FDA Sued Over Electronic Cigarette Embargo

[OutWest]

I've uploaded the other document on the court case
http://www.alternasmokes.com/SE-Memo_in_Support_of_TRO.pdf


edit to add - and here's the link to the filings that dc2k08 found and posted earlier http://www.courthousenews.com/2009/04/29/Smoking.pdf

 

[chuck7403]

While I have not read everything about this case, and am not fully versed in this area of the law, the FDA may have some defenses.

I think the FDA is exempt from notice and comment in certain situations. One such situation is for "interim rules" where the FDA can show "good cause." Good cause is usually only found in "emergency" situations. An emergency situation could be when the public health is an issue.

The agency needs to offer evidence as to why the public interest is served by the immediate implementation of the interim rule. Courts, however, are skeptical of this exception because they do not want agencies to abuse their power...

The FDA could also argue that their actions are merely "policy statements" which are not binding...

The classification of the action the FDA has been taking (detaining shipments) may be crucial in this case...

See Tennessee Gas Pipeline Co. v. FERC, 871 F.2d 1099 for some discussion of the law...

 

[Sun Vaporer]

As previously posted--anyone can look at the Complaint for Injuctive Relief right here. Since this is a Complaint requesting a Preliminary Injuction, a hearing will be marked up very quicky. A letter to the Judge is in order for me now as the Clerks do read them unlike sending one to your Congressperson-----------Sun


See http://www.courthousenews.com/2009/04/29/Smoking.pdf

 

[Jim Davis]

Bill, please share your thoughts after reading the case files.

Also, does anyone know how soon or probable a decision could be made concerning SE's requested relief (to let Electronic Cigarettes through customs) until conclusion of the suit?

At the very least it seems the FDA broke the law in not adding their addition to the national register.

There are reasons I'm not a lawyer!!!

I'm not a lawyer either, but as I understand this, the FDA does not have control yet, and Customs is holding up shipments on something that hasn't been ruled on. They're jumping the gun, and I think we have a good chance here.

 

[OutWest]

As previously posted--anyone can look at the Complaint for Injuctive Relief right here. Since this is a Complaint requesting a Preliminary Injuction, a hearing will be marked up very quicky. A letter to the Judge is in order for me now as the Clerks do read them unlike sending one to your Congressperson-----------Sun


See http://www.courthousenews.com/2009/04/29/Smoking.pdf

Good idea. The memorandum in support that was filed is also worth reading (i uploaded it and posted link a couple of posts back - top of this page)

 

[LaceyUnderall]

As previously posted--anyone can look at the Complaint for Injuctive Relief right here. Since this is a Complaint requesting a Preliminary Injuction, a hearing will be marked up very quicky. A letter to the Judge is in order for me now as the Clerks do read them unlike sending one to your Congressperson-----------Sun


See http://www.courthousenews.com/2009/04/29/Smoking.pdf

Are you suggesting we all write letters to Judge Leon? If so... then I will get started.

 

[ozrick]

Problem the company sueing them is still advertising their e-cigs as a healthier way to smoke. That is what the FDA had issues with to begin with. SE was one of the companies that started this whole fiasco by pushing the FDA to have to investigate the medical claims SE made about their e-cigs....

Their site has been updated a bit but their promo video not only says it's healthier but suggests it can be used as a NRT...

This could be bad.

 

[chuck7403]

Are you suggesting we all write letters to Judge Leon? If so... then I will get started.

What would you say in this letter?

 

[Sun Vaporer]

Are you suggesting we all write letters to Judge Leon? If so... then I will get started.

Lacy--Without a doubt--Judge's and their Clerks love input and need to know that this is NOT SOME NOVEL LITTLE TOY--rather an altrenative that so many of us use--Not to many people in that courthouse know anything about the e-cig and need to know that we use them as an alternative and got of cigarettes!!!! Mine is going out tommorow Express Mail overnight--------Sun

 

[MaxxVapor]

Are you suggesting we all write letters to Judge Leon? If so... then I will get started.

I'm thinking that's what he means exactly.

 

[chuck7403]

Problem the company sueing them is still advertising their e-cigs as a healthier way to smoke. That is what the FDA had issues with to begin with. SE was one of the companies that started this whole fiasco by pushing the FDA to have to investigate the medical claims SE made about their e-cigs....

Their site has been updated a bit but their promo video not only says it's healthier but suggests it can be used as a NRT...

This could be bad.

And salesman like this don't help:

YouTube - Smoking Everywhere Electric Cigarette with Tomer Live 1 of 4

 

[LaceyUnderall]

What would you say in this letter?

