Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY
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The problem here would be that if e-cigs are tobacco products just like cigarettes, then all claims of health-ier would vanish. Additionally, would there be a major conflict between "vapor" and "smoke?"
Seems to me that if e-cigs (and e-juice) are directly linked or defined as cigarettes, we'd end up losing more than we gain. Wouldn't we?
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Double--All bets are off on health claims as it stands now--the minute they make a health claim --then the FDA has jurisdiction without question. It is a quantum leap to call the e-cig a tobacco product, but that is really the only way it can be kept in the "sanctity" of the Brown & Williamson case, which held that tobacco products are out of reach of the FDA due to the fact that there would never be a way to "make" the use of tobacco 'safe" and would therefore cause the FDA to have to ban all tobacco products on their face. The Court held that since tobacco is already such a known danger, there was nothing the FDA could do to the product but ban it if it fell within their jurisdiction.
Now take that argurment and try to convert it over the the e-cig and it really rings a hollow bell for Judge Leon to hang his hat on. SE and NJOY really had no other argument to advance. SE is really streaching the limits in interpeting the Brown case to the e-cig as, unlike tobacco, if after studies are done, the FDA can regulate it without having to ban it outright, so long as the studies show no appreciable harm.
But since no one has ever made an application and gone through the requiste FDA approval process with the e-cig, or provided any studies, Judge Leon has his hands full in the instant case to find for them.
Sun
I think I read on a "snus conspiracy" site that there is a state(and there may be more) that define a tobac. product as anything even derived from Tobac. This may be a clever strategy if the nicotine in it is natural.
Tw--Not really--what the Court in Brown & Williamson was talking about was tobbaco--not nicotine and the fact that smoking tobacco could in no way be found to ever be save. Nicotine on the other hand can readily be found to be "within reason" safe, and hence the ablilty to regulate it---big difference between a extract of tobacco and the actual tobacco and a very large hurdle to ask Judge Leon to leap.
Sun
Sun -
I have asked this before and not sure if there was a solid answer - or that there can be -
Has there ever been a statement from the FDA saying that they want to impose a TOTAL BAN? Now or in the future? - I see them repeatedly stating that the e-cigs need to be submitted for approval - But I have yet to see any indication that they desire a BAN outright - Has anything other than speculation pointed to this popular conclusion?
And just in case I neglected to do so in the past - Thanks for all your work
Sun -
I have asked this before and not sure if there was a solid answer - or that there can be -
Has there ever been a statement from the FDA saying that they want to impose a TOTAL BAN? Now or in the future? - I see them repeatedly stating that the e-cigs need to be submitted for approval - But I have yet to see any indication that they desire a BAN outright - Has anything other than speculation pointed to this popular conclusion?
And just in case I neglected to do so in the past - Thanks for all your work
Bones--the FDA whats them to go though the application and approval process which is a "de facto" ban until "if and when" they approved. So the issue really is "will the e-cig be available anymore until it goes though the application and approval process. Remember this case is about FDA authority much more so then SE or NJOY. If Judge Leon rules that the e-cig is not a tobacco product and under the guise of the FDA---then the outcome of the case effects all e-cig suppilers with the FDA's power to impose embargos and prohibit the sale and marketing of unapporved products within their jusrisdiction.
Sun
As someone from the UK, my only experience of the FDA and drugs approved in the USA is what is mentioned in fictional TV programmes (which I do realise are twisted to fit what they need them to say and do not depict the real position on the ground, but do usually have at least some basis in fact). Bearing this in mind, please forgive me if this is just total crap!
However, you often hear things on programmes like "Little Johnny's only hope is [insert unknown medicine / treatment / drug in here] , but it isn't FDA approved and so the insurance company won't pay out for it and his parents can't afford to pay for it."
So, my question is, under what circumstances are these unapproved drugs still allowed on the market without FDA approval?
However, you often hear things on programmes like "Little Johnny's only hope is [insert unknown medicine / treatment / drug in here] , but it isn't FDA approved and so the insurance company won't pay out for it and his parents can't afford to pay for it."
