Why the FDA can NOT make illegal E-Cigs (false concern), Usage Bans in Public are the REAL problem

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Vicky

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For more that 25 years, I have worked for, with and against the United States government. I know bureaucrats because I was once one of'em.

What Tom is telling y'all is absolutely true.

There is a reason why FDA has consistently missed deadlines on the deeming regs issue, especially with regards to electronic cigarettes. Part of that reason is that HHS, the parent cabinet agency of FDA, is all-hands-on-deck over the Obamacare rollout fiasco. But another part of the reason is that the scientists and realists within the bureaucracy of HHS realize that enforcing anything approaching a ban, or significant restriction of sales, on electronic cigarettes is administratively impossible.

Judge Leon cleaned FDA's clock in the Soterra decision. FDA knows this, and knows that any overreach feared by members of this board will be met with an immediate legal challenge, and they also know that Judge Leon will clean their clock again.

This is why I am still on record as saying that FDA will back up 10 yards and punt on the deeming regulations in regards to how they might regulate electronic cigarettes. They are in a no-win situation. There are no proposable regulations that even come close to being enforceable, and the honest scientists who work for the agency know that electronic cigarettes are a safer alternative to combustible tobacco products and actually advance the agency's goal of promoting public health and safety.

They are going to ban, restrict the sales of, or hamper the distribution of products that help people live longer and healthier? I just don't see it happening.


I do hope you are right. In the mean time though, I personally think it unwise to sit still... I will rest when that becomes reality.
 

2coils

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If only it were the "honest scientists who work at the agency" calling the shots. But it's TPSAC doing that and the panel is heavily weighted with anti-tobacco and ties to the pharmaceutical industry folks.

Alleged Conflict of Interest on FDA Tobacco Panel | Competitive Enterprise Institute

Roster of the Tobacco Products Scientific Advisory Committee

Honestly, why would the FDA be any more afraid of the e-cig issue than the EU? They had little hesitation creating ridiculous regulations for e-cigarettes, even after being stopped from regulating them as drugs.

So I guess we are not conspiracy theorists after all huh?? And lets not forget Mitch Zellers previous job as a consultant working along side the pharmaceutical company(Glaxo-Smithkline). Oh and by the way, revolving door between FDA and BP as they regularly employ each other!

Thanks for posting. Its about time this B.S is exposed. Just the people we need making life decisions for us.
 

Jman8

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It does seem like we (the vaping community) frame the discussion in, at least, 2 ways:

1 - FDA, politicians and even some scientists are corrupt. Regardless of what we do, they have the authority to ban eCigs, and their history shows this to be the case.

2 - Next time a ban is proposed, get busy writing letters to politicians and spreading the word, because your letters and actions can make it so these bans are defeated. You have the power, it's all up to you!!!

Not saying there is easy shmeasy way around all this. I think ignoring possibility of #1 does make one come off as naive. I lean towards believing in #2, and that it can / does work. Yet, I do think if we are (still) using language that amounts to "take action now or eCigs will be banned forever" - then we are mixing #1 with #2 whereby we come off as a little corrupt in how we motivate fellow vapers.
 
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Rossum

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I don't think the FDA would try to do it.
Great, you're an optimist. But what if you're wrong?

We have to wait to see what the FDA will do
Why? Let them do their worst before we speak up? That makes no sense to me at all. I'd much rather stand up and be counted now.
 

Sundodger

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2 - Next time a ban is in place, get busy writing letters to politicians and spreading the word, because your letters and actions can make it so these bans are defeated.

In this context the ban is already in place. And like taxes, bans/laws are seldom repealed, especially major taxes and laws. The last major one I can think of was 21 to 18 year old drinking laws in the U.S.. Those laws were repealed only because the U.S. was in Vietnam and there was a draft going on. Once the war was over, the draft not actively drafting the "oh, we have to do it for the children" bunch got the Feds to cut off highway funds if the states didn't go back to the 21 year old drinking laws.

Funny thing that they never tell you about this is that in the 1980's I had a Accident and Health Insurance License. Every month we received news letters with insurance information. A study was done about 10 years after the drinking laws in all states had gone back to 21 years of age. Then it showed a percentage of how many lives between the ages of 16 to 20 had been saved because of the law. BUT what they never publicized was that in that same study there showed and increase of the same percentage of deaths in 21-25 year old drivers as what the decline in 16-20 year old drivers was. Coincidence? I think not. I think it shows a certain group, no matter the age is going to have problems drinking.

