Sparking controversy

It has been a year since Travis Legge, 34, of Rockford, Ill., made the switch from smoking two packs of cigarettes a day to becoming a regular user of electronic cigarettes.

“It became apparent that it was time to make a change,” said Legge, who has smoked for more than 20 years. “Since I started using them, I feel like I got more energy and it's easier to breathe.”

Legge is one of the millions of people around the world who now puff e-cigarettes instead of smoking tobacco. The rise of the new industry has triggered a sharp debate over whether the devices can play a major role in helping the nation's estimated 44 million adult smokers kick their unhealthy habit.

While critics say there's not enough research to determine the long-term health effects of e-cigarettes, proponents of the increasingly popular devices contend they are a safe alternative and could provide a major public health benefit if millions of smokers switched. Inhaling nicotine and other additives through a vapor doesn't expose users to all the harmful chemicals that accompany cigarette smoke, they say.

Clearly, better anti-smoking aids are needed. One-third of smokers who use Food and Drug Administration-approved nicotine replacement therapies such as patches or drugs are likely to relapse, according to a study by researchers at the Harvard School of Public Health, which was published in a January 2012 issue of the journal Tobacco Control. If e-cigarettes could improve the quit rate without causing as much harm, cancer rates several decades out might plummet.

“In an ideal world, if, in fact, everybody switched to a noncombustible form of nicotine, yes, from a public health point-of-view that would be very good,” said Dr. Paul Cinciripini, director of the Tobacco Treatment Program at M.D. Anderson Cancer Center in Texas. “But it doesn't have to be e-cigarettes.”

Smoking remains the largest cause of preventable death, killing nearly a half-million people in the U.S. annually. It costs businesses and their employees an estimated $193 billion a year in lost productivity and heath-related expenses. Left untreated, an estimated 60% of smokers will die of tobacco-caused diseases such as lung cancer and chronic obstructive pulmonary disease.

It now costs smokers even before they get sick. The Patient Protection and Affordable Care Act allows insurers to charge individuals or small group plans as much as 50% more in premiums for “tobacco use,” although the term isn't rigidly defined in the law. A number of large employers, including Wal-Mart and UPS, that already charge smokers higher insurance premiums as part of their wellness programs have included e-cigarettes among those products that incur the penalty.

But are e-cigarettes the same as smoking? The FDA attempted to answer that question in 2009 when it looked to ban e-cigarettes on the grounds the products were “an unapproved drug-device combination” under the Food, Drug, and Cosmetics Act. The FDA's attempt to label e-cigarettes as a drug-delivery device would suggest the agency at least considered the possibility that e-cigarettes might be used to help people quit smoking.

But a federal appeals court in 2010 ruled in favor of the manufacturers, who argued that e-cigarettes were not medical devices and should be regulated like tobacco products. The decision allowed e-cigarette manufacturers, who never claimed the puffable nicotine delivery devices helped people stop smoking, to continue marketing their products without having to go through stringent FDA testing. Regulating e-cigarettes as an anti-smoking device would subject them to lengthy clinical trials to determine their safety and effectiveness.

In the wake of the court's ruling, the FDA reversed field. A 2011 letter announced it would seek to establish rules that treated e-cigarettes the same as traditional cigarettes and other tobacco products.

The FDA has yet to establish guidelines regarding the production and marketing of

e-cigarettes. Last July, the agency stated it expected to issue rules on unspecified “tobacco products,” which many think will include e-cigarettes, later this year. FDA spokeswoman Jennifer Haliski said the agency does not speculate on the timing of its rulings.

That leaves e-cigarettes, which do not contain tobacco, in regulatory limbo. Supporters, opponents, clinicians and policymakers are on their own to determine whether the devices can significantly reduce the enormous economic damage caused by smoking or will simply become one more drag on public health.

Electronic cigarettes were first developed in China in 2003 and made their way to the U.S. and Europe three years later. Sales have been increasing every year, and with an estimated 3 million users, total revenue is expected to reach more than $1 billion by the end of 2013. Many analysts believe that within the next decade, e-cigarettes will outsell traditional tobacco cigarettes, which is now an $80 billion-a-year market.

While many physicians and anti-smoking advocates concede e-cigarettes, along with other noncombustible forms of nicotine delivery, are probably less harmful than smoking tobacco cigarettes, none said they were prepared to endorse their patients using them as a smoking alternative.

“I think there is potential for e-cigarettes to help people stop,” said Thomas Glynn, director of cancer science and trends for the American Cancer Society. “It's probably not going to be a panacea or magic bullet. But to date, the information we have on whether they help people to stop or not is mostly anecdotal. There have been a few studies and a number of ones ongoing, and the data have been mixed.”

