FDA I think we need to push the zero-nic angle in our comments

[Jman8]

I'd argue that the overwhelming majority in this community are in the latter category - vape because of the nic (and perhaps other factors - flavor and of course a consideration that it is healthier than smoking).

Just to clarify, your point is that the overwhelming majority of people in the vaping community are ex-smokers who vape because of the nic (and perhaps other factors). Is this correct?

If yes, I concur.

Hence, "We as a community do need nicotine liquid to quit smoking." Esp. those - many of the 'community' tried to quit smoking by other NRT's and were unsuccessful.

That we need to quit smoking is the place where it gets incredibly tricky. That we need nicotine to quit smoking, still tricky, IMO. That we wish to lay claim that this same overwhelming majority all tried to quit smoking by other NRT's and were all unsuccessful is so tricky that I wouldn't touch that with a 10 foot pole. Though, here in vaping community, I'm up for that discussion as I'm sure it will lead to idea that many tried, may were not able to quit.

But basic bottom line is that one doesn't need nicotine liquid to quit smoking.

And then I would just note that there are people in the vaping community who either haven't quit (which you have noted as dual users) or who never started smoking, which is also tricky, but do in fact exist. FDA is speaking to that type of (potential) user, and has their own spin on it. Here in vaping community, I would say that many ex-smokers rather not even entertain that type of vaper or any concerns they may have with product regulations.

And while not everyone in the community needs nicotine to quit smoking, there is more than a majority that do and did, therefore it is an accurate statement about the 'community as a whole'.

That doesn't make sense. The majority may, but the whole does not, and I have provided examples of those that are part of the whole in which this doesn't apply. Therefore, speaking for the whole based on majority is unfair to the minority.

Moreover, it is going into territory that tells me regulation is absolutely necessary so that quitters can be managed as quitters rather than as adults making free, individual choices. IOW, welcome to big pharma's approach to all this. I hope you like the place you just put the whole vaping community in.

All people currently vaping 0 nic, for whatever reason, are treated as no different than ex-smoker craving nicotine, and their devices (when brand new) which have zero nicotine are to be looked at as tobacco products. I find that highly unreasonable, and see no basis for it, unless I go with ANTZ or BP rationale.

 

[dragonpuff]

Our larger cause must absolutely be to have vaping be a legal product for adult consumers. A recreational device and consumer choice.

If our personal choice is to quit/reduce smoking, that needs to stay as a persona decision, and not a larger cause. A court ruling has already been rendered on this matter and it did not favor making claims around smoking cessation.

I disagree wholeheartedly. No one gives a gosh darn if you still have access to your adult hobby, whereas people in general care deeply about smoking addiction. Adopting a harm reduction stance affirms the necessity and urgency of our access to these products.

As far as the previous court ruling is concerned, that is done. E-cigs have already been classified as a tobacco product. Now that all tobacco products are in the hands of the FDA anyway, they are not going to bother resurrecting that legislation to have them reclassified as medical devices. There is no longer reason to be concerned about that.

We as a community do not need nicotine liquid to quit smoking. Some of us may think this, and while that may be true for some of us, it is not an accurate statement for the community as a whole.

What??

You're compartmentalizing again... just because a few people here and there do not need nicotine liquid to quit smoking doesn't mean the community as a whole does not need it, as the vast majority around here would argue that they do - if you don't believe me, ask them.

Jman, I am starting to believe you were, in fact, born yesterday...

 

[Kent C]

Jman8:Just to clarify, your point is that the overwhelming majority of people in the vaping community are ex-smokers who vape because of the nic (and perhaps other factors). Is this correct?

Yes

If yes, I concur.

Ok, we're good on that.

That we need to quit smoking is the place where it gets incredibly tricky. That we need nicotine to quit smoking, still tricky, IMO. That we wish to lay claim that this same overwhelming majority all tried to quit smoking by other NRT's and were all unsuccessful is so tricky that I wouldn't touch that with a 10 foot pole. Though, here in vaping community, I'm up for that discussion as I'm sure it will lead to idea that many tried, may were not able to quit.



