Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

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Sun Vaporer

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Sorry JustJulie--but that is just hot air, smoke and mirrors. Go read the first post of this thread. Your contentions are a mere pretext and I am not going to respond to nonsense like that. Personal attacks are not warranted as they show desperation. Let people make their own case.
 
As for the Brief, smoke again. I still have the PM's asking how, what, where, when, and why when it came to filing an amicus brief. Your entire post was simply a planed attack and unremarkable and all you did was shed bad light on yourself.
 
Sun
 

Sun Vaporer

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Good lord...

Everyone seems to be stuck on the tofu reference :cool:.

It was used in an analogy concerning harm reduction and was not a comparison to nicotine. It was simply an analogy comparing a low fat healthier item (Tofu) to a higher fat not-so-healthy item (Red Meat).

As in... An E-cig = usually a lower level and far cleaner (or healthier) form of nicotine delivery when compared to the higher content and far dirtier (not-so-healthy) form found in cigarette smoke.

That's all I was saying.


And sure, nicotine is a poison. But, I don't know of anyone that has been poisoned by an e-cig which makes that as close to a moot point as you can get (imo) when discussing electronic cigarette safety.


As far as the two choices go (if that's all we have), I simply prefer the drug tag over the tobacco tag and have stated my reasons why.

Very soon after e-cigs get recognized as either a tobacco product or as a drug, we will know exactly how close all of us are in our opinions on the matter.


I do hope so my friend----but I think it is going to take a long time to see an end result---we can only hope for the best and step up to the plate as often as we can where needed.

Sun
 

Mister

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More then one can "carry the flag"
I heartily agree with this. And I'm sure Kristen, Thulium, and all of CASAA agree, and that they will support as many initiatives as possible. I think some hackles have been raised on this thread for the usual reasons which occur in written communication via the net, reasons which actually don't matter at all and should now be forgotten. You all respect each other, have the same goals, and will support all productive undertakings on behalf of e-cigs. Wrong or right in recent (mis)interpretation of typed communications, time to get on with the good work.

If an action to entirely deny FDA's jurisdiction over e-cigs can be funded this really is awesome news. If it can eventually be won then the efforts to reclassify as tobacco can be dropped with great celebration.

If while such an action is progressing, or if it fails, an action to reclassify as tobacco succeeds then that's a pretty big win too. Not as great a win but still a great step forward from the current situation.

In either case I think that things which increase public awareness are even more important for the long term. A win in either case leaves doors open (much less so in the no FDA regulation action, but still there I expect) to specially tax and/or restrict e-cig usage via specific regulations such as those currently proceeding in a few states. The best way to preclude those problems in both cases will be public awareness. The more people who understand that e-cigs can save 450,000 American lives per year (over 1,200 per day!) the better. Although smokers are a minority, I expect that a majority of the population has at least one loved one. That e-cigs can nearly eliminate those people's 50% chance of dying prematurely will have to be the basis of the long term win in both cases.

What we most need is impartial coverage from major media. Having them question the blocking of a device which can save 1,200 lives per day is what will sway opinion. I don't know how to make this happen but I do believe that the more attacks, especially legal ones, against the FDA's current position, the better.
 

JustJulie

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Sorry JustJulie--but that is just hot air, smoke and mirrors. Go read the first post of this thread. Your contentions are a mere pretext and I am not going to respond to nonsense like that. Personal attacks are not warranted as they show desperation. Let people make their own case.
 
As for the Brief, smoke again. I still have the PM's asking how, what, where, when, and why when it came to filing an amicus brief. Your entire post was simply a planed attack and unremarkable and all you did was shed bad light on yourself.
 
Sun

Just because someone asked you about filing an amicus brief doesn't mean that person was involved in the filing of the AES amicus brief.

What I really want to know is what background and expertise you have that makes you feel comfortable presenting yourself as a legal expert.
 

rothenbj

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Then why did the police recently confiscate them from all places selling them here where I live?


Perhaps the FDA decided to declare the bongs and pipes unapproved medical devices. Have they also confiscated rolling paper, blunts and alligator clips, other potential drug delivery devices.
 

rothenbj

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No one here can deny that CASAA is an important ally and friend to the e-cig community. That being said, it appears to me that CASAA is offended at not being informed of any new actions being taken by suppliers against the FDA.

IMO, CASAA would be an important ally in any new legal proceeding, but it is up to the suppliers to decide if and when they want CASAA involved. Apparently, Sun has some insider information, but it is not his right or duty to pass that information on to anyone, public or private.

I have read page after page of Sun defending himself and I don't think he deserves to be treated like that. Day after day he has, at his own expense, kept us informed as to what is happening in the courts. Without Sun, we would be pretty much in the dark.

That's my two cents worth. Post flames if you like, I can take it.

Well worded. I intended to post the same once I got to the end of the thread. It really hasn't read as Sun's place to speak up. We should all respect that. I believe that if you've paid close enough attention to what's been written here, you may get a fairly good idea of potential strategies.

My guess is that this direction is fairly new in overt action, but founded on direction taken early in the PVs introduction to the US market.
 
Kerist on a cracker! The first and immediate thought that comes to mind while reading the posturing on this thread is "zip up, people, and put the measuring tapes away!"

This pointless posturing does nothing but foster distrust and animosity between us. It's divide and conquer, people, and those arrayed against us are sitting back and watching the PV industry implode under the weight of its own egos.

I've read through the last 10 pages of drivvel on this thread with disgust. Wake up and smell what you're shoveling.

What do you want here? Do you want to be the one with the 'secret society' that saved vaping so you can lord it over the rest? Phhhhht! Utterly assinine, and childish to boot.

