FDA CASAA Call to Prepare re FDA Regulations Comments

[bigdancehawk]

This came up in the Economic Impact Analysis thread. From the 'impact doc':

"We note that not all of these regulatory alternatives are necessarily legally permissible."

From the 'deeming doc':

"We do not believe that we have
the authority to alter or amend this
grandfathering date, which is set by
statute."

So it was assumed that only Congress could change the gf date. However, the FDA has requested a change in grandfather date on other occasions, but it needed an amendment to the statute. (Fitzie brought this up in the impact thread).

http://www.fdli.org/docs/default-document-library/wilcox.pdf?sfvrsn=0

See page 9. And here's one of the references:

http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM280094.pdf

Also in the "Legacy seminar":

One-on-One with Mitch Zeller, Director of the FDA Center for Tobacco Products

... there is mention of the grandfather date - how Congress created it, and while Zeller doesn't state who exactly could alter it, both the deeming and impact docs requests comments about it. The specific area of that is around 59 minutes into the recording. And he 'appears' to be sincere about this. I don't know IF he is, but if you're the type of person that would take a person at his word, or one that would throw one's words back at them ... you might go back to around 42 minutes into the recording and listen (relisten) to what he has to say. There is much fodder there for comments, imo. Plus it shows his thinking well... on how he advocates ecigs for the hardcore smokers but how he has 'concerns' about how the 'greater number of smokers' who may want to quit and how dual use (plus 'initiation' by teens) would be bad for public health. He even 'gives' that those who dual use may go on to quit. Something we didn't hear in the Senate HELP hearing.

He 'sounds' as if he could be convinced to allow ecigs to be continued to be sold and used, however, all the other stuff we know from what he has said elsewhere, and how the FDA has acted (in 2009, eg.) tends to conflict with how he 'sounds' here. And actions speak louder than words. That said - it would be wrong, imo, for some not to mention these things (quote him perhaps) in their comments.

I'm sorry, but I just don't get the "dual user" issue. Why is that a "concern"? It seems to proceed from the peculiar notion that if e-cigarettes didn't exist then people would completely quit smoking analog cigarettes. But instead they keep smoking cigarettes because they can use e-cigarettes too. What??? I can't make any sense of it.

 

[Kent C]

I'm sorry, but I just don't get the "dual user" issue. Why is that a "concern"? It seems to proceed from the peculiar notion that if e-cigarettes didn't exist then people would completely quit smoking analog cigarettes. But instead they keep smoking cigarettes because they can use e-cigarettes too. What??? I can't make any sense of it.

I can't either bdh, but this is a common thread among Zeller and company. I think they need that to make the 'larger population' argument. They give that hardcore smokers would benefit from ecigs but when operating from 'the greatest good for the greatest number' you have to make up something that gives that substance. So dual users who supposedly want to quit but don't BECAUSE of ecigarettes, is their false 'target'.

I summed up Zeller's 'syllogism' here:

http://www.e-cigarette-forum.com/fo...co-products-biggest-ally-19.html#post13236619

post #183

 

[zoiDman]

I'm sorry, but I just don't get the "dual user" issue. Why is that a "concern"? It seems to proceed from the peculiar notion that if e-cigarettes didn't exist then people would completely quit smoking analog cigarettes. But instead they keep smoking cigarettes because they can use e-cigarettes too. What??? I can't make any sense of it.

I think the Dual User issue in the context that you stated it is a Valid Concern.

But what the Critics fail to Mention is that the Dual User who Does Not Want or Can't Quit smoking do the Same thing with the Patch or with Nicotine Gum.

And that Any Reduction in Smoking. by any Means, is still Harm Reduction.

Which the FDA should Welcome if they are Truly Interested in Improving Public Health.

---

ETA: Also, I believe the Critics of Dual Users are being Deceptive in ignoring the Fact that Many People who Quit Smoking using an e-Cigarette go thru a Transitional Period of Ramping Down Smoking while Ramping Up e-Cigarette Use.

Much of this involves the Nature of their Addiction to Smoking Tobacco and the Chemicals which added to Tobacco.

But Much of it Also involves the Learning Curve associated with e-Cigarettes. And finding a Combination of Hardware and e-Liquids that work best for a given user.

