FDA Zeller on E-Cigs: It's Complicated

[Fitzie]

This was published prior to the proposed deeming regs. It's gives some more insight into what Zeller thinks about e-cigarettes.

http://www.cspnet.com/category-mana...s-data/articles/zeller-e-cigs-its-complicated

I'd love to watch this FDA webinar, 20 Years Later: Returning to FDA to Regulate tobacco, but it looks like you need a password. Perhaps some computer folks can figure that out.

Mitch Zeller, J.D., Director, Center for Tobacco Products

 

[Stosh]

I'd love to watch this FDA webinar, 20 Years Later: Returning to FDA to Regulate tobacco, but it looks like you need a password. Perhaps some computer folks can figure that out.

Mitch Zeller, J.D., Director, Center for Tobacco Products

I right clicked on the link below the "20 Years Later: Returning to FDA to Regulate tobacco" line in the text and then choose "Open in New Tab". Came right up for me, in chrome.

 

[Fitzie]

I right clicked on the link below the "20 Years Later: Returning to FDA to Regulate Tobacco" line in the text and then choose "Open in New Tab". Came right up for me, in chrome.

Thanks! I guess I just didn't wait long enough for it to load.

 

[Stosh]

Thanks! I guess I just didn't wait long enough for it to load.

I listened to it, not sure I did you a service....

 

[Jman8]

This was published prior to the proposed deeming regs. It's gives some more insight into what Zeller thinks about e-cigarettes.

http://www.cspnet.com/category-mana...s-data/articles/zeller-e-cigs-its-complicated

In this article it says,

"It is not the nicotine that kills half of all long-term cigarette smokers," said Zeller. "The nicotine creates and sustains the addictions, but it's not the nicotine that kills people."

That seems like enormous revelation coming from the head of FDA. When watching the recent hearing and Burr essentially asking Zeller to admit to this, it almost showed up like pulling teeth to get Zeller to admit to this.

Yet, just because Zeller would likely admit to this if pressed from someone other than a pro-nicotine enthusiasts, it doesn't change the nature of the mandate that he feels he needs to lead. And which the article touches upon. Zeller isn't about THR which makes him often appear like he is in the ANTZ camp. But I would say that is inaccurate. He, like science, is straddling the fence between what appears like 2 extremes, but in political reality is really just presenting accurate information with regards to a policy that is borne from extremists, some of whom are ex-smokers, who now despise that anyone would enjoy a product that they feel caused them enormous problems in their own life.

 

[toddkuen]

My thinking is that Zeller knows what to do for the long term but is faced with a troubling dilemma.

Normally no one "uses" new products until they are properly vetted, tested and approved.

In the case of ecigs they exist are are being used before this all happens - and further people no long smoke "combustibles" because of them.

Therefore he is stuck having to deal with "grandfathering" existing user (and not causing them to smoke analogs in the process).

He said things in the Senate hearing the other day that made me think he's not sure what to do - and probably doesn't want converted (no analogs) ecig users going back to "big tobacco" products.

 

[wv2win]

I found this quote interesting and disingenuous:

"Zeller added that the agency is currently seeking out information on e-cigarettes from the scientific community to better understand just that. Specifically, the FDA wants a grip on who is using products like e-cigarettes and how they are being used--with a focus on the net population health impact of different usage behaviors..........................."

There are plenty of reputable studies that have been conducted, most notably the Drexel University study, that the FDA has never mentioned or acknowledged even exist. Instead, all we read is: there are too many unknowns...........we can't be sure.

Considering that ECF has over 100,000 members with 20,000 active members, how hard would it be to reach-out to ECF management and develop a method to capture our experiences? Or how about reaching out to CASAA? They definitely know who CASAA is and there are 6000 vaping stories held by CASAA.

I don't find his statements in this article genuine when compared to his and the FDA's past actions. Actions speak much louder than words. His words are "political" while his actions are "dangerous" to our health.

 

[Kent C]

I found this quote interesting and disingenuous:

"Zeller added that the agency is currently seeking out information on e-cigarettes from the scientific community to better understand just that. Specifically, the FDA wants a grip on who is using products like e-cigarettes and how they are being used--with a focus on the net population health impact of different usage behaviors..........................."

There are plenty of reputable studies that have been conducted, most notably the Drexel University study, that the FDA has never mentioned or acknowledged even exist. Instead, all we read is: there are too many unknowns...........we can't be sure.

Considering that ECF has over 100,000 members with 20,000 active members, how hard would it be to reach-out to ECF management and develop a method to capture our experiences? Or how about reaching out to CASAA? They definitely know who CASAA is and there are 6000 vaping stories held by CASAA.

I don't find his statements in this article genuine when compared to his and the FDA's past actions. Actions speak much louder than words. His words are "political" while his actions are "dangerous" to our health.

I've considered many times that ecf is a good 'study'. All the answers to many of the questions are here.

Don't know if I posted this before - intend it for comments, but if the FDA is going to put warning labels on products, a good one would be:

"Join an ecigarette forum. The veterans and fellow vapers will help you with any safety and product questions you might have. Don't use this product without getting informed first."

 

[Nate760]

There are plenty of reputable studies that have been conducted, most notably the Drexel University study, that the FDA has never mentioned or acknowledged even exist. Instead, all we read is: there are too many unknowns...........we can't be sure.

Translation: "The research doesn't say what we want it to, therefore it doesn't exist."

