Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY
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If they didn't it is certainly too late. It is one thing to hold that card back... it's another to not have that card to play at all. I hope for their sake... they have one as well.
welcome back Legal One!
i started as way to quit analogs, but have just like to vape all day like a pipe, and feel healther because of it,
again, why is how much better we feel using this machine not imporant to fda?
and if the fda had this data for two months, is that legal? and the testing not having a analog tested with e-cig just bad....cant think of the word...you form a question and find answers, not have answers and form a question.
to say one sample that has half of what they allow in food grade pg and send out a major alert is just scary to watch.
i started as way to quit analogs, but have just like to vape all day like a pipe, and feel healther because of it,
again, why is how much better we feel using this machine not imporant to fda?
and if the fda had this data for two months, is that legal? and the testing not having a analog tested with e-cig just bad....cant think of the word...you form a question and find answers, not have answers and form a question.
to say one sample that has half of what they allow in food grade pg and send out a major alert is just scary to watch.
That's some of the best legalese I've heard yet! It's a tabacco product... tax it and move on....!
That's what I keep saying - Sun begs to differ and will whip out his Nic-Water on you
That's what I keep saying - Sun begs to differ and will whip out his Nic-Water on you
I don't beg to differ--the Court did. I really wish that argument would work. Indeed a "tobacco product" does not and can not prove a therapeutic endpoint---it also was found to be so dangerous on its face, that any regulatory scheme set forth by the FDA would have to be a ban by the Court in Brown. This is no mystery--it is right there in the holding in Brown. Unlike the E-cig that is, as we hope, is not dangerous and can be regualted by the FDA.
And yes, the Nicotine water is still very much on point--just yesderday, Nicolite Water stated that it had gone though all the FDA application and approval processes to be sanctioned under the regulatory scheme as set forth by the FDA (instead of trying to do an end run around like the e-cig manufactues). So if the Brown argument did not work for Nicolite, it surely is one that leaves much to be desired to think it is going to work here. Here is the status of Nicolite as set forth yesteday:
See Manufacturer has high hopes for nicotine water | Health | NWCN.com | Northwest News and Weather --
Sun
Alright, so as I've thought, it comes down to the legal definition of nicotine. The current problem seems to me to be focused on the "device." But the ambiguity seems to rest on the court's view of nicotine itself. Is it a drug, a chemical, an herb, etc.
Sun Vapor or Legal One;
Will it be possible for Judge Leon to set a definition for nicotine? Or must he only set a definition for the "device?" Would that definition be final, or will we then see additional court actions going all the way to the US Supreme Court?
But... if anyone can make the argument that their nicotine product is like a tobacco product... it IS the ecig. You don't drink it... you smoke it. Functionally, the ecig is the same as a tobacco cig as far as consumption to the user.
Plus... there was only one supplier of water and there are many more of us.
This isn't the FDA against one company... this is the FDA against an entire industry. Plus, we have an obnoxiously large consumer base that nicowater did not have.
Plus... there was only one supplier of water and there are many more of us.
This isn't the FDA against one company... this is the FDA against an entire industry. Plus, we have an obnoxiously large consumer base that nicowater did not have.
Double--SE is trying to make the best argument they can as it is really the only one they have--whether Judge Leon buys it or not is a whole differnent story. As I keep saying, it did not work with Nicowater and that is also a benign product. I think you will find that Judge Leon rules that the "intended use" of the e-cig is to deliver nicotine and is subject to FDA regulation. But SE has made its best argument.
Only wish SE would pony up some studies like NJOY here to refute the FDA's findings
As for an appeal--they are always availiable if there is a good faith bases that Judge Leon erred, but as for staying the decision while it goes though the Appellant process---we should not count on that.
Sun
There is still an issue about how the FDA has decided that the e-cig is a drug/device combination. If the FDA were in posession of the report containing information that e-cig catridges contained tobacco specific compounds, was this factored in to the decision? If it was, then by what reasoning did they reject the e-cig as being a tobacco product.? If it was not then, obviously, why not?
Was the determination process correctly followed since the basis for the determination is further clouded.
I can understand why the Judge has asked for a further hearing. How can he make a judgement either way when the exact nature of the e-cig is still in doubt?
Was the determination process correctly followed since the basis for the determination is further clouded.
I can understand why the Judge has asked for a further hearing. How can he make a judgement either way when the exact nature of the e-cig is still in doubt?
