FDA imposes regulations on electronic cigarettes

Since Ohio’s statewide smoking ban went into effect in December 2006, making it illegal to smoke tobacco products in bars, restaurants and most other enclosed workspaces, smokers have been forced to keep their habit in check — or at least make it more discreet.

More than two years later, some smokers still argue that the smoking ban infringes upon their personal freedom. Recent technology, however, has given them the chance to fight back and reclaim their right to suck down nicotine anytime, anywhere, without the risk of legal consequence.

In this respect, every smoker’s ticket to liberation could be electronic cigarettes.

The e-cigarette revolution

Electronic cigarettes, also known as “e-cigarettes,” are tobacco-free, battery-powered devices that vaporize a liquid nicotine solution that users can inhale for an effect similar to that of smoking a traditional cigarette. Thus, the “smoke” produced from an e-cigarette is actually a liquid vapor, as opposed to smoke created by burning tobacco leaves.

Most e-cigarettes consist of three main components: a rechargeable lithium battery, an atomizer (the heating element) and a disposable cartridge that houses the nicotine solution and also functions as the mouthpiece. The liquid, also known as “smoke juice,” is comprised of propylene glycol (90 percent), water (less than 2 percent), flavorings (less than 2 percent) and nicotine (0-8 percent, depending on the strength). Flavors include coffee, chocolate, mint, apple and, yes, tobacco.

E-cigarettes vary in size and model, some of which resemble a ballpoint pen, while others look almost identical to a traditional cigarette with an LED light at the tip to create the illusion that it’s actually burning.

“(E-cigarettes) are a realistic alternative to smoking traditional cigarettes without the harmful effects associated with the combustion of tobacco,” says Kurt Auer, an electrical engineer and co-founder of Vapor Guys, an e-cigarette distributor based in Cincinnati.

Because e-cigarettes are tobacco-free products and technically don’t produce smoke, they aren’t restricted by Ohio’s smoking ban. Thus, smokers can legally get their nicotine fix anywhere in public, although Auer suggests getting permission before using.

Aside from being able to legally “smoke” in public, Auer highlighted several advantages to using e-cigarettes instead of traditional cigarettes.

“For smokers, electronic cigarettes are cheaper, less messy and they do not leave an odor. For non-smokers, there is very little smell associated with the exhaled vapor, which is far less dangerous than secondhand smoke,” he says.

Comparing costs, five cartridges are sold for $3.99 on the Vapor Guys website (www. vaporguys.com) and are roughly equivalent to a pack of traditional cigarettes, which now cost up to $9 each. As for the smell, the vapor has a minimal odor that lingers only momentarily. But whether the vapor is safer than smoke produced by burning tobacco is a controversial topic that has attracted worldwide attention.
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Many e-cigarette companies market their products as alternatives that will help people quit smoking, but others doubt the likelihood of their products having this effect.

“It is possible in the sense that the product is an alternative and a user might fully transfer to using only e-cigarettes,” Auer says. “However, it is so similar to the act of smoking traditional cigarettes that it would be just as hard to quit e-cigarettes.”

Battles with the FDA

President Obama in June signed the Family Smoking Prevention and Tobacco Control Act, a bill that gives the Food and Drug Administration (FDA) regulatory control over all tobacco products in attempt “to impose appropriate regulatory controls on the tobacco industry.” Controversy surrounds the approval of this bill in the e-cigarette industry, particularly after the FDA stopped and seized all e-cigarette products that were being imported into the United States from China.

“We’re concerned about the potential for addiction to and abuse of (electronic cigarette) products,” says FDA spokeswoman Rita Chappelle. “Some people may mistakenly perceive these products to be safer alternatives to conventional tobacco use.”

The law defines a tobacco product as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.” Because e-cigarettes are tobacco-free products, some companies have sued the FDA for unjustly imposing the regulations.

Nevertheless, the FDA still refuses to allow e-cigarettes, e-cigars and e-pipes to cross the border because they’re considered new drugs that require FDA approval.

“The biggest problems that companies are having with the FDA right now are that companies are making claims that smoking e-cigs are safe without filing an application with the FDA and clinical trials that can back it up,” Auer says.

In essence, clinical trials must be conducted for e-cigarettes to be approved by the FDA.

“Clinical trials cost several million dollars and some take 10 years (to complete). No e-cigarette companies have that much money to invest in clinical trials, nor do they have that amount of time to deal with,” Auer says. “There’s the question of whether or not it’s even possible to conduct clinical trials because to prove that this product is safe you would need a control group — a group of people who don’t smoke. You’re not going to find anyone that will willingly subject themselves to a nicotine addiction for the purpose of a clinical trial. It’s a catch-22.”

The Philip Morris conspiracy

Another factor fueling the controversy is the influence Philip Morris Inc. had in crafting the bill. Philip Morris is the tobacco division that owns such popular cigarette brands as cigs4us.biz/marlboro-cigarette, cigs4us.biz/virginia-cigarette and Basic. Due to this influence, some people refer to the law as the Marlboro Brand Protection Act.

Pharmaceutical companies are the other major opponent.

“Pharmaceutical companies have dedicated years and billions of dollars to anti-smoking stuff like patches and lozenges, so they’re opposed because electronic cigarette products blow their products away,” Auer says.

Despite FDA regulations, e-cigarettes are still legal to sell and use in the United States, unlike in some other nations including Canada and Australia.

While the legal wrangling continues about whether clinical studies must be conducted, the precise heath risks of smoking e-cigarettes remain undetermined, as nebulous as the smoke that once filled Ohio’s bars and nightclubs.
© Copyright: Citybeat

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