Action regarding FDA: No banter here, please

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Vicks Vap-oh-Yeah

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It's not long ago that Britain thought it was the centre of the universe, some of that still lingers along with a bit of bitterness about being knocked out of first place ;)

It'll be the Chinese next so you Yanks should make hay while the sun is shining for you, you won't be at the top for much longer.


I can live with that..... If you're in the lead, you have a big, inviting target painted on your back, and everyone behind you has sharp, pointy objects.
 

yvilla

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More off topic .. Kate has got the right idea. These are not tobacco products. The "drug" is ineffectual when treating nicotine addiction. These are toys for making nice vapor. Nothing more.

Oh, TBob, if only it were so simple.

However, if the FDA insists on deeming ecigs to be "new drug devices" needing to go through the NDA process (because according to their review "they are intended primarily for the delivery of volatilized chemical substances to affect the body's structures and functions and/or to mitigate or treat the symptoms of nicotine addiction through a chemical or metabolic action on the body"), then the fact that ecigs are ineffectual in meeting that intention would just be another reason for them to fail the NDA process!

Do you think they are going to desist from their enforcement actions just because we tell them the ecig is ineffectual? At this point in the game? That, in reality, is only another way of saying what I've been saying all along - the ecig is not a new drug delivery device, because it's merely a smoking alternative, a tobacco harm reduction device. And you were the one telling me well, the FDA has determined it's a new drug!

And I'm still convinced that at least under the current law, the only way to beat the "new drug" rap is to successfully argue to the powers that be that the ecig is just a smoking alternative, and more akin to other tobacco harm reduction products, like snus, etc, as SE is trying to do with it's suit. That's the only way to get the FDA out of the picture for now.

Then of course it's the legislative battle after that.
 

Kate

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I think the Smoking Everywhere case is going to define vaping for us. I can't see them allowing the tobacco classification myself. If they say it's a drug then we need some company like Ruyan or a coalition of traders like the ECA to challenge that with another case to say it's not a drug.

If vaping doesn't meet the legal definition of drug use then there might be a case. In any event we will want the hardware and zero nic eliquid to be considered separate from nicotine eliquid. It's the nicotine that's the problem in the same way cannabis is a problem if related with hardware such as water pipes.
 
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RacoonSpirit

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I believe the fax should define e-cigarettes in the light of what they truly are. Another thread in this forum as a list of several personal vaporizers and that is exactly what these are. Some use a lighter as a heat source and others use butane in the device itself. I see these as the same thing, only using a battery and coil for the heat source. The personal vaporizers are certainly not regulated by the FDA therefore the e-cigarettes, defined as personal vaporizers, should not fall under their jurisdiction either.

The juice is a bit more cloudy. It certainly should not be considered a tobacco product since nicotine can be extracted from many other plants, and it certainly is not a new drug. There are too many NRT out there already so how can they consider it new? Granted, the idea of vaping tobacco has been around for some time, now the idea of vaping a nicotine liquid may be new and that should be the only piece of this they should address.

IMHO, the devices should not even be under their scrutiny, just as other personal vaporizers. I do not want to see the concept banned but I do beleive they will find a way to control the juice. Hopefull y I will be at a 0 level juice by then. If not, then I will be learning some chemistry as I have found a source for liquid nicotine - just google it and it will pop up.

I am keeping my fingers crossed and my prayers up that somehow the courts and judges will do the right thing here. If not, then maybe we need to get some colleges to work on this for a thesis and possibly some legal students to use it as a slingshot to launch their careers.
 

TropicalBob

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There is another case to be made for e-devices, and if Smoking Everywhere mucks it up for our practice, then we can all curse them forever. Their suit is an artful dodge, without merit. We do NOT want to go to bed with SE. This is a terrible way to get a definition of e-smoking. Either/or is a dead-end for us.

What a concept: If e-cigs are a tobacco cigarette, then the Nicotrol Inhaler is a Hav-A-Tampa cigar.

I just hope the judge doesn't laugh.

Kate is on the right track. This is not tobacco. This is, in reality, not a new drug by definition of a "drug" having psysiological effects. Bottom line with these studies: We inhale a chemical without sufficient physical impact to warrant FDA intervention in its sale.

We are, in fact, a new category, not either/or.
 

yvilla

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There has to be a lawyer or 2 on here dosent there...I would love to hear their opinions on this.

There is ... and you've heard it ...

... as far as SE taking the only legally viable course open to them to challenge the FDA's jurisdiction over their shipments.

I have been mulling over whether there exists any possibilty of equal protection or other creative claims that could be raised by consumers, but haven't come up with anything at all realistic yet!
 

Drewsworld

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How a bout this?..If nicotene is a drug...Then we are all drug addicts...Then our ecigs are our RECOVERY method...Technically if we are drug addicts then we are disabled and are protected under the ADA as a group searching for a common goal...Wow this is starting to sound rediculous...But so do their calims initially..Thats why we ned a smart savvy lawyer like yvilla!:p
 

yvilla

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How a bout this?..If nicotene is a drug...Then we are all drug addicts...Then our ecigs are our RECOVERY method...Technically if we are drug addicts then we are disabled and are protected under the ADA as a group searching for a common goal...

That's the problem - if ecigs are drugs or drug devices, then they do fall squarely within the regulatory powers of the FDA, and would need to go through the NDA approval process (before being marketed and sold in the US).

They cannot be categorized as drugs, or else they disappear for sure (in terms of being sold legally, that is).
 
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Drewsworld

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Caffine is widely classified as a drug? Nicotine is a drug? Yohimbe is a drug? Coffee and Tea are legal and so is Yohimbe extract...Nicotine is legal if you smoke it in tobacco laced with amonia and 3999 other partially known substances...Maybe we should just trademark and patent the juice and its ingredients and lock them away in a vault for thirty years like the cig companies did and worry about it then...Yvilla, please dont confuse this as flame or banter as it is not my intention, and these issues have prolly been discussed 100 times before...I just start typing a point and I get frustrated with the political BS that we are subject to...Its like everybody knows what this about and the players dodge the facts and points to manipulate the public...The reality is this is all about the benjamins for them ( the government ) and SE...For most people on this site it is a life or death matter...A quality of life issue...A travesty
 

yvilla

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Exactly Drew. Nicotine, when refined and sold expressly as a drug for smoking cessation purposes, is regulated by the FDA.

But nicotine, when contained within tobacco products, is freely sold (although regulated by a different agency, the FDA has no authority over tobacco products as of now).

With ecigs, the nicotine liquid is derived from tobacco. The FDA asserts its authority, claiming that as used and intended to be used, it's a drug/drug device combination, needing FDA approval.

My argument, ever since I saw the first FDA letter posted on this forum claiming that ecigs were drugs, has always been that no, the ecig, with nic liquid or not, is not a drug or drug device, but rather merely a smoking alternative, and a tobacco harm reduction product. I've also argued from the beginning that the FDA should thus not have any regulatory authority over ecigs. (But, I've never argued that ecigs are tobacco, or contained tobacco; of course they aren't, and they don't).

So while I have absolutely no interest or desire to "be in bed" with SE, to use TBob's words, the fact is that they are simply making the same legal argument now that I saw as the only possible argument against the FDA's claims, from the beginning.

Of course SE are only trying to protect their own financial interest, but that frankly has nothing to do with my opinion that their argument is simply the only available legal challenge to the seizures open to them given the current law and circumstances.
 
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