New Indoor Bans - Please Help!

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WOW

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Wow, you can read about the testing done for Nicotrol here Drug Approval Package: Nicotrol NDA# 020714

Thanks! It seems like it could take some time to get at what's in it, exactly, that causes the 'nails of cat' in the throat thing.

I'm curious where you heard that it was illegal in CA for doctors to support e-cigs? I'm in CA and my doc supports my choice and now considers me an ex-smoker.

Really? Maybe it's a county thing or if your doctor is a herbalist, since they naturally oppose synthetic anything? There's not a doctor in LA afik, who will put a legal tobacco product (since that's how it was classified) in a person's chart with an approval. Mine won't even though my health has improved. There's just no way unless it's FDA approved. They or at least mine, considers it a coincidence and still suggests using other methods of quitting. Maybe it has less to do with e-cigs and more with giving up the nic. I do get support to lower the nic though it goes with advise to use FDA products --- except a repeat of the Nicotrol. That #&^@ hurt!

I'll have to ask more specific questions.

thanks again for the link. :)


EDIT: We might be talking about two different products?

From FDA link - Nicotrol Company: Pharmacia and Upjohn

It says the Pfizer one is a generic .

Nicotrol NS and Nicotrol Inhaler| Pfizer: the world's largest research-based pharmaceutical company

but another company, McNeil(?) got warned about false advertising in March and April of 1998 (this link is from your link.) >>>

http://www.fda.gov/downloads/Drugs/...etterstoPharmaceuticalCompanies/UCM168264.pdf

:blink:

still trying to find what's in this 'medication' that felt like inhaling RAID (not that I know or want to know what inhaling pesticides feels like !!)
:facepalm:
 
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DragonflyVaper

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What happened at those meetings? Hopefully, success



Hello,

As you may have read, we are facing indoor bans in Northhampton MA, Albany County NY and Lowell IN. Once these indoor bans start, it's going to be hard to stop them. We need to get as many vapers to the public hearings for these two ordinances as possible. Please, if you live anywhere near either of these areas try to attend and speak out!

Northhampton:
City Hall, 210 Main Street,
Northampton, MA 01060
July 22nd,
6:30-7:30pm Council Hearing Room, 2nd Floor

Albany County: ,
112 State Street,
Albany, New York
First floor Cahill Room
7:15 p.m. on Tuesday, July 27, 2010 [see below]

Date change / update - See this note on the Albany date:
http://www.e-cigarette-forum.com/fo...rgent-notice-albany-public-hearing-no-go.html

Lowell, IN
501 E Main St
Lowell, IN
Town Hall
Monday August 9, 2010 at 7pm*****DATE CHANGED
219 696 7794
(please call to confirm time and location)

After tomorrow, there will be more information available at Vapers Coalition

Also, don't forget we are still trying to raise enough money to fund the IVAQS study. This study will look at air quality issues involving the exhaled particulates of e-cigs. We NEED this study to help fight the indoor bans. Please give what you can to either CASAA or NVC.

Thank you!
 

WOW

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Janetda - I wasn't far off -

Info at FDA on Pfizer's Nicotrol Inhalor
(8th link down)
Search Results: Pfizer Nicotrol

FDA's approval was questioned by Harvard Med School >>>

http://www.fda.gov/downloads/Adviso...uctsScientificAdvisoryCommittee/UCM222986.pdf

Definition of what's in it (fertilizer for plants) >>>
Mono-potassium phosphate:

Multi-MKP is a fully water-soluble mono-potassium phosphate fertilizer, a highly efficient source of phosphorus and potassium for plants.

http://www.haifachem.com/download/files/multi-mkp_1.pdf

The science or symptomatic argument against e-cigs and ignoring the danger of Nicotrol seems just too close to the argument against Pfizer's generic Nicotrol by Harvard. How did the FDA approve the Nictrol????????? :blink:

I was wrong, though, that Nicotrol wasn't tested.

That could definitely confuse public opinion.

:(
 

Janetda

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It's really hard to keep tracked of what happens with these legislative things. Northhampton we lost. I think Albany and Lowell are still up in the air. Lowell had it's second reading so it might have passed. There was no further discussion about the provision about e-cigs that I can tell. I don't really think anyone there knows much about e-cigs and it was thrown in only because the ALA is involved.

