FDA Zeller Actually Lets the Truth Slip Out - Let's Pay Attention

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Alexander Mundy

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View attachment 336411

FDA Regulation ECigarettes | Video | C-SPAN.org

SEE: 38:30
"If we could get all of those people [who can't or wont quit smoking conventional cigarettes] to completely switch all of their cigarettes to the non-combustible products that would be good for public health."

SO... it seems that if there is a preponderance of evidence that people do in fact completely switch that the FDA should be our ally, by their own admission.

The next step would be to demonstrate what kinds of devices actually allow or enable people to completely switch, and that the 2007 date does not provide adequate attention to what actually works.

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Just looking at things as we all start to maybe get our resources together for our official comments.

What caught my ear when I was watching it live was the "all" and "completely" which is an impossibility. I think he had that figured out as a pat answer before the meeting to stop a line of questioning and pacify the questioner.
 
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DeadbeatJeff

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Jeff, I think you're talking this one statement out of the context of the law. Zeller can say whatever he likes about various scenarios, but the statute imposes limits.

1) The 2007 state is in the law. The FDA can't change it. They can be flexible about their enforcement decisions, but they can't change that date.

2) The FDA can't just approve e-cigs as a whole. As we've discussed in numerous threads, every single e-liquid has to have its own application. And that's not just for a flavor, it's for a specific nic concentration, bottle size, VG/PG ratio. JC alone would have to fill something like 100 applications for 20 basic types. Equipment is the same deal. Vision and Kanger would each have to file 100s of applications (and registrations), with the studies and other evidence needed to show that EACH of these products wouldn't have a net negative effect on pubic health. Most of us don't think that's going to happen for either an e-liquid or a piece of equipment. After all, with tobacco cigarettes, they're all different. Marlboro 100s are not Marlboro Kings - two different products, as far as the FDA is concerned.

3) Kent's point about the overall health effects applies to everything, but it's particularly critical for the one kind of setup that can be approved with a single application: a cigAlike (in a particular flavor, anyway). So NJOY and LOGIC would have just two applications, I think - one for menthol and one for regular. Blus would have more, but Lorillard could afford it. However, cigAlikes are primarily favored by dual users. That means they're still smoking tobacco cigarettes. Since about 5% of tobacco cigarette smokers quit every year, that means that dual users of a cigAlike represent a net health negative, since they are tobacco cigarette smokers who are less likely to quit. The ANTZ no longer recognize the idea that reduced tobacco cigarette smoking means reduced harm (I can give you Siegel's blog post link on that if you want). The FDA probably doesn't either (I suspect this is somewhere in the PDF).

***

There's no question that Zeller's comment might be an embarassment to the FDA if/when all vaping is effectively banned-by-omission (i.e. nothing is ever approved). Although most people seem to think now that they will just never get around to reviewing the applications from BT and Big Vapor. Equally embarassing to the FDA is his past comment: "Smoke for the nicotine, die from the tar" (some UK prof said that back in the 70s, but I believe either Zeller or the CDC's Frieden repeated it a few years ago).

But that's all these things are ... random and possibly embarassing remarks. They have no bearing on the law.

And as long as cigAlikes are around, they probably aren't even all that embarassing.
I think my main point is that he said this on record at a committee hearing, and that as such this statement, regardless of how HE was using it or dressing it up or down, is rather powerful when presenting any case to a legislator, or when organizing data and resources for a comment to the FDA.
 

DeadbeatJeff

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What caught my ear when I was watching it live was the "all" and "completely" which is an impossibility. I think he had that figured out as a pat answer before the meeting to stop a line of questioning and pacify the questioner.

Sure, but "All" can be reasonably qualified as "a statistically relevant quantity", and his statement presupposes that ecgis are safer.

And if he then follows it up with "but if not everyone switches, ecigs could be a gateway to combustibles", we could easily debunk the claim with a quick survey-based study (the industry should rationally be on board with this sort of thing. not BV, but regular venders and producers).

And then, what argument is left? Just the matter of flavorings, which would still have to be tested for safety.

What of hardware? Another study on what devices are most effective for people. Predicated on the fact that (admittedly) ecigs are much healthier, the certification of different, effective delivery systems follows.

----------------

Just a point, but I've never really heard anyone "official" go on record in committee saying that ecigs are healthier. We usually get the "we don't know enough" line.

It would be like if the deputy director if the DEA went on record in committee that {OTHER STUFF} was significantly less harmful to people and society than {WORSE OTHER STUFF}. You don't here them say that, ever.
 
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Hulamoon

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I think it's as simple as Zeller being paid more by Big tobacco than Big Pharma particularly as he wants to revert everything vaping to the super old technology that BT has only just got to recently. If he was really serious about the public health, cigarettes should have been on the chopping board along with a whole lot of products sitting on grocery shelves and pharmacies first. That's just my own take on it of course.:)
 
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KODIAK™;13168760 said:
Note that Zeller said this *after* the deeming regs were hashed out. :D All that matters is what's in the regulations. He could've said that he personally vapes tuity-fruity in a sub-ohm rig and it wouldn't matter.

I really wish some of you guys would accept the fact that misguided and powerful people want to eradicate "e-cigs" from the planet. We have only to look at history to see what the FDA does with things the public likes. They do not "giveth". They take. We have more to gain by acting on 100% unadulterated mistrust than we do by assuming false empathy spewed from the mouth of Zeller will lead to better times.