I have been reading these posts for some time and I have to leap into the fray. Let me offer these reflections:
Brown V Williamson was decided primarily on the basis of division of powers within the three branches of government. That is, the court ruled that the FDA could not unilaterally assert control over tobacco given that the FDA was a part of the executive branch of government unless and until the legislative branch of government, Congress, gave it the power to do so. Thats why the recent legislation is so important; but, as most of you know that legislation expressly forbids the FDA from banning tobacco. Congress would not allow any ban given how important tobacco is with respect to interstate commerce and US tax revenues. And this bill would have been DOA without the support of Phillip Morris.
A number of posters have mentioned AEROS. This is a tobacco product. The inventor and manufacturer of the product went directly to the TTB (then the ATF) about 8 years ago and got that classification. AEROS also has a federal tobacco permit and pays federal tobacco excise taxes and cigarette taxes in states where it is defined as a cigarette. Note that the states differ in how they define cigarettes in some AEROS is a cigarette, but not in all. AEROS has always had small tobacco fibers in the nicotine infused paper that it uses in what it claims is its patented process. The FDA was stymied in any attempt to regulate or assert authority over this product because the tobacco definition with respect to AEROS came first, before the FDA knew it existed.
Nicotine water added tobacco fiber to its formulation when the FDA began circling in a last minute attempt to get the product defined as a tobacco product. Had they taken the product to TTB first and gotten it defined as a tobacco product they may not have had any issues with the FDA.
Current formulations of nicotine water (Nicolite) are homeopathic and exempt from the FDA approval process by virtue of the FDCA of 1938. Any formulation in the Homeopathic Pharmacopeia of the US (HPUS) is, in effect, grandfathered. The FDA monitors safety and adverse reactions to homeopathic formulations, but cannot stop the marketing of such a product until adverse reactions are reported in some number. ZICAM is a recent and very high profile example of this. However, homeopathic formulations include extreme dilutions and it is questionable whether or not a homeopathic formulation of E-cigarette cartridges would be effective for anyone for any reason. Also, its important to remember that vaporization has a longstanding tradition as a homeopathic delivery method- so its possible that homeopathic formulations in E-cigarettes would be OK- not effective, but exempt from an FDA New Drug Application and clinical trials.. Recent stories about Nicolite suggest that the FDA has approved the product. They have not- its not subject to their approval!
Various E-cigarette manufacturers sought and secured opinions from TTB that theirs were not tobacco products and not subject to tobacco taxes starting in 2007. Had they gotten a different opinion by putting some tobacco fiber in the product they would have had to pay taxes, but the FDA would not have been able to assert authority- until now, after the recent legislation. And, under that legislation, as a tobacco product, they would likely have been grandfathered from any outright ban of the products.
The arguments in the current case are fascinating and both the FDA and SE and Njoy have not done themselves any favors, given certain and specific assertions that each has made in their briefings.
Finally, despite the fact that many E-cigarette importers worked hard early on not to be considered tobacco products, there is some chance that they could make that argument here. The problem is that then the products become subject to tobacco taxes and E-cigarette marketers would be subject to tobacco permitting and licensing requirements both on a Federal level and in most states. The cost for those permits is huge- most requiring years to secure and the posting of significant financial bonds. So, even if they make their case they are creating another potential headache and obstacle.
Brown V Williamson was decided primarily on the basis of division of powers within the three branches of government. That is, the court ruled that the FDA could not unilaterally assert control over tobacco given that the FDA was a part of the executive branch of government unless and until the legislative branch of government, Congress, gave it the power to do so. Thats why the recent legislation is so important; but, as most of you know that legislation expressly forbids the FDA from banning tobacco. Congress would not allow any ban given how important tobacco is with respect to interstate commerce and US tax revenues. And this bill would have been DOA without the support of Phillip Morris.
A number of posters have mentioned AEROS. This is a tobacco product. The inventor and manufacturer of the product went directly to the TTB (then the ATF) about 8 years ago and got that classification. AEROS also has a federal tobacco permit and pays federal tobacco excise taxes and cigarette taxes in states where it is defined as a cigarette. Note that the states differ in how they define cigarettes in some AEROS is a cigarette, but not in all. AEROS has always had small tobacco fibers in the nicotine infused paper that it uses in what it claims is its patented process. The FDA was stymied in any attempt to regulate or assert authority over this product because the tobacco definition with respect to AEROS came first, before the FDA knew it existed.
