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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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California Governor vetos SB400 Electronic Cigarette Ban

Governor Schwarzenegger has vetoed California's SB400 which would have classified electronic cigarettes as a drug and banned their sale in the state until they are FDA approved. It is now up to the california senate to either pass the bill with a 2/3 majority, or add age restrictions to it.

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.

Sincerely,

Arnold Schwarzenegger

 

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Amazon.com Dropping E-Cigarette Sales Action Follows Notice of Potential Legal Liability

The Internet retailer Amazon.com is reportedly moving to stop selling or supporting the sale of e-cigarettes on its huge website. Its action follows receipt of a notice of potential legal liability for facilitating the sale of a product the Food and Drug Administration [FDA] has declared is "illegal."

The FDA also reported that it found deadly toxins and cancer-causing chemicals in the "smoke" produced by e-cigarettes and inhaled by users; an announcement which came as NBC TV Nightly News was about to blow the lid off the agency's refusal to take action, a news report which was to feature public interest law professor John Banzhaf of Action on
Smoking and Health (ASH) and his legal actions aimed at compelling the agency to finally act. www.pr-inside.com/fda-finds-deadly-chemicals-in-e-cigarette-r140 ..

Previously, after receiving a notice of potential legal liability from ASH, PayPal took a similar step, and Facebook has also reportedly banned promotions for e-cigarettes. In other venues, e-cigarettes have already been banned in Australia, Brazil, Canada, Israel, Mexico, and virtually in Oregon, restricted in Finland, Malaysia, and Singapore, threatened with legal action in Connecticut, and are the subject of a major class action law suit.

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California Senate passes electronic cigarette ban

While the country was participating in 911 memorials the California Senate was busy passing SB400 which may ban the sale of electronic cigarettes in the state until such time as they are FDA approved or "cleared".

SB400 amends STAKE or the Stop Tobacco Access to Kids Enforcement Act and started as a bill on green energy but morphed into a bill to restrict tobacco access by kids at stores. But last minute additions to the bill specifically mention electronic cigarettes and any other forms of nicotine delivered in vaporized form, classifying them as a drug device and the e-liquid as a drug, while not changing the definition of any other nicotine delivery method like cigarettes or cigars.

The bill would not only reclassify electronic cigarettes as a drug system but would also authorize governmental "enforcement action to halt the sale, distribution, or offering for sale of electronic cigarettes that can deliver inhaled doses of nicotine by delivering a vaporized solution that has not been approved or cleared by the United States Food and Drug Administration."

The bill passed 16 to 14 with 10 not present and now goes to the governors office for signature or veto. It will pass into law on October 11th, 2009 if the Governor does not veto.

 

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Legal e-Cig Blog Posts

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 personal thoughts on the debate and are not based on any scientific study. Ecigarettes 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 nicotine delivery systems.