Deeming Regulations have been released!!!!

Eskie

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Yes, and it will focus on the FDA's touching concern for the cheeldreen, whose use of ENDS is [supposedly] increasing at an "alarming" rate. It almost brings me to tears just thinking about it. It's a winning tactic to portray your opposition as callously indifferent to the welfare of cheeldreen, particularly when your judge is a Jewish mom.*

*Not to suggest that mothers of other faiths, as well as fathers, don't care about the well being of children.

At least the Nicopure/group attorneys took some of the air out of that by not only ceding the issue, but demonstrating the industry was already taking those steps without Federal regulation. Oral arguments will just be a rehash of everything already submitted, although there might be a better reading of the tea leaves watching how the judge handles them. A month or two to wait on the ruling that summary judgement are denied to both parties, and on to endless motions and depositions. Oh joy.
 

bigdancehawk

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At least the Nicopure/group attorneys took some of the air out of that by not only ceding the issue, but demonstrating the industry was already taking those steps without Federal regulation. Oral arguments will just be a rehash of everything already submitted, although there might be a better reading of the tea leaves watching how the judge handles them. A month or two to wait on the ruling that summary judgement are denied to both parties, and on to endless motions and depositions. Oh joy.
I don't think so. 95% probability that the judge will grant one of the motions, IMO. Then it's off to the court of appeals.
 

Buckeyevapen

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I don't think so. 95% probability that the judge will grant one of the motions, IMO. Then it's off to the court of appeals.
If your prediction proved true and there is a 95% chance of a ruling one way or another. Would the judges ruling be enforcedable pre or post appeal process?
 

bigdancehawk

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If your prediction proved true and there is a 95% chance of a ruling one way or another. Would the judges ruling be enforcedable pre or post appeal process?
That depends. If the plaintiffs win, the FDA will move for a stay of execution while the case is pending on appeal. If that motion is granted, the FDA will continue enforcement. If it's denied, the FDA would not be able to enforce those provisions of the regulation which the judge found to be illegal. The odds that such a motion would be granted are less than 50/50. If the FDA wins, the plaintiffs may move for a stay, but I doubt that would be granted.
 

bigdancehawk

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You really think the judge would offer a summary judgement based on just these filings?
Yes. Judicial review of agency rule making is different from most other civil suits. Think of it more like an appeal following a trial. In an appeal, all of the evidence has already been presented at trial and a decision has been rendered. On appeal, new evidence isn't allowed. The appeal is decided based entirely on the evidence already in the record at the trial court level. The parties file briefs and present arguments explaining why the trial court's rulings and/or judgment are right or wrong and the appeals court reviews the record and decides. In other words, judicial review is just that--a review.

What makes this extra tough for the plaintiffs is that the judge is supposed to "defer" to the FDA because, theoretically, they are "experts" at whatever they're regulating. So even if the judge disagrees with some of the FDA's factual findings, she may find that it's outside the proper bounds of her judicial role to overturn them if there's any evidence, however flimsy, to support them. That's why the plaintiffs' briefs wisely focus mainly on legal issues and the FDA's logical fallacies and inconsistencies, rather than getting into an argument over which side has better science behind it. FDA employees are not presumed to be experts on logic or the law and they are not entitled to any deference in those areas.
 

Eskie

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Yes. Judicial review of agency rule making is different from most other civil suits. Think of it more like an appeal following a trial. In an appeal, all of the evidence has already been presented at trial and a decision has been rendered. On appeal, new evidence isn't allowed. The appeal is decided based entirely on the evidence already in the record at the trial court level. The parties file briefs and present arguments explaining why the trial court's rulings and/or judgment are right or wrong and the appeals court reviews the record and decides. In other words, judicial review is just that--a review.

What makes this extra tough for the plaintiffs is that the judge is supposed to "defer" to the FDA because, theoretically, they are "experts" at whatever they're regulating. So even if the judge disagrees with some of the FDA's factual findings, she may find that it's outside the proper bounds of her judicial role to overturn them if there's any evidence, however flimsy, to support them. That's why the plaintiffs' briefs wisely focus mainly on legal issues and the FDA's logical fallacies and inconsistencies, rather than getting into an argument over which side has better science behind it. FDA employees are not presumed to be experts on logic or the law and they are not entitled to any deference in those areas.

So either way this is going to the appellate court. I don't think the plaintiffs would have gone this far without expecting an appeal regardless of the outcome.
 

gerrymi

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There is no credible evidence to date that vaping e-cigarettes causes anywhere close to the harm that is caused by smoking tobacco, but there is evidence that the regulations will likely drive many e-cigarette users back to smoking, and to buy e-cigarette products of unknowable quality and safety from vendors with little care for the consumer’s health. There is far too much at stake for the over 9 million Americans who currently use e-cigarettes to leave the regulations as they are.

Unintended consequences of the FDA’s e-cigarette regulations


..
 

r055co

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That depends. If the plaintiffs win, the FDA will move for a stay of execution while the case is pending on appeal. If that motion is granted, the FDA will continue enforcement. If it's denied, the FDA would not be able to enforce those provisions of the regulation which the judge found to be illegal. The odds that such a motion would be granted are less than 50/50. If the FDA wins, the plaintiffs may move for a stay, but I doubt that would be granted.

