Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY
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As am I, which is why a courtesy "heads up" from this coalition of suppliers would have been nice.
Sun, we only argued for tobacco product because we thought that was our only option. Neither I, nor CASAA, has any affiliation with Smoking Everywhere or Njoy. As a matter of fact, we have two small suppliers on our board - WEBBY and Drew from Nhaler. Don't you think if they knew about an alternative diorection they wouldn't be guiding CASAA in a different direction?
You can't leave us in the dark and then blame us for arguing on the wrong side. We only argued for tobacco vs. drug. Period. Harm reduction was the holy grail that seemed unreachable without a coilition of suppliers.
OH HELLO!
You mean there IS a coalition of suppliers?? Well, gee THAT MIGHT CHANGE THINGS.
Jesus man.
And I never implied that the suppliers should answer to us. But to sit there and watch us fighting for tobacco product status, because we thought there was no other option, and then to turn around and have you accuse us of being close-minded is ridiculous. CASAA has ALWAYS endorsed the reduced harm stance and was only settling for tobacco status for now. If you had bothered to be involved with THIS side of advocacy, maybe you would have known that.
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Regardless of the legal approach, it's in the interest of both CASSA and the supplier group to get the FDA to recant their danger statements and lies to the public about ecigs being unsafe. It's easy to steer ecig policy if you can prove them safe and have public perception on your side.
http://www.e-cigarette-forum.com/fo...6-class-action-against-fda-health-canada.html
http://www.e-cigarette-forum.com/fo...6-class-action-against-fda-health-canada.html
Even if the FDA loses the case, I don't think they will ever recant their statements. That would be admitting that they were wrong and they will never do that.
I agree with you on that one JerryRM. My only hope is that as this thing progresses and if indeed we are successful that as more positive and factual information becomes available (from unbiased/independent research and testing) and hopefully more private and public physicians speak up and speak out relating positive health benefits to their patients; also over time I would hope to see a decline in residential and commercial smoking-related fires leading to deaths, personal injuries, and property destruction; that as this flow of information becomes available we will continue to have at the forefront of our cause intelligent and responsible leaders reminding the public of these positives while reminding them of all the earlier false claims, misleading statements, and unwarranted fear tactics that were made in a grossly misguided attempt to abolish this technology and perpetuate a severly flawed 'supposed' public health strategy of abstinence only. I never expect an admission of 'wrong doing' or error on the part of the FDA and quite frankly I don't care because it too would be disingenuous and most likely self-serving. I expect little if anything legitimate and ethical from that agency - their track record speaks for itself.
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
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
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I'm a newbie. Only started vaping 3 weeks ago. Only discovered vaping because Congress made internet sales of tobacco/USPS delivery a FELONY--which put my 46 years of smoking in the "I can't afford it" range. If I get busted for a felony, they'll put me in jail AND YOU CAN'T SMOKE IN JAIL! What to do?
So I bought e-cigs and was actually SHOCKED at how easy quitting smoking was. Then discovered this forum and found out that THEY were gonna be illegal. I was aghast. So I've read this ENTIRE thread.
Seems to me that the people get pissy just because they're so FRUSTRATED. And they're passionate. And they really see the good e-cigs can do. And they want to keep them available and affordable for us and future non-smokers. Makes sense.
Originally it looked like we were stuck w/2 options. Tobacco status or drug status. Of the 2, tobacco looked like the best option (although not a good one). So the flow went that way.
Now it looks like there's a 3rd option--one which seems closer to what we would have wanted all along.
So how can we now support this option?
So I bought e-cigs and was actually SHOCKED at how easy quitting smoking was. Then discovered this forum and found out that THEY were gonna be illegal. I was aghast. So I've read this ENTIRE thread.
Seems to me that the people get pissy just because they're so FRUSTRATED. And they're passionate. And they really see the good e-cigs can do. And they want to keep them available and affordable for us and future non-smokers. Makes sense.
Originally it looked like we were stuck w/2 options. Tobacco status or drug status. Of the 2, tobacco looked like the best option (although not a good one). So the flow went that way.
Now it looks like there's a 3rd option--one which seems closer to what we would have wanted all along.
So how can we now support this option?
Kristin,
You really need to understand the history here. And a little history here might be good as many new Members do not know how or why CASAA was formed.
