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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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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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CA Banning E-Cigarettes Too Federal Court Ruling Due Soon

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 the subject of a major class action law suit. Now, reports public interest law professor John Banzhaf, they seem about to be banned in California, a move which could be followed in Kentucky and then in other states.

In related developments, e-cigarettes have been declared illegal by the FDA, the imports are being seized, and sellers might face criminal penalties; PayPal has stopped facilitating their sale; Facebook has reportedly dropped their ads; and at least one county has banned their use wherever conventional smoking is prohibited.

Also, more e-cigarette wholesalers are finding it necessary to provide product liability insurance
to their retail customers, and at least one insurance company is offering its own policies. The company explains the need for such insurance this way: "This device has not been approved by the FDA as a 'stop smoking aid' product. In fact, the FDA has issued a warning about the product (e-cigarettes) because marketers are presenting the e-cigarette as a healthier alternative to regular cigarettes. In addition, the cartridge contains several chemicals including nicotine that are hazardous to your health."

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Politics e-Cig Blog Posts

Electronic Cigarettes vs Swine Flu Vaccines, Two DIfferent Responses to a Similar Public Health Threat

My report on an article claiming E Cigarettes May Be More Effective Than Swine Flu Vaccine got me to thinking about how the FDA has responded to the public health threat of the swine flu in comparison to the public health threat of smoking. The differences are astounding.

The H1N1 Swine Flu Pandemic has now been declared a "National Emergency" and as the article pointed out

According to President Obama's Council of Advisers on Science and Technology on H1N1, "A plausible scenario is that the epidemic could cause between 30,000 and 90,000 deaths in the United States."  

Many doctors questioned the validity of these numbers and in October CBS News pointed out in a scathing report that the CDC had absolutely no idea how many actual swine flu cases there were because they had simply stopped testing people for the virus months ago.

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Chantix is Safer than Electronic Cigarettes?

I've been seeing Chantix™ mentioned in a lot of places lately. Electronic Cigarette supporters point to it as an example of how dangerous some FDA approved nicotine replacement therapies and stop smoking programs are, but to be honest, i knew little more then a few hundred people have commited suicide due to their use of this drug. So, tonight I poked around the Chantix website a bit. I was truly amazed, and a bit frightened at what I saw.

The FDA Mandated Chantix™ Warning

All FDA approved drugs now have to put certain warnings on their marketing materials. For years i've joked about the TV commercials that are 15 seconds of "use this, it's great tell your doctor you want it" and 15 seconds of "may cause your liver to explode, your eyes to pop out and in rare cases your heart to stop or your brain to explode". So, what are the side effects of this "safe" drug that managed to get FDA approval?

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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.