Wow, I really don't know what you're talking about with Nicotrol. The link you provided is regarding additives in cigarettes.

I think it's important to remember that the FDA has never said that they wouldn't approve e-cigarettes. They have only said that they consider nicotine a drug and e-cigs a drug/delivery device.
 

WOW

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Wow, I really don't know what you're talking about with Nicotrol. The link you provided is regarding additives in cigarettes.

This one?
Development by tobacco industry and use of monopotassium phosphate ...
... Dev Pharmacol Ther 1985; 8:384-395. Product Information: Nicotrol(R), nicotine
inhalation system. Pfizer, Inc., New York, NY, 2003. 10 Page 12. ...
www.fda.gov/.../CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/UCM222986.pdf

I read it as the additive in Nicotrol in the generic by Pfizer was developed by BT. I located the link by searching for Nictotrol by Pfizer and finding out they make the generic or at least one of the generics. The link from Harvard isn't commenting on tobacco imo but that BT's use of pesticides was approved in a nic delivering system that would make it a tobacco product vs a medicine. ...."Development.......and use of monopotassium phosphate...." This is on page 12 of a report that I can't find the entire text of however, the link from Harvard is part of legal proceedings in June '10 and appears from the link at the FDA to define Nicotrol as a tobacco product - again going by the blurb explaining the link to the Harvard legal request to research public safety.

If that is not what the FDA meant, why would it be on the FDA website and linked to Pfizer, unless they share the same additive? It clearly states this is a development by BT and used in Nicotrol.


I think it's important to remember that the FDA has never said that they wouldn't approve e-cigarettes. They have only said that they consider nicotine a drug and e-cigs a drug/delivery device.

Who can forget when that's the only argument they consider blowing out of proportion, while the legal system at the Federal level (and I'd really have to dig to find the link from another thread) A FEDERAL judge ruled that the FDA overstep what their legal capacity allows them to do in the case of e-cigs. It's a recreational drug like moderate drinking is considered recreation, without the effects of alcohol. There's grapes - a food(like it need to be pointed out) - in wine. Can you imagine the public outcry if the FDA had to approve or disapprove wine based on it containing grapes and wine glasses were considered a 'tainted food' delivery device? Technically, you can put an led in a cart and an e-cig batt will charge it. You can also put a small fish in a wine glass. But, this is out of the scope of what the FDA can legally try to legislate so they agree with it but still fight that it's more harmful than Nicotrol using additives found in deadly tobacco? :blink: (Is this starting to make it any clearer to you?)

The law would have to change in WA which isn't going to happen without wiping out BT on the nic, the alcohol industry on food additives and backfire on every nic pharma and every children's medicine made with additives to taste better.

Outside of that, what I'm saying is two fold - 1) Where is this court case in full and 2) Since the presence of MKP was allowed into a generic quit product and developed by BT again, how did the FDA approve the nicotrol as a drug?

I don't know what they're talking about but, it's important to point out the FDA has made deadly mistakes when it comes to nic that could support an appeal on any e-cig ban initiated by or with the FDA's way of classifying Nicotrol and perhaps the ruling of a Federal Judge who decided e-cigs are beyond the legal scope of the FDA, in the first place.

Just because someone has the right to a put a fish in a wine glass doesn't mean the wine or the glass requires FDA approval. Nic doesn't even negatively effect the vapor or anyone around them although it's reasonable to not use e-cigs around kids just to not influence them and regardless, e-cigs or not, anyone working with children should wash their hands frequently. People who want to otherwise tell someone who vapes they can't, don't have science on their side - just the opinion of an uninformed segment of society trying to make us feel we don't have enough science on our side. That fuels the fire from both sides. I just don't get that, sort of - do but, don't.

imo, there's plenty of room for appeals. The nic isn't the problem. People who use generic Nicotrol (which attempts to look like a pv) with MKP might be really putting the public at risk and blaming vaping by scewing (no 'r' in there) the facts.