The idea of CASAA was born right here in this thread by myself and another small Supplier due to our total disagreement with other Advocacy groups out there. There was no one representing the interests of the small Supplier and I never bought SE's theory of the case when it came to lumping e-cigs in with tobacco.
Webby came on shortly thereafter with extreme interest. There were numerous ideas before we advanced this new Advocacy group and put it out there for nominations for a board to be formed.
Although there were many thoughts that went back and forth, one thing that I was not going to give up on was finding an alternative way to help small suppliers in this fight.
SE and NJOY at that point in time where only looking out for themselves. A little further background is that NJOY was actually in very viable negotiations with the FDA until SE unilaterally filed suit. Any negotiations went out the window at that point.
It was my intent, and still is to this day to get representation more akin to who our Suppliers are and hopefully always with an eye to settle this case. As it stands now, there is no way of knowing if the FDA has put anything on the table or in the alternative if SE was not willing to settle. I wanted a party in there who was working toward both a settlement and a win.
SE and NJOY are well within their rights to protect their interests, but that does not mean all of our small Suppliers, many who write to me daily, should not have some representation. After all it is these Suppliers that most of use buy from.
Once CASAA was formed, I abstained from being on the board to work to that end goal. So what is going on here is the very product of the original intent of what the real founders of CASAA wanted.
None of the original founders of CASAA ever bought SE's theory of the e-cig being a tobacco product. This theory has been run by countless Federal Trial and Appellant Attorneys over the last year and 99.9% all agree it is a loser
So I have been working on acquiring representation for our Suppliers for quite some time. That is part of what I do.
So there is no need to talk to about what CASAA is and is not doing. In the formation of CASAA, I never bought into this "reduced harm status" unless the FDA threw it out as an option in settlement.
The problem with a settlement is there is no incentive for any kind of settlement unless both parties have something to lose and something to gain.
In this case there is nothing for the FDA to lose or gain. Now if you argue the case differently, by going after nicotine instead of tobacco, then, again in my opinion, the FDA has a real issue.
If you look at the classification of nicotine, the FDA lists it as practically harmless right in the same category with caffeine. 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".
Also using the media to bring this case to the forefront in a heated debate of balancing the lives saved versus whatever harm the e-cig poses would be paramount to winning over public perception. We as well as our Suppliers deserve representation that is "representative" of what we need, not some big corporate Supplier. That is why we came up with the idea of CASAA.
So do not look for this particular founder of CASAA that took on an Advisory role to be aligning with other groups as that is the very reason I came up with the idea for another advocacy group. Unless it is in our best interest, it is not going to happen. Too many times we were let down by other groups and that is not going to happen again to the Members here.
Sun
You really need to understand the history here. And a little history here might be good as many new Members do not know how or why CASAA was formed.
The idea of CASAA was born right here in this thread by myself and another small Supplier due to our total disagreement with other Advocacy groups out there. There was no one representing the interests of the small Supplier and I never bought SE's theory of the case when it came to lumping e-cigs in with tobacco.
Webby came on shortly thereafter with extreme interest. There were numerous ideas before we advanced this new Advocacy group and put it out there for nominations for a board to be formed.
Although there were many thoughts that went back and forth, one thing that I was not going to give up on was finding an alternative way to help small suppliers in this fight.
SE and NJOY at that point in time where only looking out for themselves. A little further background is that NJOY was actually in very viable negotiations with the FDA until SE unilaterally filed suit. Any negotiations went out the window at that point.
It was my intent, and still is to this day to get representation more akin to who our Suppliers are and hopefully always with an eye to settle this case. As it stands now, there is no way of knowing if the FDA has put anything on the table or in the alternative if SE was not willing to settle. I wanted a party in there who was working toward both a settlement and a win.
SE and NJOY are well within their rights to protect their interests, but that does not mean all of our small Suppliers, many who write to me daily, should not have some representation. After all it is these Suppliers that most of use buy from.
Once CASAA was formed, I abstained from being on the board to work to that end goal. So what is going on here is the very product of the original intent of what the real founders of CASAA wanted.
None of the original founders of CASAA ever bought SE's theory of the e-cig being a tobacco product. This theory has been run by countless Federal Trial and Appellant Attorneys over the last year and 99.9% all agree it is a loser
So I have been working on acquiring representation for our Suppliers for quite some time. That is part of what I do.