Not to quibble, but I'm unconvinced that all of our opponents are merely misguided. I could say more about motives, but I'll leave it at that. (Although granted, there could be some really dumb local tobacco cessation expert out there with a G.E.D. who just memorizes what they're told to memorize. I'm talking about the serious folks in positions of authority in the Government-Industrial Tobacco Control Complex. They are not just mere bumblers.)

I also think that "eradicate" is a bit strong. I've said this for a long time now - BP knows that advanced devices work as cessation. That's how we all quit, right? They'd kill to get their hands on this market, because it's worth a whole lot more than their ineffective NRT market ever was, long before NRT sales started to plummet as a result of vaping. "Medicalize" is the word that I'd use.

But at the end of the day, my petty nitpicking above is unimportant.

What's critical (as you say) is that we accept the facts as they are. The statute is what it is, the regulatory framework is what Congress put in place, the FDA's history in the harm reduction arena and its relevance to vaping can't be questioned. So it helps us not one whit to embrace optimism borne of sheer ignorance or some kind of mindless desire to "just think positive." Facts are stubborn things. We need to get used to them.
 

aikanae1

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I think it's as simple as Zeller being paid more by Big tobacco than Big Pharma particularly as he wants to revert everything vaping to the super old technology that BT has only just got to recently. If he was really serious about the public health, cigarettes should have been on the chopping board along with a whole lot of products sitting on grocery shelves and pharmacies first. That's just my own take on it of course.:)

Zeller is ex-GlaxoSmithKlein. The same ones who produce NRT's and have had a nose dive in sales they attribute to ecigs.
 

Jman8

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The statement Zeller makes holds equally true for the patch and gum. Which would be his easy out, IMO.

And if we're talking about this hypothetical place we hope all people to get to, then cold turkey would arguably be the best method for the good of public health.

I'm a proud dual user. I don't need to be gotten off combustible tobacco because I done broke the addiction.

If we could just get the whole wide world to agree with what Judge Leon said about eCigs, that they are a recreational product, for adult consumers, that would be a nice first step. That these products contribute to harm reduction is wonderful and all, but in the continuum, it is not the best of all possible choices. A federal regulator living in a world co-populated with ANTZ isn't going to say that eCigs (vaping nicotine) is the only approach to good public health.
 

Gato del Jugo

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Zeller is ex-GlaxoSmithKlein.

Yeah, but e-cigs would take away a bunch of money from all of Zeller's old buddies.. :(


"What could make Zeller’s appointment controversial is he currently serves as an executive with Pinney Associates, a pharmaceutical consulting firm that does work for GlaxoSmithKline, the top seller of nicotine-replacement therapy products.

He also worked as an executive with the American Legacy Foundation, an anti-smoking group established as part of the Master Settlement Agreement between states and the tobacco industry.
"

FDA names new head of tobacco governance group - Winston-Salem Journal: Business News
 

Myk

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Zeller is ex-GlaxoSmithKlein. The same ones who produce NRT's and have had a nose dive in sales they attribute to ecigs.
And healthy vapers don't need expensive BP meds, either.. :)

And I'm not getting my doctor recommended hepatitis vaccine because I found out it's made by GSK.
 

zoiDman

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I think if Mr. Zeller could make the Final decision on e-Cigarette/e-Liquids and if the FDA wasn't Tainted by Big Business and if the FDA was Removed from Political Tug of War over Senate Seats, that we could see a Reasonably Fair/Scientific approach to e-Cigarette/e-Liquid Regulation.

But we Don't live in that World.

In Many Ways I am Very Glad that Mr. Zeller holds the Position that he does. Because we could have Done a Lot Worse. Perhaps a Tad Better? But Definitely a Lot Worse.

BTW - It's kinda Funny how Mr. Zeller's name is the one that is out in front. And the name Margaret Hamburg is Rarely Mentioned.
 

Gato del Jugo

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I suppose you could say that he can't be biased as long as he belongs to both.

Actually, it should be viewed as being twice as worse, had it been instead just BP or BT, as there is even more $$ at stake with both camps..

The fact is, he should have zero association with either..


His bias & conflict of interest make him unfit to be in that position, and needs to be publicly called-out on that yet again..

In other words, this guy should be forced to resign...


And at least his predecessor was actually a medical doctor -- instead of a lawyer...
 
I will be asking all my doctors to get involved! They know my health better than anyone! They know how bad I was when I smoked. I wound up in the hospital every year with severe bronchitis. They in turn will get their friends involved and so on and so on...I have GOOD doctors, that really care for the patient!!!
 

Alexander Mundy

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Mr. Zeller is between a rock and a hard place. The facts concerning vaping do not matter in this struggle, he is a pawn that is being pushed from both sides from Congress, big business, and the public. I do not defend him by saying that, but there is nothing in this world that would convince me to be in his shoes.

I think if Mr. Zeller could make the Final decision on e-Cigarette/e-Liquids and if the FDA wasn't Tainted by Big Business and if the FDA was Removed from Political Tug of War over Senate Seats, that we could see a Reasonably Fair/Scientific approach to e-Cigarette/e-Liquid Regulation.

But we Don't live in that World.

In Many Ways I am Very Glad that Mr. Zeller holds the Position that he does. Because we could have Done a Lot Worse. Perhaps a Tad Better? But Definitely a Lot Worse.

BTW - It's kinda Funny how Mr. Zeller's name is the one that is out in front. And the name Margaret Hamburg is Rarely Mentioned.
 
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