I'm not going to argue on the definitions of community and the 'community as a whole' where any one individual who is part of the community has different needs and so therefore no generalization can be made about the 'community' as long as one individual deviates from the pattern of behavior. So that part is 'semantic' and I think not only the 'consensus' of which I care nothing, but the actual accepted definitions back up my side.

However, I think the point you may be getting at - we are pretty close on....

I don't consider it 'tricky'. I think we're into this area. In subject of logic, there is the relational aspects of 'necessity' and 'sufficiency' - see:
Necessity and sufficiency - Wikipedia, the free encyclopedia

As simply as I can explain, for some, nicotine is a necessary but not sufficient reason for vaping. If it were _only_ (and I think this is your valid point) nicotine, then other NRTs would work.

That said, nicotine and some type of 'vapor' is both necessary and sufficient for most - I'd say 90% of the vapers. If there's no vapor, and only nicotine then that doesn't work. And while for some - but this is usually after a 'plan or unplanned' behavior of starting out with nicotine and then lowering nic levels to zero - for them vapor has become a sufficient reason for continuing to vape, where nicotine is no longer necessary.

And more to the point, just because. in some instances, nicotine is not a sufficient reason to quit, doesn't mean that it isn't a necessary part of quitting.

For a very few, who are not dual users, going from cigarettes to no nic, may be sufficient, but I'm guessing anyone more than a 1/2 a pack a day couldn't pull that off - but that's a guess.

For some, perhaps a bigger number than the last group - both nicotine and vapor are necessary but not sufficient to approximate what they got from smoking. For them, they're interested in supplementing with WTA or snus in order to get the additional alkaloids that are not present in eliquid.

IF your only point is that people can quit cold turkey, so therefore they don't need nicotine to quit smoking... then that's not even worth discussing in this forum, imo. I would hope that isn't your point or I have misjudged you much more than Zoidman ever has. lol.

 

[Anjaffm]

I'm not going to argue on the definitions of community and the 'community as a whole' where any one individual who is part of the community has different needs and so therefore no generalization can be made about the 'community' as long as one individual deviates from the pattern of behavior. So that part is 'semantic' and I think not only the 'consensus' of which I care nothing, but the actual accepted definitions back up my side.

yup.
Care for a view from Europe? Norway, in this case?

This is one great blogpost:

The vaping giraffe: I love vaping, and I don't want to quit

What is it with vaping that keeps me from going back to smoking? Why is vaping so much more effective than chewing nicotine gum? Even though they both give me the nicotine I'm addicted to, vaping gives me a whole different experience and satisfaction. I've realized I wasn't only addicted to nicotine, I was addicted to smoking. By that I mean the whole experience of smoking, not only the nicotine but I was psychologically addicted to the ritual as well.

But the ritual in itself won't hurt anyone, neither yourself nor the people around you. So no, vaping doesn't help me to get rid of my addictions, it just gives me the opportunity to continue without killing myself, and others around me. That is why they are so successful. I think most human beings have some ritual they are addicted to, coffee in the morning, reading a book before going to sleep, chewing gum, different kinds of food that "belongs" to different situations. Most of them harmless, and therefore accepted by the public. Try to take one of your rituals away and you'll end up just as grumpy as a smoker without access to cigarettes. The ritual of smoking, and vaping, is not what harms people, and therefore not what you want to get rid of. What e-cigarettes actually do is not only letting you keep that ritual, but it even makes it better. Rather than just taking something away, it gives something more. And that is the "secret" to their success.

I love vaping, and I don't want to quit. And that is the reason I managed to quit smoking.

And this is also my take on vaping. It does not take something away but it lets me keep my beloved ritual - and it even makes it better.

100 vapers, 100 opinions.
And the blogpost above echoes my own take on the subject. (Although I personally would speak of "dependence" )

 

[Jman8]

I'm not going to argue on the definitions of community and the 'community as a whole' where any one individual who is part of the community has different needs and so therefore no generalization can be made about the 'community' as long as one individual deviates from the pattern of behavior. So that part is 'semantic' and I think not only the 'consensus' of which I care nothing, but the actual accepted definitions back up my side.