Nicotine water added tobacco fiber to its formulation when the FDA began circling in a last minute attempt to get the product defined as a tobacco product. Had they taken the product to TTB first and gotten it defined as a tobacco product they may not have had any issues with the FDA.
Current formulations of nicotine water (Nicolite) are homeopathic and exempt from the FDA approval process by virtue of the FDCA of 1938. Any formulation in the Homeopathic Pharmacopeia of the US (HPUS) is, in effect, grandfathered. The FDA monitors safety and adverse reactions to homeopathic formulations, but cannot stop the marketing of such a product until adverse reactions are reported in some number. ZICAM is a recent and very high profile example of this. However, homeopathic formulations include extreme dilutions and it is questionable whether or not a homeopathic formulation of E-cigarette cartridges would be effective for anyone for any reason. Also, its important to remember that vaporization has a longstanding tradition as a homeopathic delivery method- so its possible that homeopathic formulations in E-cigarettes would be OK- not effective, but exempt from an FDA New Drug Application and clinical trials.. Recent stories about Nicolite suggest that the FDA has approved the product. They have not- its not subject to their approval!
Various E-cigarette manufacturers sought and secured opinions from TTB that theirs were not tobacco products and not subject to tobacco taxes starting in 2007. Had they gotten a different opinion by putting some tobacco fiber in the product they would have had to pay taxes, but the FDA would not have been able to assert authority- until now, after the recent legislation. And, under that legislation, as a tobacco product, they would likely have been grandfathered from any outright ban of the products.
The arguments in the current case are fascinating and both the FDA and SE and Njoy have not done themselves any favors, given certain and specific assertions that each has made in their briefings.
Finally, despite the fact that many E-cigarette importers worked hard early on not to be considered tobacco products, there is some chance that they could make that argument here. The problem is that then the products become subject to tobacco taxes and E-cigarette marketers would be subject to tobacco permitting and licensing requirements both on a Federal level and in most states. The cost for those permits is huge- most requiring years to secure and the posting of significant financial bonds. So, even if they make their case they are creating another potential headache and obstacle.
Very informative, thanks for the insight (although some disagreements). If you have more information to the above, do share.
Seemed to sum up my general line of thinking and the overall assement of the facts at hand - He just said in one post what we have collectively said in 10,000 - Well put! -
I do note though that the Homeopathic route seems to be the best way I've seen yet to keep the devices coming - This is something I have said all along though not used the word Homeopathic- I said "aroma-therapy" - but this is just what I had in mind - I can put my own nic in it - Course then there would be the question still of -What's in the juice? It would not be regulated in any way - But we can certainly test it ourselves as a group - I'd kick in! = Nah Second though - I'd just make my own juice But I'd support you guyz! -
Also like we have all said - They (by they I mean whoever they were) screwed themselves from the start trying to avoid taxes - I understand it - Why pay fees if you can find a way not too - May have taken longer to turn profit with higher costs but the market was still there - The industry would have developed very differently - I'd have been happy to pay taxes on it - I didn't quit tobacco for the money - I enjoy the savings - But it's about health more for me - I feel BETTER! - Found the missing octave in my voice again too
Great read Mirinah - What you been waiting for? The fray is glad to see ya
I do note though that the Homeopathic route seems to be the best way I've seen yet to keep the devices coming - This is something I have said all along though not used the word Homeopathic- I said "aroma-therapy" - but this is just what I had in mind - I can put my own nic in it - Course then there would be the question still of -What's in the juice? It would not be regulated in any way - But we can certainly test it ourselves as a group - I'd kick in! = Nah Second though - I'd just make my own juice
But I'd support you guyz! - Also like we have all said - They (by they I mean whoever they were) screwed themselves from the start trying to avoid taxes - I understand it - Why pay fees if you can find a way not too - May have taken longer to turn profit with higher costs but the market was still there - The industry would have developed very differently - I'd have been happy to pay taxes on it - I didn't quit tobacco for the money - I enjoy the savings - But it's about health more for me - I feel BETTER! - Found the missing octave in my voice again too
Great read Mirinah - What you been waiting for? The fray is glad to see ya
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The pre-38 argument could never apply to an electronic cigarette. The product essentially must be in the same form, dosage and manufacture as it was in 1938 - impossible for an e-cigarette because the "dosage" form and delivery mechanism at the very least would change. Have extensively argued the 1962 amendments, DESI, GRASE and "grandfather" aspects of the FDCA in many courts. Moreover, this thrusts the product right back into the "drug" classification and would open the door to the FDA to regulate in a manner that no court will delve into given the extreme deference FDA is given on the subject of "drugs." This is long established legal precedent (see Wienberger v. Hynson, 1973 U.S. Supreme Court) As far as tobacco bonds and licenses maybe - but current regulations do not cover the electronic cigarette or its components at all. TTB would have to write them and that process is down the road if it is determined to be a "tobacco product" and subject to public comment and opportunity for input. In any event, it is clear that any product that FDA determines may "normalize" or act as a "gateway" product to smoked tobacco will meet huge resistance.