I agree with Vocalek, it isn't worth the time to argue from our position, from that point but an appeals lawyer probably could so the harassment might stop. I think it's worth compromising on the buttery flavors so everyone wins. And I've been dragged against the coals for suggesting that as a community of vapers, we consider compromising on anything. There's enough concern about those butter flavs that makes me consider it the best option against masses it could takes decades if ever, to see the benefits of vaping let alone just put up with their own opinions against us having any rights. I don't have the legal ability to convey it the way it should be said though, so everyone calms down already. It has to come from lawyers and judges, orgs, once they get it and maybe then the media. Til then educating people when we can is the best we can do, right?

HTH
 

Janetda

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I'm really sorry. But I don't understand what you're talking about. My read is that the link has nothing to do with Nicotrol. It only showed up in the search because they used Nicotrol's insert as a reference regarding nicotine transference in breastmilk:

4) Drug Levels in Breastmilk
a) Parent Drug
1) Milk to Maternal Plasma Ratio
a) 2.9 (Prod Info Nicotrol(R) Inhaler, 1997a)

IMO, the FDA will be happy to approve e-cigs when they are made by a large pharmaceutical company and go through the testing required for a drug. The FDA clearly wants all nicotine products to be considered a drug.
 

WOW

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I'm really sorry. But I don't understand what you're talking about. My read is that the link has nothing to do with Nicotrol. It only showed up in the search because they used Nicotrol's insert as a reference regarding nicotine transference in breastmilk:

lol....I don't see where you got that from and I don't want to banter back and forth. I can if you share links if nothing else to just understand if I read it incorrectly where you started your search that gave you those results. Otherwise, I'm just going to leave it as Pfizer's nicotrol is a generic that hurts to use.

IMO, the FDA will be happy to approve e-cigs when they are made by a large pharmaceutical company and go through the testing required for a drug. The FDA clearly wants all nicotine products to be considered a drug.

I agree yet it won't happen since Federal law sets their limits.
Judge: FDA Cannot Regulate Electronic Cigarettes - ABC News <<< the link I was trying to find.

Whatever is wrong with the Nicotrol, this itself, can uphold appeals or stop the harrassment and I couldn't say that until I located the link to back up the reality that for some reason, some States are ignoring to go after e-cig companies. I think it's a form of discrimination - there's more vapor that comes out of fresh brewed coffee and more a huge difference between a lack of aroma in an e-cig and the amount of perfume on a given individual you might get stuck in elevator with for 20 floors - even some of the food flavored perfumes.

Just think the fighting is truly harrassment given the limits of the FDA.


...take care


Add: btw, that lol was not @ you but generally that we're finding different info and I have no idea how you found that. Did you find the court case it was connected to? just curious....tia
 
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Janetda

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Wow, I really appreciate your enthusiasm regarding e-cigs. But I don't think you have a full understanding what is going on legally with the FDA. Judge Leon put a Stay on the FDA's confiscating SE and NJoy's products at the boarders. That's all. Then the FDA went to a higher court and got that Stay lifted, so the FDA can continue to confiscate products for now. That Stay is being considered right now and we should hear soon whether or not the Stay will stay in place. After that, NJoy still needs to go back to court for the full hearing. No matter how the Njoy issue is decided, the FDA will be the agency in charge of regulating e-cigs. The question is whether they will regulate them as a tobacco product or a drug. But either way, the FDA will be in charge. You can read more about this here in the Njoy/SE thread.

As for the Nicotrol thing, I used YOUR link. I didn't do a search of the PDF, I read it. The paper is not about Nicotrol. I believe the lines that I posted above came from page 12.

I understand that you don't like Nicotrol and you have questions as to it's safety due to your experience with it. We can leave it at that. Or you are welcome to PM or Skype me to discuss this further.
 

WOW

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Janetda,

Of course I don't or I wouldn't have posted the first post here asking about it. Thanks for the thread suggestion. I just hope it defines what or who SE is.

The thing I don't understand off the topic, is that the FDA can't make or change laws and at the Federal level, nic was classified as a tobacco product. That would make fall under the authority of the ATF (ya have to dig a little because there's little on tobacco compared to firearms. It's there though.)

