Today, the FDA rolled out plans to begin the regulation of e-cigarettes. The FDA is proposing legislation that would ban the sale of e-cigarettes to anyone under 18 (like traditional cigarettes) and, finally, establish federal oversight of what so far has been an exponentially growing market without regulation. The following article was published in the May 2014 issue of MEN'S FITNESS.

On December 17, 2014, user FFighter7231 posted a message on reddit.com’s “subreddit” message board dedicated to all things e-cigs: “6 months ago today…I smoked my last analog and will never look back…After 16 years of smoking [about one] pack a day, I’ll never touch another one. I’ve also gotten my fiancée to go vaping.”

“Vaping” refers to inhaling and exhaling nicotine-infused vapor from a small, battery-powered cylinder or similar device typically sold at pharmacies, convenience stores, and specialty shops. According to medical rules of thumb, once FFighter7232 smoked his last cigarette (or “analog”), he could expect that the carbon monoxide in his body would decrease to normal, nonsmoking levels within 12 hours. By now, six months later, the cilia in his lungs should have mostly regrown, more effectively keeping infections away. In six more months, his chances of heart disease should decrease to half that of a smoker. And in five more years, his stroke risk should decline to that of a nonsmoker.

FFighter7232, whose real name is Patrick Holdridge, lives in Herndon, VA, and is a sales manager at a swimming pool company. He’d tried to quit smoking analogs cold turkey, but nothing stopped the cravings until he found the e-cig forum and shopped around for a solid starter kit.

“The cravings and mood swings you get when you quit smoking—you become a very nasty person,” he says. “But when you quit and find you’re able to start tasting foods again, and wake up in the morning without hacking up a lung, you feel a lot better. I feel much healthier, with improved lung capacity: I can run and swim much longer than I could before, without being completely winded like I was when I was smoking cigarettes.”

With the explosion of the e-cig market—it boomed from roughly $20 million in 2008 to about $1 billion in 2013, according to trade sources,  and Citi Research estimates it will surpass $3 billion by 2015—the potential for smokers to switch to electronic forms of satisfying their nicotine addiction puts the future of tobacco cigarettes, for the first time in history, in doubt. In a June 2013 Italian study published in the journal PLOS One, 13% of participants—none of whom wanted to quit smoking—switched  from analogs to vaping exclusively.

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“We can use these products as an extraordinary tobacco-control tool,” says study author Riccardo Polosa, M.D., Ph.D. That’s what the makers, proponents, and users of e-cigarettes are hoping. And with all the buzz around e-cigs as a method to smoke “safely,” one would think public health officials would be rallying behind a device that might help save the 480,000 lives that tobacco takes in the U.S. every year.

But by and large, they aren’t. In fact, last winter, just two days after Holdridge’s Reddit post, the New York City Council voted to ban e-cigs in public places—bars, restaurants, parks—where cigarette use is already outlawed. And earlier this year, Chicago and L.A. followed suit with their own restrictions.

Just days before NYC’s vote, e-cigarette advocate and former United States Surgeon General Richard Carmona, M.D., who served under George W. Bush, wrote to the Council, saying: “I am extremely concerned…that such an effort, if successful, could do tremendous harm to what is emerging as the most promising weapon yet in the fight against tobacco-related illness and death…The Centers for Disease Control reports that adult smokers usually know they are engaged in harmful behavior and 69% would like to reduce or quit smoking. However, each year only 6% of smokers succeed in quitting…The history and data suggest we need more viable alternatives in this fight against tobacco. I believe that one such alternative is the electronic cigarette.”

Carmona now serves as chair of the Scientific Advisory Committee and on the board of  NJOY, one of the largest e-cig manufacturers in the U.S. As Surgeon General, he was vocal in his warnings on secondhand smoke, and he feels that the e-cigarette is the only way, as he says, to “make tobacco obsolete.”

But if we’re on the road to making tobacco obsolete, we might first want to look at what we’re replacing it with.

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Concern Number 1: The Particle Problem

In 2009, the FDA conducted laboratory analysis of a handful of unnamed e-cigarette brands and found toxins in the “juice,” or the liquid that’s atomized into vapor when a user drags on an e-cig. Diethylene glycol, a compound used in antifreeze, was singled out.

The Consumer Advocates for Smoke-free Alternatives Association took issue with the FDA’s findings, noting that the “FDA tested just 18 cartridges, from only two companies,” with only one testing positive for “about 1% diethylene glycol”—which is by no means a common ingredient in most electronic cigarettes, and is poisonous in large quantities. In fact, e-cigarette juice typically uses as a nicotine preservative not diethylene glycol but propylene glycol—an odorless, colorless substance that’s found in products like cosmetics and cake mix, and which the FDA considers generally safe for human consumption.

But either way, it’s one of the many particles one ingests when vaping, which makes the FDA’s larger point: that, in e-cigs, there are too many unknowns. When an e-cig user inhales vapor, he’s not only getting water and nicotine, he’s also ingesting small particles that are microscopic and hard to detect, and occasionally mysterious to researchers. The particles are becoming a major cause for concern among health professionals, because they may damage your respiratory system.