Here's the highpoints, for any and all who are interested:

-PV's have been available in the US market since 2007-8ish. They've grown in popularity since then.

-We've seen the formation of the ECA, CAASA, the Alliance & IVC. Now we're seeing another group being hinted at. These groups, from what I've seen, are hesitant to join forces with each other - more measuring and posturing, IMO, as each wants to be 'the one' who saved vaping. BAH!

-The FDA have long-since established their determination to control any and all things nicotine, and have the history to back up that determination and their RIGHT to do so. (Nico water, the lollypops, etc). They WILL have their say. Period. Congress has given them that right.

-The legal 'grey area' that PV's have enjoyed since their inception is coming to an end.

How do we want them regulated? So far, I've heard 3 theories bandied about. Drug, Tobacco, or Recreational Pharmaceutical. Each category has its problems. The discussion here should have been had a long time ago - pick a classification and stick with it. Have everyone on the same page, fighting the same fight. Every time we flip-flop our position, we are seen as a confused, angry, and disorganized group of desperate addicts, who will say anything to get our fix.

Consolidate, people! Make a decision, and follow it.


ONE purpose, ONE goal, ONE MILLION voices raised with ONE message! - Our right to VAPE!

Anything else is next of kin to chaos, and PV's go black-market.
 

JustJulie

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-We've seen the formation of the ECA, CAASA, the Alliance & IVC. Now we're seeing another group being hinted at. These groups, from what I've seen, are hesitant to join forces with each other - more measuring and posturing, IMO, as each wants to be 'the one' who saved vaping. BAH!

Well, I can't say I disagree with anything you said, Vicks . . . even the stuff I didn't requote here.

I did want to eliminate any possible confusion, though, about the AES (or the "Alliance," as it's sometimes referred to). The AES was formed for the specific purpose of filing the amicus brief and it is not a continuing entity, per se. In fact, the original members of the AES currently belong to many different PV advocacy groups.

As for the division Vicks speaks of, she's dead-on accurate. At the end of the day, we all have a common goal . . . to keep PVs legal and accessible. If vaping is to be saved, it won't be by the work of a single individual or a single group . . . it will be because of a coordinated effort of many different people all working together for a common goal.
 

kristin

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That being said, it appears to me that CASAA is offended at not being informed of any new actions being taken by suppliers against the FDA.

I have read page after page of Sun defending himself and I don't think he deserves to be treated like that.

Let me say this one more time.

CASAA is NOT offended. I, as a CASAA board member, was blindsided and incredulous that CASAA could have had the opportunity of supporting a position other than ecig as a tobacco product (which I could confidently say ALL of the CASAA board would prefer) but instead were allowed to blindly continue on the tobacco product track.

The "heads up" wouldn't have been for respect or stepping on CASAA's toes - that is NOT what this is about. A simple "We have a group who has experienced lawyers hired and we are arguing that nicotine is in a class by itself and our lawyers feel we have a good case. So could CASAA please stop pushing the tobacco product stance and push for classification X instead?" Wouldn't that have made sense? I'm just shocked that they at least didn't approach us and ask us to shut the heck up about tobacco products!

My whole goal is to save vaping - I don't care WHO does it. I'll back the people with the best army and weapons to do it. I'm sure the other CASAA board members feel the same. Like other members posting here, I've never been completely comfortable with the tobacco product classification and I only fought for it because I was under the impression that drug device was our only other option.

I'm not attacking Sun. I've been defending myself and CASAA being accused of close-mindedness. I was accused of not supporting this other classification when, to the best of my knowledge and to that of CASAA, Vapers international and the Vapers Coalition, didn't even exist. Who can I support something when I don't even know it's a viable option?? How is that accusation fair?

THAT was the only offense taken and it was by ME personally, not by CASAA.

Thulium--was it not you who said that tobacco is the way to go here? Is that not SE's and NJOY's position? We are talking about the theory of the case, not the companies. If that is not your stance, what is your stance? And I would like to hear why you think or do not think we need a tobacco argument? Personally I do not think the tobacco theory is needed. What is your take?


Sun

Again, we only fought for tobacco vs. drug device. We do NOT fight for tobacco vs. alternate classification. We only argued that because we were unaware of any other options.

But why Tobacco? Nicotine stands on its own footing. Judge Leon ruled that if a product like Nicotine has no theraputic endpoint for using, then it can not be classifed as a drug. That part of his ruling does not even start to touch and concen tobacco. If it is not a drug, then the FDA has no jurisdiction to ban it.

So why do we need tobacco in the equation? Why can't the e-cig stand on its own as the FDA puts Caffeine and Nicotine in the same classification?


Sun

Nicotine is regulated in TWO ways - as tobacco or NRTs. Any other product that has attempted another classification has been banned outright - see nicotine soap and nicotine pops as examples.

Kristin--please go back and read all of your posts about starting with the fantasy one. The one where you say we are stuck with Tobacco or Drug. You were not being open minded at all. You just dismissed it in short order. It really is hard to not look at your posts and say you kicked the idea to the curb. But if that is not your take, then that is fine too.

The Suppliers read your posts and their only comment was "we are really glad we did not post ourselves."


Sun

Again, only because I was not told that a third option was VIABLE. I knew it was there, but it seemed to be impossible to achieve at this time. I'm still a little doubtful and I hope your supplier friends' attorney's are a lot smarter than SE's attorneys.

But if you go back and read my posts yourself, you'll see that I continuously say that I would prefer a third option. There's posts all over this forum by me contending the same.

