https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54

Here’s the Judge’s conclusions taken from the report:

 CONCLUSION

This case appears to be yet another example of FDA’s aggressive efforts to regulate recreational tobacco products as drugs or devices under the FDCA. Ironically, notwithstanding that Congress has now taken the unprecedented step of granting FDA jurisdiction over those products, FDA remains undeterred. Unfortunately, its tenacious drive to maximize its regulatory power has resulted in its advocacy of an interpretation of the relevant law that I find, at first blush, to be unreasonable and unacceptable. I am mindful, however, that the purpose of preliminary injunctive relief is merely “preventative, or protective; it seeks to maintain the status quo pending a final determination of the merits of the suit.” 

 Tours, Inc., Wash. Metro. Area Transit Comm ‘n v. Holiday559 F.2d 841, 844 (D.C. Cir. 1977).

Because I have concluded that plaintiffs are substantially likely to succeed on the merits and are likely to suffer irreparable harm if I do not return the parties to the status quo ante, their respective motions for preliminary injunction are GRANTED pending a final disposition of this case. An Order consistent with this opinion is attached herewith. 

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF COLUMBIA

SMOKING EVERYWHERE, INC.,

Plaintiff,

and

SOTTERA, INC., d/b/a NJOY,

Intervenor-Plaintiff,

v.

U.S. FOOD AND DRUG

ADMINISTRATION, et at.,

Defendants.

)

) Civil Case No. 09-771 (RJL)

)

ORDER

For the reasons set forth in the Memorandum Opinion, it is this 14^th day of

January, 2010, hereby

ORDERED that Smoking Everywhere’s Motion for Temporary Restraining Order

and/or Injunctive Relief [#2], which the Court has converted to a Motion for Preliminary

Injunction (Minute Order dated May 1,2009), and NJOY’s Motion for Preliminary

Injunction [#24] are GRANTED; it is further

ORDERED that FDA shall not detain or refuse admission into the United States

of Smoking Everywhere’s electronic cigarette products on the ground that those products

are unapproved drugs, devices, or drug-device combinations under the Food, Drug, and

Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301 et seq.; it is further

ORDERED that FDA shall not detain or refuse admission into the United States

ofNJOY’s electronic cigarette products on the ground that those products are unapproved

drugs, devices, or drug-device combinations under the FDCA, absent a proffer of

evidence, consistent with the Court’s Memorandum Opinion, that NJOY’s products are

intended to have a therapeutic effect; it is further

ORDERED that the Combined Motion for Leave to Submit a Brief Amicus

Curiae and Brief Amicus Curiae in Support of Defendant FDA by Action on Smoking

and Health [#47] and Alliance of Electronic Smokers’ Motion for Leave to Participate

and File Brief as Amicus Curiae [#49] are GRANTED; and it is further

ORDERED that the Motion ofIntervenor-Plaintiff Sottera, Inc. d/b/a NJOY for

Leave to File Reply to Defendants’ September 17th Response to Proposed Amicus [#52]

and Plaintiff Smoking Everywhere, Inc.’s Motion for Leave to File Instanter a Status

Report Concerning Recent Events Which May Impact Plaintiffs Continued Existence

[#53] are DENIED.

SO ORDERED.

Richard J. Leon

United States District Judge

https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-55

From the Wall Street Journal:

WASHINGTON (Dow Jones)–A U.S. judge said the U.S. Food and Drug Administration doesn’t have authority to regulate electronic cigarettes, dealing a blow to the agency’s efforts to regulate tobacco products as drugs or devices.

http://online.wsj.com/article/BT-CO-20100114-711663.html?mod=WSJ_latestheadlines

By Jared A. Favole, Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- A U.S. judge said the U.S. Food and Drug Administration doesn’t have authority to regulate electronic cigarettes, dealing a blow to the agency’s efforts to regulate tobacco products as drugs or devices.

In a 32-page opinion, U.S. District Judge Richard J. Leon sided with electronic cigarette maker Smoking Everywhere Inc. in finding that the FDA has no authority to regulate the products and can’t stop them from entering the country.

