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Judge Rules FDA Can’t Regulate E-Cigs

January 14, 2010 By: admin Category: Articles, E-cig, FDA Vs. E-Cigs

From ABCNews.com
Judge: FDA Cannot Regulate Electronic Cigarettes
Federal judge says FDA overstepped bounds, sides with electronic cigarette makers
By MATTHEW PERRONE
The Associated Press

WASHINGTON

A federal judge says the Food and Drug Administration overstepped its authority in recent efforts to regulate electronic cigarettes.

A ruling by U.S. District Court Judge Richard Leon handed down Thursday sides with two electronic cigarette suppliers, Smoking Everywhere and NJOY, in their lawsuit against the FDA.

The companies sued the government after regulators began halting shipments of electronic cigarettes last year. The FDA said it found cancer-causing ingredients in the products, despite manufacturers’ claims that the products are safer than tobacco cigarettes.

Electronic cigarettes use a battery-operated vaporizer to produce a nicotine mist that simulates inhalable smoke. Manufacturers have touted the products as a healthier alternative to smoking because there is no burning involved.

The FDA argued that electronic cigarettes are in fact a combination drug-device, and therefore subject to stricter safety standards than cigarettes.

But Judge Leon rejected that reasoning, agreeing with manufactures that electronic cigarettes are “the functional equivalent of traditional cigarettes.”

“This case appears to be yet another example of FDA’s aggressive efforts to regulate recreational tobacco products as drugs or devices,” states Leon’s ruling. “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.”

Leon was appointed to the U.S. District Court by President Bush in 2002.

The FDA recently gained the power to regulate tobacco-based cigarettes, but since electronic cigarettes don’t contain tobacco they don’t fall under that regulation.

The Campaign for Tobacco Free Kids said Leon’s ruling, if upheld, “opens a gaping hole in the protection FDA has provided against the sale and distribution of non-tobacco products.”

E Cigs Growing in Popularity

July 07, 2009 By: admin Category: Articles, E-cig, FDA Vs. E-Cigs, Kiosks

E Cigs Growing in Popularity

If you frequent your local shopping malls, you’ve probably seen a small kiosk in the center aisles peddling some new gadget that looks like a plastic cigarette. E-cigs are generally the same shape and size of a traditional cigarette. These e-cig kiosks are popping up more and more every day as the popularity of electric cigarettes catchs on across the nation.

Electric cigarettes were originally created in China in 2004. While they are still mostly under the radar in the United States, the popularity is increasing and more and more retailers are setting up shop in shopping malls and on the Internet.

E-Cig Basics

An e-cigarette is powered by an e-cig cartridge connected to an atomozier, connected to a batter. The battery is generally charged with a USB cord plugged into your computer, a battery pack, or a wall charger.  The e-cig cartridges contain a liquid solution of nicotine and propylene glycol (the substance often used in fog machines.) E-cig cartridges also come without nicotine and often include some kind of flavoring as well. Depending on the brand of e-cigs you’re smoking, you can either refill your used cartridge with e-liquid in the flavor of your choice, or replace the disposable cartridge with another one.

Probably the best-selling factor that separates e-cigs from  traditional tobacco cigarettes is health concerns. While the FDA has yet to test the safety of e-cigs, Tthe ingredients have been ruled as safe for general use. They include propylene glycol, sometimes alcohol, natural and artificial flavorings, vinegar, and a couple of other items that make up no more than 1% of the total solution.

Because e cigs don’t contain tar, carcinogens, cancer-causing agents, and smoke, they are being heralded as the safer alternative to smoking traditional tobacco cigarettes. When a user inhales the liquid solution, which is being called “vaping”, the vapor that is released by the inhaler is not smoke, contains no odor, and does not cause second-hand smoke. In fact, recent laboratory findings show that the nicotine cannot be found in the vapor that is exhaled.

As more and more retailers of e-cigs emerge, and more and more former traditional smokers are seen vaping in places that normally have a smoking ban, e-cigs will continue to catch on. Don’t be surprised to see electric cigarettes popping up in your workplace, your neighborhood bar and even on airplanes in the near future.
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The FDA Vs. E-Cigs

June 22, 2009 By: admin Category: Articles, E-cig, FDA Vs. E-Cigs

The FDA VS. E-Cigs
The FDA has fresh jurisdiction over tobacco products and they are trying to parlay that control over the relatively new e-cigs, though they’re clearly not tobacco products.
E-cigarettes use a combination of an atomizer, battery and nicotine cartridge to create tobacco, tar and smoke free cigarette. The vapor (simulated smoke) that comes from an e-cig is generated by vaporizing a combination of nicotine and propylene glycol (usually found in fog machines.) The e-cig smoke inhales the vapor rather than carcinogenic tobacco smoke.
Though there’s no tobacco in e-cigs, that’s not stalling the FDA. They’ve recently stopped overseas shipments of e-cigarettes, components and accessories from coming into the United States. The FDA says they need to be regulated before they can be sold in the U.S.
U.S. companies manufacturing and selling E-Cigs, such as Blu Cigs,  seem to be safe so far. You can get e-cigs online, over the phone and in kiosks in just about every mall in America.
What’s confusing is that the FDA has already approved nicotine in various quit smoking aids like patches, gums and inhalers. As for the propylene glycol, the FDA has stated:
“Propylene glycol is metabolized by animals and can be used as a carbohydrate source. Propylene glycol can be ingested over long periods of time and in substantial quantities (up to 5 percent of the total food intake) without causing frank toxic effects.”
Those using e-cigs whether it be to help quit smoking traditional cigarettes, to avoid tobacco taxes, or get around enormous indoor (and sometimes outdoor) smoking bans, will have to band together to let the administration know how they feel.

