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E-Cigarettes Spark New Smoking War

(online.wsj.com)

Steve McVey and other e-cigarette makers say their smoking devices are a safe alternative to tobacco. The FDA says they should be regulated -- no buts about it. WSJ's Danny Yadron reports.

Ms. Vasconcellos imports electronic cigarettes from a Chinese manufacturer and sells them on her website, Cignot.com, to 14,000 customers. The 48-year-old is part of a growing legion of e-cigarette purveyors who are defying the Food and Drug Administration, which contends the nascent nicotine products are drug devices that require pre-market approval and may pose their own health risks. The FDA began intercepting shipments of the products from China two years ago.

New Nicotine Fix

E-cigarettes are battery-powered tubes that turn nicotine-laced liquid into a vapor mist. Sellers say they are potentially less harmful than cigarettes because they don't have the toxins of burning tobacco. A growing number of people who use them say they are an effective way to quit smoking.

The future of the fledgling industryestimated at $100 million in annual sales and risingmay hinge on the outcome of a case scheduled for oral arguments before a federal appellate court in Washington, D.C., next month. The FDA is fighting to regulate the products as drug-delivery devices, similar to nicotine gums, patches or other nicotine-replacement products. Such a classification would subject e-cigarettes to lengthy and expensive trials to prove they are safe and effective.

But many e-cigarette companies argue that their products are designed to be recreational alternatives to cigarettes, not devices to wean people off nicotine. They say they couldn't afford the high cost of clinical trials, and that any such mandate would drive many of them out of business or force the industry to go underground.

The standoff underscores a growing rift in the public health community about how to solve one of the country's most vexing health problems. About 400,000 Americans die each year of smoking-related disease. Many public-health advocates, including the FDA, say e-cigarettes are unproven as a quit-smoking tool and could prompt nonsmokers to take up the nicotine habit.

But a number of public-health advocates, including the American Association of Public Health Physicians, argue that conventional policies for getting people off cigarettes have fallen short. These groups argue that encouraging smokers to switch to e-cigarettes and other smokeless tobacco products could sharply reduce tobacco-related disease in the U.S.

Dr. Joel Nitzkin, chairman of a tobacco control task force of the public physicians group, says e-cigarettes may prove to be the most promising smoking cessation product currently on the market. He thinks they should be regulated to ensure manufacturing standards are met. But he thinks the FDA's tobacco regulations, rather than the more demanding drug device rules, provide the best framework.

Indeed, the FDA could regulate e-cigarettes under the landmark 2009 law that gave the agency broad power to regulate tobacco products. Under these rules, e-cigarette makers wouldn't be required to go through lengthy and costly pre-market approvals, in most cases. But the FDA maintains that e-cigarettes are actually drug-delivery devices that aren't subject to the tobacco regulations.

While the federal case is pending, sellers of e-cigarettes and "juice"the nicotine-laced liquid that goes into the devicescontinue to pop up online and in malls. 7-Eleven Inc. stores in California, New York, Texas and a handful of other states recently began selling an e-cigarette brand. Costco Corp. in April stopped selling a version on its website because of concerns about the FDA's stance. Wal-Mart Inc. also briefly offered a product on its website this year but discontinued it because it didn't attract much demand and the company was concerned about the FDA's position, a spokesman said.

E-cigarettes have caught fire in part because they mimic the experience of smoking. When a user sucks on an e-cigarette, an atomizer turns the liquid inside into a vaporwhich is why the practice is called "vaping" instead of smoking. Consumers typically pay $40 to $120 for a starter kit, and then pay smaller amounts for liquid refills.

E-cigarettes typically contain a solution of propylene glycola chemical used to make artificial smoke in theatrical productionswater, nicotine and flavorings such as "espresso" and "simply strawberry." The amount of nicotine varies to accommodate different consumers' preferences. Some e-cigarettes contain no nicotine.

Some scientists say e-cigarettes are probably less harmful than cigarettes because they don't involve the burning of tobacco, which produces most of the toxins that cause cancer and other tobacco-related diseases.

However, no published, peer-reviewed studies have examined the long-term health risks of e-cigarettes. Some scientists are concerned that prolonged exposure to vaporized forms of propylene glycolgenerally recognized by the FDA as safe for use in foods such as salad dressings, cake mixes and sodasmight cause harm.

"There are a lot of reasons to believe logically that e-cigarettes offer a safer profile, but I want data that demonstrates safety," says Thomas Eissenberg, a psychology professor at Virginia Commonwealth University who studies nicotine addiction.