Without an organized group and some high powered attorneys, getting into a classification of it's own is nearly impossible. If there really is such a group, then that changes things completely. I've already said that numerous times. How does that not show that I DON'T have a preference for tobacco classification and am not open to other options? I've ALWAYS been open to other options.

I'm sad to say that I have to agree with the Suppliers. The recent showing in this thread has been almost difficult to watch unfold. While denied, it's obvious that offense has been taken by at least one CASAA rep, and while I understand the passion displayed the resulting behavior has been shameful, imho. The comments should have been taken off board and into a private discussion if only because in-fighting is something that could be terribly detrimental to our cause at this early stage.

Sun, thank you so much for all of the work, time, patience, and reason. You've helped me immensely in maintaining what I feel is a decent understanding of the events unfolding and the potential repercussions of those events.

Kristin and Thulium, thank you too for the work that you do. CASAA is an important resource for all of us.

Kristin, it might be wise in the future to remember that when you post as a CASAA board member by the use of "we" rather than "I" you should remain calm, civil, and professional in those interactions. The yelling and name-calling was distasteful at best. Again, I understand your passion but feel that you should have either backed away from the keyboard until calm enough to represent your organization appropriately or posted your thoughts and opinions as personal and individual.

Jan

Jan, NO "offense" was taken by being left out of the loop. It is not "offense" but shock that this supplier group would let CASAA run around calling for tobacco product status, when that isn't even what CASAA wants. It was a rock and a hard place choice for us. Why sit there and let CASAA's efforts undermine their goal - scratch that - ALL of our goal? It makes no sense. I don't recall any "name-calling"????

Again, my offense was personal - and not as a CASAA member - that Sun accused me of being close-minded.

If you knew all of the hard work being done behind the scenes, you'd understand my passionate response and I won't apologize for that. I do more work on behalf of vapers than 90% of ECF members and won't be chided for getting a little upset and passionate one time.

I contend as well as many Attorneys that I have spoke with that absent a therapeutic endpoint, that the FDA has a real issue in claiming the e-cig a new "drug" thereby negating its jurisdiction. You do not need "another option", rather you only need to establish that the e-cig does not fall under the jurisdiction of the FDA.


Sun

So, if the the FDA doesn't control HOW nicotine is used, how were they able to immediately ban every non-tobacco and non-NRT product that has been introduced?

-We've seen the formation of the ECA, CAASA, the Alliance & IVC. Now we're seeing another group being hinted at. These groups, from what I've seen, are hesitant to join forces with each other - more measuring and posturing, IMO, as each wants to be 'the one' who saved vaping. BAH!

ONE purpose, ONE goal, ONE MILLION voices raised with ONE message! - Our right to VAPE!

CASAA has ALWAYS been willing to work with other groups and have encouraged it.

FOUR members of the CASAA board are members of the Vaper's Coalition, which is a group comprised of members of Vapers International, National Vapers Club (Spikey), CASAA and Right to Vape.

So don't accuse CASAA of posturing and trying to be the one who "saved vaping" because that simply is NOT the case. We are doing anything and everything we can to help and I know every CASAA board member agrees with me that it's not who gets us there or how, but the end result.

Anyone who sees my or Thad's comments as "posturing" is WAY off base and simply doesn't know what goes on off these forums.

Again, I'd only have been "posturing" if I were offended in some way that CASAA was left in the dark. (And not just CASAA, but the whole Vapers Coalition, because none of these other groups were made aware of this, either)

I was NOT "offended" and neither is CASAA. It's just shocking that this group let us keep fighting for tobacco classification when they KNEW we could be supporting and pushing for their agenda (which is preferable, IMO) instead. It just makes no sense, because we were essentially fighting AGAINST them.

I don't care WHO "saves vaping" as long as it's done. But I DO care that I'm not hampering their efforts! Which, according to Sun, CASAA and the Coalition have been doing just that. But it's not our fault, because we didn't KNOW.

So, the tone people are hearing in my posts is not indignation but shock and disbelief that all of these advocacy groups have been throwing their support behind tobacco classification when we could have been helping these suppliers achieve the goal of a third classification.

I completely agree we all have one goal and that we all need to work together. That was pretty much the point of all of my posts.

This is my last post about this on this thread. If anyone has any questions, please PM me.
 
Last edited:

anim8r

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Kerist on a cracker! The first and immediate thought that comes to mind while reading the posturing on this thread is "zip up, people, and put the measuring tapes away!"

This pointless posturing does nothing but foster distrust and animosity between us. It's divide and conquer, people, and those arrayed against us are sitting back and watching the PV industry implode under the weight of its own egos.

I've read through the last 10 pages of drivvel on this thread with disgust. Wake up and smell what you're shoveling.

What do you want here? Do you want to be the one with the 'secret society' that saved vaping so you can lord it over the rest? Phhhhht! Utterly assinine, and childish to boot.

Here's the highpoints, for any and all who are interested:

-PV's have been available in the US market since 2007-8ish. They've grown in popularity since then.

-We've seen the formation of the ECA, CAASA, the Alliance & IVC. Now we're seeing another group being hinted at. These groups, from what I've seen, are hesitant to join forces with each other - more measuring and posturing, IMO, as each wants to be 'the one' who saved vaping. BAH!

-The FDA have long-since established their determination to control any and all things nicotine, and have the history to back up that determination and their RIGHT to do so. (Nico water, the lollypops, etc). They WILL have their say. Period. Congress has given them that right.

-The legal 'grey area' that PV's have enjoyed since their inception is coming to an end.

