FDA FDA's Zeller: Let's Reframe Debate to Focus on Nicotine

[Endor]

I don't know whether the FDA is allowed to do this. But the CDC certainly should - can't see that happening any time soon!

I was going to write something else in this post, but this got me thinking....

Although the FDA does have oversight in certain nicotine-containing products (specifically NRT), as it stands today, it does not have any oversight with regards to e-cigarettes. That's what the deeming regulations would do.

The deeming would give them the authority to pursue a further regulatory agenda with the newly deemed products. Our belief has been that the FDA will follow the same process as for new cigarette products, meaning PMTAs and all of that craziness.

But what if they don't? What if, by some miracle, Zeller "steps up to the plate", start to address continuum of risk and reframes the nicotine debate, and treats e-cigarettes differently? Is that what he is trying to say in these comments? I certainly hope so, but am not holding my breath; the pressure from the rabid anti-nicotine crowd (e.g. Glantz et al) is very, very high right now... not to mention the states' cigarette tax/MSA budget concerns. He'd be hard pressed NOT to kill vaping through regulation.

 

[Lessifer]

I was going to write something else in this post, but this got me thinking....

Although the FDA does have oversight in certain nicotine-containing products (specifically NRT), as it stands today, it does not have any oversight with regards to e-cigarettes. That's what the deeming regulations would do.

The deeming would give them the authority to pursue a further regulatory agenda with the newly deemed products. Our belief has been that the FDA will follow the same process as for new cigarette products, meaning PMTAs and all of that craziness.

But what if they don't? What if, by some miracle, Zeller "steps up to the plate", start to address continuum of risk and reframes the nicotine debate, and treats e-cigarettes differently? Is that what he is trying to say in these comments? I certainly hope so, but am not holding my breath; the pressure from the rabid anti-nicotine crowd (e.g. Glantz et al) is very, very high right now... not to mention the states' cigarette tax/MSA budget concerns. He'd be hard pressed NOT to kill vaping through regulation.

I think you're right in that they COULD do that. They could say, we've reevaluated and vapor products don't belong in the tobacco category, or they could say we'll deem them as tobacco so that we can regulate them but we propose these much less strict regulations. However, I think the whole "we need to reframe the conversation AFTER we settle the e-cig debate"thing says exactly where they're going with this.

I hope I'm wrong.

 

[nicnik]

I saw Zeller make the same point in two different venues almost exactly a year ago. And despite some sort of continuous noise about "continuums", and "the need to reframe nicotine" I would say that precisely nothing has happened.

In fact, both times I saw Zeller speak I submitted the same question, which he did not answer (no idea whether this was moderated prior to him seeing the question): "You've mentioned that there's an urgent need to reframe nicotine but no mention of whose responsibility that would be. Is this something the FDA can or should be doing?"

I don't know whether the FDA is allowed to do this. But the CDC certainly should - can't see that happening any time soon!

Here he's discussing reframing the debate , not reframing nicotine. He puts up many raodblocks to reframing the debate, including shutting out debate reframers from conferences, and disallowing Swedish Match to tell the truth, forcing them to print inaccurate information on their packaging that contradicts the truth about the continuum of harm.

No one person controls the entire debate. Lots of people take part, and there have been many people stepping up to the plate to talk about the continuum, while he works to undermine them. If he's trying to give the impression that somewhere there is a person who could turn things around by telling the truth, that seems highly improbable, unless it is a very highly placed whistleblower.

 

[TVC70]

Do you think Lewis was talking about the FDA?

Of all tyrannies, a tyranny exercised for the good of its victims may be the most oppressive. It may be better to live under robber barons than under omnipotent moral busybodies. The robber barons cruelty may sometimes sleep, his cupidity may at some point be satiated; but those who torment us for our own good will torment us without end, for they do so with the approval of their own conscience.

-C. S. Lewis

This seems appropriate here, too:

It is not the responsibility of the government or the legal system to protect a citizen from himself.

-Justice Casey Percell

Indeed.

 

[Stubby]

If he actually cared for individuals, even one individual, then he'd stick with the first quote and not bother with the rest. But his collectivist view demands that he views the largest group - the 'net population' as he's said elsewhere, (ie. not the just hard core smokers) and it is on that where his true 'belief' lies.

