What points would you supply to the Attorneys of Smoking everywhere vs the FDA??

[palermo45]

I was curious as to what arguements you would suggest to the attorneys of SE vs the FDA?

What would you tell their attorneys to ask the FDA as a defense strategy?

I would ask the FDA when exactly did they first know that electronic cigarettes were entering the USA and being sold? (I would guess 18 months or so)

Which was the first Company you knew sold these products?
Did you contact them?
What questions did you have and what kind of information did you find out?

Did you contact them? NO... Why not? Wouldn't you be curious to find out what ingredients were in cartridges?

So you (The FDA) were fully aware that many companies were selling hundreds of thousands of units for well over a year and did nothing.
Why are you seeking halting the product now? Have you done any testing? Have you heard of 1 single documented case of someone becoming sick from using this product?

So why now??

At this point, since you freely allowed sales for so long and in such large volume, don't you think it should be your responsibility at this point to prove that electronic cigarettes are harmful rather than simply "speculating"?

The FDA allowed the sales for such a long time and the burden of proof as to the products safety should now be put on their shoulders!!

[Mitty]

Never get on the bad side of an e-cig using History Major.

If all this is the result of companies considering Electric cigarettes to be too much competition for their liking this might apply. This is an excerpt of a letter I wrote to the ECA and to Njoy regarding the FDAs goings on.

"As I pondered this situation over in my mind it occurred to me that there might be a way to open the blockade of e-cig products. I was a very astute student of history both in High school and College and the prejudicial nature of the FDAs actions made me look up some legal issues dating back to the late 19th century.

The FDAs statements regarding Electric Cigarettes as dispensing poisons and or being used to dispense drugs, do not sound as well informed as they should ; almost as if those opinions were being spoon fed to the people making these accusations . If Nicotine were, in fact, as toxic and poisonous as the FDAs statements would lead the uninformed to believe, then why have they not immediately banned all Cigarettes, cigars, chewing tobacco and snuffs as well as Nicotine patches and lozenges . Why only single out Electric Cigarettes and let these other products go unencumbered by their watchful eyes.

It would seem to me, that someone with enough money and lobbying power has attempted to manipulate the FDA to meet their goals. It is here that I believe the ECA has its best legal footing for the restoration of E-cig marketing and sales. The intentional manipulation of a Federal Agency, in this case the FDA, by large Tobacco companies and or pharmaceutical companies to remove electric cigarettes from the market would constitute not only interference in free trade by such businesses as Njoy, but would also create, in the absence of any competition, a monopoly held by Big tobacco and Nicotine replacement companies for the sole control of Nicotine dispensing products. In doing so this violates the Sherman Anti Trust Act of 1890 and successive antimonopoly laws.

Having read a synopsis of the Sherman Antitrust Act I firmly believe it presents the best legal action against the FDA ban as it creates a violation of Federal Law. As a congressman I am sure that your resources on these laws are far more substantial than mine but I wished to offer up this view as a possible direction for the immediate termination of the FDA bans. "

These are a few lines from the Sherman Act that struck me as pertaining to our situation:

"... conspiracy, in restraint of trade or commerce among the several States, or with foreign nations, is declared to be illegal"

and The Act also provides: "Every person who shall monopolize, or attempt to monopolize, or combine or conspire with any other person or persons, to monopolize any part of the trade or commerce among the several States, or with foreign nations, shall be deemed guilty of a felony"

so by getting the FDA to clamp down on one Nicotine product but not all of them might very well bring provisions into effect in our favor.

-Mitty

[ShadowDemon420]

Mitty thats a awsome letter keep up your good work!

[Mitty]

thank you. I kind of get the feeling that its all a moot point now. Does anyone know a technique for clawing your eyes out that isn't too painful? I want to get in some practice before my cartridges run out.

[Caesarea]

SOmeone must pass them the latest Laugesen report.

E-Cig safety confirmed by Medical Study!

C.

[Sun Vaporer]

Palermo45--The issue is moot now as the Judge arlready had the hearing on the merits and the case is now under review with a decision any day now. As is well known, the burden of proof on any new product lies with the applicant--the FDA is not charged with testing new products--rather their administrative function is to review an applicant's studies and testing that are submitted under the requsite guidlines that the FDA has set forth.

