AMA meeting: E-cigarettes need FDA regulation, limits on sales

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JustMeAgain

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Did you notice the cutline beneath the photo?

Smokers should "know exactly what they're inhaling," says Atlanta internist Sandra Fryhofer, MD.

Dr. Sandra must be quite a renegade, actually advocating such a unique concept.

I wonder where she was when we were all inhaling God knows what in cigarettes?

I wonder why she's not voicing concerns that millions are continuing to do so?
 

CaptJay

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Good for Doc Sandra - tell her about car exhaust fumes - she ought to lobby to ban cars immediately - or at least only let them be used with a doctor's approval..and salt and sugar should be prescription only as well - BP issues and diabetes are rife in the western world - and no kid's foods should have either added. What's that? They aren't as heavily taxed so it doesn't matter and why put doctors out of a job? oh...

Vapin' if that WERE to happen we would be expected to use only a device approved by the FDA and no doubt manufactured by BP, only with a doctor's prescription (not sure if they'd go that far seeing as you can buy patches over the counter) and also no doubt horrendously expensive. In practical terms I guess it means we all use our current stuff on the black market or buy direct from china and DIY the liquids.
The powers that be would probably fare better making it a tobacco product followed by the inevitable tax, at least that way they can still get a piece of the pie instead of hardly any at all. Imo at least.
 

Vocalek

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Vapin' if that WERE to happen we would be expected to use only a device approved by the FDA and no doubt manufactured by BP, only with a doctor's prescription (not sure if they'd go that far seeing as you can buy patches over the counter) and also no doubt horrendously expensive. In practical terms I guess it means we all use our current stuff on the black market or buy direct from china and DIY the liquids.
The powers that be would probably fare better making it a tobacco product followed by the inevitable tax, at least that way they can still get a piece of the pie instead of hardly any at all. Imo at least.

The problem is that there IS no FDA-approved vaping device which means you will have nothing at all to use that is not a black-market product. Gaining FDA approval for any drug or device is a very expensive and time-consuming process that would take, at the very least, several years.

Then there is the second problem, in that the FDA's products are all based on the concept of curing you of your "addiction to nicotine". Ever wonder why you were chewing the gum, sucking the lozenge, or wearing the patch and still getting cravings to light up? That's because the products FDA approves are required to have sub-effective levels of nicotine. They also come with directions on how to wean down and off the products within a specified time frame (usually 12 weeks.)

So FDA wouldn't approve a product that wasn't weak enough to suit them. You would not be able to adjust your nicotine levels upward if you were having difficulty substituting the e-cigarette for all of your smoked tobacco ones.

When I first started vaping, the highest level nicotine in the cartridges was 16 mg. I was having problems at that level. Surveys now show that about half of all e-cigarette consumers use 24 mg. or higher strength.

The only way FDA would ever approve an e-cigarette as effective as the ones we use now would be if they actually supported the idea of tobacco harm reduction.
 

vapinmachine

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I can't imagine how this product could be obtained via the blackmarket. It's not like they'd be sold on the streets? Also, the Liquid would be hard to get too.

I'm not sure what I'll do, most likely go back to smoking regular cigs should the product be banned. That is, of course, if I don't find a way to maintain vaping!

This e-cig can surely be seen as a DDD.. There are companies selling ...... juice, and another company marketing e-cigs to administer illegal substances. :( But in all fairness. Pipes, paper, and other things can be considered a DDD. I just hope this ends in our favor somehow.
 

rothenbj

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So what would happen exactly if they were classified as "drug delivery devices?"

Years and years of clinical trials, millions of dollars to pay for said trials, and limitations on device design, nicotine content and flavor. Did I mention prescription, exorbitant pricing and that is assuming that they ever got approved. Not a pretty sight. :2c:
 

rothenbj

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Good for Doc Sandra - tell her about car exhaust fumes - she ought to lobby to ban cars immediately......

I just had visions of a scientific lab with a handful of rats (legs up) in a glass enclosed testing unit and a lit cigarette inside the unit with side stream smoke emanating from it. The side of the unit had a fexible tube running into it with a car exhaust attached on the other end. The one scientist speaks to the others, "further proof that smoking kills."
 

vapinmachine

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This really sucks.. I hope that we can continue vaping. Vapers are a huge minority and it just seems like this ban is inevitable. I'm not sure what I can even do to prevent this? If anything, I'll just vape as long as I can. If it gets banned then I'll try to find a way to continue, if I can't find it, then I'll just revert back to smoking and probably die from it. Maybe we could file a class-action lawsuit against the AMA/FDA?
 

keveck

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Maybe we could file a class-action lawsuit against the AMA/FDA?
That wouldn't really work.

You would have to file it against whatever the FDA claimed if they banned them.

If the FDA banned them because they were drug delivery devices, you would have to prove that they were not, which would be impossible.

If they banned them because of unknown health effects, you would have to provide independent testing to prove that they are safe(which would cost a LOT of money).

Hell, even if they banned them just because of lost tax revenues you would have a hard time fighting them. The supreme court tends to lean towards our own federal agencies(they are one too).
 

vapinmachine

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I think that a lot of people would be in favor of a prescription to use an e-cig by any manufacturer just like they do with an already illegal substance. There's no need for Big Pharma to re-invent the wheel and make a new e-cig when there are manufacturers already producing them. Perhaps they'll ban e-cigs, but they may not have the resources to seize shipments, and with an increase of demand I could see groups pushing for medicinal legislation. At any rate, this is far from over, and I hope that a reasonable solution is reached.
 
