But unfortunatley, as a "medical device" the ecig may well be more likely to be killed off by the FDA, than as a simple tobacco derived alternative to cigarettes.
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But unfortunatley, as a "medical device" the ecig may well be more likely to be killed off by the FDA, than as a simple tobacco derived alternative to cigarettes.
I was only differentiating between the 2 seperate issues before the FDA. One is geared towards tobacco and has not been enacted to empower the FDA's regulating (yet). But the FDA does have jurisdiction of non-tobacco products that contain nicotine, a tobacco derivitive. The other, and more troubling, is the statutes in place for medical devices, of which the the e-cig has been purported to be based on the delivery of nicotine, not tobacco.
There are many personal vaporers on the market because the requisite red tape was fielded by filings with the FDA. Jumping thru hoops may be the more operative word here but there is a case to be made that nicotine via these devices are more harmful than NRT or vitamin inhalation.
I personally would love to see the e-cig be grandfathered in with cigarettes in the FDA bill as a smoking alternative but unfortunately the health claims got the attention of the FDA. In my humble opinion, they were forced to act on e-cigs.
You are so right. Former commissioner (and vehement smoking opponent) David Kessler wrote a book about his experiences, and he notes how two candy bars containing sugar could be treated. If one makes health claims of any type, the FDA could jump in, ban it until studies are made to substantiate the health claims for sugar, etc.
The other identical candy bar could remain on sale.
We have recently seen just such action, when the FDA challenged Cheerios for cholesterol reduction statements on packagaing. It had every right to do so, took a proper action, and doesn't deserve the jeers so many uninformed posters made.
E-cig sellers shot themselves in the foot long ago, giving the FDA all it needs for a ban. It's too late to recall statements made months ago (and still being made on some irresponsbile Web sites). Frankly, these e-smoking products should have always been sold as a novelty to replicate cigarette smoking. Let word-of-mouth do the rest for you.
But it's too late now and I hear the sound of "Taps" starting.
Have you seen the health claims made by Nutrisystem for the Diabetes program? How would the FDA see this when it's a combination of foods?
- Lost 16 times more weight
- Lowered blood sugar levels 5 times more
- Lowered A1C by 0.9
- Lowered total cholesterol level by 44.7
- Lowered triglycerides level by 44.7 mg
Look, we can only guess that they have studies to back up claims. If not, they deserve a citation for making false claims.
If you claim a health benefit, be prepared to prove it with scientifically acceptable studies.
If you claim a health benefit, be prepared to prove it with scientifically acceptable studies.
Nevermind, I just enlightened myself...these claims can be made as long as they are part of a complete diet that does so. Duh! Yes, Bob, I'm one of the uninformed, but I'm working on it.
Sorry, Bob...I went and read sections of the FD&C Act and then read the warning letter to cheerios and it made perfect sense. Cheerios was a little deceptive in the way the labeled their box. I quoted myself in the above post and corrected my mistake.
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Hi ladyraj,I was only differentiating between the 2 seperate issues before the FDA. One is geared towards tobacco and has not been enacted to empower the FDA's regulating (yet). But the FDA does have jurisdiction of non-tobacco products that contain nicotine, a tobacco derivitive. The other, and more troubling, is the statutes in place for medical devices, of which the the e-cig has been purported to be based on the delivery of nicotine, not tobacco.
I'm really confused over nicotine being a non-tobacco product when it's a tobacco derivative. Section 101 of the new bill states this:
This is so vague to me because nicotine is derived from tobacco but it's not a tobacco product because it can be classified as a drug under subsection (g)(1) because of the health claims it made (B), or is it a drug under any other of section (g)(1)?
This is so confusing...
Edit: What really gets me is that nicotine is a legal drug. If there was a safer way to get alcohol without the harmful effects on the liver, such as vaping it, would this even be happening? It seems so absurd because alcohol could be classified as a drug above (g)(1) also if nicotine can. Maybe it's just the health claims all along? If so, why all the fuss?
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I think that the FDA has the right idea. With control over its use they can be market it appropriately. These are and should be inherently, 'drug devices' more so that tobacco products. We will see them in the future prescribed to terminal smokers to ease nicotine addiction. Just a precursor to the anti-tobacco ideology of the times.
It'll all work out ok -
Personally I'd rather deal with the FDA than the ATF -
At least the FDA never burned down a house full of kids -
Just imagine -
There you are happily puffing away and a flame-throwing tank drives through your wall. Then a wild-eyed ATF agent points a gun at your head shouting -
"PUT DOWN THAT JANTYSTICK .......!"
LMAO - ahhh - I kill me - gotta keep a sense of humor about it -
Personally I'd rather deal with the FDA than the ATF -
At least the FDA never burned down a house full of kids -
Just imagine -
There you are happily puffing away and a flame-throwing tank drives through your wall. Then a wild-eyed ATF agent points a gun at your head shouting -
"PUT DOWN THAT JANTYSTICK .......!"
LMAO - ahhh - I kill me - gotta keep a sense of humor about it -
It is confusing, Smokin'Sandy. No question. There has been disagreement on this forum, and now in the courts, on exactly where the electronic cigarette fits in the marketplace.
If it's a drug product, the FDA already claims authority over it. If it's a tobacco product, then the FDA will have authority once the new bill now in the Senate is signed into law.
