Deeming Regulations have been released!!!!

ScottP

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The FDA has a system for compiling adverse drug reactions. One way outside the traditional medical path is a toll free number for anyone to report a problem with a drug. No evidence the drug caused the problem, but nonetheless it's logged. Patterns can turn up that way sooner and isn't a terrible idea.

What was clear was they know of 35 cases reported of a seizure occurring in someone who vaped. A few occurred while using illicit drugs as noted in the press release. There is no indication of any other medical history like having a preexisting seizure disorder. It's also not clear what was even being vaped. Even the notice stated there was insufficient evidence to tie the seizures to the vaping, simply that there were these reports. If they get a lot of that particular complaint I expect they'll look into it in more detail. We're upset because it involves vaping, but the statement could easily be made about Advil as the data collection is essentially the same.

I expect if they get more such phone calls they will dig further into the medical episodes and obtain more detailed information. What is simply called in on the adverse reaction phone line isn't proof of causation or even correlation. All they note is very high levels of nicotine can cause seizures as I an overdose (not nic sick). Maybe someone drank a bottle and it wasn't vaped. No one knows. I suggest to see what happens before panic ensues. Of course the general public doesn't get that, but that's a separate issue.

So if someone wanted a particular drug pulled off the market, say Chantix, they could organize a lot of people to randomly call that number and give bogus complaints? I would hope there is some sort of validation.
 

jandrew

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So if someone wanted a particular drug pulled off the market, say Chantix, they could organize a lot of people to randomly call that number and give bogus complaints? I would hope there is some sort of validation.
Not bloody likely. Chantix had many many adverse reports since it came on the market in 2006, and even had an FDA 'black box warning' put on it in 2009, followed by more reports, studies, and requests to strengthen the warnings ... but instead, in late 2016, the FDA removed the black box warning based primarily on the results of a (much criticized) mandated trial sponsored by ... can you guess? ... Pfizer (maker of Chantix), and GlaxoSmithKline (maker of Zyban/bupropion, also included in the trial).
 
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Eskie

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So if someone wanted a particular drug pulled off the market, say Chantix, they could organize a lot of people to randomly call that number and give bogus complaints? I would hope there is some sort of validation.

Yes, there would be validation. You can't draw any conclusions from a bunch of random phone calls. Adverse reactions can and are also reported directly to the manufacturer as well, who is then legally obligated to forward to the FDA as well. If there is a evidence of a pattern emerging, not just background noise, further steps would be taken to determine the validity and if a risk were identified, actions and corrective steps would be taken ranging from a change in warnings to outright removal from the market if necessary.
 
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englishmick

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The FDA has a system for compiling adverse drug reactions. One way outside the traditional medical path is a toll free number for anyone to report a problem with a drug. No evidence the drug caused the problem, but nonetheless it's logged. Patterns can turn up that way sooner and isn't a terrible idea.

What was clear was they know of 35 cases reported of a seizure occurring in someone who vaped. A few occurred while using illicit drugs as noted in the press release. There is no indication of any other medical history like having a preexisting seizure disorder. It's also not clear what was even being vaped. Even the notice stated there was insufficient evidence to tie the seizures to the vaping, simply that there were these reports. If they get a lot of that particular complaint I expect they'll look into it in more detail. We're upset because it involves vaping, but the statement could easily be made about Advil as the data collection is essentially the same.

I expect if they get more such phone calls they will dig further into the medical episodes and obtain more detailed information. What is simply called in on the adverse reaction phone line isn't proof of causation or even correlation. All they note is very high levels of nicotine can cause seizures as I an overdose (not nic sick). Maybe someone drank a bottle and it wasn't vaped. No one knows. I suggest to see what happens before panic ensues. Of course the general public doesn't get that, but that's a separate issue.

I imagine there isn't much information available on the effects of absorbing very large amounts of nicotine. People chain smoke all day without getting much more than a headache. I've got light headed a couple of times from overdoing it with a new tank. But the headache and queasy stomach would tend to make you stop long before you reach the level of a serious overdose. Nicotine is just hard to OD on. Other than, like you say, drinking it.
 