How do we want them regulated? So far, I've heard 3 theories bandied about. Drug, Tobacco, or Recreational Pharmaceutical. Each category has its problems. The discussion here should have been had a long time ago - pick a classification and stick with it. Have everyone on the same page, fighting the same fight. Every time we flip-flop our position, we are seen as a confused, angry, and disorganized group of desperate addicts, who will say anything to get our fix.

Consolidate, people! Make a decision, and follow it.


ONE purpose, ONE goal, ONE MILLION voices raised with ONE message! - Our right to VAPE!

Anything else is next of kin to chaos, and PV's go black-market.

I agree with just about everything you said :thumb:

And up until recently, I thought the majority of vapers were fairly united on at least a few things; that nicotine is not a new drug, that e-cigs provide a cleaner/healthier form of nicotine inhalation that help users quit smoking, that e-cigs are not a tobacco product and that e-cigs are devices designed to address the majority of aspects that define the habit/actions of smoking which makes them uniquely suited to assist users in quitting smoking.


So I simply can't get on board with calling this a tobacco product or saying that I didn't "quit smoking" because that's (now) considered the path of least resistance by some members. I wouldn't ever say those things when vaping in front of my co-workers or family members, since it would end any respect they have for the device.

I am allowed to vape in my office, in any of the common areas of my office building, at friend's and family's houses, just about anywhere (including permission to vape on two separate flights now) and all because I used the information gleaned from this forum. That's a LOT of freedom.

The second it becomes known as a "tobacco product" or when people think I didn't actually "quit" smoking, that freedom will immediately end. This isn't opinion. It's a fact. I'm simply not naive enough to hope or wish that it won't.

So if I don't feel even remotely comfortable using that term in real life (because I don't believe it or for the reactions that will ensue) it would be disingenuous to then use it in any other circumstance. Why would anyone get involved in a fight if they don't believe their own argument?

I do not believe it is a tobacco product, so I would fail miserably at defending such a stance. And since there hasn't been a cigarette in my hands since last October, I proudly say I quit smoking. And my friends and family will continue to suggest to smokers that they talk to me about these new devices that helped my wife and I quit smoking.
 

anim8r

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I do hope so my friend----but I think it is going to take a long time to see an end result---we can only hope for the best and step up to the plate as often as we can where needed.

Sun

Absolutely.

Even though I've started using 0-nic liquid and still plan on quitting nicotine and vaping altogether, I'm going to start getting involved in the letter writing campaign and providing funds to those actions I believe in to keep this product available for future consumers.
 
Courtesy: Health New Zealand News 2010

Critique of the WHO TobReg report on e-cigarettes


Murray Laugesen


Report on the scientific basis of tobacco regulation: Third Report of a WHO Study Group
WHO Study Group on Tobacco Product Regulation. © WHO 2009
http://whqlibdoc.who.int/publication...209557_eng.pdf


The report on e-cigarettes or ENDS, Electronic Nicotine Delivery Systems – except that some do not contain any nicotine. They are thus best defined as “devices designed for the purpose of nicotine delivery to the respiratory system in which tobacco is not necessary for their operation.”


Abstract of Critique: Swatting insects instead of killing elephants.

If tobacco smoking is the elephant in the room, electronic cigarettes are like a buzzing insect. The natural instinct is of course to kill the buzzing insect first, just in case it might be harmful. This hostile analogy however, ignores the fact that smokers who like to smoke smoke either tobacco or e-cigarettes, and a move to e-cigarettes implies a move away from tobacco for the smoker concerned. If the real aim is to end cigarette smoking, banning e-cigarettes is not a sensible first move and could be counter-productive.

TobReg, an advisory committee of the World Health Organization, is in effect calling for a ban on electronic cigarettes for the next 3 to 5 years world-wide, until manufacturers apply and regulators accept them as safe to medicinal standards, this while TobReg permits the continued sale of tobacco cigarettes.
As of March 2010, e-cigarettes are not known to have killed anyone anywhere, or caused any threat to life, despite sales of 800,000 in the USA. The same cannot be said for smoking cessation approved medicinals such as bupropion and varenicline.
Tobacco cigarettes are known to cause millions of deaths world wide, and 140,000 per year in the USA.
TobReg has previously made recommendations that WHO should mandate some reduction in the emissions of nine leading toxicants in tobacco smoke, good as far as they went, but for the individual smoker, those reductions are far exceeded by the lesser emissions of e-cigarettes.i


TobReg has almost nothing positive to say about electronic cigarettes. This is surprising, and at odds with what many smokers claim – that it helps them stop smoking, or at least cut down. We agree with TobReg that the evidence is lacking whether e-cigarettes assist smokers to quit smoking. Certainly, such claims would be premature. Health New Zealand Ltd is involved in various funding applications to repair this deficit in scientific knowledge through randomized controlled trials, but it will be 2013 or 2014 before results are available. Meantime, the absence of proof is not proof that the devices are ineffective, merely proof that research funds from independent sources are scarce..


Claims about safety. TobReg’s report “recommends that claims that ENDS are safer than cigarettes, or that they could be marketed as cigarette substitutes, be prohibited until such claims are substantiated by sufficient evidence to satisfy their accuracy to independent scientific organizations and regulatory authorities.” This requires that in the case of the FDA, manufacturers apply to conduct trials costing millions of dollars and years of delay, which no e-cigarette manufacturer to our knowledge has yet embarked on.