 

[Kent C]

I think the Dual User issue in the context that you stated it is a Valid Concern.

But what the Critics fail to Mention is that the Dual User who Does Not Want or Can't Quit smoking do the Same thing with the Patch or with Nicotine Gum.

And that Any Reduction in Smoking. by any Means, is still Harm Reduction.

Which the FDA should Welcome if they are Truly Interested in Improving Public Health.

---

ETA: Also, I believe the Critics of Dual Users are being Deceptive in ignoring the Fact that Many People who Quit Smoking using an e-Cigarette go thru a Transitional Period of Ramping Down Smoking while Ramping Up e-Cigarette Use.

Much of this involves the Nature of their Addiction to Smoking Tobacco and the Chemicals which added to Tobacco.

But Much of it Also involves the Learning Curve associated with e-Cigarettes. And finding a Combination of Hardware and e-Liquids that work best for a given user.

Absolutely right on all points. And the most common scenario mentioned by Zelller, Harkin, et. al. is supposedly the person who is a cigarette smoker, who only uses ecigarettes in areas where they can't smoke. IF that is the case, this isn't someone who is 'attempting to quit', but only someone who is accommodating their habit. But their argument using 'dual users' is that it IS someone attempting to quit and then doesn't because they find ecigs as a way for them not to quit nicotine.

And even though they'll acknowledge that it is combustible tobacco that does the most harm, they conflate 'quitting tobacco' with 'quitting nicotine' and the reality is rather clear - they are NOT the same wrt harm reduction.

Their other fallacious and truly ridiculous argument along with that, is that 'dual use is a gateway back to' (for those attempting to quit cigs) or a 'gateway to' (for initial users/teens/kids/children ) smoking cigarettes. When in fact, most smokers would like to quit or reduce their cig consumption and initial users are avoiding tobacco cigarettes by using ecigs. AND if this is the case with initial users of ecigs, the ONLY realistic way it could be a gateway, is if ecigs are banned or not made available by regulation - thereby bringing about the reality of their argument that has, at this point, no real connection with reality. Once again, taking 'intent to do good' through the gov't prism to where the result is 180 degrees opposite of the original intent.

 

[5cardstud]

I have a pretty good idea that the reasoning behind this whole charade is due to lost revenue by both big tobacco and big pharmacy. Due to the great loss in tobacco product sales and smoking cessation drugs sales both of which, we all know, is FDA approved.

 

[badwolf91]

yes but they will never admit that, and it will never be brought to the front page where people can be enlightened by the master agreements, tax revenue, big tobacco/pharma influence in govt.. ect. we have to beat them with facts, we just need these facts to be in the mainstream and not lies to be publicized out of proportion. I can see them throwing themselves into the flame if this does go through making vaping products unavailable and ruining jobs as when it finally happens maybe many American eyes will open as long as they are not saturated in lies which each lie around ecigs is becoming so farfetched that even my grandmother laughs about it when I tell her what these guys are saying. I think a lot of non smokers/vapors do not know about this, even a lot of vapors. if it goes through there will be a backlash of the sorts from those who are not seeking out information on this but we need to not let that happen. I know my comment is going to be quite long with quite a lot of links that I request they read regarding studies to help them because "they don't know"

 

[Jman8]

I'm sorry, but I just don't get the "dual user" issue. Why is that a "concern"? It seems to proceed from the peculiar notion that if e-cigarettes didn't exist then people would completely quit smoking analog cigarettes. But instead they keep smoking cigarettes because they can use e-cigarettes too. What??? I can't make any sense of it.

Here would be my take on the dual use thing in view of what I think Zeller is getting at.

I've smoked off and on in my adult life going cold turkey 3 times (for a total of around 11 years). When I say "I can quit at any time and stay quit indefinitely," I feel confident in that assertion as I've never quit for less than 1 year going cold turkey.

With vaping, the urge to quit (smoking) isn't as desirable (for me). I am comfortable dual using and proud to be a moderate smoker. I reckon to anyone that hates smoking and wishes all smokers would engage in cessation sooner than later, then I represent a segment of the population that is a risk (or stain) for "overall public health." I mainly see this the way I do because I think most of the world can't understand the concept of "moderate smoking" and feels that equates to as much harm as 'regular smoking.' I think Zeller and personnel at CTP/FDA think any amount of smoking is very hazardous and too risky.

