FDA Why Isn't Vaping the FDA Center for Tobacco Product's Biggest Ally?

[wv2win]

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I believe that Bill Godshall is right (as he always is on these points) that vapers would benefit from a GOP Senate. You have quoted me on this point. I do not retreat from what I think is probably the truth.

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I'm a moderate independent but really hope that in the upcoming mid-term elections, especially considering that the next two years is critical, that those who vape, vote in a manner that changes the control of the Senate. It could be the deciding factor in whether the Deeming Regulations stay as they are or are significantly scaled back.

 

[TomCatt]

I'm still looking for a consensus. There's the FTD "Beauty and Grace" arrangement, that comes with the vase.

Or the "Big Hug."

Which do you prefer?

..................d..

 

[wv2win]

............................
Which bring it back to the OP. I see no tactical advantage to treating the FDA as evil, liars, wanting death to vapers. It just puts a wedge to agreement, and blocks policy which could be helpful from coming about.

I think it best to treat the FDA as being wrong on items, that vaping is in actuality a good thing, convince them with the evidence that valid, because E-Cigs are safe............................

That option has already been tried. CASAA sat down with the FDA and presented them with the scientific evidence on vaping. The proposed Deeming Regulations are the result.

So explain again how your method is going to make a difference???????????????????????????

 

[toddkuen]

Excellent post.
I do not understand why the FDA can not be treated as an ally.
As soon as one says that a gaggle of hens will chirp in with a barrage of comments saying look at 2009, they are evil, they are owned by drug makers, owned by tobacco, they want smokers to smoke analogs.

Most of it hype, fear, and loathing

...

Agreed.

From what I am able to garner it would seem a fair guess that nobody has actually sat down for a one-on-one conversation with this guy.

(And not the infamous nobody of "Nobody listens to your fears, Nobody cares about your concerns, VOTE FOR NOBODY.")

As to my "If I Ran the Vaping World" comments to Rodger earlier on another post:

I think it matters what your adversary thinks/knows/feels/believes is behind you when you ride out from the troops, white flag raised high, for have a little chit-chat before the battle begins.

I learned long ago that if you have nothing but a few good ideas and sit down with someone much more powerful nothing will come of it.

Why?

Because you pose no real threat to their plans.

CASAA can show them all the facts they like but what are the consequences to Zeller if he ignores them?

When I ride out in such situations I like my adversary to know:

1) I am beyond right on my facts (law, science, technology).

2) That beyond the line of crack, battle-proven troops extending from "horizon to horizon" behind me is also highly organized gorilla warfare, top strategy and tactics, excellent planning, spies, air power, etc. all willing to die for the cause.

3) If necessary, war can start now, today.

4) That I do not want war any more than he does because its too costly compared to some arrangement which makes everyone a winner.

On the other hand, prancing around in a circle waving your fist, cursing your adversary, laughing at his ignorance, mocking him and spitting on the ground does exactly what?

The adversary here deserves respect because he's big, powerful and dangerous.

Whatever you believe Zeller's political and financial objectives might be its highly unlikely they are include or are enhanced by an ugly, long, politically-unpleasant-for-his-bosses ground war with lots of news coverage, crying children because he's killing gandma and bleeding casualties.

An ugly war like this does him no good.

And its our job to provide one if he doesn't want to save the lives of vapers.

Leadership involves more than just being right.

Someone must know Zeller and be able to set up some time for informal chatting.

If the chatting fails what do you lose? The time you spent riding out and chatting - nothing else.

(And yes, you continue to prepare for war during the chat and realize that chatting is sometimes a mere distraction while the adversary lines up their own troops.)

On the other hand, if things turn out well, you at least avoid the start of the war (but you never drop your vigilance).

I see a lot of potential "strategy pieces" here - political, science, law - that, if lined up, would make an excellent backdrop for such a chat.

Someone needs to get them lined up in a row so at least it looks like something beyond letter writing might happen if we are ignored.

 

[aubergine]

Tom is right to point out that the FDA isn't fundamentally evil (especially simply by virtue of being a government agency). Like the police force, it was designed to, and often does, serve a crucial protective function; we'd in fact be fairly screwed without it. I don't see our issue as part of a broad scheme by our current administration to destroy individual freedom and the American way of life - there's lots of that in here, it's over-familiar nonsense and I try to ignore it.* I also agree that a reasoned, amicable confrontation, armed with facts and a willingness to recognize the opposition as human is a crucial starting point in any negotiation. That's Activism 101.

