FDA Cracks Down on E-Cigarettes

The agency intends to regulate the nicotine delivery devices as drug products.

Aug. 13, 2010— -- The U.S. Food and Drug Administration on Thursday sent warning letters to five manufacturers of electronic cigarettes, noting that from now on the popular nicotine-packed devices will be subject to regulation as drugs.

The companies that received warning letters were E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig Technology Inc. and Johnson's Creek Enterprises LLC.

"Under the [Federal Food, Drug, and Cosmetic Act], a company cannot claim that its drug can treat or mitigate a disease, such as nicotine addiction, unless the drug's safety and effectiveness have been proven,"said Michael Levy, director of the Division of New Drugs and Labeling Compliance for the FDA's Center for Drug Evaluation and Research at a press conference Thursday. "Yet all five companies claim without FDA review of relevant evidence that the products help users quit smoking cigarettes.

"These products are not considered safe and effective yet."

In at least one case, the warning letter issued to a manufacturer addressed concerns other than just nicotine. According to the FDA, E-Cig Technology also markets refill cartridges for the devices that contain tadalafil, an erectile dysfunction drug, and rimonabant, a weight loss drug that has not been approved for use in the United States.

The FDA also issued a letter to the Electronic Cigarette Association in which they said the agency intends to regulate electronic cigarettes and related products in the interest of protecting the public health.

"FDA invites electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are lawfully marketed," the letter to the association reads.

E-cigarettes look like cigarettes, taste like cigarettes, and provide the same nicotine buzz. But proponents of the devices have claimed that the electronic cigarette is a far cry from traditional smokes in that the battery-powered gadgets are practically carcinogen-free.

Still, while users call this product a "miracle" and a "lifesaver," health authorities have been wary of e-cigarettes. The FDA action follows moves by several states, including New Jersey, New York, and New Hampshire, to ban them.

The e-cigarette uses an internal atomizer to vaporize nicotine, offering a smokeless, odorless, experience that manufacturers say eliminates the many health problems associated with lighting up.

Affordable and readily available online by adults and minors alike, some argue that this product, which comes in flavors like chocolate or apple, is just another way for teens to get hooked on nicotine.

Other public health organizations in addition to the FDA, including the National Cancer Society and the American Lung Association, have publically denounced the unregulated device as potentially unsafe, but that hasn't stopped thousands of smokers from going electronic.

Public Health Fears

Citing lack of research, health authorities have been quick to speak out against e-cigarettes.

The American Cancer Society, Cancer Action Network, American Lung Association and others said in a statement on the product that "absent scientific evidence, these claims…that they are safer than normal cigarettes ... are in blatant in violation of FDA rules."

And suspicions about these unregulated devices are not unfounded. The FDA survey of e-cigarettes found that one brand, Smoking Everywhere, contained diethylene glycol, a toxic chemical found in antifreeze.

"We Don't Know Enough About E-Cigarettes"

Marketing of these e-cigarettes has also been controversial. The main selling point for some advertisements is that you can puff on e-cigarettes in places that would normally ban smoking such as the office, restaurants, even airplanes.

And this is certainly a draw for most users: one California man, who wished to remain anonymous, is able to use his in the bathroom of the hospital where he works without detection.

The potential for subjecting non-smokers to the vapor of e-cigarettes led Americans for Nonsmokers' Rights to rally for bans on using them in public places:

"We don't know if the vapor is truly safe. We just don't know that much about e-cigarettes. For every environment that's already smoke-free, we believe it should be e-cigarette free," says Cynthia Hallet, executive director.

The ease of concealing an e-cigarette habit (no smoke, no smell) may also make the product more appealing to teens, some argue, and certain brands of e-cigarettes have also been accused of marketing to kids by offering candy-like flavors such as chocolate, cherry, mocha, or almond.

Though he doesn't know any teens who have latched onto the habit, Dr. Petros Levounis, director of the Addiction Institute of New York, says that "there is definitely reason for concern here."

Because teens can get them online by pretending to satisfy the age restrictions many brands place on their websites, "I wouldn't be surprised if this becomes a problem," he says.

Even if e-cigarettes lack the toxicity of tobacco cigarettes, the nicotine in them is still a stimulant substance that you would want to keep out of the hands of minors, just as you would caffeine or alcohol, says Dr. Edwin Salsitz of the Division of Chemical Dependency at Beth Israel Medical Center.

A User-Friendly Cigarette

Even with the controversy, e-cigarettes have increased in popularity since appearing in the U.S. about three years ago.

Complete with an LCD light that mimics a butt's glowing ember, e-cigarettes are designed to replicate the experience of smoking. An onlooker wouldn't even notice that it is vapor blowing from the "smoker's" lips, not smoke.

What isn't replicated, however, is the tar, laundry list of harsh chemicals, or many of the side effects associated with tobacco cigarettes.

"Nicotine alone is generally not harmful, it's the other stuff in cigarettes, the carbon monoxide [produced] and other thousands of chemicals," says Salsitz. And while tobacco cigarettes are affectionately called "cancer sticks" by some users, a preliminary survey by the FDA found that e-cigarettes have only trace levels of carcinogens.

As a result, many users report that their lungs function and sense of smell and taste return after a few weeks of using e-cigarettes -- benefits often noted by those who quit smoking altogether.

"I feel like a non-smoker," says Shannon Wright, 34, of Charlotte, N.C., who smoked a pack a day for 14 years prior to finding e-cigarettes in a mall kiosk. "My morning cough that haunted me every day is gone. I have two kids and I wanted to stop smoking. This has been the only thing that has worked."

Of course those who switch to electronic are still feeding their nicotine addiction, but the new habit is considerably healthier, doctors say.

"It appears that e-cigarettes are much safer. Yeah they are still getting nicotine, but would you rather have it alone or delivered with thousands of toxins, including 40 carcinogens," says Michael Siegel, Associate Chairman of Community Health Sciences at Boston University.

Puff Your Way to Nicotine-Free

"In an ideal world, I would prefer that all smokers stop smoking and stop using all nicotine products," says Dr. John Spangler of Wake Forest University Baptist Medical Center, but nicotine without tobacco is at least the lesser of two evils, especially for those smokers who are unable to quit, he adds.

And according to users, the switch is often seamless. Whereas the nicotine patch, gum, or other products intended to help smokers stop smoking have high failure rates, users of e-cigarettes are more often than not immediate converts.

"The first day I got it I quit smoking," says Wright, who says that she knows many other e-smokers who share her experience.

And though e-cigarettes were not originally intended as an aid for kicking a nicotine habit, some consumers have begun using it as such.

The gradation of nicotine concentrations available to consumers lends itself to a step-down program of weaning oneself off nicotine.

FDA-approved tools for smoking cessation like the patch require smokers to give up the act of the cigarette break, but with the e-cigarette, the same routine, with the same amount of puffs can remain stable while the nicotine levels are slowly decreased all the way to the allegedly nicotine-free cartridges.

"Over the 18 months I've used them, I've decreased the nicotine level gradually," Wright says, "I'm well on my way to zero."