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

[Gato del Jugo]

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."

Yeah, this is the same guy who, prior to joining Venable & hooking up with SFATA, was the FDA's Chief Counsel..

Only reason why he's no longer there is because he resigned after getting busted for spying on & making life difficult for internal whistle-blowers who were actually doing their job as mandated by Congress...


At best, I'd take what he says with an extremely large grain of salt...

 

[Gato del Jugo]

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

Well, BP has..


You know, the folks who cut his paycheck...

 

[Kent C]

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.

You're right of course, but I think you missed jman's context "when taking into account the overall public health position." This IS what they think and is the only method with which they agree 100%. All other methods only 'extend the addiction' which is what they are, unrealistically, as you point out, attempting to eradicate.

 

[Roger_Lafayette]

You're right of course, but I think you missed jman's context "when taking into account the overall public health position." This IS what they think and is the only method with which they agree 100%. All other methods only 'extend the addiction' which is what they are, unrealistically, as you point out, attempting to eradicate.

Right, and the other thing that people seem to often miss is that this is a product-by-product approval process.

While the scope and likely effect of proposed rule can be analyzed in terms of vaping as a whole, and its impact on cessation, the reality is that the tobacco act requires the FDA to provide market approval for a particular tobacco product, not a class of products.

So no matter what Zeller, McAfee, or anyone else says about vaping in general, it's going to come down to an application submitted by a particular manufacturer for a specific device, e-liquid, or piece of equipment (if the proposed rule becomes final).

That said, if we can make the case that vaping leads to cessation, this will be hugely helpful in the public policy arena. Because the FDA does not (yet) rule America.

 

[Jman8]

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.

Very much agree with this, but it is what they are after.

Let's say you can't quit cold turkey from smoking. Could you quit cold turkey from vaping, or vape 0 nicotine?

That's what they want to hear, and what they are after. The ANTZ end-game: 0 nicotine in use, no gestures resembling smoking.

Me, I'm okay with vaping, smoking, and non-smokers who vape (nicotine).

Cessation is great for those who truly desire it, but for those who enjoy smoking/vaping, I think it is, how you say, bad policy.

 

[Kent C]

Right, and the other thing that people seem to often miss is that this is a product-by-product approval process.

While the scope and likely effect of proposed rule can be analyzed in terms of vaping as a whole, and its impact on cessation, the reality is that the tobacco act requires the FDA to provide market approval for a particular tobacco product, not a class of products.

So no matter what Zeller, McAfee, or anyone else says about vaping in general, it's going to come down to an application submitted by a particular manufacturer for a specific device, e-liquid, or piece of equipment (if the proposed rule becomes final).

That said, if we can make the case that vaping leads to cessation, this will be hugely helpful in the public policy arena. Because the FDA does not (yet) rule America.

Generally agree. And would (as I suspect you would too) expand the 'make the case' for the major aspects that seem to be 'stumbling blocks' of the regulators:

1. Ecig use can, and does, end in total cessation for many hard core smokers.

2. Ecig use reduces cigarette use for dual users and results in decreasing the number of cigarettes smoked for those people, and in many cases result in total cessation.

3. While ecigs may attract a few non-smokers or ex-smokers, it is not a path to cigarettes, since the obvious downside of the bad health effects of cigarettes don't trump the positive effects of nicotine and the enjoyment of vaping.

4. That many adult vapers love flavors and actually avoid tobacco and methol flavors to avoid the behavioral aspects of their smoking habit. And therefore, for adult vapers, more flavors are a positive aspect, that helps them move away from smoking.

5. Adult vapers are affected, in a positive way, (see #4) by advertisements regarding flavors.

6. That informed vapers, including the fact that all adults now know the downside of combustible tobacco, are not going to opt for the 4000+ chemicals in cigarettes over the @4 ingredients that make up eliquids, even though a few of those ingredients may contain some of the contaminants of cigarettes but at trace levels that even the FDA estimates, on average, as 9 times less than cigarettes.

 

[Jman8]

That said, if we can make the case that vaping leads to cessation, this will be hugely helpful in the public policy arena. Because the FDA does not (yet) rule America.

