I read a page or so back that the judge requested a hearing for August 15th? (or close to it)...so we're "safe" until then at least right? Or is that just nieve?
Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY
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Moon--August 17th at 3:00 PM. As for being safe? Well the FDA's embargo is in full play--Some Suppiers are getting jammed.
Sun
Thanks for the hard work and info SUN...............we really appreciate. I think I'll just view all posts from sun vaporer from now on............lol
Well, from what I can see, it's a fallacy of logic to ban the ecig because of a single lab test that shows someone put something naughty in their ecig juice.. This would be akin to banning cars because someone removed the seatbelts. Clearly, the naughty chemical found in the SE ecig by the FDA isn't a necessary ingredient that makes vaping possible? Right? As far as I can tell, the theory of mixing extracted nicotine with either PG or VG, some water, and some flavoring and having that be safe is still sound. That being the case, the theory behind the ecig itself is most definitely sound. It's the specific implementation by this or that manufacturer that should be under attack by the FDA. Like guns and nuclear weapons, it's very hard to uninvent something that's been invented. Ecigs are here to stay.
Robbie
Robbie
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^ true. It'd be akin to saying we need to ban pet food because of that melamine incident. And, in this case we have no knowledge of any resulting injuries.
Rob--the case will not rest on this one test by any means----it was just another boulder thrown in the road. I do not think people would mind regulation in the form of standards for e-lquid content but the problem comes when the FDA wants them off the market till applications are made, studies done, and appovals issued---that takes time and money.
Sun
THis is probibily a dumb question, but couldn't those of us that use Electric Cigarettes already volunteer ourself for clinical trials? We all know how to use them and have used them for 6 months or more on average. We Vapors can show them the various ways they are used and what, if any benifits and or detriments ther have been to us.
Mitty--Only Applicants contract for clinical trials for studies being conducted for FDA approval. The Applicants are the manufactures who fund the clinical trials. There is a trial being funded right now by some entity just to study the e-cig in general that is taking on participants---it was posted last week---only problem was you could not have previously used the e-cig?
Sun
This legal stuff makes my head spin. Sun, I want to write to the judge, but can you give me some pointers on what to emphasize and what to avoid? For example, how compelling are the points I make here, or in this letter from Jeremiah? Which points are well taken, and which fall on deaf ears? What does Judge Leon need to hear in order to be swayed?
Thanks for all your life-saving work,
~~Cheryl
Thanks for all your life-saving work,
~~Cheryl
Cheryl--the letter will not fall on deaf ears--Law Clerks read them all the time and get insight. That letter from Jeremiah is very good. Just tell the your story---that is all anyone can do and "humanize" the issue---remember the Judge is from my generation --maybe yours as well, were smoking was the norm--so he can relate.
Sun
Sun,
Thanks very much for your concise response. I guess I hadn't really thought through an appeal process, where it must be based on an error in the initial ruling. Zounds!
I guess all this is going to ultimately come down to whether or not the government can figure out a way to make a lot of money. Either from the vendors or the buyers. If it's the vendors, they'll pass the cost of that money on to us. So either way, e-cigs, if they remain on the market, likely will cost a whole lot more than they do now.
Thanks very much for your concise response. I guess I hadn't really thought through an appeal process, where it must be based on an error in the initial ruling. Zounds!
I guess all this is going to ultimately come down to whether or not the government can figure out a way to make a lot of money. Either from the vendors or the buyers. If it's the vendors, they'll pass the cost of that money on to us. So either way, e-cigs, if they remain on the market, likely will cost a whole lot more than they do now.
The FdA study needs to be read with a critical eye. First the nitrosamines present were detected but not at a level that was quantifiable. THe FDA found tobacco impurities in ppb that is parts per billion, with ppb being the limit of measurement, you can safely surmise that the carinigens in the nitrosamine analytes are present in quantities not measurable- otherwise the FDA would have quantified the amounts, (cigarette smoke nitrosamines are present and measured in ppm, parts per million (or ng- nanograms; ex.the analyte NNN is measured at 390ng or 390 ppm.
While there was nicotine detected in the no nicotine cartridges this was only exhibited when the solution was subjected to 280 degrees centigrate, when the solution was heated to 60 degrees centigrate, the operating temperature of ecigs, no nicotine was found. The reason for the presence of nicotine in certain but not all of the no nicotine capsules can be attributed to using the same equipment to fill both nicotine and non- nicotine capsules. This cross contamination needs to be addressed and I am sure it will be.
Moreover the tobacco specific impurities detected in certain of the ecigs are present in all tobacco products and ad the nicotine in ecigs is derived from tobacco it is no surprise that they are present, it is important however to note that the impurities are a fraction of their presence in other tobacco products and even in NRT products such as Nicotrol. This fact is noted in the fine print of the FDA study. I urge you all to examine the study itself.
Moreover, the study as presented by the FDA can only serve to demonstrate that ecigs should be treated as tobacco products as all if the constituents therein and all of the elements identified by the FDA are in fact tobacco products/analytes.
I am displeased with the presence of DEG in one of the 19 samples, however the FDA in it's study does not quantify the amount detected, which I really wish they would. BTW DEG is one of the 4,000 chemicals in cigarettes, and if the amount detected exceeded what we find in cigarettes the FDA would have quantified in.
