that we don't want teens to get hooked on a bad habit, but.... sugar is marketed like crazy to toddlers, kids, teens etc. in a much more aggressive way and is by far more harmful in the long run. I don't vape anymore, but it was fun and passed the time. I'd much rather see FDA approved vape formulas than random suppliers with who knows what inside them.