It has little to do with collectivism, though I understand you like to use that buzzword. This is about the core philosophy of the tobacco control industry of a tobacco/nicotine free world. Anything that interferes with that goal is bad, no matter how good it is for the individual or the population at large. It is the same old puritanical, abstinence only view on tobacco/nicotine use.

What Zeller is laying out is a catch 22. There is no way to win. If people where actually truthfully informed about the relative risk of different tobacco products there is little doubt tobacco/nicotine use would go up. It would be impossible for it not to. Of course if people used low risk tobacco/nicotine products the negative health results would still be overwhelmingly positive compared to what we have today, both for individuals and the population at large. But that really isn't the point of this. His view (and the view of the tobacco control industry), if you actually read into what he is really saying, despite his rhetoric about the continuum of risk, is that THR would interfere with the goal of a tobacco free world, so therefore it is bad, no matter how good it is for the individual or the population at large. This is not collectivism, it is simply puritanism. It is a way to justify the FDA's anti-THR stance.

Zeller is pushing an impossible scenario that justifies banning any tobacco/nicotine product, no matter how low the risk.

 

[Stubby]

Whonky double post

 

[Kent C]

It has little to do with collectivism, though I understand you like to use that buzzword.

Collectivism isn't just a buzzword, it actually has a meaning:

Collectivism means the subjugation of the individual to a group—whether to a race, class or state does not matter. Collectivism holds that man must be chained to collective action and collective thought for the sake of what is called “the common good.”

Which explains Zeller, in his current position, that 'common good' is the 'public good' or 'public health' - still collective in nature, iow, not about a certain subgroup - one smoker or a minority of hard core smokers but the 'net population' as he said.

Zeller stated that hard core smokers would benefit from ecigarettes. BUT his concern was for the 'net population'. Some call that "collectivist" some just say the "greater good" - the basis of utilitarianism vs. a rights principled ethic. Our country was based on rights principles where the gov't had no action to take against someone who was harming no one, even if he was harming him/herself. Zeller's stated position is with the whole of society wrt public health, not just a group of hard core smokers that may benefit from ecigs.

if you actually read into what he is really saying, despite his rhetoric about the continuum of risk, is that THR would interfere the goal of a tobacco free world, so therefore it is bad, no matter how good it is for the individual or the population at large.

I've likely read about everything Zeller has said wrt tobacco control/nicotine. When you say that he thinks THR is bad, no matter how good it is for the individual or the population at large - he doesn't think that it is 'good for the population at large' - he says just the opposite - that it is not good for the net population. If you want to quibble about "net population' and 'population at large' then you'll be doing that with someone other than me. I think most here would not see a difference. And neither would Zeller.

This is not collectivism, it is simply puritanism. Collectivism would support THR.

I don't discount the puritanism involved, but if collectivism would support THR, then why are the collectivists, democrats, socialist democrats and progressives who support collectivism over individual rights, against THR and support the TC ANTZ in almost every instance they can? Why are they the ones sending letters to the FDA and OIRA to enact the Deeming immediately, as written, that would do away with, as Bill says, 99% of the ecigarette industry?? Why did 18 out of 20 of them oppose the amendment that would change the grandfather date to present time?

 

[nicnik]

Collectivism isn't just a buzzword, it actually has a meaning:

Collectivism means the subjugation of the individual to a group—whether to a race, class or state does not matter. Collectivism holds that man must be chained to collective action and collective thought for the sake of what is called “the common good.”

Which explains Zeller, in his current position, that 'common good' is the 'public good' or 'public health' - still collective in nature, iow, not about a certain subgroup - one smoker or a minority of hard core smokers but the 'net population' as he said.

Zeller stated that hard core smokers would benefit from ecigarettes. BUT his concern was for the 'net population'. Some call that "collectivist" some just say the "greater good" - the basis of utilitarianism vs. a rights principled ethic. Our country was based on rights principles where the gov't had no action to take against someone who was harming no one, even if he was harming him/herself. Zeller's stated position is with the whole of society wrt public health, not just a group of hard core smokers that may benefit from ecigs.