Lastly, I am surprised and bothered that 1) the FDA took this long to release the data, since the study wad conducted within one weak of SE's filing of it's lawsuit against the FDA and 2) I am amazed that the FDA did not tender this report to the court and make it apart of the record, thereby allowing Judge Leon to consider it within the scope of the parties respective arguments. With the findings of the study I don't see how judge Leon can find ecigs anything other than tobacco products. Which would subject ecigs to the new and unestablished tobacco legislation as opposed to a drug and medical device standard.
While there was nicotine detected in the no nicotine cartridges this was only exhibited when the solution was subjected to 280 degrees centigrate, when the solution was heated to 60 degrees centigrate, the operating temperature of ecigs, no nicotine was found. The reason for the presence of nicotine in certain but not all of the no nicotine capsules can be attributed to using the same equipment to fill both nicotine and non- nicotine capsules. This cross contamination needs to be addressed and I am sure it will be.
Moreover the tobacco specific impurities detected in certain of the ecigs are present in all tobacco products and ad the nicotine in ecigs is derived from tobacco it is no surprise that they are present, it is important however to note that the impurities are a fraction of their presence in other tobacco products and even in NRT products such as Nicotrol. This fact is noted in the fine print of the FDA study. I urge you all to examine the study itself.
Moreover, the study as presented by the FDA can only serve to demonstrate that ecigs should be treated as tobacco products as all if the constituents therein and all of the elements identified by the FDA are in fact tobacco products/analytes.
I am displeased with the presence of DEG in one of the 19 samples, however the FDA in it's study does not quantify the amount detected, which I really wish they would. BTW DEG is one of the 4,000 chemicals in cigarettes, and if the amount detected exceeded what we find in cigarettes the FDA would have quantified in.
Lastly, I am surprised and bothered that 1) the FDA took this long to release the data, since the study wad conducted within one weak of SE's filing of it's lawsuit against the FDA and 2) I am amazed that the FDA did not tender this report to the court and make it apart of the record, thereby allowing Judge Leon to consider it within the scope of the parties respective arguments. With the findings of the study I don't see how judge Leon can find ecigs anything other than tobacco products. Which would subject ecigs to the new and unestablished tobacco legislation as opposed to a drug and medical device standard.
If you missed it go to todays post Njoy response to fda.Also found a coupon code for Njoy-Smoke 08 (nice to save a few $$)
Lone
Lone
Why would anyone go from these to analogs
, that's just dumb, esp if these are easier to get, and think about it, kids these days love tech over analog of anything. If anything these will lure kids away from analogs (makes you wonder how much big tobacco is pushing this fda thing). I say make the use of nicotine-free (and only nic-free)versions available to anyone over the age of 16 and you'll see a huge drop in tobacco use by minors, all they need to do is make sure that the nic-free juice is safe first. I mean kids smoke because they think it's cool, not really because of the nic, and if they're gonna smoke they're gonna smoke, I'd rather them be smoking nic-free these than cigs. Hell even the small box ones with a little tweaking could be made to look way cooler than an analog cig.(I in no way support smoking or vaping by minors, I just feel if they're gonna do it anyways, and they are, better to let them vape a safe non-addictive substance than analog crap)
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Miller--we all are-- It is troubling that there was not full disclosure to the Court--but then again they are surely far from done with the discovery process.
I think we all would like to know if SE or NJOY asked by way of interogitories or production of documents if the FDA had any data with regards to the e-cig or if SE or NJOY are not in the discovery phase of this litigation. After all we are only in the first stage of this litigation and the FDA has not answered SE's or NJOY's complaint.
Sun
Honestly I am not surprised one bit. The FDA didn't have to disclose this to the courts or to SE and Njoy for that matter as they were not submitting it into evidence. The only things that are required by law to be disclosed are any documents, recordings, studies, that are going to be entered into evidence. As this was more then likely not being submitted into evidence they would not have to disclose any of it. When you think about this in a legal matter it is actually a very smart move as they could present this at any later date and the court can not ask them to provide any information to the fact. The courts also can neither confirm or discredit this study in any way shape or form. From a legal stand point they made a great tactical move. From a morality stand point it is a bold face lie to that is used to further themselves in their fight against the electronic cigarette and it's industry.
I am sure the judge is ......, the FDA's actions are an insult to the court, I wouldn't be surprised if the judge asks the FDA to submit the study to the court and give the plaintiffs an opportunity to respond. The FDA made a tactical mistake, their results which were obviously intended to pressure and or sway the court to defer to the FDA's obligation to protect the public health, however the findings if the study suggest that this is a tobacco product and not a drug. We just have to hope that ecig sellers don't continue to market the product as a cessation device.
Federal court judges take more liberty and will "push" parties around to find the "right" decision.
Federal court judges take more liberty and will "push" parties around to find the "right" decision.
Forgive the spelling mistakes and "wrong" words; I'm using my iPhone and not bothering to read what it chanes in my posts.
Actually Iv---the Fedreal Rules of Civl Procedure: F.R.C.P 26,
"Unless otherwise limited by court order, the scope of discovery is as follows: Parties may obtain discovery regarding any nonprivileged matter that is relevant to any party's claim or defense including the existence, description, nature, custody, condition, and location of any documents or other tangible things and the identity and location of persons who know of any discoverable matter. For good cause, the court may order discovery of any matter relevant to the subject matter involved in the action. Relevant information need not be admissible at the trial if the discovery appears reasonably calculated to lead to the discovery of admissible evidence. All discovery is subject to the limitations imposed by Rule 26(b)(2)(C).
The bold is the standard. Again, we are not privy to what discovery has/will be requested.
Sun
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