Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

[TheIllustratedMan]

Sun -

I wasn't trying to say that we could slip it under the radar, but rather asking whether the case would cover personal importation. Evidently it does. Which sucks.

Luckily, I have 4 batteries, 2 PTs, 9 atomizers, a ton of carts, and enough liquid. I can always make 0-nic stuff too (I'm pretty sure that I don't really need the nicotine as much as I think I do... if that makes sense).

Again, thanks for the clear-up.

-Nate

 

[Sun Vaporer]

Sun -

I wasn't trying to say that we could slip it under the radar, but rather asking whether the case would cover personal importation. Evidently it does. Which sucks.

Luckily, I have 4 batteries, 2 PTs, 9 atomizers, a ton of carts, and enough liquid. I can always make 0-nic stuff too (I'm pretty sure that I don't really need the nicotine as much as I think I do... if that makes sense).

Again, thanks for the clear-up.

-Nate

Glad to hear you are stocking up Nate. The reason I addressed trying to bring it in after a ban, is that so many people here have posted that it will not affect them just because they order from China, and that simply is not the case. Again having it in hand before a ruling is key.

Sun

 

[baddago]

So Sun, what could they say about those of us that don't use nicotine anyway? I mean, just because the device CAN vaporize nicotine, doesn't mean that everyone vapes it with nicotine. I mean, I plan on being zero nic rather quick here, and I dont have the funds to just stockpile like some can do. I am the only working parent of two, and my paydays just don't stretch that far.

Is there any way that these devices would get by as novelties without nicotine? So what if I am vaping flavoring and PG/VG. Who cares, none of those substances is a drug.

 

[Sun Vaporer]

So Sun, what could they say about those of us that don't use nicotine anyway? I mean, just because the device CAN vaporize nicotine, doesn't mean that everyone vapes it with nicotine. I mean, I plan on being zero nic rather quick here, and I dont have the funds to just stockpile like some can do. I am the only working parent of two, and my paydays just don't stretch that far.

Is there any way that these devices would get by as novelties without nicotine? So what if I am vaping flavoring and PG/VG. Who cares, none of those substances is a drug.

Baddago,

The "indented use doctrine" is what is applicable--the no-nic argument is not in play. SE and NJOY even conceeded it. The intended use of the e-cig is to deliver nicotine. The device and the e-liquid are both subject to regulation. The studies that need to be conducted include the nicotine as well as exactly what other compounds are produced when the e-liquid is vaprized including the flavoring and the pg/vg. The FDA looks to the "whole" of the product and what it produces and its effects when consumed by humans. Those are the studies that need to be done as part of the application and approval process.

Sun

 

[MVP]

Sun-
So if somebody made and marketed a New incredible Widgit! Now with Bright Blue LED Light, Enhanced Vapor Production and Black Light Sensitive Plastic. Great in the dark! Do science experiments, make a volcano. The only battery hand held Special-FX machine on the planet. Great as a toy, also over 3,000 sold, as an instrument to indicate air flow for home energy saving warm air leakage and drafts, ventilating air flows, convective air flow, hospital air flow and much more

...this case would have no bearing on such an item and could be bought and sold freely no matter what the consumer actually used it for?

BTW I really appreciate this thread. Thanks

 

[Sun Vaporer]

Sun-
So if somebody made and marketed a New incredible Widgit! Now with Bright Blue LED Light, Enhanced Vapor Production and Black Light Sensitive Plastic. Great in the dark! Do science experiments, make a volcano. The only battery hand held Special-FX machine on the planet. Great as a toy, also over 3,000 sold, as an instrument to indicate air flow for home energy saving warm air leakage and drafts, ventilating air flows, convective air flow, hospital air flow and much more

...this case would have no bearing on such an item and could be bought and sold freely no matter what the consumer actually used it for?

BTW I really appreciate this thread. Thanks

MVP--That is correct as the Widgit's "intended use" could not be considered a drug or medical device. The intended use is not one for human consumption that is "drug" or "drug delivery" device.

No matter how these are sold, the intended use has been set forth that it is an alternative to smoking to "mitigate" the the adverse affects of somking tobacco.

The FDA defines the "intended use" as:
INTENDED USE

The FDA defines “Intended Use” as:

The term "intended uses" refers to the objective intent of the persons legally responsible for the labeling of the device. The intent is determined by their expressions or may be shown by the circumstances surrounding the distribution of the device. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such representatives. It may be shown by the offering or the using of the device, with the knowledge of such persons or their representatives, or for a purpose for which it is neither labeled nor advertised.


