Action regarding FDA: No banter here, please

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yvilla

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If we do get the other kind would that mean that it would fall under current tobacco guidelines... such as taxes for instance?

Well, ecigs do not contain tobacco, so it couldn't be automatic anyway. But if they want to impose extra taxation, all they would have to do is pass legislation anyway; whether it's "lumped in" with tobacco products or not, they can do that.
 
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
This is what happens when you don't feed your e-liquid addiction:
crack_baby_a_photo_by_masonstormhead_for_flickr.jpg
 

StratOvation

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Right.

It's the "other" kind of regulation we would want - not the FDA kind of regulation, which would probably mean extinction. The kind of regulation snus have now, maybe?

Yvilla,
Aren't snus regulated exactlly like tobacco by the same regulatory agencies and taxed similarly?

Mike
 

yvilla

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Wow yvilla that would make a bottle of juice really expensive here in N.Y.

I would hate it (I'm retired, so finances matter).

But, the question of ecig taxation really has nothing to do with the question of whether we will see the continued legal availability of ecigs. As far as I can see, whether ecigs are considered tobacco products or not, or as something within their own individualized category for regulation (best case scenario, but highly unlikely), if the government wants to impose special taxes they can vote it in.

So the only truly pressing issue right now is whether they are going to be categorised as drug/drug devices, for then they disappear from the open market.
 
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StratOvation

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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.

I Wholeheartedly agree with Kate and TBobs assertions that the proper classification for an e-cig is "Un-classified". But, I also understand Yvillas point that "At this stage" (Post unsubstantiated manufacturers health claims forcing the FDA involvement) a classification of "unclassified" for an e-cig starter kit is very unlikely.
 

sherid

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Just curious if anyone has taken a look at Smoking Everywhere's website. Wow. They seem to have everything covered. I see that they now offer disposable e cigs and cigars in various flavors, a number of kits with prices not terribly higher than many others, warnings galore, etc. etc. It is the first time I ever looked at it, so it would be interesting to see if that site has drastically changed recently. I know nothing about SE other than what I have read here. Comments???
 

yvilla

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Yvilla,
Aren't snus regulated exactlly like tobacco by the same regulatory agencies and taxed similarly?

Mike

Mike, yes they are, but snus are made out of tobacco.

Again we get the gray area with ecigs, since they contain no tobacco. That's why I think they couldn't automatically be subject to "tobacco" taxes.

It's only ecigs' functional equivalence to smoking that gives rise to the argument that they shouldn't be classed as drug devices.
 

Webby

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We seem to all be bringing up viable reasons to save the e-cig. The problem is that the government has already made up it's mind and is on a roll with passing the tobacco tax.

Ever get in an argument with your spouse, and halfway through you realize you're wrong...but you have so much vested in the battle that you can't back down?

That's what's happening here. You won't get Sen. McCarthy to call off his witch hunt and the fact that the FDA is fast tracking this ban can only mean SERIOUS tobacco lobby money is behind it. Phillip Morris was a staunch supporter of the tax because they knew they were the only ones who could survive and protect their market share.

IMHO, It's like starting a basketball game with 8 year olds and making the first rule "Ok, everyone gets punched in the face before we begin..."

They can take the hit. We can't.

Of course, we can all get on Kate's Christmas List and wait for our annual "Christmas Gift Care Package" all wrapped in pretty paper >hint< :p
 

katink

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We can only fight for our dreams coming true (in this case: getting e-cigs into a category where they belong, be it TB's chinese toys or Kate's 'seperate category' or my 'not bunched in with tobacco but an own 'tobacco-harm-reduction category') if we first of all survive. There will be no possiblity to get our dreams for e-cigs to become reality, if we let e-cigs be wiped out.

If there are now only two choices, as it really seems to be, then we need to be realistic and go for survival.
After that, then comes a time in which we can build further on getting dreams to become true.