But, the FDA doesn't have the legal power to decide which way it's a regulated because it's already been classified as a tobacco. I'm not sure where you read that they do but the entire approval of e-cigs in CA was based on the State Law upholding Federal law. Google Schwartzenegger and e-cigs. His statement explains it and the Federal Judge in my previous link, who ruled on the limited powers of the FDA is saying the same thing but, in a national context. I personally think they decided on the best classification to keep it off the black market. I don't, however, think we're going to get whatever we want and the regulation will be on-line. I think they're going to try to make it safer. They can't forcibly change designs but they can force full disclosure on what is in things but I'll hold off one that -leaving that as more than a sense of it until I find and read the thread you suggested, which I hope is in this forum. :)

As far as the specific Nicotrol, if you're implying I didn't read the link we can stop right here.
You seem like a reasonably nice person but it is possible, again, we're reading two different pages. I asked you previously to share links if you wanted to discuss it. You didn't so I guess you didn't want to discuss what was part of court case on MKP being approved in a drug. I don't have the time to banter back and forth on Skype and no, I hated the Nicotrol and from what I've read it answered what is in it. I was researching for a "what is in that stuff?" while you were researching for the package insert - we simply were talking about the same thing but, looking at different or for different information. I don't think it's worth going on about because no one I know who's tried it did any better with it than I did - maybe by a day at most, then right back to analogs cause it hurt to use.

I do appreciate your helping me understand the latest from CAASA though I might never understand the mixed views on the Federal Laws and the ATF or FDA. If anyone can explain that to me, I'm all ears.

tia.

Wow, I really appreciate your enthusiasm regarding e-cigs. But I don't think you have a full understanding what is going on legally with the FDA. Judge Leon put a Stay on the FDA's confiscating SE and NJoy's products at the boarders. That's all. Then the FDA went to a higher court and got that Stay lifted, so the FDA can continue to confiscate products for now. That Stay is being considered right now and we should hear soon whether or not the Stay will stay in place. After that, NJoy still needs to go back to court for the full hearing. No matter how the Njoy issue is decided, the FDA will be the agency in charge of regulating e-cigs. The question is whether they will regulate them as a tobacco product or a drug. But either way, the FDA will be in charge. You can read more about this here in the Njoy/SE thread.

As for the Nicotrol thing, I used YOUR link. I didn't do a search of the PDF, I read it. The paper is not about Nicotrol. I believe the lines that I posted above came from page 12.

I understand that you don't like Nicotrol and you have questions as to it's safety due to your experience with it. We can leave it at that. Or you are welcome to PM or Skype me to discuss this further.
 
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Janetda

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Wow,

The ATF only deals with tax collection for tobacco, they don't regulate it. In 2009, FSPTCA was passed by Congress and signed into law giving FDA control of tobacco. The SE/NJoy case is the case Gov Schwartzenegger was referring to in his comments when he vetoed the e-cig bill last year. That case is still not settled.

The link I was using was the one you provided: http://www.fda.gov/downloads/Adviso...uctsScientificAdvisoryCommittee/UCM222986.pdf
 

WOW

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Wow,

The ATF only deals with tax collection for tobacco, they don't regulate it. In 2009, FSPTCA was passed by Congress and signed into law giving FDA control of tobacco. The SE/NJoy case is the case Gov Schwartzenegger was referring to in his comments when he vetoed the e-cig bill last year. That case is still not settled.

The link I was using was the one you provided: http://www.fda.gov/downloads/Adviso...uctsScientificAdvisoryCommittee/UCM222986.pdf

Ok, I've obviously some reading to do. It would help if you wouldn't mind sharing what SE is?

This Judge: FDA Cannot Regulate Electronic Cigarettes - ABC News was decided in January this year and the link I gave you appears from the FDA website if you put Pfizer Nicotrol in the search box along with others less legal, that reference MKP with this heading...
Development by tobacco industry and use of monopotassium phosphate ...
... Dev Pharmacol Ther 1985; 8:384-395. Product Information: Nicotrol(R), nicotine
inhalation system. Pfizer, Inc., New York, NY, 2003. 10 Page 12. ...
http://www.fda.gov/.../CommitteesMee.../UCM222986.pdf (which is now showing a page not found error but did, I think have a date of June/July of this year - which makes the 1985 date in the preview of the page impossible as having been written in June/July 10)

