Sun, that sounds great but it also sounds ground breaking. Which we all know is neither easy or cheap. I contend that snus should be considered in the same way.
The face of death?
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That does not negate the filing of another lawsuit with a different theory of the case. Again, trying to bootstrap on the loopholes of tobacco legislation instead of the e-cig standing in its own catagory is not the way to go IMO.
The FDA needs to practice what it preaches and help to speed innovations as it states in its mission statement.
Sun
To get into the reduced harm category will require PROOF, which is nearly impossible and as expensive and time-consuming as getting approval as a drug. It would have the same effect as having it declared a drug, as there is no concrete evidence at this time and studies are needed.I agree with Sun here.......lots of bad things could stem from ecigs being regulated as a tobacco product. Interstate traffic, internet shops(mailorder), strength of nicotine allowed, even the various flavors we see now could be in jeopardy as a result from what I can see.
The only category that really works is reduced harm product.....and that seems the least likely.
To get into the reduced harm category will require PROOF, which is nearly impossible and as expensive and time-consuming as getting approval as a drug. It would have the same effect as having it declared a drug, as there is no concrete evidence at this time and studies are needed.
Emphasis mine.The courts have repeatedly made clear that FDA enforcement activity is subject to the First Amendment rules regarding allocation of burden of proof in First Amendment cases. For example, the U.S. Court of Appeals for the District of Columbia Circuit held recently that the First Amendment imposes strict limitations on FDA’s power to restrict health claims made by manufacturers of dietary supplements, even when the claims are made on the product label. Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999) (“Pearson I”). In overturning a district court decision that had upheld FDA’s outright ban on such claims when use of disclaimers might have responded fully to FDA’s concerns, the appeals court stated:
The government insists that it is never obliged to utilize the disclaimer approach, because the commercial speech doctrine does not embody a preference for disclosure over outright suppression. Our understanding of the doctrine is different. . . . In more recent cases, the [Supreme] Court has . . . repeatedly point[ed] to disclaimers as constitutionally preferable to outright suppression.
Id. at 657. The court added, “[W]hen government chooses a policy of suppression over disclosure – at least where there is no showing that disclosure would not suffice to cure misleadingness – government disregards a ‘far less restrictive’ means” of achieving its policy interests. Id. at 658 (quoting Bd. of Trustees of SUNY, 492 U.S. at 479).
On remand, FDA’s First Amendment arguments were again rejected. The district court granted a preliminary injunction against FDA’s continued violation of First Amendment rights; the court required FDA to approve a health claim (for inclusion on product labeling for folic acid) regarding the positive relationship between consumption of folic acid and prevention of birth defects. Pearson v. Shalala, 130 F. Supp. 2d 105 (D.D.C. 2001) (“Pearson II”). The district court was harshly critical of FDA’s continued resistance to court orders that it comply with the First Amendment; the court said:
t is clear that the FDA simply failed to comply with the constitutional guidelines outlined in Pearson . Indeed, the agency appears to have at best, misunderstood, and at worst, deliberately ignored, highly relevant portions of the Court of Appeals Opinion.
Pearson II, 130 F. Supp. 2d at 112. The court held that under the First Amendment, FDA “must shoulder a very heavy burden if it seeks to totally ban a particular health claim.” Id. at 118. The court held that FDA had failed to meet that burden; it held that “[t]he mere absence of significant affirmative evidence in support of a particular [health] claim . . . does not translate into negative evidence ‘against’ it.” Id. at 115. In other words, the court held, any FDA efforts to regulate manufacturer dissemination of unapproved health claims must take the form of disclaimer requirements rather than outright bans on the claims, unless FDA can demonstrate that the claims are “against” the great weight of the scientific literature.3 The district court later denied FDA’s motion for reconsideration of the preliminary injunction order. Noting that FDA’s “arguments contained in the motion for reconsideration further demonstrate Defendants’ reluctance to fully comply with Pearson I,” the court reiterated its conclusion:
[T]he philosophy underlying Pearson I is perfectly clear: that the First Amendment analysis in Central Hudson . . . applies in this case, and that if a health claim is not inherently misleading, the balance tilts in favor of disclaimers rather than suppression. In its motion for reconsideration, the FDA has again refused to accept the reality and finality of that conclusion by the Court of Appeals.
