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Legal News Stories

FDA files appeal in Ecigarette case .... again

In a not completely unforeseen move, the FDA has filed an appeal to the result of their appeal in the Sotera vs FDA Ecigarette case.

Earlier this month the US Court of Appeals upheld the earlier ruling that the FDA cannot regulate ecigarettes as drug delivery devices and instead must regulate them as tobacco products. Claiming that the three-judge panel's decision "rests on a clear error of law and will undermine" the intentions of Congress who gave the FDA jurisdiction over tobacco products in 2009, the FDA asks that the entire court of appeals for the district of Colombia hold a new hearing to review the appeal and reinstate a stay of the preliminary injunction barring them from seizing ecigarette imports pending that hearing.

 

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Court of Appeals Rules Electronic Cigarettes Can Not Be Regulated as Drug Devices by FDA

The US Court of Appeals in Sottera Inc. v. Food & Drug Administration, 10- 5032, U.S. Court of Appeals, District of Columbia Circuit ruled today that the FDA lacks the authority to regulate electronic cigarettes as drug devices. This upholds a ruling made last year by Federal Court Judge Richard Leon in the original case brought by Smoking Everywhere which has since dropped out of the suit.

The FDA had argued that ecigarettes should be classified as drug devices, but the court said Ecigs can be regulated only as tobacco products under the Family Smoking Prevention and Tobacco Control Act which defines tobacco products as those "derived from tobacco" unless they are marketed as a therapeutic device, which reputable brands of electronic cigarettes are not.

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States Considering Electronic Cigarette Bans Get Advice from Doctors

State legislatures considering banning electronic cigarettes have now heard the advice of their doctors, namely the Tobacco Control Task Force of the American Association of Public Health Physicians, an organization of physician directors of state and local health departments, who say bans are going too far and that this new product may actually be of great benefit in their fight against cancer and smoking related deaths.

The AAPHP is recognized by the American Medical Association as a medical specialty society and even has formal representation in the AMA House of Delegates. These are just the people one might think politicians should be turning to for recommendations on proposed legislation affecting the public health.

However, prompted by a strong lobbying effort from groups like the American Cancer Society, the Campaign for Tobacco-Free Kids, the American Heart Association and the non smokers rights group Action on Smoking and Health, which critics claim is largely funded by drug companies out to protect their profits, many states like New York, Utah, Illinois and New Jersey have recently introduced legislation that would ban or restrict the sale of E-cigarettes or their use in public spaces.

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FDA has No Authority over Electronic Cigarettes as a Drug Device says Judge Leon

In a 32 page ruling released today for the Smoking Everywhere vs FDA lawsuit, US Federal Judge Richard Leon has said the FDA has no jurisdiction over electronic cigarettes, at least in so far as regulating them as drug delivery devices. The FDA's efforts to regulate ecigarettes as a drug has taken a severe blow and ecig makers, sellers and users around the globe are rejoicing.

In his ruling Judge Leon had scathing words for the FDA:

This case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices, Unfortunately it'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."

Ray Story, CEO of Smoking Everywhere said ""big big big victory for us." and ecigarette forums around the Internet lit up tonight with rejoicing and celebration at the good news.

What effect with this ruling have as the electronic cigarette industry faces challenges from attorney generals from California and other states as well as stiff opposition from anti smoking groups has yet to be seen.

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Key E-Cigarette Judicial Ruling Expected Shortly But It Would Not Affect Class Action Law Suits, Says Lawyer

ASH released this press release:

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Legal e-Cig Blog Posts

FDA Warns 5 Ecig makers for violations of FDCA

Friday the FDA sent warning letters to five electronic cigarette makers citing various violations of the Federal Food, Drug, and Cosmetic Act (FDCA). These violations stem from unsubstantiated health claims made by these companies in their marketing and poor manufacturing practices.

Let me say first however, none of the brands featured on this site were among them and only one of them, Gamucci, has ever been listed in our brand index.

None of this is really that big of a surprise. The FDA has been saying all along they will go after ecig makers who make health claims or claim the Ecig is a great way to stop smoking before they receive FDA approval as a smoking cessation product. While many ecig users, aka Vapers, are very steadfast in their assertions that electronic cigarettes are the greatest way to stop using tobacco ever invented, some manufacturers and distributors don't grasp that legally they just can't say that in their marketing without formal studies and scientific proof. 

