Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

[Our House]

Our House--Nicotine water does not derail the thread--to the contrary--Nicotine water is right on point as to where this case is headed.

Great! Then I'll repost my questions from the other thread:

Are you allowed to market a new brand of analog cigarette without going through the FDA approval process?

What about a new brand with one less known carcinogen?
Two less?
Ten less?
etc...

The main point is where is the line drawn between "cigarette" and "not cigarette"? Where would ecigs fit into this (if they are looking for classification as tobacco products)?

 

[miller]

All traditional cigarettes are now required to receive FDA approval. The controlling factor that distinguishes cigarettes from other "cigarette/ cigar products etc.) is the burning of tobacco, number of carcinogens is irrelevant.

 

[Sun Vaporer]

Great! Then I'll repost my questions from the other thread:

Are you allowed to market a new brand of analog cigarette without going through the FDA approval process?

What about a new brand with one less known carcinogen?
Two less?
Ten less?
etc...

The main point is where is the line drawn between "cigarette" and "not cigarette"? Where would ecigs fit into this (if they are looking for classification as tobacco products)?

New House--the cigarette was never under the guise of FDA jurisdiction until just a couple of months ago with the new legislation that passed. Before, they where regulated under specific Acts of Congress--not the FDA.

SE and NJOY are trying to argue that the e-cig is a tobacco product to avoid the jurisdiction of the FDA ----and that argurment did not work with nicotine water (nicolite) so there is no reason to think that it will work here.

Sun

 

[miller]

How would FDA jurisdiction be avoided considering the June 22 enactment of the family smoking prevention act? Ecig companies are looking at FDA jurisdiction, the only question is which standard of regulation will be applied to ecig companies; drug&devices or tobacco?

 

[miller]

Sun,

the issue of nicotine water didn't go to court did it? Was it the FDA simply over reaching in it's regulatory power or maybe bc nicotine water did not make the argument it was a tobacco product but a nutritional supplement.

 

[HighTech]

Miller--Johnson Creek uses synthetic nicotine.

Sun

Sun, could you please maybe point me to documentation that Johnson Creek is using synthetic nicotine? I have been unable to find here or on their website, and this is about the third time I've heard it... Thanks..

Here's my perspective: http://www.e-cigarette-forum.com/forum/e-liquid-reviews/28672-johnson-creek-liquid.html#post444810

 

[Sun Vaporer]

Sun, could you please maybe point me to documentation that Johnson Creek is using synthetic nicotine? I have been unable to find here or on their website, and this is about the third time I've heard it... Thanks..

Hightech--you need to speak with them directly---it is not posted on thier website last I looked.

Sun

 

[tvujec]

Sun, could you please maybe point me to documentation that Johnson Creek is using synthetic nicotine? I have been unable to find here or on their website, and this is about the third time I've heard it...

It is mentioned a few times in their mailings. Here's an example:
News from Johnson Creek Blog Archive A Letter from the Founder

 

[Bones]

New House--the cigarette was never under the guise of FDA jurisdiction until just a couple of months ago with the new legislation that passed. Before, they where regulated under specific Acts of Congress--not the FDA.

SE and NJOY are trying to argue that the e-cig is a tobacco product to avoid the jurisdiction of the FDA ----and that argurment did not work with nicotine water (nicolite) so there is no reason to think that it will work here.

Sun

Really not helping that so much time was spent trying to make the argument that it was NOT a tobacco product - When the issue was avoiding taxation -

 

[Sun Vaporer]

Today the Judge ordered that the FDA's Motion for an Extension of Time to respond to SE and NJOY's complaints be GRANTED.The FDA's respons(s) to SE and NJOY's complaints are due 20 days after this Court resolves the pending preliminary injunction motions or, if this Court's decision on the preliminary injunction motions is appealed within 20 days, within 20 days after the Court of Appeals resolves the appeal.


Appears we are headed for an interlocatory appeal no matter which party prevails on the preliminary injunction.

Sun

 

[tvujec]

Appears we are headed for an interlocatory appeal no matter which party prevails on the preliminary injunction.

If by some stretch SE and/or NJOY manage to get preliminary injunction granted, would that mean that the FDA has to release any stock while appealing the injunction?

Also, I would guess even if the above is the case, it would apply only to SE/NJOY shipments, other vendors would only be able to get their shipments released based on a full resolution of the case, not just preliminary injunction.

 

[Sun Vaporer]

If by some stretch SE and/or NJOY manage to get preliminary injunction granted, would that mean that the FDA has to release any stock while appealing the injunction?

Also, I would guess even if the above is the case, it would apply only to SE/NJOY shipments, other vendors would only be able to get their shipments released based on a full resolution of the case, not just preliminary injunction.

Tv---This case is going to set the percedent for all FDA embargos, and their jurisdiction to regulate all e-cigs--so the case is about the FDA, not really about these two companies.

If the FDA should not prevail--which is highly unlikey---the Court may very well stay the release of SE and NJOY's products and allow the embargo till the Circuit Court of Appeals rules.

Sun

 

[brandeeashlynn]

Tv---This case is going to set the percedent for all FDA embargos, and their jurisdiction to regulate all e-cigs--so the case is about the FDA, not really about these two companies.