In a report released last year, the FDA said it conducted a preliminary review of a few e-cigarettes and found poor quality control. Some cartridges that claimed not to contain nicotine actually did, and one of the 18 samples had trace amounts of diethylene glycol, a chemical used in antifreeze that is toxic to humans. The FDA says the amount of nicotine delivered varies and isn't standardized, which also raises safety concerns.

E-cigarettes were introduced in China in the mid-2000s and hit the U.S. in 2007, industry executives say. Some countries, such as Canada and Australia, effectively ban their sale, saying they have yet to be fully evaluated for safety and effectiveness. New Jersey and New York's Suffolk County bar use of the product wherever regular cigarettes are prohibited.

The National Vapers Club, an advocacy group for e-cigarette users in Valley Stream, N.Y., estimates that at least 1 million people in the U.S. use the products. The group's president, Spike Babaian, says the number of U.S. e-cigarette companies has ballooned to about 300 from roughly a dozen two years ago.

The FDA began detaining some shipments from China in June 2008 on the grounds that the products were unapproved drug devices aimed at treating nicotine addiction. Smoking Everywhere Inc., a Florida distributor of e-cigarettes, sued the agency in April 2009, claiming that the FDA had no jurisdiction over the products. Another purveyor, Sottera Inc. of Scottsdale, Ariz., later joined the case as a plaintiff.

While the case was pending, Congress, in an unrelated move, passed landmark legislation that gave the FDA authority to regulate tobacco products, which lawmakers broadly defined as "any product made or derived from tobacco that is intended for human consumption." But the agency continued to maintain that e-cigarettes were drug devices, not a tobacco product like a pack of cigarettes or can of snuff.

Richard J. Leon, a judge in the U.S. District Court for the District of Columbia, issued a preliminary injunction against the FDA in January, ruling that Smoking Everywhere and Sottera generally marketed their e-cigarettes as recreational alternatives to cigarettes, rather than as quit-smoking aids. The judge called the FDA's approach a "tenacious drive to maximize its regulatory power." He noted that e-cigarettes contained nicotine derived from tobacco and said they appeared to fall under the provisions of the new tobacco law.

The FDA won a stay of Judge Leon's ruling, pending an appeal to the U.S. Court of Appeals for the District of Columbia Circuit. The agency is still detaining and refusing entry of e-cigarettes, a spokeswoman says.

Several former cigarette smokers say they were able to kick their habit in a matter of days by switching to e-cigarettes. "My breathing is better, my sleeping is better," says Greg Hester, 42, an information-systems worker in Atlanta who had smoked cigarettes for more than 20 years.

Ms. Vasconcellos, the Illinois entrepreneur, says she began smoking at 14 and eventually smoked two packs per day. She tried unsuccessfully to quit using nicotine patches and other products. In early 2009, she tried an e-cigarette and has been using them since.

Ms. Vasconcellos, who previously worked as a computer consultant, found e-cigarettes "so life-changing that I had to let other people know about it." She began Cignot Inc. last year and says it has generated about $1.5 million in sales. Her company's website makes no specific health claims, but calls e-cigarettes a "marvelous alternative to tobacco cigarettes."

Ms. Vasconcellos says that she has lost tens of thousands of dollars on shipments from China that were blocked by the FDA and that the agency's actions make it tough to do business. The FDA has refused to allow e-cigarette battery chargers and other products Ms. Vasconcellos has ordered from China and other countries, according to FDA documents reviewed by The Wall Street Journal. To try to stay under the radar, Ms. Vasconcellos orders shipments in smaller packages and has them sent to friends' homes around the U.S.

The FDA spokeswoman says the agency has refused the entry of more than 700 shipments of e-cigarettes nationally since it began detaining and reviewing the products two years ago.

Steve McVey, owner of PureSmoker.com in Goodlettsville, Tenn., near Nashville, had $59,000 in shipments from China seized last year and has faced lengthy delays on other shipments as federal inspectors scrutinized them.

"We've almost closed up shop three or four times," Mr. McVey says.

Nevertheless, Mr. McVey says his company, Pure Enterprises Inc., collected $1.3 million in revenue last year.

To counteract pressure from the FDA, the company has begun producing some products in the U.S. Mr. McVey hired 28-year-old Jeff Hildebrand, a biomedical sciences graduate from Texas A&M University, to brew e-cigarette juice in a small laboratory.

Several other companies are producing e-cigarette liquids in the U.S., partly because of the concern the FDA raised last year about quality control in Chinese factories.