So there is no need to talk to about what CASAA is and is not doing. In the formation of CASAA, I never bought into this "reduced harm status" unless the FDA threw it out as an option in settlement.
The problem with a settlement is there is no incentive for any kind of settlement unless both parties have something to lose and something to gain.
In this case there is nothing for the FDA to lose or gain. Now if you argue the case differently, by going after nicotine instead of tobacco, then, again in my opinion, the FDA has a real issue.
If you look at the classification of nicotine, the FDA lists it as practically harmless right in the same category with caffeine. 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".
Also using the media to bring this case to the forefront in a heated debate of balancing the lives saved versus whatever harm the e-cig poses would be paramount to winning over public perception. We as well as our Suppliers deserve representation that is "representative" of what we need, not some big corporate Supplier. That is why we came up with the idea of CASAA.
So do not look for this particular founder of CASAA that took on an Advisory role to be aligning with other groups as that is the very reason I came up with the idea for another advocacy group. Unless it is in our best interest, it is not going to happen. Too many times we were let down by other groups and that is not going to happen again to the Members here.
Sun
Sun Thanks for that last post 10:38pm 4/09/10 for some reason the sytem won't let me use the quote feature. Anyway, your post and all your other comments have really helped me. I know I am going to sound crazy here because I've gone back and forth myself but after carefully reading your posts it makes more sense to me. Initially I too was against the tobacco status - for numerous reasons and I too felt that was a set-up and a loser. I was then convinced otherwise by some very thought provoking comments and opinions by some very committed and intelligent persons who shared the rationale for the "tobacco product status" and I began to feel they were right; and I have posted so several times on this and other threads. However, the whole time it has felt extremely uncomfortable inside me (and I've learned over time to trust this) I was feeling as though the "tobacco status" choice was the only viable option to keeping e-cigs available because I am sure, and I think most agree, that if it is classified as a drug-delivery device that is basically a defacto-ban. You have made your position clear to me and it makes very good sense - granted I am no attorney, I am no politician, nor do I understand the intricacies of how the FDA works and still, the strategy you have explained makes the most sense to me and in my opinion is the truest representation of the product and technology. I am also heartened to know that there is money and legal representation working on this strategy and if there is anyway in which I can help please let me know. I am also glad that you indicated that this "tobacco product" strategy has been reviewed by several Federal Trial and Appellant Attorneys and 99% felt it was a loser. I recently ran it by some attorney friends of mine (granted no experts by any stretch) but they too felt it was not a sound strategy and would likely not prevail.
As a side note to anyone who has found the ongoing "debate" or bickering as distasteful and distracting I would respectfully disagree. For anyone who has followed the recent passage of healthcare reform (whether you agree with it or not, is not my point) but rather you watched legislation in action. It's messy, ugly, sometimes bloody, sometimes disgusting. I agreed with several newscasters who likened it to the making of sausage. You may like the end product, but have you ever seen it made?!?!? YECH
This action too is going to be the same (I'm not saying I think this right or desirable but that I recognize it truly is the way of things) this is going to be a fight, it is going to be bloody and ugly and no one is going to just go away quietly into the night. So while it may be more comfortable to just be warm and fuzzy and supportive (I like those things too) that's not what is going to get things done. I am comforted that we have fighters in our corner and I appreciate the candor and the passion - we will need all we can muster and then some.
And to Kristin, I do appreciate everything you do for the forum and the cause in general and I have no problem at all with you expresing yourself fervently - in fact I respect it and it makes it easier for me to trust you. Please keep doing what you are doing you are a fighter and I respect that.
And Sun, thanks again!
As a side note to anyone who has found the ongoing "debate" or bickering as distasteful and distracting I would respectfully disagree. For anyone who has followed the recent passage of healthcare reform (whether you agree with it or not, is not my point) but rather you watched legislation in action. It's messy, ugly, sometimes bloody, sometimes disgusting. I agreed with several newscasters who likened it to the making of sausage. You may like the end product, but have you ever seen it made?!?!? YECH
This action too is going to be the same (I'm not saying I think this right or desirable but that I recognize it truly is the way of things) this is going to be a fight, it is going to be bloody and ugly and no one is going to just go away quietly into the night. So while it may be more comfortable to just be warm and fuzzy and supportive (I like those things too) that's not what is going to get things done. I am comforted that we have fighters in our corner and I appreciate the candor and the passion - we will need all we can muster and then some.