Anyway I don't see easily getting any bans or laws repealed once in place.....heh, it's for the children ya know!
 

Fulgurant

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It does seem like we (the vaping community) frame the discussion in, at least, 2 ways:

1 - FDA, politicians and even some scientists are corrupt. Regardless of what we do, they have the authority to ban eCigs, and their history shows this to be the case.

2 - Next time a ban is proposed, get busy writing letters to politicians and spreading the word, because your letters and actions can make it so these bans are defeated. You have the power, it's all up to you!!!

Corruption thrives in the dark. It shrivels when exposed, at least for as long as we have the pretense of living in a free society, anyway.

In other words, it's not a contradiction to say, on the one hand, that corrupt (or if you prefer, corruptible) officials wield massive power over us, but on the other hand that they may be shamed into doing the right thing. It surely ain't easy to shame the powers that be, but it can be done. Barely.

Not saying there is easy shmeasy way around all this. I think ignoring possibility of #1 does make one come off as naive. I lean towards believing in #2, and that it can / does work. Yet, I do think if we are (still) using language that amounts to "take action now or eCigs will be banned forever" - then we are mixing #1 with #2 whereby we come off as a little corrupt in how we motivate fellow vapers.

Let Sweden's example be your guide. Through a combination of well-placed propaganda and the presumptuous exercise of government power, the anti-tobacco camp's effectively banned Swedish snus through most of the EU, despite their absolutely irrefutable benefits to Sweden's population: Are you being manipulated? The wisdom of the WHO examined… « The counterfactual

The point of confusion and contention here seems to be the difference between capacity and action -- the FDA's legal authority versus what they will do with that authority. It is entirely possible that, as ICBR Media (sp?) argued, cooler heads will eventually prevail at FDA, for any number of reasons: fear of another court decision that might strip the FDA of some significant measure of its authority, a crisis of conscience about the very real toll in human lives that could result from a serious assault on the e-cig industry, pressure from an administration that's knee-deep in healthcare controversy -- or hell, maybe the bureaucrats will come to Tom's conclusion vis-a-vis substantial equivalence.

All of that is possible, but so are various alternatives.

And as long as FDA holds so much power over the e-cig industry, an organization like CASAA would have to be insane to ignore the possibility that FDA will abuse it. The FDA has already overreached once, and although their first effort was eventually reversed by the courts, it was a long slog to get there, and people were hurt in the interim. By the same token, the FDA recently (re-)hired a man known for his work with the anti-tobacco propagandists at WHO and American Legacy, a man who by his own words probably isn't inclined to take a restrained, scientific approach to exercising the power that's been handed to him.

All of that said, if you disagree with CASAA's rhetoric or its reasoning, there is a right way and a wrong way to go about expressing that disagreement. To argue that FDA doesn't have the legal authority to inflict incalculable harm upon the e-cig industry is to state a demonstrable falsehood. To argue that the FDA would never inflict such harm because it's run by responsible and enlightened individuals is, again, to defy any sensible interpretation of the evidence (the events of 2009). To argue that the fullest extent of FDA's authority over e-cigs would fail under court review is reasonable, but it neatly glosses over the struggle required to force a court review. Police officers don't have absolute authority either; many of their decisions can be overturned upon legal review, but god help you if you find yourself in court arguing your word against a cop's.

Anything the FDA decides to do will carry the presumption of correctness under the law, until the courts say otherwise, because Congress handed the FDA the legislative equivalent of a blank check.
 
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rothenbj

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No kidding.

I spent nearly six months modifying and patching our software to prevent disaster.
As it was, we still wound up with a couple of small glitches and one pretty significant one.

I recognized the issue over a decade before the turn of the century. Anything we wrote was already "converted" and before the noise got loud, we had all our legacy systems rewritten to deal with the century change. I laughed when the scramble happened, but was relieved when the calander flipped over and there were no significant issues.
 

rothenbj

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*Note bolded emphasis mind (had to debold your entire message, and rebold certain parts).........

Again, I find myself not (totally) dismissing what you are saying and what I feel is your honest intent in this thread.