Sun

 

[MVP]

Yeah, that's what I thought. Too bad they didn't think this all out ahead of time. But then again if it ever is "legal" I'm sure it would be cost prohibitive for me with taxes, lower nic levels, prescriptions(?) etc. I better just try to cut myself down gradually and get off nicotine even though I really enjoy it. (especially in vapor form)

 

[baddago]

Okay Sun, so if I am understanding this 100%....

Current equipment is already labeled. Therefor, if a new model is manufactured, labelled and distributed/marketed not as an e-cig, but as a novelty then that would fly?

Meanwhile the god knows how many units that were already produced, in all of their forms, are pretty much dust in the US because of the labels already given them? However, something entirely new, with a new INTENDED USE(because it is a completely new vaporization device), would be good? But our current stocks, even used no-nic, what have you, don't matter because they've already been deemed intended for nicotine consumption?

 

[TheIllustratedMan]

Seems like if you know that it's being used in a different way than the way that you are labeling it (ie. you label it as a mouth-fogger for making non-smoke rings and parlor tricks, yet know full well that it is being used to inhale nicotine) the intended use is still the way that most consumers are actually using it.

 

[whatagem]

Baddago,

The "indented use doctrine" is what is applicable--the no-nic argument is not in play. SE and NJOY even conceeded it. The intended use of the e-cig is to deliver nicotine. The device and the e-liquid are both subject to regulation. The studies that need to be conducted include the nicotine as well as exactly what other compounds are produced when the e-liquid is vaprized including the flavoring and the pg/vg. The FDA looks to the "whole" of the product and what it produces and its effects when consumed by humans. Those are the studies that need to be done as part of the application and approval process.

Sun

Just offering my 2 cents on devices being sold whether there is a ban or not....I see actual crack pipes being sold at gas stations. I've been in shops where pipes & hookahs line the walls with huge signs signs stating "It is called a tobacco pipe, do not call it anything else or it will not be sold to you!" or some such things....

It always suprises me that such things can be sold out in the open. So what's the diff of selling/importing nicotine delivery devices?

I mean, considering that they sell glass crack pipes at the gas station down the street!!!!

 

[baddago]

Seems like if you know that it's being used in a different way than the way that you are labeling it (ie. you label it as a mouth-fogger for making non-smoke rings and parlor tricks, yet know full well that it is being used to inhale nicotine) the intended use is still the way that most consumers are actually using it.

Well, who cares if you use it for whatever purpose really, that's your business. But it is meant for creating vapor from drug-free liquids. Honestly, it's all in the marketing of the things. Your argument that I know why it is used, but market it a different way, is exactly where the '....' argument WOULD hold up. Head shops know what they sell. Now, this is different from the case we see now where the product is marketed for a drug(nicotine). But if it is marketed for other uses, and used by those irresponsible ruffians who need their nic-hit, then that is their MIS-use of my product.

See where I am going?

 

[LaceyUnderall]

Here's some older links from this forum about the Aeros:
http://www.e-cigarette-forum.com/forum/smokeless-tobacco/586-aeros-smokeless-cigarette.html

http://www.e-cigarette-forum.com/fo...-anyone-tried-aeros-smokeless-cigarettes.html

http://www.e-cigarette-forum.com/fo...-something-new-aeros-smokeless-cigarette.html

http://www.e-cigarette-forum.com/forum/law-e-cigarette/23676-1980s-e-cig.html#post417130

Thank you! And to CoderGuy too who sent me a link. I have no idea how I missed this back in Feb. Must have been pre-occupied

 

[Mixmaster51]

Just offering my 2 cents on devices being sold whether there is a ban or not....I see actual crack pipes being sold at gas stations. I've been in shops where pipes & hookahs line the walls with huge signs signs stating "It is called a tobacco pipe, do not call it anything else or it will not be sold to you!" or some such things....

It always suprises me that such things can be sold out in the open. So what's the diff of selling/importing nicotine delivery devices?

I mean, considering that they sell glass crack pipes at the gas station down the street!!!!

