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

[Sun Vaporer]

But that argument does not hold water. In the case of a gun, "delivering bullets" is the unquestioned intended purposes of a gun so mentioning its ability to perform "off label" functions is not relevant unless we make the same presumption about electronic cigarettes. The argument is circular as it assumes the purpose of e-cigs is to deliver nicotine, therefore dismisses 0-nic cartridges as if they don't fulfill the intended use of e-cigarettes, and this is supposed to be evidence that the intended use is to deliver nicotine?

Thulium--just take a look at the number of Members right here that use zero nic---it is very very small. Let us be honest here. The majority of e-cig users use nicotine.

Look at it another way. Would the e-cig be of any real value if nicotine could not be used in it? No. Would the e-cig be of real value if it could only be used with nicotine? The answer is Yes.

As you say, the argument assumes the purpose of e-cigs is to deliver nicotine. That is true. Even Judge Leon found that the e-cig was a device used to enjoy "recreational nicotine". Further SE and njoy plead it. So that is what we have to work with in this case as it is part of the record.

Sun

 

[kristin]

That's what they want Kristin. These organizations financially depend on an american public addicted to cigarettes.

Yes, but they also depend on public support. The public won't like hearing that these groups are trying to ban a product that would save lives.

That's really the main intent of the EcigsSaveLives petition - public awareness.

 

[curiousJan]

Thulium--just take a look at the number of Members right here that use zero nic---it is very very small. Let us be honest here. The majority of e-cig users use nicotine.

Look at it another way. Would the e-cig be of any real value if nicotine could not be used in it? No.

I have to respectfully disagree. I almost responded to Thulium early this morning because I feel his distinction is an important one.

If a ban comes down I will certainly make an attempt at 0-nic using my PVs just because of my own recognition of the facets of my habit. The hand to mouth motion and the visible smoke/vapor are significant for me personally. And, while I'm not sure that I'd say I was at my best, I have functioned more than once for more than a year at a time without the use of nicotine and believe that I could do so again.

If I can use these devices to satisfy that behavioral aspect -- the one that I would argue is what has brought me back to smoking each and every time -- I feel quite strongly that this point needs to be recognized as beneficial and distinct from the nicotine-intake aspect ...

Would the e-cig be of real value if it could only be used with nicotine? The answer is Yes.

As you say, the argument assumes the purpose of e-cigs is to deliver nicotine. That is true. Even Judge Leon found that the e-cig was a device used to enjoy "recreational nicotine". Further SE and NJOY plead it. So that is what we have to work with in this case as it is part of the record.

Sun

... and, yup, my feelings, our feelings, none of it has any affect on the case.

 

[Vaporer]

It's very hard to fight a group like the FDA when no monetary recovery is possible even if won. They have nothing to lose and we know they have heavey hitters as backers. It should'nt be that way, but it's appearent it's true. They have nothing to lose other than thier backers support.
Way more time has been spent fighting ecigs when there are more important things they sould be focusing on. Every step they take just increases the foul odor of all this right down to the latest list of "champions" backing there cause.
So far, there has been no news of them mounting a fight of PM's latest "ecig type" product upcoming which appears far worse than an ecig. Why is that?

We won the 1st round due to Judge Leons common sense approach. IMO this case started out very wrong. The ecig was compared to an NRT not a real cigarette. We do not use ecigs as a NRT replacement, we use them to replace real cigarettes. A lab comparison should have been done against a real cigarette. It that would have happened, there would be no case.

I don't live in NY, but have supported every state in fighting a ban. All should do so to prevent a "foot hold" situation.
Numbers & noise for our case is very important now. Silence is not golden for our future.
www.e-cigarette-forum.com/forum/cas...mbers-casaa-members-call-action-new-york.html

 

[kai kane]

I have to respectfully disagree. I almost responded to Thulium early this morning because I feel his distinction is an important one.
....
If I can use these devices to satisfy that behavioral aspect -- the one that I would argue is what has brought me back to smoking each and every time -- I feel quite strongly that this point needs to be recognized as beneficial and distinct from the nicotine-intake aspect ...
... and, yup, my feelings, our feelings, none of it has any affect on the case.

Agreed. This is an important point. As 'scientific' studies have shown, there is strong evidence that the 'behavioral' aspects of inhaling smoke are, in some cases, replicated with 'vapor', and in the latter, nicotine cravings are lessened and even satisfied in some users' cases.

And agree it may not have any bearing in the extant case!