In view of the lack of notified side-effects from the use of e-cigarettes, and the 50% risk of premature death which smokers face if they continue to smoke, Health New Zealand Ltd’s view is that meantime distributors should be entitled to inform smokers as the facts become available, and in lay language. Health New Zealand research shows that e-cigarettes are safer (in common parlance) than tobacco cigarettes:

Emissions from e-cigarettes are less toxic and are less harmful to health; Comparative emissions testing commissioned by Health New Zealand Ltd that harmful cigarette smoke emissions are almost entirely absent from e-cigarette mist,ii or present in quantities about 100 times less than in the case of tobacco cigarettes.
E-cigarettes do not cause burns or fires. (There is no flame). Among over 1000 New Zealand smokers, we found tobacco cigarettes had caused burns in 60%, 5% requiring medical attention, and fires in 7% in their lifetime.iii
No evidence of harm in first day users. In a cross-over study by the Clinical Trials Research Unit, University of Auckland in 2008, questioning of 40 volunteers for adverse effects after a day of use of the e-cigarette (blinded for nicotine presence or absence), showed no difference between either and nor when compared with medicinal Nicorette inhaler.iv
E-cigarettes did not grow bacteria,1 whereas tobacco cigarettes do, associated with inflammatory lung disease.v
E-cigarettes do not produce second-hand smoke. No sidestream smoke is produced, nor any mainstream smoke; mist is inhaled and some propylene glycol is exhaled. Propylene glycol has been used in a children’s hospital to reduce risk of influenza and colds.
E-cigarettes are as safe as medicinal nicotine patches and gum with respect to nitrosamine carcinogen content. (8ng /g)1 This is hundreds of times lower than the 2 ug/g ceiling on nitrosamines recommended by this same TobReg report. for smokeless tobacco.
E-cigarettes do not contain tobacco and work by vaporization. Cigarettes burn tobacco at much higher temperatures, which break up the plant material to form small toxic molecules.


Claims that e-cigarettes are cigarette substitutes. TobReg’s report recommends a prohibition on claims that e-cigarettes are cigarette substitutes. As TobReg fails to state whether in their opinion, e-cigarettes are less harmful than cigarettes, and fail to say whether they are more harmful, TobReg is unable to say much. Nevertheless, TobReg goes further and recommends (governments) prohibit claims that e-cigarettes are cigarette substitutes – presumably because it implies they are being touted as safer than cigarettes, and TobReg is not happy about marketers making such claims until regulators confirm this is true. This seems a constriction on commercial speech.



Denial of the harm reduction principle. This report is a denial of the harm reduction principle, that smokers unwilling to quit should be allowed to maintain their previous behaviour if they must, but be encouraged to do so in a safer way. Reduction of relative harm is seen as not permissible, unless near absolute reduction of risk is proven. For example, condoms for safer sex, seatbelts for safer driving, are accepted by society, but electronic cigarettes for safer inhalation of nicotine are not yet accepted by TobReg.


Regulation as medicines or as tobacco products? TobReg recommends regulation of e-cigarettes as medicines, and approval is acknowledged as theoretically possible in the future. TobReg opposes regulation of e-cigarettes as tobacco products, but if regulated as tobacco products wants them regulated as required under the Framework Convention on Tobacco Control. However e-cigarettes do not contain tobacco, and FCTC only applies to products which do.


Regulation as medicine and as recreational product is seen in either/or terms, not both/and. TobReg proposes no middle way to regulate e-cigarettes, as has been suggested by the Royal College of Physicians London tobacco working group,.vi which proposes lighter regulation to permit the sale of non-medicinal cigarette substitutes.




Conclusion
The report says nothing against continued sales of recreational tobacco, and in effect, wants to put e-cigarettes out of reach, regulated as medicines - equivalent to a world wide ban on their sale if governments adopted the recommendation, as none have been approved as medicines and few if any are likely to be approved in the next five years. TobReg recommends virtually no claims should be made of any kind in the meantime.


TobReg assumes that e-cigarettes are a public health threat. Certainly the global distribution of low cost e-cigarettes not manufactured under any recognized international controls, are a threat to the high standards and huge investments required to bring a medicine to market, which have created a oligopolic market for major pharmaceutical manufacturers of medicinal nicotine. But that is not to say that e-cigarettes are a public health threat in the same league as tobacco cigarettes, which is the alternative. TobReg goes after e-cigarettes with a determination more logically directed at tobacco cigarettes.


TobReg’s report has little to say about patents in the e-cigarette industry which are narrowly held and not widely enforced. Fear of enforcement combined with lack of enforcement promotes cheap products and inhibits further investment in the industry.


This TobReg report is written for governments and regulators, but it is out of tune with many smokers who, unasked, have told this author and many others across the world, (www................ ) that these devices have helped them quit smoking, cut down or “smoke” with reduced risk.


TobReg has failed to appreciate the potential of e-cigarettes, preferring to focus on their current imperfections. Yet e-cigarettes could be the next best step, both for governments, as in New Zealand, obtaining only slow reduction in smoking despite wide and subsidized use of NRT; and for those continuing smokers, who have already tried and failed to quit using NRT, facing a one in two risk of dying early.


One regulation size does not fit all and the TobReg take on e-cigarettes does not assist recent moves in New Zealand aiming to end tobacco cigarette sales by 2020. E--cigarettes could be the catalyst society and smokers need, for sweetening the implementation of a national cigarette and tobacco sales ban, as proposed this year by voluntary agencies. As e-cigarettes are classifiable as tobacco products under NZ law, regulation should be achievable to a reasonable non-medicinal standard.