I'm now seriously thinking the FDA doesn't want to link the two products together openly and I don't know what the connection is cause they pulled it too fast. Just by the dates though,
if this started in 2002(?) why would a link from Harvard recommending investigation of a tobacco product and omitting e-cigs under Judge Leon, go to a higher court, which I'm guessing, after a Federal Judge ruling would be the Supreme Court? :blink: (I should probably keep my scope of legal proficiency to to street crossing laws, lol!) It is interesting though I missed anything changing about Judge Leon's ruling. So are you saying that was overturned by the Supreme Court or this is what the legal issue is about? Why is NJoy in the middle or defending itself? (The SE if you tell me what it stands for (and this is the third time I've asked someone to to explain that part) I can probably figure out what this is and what the news is. Otherwise, it was very nice meeting you, I hope this stuff stops without personal liberties being trampled to death and maybe I'll see you around the sandbox, lol!)

I thought the Family Smoking Prevention and Tobacco Control Act is for children. Short of outlawing and banning everything, which would cripple the economy, if that's the group I'm thinking it is that started what is taking up so much time of the FDA, someone needs to tell them they can put whatever rules they want on their children and most everyone would support that in law if a child was trying to use an e-cig but, they have to let others over 18 experience their rights without undo fear or harrassment.

It's really hard to figure out but I can understand how upsetting this would be and is if I got that much right. It's just absurd and in a dangerous way. BT is finished if they try to regulate/stop the sale of e-cigs to adults because the nic can't be a medicine in an analog and if they try to regulate as a medicine, Pfizer etc., loses cause that stuff just doesn't work.
Either way the outcome of what your saying their trying to do, seems to encourage social chaos and an attempt to damage the economy.

thanks for the correction but I'm still only able to make 1/2 sense out of what is going on. Still trying to figure out SE - haven't yet. And really not going to bother asking again. Whatever is going to happen if it's in such a high court, there's nothing anyone can do except those involved with the case.

c u later....
 

kristin

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WOW,

The Family Smoking Prevention and Tobacco Control Act also gave the FDA the power to regulate tobacco, but specifically stated that the FDA cannot treat tobacco as a pharmaceutical drug and cannot regulate tobacco to be 0 nicotine. That doesn't mean that they couldn't require BT to reduce the nicotine to nearly nothing, as long as it's not zero. The chances they will do that are pretty slim, though, because they are in Big Pharma's pocket and if smokers all quit because of no nicotine, BP won't have any more smoking customers to buy their nicotine cessation products and the government will lose billions in tobacco taxes!

The SE vs. FDA was ruled in SE's (SE = Smoking Everywhere - an e-cig company)/Njoy's favor by Judge Leon, but the FDA appealed and now the case is being considered by the U.S. Appeals Court. Njoy joined the case back in May 2009 as a co-plaintiff. Currently, SE has backed out of the case and only Njoy is continuing the fight.
 

WOW

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Hi Kristin ,

thanks.

I've said it before and I'll say it again you need to make yours and Janetda posts into a stickie. You two are the only one's who are updating information and word it the easy way.

Why SE would back out during(?) a Stay doesn't make sense.

None of it makes sense, to me, though. I get it but it still, in another way, doesn't make any sense.




WOW,

The Family Smoking Prevention and Tobacco Control Act also gave the FDA the power to regulate tobacco, but specifically stated that the FDA cannot treat tobacco as a pharmaceutical drug and cannot regulate tobacco to be 0 nicotine. That doesn't mean that they couldn't require BT to reduce the nicotine to nearly nothing, as long as it's not zero. The chances they will do that are pretty slim, though, because they are in Big Pharma's pocket and if smokers all quit because of no nicotine, BP won't have any more smoking customers to buy their nicotine cessation products and the government will lose billions in tobacco taxes!

The SE vs. FDA was ruled in SE's (SE = Smoking Everywhere - an e-cig company)/Njoy's favor by Judge Leon, but the FDA appealed and now the case is being considered by the U.S. Appeals Court. Njoy joined the case back in May 2009 as a co-plaintiff. Currently, SE has backed out of the case and only Njoy is continuing the fight.
 
