Fda Court Case - They Are Pushing And It's Working...

[Christopher]

And update from Sun Vapor which I thought I'd post here. The FDA is still pushing on the Njoy, SE vs FDA case. So far they are winning. They (FDA) have been granted continued rights to seize any and all shipments at the boarder. Hell or high water, the FDA does NOT want you using electronic cigarettes....

**

A major blow on the Docket Sheet today as the Appeals Court ruled that the FDA met it its burden of "a high likelyhood of sucess" on the merits of the Appeal ot issue a full Stay pending a ruling on the Appeal.

As stated:

Smoking Everywhere, Inc., et al.,

Appellees

v.

Food & Drug Administration, et al.,

Appellants

BEFORE:

Ginsburg, Griffith, and Kavanaugh, Circuit Judges

O R D E R

Upon consideration of the emergency motion for stay pending appeal, the joint

opposition thereto, and the reply; and the court's administrative stay issued February 2, 2010, it is

ORDERED that the administrative stay be dissolved.

It is FURTHER ORDERED that the motion for stay be granted. Appellants have

satisfied the stringent standards required for a stay pending appeal. See Washington

Metropolitan Area Transit Commission v. Holiday Tours, Inc., 559 F.2d 841, 843 (D.C.

Cir. 1977); D.C. Circuit Handbook of Practice and Internal Procedures 32-33 (2009).

It is

FURTHER ORDERED

, on the court's own motion, that consideration of this

appeal be expedited. The Clerk is directed to enter a briefing schedule and to calendar

this case for oral argument on the first appropriate date in September 2010.

Per Curiam

FOR THE COURT.

This means the Appeals Court is leaning with the FDA and is the worst news we could have gotten at this point. But the case is far from over.

[Christopher]

And for those of you that don't know what this is all about please read this, it's extremely important:*

This is an action sounding in equity. In April of 2009, Smoking Everywhere, Inc.(SE) filed suit against the Food and Drug Administration (FDA), to "stop FDA from improperly exceeding its delegated authority by attempting to regulate electronic cigarettes" to the extent that FDA declared such products to be a new drug and/or new drug device combination. SE further alleges that FDA exceeded its statutory authority by adding SE’s products to an FDA Import Alert list, thus allegedly preventing their admittance into the United States.

In addition to the Complaint, SE filed a temporary restraining order and preliminary injunction Motion. SE claims that its electronic cigarette allows people to inhale vaporized nicotine without the cancer causing agents found in cigarettes. SE claims that the Electronic Cigarette is a "tobacco product"

SE contends that FDA exceeded its authority by claiming that electronic cigarettes are combination drug/device products that require FDA approval. SE argues that Congress has clearly indicated that FDA does not have the authority to regulate tobacco products relying in part on the holding in FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000). SE also pleads that FDA lacks the authority to regulate electronic cigarettes because they are not drug delivery devices.

Soon to follow, NJOY, Inc. filed a Motion it Intervene in the case which was granted and advanced, for the most part, the same allegations as SE,

The FDA was quick to counter SE and NJOY and filed a brief in opposition to SE's Motion. contending that electronic cigarettes are indeed both a drug and a device, and that Brown does not exempt them from FDA’s jurisdiction. Additionally, FDA argues that SE’s marketing practices purport that electronic cigarettes are intended to "prevent, treat, or mitigate the withdrawal symptoms of nicotine addiction," thereby squarly placing them within the FDA's jurisdiction as this would consitute a "drug" subject to full regulation.

The FDA was also quick to dispute SE’s claim that the Brown Court forecloses FDA regulation of all nicotine products in general, stating that Brown only foreclosed regulation of tradional tobacco products and the electronic cigarette simply can not enjoy the sanctity of the Brown holding as it is not a traditional tobacco product, but rather a nicotine deliver system.

In the interim of the filing of this action by SE, On June 22, 2009, the Family Smoking Prevention and Tobacco Control was signed into law. This historic legislation granted authority to regulate tobacco products to the U.S. Food and Drug Administration.

The Honorable Justice, Richard J. Leon, who is assigned this case in Federal District Court in Washington D.C. requested a rehearing and further briefing from the parties after the enactment of this litigation. This delayed SE’s and NJOY’s request for injunctive relief right though the summer and into the fall.

In September, ASH filed an Amicus Curiae (Friend of the Court) Brief in Support of the FDA, followed by another Amicus Curiae Brief filed ad hoc by a group of E-cigarette users called the Alliance.

On January 14, 2010, some 10 months after this litigation was first filed, the Honorable Judge Leon issued a ruling, granting SE and NJOY a Preliminary Injunction against the FDA to stop the FDA embargo against SE and NJOY’s products coming into the United States. See Attachment 7111.