And to Kristin, I do appreciate everything you do for the forum and the cause in general and I have no problem at all with you expresing yourself fervently - in fact I respect it and it makes it easier for me to trust you. Please keep doing what you are doing you are a fighter and I respect that.
And Sun, thanks again!
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All foods that contain fat come with at least a small amount of risk.
The point I was making is that nicotine is not considered harmful, and so far, I can't find any proof that PG and food flavorings used in e-cigs are harmful if ingested.
It's the other junk in cigarettes that have been proven to be deadly, not the nicotine. Nicotine in cigarettes is legal to use. So is the nicotine in e-cigs.
So why would there be a need to define nicotine as a "new drug".
If you're saying the combination of nicotine, PG, and food flavorings make it a new drug substance, then so what? We simply mix our own liquids. Regardless of the bans, nicotine would remain legal to use. Double flavored 0-nic liquid would also be legal to purchase. The FDA doesn't come into my house and check if I'm mixing my own cocktails with the correct amounts of alcohol.
As far as the hardware is concerned... I have no worries the hardware will still be available for as long as there are vapers desiring to purchase and use them (I covered that in several other posts).
We'll see how long that lasts. I am simply not that naive. The PACT Act was written while e-cigs were NOT clearly defined. A rewrite will be inevitably discussed (if not immediately) once the courts label e-cigs with the shiney new tag; "tobacco product".
I can't understand how anyone would think this isn't a possibility.
Yes.
Nicotine is legal. So we all become mixers during the next phase. You can still buy PG, food flavorings, and nicotine. They are all legal. So are all of the remaining components. The only true threat to the market is the sale of full "kits". At worst, this is just an inconvenience.
So we take a small step back. At least we still get our flavors and hardware in almost the same fashion we do now.
We've already had time. And what's come of it so far? Conceding that it should be called a tobacco product? That's our reply? That is a giant leap in the wrong direction. That loses us a lot of ground, some of which we'll never get back. Junk science and baseless myths about e-cigs seem to be the rules of thought today. That will NOT change once e-cigs are recognized as tobacco products. It will get far worse.
Letting the FDA call the nicotine in our e-cigs a drug doesn't get them much to work with in the long run. It's already a recognized drug in several OTC products.
Thousands of people have already been ground testing this "new drug" for years. It's already progressed far beyond the initial testing phase and far more positive pressure can be applied from users and concerned family members for this "new drug" since we aren't seeing people keel over from its use. The exact opposite is true.
And, as I've stated before, there are many options left for companies (and all of us) to exploit in any proposed attempts at banning e-cigs.
Taxes on cigarettes is about 70-90 percent (depending on where you live). An equivolent tax would be hard to miss and not likely to be called "nothing" by most people.
And, once taxed... the taxes can only get higher.
Non-smokers don't care how much "tobacco products" are taxed. You won't find any sympathy from these people.
EDITED to add: Sorry, Thad, I missed your post before posting this. You already covered everything!
All I see is a lose/lose for vapers by labeling e-cigs as tobacco products.
I hold no animosity toward you or others that believe "tobacco product" is the right way to go. I just don't agree with you.
Interesting debate all. I love it when smart, creative, talented and passionate people discuss important issues relevant to my life. God knows we don't see it enough in our elected officials.
I've always wondered why the E-cig community has not explored the vitamin and suppliment theory. I know this isn't an herb in the strictest sense but that whole arena is kind of a fuzzy area anyway.
I've always wondered why the E-cig community has not explored the vitamin and suppliment theory. I know this isn't an herb in the strictest sense but that whole arena is kind of a fuzzy area anyway.
You are merely spinning your wheels. The tobacco option was noty picked by Kristin, it was imposed by the FDA. There were only two options offered. Eiother have ecig listed as a drug or a tobacco product. There were no other choices to fall back on. And to compare tofu to nicotinei is erronious. nicotine is considered a toxic substance. It has been established that 60 mg could kill. I would have likied to see the option that ecig would be recognized as a recreational substance, but the FDA does not give anyone that option.
