and @sonicdsl
Hmmm.... I never saw that which should be obvious by my reply :- ) .... it may have been my own cache or something.... thanks sonic dsl for correcting it.
FDA Another lawsuit filed! E-Vaping Coalition of America
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and @sonicdsl
Hmmm.... I never saw that which should be obvious by my reply :- ) .... it may have been my own cache or something.... thanks sonic dsl for correcting it.
Is either one of these lawsuits seeking an injunction to stop the deeming from going into effect in August pending a judicial decision?
It was actually the title on the page itself that is incorrect (or was, if now corrected). At any rate, you're welcome
Excellent.
Yes, interesting. Not sure how this plays out. I see pros and cons. Hate to put all the eggs into one basket
furthermore...
If Judge Jackson will by trying this case it should be noted she's an Obama appointee.
Okay..... maybe not
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Maybe SG... But note what retired1 pointed out. It may be a silver lining!Excellent.
Okay..... maybe not
Posting to bump this back up. Anyone can donate to "The Right to be Smoke-Free Coalition". Support the lawsuit against the FDA here:
Right to be Smoke-Free Coalition | Fight For Sensible E-Vapor Laws
(too bad this threads title does not mention this. Sonicdsl..?)
Right to be Smoke-Free Coalition | Fight For Sensible E-Vapor Laws
(too bad this threads title does not mention this. Sonicdsl..?)
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Latest docket report for the Nicopure suit. I'm exhausted, so could have overlooked it, but I see no injunction forestalling implementation of the rule on the deeming date.
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Everyone's filing briefs and arguments for the time being. The earliest an injunction could occur is in October when everyone is due back in court.
I think this is the right place to post this: Tobacco On Trial » Blog Archive » DOCKET for NICOPURE LABS v. FDA et al, Jul 29-Aug 2, 2016
Anyone want to decode that?
Anyone want to decode that?
Interesting points.... (my emphasis underlined)
47....
Specifically, Congress sought to strike a balance in the TCA between, on the
one hand, prohibiting FDA from effectively banning tobacco products, and instead ensuring that
adults continue to have ready access to such products while, on the other hand, taking steps so
that such products are not accessible to underage consumers. Further, Congress instructed FDA
to regulate tobacco products in a manner that promotes the introduction and sale of safer and less
harmful tobacco products, rather than keeping them off the market.
48. The TCA’s “Purposes” section explicitly provides that FDA must “continue to
permit the sale of tobacco products to adults in conjunction with measures to ensure that they are
not sold or accessible to underage purchasers.”
54. Finally, the TCA’s “Purposes” section provides that the statute is intended to
“strengthen legislation against illicit trade in tobacco products.” Pub. L. No. 111-31, § 3(10),
123 Stat. 1776, 1782 (2009). This indicates that FDA should not regulate deemed products,
including ENDS, in a manner that would foster a black market, such as by banning or severely
restricting the legitimate availability of a product category.
59. In fact, the only PMTAs that have been authorized by FDA to date are for eight
(8) smokeless tobacco (snus) products that have already been subject to extensive clinical and
long-term epidemiological studies.
[this is one reason why I have said that even the tobacco companies PMTA's may not be accepted. And there have been some SE applications accepted but not PMTAs which is what all* ENDS products will require. The FDA has said (as it says in the suit, there 'may be' one ecig grandfathered, where the possibility of SE is available, but that's a stretch, imo.]
I like the fact that the suit brings up one of the most overused lines of ANTZ PR - "there are no long term studies" and uses it against them :- )
FDA Concedes That No Long-Term Clinical Data Exists On ENDS Products
63. Even though FDA is forcing ENDS products manufacturers into a PMTA process
that will require long-term clinical and other similar studies, the Agency concedes that such
information does not presently exist. See, e.g., 81 Fed. Reg. at 28,984 (“there have not yet been
long-term studies conducted”), id. at 29,028 (“long-term studies are not yet available”), 29,031
(“no adequate data on long-term health effects”), id. at 29,041 (“[l]ong-term studies are not
available”); PMTA Draft Guidance at 14 (“Given the relatively new entrance of ENDS on the
U.S. market, FDA understands that limited data may exist from scientific studies and analyses;
id. at 30 (“Due to the emerging nature of ENDS products . . . FDA acknowledges that there may
be limited . . . clinical research”); 79 Fed. Reg. at 23,152, 23,157, 23,166 (FDA noting lack of
sufficient data regarding ENDS products).
So basically, not only is the PMTA process too long and extensive to be done within the time frame, it's also, according to the FDA, impossible!!??