 

[Stosh]

What struck me in Zeller's comments was the statement that "individual harm risk" might be very favorable, i.e millions of people quitting or reducing smoking, but may be overridden by the law. If the "population level harm", i.e. someone may vape, or vape and smoke, instead of quitting smoking entirely (just drop 'em cold turkey) it would require e-cigarettes to be restricted.

The absurdity of "population level harm" is if they perceive a subset of the population MIGHT behave not to their liking, the KNOWN subset of people that would be helped are not the prime consideration....

 

[Bobbilly]

This is my dual use buster from the UK public health report.

" has been suggested that there is a risk of sustained dual use among smokers who might otherwise have quit smoking completely, representing missed opportunities to achieve complete cessation. This concern clearly applies equally to NRT, which is licensed for what is in effect dual use and recommended on the grounds that dual use is likely to increase quit attempts. The concern is therefore inconsistent; if dual use is good as a pathway to quitting, that surely applies to dual use involving either NRT or electronic cigarettes."

 

[Stosh]

if dual use is good as a pathway to quitting, that surely applies to dual use involving either NRT or electronic cigarettes."

Should be, but NRT is FDA approved medicine, electronic cigarettes are recreational drug usage.....
Just because it makes sense, clearly logical, doesn't mean much to bureaucrats and lawyers.

 

[Bobbilly]

Just pointing out how the UK is looking at it. This was a report for their health agency

 

[Stosh]

Just pointing out how the UK is looking at it. This was a report for their health agency

The UK has many very good, peer reviewed studies of e-cigarettes, showing very promising results. Why they get ignored by the FDA and Washington in general is unknown and unbelievable....

 

[Kent C]

Should be, but NRT is FDA approved medicine, electronic cigarettes are recreational drug usage.....
Just because it makes sense, clearly logical, doesn't mean much to bureaucrats and lawyers.

And according to them, ecigs 'renormalize smoking'. NRT's don't.

Look at it this way, all the time, effort, tax payers money, blood, sweat, tears, that they spent toward trying to move people away from cigarettes, then they have the new kid on the block ecigs, that with the vapor and all look like cigarettes. They're all

Then look at the Dangerous Carto thread. I know not everyone agrees but it is a long thread, much participation, many 'autopsies', much discussion, all the 'steering' of the first Vision/Royal Smokers, and much of it telling the downside of burnt socks and fillers, etc. that eventually led to fillerless clearomizers that vape well without the burn, etc. THEN, proposed regulation comes along where it appears that the only thing left will be cigalikes that use cartos and we're all

 

[Kent C]

What struck me in Zeller's comments was the statement that "individual harm risk" might be very favorable, i.e millions of people quitting or reducing smoking, but may be overridden by the law. If the "population level harm", i.e. someone may vape, or vape and smoke, instead of quitting smoking entirely (just drop 'em cold turkey) it would require e-cigarettes to be restricted.

The absurdity of "population level harm" is if they perceive a subset of the population MIGHT behave not to their liking, the KNOWN subset of people that would be helped are not the prime consideration....

The problem is, there is always going to be experimenting - by teens and adults - they'll never get rid of that subset - a true subset that they're interpreting at the 'whole population level' (which it isn't) - yet they're staking everything on the idea that they can. They're willing to let the hardcore subset die, in order to try to save those they can't control.

This is a main 'lie' that we have to refute. Zeller is truly stuck on it. And again, it's the 'public good' argument. I know people don't like me conveying it, but he's the one who is saying it - I'm just pointing out what he said. Were it not for that, he seems more than willing to save the hardcore smokers. But for him, that trumps all.

 

[Katya]

Then look at the Dangerous Carto thread. I know not everyone agrees but it is a long thread, much participation, many 'autopsies', much discussion, all the 'steering' of the first Vision/Royal Smokers, and much of it telling the downside of burnt socks and fillers, etc. that eventually led to fillerless clearomizers that vape well without the burn, etc. THEN, proposed regulation comes along where it appears that the only thing left will be cigalikes that use cartos and we're all

Almost 5 years of hard work to force the industry to either improve cartomizers or to get away from that burning filler...

http://www.e-cigarette-forum.com/fo...8-4081-etc-filler-type-cartos.html#post300790

 

[Bobbilly]

And according to them, ecigs 'renormalize smoking'. NRT's don't.
:

They address that too.

"Some argue that use of electronic cigarettes, which to a degree resembles cigarette smoking, in places where smoking is currently prohibited might re-normalize smoking and undermine tobacco control efforts.[80] However, although similar in appearance, even cigalike products are easily distinguishable, both in appearance and smell, from tobacco cigarettes. Therefore, use of electronic cigarettes in smoke free places is more likely to lead to normalisation of nicotine devices than to smoking, and hence potential benefit as a support to existing well smoke-free policies."

 

[Kent C]

They address that too.

"Some argue that use of electronic cigarettes, which to a degree resembles cigarette smoking, in places where smoking is currently prohibited might re-normalize smoking and undermine tobacco control efforts.[80] However, although similar in appearance, even cigalike products are easily distinguishable, both in appearance and smell, from tobacco cigarettes. Therefore, use of electronic cigarettes in smoke free places is more likely to lead to normalisation of nicotine devices than to smoking, and hence potential benefit as a support to existing well smoke-free policies."

Yeah, I saw your other 7 posts And heard it from the horse's .... mouth, at the hearing.

 

[Katya]

"I'd like to denormalize the act of telling other people what to do."
-Andy Levy on Red Eye