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Need help from former MFS (MyFreedomSmokes) customers
Has any found a supplier or company that has tobacco e-juice like or very similar to MFS Turbosmog, Tall Paul, or Red Luck?
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Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY
- Thread starter Sun Vaporer
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Well you are right about poor decision making and marketing. This whole thing might have never happened if these 2 companies had chosen the right strategy for marketing their products. To play in the giant capitalist market of the US you need to know and abide by the rules of play. There are many questionable nutritional supplements on the market simply because they chose not to label them for what they really were. The FDA has very limited jurisdiction over nutritional supplements.
Take for example the artificial sweetener Stevia. The FDA chose to block the product if it were labeled an artificial sweetener. But it has been sold in the US as a nutritional supplement for several years. Now that all the proper test data has been supplied, the FDA has given it's blessing that it can now be sold as an artificial sweetener. The product never changed just it's classification.
With the proper council advice a similar approach could have been done for e-cigs. Ignorance on protocol is not a good excuse, it's a tragic mistake effecting the lives of thousands.
Kevin
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Thulium--we need SE and njoy otherwise this case goes nowhere and the FDA would then have full rain. We do not want that.
Sun
I agree that the longer a ruling is delayed, the better. For, even if the ruling were to reject the FDA's die-hard contention regarding the statuatory basis of its jurisdiction, the result would be to find our nicotinated vaping juice to be an unapproved 'new tobacco product'. In other words, the immediate
consequence of a ruling is virtually guaranteed to be a defacto ban.
The most important point in the brief for all of you in this forum is the following passage: SE has repeatedly emphasized the February 11, 2009 email from C. James Shen, FDA Compliance Officer for the Los Angeles District (DET-000082) [Dkt. 15-4], which stated that "we do not believe that [Smoking Everywhere's electronic cigarettes] can be relabeled to make [them] anything other than an article which . . . appears to be a drug-device combination product under Section 503(g)(1) of the Federal Food Drug and Cosmetic Act (the Act) (21 U.S.C. 353 (g)(1))." The "we" is a reference to the Office of Compliance at FDA. Translated this basicallyt states that no matter how you label, market or advertise an e-cigarette, in the eyes of the FDA it will always be a "drug delivery device." It therefore doesn't really matter what strategy SE or any company adopts - a burning tobacco cigarette is not a drug but a non-burning cigarette is - a very odd place for such an expansive body of law as cigarette regulation to only speak to such a limited product but that is FDA's stance - no matter what anyone does. This should also point out that for quite some time SE tried to work with FDA but the Agency was not going to allow anything but a "drug" interpretation and in effect, grant a monopoly to burning tobacco products.
Legal----Thanks for all of your efforts and we await the Court's Decision
Sun
Sun
The quote simply demonstrates that no matter what you do - FDA will consider this type of product a drug - you could advertise it as a deadly cousin to a regular cigarette that has no benefit whatsoever and it would still be a drug. The record in the case contains SE's communications with FDA and requests for meetings and guidance on what would be acceptable advertising and statements to be treated like a traditional cigarette - FDA's response was to issue an import alert and start an embargo so here we are. The TRO was merged by agreement by me for reasons that will hopefully become clear later but I can't comment on legal strategy due to ethical and privilege constraints. As far as the irreperable harm component - that is a high standard and can be difficult for a Court to discern - it must be more than pure monetary harm. Judge Leon has commented twice from the bench that he understands the need to move quickly but also caveated that this was a complex matter requiring a full written opinion. For what it is worth, it is easy and quick to affirm an Agency decision - a lot more difficult to overturn one so hopefully the delay is not a bad thing.
Thanks for the valuable insight and we understand there is only so much you can say. The irreperable harm component does carry a high standard, but then I would thing that the brief you filed today would bring that issue to the fore front and further meet that standard. We appreciant your time and effort and await the Court's decison.
Sun
If the Secretary is prohibited from requiring the reduction of nicotine yields of a tobacco product to zero, then it is clear that the presence of nicotine in a tobacco product (regardless of its proportion to the product as a whole)cannot be used as the basis of classifying a tobacco product as a drug under subsection (g)(1) of Section 201. For, if the presence of nicotine in a tobacco product were to render that tobacco product a drug, then not only would virtually all tobacco products be a drug, but Congress would have had no need to "provide authority to the Food and Drug Administration to regulate tobacco products" (as was stated as a purpose of the FSPTC Act, Section 3).