I've likely read about everything Zeller has said wrt tobacco control/nicotine. When you say that he thinks THR is bad, no matter how good it is for the individual or the population at large - he doesn't think that it is 'good for the population at large' - he says just the opposite - that it is not good for the net population. If you want to quibble about "net population' and 'population at large' then you'll be doing that with someone other than me. I think most here would not see a difference. And neither would Zeller.



I don't discount the puritanism involved, but if collectivism would support THR, then why are the collectivists, democrats, socialist democrats and progressives who support collectivism over individual rights, against THR and support the TC ANTZ in almost every instance they can? Why are they the ones sending letters to the FDA and OIRA to enact the Deeming immediately, as written, that would do away with, as Bill says, 99% of the ecigarette industry?? Why did 18 out of 20 of them oppose the amendment that would change the grandfather date to present time?

It's a phony collectivist argument to say that vaping is a net harm to public health. Even from a colectivism point of view, vaping is a huge public health net benefit.

ANTZ' distortion of a collectivist perspective, is in support of crony capitalism, enriching corrupt players, together making it a merging of crony capitalism with crony socialism. Corruption is not bound to ideology.

 

[Kent C]

It's a phony collectivist argument to say that vaping is a net harm to public health. Even from a colectivism point of view, vaping is a huge public health net benefit.

I agree it's a phony collectivist argument, but it IS the collectivist argument in our government (and ANTZ groups)- including the Democrat Senators that write letters, those who opposed the Cole amendment and the President who signed the Family Smoking Prevention and Tobacco Control Act, as well as the Democrats in both the House and Senate that voted for it (there were some Republicans but there are also a few Republicans that are also collectivists).

But, in this country it shouldn't be a matter of collectivist ideas - phony or otherwise, but the idea that a person has a right to do whatever they want so long as it doesn't harm others - an extension of the 'rights principle' upon which the Constitution was based.

ANTZ' distortion of a collectivist perspective, is in support of crony capitalism, enriching corrupt players, together making it a merging of crony capitalism with crony socialism. Corruption is not bound to ideology..

I agree with what you're attempting to say, except that as soon as you insert 'crony' with 'capitalism' - capitalism which is free enterprise, ceases to exist. 'Crony capitalism' while it has meaning for some who want to associate it with capitalism in general for political purposes, is an oxymoron. The same would be true of crony socialism but it is there and in mixed economies where it is more who you know, than what you do. In a free market, 'who you know' is of no consequence - only that you produce a quality product at a price the market can bear.

 

[Stubby]

I've likely read about everything Zeller has said wrt tobacco control/nicotine. When you say that he thinks THR is bad, no matter how good it is for the individual or the population at large - he doesn't think that it is 'good for the population at large' - he says just the opposite - that it is not good for the net population. If you want to quibble about "net population' and 'population at large' then you'll be doing that with someone other than me. I think most here would not see a difference. And neither would Zeller.



I don't discount the puritanism involved, but if collectivism would support THR, then why are the collectivists, democrats, socialist democrats and progressives who support collectivism over individual rights, against THR and support the TC ANTZ in almost every instance they can? Why are they the ones sending letters to the FDA and OIRA to enact the Deeming immediately, as written, that would do away with, as Bill says, 99% of the ecigarette industry?? Why did 18 out of 20 of them oppose the amendment that would change the grandfather date to present time?

You have completely misunderstood what I was saying. When you stated

"When you say that he thinks THR is bad, no matter how good it is for the individual or the population at large - he doesn't think that it is 'good for the population at large' - he says just the opposite - that it is not good for the net population. If you want to quibble about "net population' and 'population at large' then you'll be doing that with someone other than me. I think most here would not see a difference. And neither would Zeller."

You completely missed the meaning of what I said. I agree with you that he doesn't think THR is good, and that is exactly what I said, and in fact was the whole point of my post. In your enthusiasm to respond that went way over your head.

I will just ignore your whole rant about collectivism. I know you like to break things down into simplistic black and white concepts, but as I stated (not your misquotes, or at least misunderstanding) this has little to nothing to do with collectivism. It has to do with rationalizing anti-THR. The reality is of course that THR would benefit both the individual and the population at large. Zeller is simply justifying the FDA's anti-THR stance with some rather tortured logic.

 

[nicnik]

But, in this country it shouldn't be a matter of collectivist ideas - phony or otherwise, but the idea that a person has a right to do whatever they want so long as it doesn't harm others - an extension of the 'rights principle' upon which the Constitution was based.