Not trying to single you out whatagem, but you brought this up again;

I am sorry but this argument really is getting old. Yes, I understand about the glass pipes being sold, that is an issue but it is separate. However, lets leave the discussion about hookahs alone. I own two of them and I have never smoked anything illegal in my entire life, and I am starting to find this argument slightly irritating. Hookahs are the next forum down the hall to the left and there are plenty of us that will take anyone to task over the smoking illegal products through them argument. We are wasting a lot and I stress this again, a lot of energy on "NOTHING." If you want to continue to vape you need to focus on ways to bypass restrictive customs now, making your own stash, and possibly create a grey market later as a minor, very minor secondary issue.

The plaintiffs in this case did not do their homework in presenting an adequate case for themselves or the community. The FDA simply is applying a rule completely in their jurisdiction. Yes, it sucks, but that is the way of things. If you really want to do something why aren't you getting up in arms about the original reasons why most of us looked for smoking alternatives in the first place. Such issues as unequal taxation without unequal representation? That is a significant problem for the U.S. population of tobacco users as a whole and worthy of a significant expenditure of energy. Gang let's not hijack this thread if we want to discuss this stuff let's take it too a different thread. This is for Sun and his updates. Thank You again Sun for your tireless work and for putting up with so many of us and our questions.

Not trying to rant and I apologize if I come of that way,

MixMaster51

 

[MustangDriver36]

I have to say in my opinion that I think if the major tobacco companies do produce E-ciggerettes and corner the market with better products at cheaper prices then of course they will find a way to make it produce vapor that causes cancer.Yep what ever crap you aren't getting in you
e-cigg.now will surley be replaced by thousands of chemicals and of course the same side effect you get with analogs,you know death.If you think they are just happy with the money your wrong they have so much money they could probabley invent a safe ciggerette but it is also about taking lives.Yes I do believe they are murderes and know it.

 

[MustangDriver36]

Sorry I've just read a couple posts about others opinions on if it would be good for major companies to take over and produce e-ciggs and that was my opinion.But I do really want to thank Sun for keeping me posted on what is happening with the FDA.I think your doing a great job.

 

[sherid]

Okay Sun, so if I am understanding this 100%....

Current equipment is already labeled. Therefor, if a new model is manufactured, labelled and distributed/marketed not as an e-cig, but as a novelty then that would fly?

Meanwhile the god knows how many units that were already produced, in all of their forms, are pretty much dust in the US because of the labels already given them? However, something entirely new, with a new INTENDED USE(because it is a completely new vaporization device), would be good? But our current stocks, even used no-nic, what have you, don't matter because they've already been deemed intended for nicotine consumption?

Follow the Welcome to the Future - Smokefree Innotech Inc. story

 

[tannerk]

Note that there is a company going though the FDA approval process as we speak for a cigarette like shapped cartridge that holds a nicotine gel.
Sun

Do you have any specific info about this company? I've been working FDA approval angle for a better part of this month. I would certainly help in this endeavor...

 

[SSRob]

Premarket Notification, 510(k) - 21 CFR Part 807 Subpart E

A 510(k) must demonstrate that the device is substantially equivalent to one legally in commercial distribution in the United States: (1) before May 28, 1976; or (2) to a device that has been determined by the FDA to be substantially equivalent​

​

That's a good find there and I agree with your idea behind it.

 

[Sun Vaporer]

Do you have any specific info about this company? I've been working FDA approval angle for a better part of this month. I would certainly help in this endeavor...

Tannerk--last time I looked at it, was 2 years ago, but I will try to dig it up---at that point in time, it was in it's infancy.

Sun

 

[SSRob]

It's probably too late but I've started a thread in the supplier forum about us as re-sellers pushing the factories for different packaging and instruction manuals that don't reference safety, health and such. My main supplier tells me they did remove SAFE and HEALTHY from their package but the user manual is still the same.

ZERO replies from any other re-sellers.

Lacey--it is ingested. It is suppose to give you the hand to mouth sensation and the "hit" is a draw, put not vapor, rather a liquid taste that you shallow.

You know it really is a shame that the e-cig manufacters never went though the proper channels and when all the data was in, then if the FDA refused its appoval, there would be evidence to give to the Court that the e-cig is in fact safe (if that is the case), have gone though all the requiste safey features, and proper labeling and marketing---then Counsel would have something to work with.

As it stands now, the Court is given an e-cig and nicotine cartridges with an instruction booklet written in "chopped up" english, with no ingrediant list, no studies, no data---Really does not leave Counsel with much to work with???

Sun