Pearson v. Thompson, 141 F. Supp. 2d 105, 112 (D.D.C. 2001).
A lot of wishful thinking. We don't have the luxury of demanding a third option. Our choices are "drug device" or "tobacco product." Period. Wishful thinking, hemming and hawing, will only get us placed into the "drug device" and probably banned altogether. And who will fund this fantasy campaign to become a reduced harm product before the government dumps it into the drug category?
As a tobacco product now, it will give us time to lobby to move it into reduced harm tobacco, once the studies and research is completed, yet keep it on the market until that happens.
Trying to force that hand now is what would end up biting us in the .....
To get into the reduced harm category will require PROOF, The only way to keep ecigs on the market NOW is as a tobacco product.
Too little too late. Why are these suppliers hiding? Why have they not come forward to the consumer groups who are fighting for ecigs, at least? How does one align themselves with a group that has not presented themselves??Kristin---Other Suppliers filing suit is not wishful thinking, to the contrary it is coming. If you aligned yourself with some of these Suppliers, you would know that.
So no--it is not a fantasy, nor is it a fact that the only two categorizes open to the e-cig are "tobacco" or "drug". There is a good faith argument to be made for what was laid out.
Just because you read what Counsel for SE and NJOY wrote, do not think that is the "only option" because it is not.
Furthermore, who wants an FDA regulated e-cig? Who is going to use 4 mg. e-cigs? And what makes you think that the FDA will not require an approval process and show safety of e-cigs even if they are found to be a "tobacco" product?
No, the FDA can not ban a tobacco product, but there is nothing to say it can not demand an approval process which would create a de-facto ban until Suppliers complied.
Unfortunately, SE and NJOY's best case scenario here is to be deemed a tobacco product subject to FDA regulation. To think that is a "win" for the E-cig is fatal error. The FDA will lower the limit of nicotine down way below what most people need. You are not going to find 36mg or 24, let alone 18mg in a FDA regulated E-cig. Try to understand that. Try more like 4mg. and at that level, you might as well toss the e-cig out the window for most people.
So as the case would have it, it is shameful to sit here and agree that this should be the fate of e-cigs IMO.
Furthermore, this is not a campaign that needs to be "funded"---it is a lawsuit just like SE filed. Might it be consolidated with this case? Surely, but at least the theory is advanced.
To think that the only two options that can be plead in a Court of competent jurisdiction is "drug" or "tobacco" is where the real fantasy lies.
Staying the current course will not only bit us in the ...., but IMO is a path to disaster.
Sun
I believe the family tobacco act answers this, regarding reduced harm products. Before that passed, they maybe had a case.There are those that disagree:
Emphasis mine.
This is a quote from the Washington Legal Foundation's response to FDA's request for comments on implementation of the PACT Act.
Jan
Besides the fact that the FDA hasn't attempted to regulate the nicotine in actual tobacco leaf products, either. If the FDA attempts to reduce the nicotine in ecigs (as a tobacco product) but not cigarettes, they'd look like fools and it'd be a pretty easy battle.Sun,
While I agree that tobacco and drug are not the only options, it's doubtful that the FDA will be able to (unfairly) regulate an ecig down to 4mg without regulations to other tobacco products.
If ecigs do become tobacco products, the FDA will need to be consistent with its nicotine regulations if it wants to avoid product prejudice. In other words, if a cigarette is allowed up to 2mg of nicotine, then the FDA can't make the appropriate cigarette-equivalent of an ecig (or snus/orbs/etc.) contain a max of only 0.2mg of nicotine without legal repercussions.
