This is very good news indeed...a big thank you to all that have worked so hard to spread the good news regarding e-cigs. No matter what, they have certainly changed my life for the better.
DC Court of Appeals rules against FDA 3-0 and in favor of NJOY
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My question is how fast can they move to regulate it? Could we theoretically wake up tomorrow and all eliquid be under whatever regs the FDA decides to put them under? Or, would it take longer to accomplish?
This ^^^ is so much horse crap. There is no evidence that Big Tobacco had any part in this at all. They are investing millions in snus type products. It was Big Pharm that had the most to lose and funds most of the anti groups that came out against PV's. It was Big Pharm that was the largest contributor to Senator Lautenberg's campaign and who requested a ban early last year. It was Big Pharm's Trade Association that published a news letter calling for a ban of PV's. It is Big Pharm where many upper management FDA personnel go to work for after leaving the FDA.
We know the original judge in the case that ruled in favor of SE and NJOY was appointed by the previous administration. Anyone know who appointed the Appeal's Court judges?
Your comments are "on target" as always, kristin. Excellent points.
i agree 100% the whole act of getting labeld a drug is for big pharmacy , you label it a drug then let the pharmasutical companys distribute it and walla all of a sudden you see reports on how wonderfull it is and they make millions on prescriptions and their own delivery devices.
BUT , it is reported 20-30k people per week are trying e-cigs it will not be long before big tobacco starts putting money in the fight too.
Everyone who has been paying attention in the community has known for quite some time that we will be classified as either drug delivery or tobacco. Keeping in mind that this is just the appeal, and not a full win, I'm happy with the outcome. If it goes the drug delivery route, and the vendors continue to sell without following whatever regulations that would have meant, you will see most vendors go out of business or selling illegally. And while I am a 100% believer in e-cigs, I will not go to jail, take a quarter million dollar fine or be classified as a drug dealer for the cause.
So, for now, let's all enjoy this small victory. Tomorrow we can continue the main battle. Tonight, we celebrate!
So, for now, let's all enjoy this small victory. Tomorrow we can continue the main battle. Tonight, we celebrate!
Anyone care to help me decipher what the appellate judge meant by the underlined portion this paragraph? Sounds like an insult but it must have went over my head... why cant these guys write in a way that people can understand...
"In the absence of an authoritative agency interpretation, I
conclude that, unless a product derived from tobacco is marketed
for therapeutic purposes, the FDA may regulate it only under the
provisions of the Tobacco Control Act. Accordingly, because
NJOYs electronic cigarettes are derived from tobacco, I join my
colleagues disposition. What the result would be were the FDA
to offer a contrary statutory interpretation in the form of a
regulation, I leave for the day the agency decides to take that
step."
~last paragraph of the appellate courts opinion
"In the absence of an authoritative agency interpretation, I
conclude that, unless a product derived from tobacco is marketed
for therapeutic purposes, the FDA may regulate it only under the
provisions of the Tobacco Control Act. Accordingly, because
NJOYs electronic cigarettes are derived from tobacco, I join my
colleagues disposition. What the result would be were the FDA
to offer a contrary statutory interpretation in the form of a
regulation, I leave for the day the agency decides to take that
step."
~last paragraph of the appellate courts opinion
Just what I had referenced before about a third(non-drug, non-tobacco) scheme - (i.e. non therapuetic, non combustible, recreational nicotine delivery device). This will not ever happen. There are no rigorous, scientific safety studies out there to justify it.
Very well stated Kristin! The only 'fantasy' here is the idea that e-cigs could have ever been considered/classified in a separate category from either drug/device or tobacco product - had that tactic been pursued the fight would have remained, although the specific arguments would have varied, the oppposition would have been just as strong, if not more so (because a separate category would have entailed far less of an available regulatory scheme) and the battle would have inevitably ended up in the courts as well, however, with this course we would have had very little and weak legal precedent to support our case.
This is a very good victory! Of concern was Justice Garland's opinion which, in many ways I feel helped to outline the "next step" available to the FDA - that being, to go after regulating products containing nicotine (other than naturally-occuring like in the various food products) and have those products placed under FDCA jurisdiction. We fight on.....but today we Celebrate!
Congratulations to everyone involved, at whatever level.....and I again want to say a big Thank You, Excellent Job to the attorneys for Sottera.