 

[kai kane]

I posted a longer rant in a new thread, but fell it is pertinent enough to at least be mentioned here:

There is a common presumption that nicotine is 'evil', but evidence abounds that 'smoking addicts' are not satisfied by NRT's. And the plain physiological impact of nicotine in small doses is not that bad, in fact, small doses are shown to help MS and Alzheimer patients. If nicotine were so evil - we should ban all tomatoes, eggplant, etc...and the FORK, since it 'delivers' the nicotine! It's the SMOKE, your honor, not the nic!

from HuffPo:

"Marcia Angell, MD, the former editor of the New England Journal of Medicine and author of the powerful book The Truth about Drug Companies, said it plainly and directly: "Trials can be rigged in a dozen ways, and it happens all the time" (Angell, 2004, 95).

 

[Sun Vaporer]

Agreed. This is an important point. As 'scientific' studies have shown, there is strong evidence that the 'behavioral' aspects of inhaling smoke are, in some cases, replicated with 'vapor', and in the latter, nicotine cravings are lessened and even satisfied in some users' cases.

And agree it may not have any bearing in the extant case!

I have to respectfully disagree. I almost responded to Thulium early this morning because I feel his distinction is an important one.

If a ban comes down I will certainly make an attempt at 0-nic using my PVs just because of my own recognition of the facets of my habit. The hand to mouth motion and the visible smoke/vapor are significant for me personally. And, while I'm not sure that I'd say I was at my best, I have functioned more than once for more than a year at a time without the use of nicotine and believe that I could do so again.

If I can use these devices to satisfy that behavioral aspect -- the one that I would argue is what has brought me back to smoking each and every time -- I feel quite strongly that this point needs to be recognized as beneficial and distinct from the nicotine-intake aspect ...



... and, yup, my feelings, our feelings, none of it has any affect on the case.

But the issue has gone afoot. Both sides, the FDA and SE argue that the e-cig is a nicotine product. It is the classification of the e-cig being either a tobacco product (as the nicotine is derived for tobacco) or a new drug that is in issue. Judge Leon ruled that the e-cig "IS" a an alternative tobacco product for the use and enjoyment of "recreational nicotine".
　
　
Trying to skirt the issue by saying that the e-cig can be used with zero nicotine and therefore they should not be banned for that purpose fails in the eyes of Judge Leon as well as SE and NJOY.
　
　
Remember the FDA argues that the e-cig is a medical device and the e-liquid is a new drug. Judge Leon bought SE and NJOY's "tobacco" argument.
　
　
So going against an argument that has already been made by the parties in the case, that being SE and NJOY simply is not going to work here.
　
　
SE and NJOY took an all or nothing approach. So at least in this case, the zero nicotine argument will not fly.
　
　
I have been using zero nicotine for 18 months now, so no one would like to see this distinction more then I would. But it would not do much for the majority of e-cig users who do use nicotine.
　
　
Sun

 

[Thulium]

Look at it another way. Would the e-cig be of any real value if nicotine could not be used in it? No. Would the e-cig be of real value if it could only be used with nicotine? The answer is Yes.

Like others have said, I disagree that the e-cig's usefulness for its intended function is dependent on nicotine. I think that nicotine makes it MORE useful, but Dr. Eissenberg's research points to e-cigs remaining effective without nicotine.

Would coffee be of any real value if caffeine could not be used in it? Even though many people consider Decaf to be Pointless & Annoying™ and the number of decaf drinkers pales in comparison to the number of people who actively seek out higher levels of caffeine...we don't use the low number of decaf drinkers as evidence that Coffee is intended as a drug delivery system, do we?

Caffeine adds to the "pleasure" of drinking coffee. Likewise, Nicotine adds to the "pleasure" of smoking or vaping.

 

[Sun Vaporer]

Like others have said, I disagree that the e-cig's usefulness for its intended function is dependent on nicotine. I think that nicotine makes it MORE useful, but Dr. Eissenberg's research points to e-cigs remaining effective without nicotine.

Would coffee be of any real value if caffeine could not be used in it? Even though many people consider Decaf to be Pointless & Annoying™ and the number of decaf drinkers pales in comparison to the number of people who actively seek out higher levels of caffeine...we don't use the low number of decaf drinkers as evidence that Coffee is intended as a drug delivery system, do we?

Caffeine adds to the "pleasure" of drinking coffee. Likewise, Nicotine adds to the "pleasure" of smoking or vaping.

I know full well of the value of e-cigs and the use of no nic Thal--the hand to mouth is big IMO.. As I stated, I have not used nicotine in 18 months, so I am on the "decaf" as you say---but that is not how this case is being plead wheather we like it or not.