In SE v. FDA, the only issues before the court were (1) does the FDA have juridsdiction over the e-cig as it is a "tobacco like" product (that is a big stretch and did not work in the Nicotine Water case) and : (2) did the FDA violate its own administrative policy of holding hearings before ordering the e-cig embarko ( again a tough one as no hearing was needed as there were no "legal suppiers" under the guise of the FDA's theory of the case--the FDA argues that the e-cig was never legal to sell in the first place as it is a new drug and delivery device system that needed application and an approval process before it was sold. Add to the equation the trump card of "Saftey' that the FDA uses and it appears that SE and NJoy by way of intervention has a very weak case---but a Judge can do what ever he likes --

Note that NJOY makes the argument that it never made any health claims about the e-cig and hangs it's hat on this arguing that as such it is not a new drug--but again it appears to be an uphill battle.

We should see the decision handed down sometime by Friday or next Monday. I would hope Judge Leon will take into account the ramifications of his decision and let the FDA make its case in the Appeal process, but that might be a stretch also. Poor planning by e-cig manufactures was the case here IMO----------Sun

[ramblingrose]

Originally Posted by Mitty

Having read a synopsis of the Sherman Antitrust Act I firmly believe it presents the best legal action against the FDA ban as it creates a violation of Federal Law. As a congressman I am sure that your resources on these laws are far more substantial than mine but I wished to offer up this view as a possible direction for the immediate termination of the FDA bans. "

These are a few lines from the Sherman Act that struck me as pertaining to our situation:

"... conspiracy, in restraint of trade or commerce among the several States, or with foreign nations, is declared to be illegal"

and The Act also provides: "Every person who shall monopolize, or attempt to monopolize, or combine or conspire with any other person or persons, to monopolize any part of the trade or commerce among the several States, or with foreign nations, shall be deemed guilty of a felony"

so by getting the FDA to clamp down on one Nicotine product but not all of them might very well bring provisions into effect in our favor.

-Mitty

S.982 essentially voilates the Act with its protection of Philip Morris at the expense of RJ Reynolds, e-cigs and other tobacco-free products.

Laws and constitutional principals are being circumvented, twisted and tossed out to accomplish the goals of organizations with extremist ideologies, and politicians who are taking a nonproductive hard line with personal political gain on their minds.

This is all really p**sing me off. I think I'll sooth myself buying some new hardware tonight.

[grumpster]

Actually, there are two sets of facts. The facts of health and public rights and the facts of economy.

Let's take a look at the facts of health and rights.

Analogues=
nicotine-----addictive. Little or no evidence of health risk at low levels.
tar----------major health hazard
smoke-------4000 carcinogens. Enough to kill a cow.
Bad Smell----Offensive to pretty much every including many smokers.
Available to anyone of legal age despite the considerable and well known health risks.
etc, etc, etc.

E-cigarettes=
nicotine---------addictive. Little or no evidence of health risk at low levels.
Practically no odor.---Not offensive to any one. (Direct inhalation may detect a slight sweet flavor at most.
No significant health effects known.
Proven by use if not by the FDA as a effective means of quitting the use of traditional cigarettes.
Attempts being made to ban or restrict use regardless of health benefits when used a a cigarette replacement.
etc, etc, etc.


Now let's take a look at the economics of the issue.

Public use and acceptance of E-cigs =
less money for tobacco companies
less money for pharmaceutical companies
less money for government through taxes.

Restriction or ban of the use of e-cigs=
more money for tobacco companies
more money for pharmaceutical companies
more money for government through taxes.

With that kind of money involved for so many politicians and CEO's, how can public health and rights be allowed to interfere with their profits and political careers?

Maybe I'm being cynical, but if common sence were actually a part of this whole issue, there wouldn't be an issue.

[42109]

Now let's take a look at the economics of the issue.

Public use and acceptance of E-cigs =
less money for tobacco companies
less money for pharmaceutical companies
less money for government through taxes.

Restriction or ban of the use of e-cigs=
more money for tobacco companies
more money for pharmaceutical companies
more money for government through taxes.


That about sums it up!

[JustMeAgain]

I would encourage them to look very closely at the Accord marketed by PM years ago. It seems very similiar to an ecig. Of course I know the rules were different then, but I would still want to know what information can be gleaned from whatever testing, etc. PM performed.