The FDA quickly requested an Interlocutory Appeal and a Stay of Judge Leon’s ruling.

On February 2, 2010, the Appeals Court (DC Circuit), issued an Administrative Stay of Judge Leon’s ruling and on March 31, 2010, the Court granted the FDA’s Request for a Stay of Judge Leon’s ruling pending the Appeal. The Court also denied SE’s and NJOY’s Motion to Strike the Stay.

On March 31, 2010, the Washington Legal Foundation timely filed their intention to participate as amicus curiae in support of SE and NJOY.

On April 12, 2010, The Clerk ordered the briefing schedule as follows: APPELLANT FDA's Brief due 05/24/2010. Appendix due 05/24/2010. APPELLEE SE and NJOY's Brief due on 06/23/2010. AMICUS for APPELLEE, Washington Legal Foundation's Brief due 07/08/2010. APPELLANT Reply Brief due 07/22/2010

On April 27, 2010, the AMERICAN ACADEMY OF PEDIATRICS, AMERICAN CANCER SOCIETY CANCER ACTION NETWORK, AMERICAN HEART ASSOCIATION, AMERICAN LEGACY FOUNDATION, AMERICAN LUNG ASSOCIATION, AMERICAN MEDICAL ASSOCIATION, CAMPAIGN FOR TOBACCO-FREE KIDS, AND PUBLIC CITIZEN filed a Motion with the Court requesting Leave to participate as amicus curiae in support of the FDA.

We await for the Court to Approve this Motion.

We pick up the Case at this juncture on Appeal.

CONSIDERATIONS:

No matter how the Appeals Court or Judge Leon rules, the e-cigarette is going to be subject to regulations. If the Court determines the E-cigarette to be a "tobacco" product, the FDA will not be able to ban it, but would be able to make reasonable regulations such as no flavorings and a reduction in nicotine levels. The FDA can also mandate many other reasonable regulations such as possibly tamper proof and "dose specific" cartridges thereby rendering bulk e-liquid banned.

Should the Court find that the E-cigarette is in fact a medical device and drug combination, then the FDA can ban the E-cigarette until the requisite applications are made by Manufactures or Suppliers and studies are done in an effort to gain FDA approval which is a very time consuming and costly venture with no guarantees of approval.

　

　

So every business day that the Court is open, I will be checking the Docket Sheet and reporting here what, if anything happened with the case as this case will ultimately determine the future of our Electronic Cigarettes and how we use them.

　

　

The situation is indeed one of great concern to all who use the electronic cigarette as an alternative.

　

All discussion about anything to do with the case as it progresses should be made here: See http://www.e-cigarette-forum.com/for...uling-now.html

*Sun Vapor - ECF

[stormchas3r]

This sux!!! Why can't they see the big picture?

[Kragax]

I can't find a way to express my feelings on this without becoming very rude and vulagr in the presence of the good people here that I have grown to admire and respect. The Ecig underground will prevail!!

[Jeffb]

This news sux. Its going to be an interesting year, thats for sure.

[Phaseman66]

The FDA won’t approve of e-cigarettes yet because they think they may cause cancer. The weird thing is, real cigarettes are proven to cause cancer but are still legal.

I think they may want to check on the alarming rate of BPA found in our canned foods (You know, the ones we're supposed to keep around for emergencies..oh yeah, and feed to our kids) Yet, I've heard NO warnings from them to my pregnant wife to avoid canned foods! TRY DOING YOUR JOB FOR ONCE FDA!

They want E-cigs to be classified as a "new drug" so that they can line their pockets with the proceeds once 'approved' by the FDA. According to the Wikipedia entry of the Food and Drug Administration

"New drugs receive extensive scrutiny before FDA approval in a process called a New Drug Application or NDA. New drugs are available only by prescription by default. A change to Over the Counter (OTC) status is a separate process and the drug must be approved through an NDA first.

A drug that is approved is said to be "safe and effective when used as directed.""

Seems there is MONEY to be made in this, and where there's MONEY, there's government intervention.

[VaporAssassin]

This news sux. Its going to be an interesting year, thats for sure.

I agree!!!!

[Esig]

This sux!!! Why can't they see the big picture?

I agree this sux luckily for us our government is so stupid I don't even think they know what an E-Cig is. About seeing the Big picture they don't want to see it because then they see all the Big money they will loose from the Big tobacco companies

[GDub]

Yeah this is one time I hate being right. I know I've been one of the more pessimistic people here on VT when it comes to the "vapocaplypse", but I've always based my stance on the fact that big business wins 99% of the time. The tobacco industry isn't about to let some new trend as they see it disrupt sales, not even a little bit. That being said, keeping fighting it people, let your legislators know how you feel.