Yet, I still believe, in this moment that the flavors issue is the biggest concern facing the vaping community, including vendors. If you disagree with this, I'd like for you to say so in this thread and add in claims of what FDA can't do via FSPTCA. I don't yet see the clear road to victory for eCig industry on that one. I do see the case that we vapers make as far more reasonable than what any neutral or anti-vaping party constructs as 'the problem' with having an assortment of flavors........

I refuse to get involved with the premise started by the OP. Just recall this thread when the FDA finally releases their deeming regulation.

I am pointing out your main concern, flavors. If hardware is not addressed and if nicotine content and packaging is not addressed, flavoring is the only thing they can't control. If I use a 24mg liquid, a vendor can sell me a 48mg flavorless 30ml bottle and another vendor can sell me a zero nic bottle of the flavor of my choice. I dump both bottles into a 60ml or larger bottle, shake well and all is right in the world.

All other things considered, flavoring is the easiest restriction to overcome.
 

Jman8

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All other things considered, flavoring is the easiest restriction to overcome.

I think I agree.

Though thinking, in a worst case scenario, that it could be deemed illegal to have a device on you, with nicotine and flavoring together.

Again, I'm the person that is convinced black market will flourish if FDA does its absolute worst in 'regulating' eCigs, so not feeling overly concerned about worst case scenario. But do think it is biggest issue because it won't be just vaping community that will treat it as a big frickin deal.

IMO, it's the one issue that I think they feel they hold the cards on, but once going down that path, it could backfire in exponential ways that would plausibly lead a whole bunch of people become far more educated about eCigs than is the current paradigm. Though, as I said before, I don't see a clear road to victory on this, and instead am just professing about how I think it could play out.
 

Berylanna

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I think I agree.

Though thinking, in a worst case scenario, that it could be deemed illegal to have a device on you, with nicotine and flavoring together.

I think the worst-case scenario would be limiting nicotine so that we can't mix it with flavorings. There seems to be some feeling they'd have trouble with that, but if they keep the propaganda going without us opposing it, they could ban useful nic strengths, lose in court, then go to the Democrats to get a law passed to let them. Which would break my heart, again, as a liberal. (The other worst case is if I have to DIY because I'm HORRIBLE at cooking OR e-liquid DIY, I think I'm missing an "art of flavor" gene....) [/QUOTE]

Again, I'm the person that is convinced black market will flourish if FDA does its absolute worst in 'regulating' eCigs, so not feeling overly concerned about worst case scenario. But do think it is biggest issue because it won't be just vaping community that will treat it as a big frickin deal.

I don't want to support gangs, we lose kids to stray bullets as it is. I can just see BT taking over "medical" herbs as gangs take over nicotine, and the harm from prohibition keeps going and going and...

But despite my horror I'd probably hope for and participate in the black market (as a buyer.) I HATE that!

IMO, it's the one issue that I think they feel they hold the cards on, but once going down that path, it could backfire in exponential ways that would plausibly lead a whole bunch of people become far more educated about eCigs than is the current paradigm.

From your mouth to God's ear.
 

tombaker

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Tom doesn't have a legal argument, and he never did. Every time he's pressed on the matter of the FDA's powers, he reverts to an argument that FDA will not fully use those powers. That's not reason; that's faith. He's welcome to his beliefs; under different circumstances I might even be encouraged by his optimism -- but as it stands, I'm forced to write him off as yet another contrarian internet know-it-all who really knows squat.

If you were able to press me on something on the facts, please proceed, instead of the above empty, cut and paste blurbage. I am able to respond. What I am saying is that the purveyors of FUD, and mis-readings of the law, and what regulators can do.

1. The FDA can not regulate E-Cigs as drugs or medical devices, provided they are not marketed as such. Major Win by Sottera.

2. The FDA can deem E-Cigs as a Tobacco Product, and said it will do so, but has delayed that for over 2 years, they are just this month starting to ask for public comments.

3. What the FDA can do with Tobacco Products under the act is primarily control youth marketing, which the act is designed for. The FDA is entirely against analog cigarettes, but under the same act can not ban them. The FD&C Act understands that the products it controls are harmful, and some of them are less harmful. But if it had the powers you believe it does for E-Cigs, it would have been using those powers all over the place on Cigarettes.