“This case appears to be yet another example of FDA’s aggressive efforts to regulate recreational tobacco products as drugs or devices,” Leon said in his ruling. He added the FDA’s “tenacious drive to maximize its regulatory power has resulted in its advocacy of an interpretation of the relevant law that I find, at first blush, to be unreasonable and unacceptable.”

The FDA has seized shipments of electronic cigarettes, which look and taste like cigarettes but don’t contain tar. Smoking Everywhere, one of the largest makers of electronic cigarettes, had challenged the FDA’s authority over the products.

-By Jared A. Favole, Dow Jones Newswires; 202-862-9207; jared.favole@ dowjones.com

http://www.nasdaq.com/aspx/stock-market-news-story.aspx?storyid=201001141419dowjonesdjonline000588&title=federal-judge-fda-has-no-authority-over-electronic-cigarettes

SMOKESTIK® PRODUCT UPGRADE:

SmokeStik®, the world’s most publicized brand of electronic cigarette, has just introduced a new Cartomizer Technology. The cartomizer offers a number of benefits over the old atomizer method:

1. Cartomizers give you significantly more puffs than the atomizer and cartridge method.
2. SmokeStik® Cartomizers produce more smoke and a more realistic feeling of smoking.
3. Cartomizers are disposable and eliminate the need for an atomizer, making the SmokeStik® easier to use as its now only a 2 piece product.

We find that most people like the cartomizer system over the older cartridge system…although it is a bit more expensive at the outset..You do get much more smoke and many more “puffs” from the new system.

A cartomizer is a combination of an atomizer and a cartridge. It works in the same manner as atomizers except they are disposable units which are not meant to be refilled (although some users do refill them). We don’t recommend refilling them because the heating element is disposable and long term use may result in burning of the wick. A cartomizer offers several advantages over an atomizer: Firstly, a cartomizer is easier to use (you just simply screw the cartomizer onto the battery and your SmokeStik is ready for use). Secondly, cartomizers last longer than prefilled cartridges in terms of puff count. Also, you get a lot more vapor and do not need to inhale as strongly.

Petition to FDA:

The E-Cigarette as Tobacco Product (rather than drug/device combination)

Prepared by Joel L. Nitzkin, MD, on behalf of the Tobacco Control Task Force of the AmericanAssociation of Public Health Physicians (AAPHP), December 22, 2009AAPHP urges the Food and Drug Administration (FDA) to classify nicotine vaporizers (Ecigarettes) as a tobacco product…

To see the full petition, go to:

http://www.aaphp.org/special/joelstobac/fdapetition.pdf

New Study Reveals Quitting Smoking is Good but Switching to Low-risk Nicotine Products is Usually Better:

http://www.tobaccoharmreduction.org/papers/press.htm

Some quotes:

“For the average smoker, the study finds, smoking for just one more month poses a greater health risk than a lifetime of using one of the increasingly popular low risk products like snuff, snus, the new electronic imitation cigarettes, nicotine lozenges, or some other non-combustion alternative.”

“It has long been known that while no nicotine product is completely harmless, harm reduction products pose only about 1% the risk from smoking,” says Dr. Phillips, “and this difference is so great that for the average smoker, using a smokeless product for the rest of his life poses about the same risk as 30 days of continuing to smoke.”

If you want to read the full article on which the press release was based, go to:

http://www.harmreductionjournal.com/content/6/1/29

By Professor Carl V. Phillips, University of Alberta, School of Public Health in Edmonton, Alberta, Canada

Read The Consumers Advocates for Smoke-Free Alternatives Assocation’s letter to the FDA:

http://casaa.org/casaa122809.pdf

Electronic cigarette promoted as ‘safer alternative’

http://www.thefranklinnewspost.com/article.cfm?ID=15163

We now have SmokeStik cartomizers in stock.  They work great!  They produce a huge ploom of vapor and no liquid accidentally on your lip.  The built-in atomizer heats instantly so that the first drag produces vapor.  Each cartomizer is approximately equal to 4 to 5 cartridges.  Give them a try!!

November 17, 2009

With backing from major physician groups nationwide, should the FDA reconsider its stance on the now infamous e-cigarette?

http://lungcancer.einnews.com/247pr/125065

 Doctors are asking the FDA to put science ahead of politics…  We’ll see what chance that has of occurring…