"They are electronic, alternative smoking devices that simulate the sensation of smoking. They do not expose the user, or others close by, to harmful levels of cancer-causing agents and other dangerous chemicals normally associated with traditional tobacco products."
-- Craig Youngblood, president of InLife, an e-cigarette company.
"They are nicotine delivery devices intended to be used like a cigarette. What happens to someone who stops inhaling the tars of cigarettes and inhales only nicotine? We don't know. There is at least the potential for harm."
-- Norman Edelman, MD, chief medical officer, American Lung Association
"We are concerned about the potential for addiction and abuse of these products. We don't want the public to perceive them as a safer alternative to cigarettes."
-- Rita Chapelle, FDA spokeswoman.
E-cigarettes don't make real smoke, yet they've ignited a firestorm of controversy.
You may have already seen e-cigarettes -- electronic cigarettes -- for sale on the Internet or at one of at least 62 kiosks at malls across the U.S.
E-cigarettes are safer than cigarettes, their makers say or imply. But until e-cigarettes are proven safe, the FDA is refusing to let them into the country and may soon ban their sale, as major U.S. medical associations have asked.
"We have an open investigation into this issue," FDA spokeswoman Rita Chappelle tells WebMD. "What is happening right now is FDA has reviewed several e-cigarettes, e-cigars, and e-pipes, and have refused entry of these products into the country. We acted because these products appear to require FDA approval for marketing, and have not been reviewed by the agency."
An informal FDA review of some of these products "indicated that these products are not currently approved," Chappelle says.
If the FDA bans e-cigarettes, an action many observers believe imminent, it won't be the first North American agency to do so. Last month, Canada's health agency banned the importation or sale of e-cigarette products.
What's all the fuss about? At the heart of the issue is a debate over what the e-cigarette really is.
What's an E-Cigarette?
Like gunpowder, the e-cigarette is a Chinese invention. The first ones came from the Ruyan company in 2004. According to media reports, Ruyan says it sold 300,000 e-cigarettes in 2008, and it's far from the only company making the devices.
The e-cigarette comes in many shapes and sizes. Many look more or less like long cigarettes; others look like cigars or pipes. They all work the same basic way:
- The user inhales through a mouthpiece.
- Air flow triggers a sensor that switches on a small, battery-powered heater.
- The heater vaporizes liquid nicotine in a small cartridge (it also activates a light at the "lit" end of the e-cigarette). Users can opt for a cartridge without nicotine.
- The heater also vaporizes propylene glycol (PEG) in the cartridge. PEG is the stuff of which theatrical smoke is made.
- The user gets a puff of hot gas that feels a lot like tobacco smoke.
- When the user exhales, there's a cloud of PEG vapor that looks like smoke. The vapor quickly dissipates.
- E-cigarettes contain no tobacco products; even the nicotine is synthetic.
The devices retail for $100 to $200. Refill cartridge packs vary in price depending on nicotine content, and liquid for do-it-yourself refills are sold, too. Each cartridge is good for several uses.
So what's an e-cigarette good for?
Different e-cigarette marketers stress different points:
- For smokers who don't plan to quit tobacco, some firms point to e-cigarettes as a way to "smoke" in smoke-free environments such as airplane lounges, restaurants, and workplaces.
- For smokers who don't want to give up their nicotine addiction, some firms suggest that switching to e-cigarettes will reduce the harm of their habit.
- For smokers who want to quit, some firms suggest that e-cigarettes may help people transition from smokers to nonsmokers (the World Health Organization has asked marketers not to make this claim).
Craig Youngblood, president of the InLife e-cigarette company, says that since regular tobacco is very bad for you, something that assuages your nicotine habit without smoke must be less bad.
"In our product you have nicotine or no nicotine, PEG, and some flavoring. In cigarettes you have nicotine, PEG, and 4,000 chemicals and 43 carcinogens," Youngblood tells WebMD. "There are 45 to 50 million people already addicted to nicotine. Should they have the choice to satisfy their addiction by other means? ... I am a proponent of harm reduction. People have rights and choices and should be allowed to make them."
Youngblood says his company makes no health claims. He rejects the idea that his product is a smoking cessation device and says his company does not make that claim. He also says his product is not sold to minors.
Youngblood does make this claim: E-cigarettes are green.
"There is no pollution of the environment with this product," he says. "The vapor is not the same as smoke. And for every odor-free e-cigarette cartridge people throw in the trash, smokers throw 20 smelly cigarette butts out their car windows."
Some firms do suggest that e-cigarettes are safer than tobacco cigarettes. Most point to a Ruyan-funded study by tobacco researcher Murray Laugesen, MBChB, of Health New Zealand, a private research firm.
Laugesen analyzed Ruyan e-cigarettes and found nothing inherently bad in them -- that is, they contained what they said they contained and posed little threat of immediate harm.
But this was not a clinical study, notes Norman Edelman, MD, chief medical officer of the American Lung Association, one of the organizations that has called for an FDA ban on e-cigarettes.
"Laugesen is trying to project what the effects of e-cigarettes might be, but he doesn't really know," Edelman tells WebMD. "There are no clinical studies of long-term use of these products."
And some firms do claim that e-cigarettes help people quit smoking. After all, there's an FDA-approved nicotine inhaler already in drug stores -- Pfizer's Nicotrol. It doesn't look much like a cigarette, but it doesn't look much different than some e-cigarette products.
What's the difference?
"The Nicotrol inhaler is an approved smoking cessation device," says the FDA's Chapelle. "Because these e-cigarette products haven't been reviewed by the agency, their labeling has to be reviewed, their intended use has to be reviewed, and all of their ingredients and components have to be reviewed."
Edelman says nicotine addiction is bad and that people with the habit need help quitting, not help continuing their habit in more socially acceptable ways.
And there's no proof that e-cigarettes don't cause long-term harm. That's what bothers all the health experts who discussed e-cigarettes with WebMD.
"We cannot say they are good or bad because we don't have any scientific proof," says Eliana Mendes, MD, a pulmonology researcher at the University of Miami.
"What happens to someone who stops inhaling the tars of cigarettes and just inhales nicotine? We don't know," Edelman says. "We are talking about use that might be three years, five years, 10 years, we just don't know. Once you have the nicotine habit, you are not likely to quit."
Rather than quit, e-cigarettes might worsen users' nicotine habits, says Michael Eriksen, ScD, director of the institute of public health at Atlanta's Georgia State University and former director of CDC's office of smoking and health.
"I have seen no evidence that people switch from tobacco cigarettes to e-cigarettes or other smokeless tobacco products," Eriksen tells WebMD. "If you look at how smokeless products are marketed, they are sold as something to use at times you can't smoke. The implication is you will increase nicotine exposure, not reduce smoking. We'll just be encouraging people to use more nicotine."
Youngblood says his e-cigarette products are being marketed only to people who already smoke and already have a nicotine addiction. But Eriksen says the unregulated sale of these products might get new users hooked -- users who might then start smoking.
"Will e-cigarettes get fewer people smoking? Or will people start with e-cigarettes and graduate to tobacco cigarettes? It is unknown whether these things are good, bad, or indifferent," he says. "If for every person who used e-cigarettes there was one fewer person smoking tobacco cigarettes, that would be good. But there is no evidence that will occur."
And there's one more issue that troubles doctors. University of Miami pediatrician and lung specialist Michael Light, PhD, says underage users will get their hands on e-cigarettes -- even if marketers like Youngblood refuse to sell them to minors.
"It will be easy for kids to get the product," Light tells WebMD. "It could be a way to get kids into the nicotine habit to get them to smoke. It is a ploy."