Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY
- Thread starter Sun Vaporer
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The "indented use doctrine" is what is applicable--the no-nic argument is not in play. SE and NJOY even conceeded it. The intended use of the e-cig is to deliver nicotine. The studies that need to be conducted include the nicotine as well as exactly what other compounds are produced when the e-liquid is vaprized including the flavoring and the pg/vg. The FDA looks to the "whole" of the product and what it produces and its effects when consumed by humans. Those are the studies that need to be done as part of the application and approval process.
Sun
Right, not missing the point at all, but what I am asking is have all those other products gone through the process?
CoderGuy
Yes, you are indeed correct. My thoughts are not on this case, but rather the full approval as required by FDA. I've posted earlier that FDA approval process varies greatly and entirely dependent on the class and/or exciting product. Everyone seems to think that approval process=10y/350mil. It is simply not the case.
My question to you Sun is, would you happen to know the class (I,II or III) that e-cig falls into?
Some have some haven't. In case of tabacco, it was grandfathered in and PM & RJ had their share of issues. Gum and patches had to go though the process.
OK thanks tannerk, that's what I was wondering. I forgot about the ole grandfathering thing.
Thanks...CoderGuy
The FDA classifes nicotine and caffine as a "mild stimulant" and has never actually put it into and of the Class I, II, or III catagories for this purpose.
Sun
I see, that's why I can find any info. Thanks. Any update on this case?
These products where never in their jurisdiction--they where under the jurisdiction of the ATF, so the FDA was never involved with them until now with the new legislation that just passed.
Sun
When the Docket updates, it usually does so either at noon or 4:30 PM--There was nothing at noon but I will pull it again at 4:30 EDT.
Sun
That makes sense, thanks. Nicotine is in their jurisdiction however as it is the drug we are talking about and the drug delivery method. It all makes sense now
CoderGuy
Sun,
One question that's bothered me for a long time is why there's never been a class-action suit that might have gone to the US Supreme Court on the constitutionality of banning smoking within a privately owned business (e.g., bars and restaurants). I understand the legal concept of "public access," but doesn't right to privacy trump access by choice?
It seems to me that the FDA stepping into business on the basis of a legal product (cigarettes) would be such a constitutional issue. From there, wouldn't the same type of interference with e-cigs be founded on the same arguments?
In other words, aren't we coming up against basic constitutional law in some of this stuff? If so, why aren't there those suits?
One question that's bothered me for a long time is why there's never been a class-action suit that might have gone to the US Supreme Court on the constitutionality of banning smoking within a privately owned business (e.g., bars and restaurants). I understand the legal concept of "public access," but doesn't right to privacy trump access by choice?
It seems to me that the FDA stepping into business on the basis of a legal product (cigarettes) would be such a constitutional issue. From there, wouldn't the same type of interference with e-cigs be founded on the same arguments?
In other words, aren't we coming up against basic constitutional law in some of this stuff? If so, why aren't there those suits?
It is my understanding that many of those bans are based on the employee protection. That's how some bar owners in e.g. San Francisco found a workaround by asking employees to become minority owners of the business. Therefore there are no employees to be protected.
Tobacco grandfathered in??? My, how convenient. Wouldn't that include nicotine being grandfathered in?
Yes tannerk you are correct. The testing was not in the US. A point I forgot about.
Sun I take it still nothing on the docket at 4:30 huh? The suspense is killing me. Thanks for the hard work tracking it for us all.
Sun I take it still nothing on the docket at 4:30 huh? The suspense is killing me. Thanks for the hard work tracking it for us all.
Now I don't know a lot about the law but from what I do understand is that if they win this it could be very powerful for imports since it gives so much control to lawyers to bring up in the case of "njoy vs the fda" the judge would have to view other companies just as equal to the one of njoy and would give imports a big leverage in the favor of e-smokers.
Am I on the right path?
Am I on the right path?
DoubleTrouble--The one word is "safety". There is no enumerated right in the Constitution to smoke. The right to smoke in a privately owned building that is used for commercial purposes is subject to regulations such as imposing bans on smoking is due to the fact that the business needs an occupational license.
The Courts have held that local and Federal government can impose reasonable safety standards on these types of properties and that the holder of an occupational license is bound by these restrictions. According to case law, "safety" is why smoking bans are legal and can not withstand a challenge in the Courts. On a side note--the US Supreme Court only hears some 50 cases a year---down from over 200 just 15 year ago. Why? Good question.
Sun
The instant case is not so much just about any one company, rather it is about the FDA and wheather or not it over exceeded its authority.
Sun
There was no movement on the Docket Sheet today. Absent some other filing by SE or NJOY, Judge Leon does not have much room here---Sun
Sun
Firstly, a sincere thank you for your updates and insight!
From what I have read here, the outlook looks pretty grim...
My question to you is this:
Is there any filing you can imagine, on the part of SE or NJOY, that could tip the scale?
Firstly, a sincere thank you for your updates and insight!
From what I have read here, the outlook looks pretty grim...
My question to you is this:
Is there any filing you can imagine, on the part of SE or NJOY, that could tip the scale?
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