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vapinmachine

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They can go ahead and ban them like they do cigarettes. They can go ahead and tax them, and they can go ahead and reduce flavoring options. Heck, they can go ahead and make them available through prescription only. But please, don't ban them altogether! That's not going to prevent ME or thousands of others from getting their hands on them. Why does this system seem so black and white? Why does the AMA and FDA refuse to take a scientific approach? I understand their concerns, but it seems to me that they're turning a blind eye to the truth.
 

keveck

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I'm totally against the prescription idea. BP, BT, HMO's, and the government will all get a chunk of the money. It'll be smoke everywhere prices on EVERYTHING. I can just imagine... $150 for a 510 with one battery...cartos are $10 ea. and you'll only be allowed 5 per month at 8mg...

The nicotine will come from tobacco derived from BT's fields, the hardware will come from China and be marked up like crazy, the insurance companies will barely cover costs and call it non-formulary, and the government will tax the hell out of it. The middleman(whoever decides to market it) will have to pay for clinical trials and "research" and will pass all of those lovely costs on to you.

Sounds fun.
 

bassnut

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That wouldn't really work.

You would have to file it against whatever the FDA claimed if they banned them.

They're still "claiming" and harping on this issue:

The FDA said it detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, during examination of a small sample of cartridges from two leading e-cigarette brands. In several other samples, the agency identified carcinogens in the cartridges, including nitrosamines, which can be found in tobacco smoke.
...which they're taking a beating for in court right now....at least I hope it's a beating.

This might be a good time to revisit Vocalek's article again:

http://www.e-cigarette-forum.com/fo...fda-misleading-report-strategy-backfires.html
 

Vocalek

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They can go ahead and ban them like they do cigarettes. They can go ahead and tax them, and they can go ahead and reduce flavoring options. Heck, they can go ahead and make them available through prescription only. But please, don't ban them altogether! That's not going to prevent ME or thousands of others from getting their hands on them. Why does this system seem so black and white? Why does the AMA and FDA refuse to take a scientific approach? I understand their concerns, but it seems to me that they're turning a blind eye to the truth.

I couldn't agree with you more. I have agonized over the question of why. Many will tell you that it's all about money. I think it is partly about that, but it's more than that. I think they are starting out with a flawed set of premises and basing all their decisions and actions on that set.
  • Nicotine is an addictive drug, no different than alcohol, ......, or ........
  • Because nicotine is addictive, it must be harmful.
  • The only way to overcome an addiction is to totally stop using the addictive substance.
If you fervently believe these ideas, it is perfectly "logical" to believe that you are nothing but a helpful and good person if you take action to "protect" nicotine users from their own weak-willed lack of character. In other words, it's a moral issue.

The problem lies in the fact that their premises (to quote a songwriter) "ain't necessarily so."

Most scientists believe nicotine is addictive, but there are those who question that "fact." I think it is strange, for example, that I don't experience cravings for vaporized nicotine, the way I used to feel cravings on a very frequent and regular basis for a smoke.

But even if everyone agreed on nicotine being addictive, it still is very different from ...... and ........ When people use these two drugs recreationally, they are using them with the intention of escaping from reality for a while. Their judgement becomes impaired. Their physical coordination can be impaired. Often, they cannot safely operate a car or other machinery.

People use nicotine with the intention of being better able to deal with reality. They are trying to increase thier alertness and their ability to concentrate and remember things. (Why do you think so many folks pair up having a smoke with drinking, even if they are not regular smokers? The nicotine overcomes the sedative effects of the alcohol.) Their judgement isn't impaired. Someone who is "on" nicotine is a much better driver than someone who is withdrawing from nicotine. I know this from vivid experience.

If you take away the dangerous delivery mechanism of inhaling smoke, long-term use of nicotine is fairly innocuous. Unlike alcohol use, nicotine use doesn't destroy the liver. Unlike long-term ....... use, nicotine use doesn't cause paranoia. Unlike ...... use, nicotine use doesn't destroy kidney function.

Finally, there are other alternatives besides abstinence. A certain percentage of ...... users never fully recover from their experience. They suffer from a permanent state of distress when abstinent. Methodone relieves the distress without the euphoria associated with antisocial behaviors in ...... use.

I believe nicotine maintenance is a strong parallel. Getting rid of the smoke reduces the physical harm. We know from the experience of Swedish snus users that providing adequate doses of nicotine allows many to stop using smoke as their intake method.

We know from the experience of electronic cigarette users that inhaling adequate doses of nicotine from vapor allows us to painlessly refrain from inhaling smoke.

Now if only we can get the tobacco control community to let go of their delusions and start working with the facts instead.
 

JerryRM

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Well, ban them or not, a law is just a law, it's not anything holy or sacred. There have been bad, even evil laws before. There was a law that made it illegal to hide runaway slaves, they had to be returned to their "owners" or else. There were laws that banned inter-racial marriage and of course the one that organized crime loved - Prohibition.
A ban on e-cigs would fall into this category. :2c:
 

sherid

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So we'll all be buying our e-cigs from a speakeasy after the ban.

Finally, the mafia is back in business! :)

No, because BT has one ready to go. It also has precedence in selling them, going back to previous, more primitive models such as the Accord and Heatbar. To believe anything else is terribly naive IMO. I have a friend whose husband has a non-tobacco related contract with RJR in Richmond. He offered to bring one of the e cigs they have been testing with clients home to his wife. He was unable to do that though since they are doing some more work before further testing. Is he lying? I don't think so.
 
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