Under the 1938 grandfather clause (see 21 U.S.C. 321(p)(1)), a drug product that was on the market prior to passage of the 1938 Act and which contained in its labeling the same representations concerning the conditions of use as it did prior to passage of that Act was not considered a new drug and therefore was exempt from the requirement of having an approved new drug application.
Under the 1962 grandfather clause, the Act exempts a drug from the effectiveness requirements if its composition and labeling has not changed since 1962 and if, on the day before the 1962 Amendments became effective, it was (a) used or sold commercially in the United States, (b) not a new drug as defined by the Act at that time, and (c) not covered by an effective application. See Pub. L. 87-781, section 107 (reprinted following 21 U.S.C.A. 321); see also USV Pharmaceutical Corp. v. Weinberger, 412 U.S. 655, 662-66 (1973).
The two grandfather clauses in the Act have been construed very narrowly by the courts. FDA believes that there are very few drugs on the market that are actually entitled to grandfather status because the drugs currently on the market likely differ from the previous versions in some respect, such as formulation, dosage or strength, dosage form, route of administration, indications, or intended patient population. If a firm claims that its product is grandfathered, it is that firm's burden to prove that assertion. See 21 CFR 314.200(e)(5); see also United States v. An Article of Drug (Bentex Ulcerine), 469 F.2d 875, 878 (5th Cir. 1972); United States v. Articles of Drug Consisting of the Following: 5,906 Boxes, 745 F.2d 105, 113 (1st Cir 1984).
Under the 1962 grandfather clause, the Act exempts a drug from the effectiveness requirements if its composition and labeling has not changed since 1962 and if, on the day before the 1962 Amendments became effective, it was (a) used or sold commercially in the United States, (b) not a new drug as defined by the Act at that time, and (c) not covered by an effective application. See Pub. L. 87-781, section 107 (reprinted following 21 U.S.C.A. 321); see also USV Pharmaceutical Corp. v. Weinberger, 412 U.S. 655, 662-66 (1973).
The two grandfather clauses in the Act have been construed very narrowly by the courts. FDA believes that there are very few drugs on the market that are actually entitled to grandfather status because the drugs currently on the market likely differ from the previous versions in some respect, such as formulation, dosage or strength, dosage form, route of administration, indications, or intended patient population. If a firm claims that its product is grandfathered, it is that firm's burden to prove that assertion. See 21 CFR 314.200(e)(5); see also United States v. An Article of Drug (Bentex Ulcerine), 469 F.2d 875, 878 (5th Cir. 1972); United States v. Articles of Drug Consisting of the Following: 5,906 Boxes, 745 F.2d 105, 113 (1st Cir 1984).
Today the FDA moved for an extension of time to respond to SE's and NJOY's complaints. The FDA's answer to SE's and NJOY's complaint is due July 27, 2009. The FDA seeks an extension of time to respond to both complaints until 20 days after the Court resolves the preliminary injunction motions that are presently pending or, if this Courts decision on the preliminary injunction motions is appealed within 20 days, within 20 days after the Court of Appeals resolves the appeal.
Since this Motion is assented to by all the parties and is procedural, Judge Leon will most likey approve it.
Sun
Since this Motion is assented to by all the parties and is procedural, Judge Leon will most likey approve it.
Sun
Sun I agree completly.....If SE had actually presented completed studies on thier products as NJOY has attempted to do I think the fix we are in right now may have been prevented.Where does SE sit on this matter of studies and contents of thier products?I would really like to know!
The Wiz!
Vaporpal--the FDA is still allowed--the Court has had this case since April and obviously sees no need to stop the embargo.
Sun
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