You really think the judge would offer a summary judgement based on just these filings?
Best case scenario where the courts throw out the FDA reg's and Government doesn't tax the hell out of anything Vaping.. But to be perfectly honest with how corrupt our Government is I very highly doubt this will come to be. We're going to get screwed people, this is the reality. I sincerely hope that I am wrong and with all time and money I've spent will just have a lot of gear to use, trade and/or sell.
 

skoony

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At least the Nicopure/group attorneys took some of the air out of that by not only ceding the issue, but demonstrating the industry was already taking those steps without Federal regulation. Oral arguments will just be a rehash of everything already submitted, although there might be a better reading of the tea leaves watching how the judge handles them. A month or two to wait on the ruling that summary judgement are denied to both parties, and on to endless motions and depositions. Oh joy.
I am not sure this will result in the outcome you anticipate.
This doesn't negate the testing necessary using -18 year olds
in the studies you have to submit.
Granted one couldn't include them for all the obvious reasons but,
that testing is still required. Analysis of those that don't or unlikely
to use or not use tobacco products.
This little gem means complete clinical analysis of everyone in the world.
 

Mazinny

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HR 2058 and Cole/Bishop written by Altria
I think it's also a conflict of interest when Big Tobacco (Altria) has actually aided the FDA in how to write up these regulations, since we are their competition.
Here is some more evidence pointing to the fact that not only Altria didn't help write the deemings, it is actively fighting the deemings. This article provides evidence that the HR 2058 was pulled verbatim from
Altria's draft, given to Rep. Tom Cole by Altria, two weeks earlier.

Documents obtained by The New York Times show that Altria last year distributed draft legislation on Capitol Hill that would eliminate the new requirement that most e-cigarettes already on sale in the United States be evaluated retroactively to determine if they are “appropriate for the protection of public health.”

The proposal was endorsed by the R.J. Reynolds Tobacco Company, which has its own e-cigarette unit, as well as the National Tobacco Company, a major seller of loose tobacco, and trade associations representing the cigar industry and convenience stories, the documents show.

Altria delivered its proposal, entitled “F.D.A. Deeming Clarification Act of 2015,” to Representative Tom Cole of Oklahoma in April 2015, the documents show, even before the F.D.A. rule became final.

Just two weeks later, Mr. Cole introduced the bill — with the title and 245-word text pulled verbatim from the industry’s draft.


http://www.nytimes.com/2016/09/03/u...n-region&region=top-news&WT.nav=top-news&_r=0

http://www.nytimes.com/interactive/2016/08/26/us/politics/document-tobacco-lobbying-documents.html
 
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Bea-FL

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Yes. Judicial review of agency rule making is different from most other civil suits. Think of it more like an appeal following a trial. In an appeal, all of the evidence has already been presented at trial and a decision has been rendered. On appeal, new evidence isn't allowed. The appeal is decided based entirely on the evidence already in the record at the trial court level. The parties file briefs and present arguments explaining why the trial court's rulings and/or judgment are right or wrong and the appeals court reviews the record and decides. In other words, judicial review is just that--a review.

What makes this extra tough for the plaintiffs is that the judge is supposed to "defer" to the FDA because, theoretically, they are "experts" at whatever they're regulating. So even if the judge disagrees with some of the FDA's factual findings, she may find that it's outside the proper bounds of her judicial role to overturn them if there's any evidence, however flimsy, to support them. That's why the plaintiffs' briefs wisely focus mainly on legal issues and the FDA's logical fallacies and inconsistencies, rather than getting into an argument over which side has better science behind it. FDA employees are not presumed to be experts on logic or the law and they are not entitled to any deference in those areas.
Is it allowed by ECF rules to ask how you know so much about the way court law works? If not I apologize and ignore the question.
 

Mazinny

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HR 2058 and Cole/Bishop written by Altria

Here is some more evidence pointing to the fact that not only Altria didn't help write the deemings, it is actively fighting the deemings. This article provides evidence that the Cole/Bishop amendment was pulled verbatim from
Altria's draft, given to Cole by Altria, two weeks earlier.

http://www.nytimes.com/2016/09/03/u...n-region&region=top-news&WT.nav=top-news&_r=0

http://www.nytimes.com/interactive/2016/08/26/us/politics/document-tobacco-lobbying-documents.html
Like it or not, BT are our allies in the fight against the deemings, and specifically to change the predicate date. They have the lobbying muscle, not us. No BT, no Cole/Bishop amendment.
 
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zoiDman

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Like it or not, BT are our allies in the fight against the deemings, and specifically to change the predicate date. They have the lobbying muscle, not us. No BT, no Cole/Bishop amendment.

I wonder how well a BT perceived authored Amendment to an Appropriation Bill would/will go over with some House and Senate Members?
 

Mazinny

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I wonder how well a BT perceived authored Amendment to an Appropriation Bill would/will go over with some House and Senate Members?
I mean it passed 31 to 19 in committee. Is there a reason why the margins shouldn't be similar in a full vote ? It seems we have most Republicans and BT friendly Democrats on our side. Perhaps it depends on who gave more to them, BP or BT :)
 

zoiDman

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I mean it passed 31 to 19 in committee. Is there a reason why the margins shouldn't be similar in a full vote ? It seems we have most Republicans and BT friendly Democrats on our side. Perhaps it depends on who gave more to them, BP or BT :)

That is Yet to be seen.
 
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Mazinny

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That is Yet to be seen.
Yeah, come to think of it some members may chose to vote against, if it is widely known the bill and/or amendment was literally authored word for word by Altria. I wonder how many people knew this within the industry ? Did SFATA, VTA, CASAA etc.. know of this ?
 

seminolewind

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Yeah, come to think of it some members may chose to vote against, if it is widely known the bill and/or amendment was literally authored word for word by Altria. I wonder how many people knew this within the industry ? Did SFATA, VTA, CASAA etc.. know of this ?

I knew it. But everyone here said "prove it". I know the FDA asked BT about the wording of this regulation. I was sooo mad.
 
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