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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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Electric Cigarette a Treatment for Parkinson's Disease Hopes USACIG

USACIG, maker of the "Electric Cigarette" announced they have signed an exclusive agreement with Hop-on to submit it's electronic cigarette technology to the FDA for clinical studies for the prevention and treatment of Parkinson's disease.

Recent studies by the Parkinson's Institute and Clinical Center lead by Maryka Quik, Ph D have indicated intermittent nicotine treatment can reduce medication induced dyskinesias by as much as 50%. USACIG is hoping their electronic cigarette might be the perfect way to deliver nicotine to Parkinson's patients.

Peter Michaels, CEO of Hop-on, the company one usually associates with multi media services, the first disposable cell phone and the licencing of technology like CDMA, GSM and WIFI, says they are excited to be the exclusive agent for FDA submission.

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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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Medical + Legal + Politics e-Cig Blog Posts

Electric Cigarette to seek FDA approval as Parkinson's Treatment?

 A couple of days ago we reported that USACIG has secured a deal with Hop-on to act as their agent to submit an application to the FDA to allow them to begin clinical studies to see if their Electric Cigarette could be an effective treatment for Parkinson's Disease.

This was a surprise move to many people, me included. So i've been looking into it.

Yes, there is some evidence that nicotine could be a treatment for PD and it's been shown smoking may be a major factor in the reason smokers have a lower instance of PD than non smokers. One study from the College of Medicine at the University of Vermont concluded:

We have begun quantitative studies of both acute and chronic nicotine in PD to assess both cognitive and motor effects. Fifteen (15) nondemented subjects (age 66 +/- 5.3; M/F = 11/4) with early to moderate PD (mean Hoehn-Yahr stage = 1.77; MMSE = 28.6) received a dose-ranging study of intravenous nicotine up to 1.25 microg/kg/min, followed by chronic administration of nicotine by transdermal patch with doses ranging up to 14 mg per day for 2 weeks. Testing occurred both during drug administration and up to 2 months after drug cessation to look for prolonged effects.

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Anti Smoking Vaccine gets $10 million and Fast Track Status

Breaking news on the vaccine front!! If I were John Banzhaf I'd be sending out press releases saying "in response to my recent blog posts regarding vaccines, the National Institute of Health announced they are giving a $10 million dollar grant to the developers of NicVAX, the anti smoking vaccine, to fund phase III testing." But I won't.

What is NicVAX? An anti-smoking vaccine?

NicVAX is a new injectable vaccine developed by Nabi biopharmaceuticals of Rockville Md which the FDA has already granted "fast track status" to that researchers claim will help people quit smoking and prevent them from relapsing.

NicVAX has already passed initial regulatory hurdles to show the idea is sound and now move to clinical trials where patients are given six monthly shots. Early results show that smokers using the vaccine had a higher rate of success at abstinence from tobacco than those given the placebo.

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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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E Cigarettes May Be More Effective Than Swine Flu Vaccine?

Ok, so i'm doing a search and what do i see in the News section? "E Cigarettes May Be More Effective Than Swine Flu Vaccine". Now you know I have to read this. What? Talk about outrageous health claims. Holy Swine Flu Batman!

As I expected, this press release published in the Earth Times is referring to the study in 1942 conducted by Dr. Oswald Hope Robertson of the University of Chicago's Billings Hospital. He was studying the effects Propylene Glycol might have as a germicide. It's really a fascinating study which is being pointed at more and more lately by electronic cigarette supporters. While it's old and the FDA probably doesn't consider it valid research and anti smoking activists just roll their eyes, it is interesting to look at. I'll have to do a more in depth analysis of the entire study sometime.

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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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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.