4. The 2007 date is not set in stone legally. It is also important to understand that February 15, 2007 was selected as the original Grandfather Date because that was the date that the bill eventually became the Tobacco Control Act was first introduced into Congress, thereby putting the tobacco industry ( i.e. , manufacturers of cigarettes, smokeless tobacco, and roll-your-own tobacco) on official notice that it was going to be regulated by FDA. At the time, Congress had not contemplated including e-cigarettes (which were just being introduced into the U.S. market) or other non-traditional tobacco products in the legislation. For this reason, it simply would not make sense for the Deeming Regulation to mandate February 15, 2007 as the grandfather date for e-cigarettes. Rather, using the same logic of “first notice,” there are two much more likely potential grandfather dates for e-cigarettes and other deemed tobacco products. he first would be the date that the NPRM for the Deem-ing Regulation is actually published in the Federal Register ( i.e. , Dec 2013). he second potential grand- father date would be April 25, 2011 – the date the Agency published its letter to stakeholders indicating that it intend- ed to capture e-cigarettes through the Deeming Regulation.

5. E-Cigarettes were on the market in 2007 under the worse case scenario, every E-Cig today is Equivalent to every Grandfathered E-Cig. electric coil, fluid, vapor, unfiltered. There would be no factual basis to suggest their is any substantial difference in what is being sold now, as to what was grandfathered.

6. Products for sale now, analogs, have submitted forms, the FDA has not processed them, and all the products remain being sold. This implodes the theory that they can ban all current E-Cigs at a whim.

7. The FD&C Act prohibits banning Tobacco products, and you have to construct a fantasy to suggest they will do so.

8. The past actions of the FDA were denied by the courts, suggesting they will do an end run around the courts, is naive. The FDA now has one tool to work with, its the FD&C Act, which can not ban them, and can not tax them.

9. Its a waste of time and effort to worry about what the FDA may do. Pointing people to do so is working against Vapors. Everything being said about the FDA, was said 2 years ago, and its been wrong every day since. 2011 they thought the FDA was right about to.... The currently groups are doubling down on the broken watch theory, waiting for the time when the watch is right twice a day. 2 years, and they have not been right.

10. The FDA is not the problem, I outline why, and even if you don't believe me, or others, the evidence of the past 2 years of being on the wrong side of history, should give you some pause.

11. When the "End is near" crowd is faced with each new day, they are looking for another boogie man. So it gotta be Big Tobacco. Who cares about Big Tobacco's BLU e-Cig. Its a great product, doing advertising with Jenny, and helping everyone. V2cigs is the biggest, and its not big Tobacco, but I guess its an evil corporation or something. If any E-Cig is legal, all are, and all are equivalent. If BLU puts up the legal muscle to blow through the doomsday proficiency, why should I care? You got people selling a feckless idea that the FDA will hand over the E-Cigs entire marketplace to Big Tobacco. Nuts plain and simple. People have tried the MarkTen, its a junk as a vape, should I care they come into the marketplace also.....apparently its the end of the world?

12. Heck faced with all of this the FUD fall back becomes, they will ban APV devices of all types. Ban batteries, and clearomizers, the protank will be wiped off the face of the earth. Get a grip, I can use all of that to Vape 0 nicotine liquid, which the FDA has zero control of. The hardware can not be touched....ample parallel examples.

This thread is attempting to point out what is the real problem, and to stop fighting imaginary beasts, and worse thinking that asking people to spin their wheels is proof "its working".

The real problem is the title of this OP, its Bans. Bans with nothing from the FDA at all.

------Today 1-2-2014 the entire University of California system of colleges banned E-Cigs (and other Tobacco Products) except for a single college, that's real.
 
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tombaker

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If you are saying that CASAA (as an organization or through statements made by official spokespersons) endorses or participates in making such accusations, I would have to disagree with you. I cringe with you when I see such accusations, but I cannot dismiss the possibility.....

Stanton Glantz, Ellen Hahn, Prut Talbot, Linda Rosenthal - they are all willing to lie and cheat to further their anti-tobacco, anti-nicotine, anti-smoker/Vaper agenda and don't care how many die as a result.

Its probably fairly hard to dismiss because CASAA is doing it in the same post.

