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

[Sun Vaporer]

Wouldn't applying for FDA approval (which didn't have oversight of tobacco products at the time) been the same as admitting ecigs are drug/drug delivery device combinations?

MVP--it would have been basically at that point back then a "So What"--just like this liquid nicotine. It looks like it is going to get approved and be avaliable over the counter. The "tobacco" card was played due to the legal fiction that applied at the time.

IMO a product can be introduced that is neither an NRT or a tobacco product like this liquid nicotine and be approved. We are locked into the tobacco argument only becasue of the way things unfolded and the fact that at the time of filing, it was SE's best legal argument.

Sun

 

[Sun Vaporer]

Today there was no filings with the Appeals Court. I would not be surprised to see something forthcoming about the tracking order of the Appeal from SE as 5 months is simply to long for them to wait according to their previous filings with Judge Leon in the District Court.


Sun

 

[MVP]

IMO a product can be introduced that is neither an NRT or a tobacco pruduct like this liquid nicotine and be approved. .

Sun

Touche' Good point!

 

[DC2]

"All of the world's economic systems - socialism, communism, fascism and even the vaunted free enterprise capitalist system - perpetuate social stratisfication, elitism, Nationalism and racism, primarily based on economic disparity. As long as a social system uses money or barter, people and nations will seek to maintain positions of differential advantage. If they cannot do so by means of commerce they will resort to military intervention."

Another belief of the project, and one that is shared by many reputable economists, psychologists and sociologists: The natural evolution of ANY economic system which is primarily monetary/barter based, is an evolution towards fascism. Are we not seeing that inevitable evolution taking place in our country.

What does this have to do with monetary/barter system based economies?
What alternative economies are there other than communist/socialist?

It seems to me to be a simple matter of human nature, and the struggle for resources.

Under any system where resources are not shared equally and globally, there will always be haves and have nots. And since the idea of sharing resources equally and globally is nothing more than a fantasy, there will always be haves and have nots.

This is why there will always be war, no matter what the dreamers dream of.
Sad but true.


Edit: And please don't take that for an endorsement on socialist/communist systems. The philosophy behind such systems is again another fantasy, and those types of systems will never work. It requires those who are capable to do more than their share for less reward than others are getting for less work, or less valuable work. It rewards neither hard work, nor efforts to improve the human condition.

It also encourages those who are lazy to be lazy.
It is somewhat like a massive welfare system.

 

[Sun Vaporer]

Touche' Good point!

What needs to happen here is a Manufacture/Supplier applying as a new product to the FDA that stands on its own, is NOT an NRT or a tobacco product, but rather a harm reduction alternative nicotine delivery product that will save millions of lifes, and then argue that the FDA is not following its Mission Statement in protecting the public by forclosing the e-cig from the market, and seek judical relief requesting an injunction by the Court to order that the e-cig be allowed into commerce here in the US for manufacturing, distribution, marketing, and sale to adults.


Trying to weave though and piggy back on the loopholes of tobacco laws just is not going to work IMO. It is not only a bad idea, but to me, it is a loser. There is no reason the e-cig has to be a "tobacco" product to make a good faith argument that it has a ligitimate purpose and public policy concerns demands that it be released to smokers so they have an alternative nicotine delivery system rather then be locked into "death" by cigarettes.


Sun

 

[D103]

In response to BigJimW's recently posted rant on You Tube, the FDA isn't interested in collecting money from smokers, and there's no big government conspiracy against e-cigarette consumers.

Rather, its just one FDA official (Josh Sharfstein) who has been misrepresenting the evidence about e-cigarettes and has been trying to remove them from the market.