Activism 401 and beyond, though, recognizes the need to understand that not every cop is a good cop and that a police force designed to protect may also be riddled with corruption and (all too human) malice - Tom's experience of being pulled over by a cop with whom he might effectively reason is entirely different from that of an hispanic man on a late night grocery run in parts of Arizona, a Sikh in any backwater that can't tell turbans apart and a black man just about anywhere.
For the cop analogy to work, the cop must 1. have a good reason to make the stop (OK, it's the FDA'S job to make sure that we aren't poisoning each other) and 2. not be governed by interests beyond keeping the highway safe. The latter possibility becomes acute when appeals to reason, presentation of fact and the raising of legitimate ethical concerns appear to fall upon deaf ears. If after much effort to respectfully communicate fails, it's reasonable to conjecture that those ears are willfully deaf.
Even a simple, dogged prejudice (ie, nicotine in any form is an unequivocal social evil that requires ferocious suppression) undoes the benevolence of power pretty quickly.

That analogy might seem strained - those FDA suits aren't beating innocent people up in dark alleys - but if we agree that ecigs save lives, then our outrage is far from frivolous.

If it's all just a big misunderstanding, or a reasonable attempt to get to the facts of the matter, then excellent! We'll see it quickly resolved by friendly chats and reams of evidence. I'm all for it. My respect for the agency that busted Chinese dog treats and prevented harm to my canine buddy will be (partially)
restored.

If, however, divers forces extraneous to and even indifferent to public safety are driving this show, which appears very evident to some of us, then what would seem to be a call to healthy optimism and civilized restraint is, in effect, a dangerous call to inaction, or misdirected action.

*On the other hand, we're all shaped by our experience. Right or left, the most passionate and credible amongst us have been deeply and personally burned by government power run amok. Our values and goals are sometimes diametrically opposed, as is our take on nearly every damned issue (to the delight of our real overlords, who have exploited 'divide and conquer' to the max here - we are severely played, all of us; we can't even agree on who's playing us), but the instinct that questions and challenges entrenched and overweening authority is crucial.

 

[Oliver]

One of the most interesting comments from the presentations at the SFATA conference came from Ralph Tyler of law firm Venable.

He said: "don't expect the FDA or any government organisation to understand what they are regulating. It is your job to educate them"

There were chuckles from the audience to which he replied: "That's not meant to be a joke. I'm serious."

So, possibly that's your answer? Because they simply do not know what they're dealing with. Remember, the US does not have good population level data on the impact of vaping products. And read this tweet from Jeff Stier, watching Dr. Leischow of the Mayo Clinic presenting at the TMA conference:

[tweet]469484595298451456[/tweet]

 

[kristin]

If we could "just sit down" with Mr. Zeller, we would. But we mere mortals do not get an audience with His Excellency. We must meet with his advisors at "listening sessions," write letters, submit comments and testify at TPSAC hearings - all of which we have done. The FDA has been provided REAMS of scientific information and survey results providing evidence of efficacy and safety. CASAA even called off the "FDA dogs" during this period and played nice, avoiding any public criticism of the FDA...until they issued the proposed rules and proved to us they had ignored everything we had presented.

If you can arrange for a one-on-one meeting with the man, please let us know how you did it.

 

[aubergine]

If we could "just sit down" with Mr. Zeller, we would. But we mere mortals do not get an audience with His Excellency. We must meet with his advisors at "listening sessions," write letters, submit comments and testify at TPSAC hearings - all of which we have done. The FDA has been provided REAMS of scientific information and survey results providing evidence of efficacy and safety. CASAA even called off the "FDA dogs" during this period and played nice, avoiding any public criticism of the FDA...until they issued the proposed rules and proved to us they had ignored everything we had presented.

If you can arrange for a one-on-one meeting with the man, please let us know how you did it.

That's the thing. Efforts to educate have been going on for years. Some of this can be chalked up to just dogged, prejudiced stupidity (endemic in Congress) but there's money at stake here, and at some point idiocy intersects with cunning.