I'll be making the case that vaping leads to reduction of smoking cause I see evidence all around for this, and just makes most sense.

Individual truly has to want to (stay) quit for cessation to work. I am clearly at a point where I do not crave a smoke, but I still desire one. Claiming that my desire equals some sort of 'addiction' at work makes me question one's education/understanding of such matters, regardless of their (alleged) expertise, experience. Always always glad to discuss such matters with anyone that is interested in a truly rational discussion on that topic.

 

[Rossum]

Right, and the other thing that people seem to often miss is that this is a product-by-product approval process.

While the scope and likely effect of proposed rule can be analyzed in terms of vaping as a whole, and its impact on cessation, the reality is that the tobacco act requires the FDA to provide market approval for a particular tobacco product, not a class of products.

So no matter what Zeller, McAfee, or anyone else says about vaping in general, it's going to come down to an application submitted by a particular manufacturer for a specific device, e-liquid, or piece of equipment (if the proposed rule becomes final).

That said, if we can make the case that vaping leads to cessation, this will be hugely helpful in the public policy arena.

Cessation of what? Actual smoking (and almost all the harm associated with it)? I think we have plenty of evidence that it does.
But nicotine use and/or behavior that looks like smoking? I doubt we can come up with evidence that vaping does that. And that's the rub. I think they want the latter more than the former.

 

[Bobbilly]

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?

He has emphasized that numerous times however from what I have seen any other sources are nearly impossible to get on the scale you need. My question is if you had nicotine how would they determine it came from tobacco and not a eggplant?

 

[Roger_Lafayette]

Excellent points, all.

I would only quibble just a teensy bit with your #2, to the extent that we cannot argue that reduced tobacco cigarette smoking translates to reduced mortality: Anti-Smoking Advocate Incorrectly and Irresponsibly Tells Public that Smoking Half Pack Per Day is No Better than Smoking Two Packs Per Day

If you're correct that substantial reduction leads to complete cessation, that will be very helpful, but it's a tricky argument to prove via a longitudinal population study, which is probably the only kind of evidence that's going to work. Even in a controlled study environment, it might be hard.

Although we do know that reduction leads to cessation frequently over the short term (within, say, six months or so). But even if someone drops down to (say) one cigarette a week after years of vaping from 3 PAD, we will lose both the mortality and the morality ("they're still smoking") argument on this.

The other picky point here is that without complete cessation, the ANTZ can argue that relapse is more likely. The FDA has already signaled its intention to to make that argument about vaping in one of the PDFs that was recently posted - which is why we probably need to be able to show that (complete) cessation is long-term.

This is why I think we're going to have to hang our hat on the cessation peg without arguing reduction - at least until we have that kind of more nuanced data. (We might, someday.)

(And yes, I know that all these points apply to NRT. But that probably isn't going to matter much to the average nonsmoking/nonvaping member of the public or a legislature etc.)

Generally agree. And would (as I suspect you would too) expand the 'make the case' for the major aspects that seem to be 'stumbling blocks' of the regulators:

1. Ecig use can, and does, end in total cessation for many hard core smokers.

2. Ecig use reduces cigarette use for dual users and results in decreasing the number of cigarettes smoked for those people, and in many cases result in total cessation.

3. While ecigs may attract a few non-smokers or ex-smokers, it is not a path to cigarettes, since the obvious downside of the bad health effects of cigarettes don't trump the positive effects of nicotine and the enjoyment of vaping.

4. That many adult vapers love flavors and actually avoid tobacco and methol flavors to avoid the behavioral aspects of their smoking habit. And therefore, for adult vapers, more flavors are a positive aspect, that helps them move away from smoking.

5. Adult vapers are affected, in a positive way, (see #4) by advertisements regarding flavors.

6. That informed vapers, including the fact that all adults now know the downside of combustible tobacco, are not going to opt for the 4000+ chemicals in cigarettes over the @4 ingredients that make up eliquids, even though a few of those ingredients may contain some of the contaminants of cigarettes but at trace levels that even the FDA estimates, on average, as 9 times less than cigarettes.

 

[Roger_Lafayette]

Oops, this post ended up in the wrong thread.

 

[Kent C]

Roger_Lafayette:Excellent points, all.