For CASAA via their only Vice President, to go the record, that specific people and professionals are liars and cheats, who don't care about how many people die, is reprehensible. It is certainly not true they don't care about death. Calling Stanton Glantz, Ellen Hahn, Prut Talbot, Linda Rosenthal cheats and liars is defamation and libel, which CASAA should immediately retract.

I looked up quickly Dr. Stanton Glantz, who has a long history, and is currently suggesting that second hand vape gives off enough 2nd hand nicotine to be a consideration. But if you look at the study design they have the exposure to 2nd hand vape as 1 hour long. I would call that flawed science, because the experiment did not replicate the real world. Especially with it being a confined space. So I am not likely a fan because bad science is bad science. The put people in an exposure chamber for 1 hour, and found out its 10 times less than analogs, but still monitor-able. Modern sensors can register anything....and its already being compared to 2nd hand smoke risks.

So I can challenge the science easily, I can work the problem of his opinions on bad science.

But for CASAA to defame the man saying he is a liar, cheat, and cares nothing if people die, is abhorrent. How can CASAA the go about being an advocate for rational vapers, when they attack the other side with such unbridled hatred?

Nobody is going to listen to CASAA and give it's views any credibility in public forums when they use these tactics. I am sure they care about whether people live or die, on what they do in their professional lives, they are not monsters. Let's be real.
 

AegisPrime

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But for CASAA to defame the man saying he is a liar, cheat, and cares nothing if people die, is abhorrent. How can CASAA the go about being an advocate for rational vapers, when they attack the other side with such unbridled hatred?

Nobody is going to listen to CASAA and give it's views any credibility in public forums when they use these tactics. I am sure they care about whether people live or die, on what they do in their professional lives, they are not monsters. Let's be real.

Ostensibly I agree with you however, it seems readily apparent in Glantz' public appearances and stance on e-cigarettes that the man is favouring flawed studies to get the distorted message across that e-cigarettes should be regarded in the same light as smoking.

The man's issue seems more of an idealogical one than something based on science and the benefits of THR - and spreading FUD about the safety of e-cigarettes is confusing smokers and non-smokers alike - or, to quote Doctor Michael Siegel:

It has become clear that many electronic cigarette opponents in the tobacco control movement really don't care about the science. They have a pre-existing opposition to electronic cigarettes on ideological grounds. So the actual facts don't matter. The truth must not get in the way of the ideology.

Apparently, quitting smoking is not the goal. You have to quit smoking the right way. And that way happens to be an extremely ineffective method, one with a 90% failure rate. But it does provide income to many anti-smoking groups, through their funding by the pharmaceutical companies that manufacture these largely ineffective drugs.

Calling someone out as a liar and a cheat may be bad form - but when that person is a liar and a cheat, is it inappropriate? And clearly, from the lack of support shown towards e-cigarettes as a valuable aid in THR, these people don't care about the lives of smokers.
 

k3vin

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Its probably fairly hard to dismiss because CASAA is doing it in the same post.

For CASAA via their only Vice President, to go the record, that specific people and professionals are liars and cheats, who don't care about how many people die, is reprehensible. It is certainly not true they don't care about death. Calling Stanton Glantz, Ellen Hahn, Prut Talbot, Linda Rosenthal cheats and liars is defamation and libel, which CASAA should immediately retract.

I looked up quickly Dr. Stanton Glantz, who has a long history, and is currently suggesting that second hand vape gives off enough 2nd hand nicotine to be a consideration. But if you look at the study design they have the exposure to 2nd hand vape as 1 hour long. I would call that flawed science, because the experiment did not replicate the real world. Especially with it being a confined space. So I am not likely a fan because bad science is bad science. The put people in an exposure chamber for 1 hour, and found out its 10 times less than analogs, but still monitor-able. Modern sensors can register anything....and its already being compared to 2nd hand smoke risks.

So I can challenge the science easily, I can work the problem of his opinions on bad science.

But for CASAA to defame the man saying he is a liar, cheat, and cares nothing if people die, is abhorrent. How can CASAA the go about being an advocate for rational vapers, when they attack the other side with such unbridled hatred?

Nobody is going to listen to CASAA and give it's views any credibility in public forums when they use these tactics. I am sure they care about whether people live or die, on what they do in their professional lives, they are not monsters. Let's be real.