But you are saying one person here, when dual users are a number that is more than one of us. Plus, imagine a point where all ex-smokers have converted over, and vaping still exists. In that world, new users would be all non-smokers.

The community as a whole thing is not semantical. Is it semantical to say the white community, as a whole voted for Barack Obama? I mean if the majority did, then by your logic, the white community, as a whole did. If you are a white person, you voted for Barack. That is what you are essentially saying by sticking to this sort of logic.

I don't consider it 'tricky'. I think we're into this area. In subject of logic....

Yeah, I understand logic, but my assertion of tricky wasn't dealing with philosophical logic. I'm saying it is politically tricky. Judge Leon was pretty clear (IMO) that eCig vendors shouldn't be marketing themselves with claims of cessation. In 2012 (when I was getting into vaping), I saw that sort of claim fairly often. Nowadays, I rarely see it. If consumers want to make that claim, I say go for it. But to tell industry they ought to, is I think very tricky politically.

My understanding from the Soterra case is that a vendor can make the cessation claim. They really and truly can. But then they are subject to regulation as a medical device / drug deliverer. Conversely, if you don't wish to seek regulation as a drug deliverer, then you will not market yourself with any hint towards cessation.

For a very few, who are not dual users, going from cigarettes to no nic, may be sufficient, but I'm guessing anyone more than a 1/2 a pack a day couldn't pull that off - but that's a guess.

Your "but that's just a guess" equals my "that is where it gets tricky."

IF your only point is that people can quit cold turkey, so therefore they don't need nicotine to quit smoking... then that's not even worth discussing in this forum, imo. I would hope that isn't your point or I have misjudged you much more than Zoidman ever has. lol.

This is actually closer to the point I was or am making.

I see you as saying that if you are in the vaping community, then chances are very good (90% likely) that you are a person who is an ex-smoker who "needs" liquid nicotine to vape in order to quit smoking.

My point "We as a community do not need nicotine liquid to quit smoking" probably would've been better made if I clarified that with "we as a community desire nicotine liquid to quit smoking." That is pretty much all I was getting at with that point.

But as it relates to this thread, my actual point was that you do not need a device manufacturer to make a device (that contains zero nicotine) to market themselves in such a way that says, "this device is for vaping nicotine." Whereas same manufacturer could just go with "this device is for vaping, but is not intended for nicotine liquid," and would overcome FDA rationale, plus deal with reality that these devices are NOT tobacco products according to FSPTCA.

This point about what majority of the community thinks it needs to stop smoking is tangential to what Gato was getting across. It obviously relates, but if non-nicotine products are included, when they really do not need to be, and in Gato's situation are not tobacco products, then it becomes a rather absurd argument about what is a nicotine/tobacco product. I fully expect anyone going in this direction will be exploited (via loopholes and underground markets) to show that they cannot possibly keep up with that sort of justification (that these devices are tobacco products). If me and 10 people have found a way to use a pencil to vape nicotine, does this mean that all pencils from now on are tobacco products, even if pencil manufacturers start ad campaigns that say "this product is not intended for vaping nicotine?" IMO, that is how absurd this path becomes if FDA goes down it.

On the other hand, if vapers really do desire vendors to advertise products as "intended for vaping nicotine" and/or as "this product will help you quit smoking," then I would say the vaping community deserves regulations from the FDA in the form of FSPTCA.

 

[Jman8]

I disagree wholeheartedly. No one gives a gosh darn if you still have access to your adult hobby, whereas people in general care deeply about smoking addiction. Adopting a harm reduction stance affirms the necessity and urgency of our access to these products.

As far as the previous court ruling is concerned, that is done. E-cigs have already been classified as a tobacco product. Now that all tobacco products are in the hands of the FDA anyway, they are not going to bother resurrecting that legislation to have them reclassified as medical devices. There is no longer reason to be concerned about that.

eCigs have not been officially classified as a tobacco product, and is what the deeming proposal is for. Until Final Rule is in effect, eCigs are an unregulated product that the FDA sees as unregulated tobacco product. Many people (vapers and non-vapers) have trouble understanding that designation. But once Final Rule goes into effect (assuming proposed items remain about the same), then it won't matter what vapers or non-vapers think because vendors will know the market in which they have to participate legally in order to stay in business (in the open market).