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My Suggested Response to the Appellate Court Stay of Judge Leon's Ruling

Over at the Electronic Cigarette Forum's Smoking Everywhere V. FDA Daily Docket Sheet Update there has been great debate this week about how the vaping community should respond and proceed after the U.S. Court of Appeals sided with the FDA in the Smoking Everywhere vs FDA case resulting in a stay of Judge Leon's previous ruling denying their jurisdiction over ecigs until at least September when the court will hear arguments and make a final ruling.

Needless to say most people are outraged, some are confused and sadly many of those the vaping community looks up to as leaders have been arguing with each other instead of taking action while some vendors seem to be finally ready to challenge the FDA themselves.  

As usual in matters this important regarding things I've taken hours to consider and write my thoughts about, I figured I'd share here as well.

 

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FDA approved electronic cigarette

So, i'm out hanging on Twitter and I see this twit go by:

Buy the only FDA approved electronic cigarette on the market

Of course I have to go see what this is all about. So, I click through and what do I find on the Elektric Blue website?

The Elektric Blue Electronic Cigarette is FDA Approved as a medical device. This product does contain nicotine which has been proven to be highly addictive. This product may not be used by individuals under the age of 18. (emphasis added)

and it also goes on to say in the bullet list of advantages "Proven to help quit"

Does Elektric Blue have any documentation listed on their site to back up these claims? Of course they don't because they are blatantly FALSE. Lie's I say, all lies!!!!

There are no FDA approved electronic cigarettes and any company that makes such claims really make me angry. They deserve whatever the FDA throws at them.

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Schwarzenegger vetos ban on Electronic Cigarettes

It's back to the California Senate for senator Ellen Corbetts SB 400. What started out as a green energy and vehicle bill, then morphed into a protect the children from cigarettes bill and finally in early september became a bill to ban the sale of electronic cigarettes until they were FDA approved or "cleared", is now back on her desk once again.

The sad part for the senator, the last minute additions of the electronic cigarette ban have left her other modifications to the Stop Tobacco Access to Kids Enforcement Act on the cutting room floor as well.

Governor Schwarzenegger said in his message to lawmakers:

To the Members of the California State Senate:

I am returning Senate Bill 400 without my signature.

While I support restricting access of electronic cigarettes to children under the age of 18, I cannot sign a measure that also declares them a federally regulated drug when the matter is currently being decided through pending litigation.

 Items defined as “tobacco products” are legal for anyone over the age of 18. If adults want to purchase and consume these products with an understanding of the associated health risks, they should be able to do so unless and until federal law changes the legal status of these tobacco products.

 For this reason, I am unable to sign this bill.

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Help California convince Governor Schwarzenegger to veto SB400

Kamanjah over at the e-cigarette-forum is leading the charge to convince Governor Schwarzenegger that SB400 should be vetoed. As she points out very well in her sample letter, originally this bill was about green energy and only green energy, then somewhere along the way all that got tossed out and it became about tobacco, to finally end up banning electronic cigarettes.

I urge everyone who support electronic cigarettes, particularly the citizens of California whose voices are really the only ones who matter to the governors office to send in a letter or call or email or fax him. Help get the word out that he should veto this bill. If he doesn't do anything by Oct 11th, it becomes law automatically even without his signature.

And hey, if you think e-cigs should be banned, send a letter too. Democracy in Action.

-----------------------------------------

Contact Governor Schwarzenegger online

or

Phone: 916-445-2841
Fax: 916-558-3160

Governor Arnold Schwarzenegger
State Capitol Building
Sacramento, CA 95814

----------SAMPLE LETTER------------

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copyright 2009 all rights reserved *Electronic Cigarettes have not been proven to help you quit smoking and no such claims are being made here. These are the authors or visitors personal thoughts on the debate and are not based on any scientific study. E-cigarettes are a smoking alternative and are not marketed as a smoking cessation device and no legitimate manufacturer makes any such claim. E-cigarettes should not be confused with any FDA approved nicotine replacement therapy, for, like cigarettes, they are not FDA approved.

The author receives a portion of the sale of electronic cigarettes advertised here.