SE, NJoy vs FDA -- Discussion
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Question, anyone (well, questions):
The understand I'm getting is that the FDA's filing for a new appeal (when I was 6, I used to call this sort of thing a do-over) would, if granted, be held before the full DCC Court of Appealsthe same 13-member body from which the 3-member panel was drawn. True?
If so, Does this not mean the FDA would make the same 0-2 case (0-4, if you want to count the actual number of legal opinions) beforeamong othersthe same three jurists they've already publicly stated don't know what the &%$# they're doing and ought to go back to law school? Ok, I paraphrased that. But that's essentially it, right?
Now, I'm getting that the new appeal being granted at all isn't a slam dunk. Does anyone know the actual likelihood? How long does it generally take for a decision to be made? If it's granted, is a judgement on it likely in 2011?
The understand I'm getting is that the FDA's filing for a new appeal (when I was 6, I used to call this sort of thing a do-over) would, if granted, be held before the full DCC Court of Appealsthe same 13-member body from which the 3-member panel was drawn. True?
If so, Does this not mean the FDA would make the same 0-2 case (0-4, if you want to count the actual number of legal opinions) beforeamong othersthe same three jurists they've already publicly stated don't know what the &%$# they're doing and ought to go back to law school? Ok, I paraphrased that. But that's essentially it, right?
Now, I'm getting that the new appeal being granted at all isn't a slam dunk. Does anyone know the actual likelihood? How long does it generally take for a decision to be made? If it's granted, is a judgement on it likely in 2011?
Already talked about Politically. A few pages back I posted the relevant Federal Appellate Rule, which specifically states that a rehearing en banc - before the full court - "is not favored and ordinarily will not be ordered unless:
(1) en banc consideration is necessary to secure or maintain uniformity of the court’s decisions; or
(2) the proceeding involves a question of exceptional importance."
Likelihood is very low.
Here's that post: http://www.e-cigarette-forum.com/fo...e-njoy-vs-fda-discussion-117.html#post2348239
(1) en banc consideration is necessary to secure or maintain uniformity of the court’s decisions; or
(2) the proceeding involves a question of exceptional importance."
Likelihood is very low.
Here's that post: http://www.e-cigarette-forum.com/fo...e-njoy-vs-fda-discussion-117.html#post2348239
Seriously, the whole "unproven smoking cessation claims" argument is an FDA deception. When the FDA says "smoking cessation product" what they really mean is "nicotine addiction cure." The FDA asserts that saying something helped you "quit smoking" is a claim of treating or mitigating a disease, even though nicotine addiction is what is considered the "disease," not the action of "smoking." Smoking is a result of the so-called disease, not the disease itself. It's also completely illogical to argue that someone who is no longer inhaling smoke hasn't quit smoking because they still are addicted to nicotine. That's like arguing that I'm still a "coffee drinker," after I've switched to Pepsi, because I'm still getting caffeine.
To get into trouble for making "smoking cessation claims" is ridiculous, because smoking is not a disease and few if any vendors ever made "nicotine addiction cure" claims. The FDA also went after companies who never made either claim, but just posted testimonials - some of which included customers who said they quit using tobacco cigarettes, but never claimed they were cured of nicotine addiction.
So, even if no company EVER made "smoking cessation claims," the FDA would have gone after them one way or another. It was a damned if you do, damned if you don't scenario.
It's amazing how many things that the FDA, working in concert with the pharmaceutical companies, have turned into a "disease". There is even an ICD-9-CM medical code for having high cholesterol numbers, when that actually isn't a disease at all. Scientists have noticed a correlation between higher cholesterol levels and cardiovascular disease, but correlation isn't necessarily causation. It may be that whatever substance is causing the cardiovascular problems (possibly C-reactive proteins) gets elevated at the same time that cholesterol levels do.
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The alphabet soup group has filed an amicus brief in support of the FDA's request for a rehearing/rehearing en banc.
Once again, I am stunned that some of these people are able to sleep at night.
Once again, I am stunned that some of these people are able to sleep at night.
"The amici are all national
organizations committed to preserving the public health and have each been at the
forefront of efforts to regulate the use of cigarette and other tobacco and nicotine delivery
products in the United States in order to reduce the morbidity and
mortality caused by tobacco use."
"Additionally, through state
and specialty medical societies and other physician groups, seated in the AMA’s
House of Delegates, substantially all United States physicians, residents, and
medical students are represented in the AMA’s policy making process."
So now nicotine is synonymous with tobacco and the AMA speaks for EVERY physician, resident and medical student. Even those who have encouraged their patients to continue use of e-cigs and even those who rally for their use.
organizations committed to preserving the public health and have each been at the
forefront of efforts to regulate the use of cigarette and other tobacco and nicotine delivery
products in the United States in order to reduce the morbidity and
mortality caused by tobacco use."
"Additionally, through state
and specialty medical societies and other physician groups, seated in the AMA’s
House of Delegates, substantially all United States physicians, residents, and
medical students are represented in the AMA’s policy making process."
So now nicotine is synonymous with tobacco and the AMA speaks for EVERY physician, resident and medical student. Even those who have encouraged their patients to continue use of e-cigs and even those who rally for their use.
havent these hypocrite groups filed briefs for their fda support before??
the judges are probably disgusted
all this time & taxpayer $$$ wasted they can be regulating ecigs as a tobacca product like the laws/courts state. instead of doing their job protecting the the public health, fda is "working" for big pharm. this is corruption.
the judges are probably disgusted
all this time & taxpayer $$$ wasted they can be regulating ecigs as a tobacca product like the laws/courts state. instead of doing their job protecting the the public health, fda is "working" for big pharm. this is corruption.
The alphabet soup group has filed an amicus brief in support of the FDA's request for a rehearing/rehearing en banc.
Once again, I am stunned that some of these people are able to sleep at night.
For us laypersons, how does this affect the likelihood of success?
The DC Circuit Court rules state that:
35 "(f) Brief of an Amicus Curiae. No amicus curiae brief in response to or in support of a petition for rehearing en banc will be received by the clerk except by invitation of the court."
Let's hope these idiots get their motion and their brief thrown back in their faces!
35 "(f) Brief of an Amicus Curiae. No amicus curiae brief in response to or in support of a petition for rehearing en banc will be received by the clerk except by invitation of the court."
Let's hope these idiots get their motion and their brief thrown back in their faces!
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As I feared, whether by intent or not, Judge Garland left open the door for this action, not that the FDA et.al wouldn't have done it anyway, but still, it makes me quite nervous re: the specific focus on Judge Garland's opinions especially concerning the possibililty of the FDA's ability to adopt additional and specific exclusionary provisions to bump the e-cig into the FDCA classification. The roller coaster continues, I sincerely hope that the court holds fast and refuses their petition for rehearing en banc.
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