Tom,if you would use your time and energy.anger,dis-dain,hatred,contempt.etc..etc.. and go after all the crap that is posted out there by Stanton Glantz, Ellen Hahn, Prut Talbot, Linda Rosenthal and others to try and bring vaping to it's knees, I bet you would earn your wings. ;)


The problem is tom,you are preaching to the choir.DO we ALL hope it will be as easy and as rosy as you put forth in your posts??? HELL YES...

Do we as Adults who have been around awhile who have seen and heard how government works,and many times fails to work go sit round the campfire and sing kuhm-by-yah and have faith that the government has OUR best interests in mind? HELL NO...


So NOW EVERYONE ON ECF..... Repeat after me" TOM YOU ARE RIGHT,WE ARE WRONG,THE GOVT. KNOWS THE RIGHT THING TO DO,WE ARE SORRY WE BEG YOUR FORGIVENESS TOM,THAT WE COULD BE SUCH SHEEP,AND NOT KNOW THAT THE GOVT. ALWAYS HAS OUR BEST INTEREST IN MIND,AND THEIR POCKET-BOOK.":blink:


OK,Now Tom, Go,fight the bad science,and the nay-sayers who spew forth rumors and innuendo.The ones who repeat for a few years now,and continue to say that "trace" amounts of a chemical were found in an e-cig cartridge in 2009.And if vaping is allowed,young people will use it as a gateway to "OH MY" actual SMOKING...

That is where your battle needs to be Tom..... Don't miss the forest for the trees.
 

AegisPrime

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I don't know enough about US policy-making or the remit of the FDA to make a comment either way on how the 'deeming' process will pan out.

What I will say from an EU perspective is that the e-cig component of the TPD was clumsily and inadequately hacked into some legislation that e-cigarettes absolutely do not belong in. MEPs were aggressively lobbied by both BT and BP to produce an outcome favourable to them and the end result provides no protections to e-cigs and no clear direction to member states.

Something with so much potential to benefit public health deserved a careful and thorough review to prevent the EU (and its members) from making the same mistakes that were made with snus and yet once again, the people that we (Europeans) trust to have our best interests in mind have failed to consider those interests.

I sincerely hope that the US leads the way in e-cigarette legislation and provides an open, competitive marketplace where innovation is rewarded and consumers have a wide range of quality products to choose from to meet their cessation and vaping needs - because lord knows, the EU bureaucrats couldn't have screwed things up much more if they'd tried...

At least they're not banned outright I suppose :blink:
 

Berylanna

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Its probably fairly hard to dismiss because CASAA is doing it in the same post.

I looked up quickly Dr. Stanton Glantz, who has a long history, and is currently suggesting that second hand vape gives off enough 2nd hand nicotine to be a consideration.

So I can challenge the science easily, I can work the problem of his opinions on bad science.

But for CASAA to defame the man saying he is a liar, cheat, and cares nothing if people die, is abhorrent. How can CASAA the go about being an advocate for rational vapers, when they attack the other side with such unbridled hatred?

Nobody is going to listen to CASAA and give it's views any credibility in public forums when they use these tactics. I am sure they care about whether people live or die, on what they do in their professional lives, they are not monsters. Let's be real.

What you apparently have not done is listen to him on the radio. Whatever he is "currently" saying varies wildly. And his attitude is totally apparent in the manner of his handling questions. There are very few people that vapers tend to put into the category of being deliberately disingenuous, but that attitude was not reached lightly. And I have sat in a room watching Ellen Corbett basically lie on the record to the Senate Health Committee on the issue of whether or not she ever tried to ban ecigs from adults. It's on video.
 
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kristin

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Tom, I'm sorry, but if you had to actually look up Stanton Glantz online, then it confirms for me that you know far less about this issue than you are pretending and that seriously calls into question your expert opinion on the situation. You still haven't told us what makes you an expert on interpreting the FDA's powers under FSPTCA? Until I know that your expertise is superior to all of the other opinions given to us by experts in tobacco control and THR, I think I'll continue to listen to those people who have been involved in this process for years, rather than someone who supports his argument by just telling us that everyone else is wrong and he is right.

As far as my "defamation" of the likes of Glantz, you apparently haven't been following CASAA's antiTHRlies.com blog. smh
 
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