I would only quibble just a teensy bit with your #2, to the extent that we cannot argue that reduced tobacco cigarette smoking translates to reduced mortality:

That's your own "internal conversation" quibble. Mortality was no part of what I said. Nor was it intended. I'm well aware of the timeline of what happens after stopping smoking and know that the one thing that doesn't decrease until 10 years of not smoking is the vulnerability to lung cancer, which iirc, is reduced by 50% at that point, but not eliminated.

If you're correct that substantial reduction leads to complete cessation, that will be very helpful, but it's a tricky argument to prove via a longitudinal population study, which is probably the only kind of evidence that's going to work. Even in a controlled study environment, it might be hard.

Again, well aware of the lack of studies. And there will not likely be, in time to make that case. If I mention these in 'comment' I will make a point that this comes from being on ECF for almost 5 years. And while they will use anecdotal evidence of say an exploding battery, that we at ECF actually know the specifics of how it happened and whether it was user error or manufacturing defect. And along the same line, one might consider as 'anecdotal' of a person saying that they quit smoking or reduced their smoking, but when you have 10's of thousands of these 'anecdotal incidences' with people using calculators on how much they saved with vaping vs. smoking, or how many consecutive days it's been since they had a cigarette, in every post they write, the tag of anecdotal becomes more of a behavioral study than they'd like to admit. As I posted recently "ECF IS a "study"" and frankly it is much more comprehensible and more certain that most of the 'studies' I've seen for or against. Although it is a long one BUT the data IS here. And it is no more subjective than respondents in their studies who are asked the same questions. Within the context of their own life and the circumstances related in many of the posts here, it is much more real/objective than asking a kid how many times they smoked in the past month.

Although we do know that reduction leads to cessation frequently over the short term (within, say, six months or so). But even if someone drops down to (say) one cigarette a week after years of vaping from 3 PAD, we will lose both the mortality and the morality ("they're still smoking") argument on this.

Again, mortality was no part of my post - and not intended but it is a 'd'uh' factor as a given. I'll grant that. Their 'morality' argument is the 'public good' argument and while this was never intended as a political post, there is a difference in viewpoints as to how 'moral' that is. Madison's 'general welfare clause' as he explains in the Federalist Papers goes like this - paraphrasing - since what all individuals have in common are certain rights by Nature's Laws, that a gov't that upholds and protects those individual rights also upholds the 'general welfare' by doing so. That the whole is not greater than the parts and there is nothing 'moral' about the public good that doesn't reduce back to the individual.

And in the case of Zeller's comments at the hearing, there is nothing 'moral' about allowing hard core smokers and dual users to die in order to keep kids from experimenting, since no laws will keep kids from experimenting anyway. Cigarettes can't be sold to minors, yet the CDC has all the statistics on how many thousands of them do! EVERY YEAR.

The other picky point here is that without complete cessation, the ANTZ can argue that relapse is more likely.

They can, but it simply is not true because of #3. "More likely" is measured in probabilities. If something isn't 100%, then there is more likely that 1% would occur if 100% isn't assured. It is 'more likely' that someone doesn't use a seat belt if there isn't alarms or lights going off in their car. It is 'more likely' that if vendors are put in jail for selling to minors, that no minors will drink alcohol. But is also more likely that a cop will be shot by dealers when the penalty for dealing is a life sentence, or that a victim of mere robbery will be killed because they are an eyewitness to a crime. So 'more likely' has a range and as far as vaping goes, the fact that the FDA, EPA, CDC has made it widely known that cigarettes can cut 10% of your lifespan, as well as all the other illnesses and sufferings, it is NOT more likely that when someone has a safer alternative that satisfies the nicotine and visuals (vapor), without the 4000 harmful ingredients, that they will revert to cigarettes.


The FDA has already signaled its intention to to make that argument about vaping in one of the PDFs that was recently posted - which is why we probably need to be able to show that (complete) cessation is long-term.

This is why I think we're going to have to hang our hat on the cessation peg without arguing reduction - at least until we have that kind of more nuanced data. (We might, someday.)