The device in and of itself is either going to be deemed a Tobacco product and left on the market or it is goint to be deemed a medical device and banned until/if an approval by the FDA is ever obtained.

At least in this Case.


Sun

 

[kai kane]

But the issue has gone afoot. Both sides, the FDA and SE argue that the e-cig is a nicotine product. It is the classification of the e-cig being either a tobacco product (as the nicotine is derived for tobacco) or a new drug that is in issue. ...
Sun

Nicotine is obviously not a 'new' drug - BUT the ecig is considered by the FDA to be a new 'drug-delivery' device.

However, smokers have been using IMO the same or similar 'drug-delivery devices" for centuries: nicotine in tobacco is heated to the point of vaporization (and beyond, in the case of smoking) and then inhaled via the mouth for absorption (adsorption?) in the respiratory system. Was that Judge Leon's logic? "A rose is an e-rose"???

Should the FDA then be making the case that a cigarette is a "drug delivery device"???


BTW, many mahalos to Sun and the many others for supporting this consideration!

 

[Drozd]

It's very hard to fight a group like the FDA when no monetary recovery is possible even if won. They have nothing to lose and we know they have heavey hitters as backers. It should'nt be that way, but it's appearent it's true. They have nothing to lose other than thier backers support.
Way more time has been spent fighting ecigs when there are more important things they sould be focusing on. Every step they take just increases the foul odor of all this right down to the latest list of "champions" backing there cause.
So far, there has been no news of them mounting a fight of PM's latest "ecig type" product upcoming which appears far worse than an ecig. Why is that?

This makes me wonder...true that there can be no money recovered from the FDA...But what about all those other groups...

What I mean is they filed brief saying they are on the side of the FDA and want a ban...so they've insinuated themselves into the situation...
Now couldn't someone go after them for the money, as in all reality they're going against their mission statement of saving lives and reducing tobacco related health issues by in essence persuing a ban that would put hundreds of thousands of smokers back on combustible cigarettes...if their actions directly cause me to go back to smoking can they be held accountable for that?

 

[JerryRM]

This makes me wonder...true that there can be no money recovered from the FDA...But what about all those other groups...

What I mean is they filed brief saying they are on the side of the FDA and want a ban...so they've insinuated themselves into the situation...
Now couldn't someone go after them for the money, as in all reality they're going against their mission statement of saving lives and reducing tobacco related health issues by in essence persuing a ban that would put hundreds of thousands of smokers back on combustible cigarettes...if their actions directly cause me to go back to smoking can they be held accountable for that?

They believe in "quit or die". They would probably argue that banning e-cigs did not force anyone back to smoking. We should have all just quit, going back to smoking was our choice.

 

[kristin]

I have to respectfully disagree. I almost responded to Thulium early this morning because I feel his distinction is an important one.

If a ban comes down I will certainly make an attempt at 0-nic using my PVs just because of my own recognition of the facets of my habit. The hand to mouth motion and the visible smoke/vapor are significant for me personally. And, while I'm not sure that I'd say I was at my best, I have functioned more than once for more than a year at a time without the use of nicotine and believe that I could do so again.

If I can use these devices to satisfy that behavioral aspect -- the one that I would argue is what has brought me back to smoking each and every time -- I feel quite strongly that this point needs to be recognized as beneficial and distinct from the nicotine-intake aspect ...



... and, yup, my feelings, our feelings, none of it has any affect on the case.

Agreed. This is an important point. As 'scientific' studies have shown, there is strong evidence that the 'behavioral' aspects of inhaling smoke are, in some cases, replicated with 'vapor', and in the latter, nicotine cravings are lessened and even satisfied in some users' cases.

And agree it may not have any bearing in the extant case!

0mg may be viable for people who have already benefitted from the nicotine ecig use and weaned off. But few can deny that the appeal to even start using the ecig was that they provided the nicotine fix in the beginning.

The CASAA Survey shows that only 2.4% of the respondents use 0 nicotine. 59.3% use 18mg or higher. Only 39.1% stated that the ability to wean off nicotine altogether extremely influenced their continued use of ecigs.

We have to remember that we are not just fighting to keep ecigs as we need them, but for all of the people who could benefit from them in the future. They will not have the same draw to current smokers without the nicotine - it's only later, as experienced vapers, that we can see the light at the end of the nicotine tunnel.

 

[curiousJan]

0mg may be viable for people who have already benefitted from the nicotine ecig use and weaned off. But few can deny that the appeal to even start using the ecig was that they provided the nicotine fix in the beginning.