Either way, we e-smokers are in for a bumpy ride.
As a "new drug", the liquid and device will need required safety and efficacy studies. But some makers, notably Ruyan, have been at work on those needed studies. Ruyan has almost said (but hasn't) that it will attempt to get the e-cig certified as a Nicotine Replacement Therapy product.
That's an interesting route, and it might mean that only three months of study is needed, rather than years. Ninety days is the normal time prescribed for NRT products. Are they used that way? No. We all know people who have chewed nicotine gum for years. A former boss of mine has sucked nicotine lozenges for about five years now. But smoking cessation products are meant for three months of use before quitting cigarettes completely.
If we e-cig users quit cigarettes, but continue using our NRT product, well, so what? Same thing happens with other NRTs.
Now, if we're a tobacco product, the prospect of market success diminishes, in my opinion. We will be a "new product" and face an FDA subcommittee of scientists who must approve each new product. The word from Senators is that new products have no chance of approval. E-cigs will be rejected.
Course, if Philip Morris wants approval of its Aria nicotine inhaler ... that's another story. If Big Pharma comes up with medicinal nicotine liquid and a delivery system that vaporizes that liquid .. that's another story. If Altria buys Janty, nJoy, Crown7 and Smoking Everywhere .. that's another story.
Adding to the confusion is the fact that we have no idea what is being done behind Washington's closed doors. But you can bet that plenty is. Lobbying must be 24/7. There is too much money at stake here not to go all out, if you're Big Pharma or Big Tobacco. This is a sizable chunk of future revenues hanging on actions now.
A ban today is a profit tomorrow.
If it's a drug product, the FDA already claims authority over it. If it's a tobacco product, then the FDA will have authority once the new bill now in the Senate is signed into law.
Either way, we e-smokers are in for a bumpy ride.
As a "new drug", the liquid and device will need required safety and efficacy studies. But some makers, notably Ruyan, have been at work on those needed studies. Ruyan has almost said (but hasn't) that it will attempt to get the e-cig certified as a Nicotine Replacement Therapy product.
That's an interesting route, and it might mean that only three months of study is needed, rather than years. Ninety days is the normal time prescribed for NRT products. Are they used that way? No. We all know people who have chewed nicotine gum for years. A former boss of mine has sucked nicotine lozenges for about five years now. But smoking cessation products are meant for three months of use before quitting cigarettes completely.
If we e-cig users quit cigarettes, but continue using our NRT product, well, so what? Same thing happens with other NRTs.
Now, if we're a tobacco product, the prospect of market success diminishes, in my opinion. We will be a "new product" and face an FDA subcommittee of scientists who must approve each new product. The word from Senators is that new products have no chance of approval. E-cigs will be rejected.
Course, if Philip Morris wants approval of its Aria nicotine inhaler ... that's another story. If Big Pharma comes up with medicinal nicotine liquid and a delivery system that vaporizes that liquid .. that's another story. If Altria buys Janty, nJoy, Crown7 and Smoking Everywhere .. that's another story.
Adding to the confusion is the fact that we have no idea what is being done behind Washington's closed doors. But you can bet that plenty is. Lobbying must be 24/7. There is too much money at stake here not to go all out, if you're Big Pharma or Big Tobacco. This is a sizable chunk of future revenues hanging on actions now.
A ban today is a profit tomorrow.
Check on Johnson Creek juice website, they are FDA approved. Do not know or understand what the implications are, but they do have to stand down for inspections. It more than likely is given for the use of Proylene Glycol. At any rate, the certificate is displayed.
I will be curious to see if a fine Meershaum pipe cannot be imported after this "take over"...it is, in accordance, a nicotine delivery system, designated Medical Device.
Have you read the DeKang thread TB? They are in the process of getting their liquid through FDA-approval.
Thank you Bob. Yes, I was thinking along those lines also, but I couldn't decide which would take more time to get approved; NRT or a reduced harm tobacco product. From what you say about Ruyan, NRT may be the way to go. I can always go the Walgreens and open a charge account so I can afford the liquid.
Really though, as long as they stay legal, I'll be okay with it. I'm pretty sure behind those closed doors there are many people that could probably be called Corporatists. With Phillip Morris behind those doors also, I have little doubt that there will be an introduction of a nicotine inhaler from their R&D department.
Bank on it. I don't think there's any doubt that the cigarette lobby understands that vaporizers are the future of smoking. It's highly likely that all the big tobacco producers have had products like these waiting in the wings for decades. They support banning the current crop of e-cigarettes because they're not getting their cut. A ban on them will inevitably lead to RJR, PM and the others releasing their own version of the e-cigarette in due course. And it'll probably be more expensive, filled with chemical additives and featuring completely disposable consumables that clutter up the environment and aren't refillable. If e-cigarettes had been introduced by a US company rather than a Chinese one, we probably wouldn't even be having this discussion.
Thanks everyone for posting all the info. I am so depressed to hear it though,
just want to cry. I thought I could never quit smoking & the e-cig has been an absolute miracle for me! It's horrible to think we may lose this option! so so sad!!!!!!!
just want to cry. I thought I could never quit smoking & the e-cig has been an absolute miracle for me! It's horrible to think we may lose this option! so so sad!!!!!!!
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