I disagree, our own numerous personal experiences and those of which we are well aware on a daily basis from being here IS or can be a factor. Studies would help, but without them, our own experience is the next best thing, and imo, better because it talks of real world experience rather than cold statistics - of course being able to communicate that is also important.

(And yes, I know that all these points apply to NRT. But that probably isn't going to matter much to the average nonsmoking/nonvaping member of the public or a legislature etc.)

There are a lot of laws that deal in subjects with which many legislators have no experience. That doesn't stop them. lol. They rely on staffs and studies of course and input from their constituents who elect them. What do you think might be the most important to them?

 

[PepperMonkey]

(And yes, I know that all these points apply to NRT. But that probably isn't going to matter much to the average nonsmoking/nonvaping member of the public or a legislature etc.)

Very, very true. People, including legislators, have much bigger fish to fry - attention spans are limited, competing priorities are scattered everywhere, and so forth. Everyone has differing day-to-day concerns, and on this forum, we're hearing from quite a cross-section of the population, and actually a very small one at that.

What I'm finding interesting (and my radar is very sensitive these days), is how accepting of the vape people who I encounter seem to be, the vast majority non-smokers: At a dinner party, "coming out of the closet," and whipping out my Evod (after dinner of course and then explaining and asking politely, always), and getting the "Sure, that's really cool. Wow;" Or someone's sister saying "My brother quit smoking overnight;" or the primary care Dr. who does a jig when you announce the news (our friends, primary care Drs.); or being queried by neighbors, and receiving surprise and a degree of curiosity; or walking by a B&M vape shop (located conveniently a few doors down from the cigar shop - how's that for contrast?) or line cooks on the street; and on and on. The point is that there will be, I think, a lot of very organic instances like this that may normalize vaping. Societies do not exist by regulation alone, but also by everyday social interactions. Political power could sink the vape, which in the case of many on this forum, like myself, would be horribly tragic. I also understand that politics and the regulatory process both works in ways that nobody can really understand, as in many other cases.

Not intending to be polyanna-ish here, but I think that when people see positive results in everyday people they know, then even in passing when mentioned in the media or in conversation, a positive association will be made, or at least a less negative association. It's still the first inning, but I've raised more than a few eyebrows among people who knew what a hardcore smoker I used to be and for how long. Once The Mighty Vapor Genie is fully out of the bottle, I think (perhaps wishfully) it'll be tough putting him/her back.

 

[toddkuen]

From my perspective (to bobbilly's point) nicotine is

A) not covered by any tobacco act because its part of the National Formulary (google "nicotine USP Formulary")

B) if extracted from tobacco may still contain various components that could be traced back to tobacco (99.7% pure is not sufficient) making it potentially subject to regulation.

C) easily made on a variety scales chemically or biologically but may contain unsuitable components to be filtered out ($$'s).

D) A botanical under the vitamin laws because its in much of the plant food we eat. No one is addicted there.

E) Not addictive according the FDA web site associated with gum and patches.

Nicotine from "other sources" is currently expensive relative tobacco nicotine - duh - so is wind or solar energy relative to gasoline.

Why? Manufacturing and distribution infrastructure.

We know that every ex-smoker here can and did spend up to $5-$7 a day on cigarettes - maybe $1500/year.

We know that vaping costs maybe 20% of that today, maybe $300/year (excluding fancy equipment).

So nicotine from other sources can add up to about $1200/year in cost and everyone here will still pay it to vape instead of smoke because it will still be cheaper.

Once it crosses the cigarette cost people will again start to smoke.

Say there are a million vapers (low estimate) x $1199/year on non-tobacco nicotine = instant $1.2 BILLION dollar industry (hockey stick growth).

So I could spend $100 million to develop this source, wait for Zeller to crush tobacco nicotine, and bingo - you're a billion dollar business.

Sure people will complain - but there will be no choice because it will cost less than tobacco.

Of course, as more and more vapers appear the numbers become even more attractive.

But no, let's ignore all this and simply rely on what? Waiting for Zeller to return our calls?

Bet your bottom dollar vaping will never be this cheap again and you can rest assured that these kinds of products will magically appear as soon as he drives a nail into nicSelect and friends vaping products.

Little wonder SFATA has their own organization...