Competing interests: In 2008,Health New Zealand Ltd was commissioned by Ruyan to research the Ruyan e-cigarette in 2008, but has no financial interest in e-cigarettes or any e-cigarette company. In 2009, Dr Laugesen was commissioned by WHO along with Dr Richard O’Connor (Roswell Park USA) to wrute a background paper for TobReg on Electronic Cigarettes.


i Burns DM, Dybing E, Gray N, et al. Mandated lowering of toxicants in cigarette smoke: a description of the World Health Organization TobReg Proposal. Tobacco Control 2008;17:132-41.

iiwww.healthnz.co.nz/Dublin.htm

iii Smith J, Bullen C, Laugesen M, Glover M. Cigarette fires and burns in a population of New Zealand smokers. Tob Control 2009; 18: 29-33.

iv Bullen C, Glover M, Laugesen M, et al. Effect of an e-cigarette on cravings and withdrawal, acceptability and nicotine delivery: Randomised cross-over trial. Tobacco Control, in press, 2010. http://www.healthnz.co.nz/ecig_effect-2.pdf

v Pauly JL, Smith LA, Rickert MH, et al. Review: Is lung inflammation associated with microbes and microbial toxins in cigarette tobacco smoke? Immunol Res 2010 March. On line 11 Sept 2009. DOI 10.1007/s12026-009-8117-6.

vi Royal College of Physicians. Ending tobacco smoking in Britain: radical strategies for prevention and harm reduction in nicotine addiction. A report by the Tobacco Advisory Group of the Royal College of Physicians. London: RCP, Sept. 2008.

They make a strong case and I do tend to agree with their conclusions. I am not completely convinced of the feasibility as it does seem to come out of left field, but I could get behind this. :thumb:
 

Hudsonkm

Senior Member
ECF Veteran
Jan 7, 2010
161
14
49
Illinois, US
I am a tad bit confused.

This article linked below states that the court of appeals has banned E-Cig import indefinitely. Is this not part of the original NJOY vs FDA case or is the article just incorrect?

Link

2010-04-01 21:14:54 - The importation of e-cigarettes will be banned indefinitely as the result of a unanimous ruling by the U.S. Court of Appeals. The court agreed to permit their continued import ban while it considered an appeal from a lower court ruling which had prohibited the Food and Drug Administration [FDA] from stopping the imports of this new product, reports public interest law professor John Banzhaf of Action on Smoking and Health (ASH), who participated in the legal proceeding.
 

ECGuy

Unregistered Supplier
Oct 14, 2009
61
0
New Mexico
Courtesy: Health New Zealand News 2010

They make a strong case and I do tend to agree with their conclusions. I am not completely convinced of the feasibility as it does seem to come out of left field, but I could get behind this. :thumb:

We need to get behind stuff like this. I said I was going to stay out of this discussion, but over the last few days, i've just become so infuriated with the whole situation and this discussion that I finally must speak my mind.

I know my thoughts are not really welcomed here in this forum, but I'm going to post anyway and hope they don't mod it or ban me. I just have to get some of this off my chest.

1- The arguments over he said she said what did you say??


Enough already. We've wasted a week now going over the same old thing over and over and over again. All it does is incite more drama and division, which is the last thing we need at the moment. Yes, some things were misunderstood, others were not, some were insulted, some were put down, some just got plain blindsided. It happens in politics.

It's time for the vaper community to have some leaders. And not to insult anyone or point a finger at certain individuals or any one group but:
Do you see anyone taking the flag and rallying the troops? I certainly don't. Instead I see our "leaders" wasting time arguing moot points and frivolity.

WE are all very opinionated people. It's just part of the personality profile of vapers I think, LOL. I know I'm pretty opinionated, and it's gotten me in trouble in the past and will again in the future. Most of the ecig "activists" are also very opinionated too and in the end it only hurts our cause to show that in public.

Leaders can not be opinionated and quick to fly off the handle, neither can effective activists. Vapers need a strong voice at the moment, someone to act as a calming influence and guide the discussion and the fight in the right direction. Let's put our efforts into that and keep our personal battles between us. There simply is no time for bickering in public.

As Vicks said "zip up, people, and put the measuring tapes away!"

the Secret Societies and "We Saved Vaping" Brag Rights

As Vicks pointed out, this has been going on for a long time. Our "society" if you will, has been split now for a long time and further splits just happen more and more. Opinionated people with strong personalities often times have trouble working together and we've seen that happen over and over in this fight.

It's time for this to stop. Our enemies may not all get along, they all have their own little groups with their own take on things, their own agendas, their own personalities, but when it comes to the important stuff, they all manage to put their differences aside and work together towards their common goal; namely killing us.

Look at the info put out by groups as diverse as ASH and the American Cancer Society, same talking points, same issues, same info just presented in a slightly different way. They are focused and clear.

As i've said before in this forum and others: They are running their playbook, a playbook they've had years to develop and one that works very well. These people are professionals at activism and they are kicking our asses in the public arena.

It's time to band together and work together and work hard. We have six months people, maybe less, maybe more. But the time for sitting on our duffs and wringing our hands over how unfair it is in forums is over. The time to stand up and fight is here and fighting amongst ourselves does nothing.

Tobacco vs Drug vs Reduced Risk

I've been saying since day one the argument for classifying us as a tobacco product is a flawed one. So have many others. As Kirstin points out though, those were the only two we thought we had available and tobacco seems the lesser of two evils, the one we might achieve, the one that would give us time to explore other options.

The Family smoking act and the PACT act and the recent court decisions and state legislation have severely crippled this argument. Yes, Njoy and SE threw all their eggs in that basket, so did a lot of other organizations. Will it work? I doubt it, but maybe. There's still hope, although fleeting.

Drug device is a classification we all don't want. We know what will happen if ecigs are classified as drugs. Even if they are approved, it won't be any of the current companies who get it approved, it will be a pharmaceutical or tobacco company because it's going to take years and millions. We all know this.