The CASAA Survey shows that only 2.4% of the respondents use 0 nicotine. 59.3% use 18mg or higher. Only 39.1% stated that the ability to wean off nicotine altogether extremely influenced their continued use of ecigs.

We have to remember that we are not just fighting to keep ecigs as we need them, but for all of the people who could benefit from them in the future. They will not have the same draw to current smokers without the nicotine - it's only later, as experienced vapers, that we can see the light at the end of the nicotine tunnel.

Ah, but the distinction is that we didn't have to choose ... we could have our e-cig and our nicotine too. The fact of the matter is that for some just the satisfaction of the psychological and behavioral components will be enough. I think I may be one of those, and for clarity, I'm someone currently using 24mg/mL niquid ... but then again, I didn't have to choose.

Now if that choice is made for us by the Court and the FDA, I certainly think that it would be worth the effort to advance the beneficial aspects of the satisfaction of the psychological and behavioral 'smoking' components of the e-cig.

I guess I'm saying I hope the at least fall-back position argument of 0-nic is not being diminished by the all-or-nothing tobacco-product argument being presented currently.

Sun (and all), I must apologize for the tangent because I realize that this train of thought is irrelevant with respect to and means absolutely nothing toward the current case and isn't really on topic for this thread.

Jan

 

[Sun Vaporer]

I guess I'm saying I hope the at least fall-back position argument of 0-nic is not being diminished by the all-or-nothing tobacco-product argument being presented currently.

Sun (and all), I must apologize for the tangent because I realize that this train of thought is irrelevant with respect to and means absolutely nothing toward the current case and isn't really on topic for this thread.

Jan

No need to apologize Jan---we are all a little frustrated at how this played out. This argument was never advanced in the record below so it can not be raised on appeal now.
　
　
There were many things that might have been done differently in this case. That being said, I do believe that we are dealing with very competent Counsel with SE and NJOY as well as the FDA. Counsel for each of the entities is paid to advocate zealously for their clients and to win.
　
We just have to hope that we land on the right side of the fence.

Sun

 

[timothymass]

it sucks about New york maybe they will ammend the bill to where adults will be able to use them i mean i think they over expressed the problem of children getting the devices

 

[Vaporer]

Drodz,
That seems like it would be trying to sue a paid witness in the case since the "johnny come latelys" weren't named in the original suit and have nothing to physically do with the seizures other than support. If that makes any sense at all.

 

[Drozd]

Drodz,
That seems like it would be trying to sue a paid witness in the case since the "johnny come latelys" weren't named in the original suit and have nothing to physically do with the seizures other than support. If that makes any sense at all.

I see it more as an acomplice to a crime than say a witness..

if say the ALA was leaning on the FDA to take steps and they did...and the FDA is untouchable...but the ALA isn't..

if I give you a gun and talk you into shooting someone and I'm there with you...I'm just as responsible as you are..

 

[kai kane]

I see it more as an acomplice to a crime than say a witness..

if say the ALA was leaning on the FDA to take steps and they did...and the FDA is untouchable...but the ALA isn't..

There is a chain of events (please correct me if i'm wrong and there is no chain!) :

- Mr. Banzhoff publicly declared that he/ASH threatened the FDA that he would call them out in the media if the FDA did not take action by a certain date.

- the FDA then held a last minute media blitz announcing: the supposed deadly threat in a specific company's product, which directly affects Njoy/SE's bottom line.

-I believe I read that Mr. Banzhoff, wrote a PR directly afterward, criticizing the FDA for their report but still claiming he pressured them. maybe i read it on his website.

-When did Paypal, Authorize.net, Amazon, eBay, etc. reject trade and why? (Class Action by all vendors?) Looking at the products' retail pricing and the distribution volumes at Longs/CVS . . .a fair amount of cash is involved.

Wiki describes a "Tortious Interference" case:

Tortious interference with business relationships occurs where the tortfeasor acts to prevent the plaintiff from successfully establishing or maintaining business relationships. This tort may occur when a first party's conduct intentionally causes a second party not to enter into a business relationship with a third party that otherwise would probably have occurred.

Has ASH intentionally damaged SE's business? (Oregon "ban", etc.) And has ASH distributed half-truths and falsehoods regarding SE products in order to do so? And how is ASH funded? Any BP $$$ there???

And isn't there a litigating attorney on ECF somewhere??? They'd probably tell me I'm dreamin'

 

[Vaporer]

I see it as you wanting to sue the cheerleaders and I cant see that happening.
It would be nice though...heck, it may be possible for all I know abt the law...which is very little.
And less as this case goes on!