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“They get very deep into your lungs,” says Stanley Glantz, Ph.D., of the Center for Tobacco Control Research and Education. “They’re so small they get across the alveoli into your bloodstream.” This is similar to how analog cigarettes work.

“You burn the tobacco and that generates an aerosol, or smoke, of very small particles, which then carries the nicotine into your lungs where it can be absorbed,” says Glantz. “E-cigarettes generate a similar aerosol by taking glycerin, a nicotine mixture, plus whatever else is in it, and heating that up to generate the aerosol; that’s what you inhale. They have to carry the particles because that’s how they deliver the nicotine.”

Inhaling small particle matter is considered risky, healthwise; aside from the glycerin and nicotine, says Glantz, “people have measured heavy metals in them as well.” In fact, a disturbing January 2014 study by the University of California–Riverside found small amounts of tin, silver, iron, nickel, and aluminum in one brand.

Small-particle inhalation has also been traced to respiratory problems, including damaged lung tissue. Though inhaled e-cigarette vapor is estimated to contain far fewer damaging particles than tobacco smoke (and certainly none of the tobacco residue like tar that damages a smoker’s lungs), the exact amount is unknown. In 2012, Greek researchers found that short-term use of e-cigs could constrict airways, leading to concerns about their long-term effects on the lungs.

“When I look at some of the advertising materials, there are a lot of claims that this is pure water vapor” that e-cig smokers are inhaling and exhaling, says Maciej Goniewicz, Ph.D., of the Roswell Park Cancer Institute. “No, this is a mixture of the nicotine, the solvents for nicotine, and flavorings…Nicotine isn’t the worst chemical in a tobacco [cigarette] or in e-cigs,” Goniewicz says. “It’s all the other chemicals.”

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Concern Number 2: The Nicotine Monkey

Nicotine is unquestionably one of the most addictive substances on earth. It travels quickly through the bloodstream to the brain, where it relaxes the user, relieving stress (despite upping heart rate) and even temporarily stimulating memory and reducing depression, technically making it a stimulant. “Nicotine mimics a chemical called acetylcholine, which is the chemical through which nerves communicate with each other,” says Glantz. “That’s what leads to its addictive characteristics.”

Many cigarette smokers who wish to quit try smoking-cessation aids: gums, sprays, lozenges, or patches that replace the nicotine they’d normally take in, without the slew of additional carcinogens. These methods are effective to varying degrees, but not surefire. A 2012 study in the journal Tobacco Control showed that nicotine gums and patches were only effective in the short term, and didn’t keep smokers off cigarettes in the long run any more than quitting cold turkey.

Now, smokers like Holdridge are switching to e-cigs because they feel this could be the game changer. A device that simulates smoking—satisfying the hand-to-mouth motion and the inhalation of nicotine—could be far more effective in curbing a smoker’s craving.

Cigarettes typically contain about 12–15 milligrams of nicotine, of which only about 1–2 milligrams are absorbed into the body when smoking. The nicotine content of e-cigarettes can vary greatly, ranging from 0 to more than 30 milligrams of nicotine, depending on which replaceable cartridge or refillable liquid a user purchases.

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But taking in any amount of nicotine gives health advocates pause.

“I’m not sure why, in a general way, we’d want to sell nicotine addiction,” says Neil Schluger, M.D., chief scientific officer at the World Lung Foundation. “We know there have been adverse health effects linked to nicotine. It can raise blood pressure, for example, and cause problems in pregnant women.” Another problem with e-cigs is that, unlike combustible cigarettes, they don’t burn out. The cartridge carrying the juice to make the vapor can run out of liquid, or the battery can die—but that’s after 200–400 puffs, well over a pack of cigarettes’ worth of nicotine exposure. Conceivably, a user, especially one who isn’t used to nicotine exposure, could puff himself into nicotine poisoning.

What’s more, in 2013, Brown University’s Chi-Ming Hai, Ph.D., published a study showing that prolonged exposure to nicotine, even in e-cigs, could lead to atherosclerosis, a major contributor to heart disease. Nicotine stimulates rosettes, or clusters of invasive material that accumulate on the surface of cells, which ruin the scaffolding that protects vascular cells in the heart. Since e-cigs don’t burn out, Hai worries that extended exposure could do vapers in.

“I’m speculating,” he says, “but I think a potential problem is that if it’s so easy to get nicotine in your system, there’s no reason why people would not keep pushing the levels.”

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Concern Number 4: (Im)proper Regulation

If e-cigs could be a more effective nicotine-delivery device, why aren’t they regulated as such, like nicotine gums? As Schluger notes, e-cig makers could have gone to the FDA, participated in medical trials, and sold their products as drug-delivery devices. “But that’s not what they did,” he says. Instead, they went to market unregulated.    