 

[AgentAnia]

One of the most interesting comments from the presentations at the SFATA conference came from Ralph Tyler of law firm Venable.

He said: "don't expect the FDA or any government organisation to understand what they are regulating. It is your job to educate them"

There were chuckles from the audience to which he replied: "That's not meant to be a joke. I'm serious."

So, possibly that's your answer? Because they simply do not know what they're dealing with. Remember, the US does not have good population level data on the impact of vaping products. And read this tweet from Jeff Stier, watching Dr. Leischow of the Mayo Clinic presenting at the TMA conference:

[tweet]469484595298451456[/tweet]

This is the most disquieting statement I've seen to date regarding the FDA, especially as applied to the CTP. I *DO* expect regulators to understand what they're regulating. If it's my job to educate them, why do I need them at all?

 

[toddkuen]

One of the most interesting comments from the presentations at the SFATA conference came from Ralph Tyler of law firm Venable.

He said: "don't expect the FDA or any government organisation to understand what they are regulating. It is your job to educate them"

There were chuckles from the audience to which he replied: "That's not meant to be a joke. I'm serious."

So, possibly that's your answer? Because they simply do not know what they're dealing with. Remember, the US does not have good population level data on the impact of vaping products, and the FDA has now stated (at the TMA conference) that it cannot pay for this research because it's not looking to regulate e-cigarettes as drugs!

I am not really surprised about that comment.

Remember, almost no one outside the vaping community, government or otherwise, really has a clue either about what vaping is.

What we might imagine as rational and/or normal "regulator" behavior in a context like this has nothing to do with what and how they perceive their jobs as regulators or what regulations they themselves are bound by.

So really, after all this, no one has set up/established some kind of relationship with Zeller or his staff?

I somehow foolishly imagined, based on all the noise here and elsewhere, that this communication was in fact ongoing at some level.

If in fact its not, as the post above seems to indicate, I find this simultaneously extremely troubling, sad and pathetic.

None-the-less I will throw down the gauntlet here and volunteer myself to make a pass at starting this communication and education process. I have a broad perspective on vaping (family vape shop ownership with ejuice, own/develop tech for/etc. mod company, wife/family members not smoking analogs for 3+ years, not prone to hysteria, can listen, hopefully articulate, etc. etc.)

So I guess my next step is to email or pick up the phone and ask for an appointment?

I'll stew on this for a couple of days but really there seems to be no other options...

 

[Jman8]

BTW I want to claim credit for originally having the idea of sending flowers to Mitch Zeller.

Tobacco flowers?

 

[Oliver]

Please note my corrected post - I slightly misunderstood what Jeff was getting at. I've posted his tweet instead.

Note - it's very positive that a Mayo Clinic doctor is speaking on this. He also mentioned the Smoking Toolkit study in his presentation....

 

[Jman8]

If we could "just sit down" with Mr. Zeller, we would. But we mere mortals do not get an audience with His Excellency. We must meet with his advisors at "listening sessions," write letters, submit comments and testify at TPSAC hearings - all of which we have done. The FDA has been provided REAMS of scientific information and survey results providing evidence of efficacy and safety. CASAA even called off the "FDA dogs" during this period and played nice, avoiding any public criticism of the FDA...until they issued the proposed rules and proved to us they had ignored everything we had presented.

If you can arrange for a one-on-one meeting with the man, please let us know how you did it.

All this is reality of what we (pro-vapers) are actually up against.

Yet, to think it comes down to Zeller is hard to understand as reasonable. If Zeller became 'biggest pro-vaper ever,' I reckon he wouldn't last too much longer as head of FDA. So, then the next person would become our boogeyman.

As a relevant side point, can anyone reading this sit down today and have informal chat with board members of CASAA? I ask this because a) it is relevant to the larger point and b) because I find it rather impossible. "They're busy" - is patent response, and I understand this. Is not Zeller busy? Can he afford time daily for the millions that would love to have an informal chat with him?

To me, it's this notion that it is just one person that is leading this charge. If we took all of ANTZ out of the equation, all of the federal government (leaders) out of the equation, plus BT, plus BP, plus ALA and ACS - all gone. Then just had pro-vapers and non-vapers, I'm not sure we'd fare a whole lot better. Take all of the non-vapers out, and I'm wondering if dual users would be fully accepted or would what's left seek to regulate that out of existence along with cigalikes? Perhaps not, but this is how I look at the larger debate. This is partially an FDA issue, but is, in reality, a 'we the people' issue. Always has been, always will be.