Slate Magazine E-Cig Article

June 19, 2009 By: admin Category: Articles, E-cig, E-Cigar

From Slate:

First there was smoked tobacco. Then there was smokeless tobacco. Now there’s something in between.

It’s vaporized nicotine, aka “vaping.” It isn’t quite tobacco, and it isn’t quite smoking. Should we ban it, since it’s sort of like smoking? Or should we tolerate it, since it’s different in important respects? Does the war on smoking require total victory, or can we accept a peace deal that lets the industry, in some form, escape?

Let’s start with a bit of background. Vaporized nicotine has been around in various forms for at least two decades. Lately, it’s been spreading across the world in the form of “electronic cigarettes.” Two months ago, Slate‘s Emily Yoffe tried them out and reported:

The e-cigarette contains no tobacco and produces no smoke. Instead, it is an ingenious electronic device. … The “filter” is a receptacle for nicotine suspended in propylene glycol—the main ingredient in deodorant sticks and artificial smoke machines. … When the user sucks on the filter, a nicotine-laced vapor is produced, satisfying a smoker’s cravings. … [One product] allows you to choose filter cartridges with different levels of nicotine. I selected “none,” which meant my e-cig was the buzz-free equivalent of nonalcoholic beer. The cigarette came in flavors such as tobacco, vanilla, mint, and apple. … Fortunately, as bad as the mist tasted, there was no noticeable odor, and it dissipated almost immediately, and thus didn’t create a secondhand vapor problem.

Yesterday’s Wall Street Journal and New York Times followed up with similar reports. “The vapor can be inhaled and then exhaled, creating a cloud that resembles cigarette smoke but dissipates more quickly and doesn’t have the lingering odor,” says the Journal. The Times described an e-cigarette that “delivered an odorless dose of nicotine and flavoring without cigarette tar or additives, and produced a vapor mist nearly identical in appearance to tobacco smoke.”

So is vaping smoking? Let’s run the checklist. Cigarette? Yes. Smoke? No. Cloud? Yes. Odor? No. Tar? No. Nicotine? Optional.

Good luck sorting this one out.

The first practical question is whether you can vape in places where smoking is now forbidden. Yoffe tried this and got a mixture of technical tolerance and social disapproval. The Journal adds:

Users have had varied experiences vaping in public, ranging from indifference to odd glances. On a recent day, Shai Shloush, 25, from Knoxville, Tenn., huddled in the back of a movie theater to watch the new Star Trek movie. He powered up his e-cigarette and puffed away. “I was covering the LED part so people wouldn’t notice,” said Mr. Shloush, a former smoker. “Every once in a while I’d be really sneaky about letting out the smoke.”

The Times claims that “because they produce no smoke, they can be used in workplaces, restaurants and airports.” One user, for example, reports that “when everyone was smoking outside in the cold, I just stood in the warm bar, smoking.”

The next question is whether we should officially regulate them like cigarettes. According to the Journal,

The American Lung Association, along with the American Cancer Society Cancer Action Network, the American Heart Association and the Campaign for Tobacco-Free Kids, recently called for e-cigarettes to be removed from the market. The groups say e-cigarettes have yet to be proven safe and that kids may be attracted to the products, some of which come in flavors like chocolate and strawberry. “Nobody knows what the consumers are actually inhaling,” says Erika Sward, director of national advocacy at the American Lung Association.

Governments seem to be buying this view. The FDA has officially barred importation of e-cigarettes. “These appear to be unapproved drug device products,” a spokeswoman tells the Times, “and as unapproved products they can’t enter the United States.” Australia and Hong Kong have also prohibited the devices.

That’s a pretty awkward position. We restricted smoking, tobacco sales, and advertising based on decades of evidence that smoking was harmful to smokers and bystanders. Now we’re treating electronic cigarettes the same way based on … what? That “nobody knows” how bad they might be? The elements of smoking that justified our war on tobacco—carcinogens, combustion, secondhand smoke, even nicotine—have been removed or made optional. Is it really logical to ignore these differences?

And why should we presume that vaping is as dangerous as smoking, when research on vaporized marijuana suggests the opposite? Here are two such reports quoted last week in the Human Nature blog. First, a 2007 paper in Clinical Pharmacology & Therapeutics:

Whereas smoking marijuana increased CO [carbon monoxide] levels as expected for inhalation of a combustion product, there was little if any increase in CO after inhalation of THC from the vaporizer. This indicates little or no exposure to gaseous combustion toxins. Combustion products are harmful to health and reflect a major concern about the use of marijuana cigarettes for medical therapy as expressed by the Institute of Medicine.

And second, a 2007 study in the Harm Reduction Journal, which found

that respiratory symptoms like cough, phlegm, and tightness in the chest increase with cigarette use and cannabis use, but are less severe among users of a vaporizer. … The odds ratio suggests that vaporizer users are only 40% as likely to report respiratory symptoms as users who do not vaporize, even when age, sex, cigarette use, and amount of cannabis consumed are controlled.

Let’s be blunt about what’s going on here. We tolerated smoking until science proved it was harmful to nonsmokers. As momentum grew, the war on smoking became cultural, with disapproval and ostracism of anyone who lit up. Electronic cigarettes have removed the war’s scientific basis, but our cultural revulsion persists. Therefore, so does our prohibition and condemnation.

Maybe what we need is a convergence of the tobacco debate with the marijuana debate. In each case, vaporization is dissolving the categories and grounds that warranted prohibition. Liberals can see this, but only in the case of pot. Conservatives can see it, but only in the case of tobacco. Go talk to one another. The engineering and re-engineering of drugs will only get more complicated as technology improves. We’d better start thinking rationally about it.

see the full article here: http://www.slate.com/id/2219690/pagenum/all/#p2