So, a dual user who has cut back on smoking may sound great to many people, but to those in the game who's primary goal is cessation, it represents a (more of the same) problem, of smoking. If dual user goes onto cease smoking at some point, then likes of Zeller could plausibly go along with idea of dual using (and extension of time allowance for using BP's NRT's would seem to support this claim). Yet, if dual user is showing no signs of wanting to stop and/or is getting into smoking at rate that is more than (ever) before, I reckon CTP / ANTZ want to tackle that as a problem that needs to be stamped out.

I actually can relate to the perception of dual using being an inherent problem.
But strongly believe it is misunderstood and seemingly is met with little desire, by most people, to see it as something that is possibly very good for certain individuals (and even less understood as a good thing for public health).

 

[Bobbilly]

Here would be my take on the dual use thing in view of what I think Zeller is getting at.

I've smoked off and on in my adult life going cold turkey 3 times (for a total of around 11 years). When I say "I can quit at any time and stay quit indefinitely," I feel confident in that assertion as I've never quit for less than 1 year going cold turkey.

With vaping, the urge to quit (smoking) isn't as desirable (for me). I am comfortable dual using and proud to be a moderate smoker. I reckon to anyone that hates smoking and wishes all smokers would engage in cessation sooner than later, then I represent a segment of the population that is a risk (or stain) for "overall public health." I mainly see this the way I do because I think most of the world can't understand the concept of "moderate smoking" and feels that equates to as much harm as 'regular smoking.' I think Zeller and personnel at CTP/FDA think any amount of smoking is very hazardous and too risky.

So, a dual user who has cut back on smoking may sound great to many people, but to those in the game who's primary goal is cessation, it represents a (more of the same) problem, of smoking. If dual user goes onto cease smoking at some point, then likes of Zeller could plausibly go along with idea of dual using (and extension of time allowance for using BP's NRT's would seem to support this claim). Yet, if dual user is showing no signs of wanting to stop and/or is getting into smoking at rate that is more than (ever) before, I reckon CTP / ANTZ want to tackle that as a problem that needs to be stamped out.

I actually can relate to the perception of dual using being an inherent problem.
But strongly believe it is misunderstood and seemingly is met with little desire, by most people, to see it as something that is possibly very good for certain individuals (and even less understood as a good thing for public health).

Personally dual users are "who cares". It has no bearing on the issue on ecigs. NRT supports dual use so why is it a problem?

When they say "no known amount of smoking is safe. They mean it isn't important enough for us to calculate, because we want you to quit.





Sent from my iPhone using Tapatalk

 

[DC2]

I feel rather pessimistic about the prospect of getting through their thick skulls. Nevertheless, here's what I wrote. I'm mad at them, so please tell me if it's too harsh.

That's damn near perfect.

 

[bigdancehawk]

I can't either bdh, but this is a common thread among Zeller and company. I think they need that to make the 'larger population' argument. They give that hardcore smokers would benefit from ecigs but when operating from 'the greatest good for the greatest number' you have to make up something that gives that substance. So dual users who supposedly want to quit but don't BECAUSE of ecigarettes, is their false 'target'.

I summed up Zeller's 'syllogism' here:

http://www.e-cigarette-forum.com/fo...co-products-biggest-ally-19.html#post13236619

post #183

You've made a valiant attempt to get inside Zeller's head and I commend you for it. I hope you were able to regain your sanity after the experience.

Let me try it: The movement to marginalize smokers has been wildly successful. Smokers have been made to feel like outcasts. They can't smoke in most indoor spaces, including their own offices, and have been forced to huddle outside in the rain, snow, cold, and oppressive heat. Many businesses won't hire them. This wasn't a mere byproduct of ANTZ activity; it was a stated objective to "de-normalize" smoking.

The idea is to make smoking such an uncomfortable inconvenience and smokers so universally despised and isolated that they quit. But if smokers are allowed to vape in public, then many will probably continue to smoke in their homes, cars, etc., and the "beneficial" effects of isolating and demonizing them will be compromised.

That's the best I can do.

[Gary Larson did a better one. It depicted about a half dozen smokers puffing away in the desert with a helicopter gunship circling overhead, shooting at them. The caption read something like, "At noon today, the last living gang of smokers was located in the Arizona desert."]