FDA is charged with task of preventing all people, namely children, from starting or enjoying a habit of using products derived from tobacco. To think this will one day mean they are to be advocates for THR whereby people use a less harmful form of tobacco is challenging to see how that will be the case. Add ANTZ back into the equation, and I'm thinking it won't ever be the case.

If education were truly the answer, and perhaps it is, then ANTZ need to be 'won over' at some point, otherwise I think they can be safely counted on as opposing all products that contain nicotine/tobacco. From what I gather, our current unwritten strategy is to make ANTZ irrelevant when it comes to the adult discussion needing to be discussed for the path forward.

But what the pro-vaper is either reluctant to discuss or refuses to acknowledge is that cold turkey is still the best method around, when taking into account the overall public health position. And as long as our side downplays that, then we leave door wide open for criticisms and controversy. Likewise, what the anti-vaper is reluctant to discuss or refuses to acknowledge is that people enjoy (actually enjoy) using products/substances that have been around for thousands of years. They'd rather paint the picture that the products carry with them an inherent problem, unlike all the other zillion products out there, all of which carry some degree of harm to human beings. And as long as that side downplays this fact of life on earth, they leave the door wide open for criticisms and controversy.

The reason why FDA is not the biggest ally to date is because no more than 6 years ago, they sought to challenge these products being imported into the country without their expressed consent. They lost that challenge and have been behaving, at least a little, like a scorned child who couldn't regulate it that way, so let's try it this other way. Which would be fine if they were willing / reaching out to the industry foremost to find fair regulation. Instead, they often appear to be taking marching orders from ANTZ and BP. And if at all taking guidance from 'vaping advocates' it only appears to average vaper as coming from BV, or BT. Both BT and BV deserve a seat at that table, but if FDA can't find way to extend their reach to include all, or most of little V, and prop up consortium of little V as equal advocates, then there is reasons for 'average vaper, once heavy smoker' to believe this is not about my interests. Average vaper can reach out endlessly to FDA and the like and come up empty handed routinely. How about just once, the big guys take the back seat and put 'average guy' in the front seat, just to see how things might shake out politically going that route. Oh that's right, from the big guys perspective, they have everything to lose/sacrifice by going that route.

Or everything that's part of the inherent problem.

 

[Oliver]

By the way (I'm just going to stick it here because it doesn't really warrant it's own thread, and some people will find it interesting): Center for Tobacco Products Moving Information

The CTP is moving location. Looks like it's going to take 3 weeks to complete the move.

 

[Oliver]

I hope you didn't take this as a dig against yourself or CASAA. It truly wasn't meant to be - I know you've tried.

No, it's absurd that this is the situation, but I've just been informed that the FDA estimates there to be approximately 140 individual businesses involved in the e-cigarette industry. Well, we have 625 (yes, 600) US ecig ONLINE businesses registered at ECF! And over 1600 registered in total (including many that are no longer trading). At a push, I'd say we have 900 actively trading businesses registered - and that's only the ones who registered with ECF.

SFATA estimate 14000 vapestores nationwide. Some businesses clearly own multiple stores - but still....

So, where does the FDA get its information from? I think Carl's right - it's only interested in the "bound volumes" of academic publications.

If we could "just sit down" with Mr. Zeller, we would. But we mere mortals do not get an audience with His Excellency. We must meet with his advisors at "listening sessions," write letters, submit comments and testify at TPSAC hearings - all of which we have done. The FDA has been provided REAMS of scientific information and survey results providing evidence of efficacy and safety. CASAA even called off the "FDA dogs" during this period and played nice, avoiding any public criticism of the FDA...until they issued the proposed rules and proved to us they had ignored everything we had presented.

If you can arrange for a one-on-one meeting with the man, please let us know how you did it.

 

[Kent C]

You mean the flowers to Mitch Zeller?

I was hoping we could take up a collection, and make sure that some were also sent to Stanton Glantz.

We should send flowers to Zeller from Glantz

 

[Bobbilly]

If you can't get to the man. Get to his minions. Is he married? Invite her out for a ladies nigh out.