Yvilla (and/or others with legal/lawyer backgrounds): what are your thoughts on possibility's for class-suits please. Are there any chances there now; and will there be any chances there áfter having been categorized as a tobacco-product, be it in a special sub-category?
 

Webby

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Don't get me wrong, grass roots may be our only hope of keeping them from falling into a years-long "FDA Investigation" Who knows how long they will be "studied". I have no doubt the FDA will reverse it's decision and PVs will be vindicated (but like others have said) how long will it take and how many lives will be lost?

I love this final quote from Where's the Fire?: The rush to ban electronic cigarettes is hazardous to smokers' health. - Reason Magazine

"The standard for lower-risk products for use by current smokers," argues the American Association of Public Health Physicians, "should be the hazard posed by cigarettes, not a pharmaceutical safety standard." Telling smokers they may not use e-cigarettes until they're approved by the FDA is like telling a floundering swimmer not to climb aboard a raft because it might have a leak.
 

yvilla

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Katink, I have been thinking on these issues and possibilities for a long time now - I'm almost obsessed with this, as many of us are. But I haven't come up with any strategy for a consumer legal challenge to the FDA that seems viable. So I've also been considering who I could approach to brainstorm with.

I really didn't want to mention that I was a lawyer here, both because I'm retired and because civil litigation was not my area of specialty - my whole career was devoted to criminal defense law. So I'm just in the same predicament as everyone else here, and my legal background only gives me a bit of an edge in knowing the way the system works, that's all. But, Drew's post just before I did come out with it "drew" it right out of me, together with my frustration in trying to get some points across that I do feel very strongly about.

If I do come up with any potentially helpful input or ideas, I will definitely post more on this.
 

Kate

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Have you seen this Yvilla:

"... Products like Nicogel take advantage of the unregulated grey area between tobacco products and tobacco cessation products. The cancer society believes Nicogel is not subject to FDA approval so long as it does not claim to be a product that will help a smoker quit.

Indeed, with no apparent regulatory requirement, there are also no data from clinical trials to prove that the product is safe and effective, Dr. Glynn pointed out.

"No independent research has been conducted to validate whether it's effective and safe," he said and added that there is "no indication of toxicity or level of nicotine it delivers" beyond what Blue Whale Worldwide claims."
Medical News: Nicogel in the Hand a Surrogate for Tobacco in the Lungs - in Primary Care, Smoking & Tobacco from MedPage Today

If other nicotine products are not seen as drugs or tobacco then is there a chance that vaping could slip into that grey area and be unregulated?

What do you think will happen if the devices and eliquid become tobacco products? Are they likely to be banned?

Do you see any way that we could split the hardware and zero nic eliquid from nic eliquid for regulatory purposes?
 

yvilla

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Kate, I hadn't seen that article. But that portion you quoted about the unregulated gray area is exactly what had been said about ecigs previously - even by the regulatory bodies here in the US themselves.

It really seems that it was the increasing traction gained here by ecigs, and the abundance of bad marketing with cessation claims, that caused the FDA to change its position.

I don't think arguing that ecigs are the functional equivalent of cigarettes, or that they are merely a cigarette alternative, a tobacco harm reduction product, necessarily equals calling them a tobacco product - the fact is they don't contain tobacco, they do exist in that gray area.

But we do need to insist legally that ecigs, even when meant to be used with nic liquid, do not belong in the category of drugs/drug devices where the FDA is trying to place them. And I tend to agree with the multitude of posts we've seen that argue that ultimately the devices themselves, separated from nicotine liquid, cannot be kept off the market. I think the FDA will lose that one, but it may be a protracted battle.
 

Kate

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I wonder if the FDA have any case to regulate traders who make absolutely no claims like Janty. It might be that they can only act if someone steps out of line and out of the grey area. Smoking Everywhere made any and every claim they could and personally I would have stopped them trading myself if I could.

My fingers are crossed that hardware will end up like water pipes - split off from the active drug. Nicotine eliquid is another matter and I can see that it could well take years to settle regulation for that.
 
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