There is reason to be concerned with any vendor that wishes to market themselves as something akin to "harm reduction" or "smoking cessation" or in this vein. If they are in that direction, they still risk being regulated not as a tobacco product, but as a medical device or drug deliverer. I believe this will be the case 20 years from now, and perhaps forever. Stay away from the need to market yourself in that fashion, and FDA (or other regulatory bodies) likely won't care to nail you in that way. They may still wish to nail you as tobacco product that contributes to all the things ANTZ say are wrong with tobacco products in society. But consumers and laypeople (includes article writers, CASAA, and whole bunch of others) can say that eCigs make for wonderful tool towards harm reduction. That will hopefully always be okay in our world society.

Gato is using devices that many of us use, and which when purchased brand new, do not constitute a "finished tobacco product." They are devices that do not contain nicotine, and to work as intended, do not need liquid nicotine. Gato vapes liquid flavoring that contains zero nic, thus also not a tobacco product. So, Gato is a member of the vaping community, but is not part of the majority of vapers who are vaping nicotine. Yet, the FDA needs to think long and hard about going in the direction of regulating devices which do not contain tobacco and which could, rather easily, be marketed as "not intended for vaping nicotine."

We as commenters during this time where our say matters ought to be pushing the FDA on this point. It potentially has high benefit for vapers who vape nicotine to push this as it would mean that devices, which are not finished tobacco products, cannot be regulated as tobacco products (period).

Why we would choose to have it another way, as vapers in a political fight, is beyond me, and yet here I am on a thread arguing this point with fellow vapers. I anticipate the FDA as going in this direction, though pretty sure they won't go full throttle in that direction. If they do, they will lose. That position will be so easy to exploit, it is not even funny. Well, it's a little funny, but mostly absurd.

 

[Kent C]

But you are saying one person here, when dual users are a number that is more than one of us. Plus, imagine a point where all ex-smokers have converted over, and vaping still exists. In that world, new users would be all non-smokers.

We're talking by each other. I don't understand your point. If it is similar to the OP, then I guess we'll just disagree. The idea to say or redefine an ecig as not a nicotine device is really a simplistic 'workaround' that isn't true (mostly) and fools no one, esp. government. It's analogous to someone saying 'this isn't ....., it's hemp!' ... and the cop goes, 'Oh, ok, nevermind'

 

[Jman8]

I don't understand your point. If it is similar to the OP, then I guess we'll just disagree. The idea to say or redefine an ecig as not a nicotine device is really a simplistic 'workaround' that isn't true (mostly) and fools no one, esp. government. It's analogous to someone saying 'this isn't ....., it's hemp!' ... and the cop goes, 'Oh, ok, nevermind'

As a fellow vaper, explain to me how any vaping device is a finished tobacco product.

Right now I am vaping on a 808D battery, please explain to me how that is a finished tobacco product.

Also using a clearo. When I bought that brand new, please explain to me how that is a finished tobacco product.

And while you're at it, please explain how zero-nic eLiquid is a finished tobacco product.

Good luck!!!

 

[Kent C]

As a fellow vaper, explain to me how any vaping device is a finished tobacco product.

Right now I am vaping on a 808D battery, please explain to me how that is a finished tobacco product.

Also using a clearo. When I bought that brand new, please explain to me how that is a finished tobacco product.

And while you're at it, please explain how zero-nic eLiquid is a finished tobacco product.

Good luck!!!

Wow.... Good night, and good luck.

 

[Gato del Jugo]

Logic is going to have very little to do with winning - or losing - this battle.

Logic is oftentimes used successfully in the court of law..


Again, although I vape, I do not use a tobacco product.. And there are many others like me out there..

Only time will tell, but I believe zero-nic is one of our biggest friends in this battle...

 

[Rickajho]

Wow.... Good night, and good luck.

Some people can't see the forest of points for the trees of points.

 

[Kent C]

Some people can't see the forest of points for the trees of points.

I think it might be good to make those points .....to the FDA, perhaps, and I have .... my 'cat' analogy - but if anyone thinks that it will be convincing, well.... I just won't finish that. I'll just say that if that had a possibility of convincing, we would have never seen the deeming proposal in the first place.