 

[toddkuen]

I think Zeller made it clear in the Senate meeting with Harkin he is obligated to

A) Regulate tobacco products but not nicotine from other sources (I forget exactly where but I think its posted on another thread).

B) Stem the flow of deaths from "combustible tobacco products" (a new term I had never heard before - clearly meant to differentiate between "vaping" or "chewing" and "smoking").

Now one interpretation of these tea leaves is that he means: "vapers, get your *** out of "tobacco from nicotine" and you're not in my jurisdiction."

Perhaps this is accomplished with better filtration, non-tobacco sources or by simply reading and testing the existing law as it was written.

"Combustible tobacco products," apparently, is the far bigger threat.

In any negotiation where youd goal is not to obliterate the other side "telegraphing messages" is often employed.

If his goal is obliteration why not just lump ecigs in with everything else, why go out of your way to say what he did?

 

[Roger_Lafayette]

I think Zeller made it clear in the Senate meeting with Harkin he is obligated to

A) Regulate tobacco products but not nicotine from other sources (I forget exactly where but I think its posted on another thread).

B) Stem the flow of deaths from "combustible tobacco products" (a new term I had never heard before - clearly meant to differentiate between "vaping" or "chewing" and "smoking").

Now one interpretation of these tea leaves is that he means: "vapers, get your *** out of "tobacco from nicotine" and you're not in my jurisdiction."

Perhaps this is accomplished with better filtration, non-tobacco sources or by simply reading and testing the existing law as it was written.

"Combustible tobacco products," apparently, is the far bigger threat.

In any negotiation where youd goal is not to obliterate the other side "telegraphing messages" is often employed.

If his goal is obliteration why not just lump ecigs in with everything else, why go out of your way to say what he did?

I have repeatedly responded to your posts with one simple suggestion, which basically amounts to this sentence, which I will express in some rather blunt terms: "If your insights are so valuable, then please demonstrate this, instead of posting about it."

Your posts suggest that you apparently believe that you have unearthed some kind of as-yet-undiscovered legal loophole in the tobacco act (FSPTCA). I have made several suggestions to you about how this message could be communicated, for example by sending registered letters to the various recognized "legal eagles" in this fight (folks like Azim Chowdhury, Greg Conley, CASAA Pres. Julie Woessner, etc.). Or take out a newspaper ad if nothing else works (you did indicate at one point that you were willing to put up $10K for the cause of vaping).

All of this talk about what the FDA supposedly knows or thinks has to be examined in the context of their history, the workings of the US government in general, and so forth. I do not claim to be an expert on any of this stuff (or anything else for that matter). But it seems that there's some fairly good evidence of prior actions on the FDA's part with regard to vaping as well as ST (smokeless tobacco). Speculation about what Zeller personally knows or thinks is just that - mere conjecture. In my mind, such blather is little more valuable than wondering about what variety of floral arrangement he might prefer.

It seems that once again, the efforts of CASAA/ECF (along with other orgs) have borne fruit in California. AB 1500 appears to be dead - and I heard it myself from a legislative aide about an hour ago. Vapers have not yet lost a single state battle so far this year, although obviously that may change.

In my book, the proven track record of CASAA beats idle chatter any day of the week, no matter how many arguably plausible claims of insight, erudition, and experience are contained in the latter.

Those of you who seem to think that you can change Zeller's and/or the FDA's mind about the scope and likely effect of the proposed rule are welcome to make such an effort. Do whatever you please. But for heavens' sakes, I implore you to do us all a favor by showing us what you can do, instead of posting about it.

Once you (and that means anyone) have saved the day with your insight, your brilliance, and your experience, I will be among the first ECF denizens to warmly congratulate you. And please spare me from the trouble of reading additional arguments which effectively begin with the phrase "If I were king of the vaping world, I'd ..."

CASAA has shown what it can do..

The proof of the pudding is in the eating - not the touting.

 

[Rossum]

But what the pro-vaper is either reluctant to discuss or refuses to acknowledge is that cold turkey is still the best method around, when taking into account the overall public health position.

Huh? "Public health officials" have been telling us for that we should just quit for 50 years now. Cold turkey may work for some, and that's great. But there are tens of millions people in the US and a billion or so in the world for whom "just quit smoking" simply does not work. That makes in at ineffective method as far as the public health position is concerned.