[noXious]

Seems easier to just walk them into the country. No?

...should it come to that *shrug*

Edited May 19, 2010 by noXious

[NeRo9k]

It's all about the money.

[actor92191]

The Ecig underground will prevail!!

that's what I'm talkin about. can you say "e-liquid drug dealer"?

You guys must remember... if Ecigs are eventually outlawed in its entirety in the U.S., the actual PV and atomizer itself will not be illegal!! It's just the e-liquid with nicotine that will be illegal. All the 0-nic vapers will be unaffected.

Legal or Illegal, we'll all still have our e-liquid The fda can lick my balzzzzzzzz

Edited May 19, 2010 by actor92191

[GDub]

You guys must remember... if Ecigs are eventually outlawed in its entirety in the U.S., the actual PV and atomizer itself will not be illegal!! It's just the e-liquid with nicotine that will be illegal. All the 0-nic vapers will be unaffected.

Legal or Illegal, we'll all still have our e-liquid The fda can lick my balzzzzzzzz

I agree that they cannot outlaw straight PG or VG along with all the various flavorings, but if they classify the e-cig atomizer as a drug delivery device they can outlaw it. Now I've seen some nice threads on rebuilding various atomizers so I never throw mine away, I just put them in my dead atty graveyard on the chance that I have to rebuild them some day in the future.

Edited May 19, 2010 by GDub

[Luke]

Keep writing/calling your congress people, state reps and so forth. This is a battle that will keep going on, doesnt take but a few mins of your time every once and a while to speak up for something you believe to be right. Pour on the pressure. "Power to the Vaper"

Luke

[Vacker1229]

This news sux. Its going to be an interesting year, thats for sure.

Dang the bad luck -- totally sux!! Yes a VERY intersting year! I just knew this was not a good thing from the get go. SE also sux!!

Edited May 19, 2010 by Vacker1229

[benjamin1990]

This is terrible! I was hoping that this was something i could use for years to come and now it seems like everyone is trying to stop that! i dont understand why everyone has to ruin our fun and ruin our chance at trying to get healthier! We are using the e-cig cause we dont want the harmfull effects of the Analog cig! i just dont understand how people can not see this! Is there anything we can do to convince them that e-cigs are amazing! and that its not like we are doing drugs! We could be out there smoking pot and selling it! or we could be out there selling even more harmful drugs to people but no they dont care about that! I just dont understand! I really sont hate much but i HATE the fda! they dont even need to be capitalized.....they dont earn enough respect from me to be!

[snubber]

Maybe we'll have our own e-liquid "moodshiners"?

This whole deal is just absurd.

[deadeye]

and maybe triple encrypted websites with multiple passwords to sell the stuff

[nana]

I want the passwords!!

[StringDancer]

To contemplate our worthless government outlawing ecigs or juice is frustrating as hell.

But ya know what... I've already made up my mind that if ecigs or juice ever truly become impossible to buy, either over the web or through the black market... I'll just quit nicotine and be done with it. There's no way I'll go back to analogs, paying the insane sin taxes to this bone-headed government and enduring the grief that goes along with smoking in this health-nazi country.

Think about it for a second. Already, with ecigs, we're consuming less nicotine than we did as smokers. And as a result, I personally find it much easier these days to go longer between vapes without cravings, say at a movie or whatever. I know beyond a doubt that if I set my mind to it, I could just let go of vaping and move on with life, fueling my determination with the general disdain and disgust I feel these days for our incompetent government and the corporations that control it. Old Andrew Jackson was right when he warned us of the dangers of corporate power usurping the liberties of the common people.

I'd prefer to happily vape away for the rest of my life, but if the morons pulling the strings think they can yank me back to my old addiction, they will be sorely disappointed. I'm done with tobacco, the FDA, Big Pharma and all the elected, corporate-owned nincompoops running this country into the ground. They can all kiss my keister.

Glad to get that off my chest. I feel better now.

Edited June 16, 2010 by StringDancer

[Bigjim]

Haha, I never actually seen the word "nincompoops" before, had to read it twice! Thank you for the laugh!

I totally understand how ya feel. It really is sad that the mighty dollar rules all.

[Vacker1229]

I want the passwords!!

Hmmm, maybe secret decoder rings with V|T on them??

[JagSol]

Hmmm, maybe secret decoder rings with V|T on them??

Buy one now, receive a free decoder ring! Use it to discover coupons to get a discount on your next purchase! Act now and also receive a "I'm not smoking, I'm vaping!" hat!