Johnson Creek Enterprises LLC, a Wisconsin firm that makes its own "smoke juice," says it lists all the ingredients on its packaging and uses childproof caps. (Nicotine, the main addictive ingredient in tobacco products, can be poisonous in high doses. It generally is thought to be noncarcinogenic, though it has been linked to high blood pressure.)

Christian Berkey, a former Apple Inc. assistant store manager who founded Johnson Creek Enterprises, says he would prefer to have the industry regulated as a tobacco product to create standards for quality and establish a level playing field.

Johnson Creek sells its juice for e-cigarettes to blu Cigs, one of the industry's largest players. Jason Healy, president of blu Cigs, says the Charlotte, N.C., company's sales are on pace to reach $30 million this year.

The FDA spokeswoman says the agency is aware that some companies are manufacturing e-cigarette liquids and other equipment in the U.S. but has taken no enforcement actions against them to date. She declines to elaborate on why.

Several advocates for tobacco control, including the American Lung Association and the American Legacy Foundation, say e-cigarettes require deeper study. These advocates are concerned the products could appeal to nonsmokers, especially youth, and encourage them to smoke regular cigarettes. Some tobacco-control advocates also worry that e-cigarettes are often sold online, where it is difficult to verify that a buyer is at least 18 years old.

Owners of U.S. e-cigarette companies say that any federal-court ruling allowing the FDA to treat the products as drug devices and require pre-market approval would drive many of them out of business and create a black market.

"If the government tries to suppress this, it will go underground," says David Dettloff, 48, owner of FreedomSmokeUSA, a Tucson, Ariz., seller of e-cigarette juices. "Ninety percent of everyone who vapes is so glad to be off cigarettes that they would buy it in the drug market."


New smoking cessation therapy proves promising

(www.eurekalert.org)

DURHAM, NC A novel technology for delivering nicotine to the lungs may soon give smokers a new way to kick the habit.

When compared to the nicotine vapor delivery system used in the Nicotrol/Nicorette inhaler, the new technology proved more effective at delivering nicotine to the blood stream. As a result, it provides immediate relief of withdrawal symptoms, according to Duke University Medical Center researchers. Users also reported the new nicotine delivery method was more tolerable than the current inhaler because it caused less throat irritation.

"We wanted to replicate the experience of smoking without incurring the dangers associated with cigarettes, and we wanted to do so more effectively than the nicotine replacement therapies currently on the market," said Jed Rose, Ph.D., director of the Duke Center for Nicotine and Smoking Cessation Research where the technology is being developed. He presented the data today at the Society for Nicotine and Tobacco Research (SRNT) in Baltimore, MD.

The Nicotrol inhaler is a smoking cessation therapy that delivers nicotine vapor to the mouth and upper airways, but little of it reaches the lungs.

Duke's new technology employs a unique method to deliver nicotine to the lungs. In today's presentation, the researchers show the new lung delivery technology results in rapid absorption of nicotine that provides immediate relief of withdrawal symptoms and also re-creates some of the familiar sensations that are pleasurable to smokers.

Current methods that deliver medicine to the lungs -- metered dose sprays, dry powder inhalers or nebulizers that create a fine mist do not replicate the natural inhalation used by smokers when drawing on a cigarette. And, because medication residue often deposits in the mouth and throat, doses aren't always high enough to ensure the appropriate amount reaches the lungs.

Duke's new technology combines the vapor phase of pyruvic acid, which occurs naturally in the body, and nicotine. "When the two vapors combine, they form a salt called nicotine pyruvate," explains Rose. "This reaction transforms invisible gas vapors into a cloud of microscopic particles which is inhaled, just like a smoker inhales from a cigarette."

In a study of the new Duke technology, nine healthy smokers inhaled 10 puffs of nicotine pyruvate in increasing doses, 10 puffs from a Nicotrol/Nicorette inhaler cartridge, and 10 puffs of room air (placebo). Blood was drawn before and after each set of inhalations. When the results were analyzed, the Duke researchers noted rapid increases in plasma nicotine concentrations following the nicotine pyruvate inhalations and less complaints of harshness/irritation when compared to the Nicotrol/Nicorette control cartridge. The smokers also said their cravings for cigarettes were substantially alleviated following the nicotine pyruvate inhalations.

"Compared to the current nicotine vapor inhaler, we are able to give smokers more nicotine, although still less than a cigarette, with less irritation, resulting in reduced cravings," said Rose. "Thus we are able to achieve a therapeutic effect with greater tolerability."

More research is needed to examine the safety and effectiveness of prolonged use of the inhalation system, and to assess its role in helping people quit smoking. But, Rose says if all goes well, he anticipates the product could become commercially available within three to five years.