 

[Kent C]

That's the best I can do.

That's pretty damn good, imo. They really hate it when people don't do what they say but workarounds are absolutely despised. lol

I call smoking designated areas - mini leper colonies (with no disrespect to those with Hansen's disease).

 

[DC2]

Let me try it: The movement to marginalize smokers has been wildly successful. Smokers have been made to feel like outcasts. They can't smoke in most indoor spaces, including their own offices, and have been forced to huddle outside in the rain, snow, cold, and oppressive heat. Many businesses won't hire them. This wasn't a mere byproduct of ANTZ activity; it was a stated objective to "de-normalize" smoking.

The idea is to make smoking such an uncomfortable inconvenience and smokers so universally despised and isolated that they quit. But if smokers are allowed to vape in public, then many will probably continue to smoke in their homes, cars, etc., and the "beneficial" effects of isolating and demonizing them will be compromised.

For anyone who doesn't understand what bigdancehawk is talking about...
Rampant Antismoking Signifies Grave Danger

The above is a MUST READ for every vaper.
If you haven't read that yet, you don't even know what you're truly up against.

 

[Kent C]

For anyone who doesn't understand what bigdancehawk is talking about...
Rampant Antismoking Signifies Grave Danger

The above is a MUST READ for every vaper.
If you haven't read that yet, you don't even know what you're truly up against.

It starts with a Cass Sunstein 'nudge' and then:

 

[bigdancehawk]

That's damn near perfect.

Well, thank you kind sir! (If by chance you're a woman I'll have to amend this).

 

[Cool_Breeze]

What..? In all that no mention of William Jefferson Clinton..?

For anyone who doesn't understand what bigdancehawk is talking about...
Rampant Antismoking Signifies Grave Danger

The above is a MUST READ for every vaper.
If you haven't read that yet, you don't even know what you're truly up against.

 

[DC2]

What..? In all that no mention of William Jefferson Clinton..?

What do you mean?

 

[Cool_Breeze]

What do you mean?

Under Clinton, federal taxes doubled the cost of cigarettes overnight...at least where I live. If I remember correctly, the federal and state tobacco lawsuits were initiated under the Clinton administration. As well, many of the later crop of health officials (think local bans) cut their teeth in that era.

William Jefferson Clinton was instrumental in forming the current outlook on tobacco.

The article referenced makes no mention of Clinton.

 

[dragonpuff]

The fourth call to action was announced today! Honestly, I have yet to write my draft, mainly because I was hoping for some answers to my questions first... but no matter! I am a recent college grad, which means four things: 1) I am a well trained writer; 2) I can figure out things as I go with minimal advisement (i.e. no answers to my questions); 3) I am excellent at putting things off til the last second, working under a tight deadline, and making it look like I've spent months on it; and 4) I'm currently unemployed! I have plenty of time to write this today!

As for dual use, I do agree that it's mainly a concern because the goal of Mitch Zeller and his peeps is to eliminate smoking entirely, making it effectively history. That's a lofty goal, but they might wanna slow down a tad because we, as a society, are nowhere near that yet. Furthermore, from what I can tell, dual users are a minority in the vaping community; it appears (we need real studies on this, not the garbage smoking = vaping = not-really-quitting studies I keep seeing...) the majority of smokers who begin vaping quit smoking, many of them surprisingly quickly. So even if dual use were a real concern, it is at best a marginal one and ought not to have such a drastic affect on policy making that it makes it harder for vapers to really quit. That would mean going backward and creating more smokers out of those who have otherwise quit.

I think I'm going to include a variation of that last paragraph in my draft.

 

[cthulhufan]

Submitted! Good on 'ya to everyone else out there who took a few moments out of their busy schedules to contribute!

 

[zoiDman]

Submitted! Good on 'ya to everyone else out there who took a few moments out of their busy schedules to contribute!

Cool!

Wouldn't it be Nice if Every Active Member of the ECF made a Submission? And then Turned around and got 3 People like their Wife/Husband, Friends or Co-Worker to do the Same.

Everyone has People around them that have seen the Benefits when a Person Switches to e-Cigarettes. They should Also submit the Comments to.