Reduced Harm vs recreational does seem to be our best bet. Reduced harm is going to be a hard fight. the laws clearly state what is needed for that and were very craftily written to make it difficult. Yes, the FDA is mandated with encouraging harm reduction strategies and products but the rules on what that is and the requirements for medical proof and public benefit are so strict, I doubt we have the time or energy or money to make that happen.

Recreational seems our only option. Or is it?

Public Perception and PR

What is killing us is we completely lack any PR.
Did we read Thuliums post about the Sensor Pad?? Did you notice what saved them? Was it court battles or studies or sidestepping or consumer advocacy groups?? NO. It was PR.

It was the Wall Street Journal and 20/20. It was a sympathetic congressman, users and doctors who testified the product worked. It was a well crafted PR campaign.

PR is king. It's what our enemies have that we do not. The reason the anti smoking folks get all the press is simple. They go after it. They hire the PR people. They hire the lobbyists. They have the resources and the known names and the well crafted arguments that sell air time and newspapers.

Simply put: They work it. We don't.

BUT PR takes money so do lobbyists!!

Yes. And this is where we have failed the most. This is where our enemies have us beat hands down. And it's our own fault.

We have a lobbyist in Washington. He's good too. He's an ex Congressman. His office is two blocks from capitol hill. He's well spoken and skilled at public speaking. He knows the right people. He was a great asset to our community and was making some inroads last year, getting some press, people were listening to him.

But did we help him? NO, we did not. WE whined and complained he wanted too much money. WE complained his members were the evil big boys out for profit. Membership to the ECA is too expensive said mom and pop mixing juice in their basement and Bob selling ecigs out of his garage.

So we started our own grass roots groups. Which is good. Some of them are doing good things. But are they going to raise enough money to win this fight with auctions and concerts? NO, they are not. Do they have the resources and experience to be effective? NO they do not.

The entire community refused to donate any money for things that work or to hire some pros.

As a matter of fact we actively encouraged and promoted the companies with the lowest prices while calling anyone who charged a decent price to afford advertising, attorneys, lobbyists, PR people and professional activism a "scam" or a "fraud". We turned them away from forums like this and instead promoted he who would sell us the cheapest mod, the cheapest juice, the cheapest kits. $99 bucks!!! we screamed and bought the $39 versions instead. Then we told everyone who would listen to do the same.

Now where is the money for PR? Where is the money for ads? Where is the money for radio? Where is the money to get our voice heard by the people who matter?? Where is the money to hire some professionals who can get things done?

Where is the money for anything? There isn't any. The profit margins for most of the "reputable" and "approved" companies out there are so low they are lucky to afford some Adwords, let alone a $10,000 national radio campaign or a $4000 full page ad in a magazine or a $100,000 a year lobbyist.

Now you watch, mom and pop are out of business. Bob too. The FDA is going to squash them as quickly as they can. The only ones who can survive are those that are already pretty big, or those who can band together to fight as one. (which they should have been doing the entire time but instead waited till now. lets hope its not too late.)

So, SE is what people see. They are the company with the money, they are the ones with the attorneys, they are the ones with the name and the PR power. And yes, IMHO they are scumbags and PR ...... out for themselves and could care less about the rest of us and have done as much, if not more damage to our cause than ASH. That's true. But like it or not, they are the ones getting all the attention.

Don't make any claims, Stay Under the Radar, Shun anyone who does

Over the last year i've watched this industry go from a handful of companies to literally hundreds. And some of them are pretty good! Small companies out to do right, provide great products and great service. Men and women who saw opportunity and thought they could do it better. I applaud each and every one of them.

But in the beginning most of us found vaping through the first few "big" companies. The ones who said "smoke anywhere!" "No carcinogens". "Safer!!" Of course we did. Who is going to buy a "smoking alternative that we can't really tell you the benefits of"? "is it safe?" we can't tell you. "do doctors like it" we can't tell you. "Can I quit smoking?" Go to the forums and ask, we can't say.

It was only after these first few companies got us all started that we formed our little groups, started our forums and built up this huge grassroots "cottage" community that allowed these small companies to find a market. It was those of us who already knew the benefits of vaping that could buy from these small guys without needing to hear any claims or see any advertising. It's the guys who do the radio ads, the publications, the heavy marketing who get people interested in ecigs. Then they come to places like this and find the cottage market.

But as time went on, and the pressure from the FDA grew, we said "don't make any claims" "Don't mention any studies" "don't talk about what doctors say" don't say you quit smoking, don't mention anything except "it's a smoking alternative. Then we decided you could perhaps say "no tar" or "no smoke" but that's it!! No medical quotes, no nothing. Shun anyone who does. And that's just what our enemies wanted us to do.

Heck, even I've been classified here as one of the rogue "unregistered suppliers" and unable to post links to anything useful because I had one company listed on my site that made the ECF blacklist by saying "no carcinogens" and i'm quick to point out some of the medical studies and quote the doctors in my blog. It made people nervous and since i make a few bucks from affiliate links, even though i've never once pushed any ecig here and even my site is not geared towards selling, but rather news and opinion, I'm classified as a rogue supplier. So be it. OK. Whatever.

And there were valid reasons for that. the FTC and the FDA and the WHO were breathing down our necks. After the FDA report it was hard to say "no carcinogens" and the FTC says you can't say "stop smoking" without studies. So now what do the companies do? They make no claims and instead, as at least one prominent "approved ECF supplier" does on their site FAQ about why there is no info about the benefits of vaping or if it will help you quit smoking, you just say "join a forum and ask there".