Collectivism isn't all bad, but I strongly agree that "a person has a right to do whatever they want so long as it doesn't harm others".

 

[Lessifer]

Collectivism isn't all bad, but I strongly agree that "a person has a right to do whatever they want so long as it doesn't harm others".

I'm not going to respond to the other two, because that seems a little pointless...

To me, the issue here is the definition of "harm others." For most of us here, that means even if vaping might be doing some sight harm to me, there is no evidence of physical harm to anyone else. For Zeller and the FDA, nicotine use is seen as a harm, they don't acknowledge that near zero risk, or any potential benefit. So, if it leads to people continuing to use nicotine, that's bad. It's especially bad if you believe nicotine use will lead to more smoking, because smoking costs the government money(supposedly), and that in itself is seen as harm to an "other," I think.

 

[Oliver]

I'm not going to respond to the other two, because that seems a little pointless...

To me, the issue here is the definition of "harm others." For most of us here, that means even if vaping might be doing some sight harm to me, there is no evidence of physical harm to anyone else. For Zeller and the FDA, nicotine use is seen as a harm, they don't acknowledge that near zero risk, or any potential benefit. So, if it leads to people continuing to use nicotine, that's bad. It's especially bad if you believe nicotine use will lead to more smoking, because smoking costs the government money(supposedly), and that in itself is seen as harm to an "other," I think.

Marketing is the locus of the "harm to others"; so those selling vape products are creating harm if they're selling to those who do not smoke or those who are young.

The fundamental crux of the matter is whether nicotine use is "OK" in the absence of the health risks from smoking.

 

[Lessifer]

Marketing is the locus of the "harm to others"; so those selling vape products are creating harm if they're selling to those who do not smoke or those who are young.

The fundamental crux of the matter is whether nicotine use is "OK" in the absence of the health risks from smoking.

True, but then there's the conundrum of "was this person going to start smoking?" It's difficult to ascertain, but, unless there is a point in time when SMOKING is not an option, it should be considered for a true net health calculation.

Also, how do actually make the calculation whether nicotine use(sans smoking) is a health risk or a health boon without more complete information on the risks and benefits of nicotine use? So far it's been a case of "Smoking is bad, so nicotine is bad too." You've got NRT which the FDA has approved for long term use, so nicotine can't be all that bad. You've got some researchers looking into possible benefits of nicotine for mental health, and possibly even cardiovascular health.

Add to that, even with the most aggressive marketing known to man, the decision to purchase and use a product is an individual choice. Unless, of course, we don't have the freedom to choose our own actions when they may only harm ourselves and not others.

ETA: Is the vendor selling something to me, or am I buying something from the vendor? I would argue it is the latter.

 

[Alexander Mundy]

The thing I zeroed in on was this question by Zeller concerning Nicotine: "What is the longer-term use for those who need it?" This implies that he knows there are those whom need long term use of Nicotine. I and many are in that class. I was at my wit's end trying to quit and also retain any kind of day to day normality of self. After numerous "quits" I had resigned myself to being a smoker for life with the possible consequences. Vaping was a grasp at something I truly didn't think would work after all the mainstream trys. Course it was virtually unknown locally then and I thank goodness I found ECF. Point is that most all ANTZ I have heard deny the reality that there are those of us that (for what ever reason) cannot live a "normal" day to day existence without it. I lived miserably every day for over a year on my cold turkey "quit".

 

[Endor]

Marketing is the locus of the "harm to others"; so those selling vape products are creating harm if they're selling to those who do not smoke or those who are young.

The fundamental crux of the matter is whether nicotine use is "OK" in the absence of the health risks from smoking.

This point is quite valid, and is being leverage heavily by some health groups (the whole "gateway" theory), especially the California DPH.

Lessifer is right, it is difficult to ascertain if a current non-smoker using an e-cigarette would have smoked anyway. Certainly the CDC data indicates this by showing that "tobacco" use, when factoring in e-cigarettes, hasn't declined overall among teens. I read this to mean that the number of teens predisposed to tobacco use (e.g risky, self-harming behavior) hasn't really changed, but that some of them are using e-cigarettes instead of normal cigarettes. Is this a net improvement to health overall? I'd argue yes, but this data is always spun the other way: e-cigarettes are attracting teenagers to a lifetime of nicotine addiction, even though the stats show most teens don't even use nicotine-containing e-liquid.