“[Selling an e-cig as a nicotine-delivery device] restricts where you can sell it, how you can sell it, and the time line for it,” says Miguel Martin, president of Logic, an e-cigarette company. “It’s contrary to how cigarettes are marketed and sold.”

The fact that e-cig makers sidestepped FDA testing has health officials concerned. They see the ease with which one can buy an e-cigarette, smoke it anywhere, and inhale a not-insignificant amount of nicotine in one sitting. Regulators are starting to draft laws to regulate e-cigs either as tobacco products or drug-delivery devices. Meanwhile, studies and anecdotes like Holdridge’s show that, for adult smokers, e-cigs could be a new, more effective take on nicotine gum, regulated or not.

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“There’s no tobacco and nothing combustible in an e-cigarette,” saysformer Surgeon General Carmona. “There are no cancer-causing ingredients in it. Really, it’s just a nicotine-delivery device. Our opinion was that it should be regulated just like nicotine gum or nicotine sprays.”

Though technically they don’t brand e-cigs as “smoking-cessation aids,” makers often come dangerously close to that, and the fine line between making health claims and offering an alternative to smoking has many confused. When we asked manufacturers and health officials, “Are e-cigarettes safer than combustible cigarettes?” the answer was usually a nonanswer.

“We are precluded from making any health claims, precluded from making any claims that it’s a quit assist,” says Logic president Martin. It’s a semantic juggle: Manufacturers don’t call it “quitting smoking” but “switching” from cigarettes to e-cigarettes. Despite anecdotal evidence that e-cigs may help smokers quit, many antismoking advocates fear that what they’re really doing is undoing the progress that’s been made over the last half-century.

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Concern Number 5: Kid Addicts

Kevin Spacey, as Frank Underwood in House of Cards, lounges on the floor of his apartment and offers his wife, played by Robin Wright, a hit of an e-cigarette. “You should try it,” he says. “It’s addiction without the consequences.”

That’s how the devices are often viewed: as risk-free addiction. But e-cigs may have adverse effects not only on smokers, but on a future we haven’t even begun to see.

“[E-cigarettes] are being made, marketed, and sold in ways that are very similar to how cigarettes were 40 or 50 years ago,” says Tim McAfee, M.D., director of the CDC’s Office of Smoking and Health. “There are TV ads, you can buy them at malls from unlicensed vendors. It’s not even against the law in half our states for children to buy e-cigs.”

In fact, in a new study in JAMA Pediatrics, young e-cig users were more likely to become tobacco smokers—progressing from e-cigs to analogs—and to be heavier smokers than kids who’d never touched an e-cig.

Several manufacturers already sell products that health officials see as clearly aimed at kids, such as bubblegum and cotton-candy flavored e-cigs. While bigger manufacturers like Logic and NJOY, who, for the most part, want to work with the FDA, have avoided these explosive allegations by making only tobacco- and menthol-flavored offerings, smaller distributors could be attracting a new generation to nicotine addiction. According to the CDC, 90% of smokers get addicted to smoking before age 18; and about 1.8 million kids tried e-cigs in 2012—up 10% from the year before.

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“Years ago the tobacco companies targeted children because at that age it’s easy to addict people,” says Schluger. “Tobacco companies have a very large investment in the e-cigarette business.” Indeed, Lorillard, which owns the Newport brand, acquired Blu eCigs in 2012, and, more recently, Altria Group Inc., which makes Marlboros, bought Green Smoke. If Big Tobacco is looking for an investment into future addiction, they’ve likely found it in e-cigarettes.

“We don’t want to start a new generation of nicotine addicts,” says  Carmona, speaking on behalf of NJOY. “We want to use this to make tobacco obsolete. Many of my colleagues feel that we shouldn’t be using e-cigs; we should just make sure no one smokes. Well, we tried that for half a century, and we’ve plateaued out.”

This year, 50 years after the hallowed Surgeon General report on the dangers of smoking, a new Surgeon General report came out stating that more scientific study on e-cigarettes is needed.
“Further research and attention to the consequences as well as regulatory measures will be necessary to fully address these questions,” it states. While that may sound anticlimactic, it’s the first time e-cigs have been mentioned in such a report.

The Bottom Line (If There Is One)

Theoretically, just under a decade from now, if Patrick Holdridge doesn’t relapse, his risk of dying of lung cancer should be sliced in half. And in 20 years, his chances of developing pancreatic cancer should be the same as if he’d never smoked. But because the long-term effects of e-cigarettes aren’t known, guarantees just aren’t available.

Jimmy Fallon, in the twilight of his tenure on Late Night, summed it up nicely in a bit on New Year’s resolutions. “Pro: Switching from regular cigarettes to e-cigs,” he announced. “Con: They’ll still kill you, but the mystery of how is half the fun!”

Inhaling anything but oxygen into your body is a risk. Smoking cigarettes has always been like gambling with dice weighted in the house’s favor: You can play, but you can’t win. For nonsmokers, vaping could be a seat opening up at that table.

But for ex-smokers like Holdridge, there’s a sense that they’ve finally beaten the house.

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