68. At the same time, notwithstanding FDA’s uncertainty, the Agency acknowledges
that additional studies and research may further confirm that ENDS products have a lower risk
profile than traditional tobacco products. See, e.g., 81 Fed. Reg. at 29,030 (“FDA recognizes
that completely switching from combusted cigarettes to ENDS may reduce the risk of tobacco
Case related disease for individuals currently using combusted tobacco products, given the products’
comparative placements on the continuum of nicotine-delivering products”); id. at 29,032 (FDA
“agrees that the exhaled aerosol from ENDS users is potentially less hazardous than secondhand
smoke from combusted cigarettes”); id. at 29,035 (“FDA agrees that use of ENDS is likely less
hazardous for an individual user than continued smoking of traditional cigarettes”); id. at 29,039
(FDA conceding that “ENDS may potentially provide cessation benefits”).
This would be a good place for Zeller's famed comment:
"If we could get all of those people [who can't or wont quit smoking conventional cigarettes] to completely switch all of their cigarettes to the non-combustible products that would be good for public health."
Although he 'revises' it in the next passage....
"But our job as the regulator is to figure out what is going on at the population level and it includes the much larger group of smokers not like the first group I defined, a much larger group of smokers who are concerned about their health and who are interested in quitting and what happens instead of those people completely substituting with a non-combustible product, they start using both, and then along the way they wind up becoming less interested in quitting. So then we would say that might not be good for public health, and our job is to figure out what is the net of all of those possible behaviors including any initiation which would not be good for public health and then try to make public policy on top of that."
[from an earlier post]
And the true fallacy of the idea that dual use will lead back to smoking is shown in his own understanding of the people in the 'larger group': those "who are concerned about their health and who are interested in quitting." But those who are 'concerned about their health' would be those who already know that they should be concerned, and about what they are concerned. IE. that smoking combustible tobacco can lead to illness and early death. If they've found their way to ecigarettes and choose that as an alternative, they do that for the very reason why they are 'concerned about their health!' and have likely done a bit of research on it.
But Zeller ignores the obviousness of the above and of the implications of what he says. He invalidates his own premise: of 'those who are concerned' and concludes by saying they will go back to smoking and what? forget about what they were concerned about?
The "syllogism" would look something like this:
A large group is very concerned about their health.
Quitting smoking would eliminate that concern.
Therefore: The will continue to smoke.
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Also meant to include this - the source of the term "deeming" no doubt... from the Tobacco Control Act....
31. FDA was initially charged under the TCA with regulating “all cigarettes, cigarette
tobacco, roll-your-own tobacco, and smokeless tobacco.” In addition, it was given authority to regulate in the future “any other tobacco products that [the Agency] by regulation deems to be subject to this chapter.” 21 U.S.C. § 387a(b). The Deeming Rule subjects a wide range of ENDS products to the TCA’s requirements. 81 Fed. Reg. at 28,975.
Excellent and very solid / encouraging points of logic in the lawsuit, as was your breakdown and commentary of it.
Nicely done, Kent!
I'm Not a Lawyer.
But as I understand it, an Amicus Brief is a Document that is filed with the court by a Party who has an Strong Interest in the Litigation but is a Not a Litigant. And these Interested Non-Litigant Parties are refereed to as an Amicus Curiae (Friend of the Court).
So we might Ask someone like Dr. F to present some information which we feel could Help Us. Even though he is Not a Litigant on our side who is Seeking a Remedy.
Don't know much about the Motions that were Denied? But it sounds like the Judge did not feel they contained Relevant Information that could be used in supporting our side of the Argument.
Two of the motions were denied without prejudice. That means the parties can "correct" the issues noted by the court (in this case, it appears that Bates and Vape a Vet Project briefs must state their position as directly related to Plaintiffs' claims - ref. LCvR 7(o)2) and file a new motion. By denying without prejudice, Judge Amy Berman Jackson is saying she's open to hearing what the Amici Curiae have to say.
The CASAA motion to file an amicus brief was denied because FDA did not have the survey of 20k vapors that CASAA wanted to present when they developed the regs - i.e., the survey is not part of FDA's administrative record.
This is interesting: Judge Jackson is clear that the case will be decided based on the administrative record. So, what information is in the record? Will Senator Johnson's information requests demonstrate that FDA actions willfully ignored both scientific evidence and economic impact?
The CASAA motion to file an amicus brief was denied because FDA did not have the survey of 20k vapors that CASAA wanted to present when they developed the regs - i.e., the survey is not part of FDA's administrative record.
This is interesting: Judge Jackson is clear that the case will be decided based on the administrative record. So, what information is in the record? Will Senator Johnson's information requests demonstrate that FDA actions willfully ignored both scientific evidence and economic impact?
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I have read the complaints. The plaintiffs are all seeking injunctions. That's what plaintiffs always seek in these cases. To butcher a biblical passage, "You can see, but you may not find." We'll see what happens.
Correction: Plaintiffs seek an injunction in their complaint(s). However, there is no separate motion seeking an emergency injunction. The injunctive relief claim(s) will be decided on summary judgment.
In cases I've worked on in federal court, we always file separate motions for emergency injunction. No clue why Plaintiffs aren't doing that here, but I haven't checked the docket recently, so maybe they have.
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