OH PLEASE! You offend the sensibilities of "thinking adults". While I agree there is no "big govt. conspiracy" per se against e-cigs you are grossly naive if you truly believe that 'one FDA official' is soley responsible for the obviously organized resistance to e-cigs being allowed in the market place; and that there are not very large and serious considerations, both financial and political involving the FDA, Big Tobacco and Big Pharma, not to mention state govts and the federal govt. Case in point would be the FDA's recent 'report' re: supposedly testing electronic cigarettes and their contents. Their 'report' was unscientific, misleading, disingenuous, self-serving and bordered on unethical. These are not my opinions alone - you can find numerous articles written by public health physicians and healthcare providers echoing the very same sentiments regarding the FDA's report and indeed the FDA's actions up to this point on this entire subject. There are multiple Bans occurring in numerous states in this country based almost entirely on 'politics and money' - all one has to do is read the various Bills and comments by their supporters to see the serious lack of scientific information. Yet a technology with such huge potential health benefits (in terms of harm-reduction) is being banned outright and I am to believe this is all because of 'one FDA official' ?!?!?!?

 

[CJsKee]

I think you're correct D103...too much going on for it to be just one person!

But back to the liquid cig...couldn't this be a good thing for the e-cig? If the L-cig can get approval, would it be asking too much to have the same considerations applied to the E-cig?

 

[Captu4ik]

I am to believe this all because of 'one FDA official' ?!?!?!?

Have youi checked this guy out ? Sharfstein was never a practicing Doctor, always worked for the government. And he's been against Tobacco since he started. He's an idealist, a bleeding-heart when it comes to heroine addicts. And, he's Principal Deputy Commissioner of the FDA . He was acting Commisioner. Sounds like he's #2 there, now.

I believe it ...

 

[DC2]

Mr. Godshall, I respect your opinions very much, as should everyone. I doubt anyone here is as close to the situation as you are, or has their finger on the pulse of things as well as you do.

That being said, common sense, while often wrong, leads the average person to believe that there are a lot of people, and a lot of money, involved in the attempts to crush out electronic cigarettes.

If you could provide any information to help us understand our enemy better, then we would all have a better chance of fighting that enemy successfully. And there are many of us spoiling for a fight.

 

[D103]

Yes, Please Mr. Godshall, enlighten us "average persons" with apparently "wrong common sense" as to the true nature of our oppressor(s) so that we may better understand from whom and from where the oppostion comes and in so understanding, be better equipped to fight the good fight. By the way I mean no disrespect to you personally Mr. Godshall I am just stating, albeit venting, some of my opinions, observations and frustrations with this whole situation and if I've offended anyone, I apologize - it's just that I find some statements made too hard to believe.

 

[D103]

What does this have to do with monetary/barter system based economies?
What alternative economies are there other than communist/socialist?

It seems to me to be a simple matter of human nature, and the struggle for resources.

Under any system where resources are not shared equally and globally, there will always be haves and have nots. And since the idea of sharing resources equally and globally is nothing more than a fantasy, there will always be haves and have nots.

This is why there will always be war, no matter what the dreamers dream of.
Sad but true.


Edit: And please don't take that for an endorsement on socialist/communist systems. The philosophy behind such systems is again another fantasy, and those types of systems will never work. It requires those who are capable to do more than their share for less reward than others are getting for less work, or less valuable work. It rewards neither hard work, nor efforts to improve the human condition.

It also encourages those who are lazy to be lazy.
It is somewhat like a massive welfare system.

Sorry for the seemingly off-topic comments. These are just observations from a theory of a future "resource-based, global system". Many feel this is truly a fantasy, perhaps, but there are some truly interesting implications and possibilties. I too do NOT advocate socialism/communism or any form of fascism.

 

[DC2]

These are just observations from a theory of a future "resource-based, global system". Many feel this is truly a fantasy, perhaps, but there are some truly interesting implications and possibilties. I too do NOT advocate socialism/communism or any form of fascism.

I'm interested. Would I get more information at the Venus Project website?

 

[BigJimW]

I think you're correct D103...too much going on for it to be just one person!?

If that were the case, John Banzhaf would be green with envy. It's simply not a "one man band" situation. There is a lot more too it than that.

 

[JerryRM]

What needs to happen here is a Manufacture/Supplier applying as a new product to the FDA that stands on its own, is NOT an NRT or a tobacco product, but rather a harm reduction alternative nicotine delivery product that will save millions of lifes, and then argue that the FDA is not following its Mission Statement in protecting the public by forclosing the e-cig from the market, and seek judical relief requesting an injunction by the Court to order that the e-cig be allowed into commerce here in the US for manufacturing, distribution, marketing, and sale to adults.