 

[Lessifer]

This point is quite valid, and is being leverage heavily by some health groups (the whole "gateway" theory), especially the California DPH.

Lessifer is right, it is difficult to ascertain if a current non-smoker using an e-cigarette would have smoked anyway. Certainly the CDC data indicates this by showing that "tobacco" use, when factoring in e-cigarettes, hasn't declined overall among teens. I read this to mean that the number of teens predisposed to tobacco use (e.g risky, self-harming behavior) hasn't really changed, but that some of them are using e-cigarettes instead of normal cigarettes. Is this a net improvement to health overall? I'd argue yes, but this data is always spun the other way: e-cigarettes are attracting teenagers to a lifetime of nicotine addiction, even though the stats show most teens don't even use nicotine-containing e-liquid.

Shouldn't they have to prove that vaping IS risky, self-harming behavior first? Or that nicotine use, without tobacco, even leads to addiction?

 

[Kent C]

You have completely misunderstood what I was saying. When you stated

.....(my quote)...

You completely missed the meaning of what I said. I agree with you that he doesn't think THR is good, and that is exactly what I said, and in fact was the whole point of my post.

Ok. Here's what you said in your original post before you edited it:

"if you actually read into what he is really saying, despite his rhetoric about the continuum of risk, is that THR would interfere the goal of a tobacco free world, so therefore it is bad, no matter how good it is for the individual or the population at large."

It was you that missed my point - probably from your aversion to the word 'collectivism' which actually best describes Zeller's argument. It wasn't about that he thought THR is bad, he obviously does, but it was in the frame you put it - 'no matter how good it is for the individual or the population at large'. My point that he, in no way, thinks THR is good, for the population at large, and he stated this quite clearly. And it is his 'net population' where the deeming, not THR, would be good for public health, for the public health of the State' and hence, has a collectivist connotation to it vs. any rights connotation.

That said, it IS, as nicnik pointed out, and with which I agree -a phony collectivist argument BUT, not from their viewpoint - which is what I was pointing out.

I will just ignore your whole rant about collectivism. I know you like to break things down into simplistic black and white concepts,

If you would have ignored it in the first place, we wouldn't be having this conversation, but you don't ignore those things I say. And you always inject the pejorative and insults when you do.

"Not black and white Ritter, right and wrong." Jack Ryan "Clear and Present Danger"

 

[Kent C]

Collectivism isn't all bad, but I strongly agree that "a person has a right to do whatever they want so long as it doesn't harm others".

And yet it is collectivism or the concept of public health or the good of the state (forms of collectivism) that actually does stop a person from doing some of those things that harm no one.

There are certain things that individuals can't do - as the Founders understood - Defense against foreign invasion/threat - but it is still good for individuals and society as a whole, when the Military collectively (and yet peopled by individuals willing (in a non-draft situation)) handle the general defense. And Justice is best handled by the State when it can do so without taking sides. Unfortunately, that is no longer the case in many cases. Another area where 'cronyism' or simple corruption comes into play.

 

[Kent C]

I'm not going to respond to the other two, because that seems a little pointless...

To me, the issue here is the definition of "harm others." For most of us here, that means even if vaping might be doing some sight harm to me, there is no evidence of physical harm to anyone else. For Zeller and the FDA, nicotine use is seen as a harm, they don't acknowledge that near zero risk, or any potential benefit. So, if it leads to people continuing to use nicotine, that's bad. It's especially bad if you believe nicotine use will lead to more smoking, because smoking costs the government money(supposedly), and that in itself is seen as harm to an "other," I think.

Only if health care is 'socialized' either by gov't or by insurance companies. Which of course, it is. But with private insurance, people have a choice. With gov't - no choice involved - it's mandated. And that's where the real 'crime' is. Not in how it affects others wallets - although that's part of it as well. Take away the socialization, and then there is no harm. Which is how it should be.

One could say, perhaps cynically, that, that was their idea in socializing in the first place - to show harm to others when there were none - that way they can control behavior. It's their 'workaround' regarding individual rights :- )