Because as much as we say "don't make any claims or mention any studies or say you can quit smoking" that's a lot of what we do around here isn't it?? Most of us have "Smoke free for ______ days" banners and we talk a lot about studies and such.

AND WE SHOULD. Our enemies don't want us to talk about this, but we need to.

Its time to talk about it

Every single time our enemies hit us, we back down. Every demand they make we comply. So far what has it gotten us? Not a damned thing.

They call us dangerous and we can't defend ourselves. They say no studies and we can't show the ones there are. They say "second hand vapor" and we do nothing. They say "contain carcinogens" and we do nothing to explain that while that is technically true, the amounts present are so small the FDA can't even quantify how much there is.

Now we've all decided to just say "Smoking Alternative" and what does the WHO do?? “recommends that claims that ENDS are safer than cigarettes, or that they could be marketed as cigarette substitutes, be prohibited until such claims are substantiated by sufficient evidence to satisfy their accuracy to independent scientific organizations and regulatory authorities.”

So there goes that.

WHAT IS MY POINT??

My point is simple: We are out gunned, we are out funded and we've retreated to the edge of the sea. WE are losing the war quickly. It's all going to be over this year if we don't press forward NOW!

It's time to put our money where our mouths are. It's time to band together. It's time to get some action done. It's time to get busy ladies and gentlemen.

CASH
It's time for every company to put up some cash. It's time for every vaper to find a group they like and support them with time and/or money.

Just look at the numbers of this forum alone. 34,000+ members? 7,854 active? Do the math, $20 bucks each is a chunk of change we can use to hire some pros and get our voice heard where it matters most.

PR, LEGAL and LOBBYIST PROS
It's time to call in the pros. All our discussions in the forums and our armchair quarterbacking of the debate does nothing. Get some real pros in here and put together a strategy that's going to work.

Grassroots is great. I love it. I participate in many, and some are having great success. But it takes time. And it seems time is exactly what we don't have.

IF we want to vape next year, we need to get our voice heard on some major media right now. WE need face time with the politicians and policy makers. Only pros can make that happen. ASH has theirs, the ACS and the tobacco free kids have theirs. It's time for us to have some of our own.

WIN THE HEARTS AND MINDS

Get out and talk to everyone you can. Write anyone who will listen. Take a few minutes a day and share your story with anyone who will listen. Congressmen, legislators, newspaper editors, news reporters, hell, even the neighborhood gossip. Whatever works!!

Tell everyone the benefits of ecigs. Tell them how you quit smoking the moment you picked one up. Tell them you are certain this product saved your lives and the government wants them banned.

OUR ORGANIZATIONS NEED TO DO BETTER AND WE NEED TO HELP THEM

I know it's tough. I know none of you are pros. I know this is overwhelming, confusing and you are doing the best you can with the limited resources available. I really do. As much as I've criticized some of you in the past I do know how hard activism is.

BUT we have to do better. You have to do more, you need to be more active in sending out updates and action alerts. How many of you have gotten one single thing from any organization in your email about the new laws? the new court cases?

How many of you are like, I believe it was CS2? who said he needed guidance and education to know what to do?? He pleaded for some leadership, he pleaded many times in this thread alone to be told what he can do to help.

Organizations, you are charged with that. You say so in your mission statement. Can you honestly say you've done all you can to lead?

Companies: Mobilize your customers!! Help get the word out. You are the ones with the mailing lists. You are the ones who mail the boxes. You are the ones who can get the word out fastest and the ones with the most to lose.

People, you are charged with helping them. Can you honestly say you've done the best you can to follow??

I can't. I've not done the best I can either. There is much more I could have done but I let some people's bad attitudes and my dislike for a few people and my fear of being banned from forums because of my sometimes unpopular opinions convince me to give up and just do what I can with my blog.

Well, no more. I'm not going to stand on the sidelines anymore. like me, don't like me. Trust me. Don't trust me. Ban me, don't Ban me. Label me however you like because I believe so much in ecigs that I sell a few now and then. I don't care anymore. There simply isn't any time left now.

I don't have any money and i have too little time, but what I do have will be spent fighting to keep vaping legal.

Who wants my help?? I stand ready to assist in anyway I can. I'm already a member of everyone save for the ECA I think. Put me to work, I beg you.
 
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Hudsonkm

Senior Member
ECF Veteran
Jan 7, 2010
161
14
49
Illinois, US
Many good points in that post.

As the in-fighting continues, the laws and regulations will continue to move forward.

By the time everybody finally decides to cooperate on our end, it might be too late.

We really need to run some of our own tests in terms of taking various e-liquids in and having them analyzed to see what is found. Aren't there universities that will do this for a small fee?
 
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ECGuy

Unregistered Supplier
Oct 14, 2009
61
0
New Mexico
Many good points in that post.

As the in-fighting continues, the laws and regulations will continue to move forward.

By the time everybody finally decides to cooperate on our end, it might be too late.

We really need to run some of our own tests in terms of taking various e-liquids in and having them analyzed to see what is found. Aren't there universities that will do this for a small fee?


There are some universities who will do that, but no, it's not a small fee. And since many universities get some major funding from our enemies, not a whole lot of them are willing to jeopardize the millions they get from tobacco and drug companies to help us out.

Besides, it's already been done. We have tons of studies and lab reports showing juice is safe. But we can't say so. Meanwhile John Banzhaf just keeps saying "we just don't know" "component of antifreeze" "PG is unsafe" "nicotine is a poison".

Why? Cause he doesn't sell anything. He just takes millions of dollars from people who do.
 
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