Part of the problem is the FDA has dug themselves into a hole. They can't start regulating it now without giving the appearance of conceding. All that's left for them is a fight to the death and as they die they will regulate the bejesus out of all things e-cig.
SE, NJoy vs FDA -- Discussion
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Yup, just out of spite because they didn't get their way, they will probably try to make the e-cig practically useless. Let's hope those FDA bosses aren't in power for too much longer.
2 face hypocrite fda
they scream nic ecigs are drug products but state rj renyolds smokeless dissovable chewables are tobacca products. lol
Letter to Industry on Dissolvable Smokeless Tobacco Products (R.J. Reynolds Tobacco Company)
Snus News & Other Tobacco Products: R.J. Reynolds Tobacco confirms Camel Dissolvables being pulled from all 3-test markets..
they scream nic ecigs are drug products but state rj renyolds smokeless dissovable chewables are tobacca products. lol
Letter to Industry on Dissolvable Smokeless Tobacco Products (R.J. Reynolds Tobacco Company)
Snus News & Other Tobacco Products: R.J. Reynolds Tobacco confirms Camel Dissolvables being pulled from all 3-test markets..
I am filing a lawsuit this week against the local FDA (Egypt) who followed the US FDA to the letter, and banned the whole product category, even for personal import and use, and even if it is nicotine free. The lawsuit is based in the njoy lawsuit, and its outcome affects me greatly.
There is a point that has not been discussed, and it gives me some pleasure. I think the main instigator is the pharmaceutical companies, Pfizer, Glaxo and Pharmacia, not the tobacco companies! This ruling turns it upside down for them, it means that ALL nicotine products are tobacco products and not subject to FDA oversight as drugs. It shoots a 3 billion dollar market, which everybody will try to enter, a market they spent 20 years developing, and financing every anti smoking group from the WHO to ASH.
I think this is a great part of the reason for the panicky activity going on right now.
An aspect that worries me a little, is the controversy over nicotine products and Tobacco and it might give probable cause for another supreme court hearing, a la "Brown and Williamson" to decide the second part of the story. Are all Nicotine products Tobacco Products or are they Drugs?
Can anyone in the know answer that question?
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These companies are probably the main instigaters here in the U.S. as well. The organizations that receive huge donations from them petitioned the FDA to ban the products and have sent out model legislation wording to their state and local chapters to try to ban them at the local level. The Big Four are the American Cancer Society, American Heart Association, American Lung Association, and Campaign for Tobacco-free Kids. The American Medical Society has also chimed in, and we all know how much doctors are given by the pharma companies.
You might be right. Thousands and thousands of more healthier americans might hurt the big pharma profits. And here I thought the tobacco industry was running things over at the FDA. Heh. Now don't even go mentioning holistic doctors (what our ancestors had 100 years ago), that might get you hung, or at least thrown in jail to be "made an example of".
I suspect the following line from the petition for rehearing may be foretelling:
"FDA is in a better position than a court to ensure
that its implementation of this grant of authority furthers Congress’s overarching goal
to confront “the tobacco problem.”
Is this not just laying the groundwork for FDA to follow Judge Garland's opinion when concurring in the judgement:
"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."
Is FDA just laying the groundwork to sidestep the legal interpretation of B&W and the Tobacco Act using Chevron?
sounds like they want to sidestep the whole government structure. Kind of like telling a novice poker player your pair beats their straight because you know the game and they don't. It also seems like a spit in the face to most of the judges. Telling them they can't rule on this because that might cut into their authority by interpreting the law, which is, after all, the courts job.
With all the hoopla going on I completely missed Julies Birthday yesterday!
Happy Birthday JJ!! I hope you had a wonderful FDA free day!
Wiz!
Happy Birthday JJ!! I hope you had a wonderful FDA free day!
Wiz!
You're right Bshalaby, it has always been the giant pharmaceuticals that have been trying to squash and kill ecigs. Because ecigs totally threaten their bottom line - profits - as ecigs are so much more effective than the woefully ineffective and hugely expensive Pharma nicotine products, and are much more enjoyable to use as well. And as Vocalek posted, the huge so-called "health" groups that receive millions in funds from the pharmaceuticals have been their front men in that struggle all along.
However, in this you are wrong. Neither the court ruling nor the tobacco legislation changes anything with respect to nicotine-based pharma cessation products. The definition of "tobacco product" in the statute, in relevant part, is as follows:
(rr) (1) The term tobacco product means any product
made or derived from tobacco that is intended for human
consumption, including any component, part, or
accessory of a tobacco product . . .
(2) The term tobacco product does not mean an article
that is a drug under [the FDCAs drug provision], a
device under [the FDCAs device provision], or a
combination product described in [the FDCAs
combination product provision].
21 U.S.C. § 321(rr).
As you can see, section one of the statute is what makes ecigs a "tobacco product". But section two is what keeps pharma nicotine products in the same category - drug products - that they have always been in. As the Court of Appeals decision also says: "The Tobacco Act itself states that it does not affect, expand, or limit the FDAs jurisdiction to regulate products under the drug/device provisions of the FDCA, 21 U.S.C. § 387a(c)(1)."