 

[Roger_Lafayette]

<snip>

I think we're grinding this one down, but I will make one point about mortality. Whenever I read an anti-vaping article, or hear an anti-vaping diatribe, it always seems to begin with the tired old statistic about deaths from smoking-related illnesses. Usually the speaker or writer will go on to lump vaping in with tobacco cigarette smoking.

(In fact that's just what Zeller did on the PBS News Hour, which was his only videotaped interview as far as I know that ocurred after the proposed rule was released. In fact I don't believe he's done any other interviews. This is one reason why I'm extremely skeptical about his intentions, and find my eyes rolling whenever I read posts written by folks who seem not to share my attitude.)

So no, smokkng-related mortality isn't just my own "internal conversation" - it's a major part of the public discussion that we have about smoking here in the US and probably everywhere in the world. We can tell ourselves that this number is inflated because every smoker who dies of (say) diabetes or a heart attack is counted as a death due to smoking, even if they're hundreds of lb.s overweight.

Granted you didn't mention that point in your post. But mortality is the elephant in the room - if we're not talking about it, then our potential ability to reach nonsmoker/nonvapers is greatly diminished. Which in turn means that we have to be discussing (complete) long-term cessation, at least if Siegel is right in that blog post to which I linked before. We can mention reduction as a pathway to cessation, but permanent reduction does us minimal good.

Our strongest argument by far is that vaping will eventually do to tobacco cigarettes what the computer did to typewriters (Herzog?).

<snip>

Excellent observations, thank you

Although ... um ... can we not use the word "normalize"

(I know what you meant, I just can't stop myself from reacting instinctively when I see it ;-)

 

[PepperMonkey]

Bet your bottom dollar vaping will never be this cheap again

Yes, I've been thinking about when I'm going to be saying to myself "Remember when juice cost 8 bucks a bottle..." I don't know when, but looking at some of the NJ proposals, it's not encouraging.

 

[PepperMonkey]

Although ... um ... can we not use the word "normalize"

(I know what you meant, I just can't stop myself from reacting instinctively when I see it ;-)

Right on Rog, understood.

Words in fact do matter a great deal; I, for example, never ever say the e-c&* word.

 

[Rossum]

So I could spend $100 million to develop this source

Only if you had (or could borrow) $100 million. Thing is, people who have (or can borrow) that kind of money are rarely willing to invest it into something as speculative as the FDA "crushing" nicotine from tobacco, something which they can't really do anyway because most nicotine from tobacco is produced outside the US. So even if it's "crushed" in the US, the business that you invested in will be competing with anyone who's willing to smuggle it in, and there will be lots of such people, given the cost difference.

 

[Roger_Lafayette]

<snip>
So I could spend $100 million to develop this source, wait for Zeller to crush tobacco nicotine, and bingo - you're a billion dollar business.

Sure people will complain - but there will be no choice because it will cost less than tobacco.

Of course, as more and more vapers appear the numbers become even more attractive.

But no, let's ignore all this and simply rely on what? Waiting for Zeller to return our calls?

Bet your bottom dollar vaping will never be this cheap again and you can rest assured that these kinds of products will magically appear as soon as he drives a nail into nicSelect and friends vaping products.

Little wonder SFATA has their own organization...

So you stand to make a huge pile of dough. Good luck.

Some of your investors might balk, however, once they discover how easy it would be for a congressional staffer to redraft the FSPTCA, as I explained in another post (which I won't bother to dig up, unless someone really doesn't believe me). And no, that doesn't mean that eggplant will be banned.

Given the current gridlock in Congress, it might be interesting to watch, but we don't have much evidence right now to support the idea that either party would want to stick its neck out on behalf of vapers (or BT) by opposing this. State and local jurisdictions, of course, could rapidly adjust their tax laws - were it necessary to do so.

Anyway as I keep saying - if you think you can make all that dough, please be my guest. Proving the pudding is better than touting it.

We have already been through all of this in mind-numbing detail.

 

[Bobbilly]

What I like as an engineer is when someone says but the study shows us that can't happen when I'm standing right there with a broken anchor bolt in my hand. Same with these cessation studies. Essentially they are saying but people aren't quitting because the numbers in the lab don't say so.