If the FDA should not prevail--which is highly unlikey---the Court may very well stay the release of SE and NJOY's products and allow the embargo till the Circuit Court of Appeals rules.

Sun

So my question is how long do we have till the final ruling? one month 6 months or less?

 

[Sun Vaporer]

So my question is how long do we have till the final ruling? one month 6 months or less?

Brenda--it really is a two prong effect. If the FDA wins on the district level then the FDA will continue its stepped up enforcement while on appeal as Judge Leon will more then likely defer to the FDA. An appeal could take many months, but since it will be an interlocatory appeal, they are acted on faster then an appeal from a final judgement.

I would like to see the parties try to settle this case with SE and NJOY conceeding to FDA regulations based on an extremely fast track to getting the Applications and requiste studies done and an approval. That is a viable option the parties do have if all concerned want to be reasonable about the issues advanced.

Sun

 

[grimmer255]

I have a question about this. Does anybody know if the FDA were lying to the judge in court about what is in these ecigs. According to this Date: May 4, 2009

To: Michael Levy, Supervisor Regulatory Counsel, CDER, Office of Compliance, Division
of New Drugs and Labeling Compliance

From: B.J. Westenberger, Deputy Director, CDER/OPS/OTR, Division of Pharmaceutical
Analysis
Subject: Evaluation of e-cigarettes

Because that means they knew what is in those ecigs since that date...and if they were lying to the public and to the judge then thats with holding evidence and Perjury. Cant the lawyers use that against them in this case? I would put together news articals and news videos CNN, NBC, FOX News...ect.... after may 4 that proclaim that the FDA has no proof of what is inside these ecigs...I would give everything i got to win this case. Even if it made a small dent it will still be enough to throw them off.

 

[eric]

Good point.

 

[Sun Vaporer]

I have a question about this. Does anybody know if the FDA were lying to the judge in court about what is in these ecigs. According to this Date: May 4, 2009

To: Michael Levy, Supervisor Regulatory Counsel, CDER, Office of Compliance, Division
of New Drugs and Labeling Compliance

From: B.J. Westenberger, Deputy Director, CDER/OPS/OTR, Division of Pharmaceutical
Analysis
Subject: Evaluation of e-cigarettes

Because that means they knew what is in those ecigs since that date...and if they were lying to the public and to the judge then thats with holding evidence and Perjury. Cant the lawyers use that against them in this case? I would put together news articals and news videos CNN, NBC, FOX News...ect.... after may 4 that proclaim that the FDA has no proof of what is inside these ecigs...I would give everything i got to win that case.

Grimmer--they are the Defendent and they have not even answered SE and NJOY's Complaint--there was no disclosure to the court necessary at this juncture as they have not gone though the dicovery process.

Add to that that the FDA does not care, for the purposes of this litigation even if they are clean as Nicotine Water---this is a jurisdictional battle over stopping the importation, sale and marketing of the e-cigs till they go though the application and approval process. So the short answer is no as they have not made any arguments to the Court that they are unsafe --rather the issue is one of regulation of a drug---the lab results of the FDA do not really have a bearing on the case to date---will they now may very well be a different story.

Sun

 

[grimmer255]

then why doesn't SE and NJOY put together the list of crap in NRT products and show that ecigs are as safe and reliable as NRT products to counter there findings....that way it could make the judge question the FDA motives....maybe the judge will still allow ecigs but make every company go through getting FDA approval. Then all the suppliers will have to go through FDA registration. just a thought...maybe shooting for the moon but this day in age anything is possible at the right time and in the right moment.

 

[Sun Vaporer]

then why doesn't SE and NJOY put together the list of crap in NRT products and show that ecigs are as safe and reliable as NRT products to counter there findings....that way it could make the judge question the FDA motives....maybe the judge will still allow ecigs but make every company go through getting FDA approval. Then all the suppliers will have to go through FDA registration. just a thought...maybe shooting for the moon but this day in age anything is possible at the right time and in the right moment.

Grimmer--NJOY has been holding back as well--they have lab results that are suppose to show the e-liquid is clean as a whistle, but still have not released it (Wendsday is the date I am told). But this plays even more into the hands of the FDA---now you have a "battle of the experts" on your hands as to the saftey of the e-cig---and when that happens, it is very easy for Judge Leon to throw his hands up in the air and hold--"the evidence shows confilicting safety results and I must defer to the regulatory agency in place by Congress,( The FDA)-- that the FDA is best suited to resolve these issues and regulate them.

Remember---Courts do not like to step foot across the seperations of powers into Congress' legistatively enacted agencies like the FDA and give broad deference to them.

Sun

 

[grimmer255]

its a $100,000,000 industry thus far this year. we have more than enough evidence that people have quit smoking or cut down using this product. probably with better results...the petition alone stands some ground.....all we need is more testing by labs in the US with 20 different liquids each from different companies. Njoy is obviousely holding more ground so give them the info or maybe more suppliers including JC should jump in on this and prove there case. obviously the judge does not know about JC or other suppliers. or at least give this info to the press....