Bob--the issue is "Does the FDA have jurisdiction over the e-cig". The "tobacco" option came from SE as at the time of filing suit, calling it a tobacco product would negate FDA jurisdiction. Back when this suit was filed the FDA did not have jurisdiction over tobacco at all. That changed in midstream last year when Congress gave the FDA jurisdiction to regulate but not ban tobacco products. SE decided to stay with their "tobacco" argument.
We have never been limited to "Drug" or "Tobacco"---to the contrary, SE boxed us into that. 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
Good lord...
Everyone seems to be stuck on the tofu reference
.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.
You are confusing me, Sun. You started this discussion by saying that we would be in a better position if Smoking Everywhere had simply applied to the FDA in the first place--now you are saying that the e-cig is not under FDA jurisdiction. Which is it?
Yes--no tobacco, no drug. Under SE's theory, they would need to file. But that is SE. More then one can "carry the flag" Thulium and it does not have to be SE leading the way.
Sun
I understand that it doesn't have to be SE leading the way... and it would certainly be my preference for it to be a different business.
What I don't understand is how you can say that the FDA doesn't have jurisdiction and then praise the unnamed businesses for having submitted an application to the FDA and chide SE for not applying to the FDA as you have done in this thread.
SE's "theory" is that they have consistently marketed their product for recreational use and since the FDA did not regulate tobacco at the time, SE did not need to apply for FDA approval. In fact, since the FDA has still not published the requirements for MRTPs, it seems like it would behoove SE specifically to NOT apply to the FDA so that their argument remains consistent.
You've said that certain other suppliers have already applied for FDA approval, yet you say they aren't under FDA jurisdiction. Why would you submit an application for approval to an agency that you don't believe has jurisdiction?
Thulium---there are some Suppliers here on this Forum that filed with the FDA but claimed their product was not a drug. There hope is a denial so they have standing to litigate. They did not have any products seized like SE or NJOY so that would be the only way they could get standing.---You need standing. That is why the FDA has not refused as that would give them standing to litigate.
Sun
I was one of the original members of the Alliance who filed the brief. The original group was quite small, for obvious reasons, and we all kept our own counsel, speaking only to each other and our attorney. I would be very surprised if any of the original group contacted you while we were in the process of preparing the brief. Frankly, you are not an attorney, and while you obviously have some knowledge of the law, we had legal counsel. There was no need to consult you.
While we did not feel the need to consult you or seek advice from you in filing the brief, we did feel badly that you were so obviously blind-sided. In fact, your posts immediately after our filing were actually sowing seeds of panic as you posted about how you had never seen such a thing, how you didn't know who the Alliance was, and how the judge wouldn't allow the brief to be admitted without the names of the Alliance members appended to the petition.
We promptly came forward because we were concerned about the rampant speculation, speculation that you were fostering. Once we came forward, all the posts you made that displayed your lack of knowledge were deleted, presumably by you. To anyone who followed the thread at that time and saw the posts made during those several hours, it was abundantly clear that not only were you not at all involved in advising on the brief, you had no idea that a brief had even been prepared.
After the brief was filed and after we confirmed it with our attorney, we let folks know that anyone who wanted to join the Alliance for purposes of supporting the brief were welcome to do so. Perhaps it is one of those folks who joined after the fact who was "bombarding" you with PMs, but, if so, they were not involved in the original filing.
My purpose in posting this is not to embarrass you, but, rather, to suggest that while you've provided a valuable service to the vaping community and to the ECF forum in general, I can't help but feel that you've set yourself up as some sort of legal expert here, someone with some sort of inside knowledge, and it's not at all clear that you really do have such an expertise.
I have been on this forum since January of 2009, more than a year now. I have followed this thread from the beginning. In that time, I have seen you delete (1) posts from Legal One, lead counsel for SE, (2) posts from Yvilla, a licensed attorney, and (3) your own posts when down the road facts and events proved you wrong and made you look less than credible.
I would respectfully request that if you seek to give advice and opine on this thread under the guise of being some sort of legal expert, you share with the members of the forum what expertise and background you have. In that way, those of us who follow this thread can better decide how much weight and credibility to give your pronouncements.
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