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WOW

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To Wow - all of the legal documents about this case are available at the CASAA website. It would be worth your while to read them to familiarize yourself with this case. I do believe, however this case is decided in the District court, it will ultimately end up in front of the Supreme Court.

Thanks for the suggestion. I really had no idea that there was an open case involving SE/NJoy. I thought this fell into the bans of where vapers can vape and not an attempt to force a change in or availability of e-cigs or e-cig products.

I do need to read a lot more to grasp it before posting any more about it but I really do appreciate everyone's help to get me pointed in the right direction to not keep getting sidetracked....though I still want to know who's name Vocalek advises not to post....incase I got that wrong. :facepalm:

I'll catch up with ya guys...just not easy reading but, understanding the basics of who is trying to sue who and over what was 1/2 the battle. (I was off-line for a while and it seems I did miss when this became a hot topic)

thanks again. :)

Take care.
 

kristin

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SE changed hands and the new owner didn't want to keep paying for the lawyers, I guess.

The name Vocalek jokingly says is "he-who-shall-not-be-named" is John Banzhaf of ASH. We just don't want to link to him or give him any more internet exposure than he already gets. The man is a publicity-seeking, self-serving _______!
 

kristin

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Vocalek

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The players:

Plaintiffs: Smoking Everywhere (abbreviated "SE") and Sottera, Inc. (dba NJOY)
NOTE: The original plaintiff was SE. NJOY petitioned to be added as an "intervenor plaintiff" because it was having exactly the same issue as SE with the defendants. Recently, SE withdrew from the case. The reason was not stated but it is believed that they are having financial problems. Currently, the only plaintiff is NJOY.

Defendants: U.S. Food and Drug Administration, Joshua Sharfstein, Margaret Hamberg; U.S. Dept. of Health and Human Services, Charles E. Johnson and Kathleen Sebelius

The issue: FDA claims that e-cigarettes are an unapproved drug-delivery device which the FDA regulates under the Food Drug and Cosmetics Act (FDCA). FDA has been seizing the plaintiffs' incoming shipments of products. The plaintiffs stated that the FDA has improperly exceeded its authority. Realizing that it may take months or years for the case to be heard and decided, the plaintiffs filed a motion asking the district court for an injunction to stop the FDA from seizing the products until the case is decided. http://www.casaa.org/files/smoking-everywhere---complaint.pdf

Meanwhile: The Family Smoking Prevention and Tobacco Control Act ("Tobacco Act") was signed into law, giving the FDA authority to regulate tobacco products.

The actions:

1) Judge Richard J. Leon of the district court granted the injunction sought by the plaintiffs. This made it illegal for the FDA to continue seizing incoming shipments.
http://www.casaa.org/files/SE-vs-FDA-Ruling.pdf
Judge Leon's Opinion document (http://www.casaa.org/files/SE-vs-FDA-Opinion.pdf) held that the FDA had exceeded its authority because electronic cigarettes are not intended to treat a disease. He suggested that FDA regulate the products as tobacco products under the new "Tobacco Act"

2) FDA filed an appeal in the U.S. District Court of Appeals for the District of Columbia (the next higher court). Whenever a party appeals a lower court action (in this case, the Injunction granted by Judge Leon), the Appeals court automatically grants a Stay of Execution. This Stay is temporary until the Appeals Court either upholds the lower court's ruling (in which case the Injunction would be back in force) or finds in favor of the Appellant and grants a permanent Stay. Meanwhile, the Stay makes it legal for the FDA to go back to seizing incoming product shipments.

Oral Arguments were heard on September 23 and we now await the decision of the Appeals Court.

The Future: Regardless of which way the Appeals Court rules on the question of the Injunction, the case will be returned to the District Court so that the full case can been heard.

Keep in mind that the actual full case has not been heard yet. No evidence has been presented and no witnesses have been called. The Appeal automatically put the case itself on hold until the Appeals process is completed.

After the Appeals Court rules, the losing party could ask the issue of the Injunction to be heard by the Supreme Court. The Supreme Court has a tendency to accept only those cases where there is a question of the U.S. Constitution involved. I'm not sure what Constitutional Issue might be raised by this. It seems most likely that after the Appeals Court rules, the case will be placed on the Docket of the District Court.
 
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