He also says the novel inhalation system may one day prove useful for delivery of other medications. Duke has filed patent applications on the new technology, which was invented by Rose and his colleagues, including his brother, Seth D. Rose, Ph.D., Duke colleague, Thangaraju Murugesan, Ph.D., and James E. Turner, an inventor of the Nicotrol/Nicorette inhaler.

Collaborators on the project included Turner, Murugesan, and Frederique M. Behm of Duke University Medical Center, Chris J. Wynne, of the Christchurch Clinical Studies Trust, Christchurch, New Zealand, and Murray Laugesen, of Health New Zealand Ltd., Christchurch, New Zealand.


Electronic Cigarettes: Are They Safe?

Battery Powered Cigarettes Give The Nicotine Kick Without The Tobacco

(www.cbsnews.com)

Electronic cigarettes are popping up in shopping malls, kiosks and online.
You might not be lighting up tobacco, but are they a safer alternative to regular cigarettes?

Doctor Jonathan Whiteson from New York University's Cardiac and Pulmonary Wellness and Rehabilitation Program talked to Early Show co-anchors Julie Chen and Harry Smith about the product.

"Are they safe?" Chen asked.

"We don't know, but we don't think so," Whiteson said.

"It's not tobacco that you're smoking, then what is it?" Chen asked.

"It's not smoking. What you're actually inhaling is a vapor. These electronic cigarettes are battery powered and they vaporize nicotine, so you're inhaling the nicotine vapor. So, you're getting the nicotine hit, but without the toxic smoke and contents of the cigarette and the tar. However, there's no proof that these cigarettes are safe. No proof whatsoever. They are made in China. They're unregulated. Certainly not approved by the FDA," Whiteson said.

Smith, who smoked in his 20's and said that the best thing he'd ever done was quit, was curious to see what the sensation was like and tried the product.

Though very distasteful to Smith now, he said that the electronic cigarettes reminded him a lot of smoking.

"We don't know if it's safe at all, period. Again, this is unregulated. We don't know how much nicotine is exactly there. We don't know how much is being delivered. We don't know the contents of the vapor. This has not been studied," Whiteson said.

"So does this mean it could be worse for you than cigarettes?" Chen asked.

"It could be. The manufacturers think it's safer, but it could be worse. We just don't know at this time," Whiteson said. "We have no analysis of the vapor."

"So why does it exist? It sounds like a gimmick. They make you think you can get off cigarettes by smoking this," Chen said.

"That's right. It's a smoking cessation product, but it isn't. Again, it's not FDA approved, it's not been tried and tested," Whiteson said.

"Does that mean you could get addicted to this, which could be worse?" Chen asked.

"Absolutely. My biggest concern is these things are marketed to younger people, to adolescents. And my biggest concern is that adolescents are going to start smoking these cigarettes thinking they're not getting any dangerous products. But the first hit of nicotine can make you addicted, and that is so concerning. We already have more adolescents than adults smoking, and the last thing we want to do is encourage them to smoke more," Whiteson said.

"What is the best way to quit smoking cigarettes?" Chen asked.

"The best way to quit is through discussions with your physician in a program that's recognized as smoking cessation, to use nicotine replacement that's approved by the FDA, either a patch, gum or lozenge and also to work on the behavioral changes, so that emotionally you can be ready to quit and you can be prepared if there are any triggers to start you smoking," Whiteson said.


E-Cigarette Legal Battle Comes to Close

The Food and Drug Administration recently announced it will regulate electronic cigarettes as tobacco products, in other words, just like regular cigarettes. The agency had previously been pushing to regulate the smokeless cigarettes as drug delivery devices, but lost a court battle in early 2011. The FDA decided not to appeal the courts decision, which puts to rest a legal battle that had been ongoing since 2009.

E-cigarette manufacturers and distributors and I imagine e-cigarette smokers consider the FDAs decision not to appeal a major victory. If classified as drug delivery devices, e-cigarettes would be subject to much tighter regulations. Anti-smoking groups are expectedly disappointed the agency has accepted the courts ruling.

E-cigarettes were first released overseas in 2002, but did not become readily available in the US market until 2006. E-cigarettes are plastic or metal battery-powered devices that use chemicals to turn liquid nicotine into vapor. They are designed to look and feel like regular cigarettes, but do not contain tobacco or produce smoke. As more places ban smoking indoors, e-cigarettes have become more popular. However, some states have begun banning electronic cigarettes indoors as well.

