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

[TheIllustratedMan]

Yeah, that's my fear as well. I may just write that letter anyway.

 

[Sun Vaporer]

Yeah, that's my fear as well. I may just write that letter anyway.

Please do---Law Clerks read these all the time. It is common--even encouraged at pre-trial conferences for the parties to sit down with the Judge and discuss any possiblities of settlement. A fast track approval, if put on the table, and if the parties are reasonable, is the most viable alternative that would benefit us as consumers.

These letters are like "little friend of the Court briefs"

Sun

 

[deewal]

IllMan--anything is possible in the Judge's Chambers, but we are so far into this that I thing that they would have already done this and it stalled rather then going though another hearing. It is possible though. I would hope that SE and njoy are taking a hard look and the FDA might be reasonable, but my gut tells me all the parties want a ruling and have taken a hard line stance do to the time frame and the conduct of the parties---everyone has their heals dug in at this point.

Sun

The conduct of the parties SE and njoy has been very inept if not downright suspect. They bought this action against the FDA, then played for time (which conveniently gave the FDA more time to build their case and manipulate the Media and also gave ASH the opportunity to add their Brief) but have done nothing at all themselves to further their case. I suspect ECA did'nt submit a Brief themselves because they are more or less being led by the nose by njoy. This behaviour has only led to a weakening of their case. It's almost as though it had been planned that way. If so it's worked perfectly.
I have a nasty feeling we've been Duped.

 

[nojoyet]

"All in all, this Brief by ASH in no way sheds any new light for the Court's consideration, rather it is just a rehash of what ASH previces for their own interests, as issues.


Sun"

Agreed.

Perhaps the real reason behind ASH's Brief is to bring to the minds and attention of those involved in this case only one word - Banzhoff -

A way of encouraging thoughts of the consequences should he and his thinkalikes become more involved, without making any statement to that effect.

 

[cassavetes]

Thanks for keeping us informed, Sun.

 

[Sun Vaporer]

The conduct of the parties SE and NJOY has been very inept if not downright suspect. They bought this action against the FDA, then played for time (which conveniently gave the FDA more time to build their case and manipulate the Media and also gave ASH the opportunity to add their Brief) but have done nothing at all themselves to further their case. I suspect ECA did'nt submit a Brief themselves because they are more or less being led by the nose by NJOY. This behaviour has only led to a weakening of their case. It's almost as though it had been planned that way. If so it's worked perfectly.
I have a nasty feeling we've been Duped.

Deewal makes one of the most valid points here---ECA does not ask the Court for leave to file a Brief---sure does make it look like the ECA does not think it is important enough, sends a hollowing messege, and it sure does feel like we have been Duped.

Sun

 

[Sun Vaporer]

Thanks for keeping us informed, Sun.

Cass--you are welcome and I sure will--every day till we get a ruling--you can count on it.


Sun

 

[LoneRanger]

The conduct of the parties SE and NJOY has been very inept if not downright suspect. They bought this action against the FDA, then played for time (which conveniently gave the FDA more time to build their case and manipulate the Media and also gave ASH the opportunity to add their Brief) but have done nothing at all themselves to further their case. I suspect ECA did'nt submit a Brief themselves because they are more or less being led by the nose by NJOY. This behaviour has only led to a weakening of their case. It's almost as though it had been planned that way. If so it's worked perfectly.
I have a nasty feeling we've been Duped.

Se & Njoy Had no choice but to bring action against FDA There is millions of $$ worth of product sitting in customs that has already been paid for.They were hoping that this was over with a long time ago!

 

[Sun Vaporer]

Se & Njoy Had no choice but to bring action against FDA There is millions of $$ worth of product sitting in customs that has already been paid for.They were hoping that this was over with a long time ago!

Lone---the pleadings simply do not support this contention. The thrust of the Complaint advanced by SE and NJOY was to attack the present and future vailidity of the FDA's regulatory powers over the e-cig. The secondary collarteral issue is of course to get their product released. SE and NJOY could have easily settled this case if all they sought was the return of their product. That is not all that they pray for by any means. They want the Court to conclude that the E-cig is not within the powers of the FDA to regulate, both present and future.


Sun

 

[grimmer255]

The thing is the federal government gave the power to the FDA to control what is a drug. The FDA has control over nicotine. Bottom line is nicotine is a drug. Its highly addictive and acts like caffeine. And can help people with ADHD and other problems based on the research that is being done, and the current tests shows potential.