 

[zoiDman]

...

No tobacco? Completely out of the FDA's jurisdiction...

...

I have Heard Mr. Zeller mention in interviews, or answer Direct Questions and his Answers have been Consistent and the Same.

"If an e-Liquid does Not Contain Nicotine that is derived from a Tobacco Plant, or if the e-Liquid contains No Nicotine, the FDA Does Not have the Authority to Regulate it."

As to Hardware, that gets kinda Convoluted.

I'm not sure how the FDA Can Regulate a VAMO "Flashlight" if the Description makes No Mention of the Intended use.

Same with Clearos / Cartos / Tanks. I'm not sure how Effective the FDA will be in Regulating these Items as long as they are Not Sold in a Kit that Contains Nicotine.

 

[Jman8]

I think it might be good to make those points .....to the FDA, perhaps, and I have .... my 'cat' analogy - but if anyone thinks that it will be convincing, well.... I just won't finish that. I'll just say that if that had a possibility of convincing, we would have never seen the deeming proposal in the first place.

Could be said about all comments submitted to the FDA.

This one, as Gato has correctly noted is a very pertinent point to what the deeming regs are stating.

They simply cannot win on this point. I don't even see how it is possible. But I can see them trying to win, and winning on some tiny battles. Yet, the war on no-nic products is a losing proposition and as I have noted will be exploited forever and a day.

You have just stated it is (or might be) good to make those points to the FDA. If you stay to this point, then you are in full agreement with what I see OP getting at. If you are making other points about what they might do, could do, will do or whatever, then I see that as taking away from your own statement of "it would be good to point this out to the FDA."

Obviously if FDA saw vaping as vaping enthusiast sees vaping, then the proposed regulations wouldn't be written in the way they were. But as FDA shows up as rather clueless about "what is an eCig" and "how does this relate to tobacco products of which FSPTCA is designed to regulate," then FDA really ought to be made aware that unlike almost all other tobacco products existing, this one has an option that does not fit the definition found in FSPTCA. And is why devices, which are not finished tobacco products, really ought not be considered up for regulation. Designating them as components will open a can of worms that there is no way the FDA is equipped to deal with. If anyone, including the FDA thinks this is possible then I would respond with:

Wow! Good night and good luck.

 

[Kent C]

Sigh... this is the whole point of "deeming". They know it isn't a tobacco product. They want to control it. It isn't a drug - so says Judge Leon - so the way to bring it under their control is to redefine what it is - to 'deem it' a tobacco product. They know what an ecig is. They knew or at least know now, the some people vape no nic - doesn't matter, they're still deeming it so.

When someone would attempt to make the argument that it ISN'T a tobacco product. They'd laugh and say - yeah we know that, that's why we're deeming it as a tobacco product, otherwise it would have ALREADY been under our control. If anyone doesn't get this and think that they can 'outsmart' the gov't by simply doing their own "deeming", then they really don't understand what's going on here.

You can say, taxing is stealing. They, if they're honest will say, yeah, but we have the power to do it. Subsidies are fencing operations. Again, if honest, they say "yep" with a smile. If they're not honest or think you don't really know, then they'll make up some BS story of how something isn't what it is. So when I say 'tell it to the FDA' since you seem to think they fall in that 'really don't know' category, I'm really saying don't tell me about it, because I'm not in the category

 

[Anjaffm]

Sigh... this is the whole point of "deeming". They know it isn't a tobacco product. They want to control it. It isn't a drug - so says Judge Leon - so the way to bring it under their control is to redefine what it is - to 'deem it' a tobacco product. They know what an ecig is. They knew or at least know now, the some people vape no nic - doesn't matter, they're still deeming it so.

When someone would attempt to make the argument that it ISN'T a tobacco product. They'd laugh and say - yeah we know that, that's why we're deeming it as a tobacco product, otherwise it would have ALREADY been under our control. If anyone doesn't get this and think that they can 'outsmart' the gov't by simply doing their own "deeming", then they really don't understand what's going on here.