So long as a nicotine product is developed, approved, and marketed specifically with the intended use of treating nicotine addiction and/or smoking cessation, it can and will be regulated by the FDA under the FDCA as a drug product. And that propostion includes any given ecig brand that wants to market itself specifically as a cessation device. And so said the Court of Appeals decision as well. But ecigs that are marketed solely as a smoking alternative, or as tobacco products are traditionally marketed, solely for recreational use, they are only subject to regulation under the tobacco act (well, so long as the Court of Appeals decision is not overturned, which I doubt will happen).
It makes me mad that some originally marketed e-cigs as a cessation device in the first place, I just took it up so I could "Smoke" without affecting everybody around me adversely. It just turned out that I stopped smoking analogs altogether after my first PV experience. That was not my intention, I just like to smoke(Vape Now).
Thanks,
Jeff!
Thanks,
Jeff!
If they ban it, they will not stop me from getting my liquids and atomizers from China. But it will suck that many of the would be saved smokers will die. Everyone in power at the FDA should be put in prison for life.
relax
the courts ruled in our favor twice
this from legal one (who should know)
FDA appeal
Folks:
The FDA was dealt a serious blow to its authority and it is acting in desperation to try and save a few careers. Tactically they played into a huge trap and now they are stuck. By classifying this as a tobacco product and arguing along the Brown and Williamson case line we put FDA into a very difficult position legally. I expected that they would not try and agree that this is a tobacco product but would rather fight to the end that it is a drug/device which would walk them into the same logic path in Brown and Williamson. Brown and Williamson really does not make sense if you really dig into the logic but it is the law. If a burning cigarette is not a drug/device that delivers nicotine neither can a battery powered one be a drug/device - changing the mode of action from combustion to electronic thermal gradient increase to get nicotine out of a tobacco product doesn't change the ultimate nature of the "device". Now that the e-cigarette is effectively linked to conventional cigarettes the only real way to undo this is to re-write Brown and Williamson which will impact the tobacco industry - not likely. Filing for re-hearing and taking as many cuts at the apple as possible gives FDA political cover and that is what the bureaucrats seek right now. Enjoy the moment and the fact that the more attention and debate this gets the more difficult it is to deny the simple truth that in the end, an electronic cigarette is a less harmful way to "enjoy" the primary desired component of tobacco - nicotine. Once you get the argument to the real issue - whether humans can use nicotine as a recreational product - you will have many allies in the tobacco industry.
the courts ruled in our favor twice
this from legal one (who should know)
FDA appeal
Folks:
The FDA was dealt a serious blow to its authority and it is acting in desperation to try and save a few careers. Tactically they played into a huge trap and now they are stuck. By classifying this as a tobacco product and arguing along the Brown and Williamson case line we put FDA into a very difficult position legally. I expected that they would not try and agree that this is a tobacco product but would rather fight to the end that it is a drug/device which would walk them into the same logic path in Brown and Williamson. Brown and Williamson really does not make sense if you really dig into the logic but it is the law. If a burning cigarette is not a drug/device that delivers nicotine neither can a battery powered one be a drug/device - changing the mode of action from combustion to electronic thermal gradient increase to get nicotine out of a tobacco product doesn't change the ultimate nature of the "device". Now that the e-cigarette is effectively linked to conventional cigarettes the only real way to undo this is to re-write Brown and Williamson which will impact the tobacco industry - not likely. Filing for re-hearing and taking as many cuts at the apple as possible gives FDA political cover and that is what the bureaucrats seek right now. Enjoy the moment and the fact that the more attention and debate this gets the more difficult it is to deny the simple truth that in the end, an electronic cigarette is a less harmful way to "enjoy" the primary desired component of tobacco - nicotine. Once you get the argument to the real issue - whether humans can use nicotine as a recreational product - you will have many allies in the tobacco industry.
- Apr 2, 2009
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I largely agree with Legal One's most recent posting.
Now is the time for consumer and public health advocates to criticize the FDA (more specifically FDA Deputy Commissioner Josh Sharfstein) for wasting millions of dollars of taxpayers money litigating this case, and for delaying the inevitable promulgation of tobacco regs to reclassify e-cigarettes (and other smokefree nicotine products that aren't approved by FDA to treat nicotine dependence) as tobacco products.
Every week and month that FDA litigates this case is another week and month before the FDA will actually regulate the products. Although e-cigarette pose very minimal and easily managable health and safety risks, the FDA refusal to propose even modest regulations for the products (i.e. reclassifying them as tobacco) is increasing the likelihood that adverse events could occur with the products.
If FDA officials really cared about public health and safety, they would end the agency's quixotic litigation strategy.
Now is the time for consumer and public health advocates to criticize the FDA (more specifically FDA Deputy Commissioner Josh Sharfstein) for wasting millions of dollars of taxpayers money litigating this case, and for delaying the inevitable promulgation of tobacco regs to reclassify e-cigarettes (and other smokefree nicotine products that aren't approved by FDA to treat nicotine dependence) as tobacco products.
Every week and month that FDA litigates this case is another week and month before the FDA will actually regulate the products. Although e-cigarette pose very minimal and easily managable health and safety risks, the FDA refusal to propose even modest regulations for the products (i.e. reclassifying them as tobacco) is increasing the likelihood that adverse events could occur with the products.
If FDA officials really cared about public health and safety, they would end the agency's quixotic litigation strategy.
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