Chuck - I refer you to Sun's comments. I also would remind you that keeping true to yourself and writing about your own experience with the ecig will create an emotional, yet rational letter. Those will be read and considered.

Don't worry about all of the other stuff. If you start to write and find yourself reaching above your head... then your letter will not come off as you intend it to. It will also become a miserable experience and it shouldn't be.

 

[J W in Texas]

The FDA could also argue that their actions are merely "policy statements" which are not binding...

I could believe the fda would say anything to offer a defense but they would be hard-pressed to get a judge to believe that stopping product is only a "policy statement". It would sound ludicrous to say that prohibiting a company from selling their product, thereby crippling their profit, is not binding.

Just my thoughts on that particular defense of the fda action...

 

[Sun Vaporer]

What would you say in this letter?

Chuck--adress it to the Honrable Judge and his Clerks and state your experience with using this alternative and the fact that you do no longer need to expose yourself or others to cigarettes--a clean, clear, and short letter directly to the point stating that this is a very viable alterantive to cigarettes and you do not want to return to smoking ever again---I am sending them a kit as well so the clerks can check it out and see what the yeck it is instead of having to guess----Sun

 

[TropicalBob]

The judge faces one basic question only: Is the electronic cigarette a tobacco product? That is the core argument from which all else extends.

We've argued that question here, with divergent views. I was, and remain, of the opinion that the e-cig is not a tobacco product any more than Nicorette gum is a tobacco product. But I'm happy that some resolution is being forced. Smoking Everywhere has a huge shipment tied up, and that financial fact forced the filing of the suit.

As others have noted, however, Congress is going to hand the FDA full control of all tobacco products and all harm reduction alternatives by May's end. This suit's resolution will be moot at that time.

 

[LaceyUnderall]

Chuck--adress it to the Honrable Judge and his Clerks and state your experience with using this alternative and the fact that you do no longer need to expose yourself or others to cigarettes--a clean, clear, and short letter directly to the point stating that this is a very viable alterantive to cigarettes and you do not want to return to smoking ever again---I am sending them a kit as well so the clerks can check it out and see what the yeck it is instead of having to guess----Sun

oohh... and they will love it. i haven't been to a courthouse yet where the clerks aren't hiding out back with their tobacco!

 

[Sun Vaporer]

The judge faces one basic question only: Is the electronic cigarette a tobacco product? That is the core argument from which all else extends.

We've argued that question here, with divergent views. I was, and remain, of the opinion that the e-cig is not a tobacco product any more than Nicorette gum is a tobacco product. But I'm happy that some resolution is being forced. Smoking Everywhere has a huge shipment tied up, and that financial fact forced the filing of the suit.

As others have noted, however, Congress is going to hand the FDA full control of all tobacco products and all harm reduction alternatives by May's end. This suit's resolution will be moot at that time.

TB I do not see moot being an issue here as the Complaint can always be amended to conform to the pleadings----Sun

 

[Kate]

This looks like it will come down to a legal definition of what a tobacco product is. This is Ruyan's line:

"Ruyan® e-cigarette is designed to be a safe alternative to smoking. The various test results confirm this is the case. It is very safe relative to cigarettes, and also safe in absolute terms on all measurements we have applied. Using micro-electronics it vaporizes, separately for each puff, very small quantities of nicotine dissolved in propylene glycol, two small well-known molecules with excellent safety profiles, – into a fine aerosol. Each puff contains one third to one half the nicotine in a tobacco cigarette’s puff. The cartridge liquid is tobacco-free and no combustion occurs."

http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf

Even if we want vaping to be seen as using a tobacco product for now, will that help with anything other than short term profits? Could there be more damaging long term implications of being seen as tobacco?

 

[LaceyUnderall]

As others have noted, however, Congress is going to hand the FDA full control of all tobacco products and all harm reduction alternatives by May's end. This suit's resolution will be moot at that time.

Unless this lawsuit causes a pause on the Hill. If there is enough of an uproar over this, it may just cause some more people to come out of the wood work.

And as someone mentioned earlier in this thread... Now EVERYONE will know about the ecig. This is good! How many non-smokers are out there... wishing something would come along for their smoker spouses/partners and have no idea of this? Those people need to be reached and this may do it.

Ahhh... more sunshine.

 

[Jim Davis]

The judge faces one basic question only: Is the electronic cigarette a tobacco product? That is the core argument from which all else extends.

But is that the case at point in time? I'm not close to knowing the law, but it seems to me that they're holding up something that they have no legal control over right now.