You can say, taxing is stealing. They, if they're honest will say, yeah, but we have the power to do it. Subsidies are fencing operations. Again, if honest, they say "yep" with a smile. If they're not honest or think you don't really know, then they'll make up some BS story of how something isn't what it is. So when I say 'tell it to the FDA' since you seem to think they fall in that 'really don't know' category, I'm really saying don't tell me about it, because I'm not in the category

Precisely!
Especially the bolded part.
And "arguing about the emperor's beard" is not going to change that fact.

 

[DaveP]

It's more about continuing the revenue stream from a dwindling product by transferring the tax liability to its replacement. Nicotine is the key factor, but its the delivery system that makes it attractive to former smokers. Nicotine gum and sprays just didn't do the trick to attract smokers, ecigs did. So now we have to take on the load of supporting tax laws that were designed to make an industry pay for its sins through monetary compensation to government.

Only, we are fairly certain that it wasn't nicotine that caused the ills and maladies of tobacco. Ironic, isn't it? It's kind of like taxing electric cars just because their fossil fuel predecessors ruined the environment and someone has to pay.

 

[Jman8]

Sigh... this is the whole point of "deeming". They know it isn't a tobacco product. They want to control it. It isn't a drug - so says Judge Leon - so the way to bring it under their control is to redefine what it is - to 'deem it' a tobacco product. They know what an ecig is. They knew or at least know now, the some people vape no nic - doesn't matter, they're still deeming it so.

When someone would attempt to make the argument that it ISN'T a tobacco product. They'd laugh and say - yeah we know that, that's why we're deeming it as a tobacco product, otherwise it would have ALREADY been under our control. If anyone doesn't get this and think that they can 'outsmart' the gov't by simply doing their own "deeming", then they really don't understand what's going on here.

This makes them sound entirely unreasonable in their deeming. I agree they want to control it, but I see them doing so in a way that is not entirely unreasonable. As Zoid's quote from post #33 conveys.

From what you are saying, they will deem pencils as tobacco products. Someone reading this could claim, "there's no way that will happen," and I could just then use your exact wording here, and then what would the argument be?

The liquid nicotine that almost all of us use (leaving door open for .001% that may not) is extracted/derived from tobacco. So, in their interest to control the drug that nicotine is, they are going after eCigs as a tobacco product. Again, Leon didn't say they couldn't go after it as a drug, but did say that absent claims of some sort of 'therapy' then they couldn't go after vendors as if they are engaging in a medical claim.

That same sort of reasoning ought to apply to the 'tobacco' part of 'tobacco product.' I agree it may not. To the degree it may not, FDA will be digging a hole that the only way out of it will be key decision maker (in FDA, Congress, etc.) that says you can no longer classify just anything as a tobacco product. In the event they may do the deeming of non-tobacco items as tobacco products, it behooves vaping community to push this angle. It could highly benefit the vaping community, and yet it could go the other way which allows FDA to dig itself into a hole, while also curtailing all products from the legal market. Black market will have no issue overcoming this sort of silliness.

 

[NorthOfAtlanta]

Try this, read Kent C's post and replace deem with declare and you have what is really happening.

After they have established that if used recreationally it is the same as tobacco so they can replace their income stream we will start hearing that it's just a chemical that has medicinal qualities and BP will start releasing new miracle patented drugs.

Win-win for BP and BG.

 

[zoiDman]

...

When someone would attempt to make the argument that it ISN'T a tobacco product. They'd laugh and say - yeah we know that, that's why we're deeming it as a tobacco product, otherwise it would have ALREADY been under our control. If anyone doesn't get this and think that they can 'outsmart' the gov't by simply doing their own "deeming", then they really don't understand what's going on here.

...

This is Pretty Much the Long and the Short of it.

---

Seems like this Horse has be Beaten 27 Ways to Sunday. When is it time to move on to the Next Phase of the Approval Process?

http://www.reginfo.gov/public/reginfo/Regmap/regmap.pdf


The "Nicotine Containing e-Liquid Isn't a Tobacco Product" Train Left the Station a Long Time Ago. And it Ain't Coming Back.

---

BTW - How does the Regulatory Flexibility Act work?