EDIT: and of course the FDA will need to take quantities into consideration, otherwise ecig manufacturers will just start shortening the duration of their "4mg" cartridges.![]()
Kristin---Other Suppliers filing suit is not wishful thinking, to the contrary it is coming. If you aligned yourself with some of these Suppliers, you would know that.
So no--it is not a fantasy, nor is it a fact that the only two categorizes open to the e-cig are "tobacco" or "drug". There is a good faith argument to be made for what was laid out.
Just because you read what Counsel for SE and NJOY wrote, do not think that is the "only option" because it is not.
Furthermore, who wants an FDA regulated e-cig? Who is going to use 4 mg. e-cigs? And what makes you think that the FDA will not require an approval process and show safety of e-cigs even if they are found to be a "tobacco" product?
No, the FDA can not ban a tobacco product, but there is nothing to say it can not demand an approval process which would create a de-facto ban until Suppliers complied.
Unfortunately, SE and NJOY's best case scenario here is to be deemed a tobacco product subject to FDA regulation. To think that is a "win" for the E-cig is fatal error. The FDA will lower the limit of nicotine down way below what most people need. You are not going to find 36mg or 24, let alone 18mg in a FDA regulated E-cig. Try to understand that. Try more like 4mg. and at that level, you might as well toss the e-cig out the window for most people.
So as the case would have it, it is shameful to sit here and agree that this should be the fate of e-cigs IMO.
Furthermore, this is not a campaign that needs to be "funded"---it is a lawsuit just like SE filed. Might it be consolidated with this case? Surely, but at least the theory is advanced.
To think that the only two options that can be plead in a Court of competent jurisdiction is "drug" or "tobacco" is where the real fantasy lies.
Staying the current course will not only bit us in the ...., but IMO is a path to disaster.
Sun
The Tobacco Act authorizes the FDA to develop specific standards for evaluating products that companies intend to promote as reduced exposure or reduced-risk products. Such products would be those, as indicated by the manufacturer explicitly or implicitly, that present a lower risk of tobacco-related diseases or that are less harmful than other commercially-marketed tobacco products; tobacco products or their smoke that contain a reduced level of a substance or whose use results in a reduced exposure to a substance; or tobacco products that, when smoked, do not contain or are free of a particular substance. The FDA is granted the authority to regulate reduced-exposure and reduced-risk health claims and to ensure that there is a scientific basis for the claims that are permitted.
Ladyraj, by that I mean that if SE and NJOY do win, the FDA is going to gain regulation over the e-cig as a "tobacco" product and will have the ability to greatly reduce the nicotine content. An e-cig yielding 4mg. of e-liquid is not going to do anything but "cut the legs out" from under the high effective ratio the e-cig currently enjoys thus rendering it an "approved failure". The tobacco legislation does not allow regulation to zero, but it leaves open the "amount" to be deemed reasonable to the FDA---and that will "bit us in the ...." when it comes to aligning the e-cig with tobacco—IMO, it is a fatal mistake.
Why does everyone panic and assume the limit will be 4mg??
...3 drops of "Very High" strength e-liquid is less than 4mg and would easily satisfy the craving for a single cigarette so a 4mg e-cig doesn't scare me. Personally, I've been using Octane liquid with a driptip and LR atty, so "my e-cigarette" usually has less than 2mg of nicotine and it satisfies like an analog.
I'm being facetious, of course. The tricky thing is most cartridges hold enough e-liquid to replace more than one cigarette, but it is premature and counterproductive to assume that dosage limits will not take that into account.
Please read carefully what I'm saying. I never said that the STANCE was fantasy. What I said was that trying to get that RIGHT NOW is a fantasy. We need to do something to keep ecigs on the market until we can prove that ecigs fit in the harm reduction/tobacco product classification. I'm right in there with the rest of them - I WANT reduced harm classification!.
I did read it and even commented on it.That is your opinion Kristin and you are entitled to it. But that is not the direction that this new advancment is going to take.
You must not read posts. My post clearly stated that there is going to be another case coming on board by a different set of Suppliers with a different theory of the case. There is no fantasy, as it is coming right down the pike.
Sun