ScottP

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I just heard the FDA went after a popular diy vid maker and said he couldn't make vids about eliquid/vaping. It is now being called a soda streaming channel. I sure hope that was an April fool joke and not for real. Does anyone know?

Where did you hear this and do you know the name of the reviewer? It's hard to confirm or debunk without more details.
 

rosesense

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    Where did you hear this and do you know the name of the reviewer? It's hard to confirm or debunk without more details.

    I just didn't want to break any rules about posting links or anything. It is on the DIYorDiy site, under videos, posted on 4/1/19.
     

    ScottP

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    I just didn't want to break any rules about posting links or anything. It is on the DIYorDiy site, under videos, posted on 4/1/19.

    I just looked and he has posted 3 DIY eliquid videos since he posted that one on 4/1. So yeah I am going to say it was an April Fools joke.
     

    rosesense

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    I just looked and he has posted 3 DIY eliquid videos since he posted that one on 4/1. So yeah I am going to say it was an April Fools joke.

    Where did you see the diy recent vids? I only see other mixers on there, not Wayne's.
     
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    ScottP

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    Where did you see the diy recent vids? I only see other mixers on there, not Wayne's.

    I went to the actual DIYorDie Youtube channel and looked at recent videos. I also just now clicked on the one from yesterday....watch the first 30 seconds....

     
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    stols001

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    The FDA does "fact check" these reports but only after the fact and after a lot of folks have died. Usually prolonged Q T intervals on stuff like Seldane.

    They tend to leave psych drugs alone has been my experience.

    They also don't get a TON of like, info or even investigators so there has to be a relatively CLEAR cut set of "I took X and I died from THIS." Type of thing. Like how none of the calcium supplements for old women (think, when they broke a hip, they shattered like glass.)

    But this stuff takes forever. It is also YET another reason I use generics whenever possible. FDA studies are 12 weeks LONG. A lot can not happen in 12 weeks.

    I don't think the FDA will be researching that whole "seizure activity" thing very hard or very soon but is SO LOVELY they are sharing the unsupported DATA I must say....

    Anna
     

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    BillW50

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    The government pays the healthcare bill and they are broke so they are desperate to save money. Vaping does that for them and they know it.
    Most countries in Europe and Canada has free healthcare too. But it is only the UK that supports vaping. So how do you explain that one?
     

    jandrew

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    Most countries in Europe and Canada has free healthcare too. But it is only the UK that supports vaping. So how do you explain that one?
    Well, Canada seems to be taking a reasonable regulatory stance at the moment and even officially see it as a viable way for adults to quit smoking:
    Vaping and quitting smoking - Canada.ca
     

    ScottP

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    Most countries in Europe and Canada has free healthcare too. But it is only the UK that supports vaping. So how do you explain that one?

    My guess is that every country looks at what they are bringing in from cigarette taxes and compares that to what they could save in healthcare for their citizens if they all switched to vaping and uses that cost/benefit analysis to decide if that specific country will support vaping or not. Lobbyists may also have more sway in some countries than others.

    In the US the government gains nothing while losing tax money if people switch to vaping AND Big tobacco and Big pharma both have very strong lobbying arms. Not only that but these big entities have deep pockets to fund a ton of anti-vaping propaganda to sway public opinion.
     

    BillW50

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    In the US the government gains nothing while losing tax money if people switch to vaping
    Don't count on it. Wisconsin is close to passing a 71% tax on anything to do with vaping (not just e-juice). And the tax isn't based on the price you paid, but on the retail price of the product. Of course, there are many states and communities that also has high taxes on vaping. But they still rather you smoke instead of vape. And it is only a matter of time before the US Government adds their own vaping tax. If they don't ban it first. :(
     
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    ScottP

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    Don't count on it. Wisconsin is close to passing a 71% tax on anything to do with vaping (not just e-juice). And the tax isn't based on the price you paid, but on the retail price of the product. Of course, there are many states and communities that also has high taxes on vaping. But they still rather you smoke instead of vape. And it is only a matter of time before the US Government adds their own vaping tax. If they don't ban it first. :(

    The states are doing that because of the whole tobacco settlement that they are losing money on. The Federal government, even if they do tax vaping, are still heavily influenced by the lobbyists I mentioned.
     

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