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

[yvilla]

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The FDA's filings in this case never cited that provision because the FDA was arguing that e-cigarettes are drugs/devices. But since Judge Leon ruled against the FDA on that argument, the FDA could redefine e-cigarettes as tobacco products, and cite the "adultered tobacco product" or other provisions in the FDA tobacco law in another attempt to try removing e-cigarettes from the market.

Bill, this date provision has been a concern of mine since the legislation was passed (as I always knew we had a good chance Judge Leon's ruling would go this way - because it was legally correct ).

However, I have seen no one state clearly that their particular ecig was on the market before that critical date. Njoy's filings in this case did mention a date, but it was a bit later in 2007.

So my question to you is, are you aware of any ecig seller or manufacturer who can legitimately claim they were in the US market on February 15, 2007?

[sherid]

Serves Banzhaf right. First we troll him, now he looks like an ass to the court. I think he should stop to save whatever little shrad of respect he has left in the world and to ASH.

Do you have a link to that ASH brief?

Has anyone looked at Introduction to Action on Smoking and Health, ASH main page?
ASH begins 2010 successfully having fought for your rights as a nonsmoker. Last year, we intervened in dozens of legal proceedings to push for a ban on e-cigarette sales to minors and to keep dangerous secondhand nicotine out of malls, airplanes, and even hospitals. We thank the attorneys general and the national media for their great support of ASH's proposals to keep the public safe from e-cigarettes.
Second-hand NICOTINE? WOW

[JerryRM]

Of course, you might get some nicotine on your hands, when topping off your cart and then shake hands with someone who then picks up their baby and the kid's an instant nicotine addict.

It makes as much sense as "third hand smoke"!

[Sun Vaporer]

Several pages ago, Sun wrote:

"I would take exception with your concusion here Bill as IMO, the FDA would have argued that as an "even arguendo" and they failed to. If you take a hard read of the decision, Judge Leon did not leave the door open to find them as a "adulterated tobacco product". That is my take on it."

It appears that Sun misunderstood my statement (and I think of those by Phi) indicating that the FDA may still try to keep many/most e-cigarettes off of the market by redefining e-cigarettes as tobacco products (as Judge Leon suggested), and then by claiming that many/most e-cigarette brands are "adultered" tobacco products because they were not on the market before February 15, 2007.

The FDA's filings in this case never cited that provision because the FDA was arguing that e-cigarettes are drugs/devices. But since Judge Leon ruled against the FDA on that argument, the FDA could redefine e-cigarettes as tobacco products, and cite the "adultered tobacco product" or other provisions in the FDA tobacco law in another attempt to try removing e-cigarettes from the market.

Bill--I hear what you are saying but you really need to go back and look at the pleadings and you will find that the FDA did in fact advance "even arguendo's" but failed to advance a fall back position like the one you set forth.

Unlike some, IMO this case was by no means a easy one for Judge and the law was never clearly on anyone's side. That is why the appeal is going to be critical.

It was Judge Leon and his legal staff alone that came up with the intended use argument stating that Smoking Everywhere's marketing material actually helped define the use as one that in no way or form included any mitigation or treatment. The parties never plead it and it was never discussed on this board or any other for that matter. That is and was Judge Leon's creation. NJOY even went so far as to distiguish itself from SE. It is SE's claims that allowed Judge Leon to show that the e-cig actually "promotes" the use, rather then negate it.

This reasoning by Judge Leon will be one of the issues subject to a attack on appeal.

But getting back to running around talking about an "adulterated tobacco product", I simply do not see in the cards. What I see is a recreational tobacco like product coming out of that ruling.

Should it hold up on Appeal, we will continue to be in much better position then prior to the ruling.


Sun

[Legal One]

We argued intended use extensively - in oral argument and throughout the briefing - here is one passage from our reply brief. A Judge can not introduce argument's that are not made as that would be injecting issues into the record that the parties did not raise and hence make it quite appealable - Judge Leon did a good job of buttoning up the legal rationale but the intended use argument was in my opening statement to the court and so on.

SE's product is simply designed and intended to provide users with an alternative means of smoking enjoyment without the undesirable by-products associated with traditional cigarettes, including tar, smoke, or odor. See id. ("Smoking Everywhere E-cigarette is simply a healthier alternative to traditional smoking."); see also AR DET at 49 ("The main reasons people use . . . E-cigarette include: healthier way to smoke, freedom to smoke anywhere and everywhere, no first or second hand smoke, no smoke or odor, non-flammable, convenient and cheaper than traditional cigarettes.")2 Further, the FDA has made clear that, no matter what labeling is included with SE's products, the FDA considers them "drug-device combination products" and will attempt to ban their importation into the United States. (See AR DET at 82 ("We do not believe that this product can be relabeled to make it anything other than an article which . . . appears to be a drug-device combination product . . . where its marketing in the United States would appear to violate sections 505 of the Act and 501(f)(1)(B) of the Act.").)

[yvilla]

Legal One, do you have an answer to my question to Bill above? Were any ecigs being marketed in the US prior to February 15, 2007?

Do you have a strategy to deal with this date provision in the future course of affairs?

[Sun Vaporer]

Legal One--then you should be ready on Appeal as the FDA is going to go after the Intended Use like "white on rice" and I am sure you will be ready to hold your ground.

You did in fact make some arguments about your marketing, but what I find interesting is that NJOY thought they had one up on you, so to speak because their repeated stated that they have never made any claims. NJOY was expecting a split decsion---seems that was all smoke at this point and I wonder if they will shift tactics or hold their ground.

The Judge's decision is quite clear that he found the intended use grounded in SE's marketing to be one of boasting use rather then mitigating it or treating it thereby ruling the intended use was for recreational use of a tobacco like product.


Sun

[Sun Vaporer]

The Docket Sheet was clear today. We now are looking for a Notice of Appeal to be filed by the FDA with the Court. The Clock is running.


Sun

[Kurt]

Kurt,
Per what seemed like an indirect request. Feel free to email or msg me in regards to these results. These were done by a third party and were NOT paid for by my company. These lab results, coupled with the ruling over the FDA, should ensure that my product liability insurance remains...and we don't get dropped. Somewhat of a protective measure for the customers.

http://www.libertystix.com/LibertySt...ysis072309.pdf

Sebastian: good man!! This is exactly the sort of detailed analysis everyone should be doing, and I believe will be required in the not to distant future. I now recall that someone here mentioned Liberty doing this but had not looked into it. Fantastic work, you set a most valuable precedent for other vendors to follow suit. Way to raise the bar before you have to. And, BTW, this is the most detailed such analysis I have seen for vaping juices yet. Outstanding, and thank you for doing this. Other vendors should take heed.

[Susanjane]

Sun Vaperer,

Could you tell me more about the appeal? I've tried to lead the last ten or so pages of this thread, but I still wasn't aware that an appeal to Judge Leon's decision had been filed.

Thanks.