The sole purpose of the e-cig is to give the user a dose of nicotine to satisfy the addiction of smoking and be used as a cigarette. But when SE and other companies began adding health claims and everything else.....it turned it into a drug delivering device. There's no changing that fact. SE and the FDA need to come to some kind of agreement. If they can't this will get ugly...

 

[LoneRanger]

Lone---the pleadings simply do not support this contention. The thrust of the Complaint advanced by SE and NJOY was to attack the present and future vailidity of the FDA's regulatory powers over the e-cig. The secondary collarteral issue is of course to get their product released. SE and NJOY could have easily settled this case if all they sought was the return of their product. That is not all that they pray for by any means. They want the Court to conclude that the E-cig is not within the powers of the FDA to regulate, both present and future.


Sun

Sun,You are correct.One of the clean companys that N E V E R made any health claims (and we all know who they are) NOT looking to just get the product back.Product has already been paid for.They are looking for placement of product in u.s. market without the fear of the plug being pulled-You know this but others may not.As far as ECA maybe too many cooks spoil the soup?

 

[LoneRanger]

Sun,You are correct.One of the clean companys that N E V E R made any health claims (and we all know who they are) NOT looking to just get the product back.Product has already been paid for.They are looking for placement of product in u.s. market without the fear of the plug being pulled-You know this but others may not.As far as ECA maybe too many cooks spoil the soup?

Once being involved in other line of work and dealing with major manufacturers of consumer products Their stance is:You purchased you own- no returns unless defective And for credit to account only(no cash refunds)If the product cannot be sold in market place then what do you do? In this case give it your best shot and if not in favor turn off the light.

Hoping the best for everyone,

Lone

 

[Sun Vaporer]

Sun,You are correct.One of the clean companys that N E V E R made any health claims (and we all know who they are) NOT looking to just get the product back.Product has already been paid for.They are looking for placement of product in u.s. market without the fear of the plug being pulled-You know this but others may not.As far as ECA maybe too many cooks spoil the soup?

Lone--I am afraid that is all too true---when it comes to the ECA their is no clear path and the priorities are lacking at best.

For the ECA to not even bother to file a brief like ASH really shows that they are out to lunch. It really does sent a loud bell to the Court that the ECA really could care less about the biggest attack yet on e-cigs---one that could bring the entire industry to a halt and all the ECA is doing is sitting around releasing PR statments. Wake up ECA, this case is not going to be swayed by media ---it is going to be decided based on the law. How to you counter that? At least file a brief wth the Court stating that you support reasonable regulation of the industry, but also that the evidence shows that the FDA could work with the industry and come to a resolution here for a fast track approval.

There is both case law and precedence on this and the ECA could point this out to the Court. We are not talking about a lot of money to file leave of the Court and a brief-------so please ECA, do not give us that excuse. You can bang out PR statements till the cows come home---but that is not going to save the day and should not be the priority now.

Sun

 

[DaBrat]

Lone--I am afraid that is all too true---when it comes to the ECA their is no clear path and the priorities are lacking at best.

For the ECA to not even bother to file a brief like ASH really shows that they are out to lunch. It really does sent a loud bell to the Court that the ECA really could care less about the biggest attack yet on e-cigs---one that could bring the entire industry to a halt and all the ECA is doing is sitting around releasing PR statments. Wake up ECA, this case is not going to be swayed by media ---it is going to be decided based on the law. How to you counter that? At least file a brief wth the Court stating that you support reasonable regulation of the industry, but also that the evidence shows that the FDA could work with the industry and come to a resolution here for a fast track approval.

There is both case law and precedence on this and the ECA could point this out to the Court. We are not talking about a lot of money to file leave of the Court and a brief-------so please ECA, do not give us that excuse. You can bang out PR statements till the cows come home---but that is not going to save the day and should not be the priority now.

Sun

What frightens me more Sun is that the ECA's lack of action may send the signal that these products are INDEED dangerous. Was the ECA just thinking a good show ONCE would be enough? For something this important they should have realized the need to be 'All in'.

PR statements lack substance... they can leave that alone. We as members have struck back against everything that has been released with our own personal experience. Where are these so called PR statements? Haven't seen anything stand alone on any major news.

I only hope and pray that SE. NJOY and ECA have some serious guns up their sleeves.

Anyone know if menthol crystals are sold over the counter anywhere? No experimenting with juice but at least want something to fill my cart worse case scenario.