This is a very good victory! Of concern was Justice Garland's opinion which, in many ways I feel helped to outline the "next step" available to the FDA - that being, to go after regulating products containing nicotine (other than naturally-occuring like in the various food products) and have those products placed under FDCA jurisdiction. We fight on.....but today we Celebrate!
Congratulations to everyone involved, at whatever level.....and I again want to say a big Thank You, Excellent Job to the attorneys for Sottera.
And let us not forget the excellent ground work laid by the attorneys for Smoking Everywhere, who now await payment for their efforts.
I'm still trying to understand how this is such a fantasy. It certainly wouldn't have been the first time that new , totally novel product, created the necessity for a different regulatory scheme. The main problem here(and it's been mentioned a zillion times since I started on this forum) is that way the product was originally stealth marketed in the USA(via mall kiosks and internet) while, at the same time, making unsubstantiated safety/health claims. This is what set up this whole situation. A properly focused marketing introduction(one that included the appropriate bureaucratic entities from it's inception) could have easily led to this.
I'm also not sure what your fighting on against. Ecigs/eliquid will be regulated as tobacco products under the FSPTC Act as the FDA now sees fit. If you're suggesting fighting against THIS regulation and hope that ecigs remain totally unregulated(as they have been for the last 3 years); now that's a fantasy.
NJOY got what it wanted. They've already changed their business model to comply with, at least what they believe, to be the proper FSPTC Act regulatory structure(which is nothing like the incarnation of the rest of the industry). NJoy won, the rest of us lost.
Not to pick on you again (since I just did in the other thread), but this is patently wrong. NJOY has been on the shelves in retail stores since long before the lawsuit. Nobody's hiding the products. It's just that a lot of major retailers were not willing to carry it. That may change now.
Also, "the product" did not make unsubstantiated safety/health claims, some suppliers did. Those who didn't make such claims need not be subjected to your blanket statement. You sound just like the antis we're constantly fighting against.
Compared to the current "zero " regulation of E-cigarettes, even regulation as a tobacco product will be extreme.
Manufacturers of E-cigarettes that are defective and their are many of those, will face penalties.
Taxes
Limited or zero flavors
Much lower nicotine levels.
Even the possibility of some locations enforcing a general tobacco ban, which would now include E-cigarettes.
( I believe there are already such bans in some places ? )
Manufacturers of E-cigarettes that are defective and their are many of those, will face penalties.
Taxes
Limited or zero flavors
Much lower nicotine levels.
Even the possibility of some locations enforcing a general tobacco ban, which would now include E-cigarettes.
( I believe there are already such bans in some places ? )
markarich, I agree with you that had the e-cig "initially" been marketed differently in the U.S. - from the very beginning, then maybe a different classification could have been pursued(although I don't agree with your assertion it would have been achieved easily). I also agree with you that in the bigger picture this would have been far, far better - for vaporers and the industry as a whole if we'd succeeded along those lines, but given that it came to the U.S. via the route you accurately describe, I feel (only my opinion) that this was the only viable option left to us. Had we pursued a separate classification I believe it would have only strengthened the FDA, ALA, AHA, ACS et al postition that it fall under the classification of a drug delivery device-especially given that nicotine is addictive. Re: "fighting on..." I certainly have never held the belief, nor the desire, that e-cigs remain totally unregulated, but I feel that the FDA's next step will be an attempt to fight e-cig classification as a tobacco product and focus their efforts towards regulating nicotine in all nicotine-containing products(except those food products where nicotine occurs naturally).
This is a fear that I never quite understood people having; at least, not unless it would also apply to other tobacco products.
At the moment, low (and ineffective) levels of nicotine are only found in pharmaceutical products such as gum, patches, etc. Why should ecigs be held to a higher standard that regular cigarettes and other smokeless tobacco products? If the FDA does such a thing, ecig manufacturers can sue for unfair treatment and will win pretty easily.
E-cigarettes don't fall under the definition of "cigarette" as they also doesn't come "rolled" or isn't intended to be rolled. So the flavor issue doesn't apply under current federal law. At this point, you won't need to order from China, but should they somehow get flavors removed from non-cigarette tobacco products in the U.S. it shouldn't affect imported liquid.
Our next battle might well be lobbying Congress as the ruling leaves open the ability of Congress to pass laws classifying ecig as drugs. Watch out for Lautenburg since he is quite capable of doing just that. We are going to need lots of friends in Congress.
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