So, my question is, under what circumstances are these unapproved drugs still allowed on the market without FDA approval?
The Federal Food, Drug, and Cosmetic Act (FDC Act) defines "drug" as any article "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or function of the body." All drugs and devices must be labeled with adequate directions for all intended uses. Labeling includes any written, printed or graphic material that accompanies a product. Intended use is determined by the facts at hand. Products not generally recognized as safe and effective by experts are considered "new." Improper labeling is called misbranding. Marketing a "new" or misbranded drug or device in interstate commerce is a federal crime. Marketing without adequate directions for use is also a federal crime.
When products are marketed improperly, the FDA may issue a warning letter specifying the violations and demanding to know how the problem will be corrected. If a warning is ignored, or if the FDA decides to begin with more forceful action, the agency can initiate court proceedings for a seizure, injunction, or criminal prosecution. Marketers of legitimate products usually correct the problems immediately. Marketers of quack products vary. Some comply, but many stall, attempt to obfuscate, and/or continue to do as much as they think they can get away with.
Sun
When products are marketed improperly, the FDA may issue a warning letter specifying the violations and demanding to know how the problem will be corrected. If a warning is ignored, or if the FDA decides to begin with more forceful action, the agency can initiate court proceedings for a seizure, injunction, or criminal prosecution. Marketers of legitimate products usually correct the problems immediately. Marketers of quack products vary. Some comply, but many stall, attempt to obfuscate, and/or continue to do as much as they think they can get away with.
Sun
So the answer to my question is - NO -
Bones--the sort answer to your question is yes. The FDA is saying that that you do not "ban" a product that was never approved to begin with---rather you stop it dead in its tracks and call for it to go though the approval process. Read what I just posted and you will see that Supplier's are going to face possible criminal prosectution should the FDA be found to have the authority to regulate e-cigs. So playing with words here is a dangerous venture indeed.
Your question is a very viable one Bones and as you can see, the FDA has a way of dancing with words
Sun
Sun -
I have asked this before and not sure if there was a solid answer - or that there can be -
Has there ever been a statement from the FDA saying that they want to impose a TOTAL BAN? Now or in the future? - I see them repeatedly stating that the e-cigs need to be submitted for approval - But I have yet to see any indication that they desire a BAN outright - Has anything other than speculation pointed to this popular conclusion?
And just in case I neglected to do so in the past - Thanks for all your work
this is off topic again. a new thread was started for off topic chat
There is a reason SmokeInnotec is saying this, "The device is an electronic stick (‘Zig’) in which a filter fits which contains the aroma and the tobacco solution" Note, tobacco solution which IMHO classifies it as a tobacco product Welcome to the Future - Smokefree Innotech Inc. If I remember correctly, the first time I read about this one, it distinctly said there was no tobacco. Now, that has changed.
Just to clarify, any conversation or questions about the Case, manuvers of the parties, or stances by the parties such as the FDA's position is fair game here on this thread. Larger scope discussions like politics belongs in the off topic thread. As I previously said we encourage discussion about the case and the Parties positions. Thanks again.
Sun
Sun
Stupid question -- customs is currently seizing some shipments of e-cigs & paraphernalia. But PS has just come out with a rockin', wildly popular new product, and JC seems firmly entrenched. Based in the USA, they don't have to worry about customs seizures. What will they have to do to wiggle around the FDA's clutches, should worse come to worse?
~~Cheryl
~~Cheryl
Short anwser Cheryl--should the FDA prevail, they will have to fold until they make application and go though the appoval processes. It makes no difference with the FDA where the e-cig is made.
Sun
I have called and faxed my legislators, and the FDA. I have advocated the e-cig everywhere I go. I have written to the White House. I DO NOT want to go back to analogs! What else can I do?
~~Cheryl
~~Cheryl
writing the judge won't do any good. he can't read anything that will effect the case
Kool--Judge's Law Cleaks read mail all the time ---Makes for some good reading during recesses and they give a lot of input to the Judge as well as writting the opinion.
Sun
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