Furthermore, if the presence of nicotine cannot be used as the basis of classifying a tobacco product as a drug, then neither can the presence of nicotine be used as the basis of discerning intent under subsection (g)(1).
Consequently, the only basis of discerning an intent that would render a tobacco product a drug are statements, claims, and representations made by a tobacco product manufacturer, supplier, or retailer.
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I for one appreciate Legal One's post and it fully supports the fact that this is not and never has been about "claims" of anything. It doesn't make any difference to the FDA if this is claimed to cure acne and cancer (the FTC might care, however!). Or if no claims at all are made. It is only the intended use that is important. And the FDA, not Webster's, determines intended use.
One can only hope that the judge sees the intended use as exactly the same as a presently fully legal product sold and used daily by 46 million Americans: The tobacco cigarette.
There lies the truth about e-smoking.
One can only hope that the judge sees the intended use as exactly the same as a presently fully legal product sold and used daily by 46 million Americans: The tobacco cigarette.
There lies the truth about e-smoking.
You should point LegalOne to your video where you indeed made the e-cig a full blown tobacco product. I'd love to see THAT being admitted as evidence. That video could very well prove something.
Yeah... "dangerous" experimentation with an unapproved product.
I hate it when I sound conservative, but whatever happened to "use at your own risk"?
Went out the window since this country became a nanny state.
(BTW, Snus and Propolyne Glycol (Also VG) have all been both proven safe. PG has over 60 years research, VG is nothing but a food grade product with decades of research to back it up, and Snus has been used by the Swedes for hundreds of years with no ill effects). What TB found has very little risk to it. But I would not be surprised for the FDA to come out with some bull**** story on that too.
But they would have to come out with a bull**** story on it or they would risk losing the Funding from their "Clients" BP and BT.
It is very obvious..isn't it? Tobacco products that kill thousands per day are legal...so are prescription drugs that kill such as chantix. Then we have the patches and gums which we all know don't work. Along comes the ecig and the FDA conveniently decides it should be banned...yet we all know it is much safer than tobacco and chantix, and it is effective in comparison to patches and gums. It's all about monopolies and money and the FDA will never admit it but they know it!
Judges are not dummies and regardless of what anyone thinks you can bet your bottom dollar Judge Leon is aware of all these monopolies, and I would bet my bottom dollar he has done extensive research on the ecig. I hope he gives the FDA the boot. It would not be the first time he has ruled against the government. I can't wait to read his ruling.
But where is Judge Leon getting the information about the e-cig? From the FDA, that's who. I tend to doubt Judge Leon reads this place on a daily basis, so he has to rely on an agency that obviously has no problem in lying and distorting facts to fit their self-serving agenda.
I too hopw he gives the FDA the boot, but at this stage of the game, I tend to doubt that will happen.
I have a feeling this is taking so long because Judge Leon knows more than you think about electronic cigarettes. He really could have made his ruling a long time ago if he wanted to.
I still have some hope left, he has been provided a few different angles to look at.
Argeed. I think if Judge Leon had full trust in the FDA. This case would of been over long ago in favor of the FDA. I think it's best to think he is looking for further answers.
Well, at least he didnt make a quick and dirty decision as he could have easily. Hopefully he has done some homework on the PV and seen its sucess rate vs the present FDA approved NRTs.
At that, he should realize his decision not just effects present users but 400,000 deaths each year from now on.
The longer this goes before a decision is handed down the higher my faith is it will be a more defined one than just cut and dry.
At that, he should realize his decision not just effects present users but 400,000 deaths each year from now on.
The longer this goes before a decision is handed down the higher my faith is it will be a more defined one than just cut and dry.
Didnt someone in the last year just get smeared for using the internet to do independent research? I cant remember any details but I do remember whoever wrote it mocking them for smearing him/her it was hillarious, something about how they must think the net is only used for internet porn...
but i digress, we do occasionally have some public officials who go beyond their spoon-fed information from their "traditional" sources. We can just hope that Leon is one of those who arent afraid to use their brains....
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