Trying to weave though and piggy back on the loopholes of tobacco laws just is not going to work IMO. It is not only a bad idea, but to me, it is a loser. There is no reason the e-cig has to be a "tobacco" product to make a good faith argument that it has a ligitimate purpose and public policy concerns demands that it be released to smokers so they have an alternative nicotine delivery system rather then be locked into "death" by cigarettes.


Sun

Excellent point, Sun !! It is neither a drug nor a tobacco product. The ingredients in the e-cig are found in other items that are ingested and/or inhaled and have been approved by the FDA. As for the nicotine content, that doesn't make it a "tobacco product", anymore than a tomato, potato or eggplant is a "tobacco product".

It is a "smoking alternative" and deserves it's own category...period.

I still believe that SE and NJoy, should be lobbying Congress, instead of messing around with the FDA and the courts.

 

[Thulium]

We would have a much stronger case in Court if SE or NJOY had actually sought approval and were denied.

Sun

On the one hand, I suspect this point might account for the appellate's stay on Judge Leon: The court may feel that because the plaintiff's product has not been submitted for FDA approval, lifting the stay might not be warranted even if the other points of Judge Leon's decision stand.

However, there is something of a Catch-22, one of the reasons Smoking Everywhere didn't submit their product for FDA testing is not only that they believed it was not subject to FDA approval since it was brought to market before the FDA had approval authority over recreational tobacco products and they did not want to call down the attention of the FDA... The problem is the FDA doesn't have a functioning approval process for existing tobacco products, much less any idea how to go about regulating something new.

Now the FDA is complaining that they don't know how to create an approval process for Modified Risk Tobacco Products (MRTP) because they haven't received any applications--It's like blaming the cart for being in front of the horse! I still think the FDA might be surprised how many applications for MRTP's they would receive if they so much as had an approval process.

 

[JerryRM]

If that were the case, John Banzhaf would be green with envy. It's simply not a "one man band" situation. There is a lot more too it than that.

Jim, I don't even want to think of Banzall running the show !!!!!

 

[D103]

I'm interested. Would I get more information at the Venus Project website?

Yes, The Venus Project - those are the ideas to which I was making reference - granted probably not as accurately as I could have but still
some very intriguing ideas. And I do believe that our system of govt. - capitalist, free enterprise is evolving into something much less appealing
and ever more oppressive. We appear to be trying to solve "social problems" with the law and the law only and I believe this is a very big mistake, not to mention it fails miserably.

 

[D103]

On the one hand, I suspect this point might account for the appellate's stay on Judge Leon: The court may feel that because the plaintiff's product has not been submitted for FDA approval, lifting the stay might not be warranted even if the other points of Judge Leon's decision stand.

However, there is something of a Catch-22, one of the reasons Smoking Everywhere didn't submit their product for FDA testing is not only that they believed it was not subject to FDA approval since it was brought to market before the FDA had approval authority over recreational tobacco products and they did not want to call down the attention of the FDA... The problem is the FDA doesn't have a functioning approval process for existing tobacco products, much less any idea how to go about regulating something new.

Now the FDA is complaining that they don't know how to create an approval process for Modified Risk Tobacco Products (MRTP) because they haven't received any applications--It's like blaming the cart for being in front of the horse! I still think the FDA might be surprised how many applications for MRTP's they would receive if they so much as had an approval process.

I totally agree Thulium - now the question remains for me; is this just a cover your *ss dodge on their part or a stalling tactic until they figure out how they can successfully Ban e-cigs or have total control over them re: manufacturing, sales, distribution and consumption, to include excessive taxation. By the way I am very glad to see you are on the board of directors for CASAA.

 

[kristin]

The American Lung Association is behind the state ban attempts, not the FDA. The ALA has been sending their lobbyists & letters out to the state legislators.

If Bill says that one guy is behind the anti-ecig push in the FDA, I am inclined to believe him. All it takes is one prohibitionist with power to influence policy.

 

[JerryRM]

The American Lung Association was founded because of Tuberculosis. Good news, TB is pretty much under control, you can go away now !!!