 

[HighTech]

and all the ECA is doing is sitting around releasing PR statments.

and collecting donations... 8-o

 

[TheIllustratedMan]

I have composed a letter to his Honor, advocating for a compromise. I will have to snail-mail it, so it won't arrive until after the hearing, but I hope that it does some good. I am also carbon-copying it to Smoking Everywhere, njoy, and the FDA. I urge all of you to either write your own letter or go ahead and send mine. We're in the final stretches here, and anything we can do is beneficial.

The Honorable Justice Richard J. Leon
Clerk's Office
United States District Court
for the District of Columbia
333 Constitution Avenue, N.W.
Washington, D.C. 20001



Dear Judge Leon:

I am writing in regards to the court case SMOKING EVERYWHERE, INC. v U. S. FOOD AND DRUG ADMINISTRATION. While there is a concise list of names involved in this case, there are thousands of unnamed parties who have a definite interest in the outcome: the users of the electronic cigarette.
The two sides being presented in this case are very absolute, and both sides have downfalls for the consumer. If the electronic cigarette is determined to be a tobacco product, and outside of the FDA’s usual jurisdiction, it becomes open to taxation the way any other tobacco product is. It also leaves in question the exact composition of the consumable portions of the device, and no way for the consumer to know exactly what he is putting into his body. On the other hand, if the electronic cigarette is deemed a medical device and subject to all of the FDA’s regulations regarding such, it will result in a gap in use for those currently using the device while those selling it seek approval. It will also limit the options available in the marketplace, as the extensive testing could bankrupt most of the smaller companies on the scene today. Keeping this in mind, I urge you to suggest a compromise that would be beneficial to all parties.
The idea that the electronic cigarette is a tobacco product would have to be set aside in favor of the FDA’s assertion that it is a medical device. This would allow both sides to initiate an approval process. If the vendors were allowed to continue selling their products during the process, they would have a steady income stream to allow for extensive testing and verification of their claims.
Meanwhile, as a sign of good faith, the vendors would agree to discontinue advertising except on their own storefronts and websites, and agree to discontinue the use of mall kiosks. This would limit the expansion of the customer base, effectively containing any potential negative health effects to those who are already using the device.
As for the actual approval process, the FDA would work with the vendors to develop reasonable benchmarks to meet along the way. A third party would be employed to ensure regular quality control reviews and that standard safety practices were in use.
There would also have to be an accord on the issue of prolonged use of a Nicotine Replacement Therapy. Since the electronic cigarette has the potential to be used without nicotine, there should be some investigation into approval for long-term use after the nicotine addiction has been broken.
It is my sincere hope that the parties involved in this case can reach some kind of agreement that does not leave us, the consumers, out in the cold. Whether through the proposal in this letter, or some other compromise, it is possible for everyone with an interest in this case to win.
Thank you for your time and consideration.

Sincerely,



Nathan P. Dunn


cc. Smoking Everywhere
nJoy
U.S. Food and Drug Administration

 

[Sun Vaporer]

Illus---Great letter. If we can get them thinking settlement, we may have a better chance of a fast track approval. I have sent several and would encourage others to as well.

This case, as it stands, simply does not appear to be winnable at all and it is time we started to try to get the parties to work with the FDA instead of against it. Then if it shows that the FDA is being unreasonable after the studies show "reasonable saftey", there is a viable case to be made that the FDA is running afowl with their mission as mandated by Congress.

Sun

 

[Sun Vaporer]

What frightens me more Sun is that the ECA's lack of action may send the signal that these products are INDEED dangerous. Was the ECA just thinking a good show ONCE would be enough? For something this important they should have realized the need to be 'All in'.

PR statements lack substance... they can leave that alone. We as members have struck back against everything that has been released with our own personal experience. Where are these so called PR statements? Haven't seen anything stand alone on any major news.

I only hope and pray that SE. NJOY and ECA have some serious guns up their sleeves.

Anyone know if menthol crystals are sold over the counter anywhere? No experimenting with juice but at least want something to fill my cart worse case scenario.

Debrat--You are right on point--ECA's silence sends a loud alarm that something is wrong. I just do not know what their thinking is????????

Sun

 

[TheIllustratedMan]

Any chance of a surprise appearance at the hearing tomorrow? Appearing as a witness for the plaintiff or some such?

 

[grimmer255]

I dont understand why the ECA are not acting. They took donations and promised to help keep these e-cigs available. Well they went half way and it sickens me that they took these peoples donations and haven't worked with the FDA or any interest groups that are against the E-cigs...Instead they're writing letters saying how wrong the reports are.....thats not what the ECA was made for. There purpose is to work with everyone to come up with some kind of agreement and make sure these manufacturers are keeping up with standard quality control. Correct me if im wrong though.