A lack of scientific evidence about health claims and the drawn-out court battles with the FDA have allowed electronic cigarette makers and sellers to operate in somewhat of a gray zone. Until now, e-cigarettes were not clearly classified as either drug delivery devices or tobacco products, so sales to minors and manufacturing flavored products had previously been legal. However, some e-cigarette manufacturers, such as Sottera, have come under fire for targeting minors. Many states have now passed legislation to prohibit e-cigarette sales to minors.

Some e-cigarette makers say their products are healthier alternatives to regular cigarettes, but the FDA warns that they often contain harmful toxins and may be addictive. Some people use the devices to try to quit smoking, but no studies have proven whether they actually curb smoking cravings.  The FDA has cited companies, such as Dragonite International (formerly Ruyan America), for making unsubstantiated health claims. E-cigarettes are relatively new to the market and there is little research on the products safety compared to traditional cigarettes.

The days of legal loopholes and lacking laboratory testing may be short-lived, however. While e-cigarettes wont be subject to the strict regulations and clinical trials of drugs, they will now have to comply with federal laws that apply to regular cigarettes and other tobacco products.



ZEROCIG electronic cigarettes feel, taste and look like a traditional cigarette, only produces zero tar,  smoke, odor and ash. ZEROCIG only releases rich, fresh smokeless vapor which provides you with the ease and convenience of smoking where traditional cigarettes are usually banned.


ZEROCIG believes premium electronic cigarettes do not have to come with a huge price especially when the advantages from switching from traditional cigarettes can be a beneficial and significant change. Thats why we aspire to keep our prices low, so you everyone can experience the benefits from making the switch!


Smokeless cigarette facts


ZEROCIG allows you to enjoy the experience of the smoking sensation without the lingering cigarette odor. ZEROCIG contains mainly water, flavorings, nicotine and propylene glycol making your environment more comfortable for you and your loved ones. Here is a short list of ingredients youll be leaving behind by making the switch to smokeless cigarettes:

             Carbon Monoxide (found in car exhaust)

             Arsenic (rat poison)

             Ammonia (found in window cleaner)

             Acetone (found in nail polish remover)

             Hydrogen Cyanide (gas chamber poison)

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             Sulphur Compounds (found in matches)

             Lead

             Volatile Alcohol

             Formaldehyde (used as embalming fluid)

             Butane (lighter fluid)

 

How It Works:

Electronic Cigarettes are more commonly used for smokers that have tried other forms of nicotine replacement therapy with little to no results. For smokers that find it difficult to stop their addiction, E Cigarettes (or e cig) allows its users to comfortably wean them off while still enjoying the sensation of smoking a traditional cigarette. However, electronic cigarettes are gaining popularity by use of traditional smokers in subsidizing their habit.


An e-cigarette delivers nicotine vapor without the tar or other carcinogens that pollute our air and lungs. The user controls the amount of nicotine that is being vaporized. This allows users to choose to gradually decrease the amount which ultimately would lead to cession of smoking. Nothing burns; only a drop of nicotine is mixed with vapor to mimic the feeling of smoke being inhaled into the lungs. There is no lingering odor, no smoke, no mess or carcinogens. This proves to be a clean and healthier alternative to what most non-smokers find to be a very bad habit.


Assembling:


1. The First thing you will need to begin your ZEROCIG E Cigarette experience is your own starter pack. In it, you should receive: 1 Rechargeable Lithium Battery, 6 cartridges (flavors vary) - nicotine strengths (also vary), 1 USB (Multi Charger)1 Easy Start Manual.


2. Your ZEROCIG startup kit comes with a USB plug, this is your e-cig charger. Plug your USB plug into a port, generally a lab top or pc. Place the USB charger into the e cigarette body holder (you may have to twist the two together). Initially you might have to wait 2 hours for the first charge then 1 to 2 for a recharge. ZEROCIGs have a light to tell you when its finished charging. You may want to have one charging while you are using another.


3. Once your ZEROCIG has charged, you will need to put your electronic cigarette together. ZEROCIG has a two piece unit: battery and cartridge.

 

4. Once you've put together your ZEROCIG, you can begin your electronic cigarette experience. Puff on your e cig and inhale as you would a regular cigarette. As you draw, the nicotine is heated and you will inhale and then release water vapor (steam), instead of smoke. One ZEROCIG refill cartridge is equivalent to thirty cigarettes!


5. When you are done with your ZEROCIG, set it down. ZEROCIG will alert you with an LED light when it is time to recharge the battery. When vapor is no longer emitted, you may need to recharge your battery. If you do need to recharge unscrew the atomizer battery from the cartridge and recharge with your USB plug.



Affiliate Program content:


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