Danny McGoldrick, vice president for research at the Campaign for Tobacco-Free Kids, said the problem with people using e-cigarettes as a way to quit smoking lies with the lack of information about their safety. People who use them could stop using nicotine replacement therapy (NRT) products that have been federally proven to be safe and effective.

“Everyone wants more effective smoking-cessation devices, and what we need is some science and some evidence,” McGoldrick said. “We need innovative products to help people quit smoking, but they need to be safe and effective, and they need to not encourage new smoking or relapse for former smokers.”

An e-cigarette basically consists of a solution containing propylene glycol, which is used as a food preservative; vegetable glycerin, a sugar substitute; polyethylene glycol, a compound used in medicines and skin creams; and concentrated levels of nicotine, none of which are known to cause cancer. By contrast, there are approximately 600 ingredients in a tobacco cigarette, which can create an estimated 4,000 chemicals when smoked, according to the American Lung Association. Such chemicals include lead, ammonia, a household cleaner and formaldehyde, all of which are known carcinogens, according to HHS.

Prices can vary, ranging from $12 to $15 for disposable units that last for a day or two, to higher-range devices that run about $200. Popular brands such as Blu and NJoy usually start between $60 and $70 for a starter kit, which consists of a pack to hold the e-cigs, two rechargeable batteries, a USB charger and wall charger, and up to five flavor cartridges.

E-cigarette supporters tout the devices' ability to mimic smoking by requiring users to inhale and exhale the vapor. That offers a behavioral advantage over products such as the nicotine patch or gum.

Dr. Michael Siegel, a physician and professor of community health sciences at Boston University, compared the use of e-cigarettes with the way methadone is prescribed to heroin addicts. “This is basically what I would call a harm reduction strategy,” he said.

But much is still unknown about the potential health effects of the chemicals in e-cigarettes, said Dr. D. Kyle Hogarth, medical director for the University of Chicago Medical Center's Pulmonary Rehabilitation Program. “These are like vitamins, supplements and everything else that's a complete Wild West,” he said. There could be “a lot of other garbage in there.”

So far, studies have offered conflicting results on the potential health impact of e-cigarettes. One study of 10 reusable and disposable e-cigarette models by the French magazine “60 Million Consumers” claimed levels of formaldehyde close to the levels in tobacco cigarettes.

A 2009 FDA study reported finding toxic chemicals in e-cigarette vapors such as diethylene glycol, an ingredient used in antifreeze. A 2012 study published in the journal Chest by Greek researchers at the University of Athens found changes in the lung function of healthy smokers who puffed on an e-cigarette for as long as five minutes.

But an independent analysis conducted by Drexel University School of Public Health Professor Igor Burstyn found the contaminants in e-cigarettes did not pose a significant health risk. “There is no serious concern about the contaminants such as volatile organic compounds in the liquid or vapor produced by heating,” he said.

Dr. Richard Hurt, founder and director of the Mayo Clinic's Nicotine Dependence Center, said if e-cigarettes were proven to be an effective means of helping people quit smoking, then many clinicians would most likely be on board with their use considering the devastating effects tobacco has on the health of the smoker and bystanders. “It's one of those things where the cart is way out before the horse—and the horse would be the science,” he said.

Critics cite the lack of regulation as the driving force behind the large-scale marketing push by e-cigarette makers, some of which are owned by tobacco companies. Actor Stephen Dorff, actress Jenny McCarthy and singer Courtney Love have all appeared on television commercials endorsing the devices.

And that has started to affect sales of FDA-approved nicotine replacement therapy devices. An analysis of the NRT market released in April by the consumer strategy research firm Euromonitor International found sales of Nicoderm CQ patches, which release nicotine through the skin, fell by 8% in 2012 as a result of “competitive disadvantages against oral NRTs (nicotine gum and lozenges) and e-cigarettes.”

The marketing push has led anti-smoking advocates to push the FDA to move faster in issuing rules. They believe heavy advertising by e-cigarette makers will encourage ex-smokers and some nonsmokers, such as children, to start using the product. They fear e-cigarettes may become a gateway drug to regular smoking.

“We are certainly concerned about the claims that are being made with regard to

e-cigarettes,” said Erika Sward, assistant vice president at the American Lung Association. “We're concerned that they may start kids on a lifetime of nicotine addiction.”

In the Centers for Disease Control and Prevention's most recent National Youth Tobacco Survey, the number of middle school and high school students who reported using an e-cigarette doubled, from 3.3% in 2011 to 6.8% in 2012.

“The increased use of e-cigarettes by teens is deeply troubling,” said CDC Director Dr. Tom Frieden. “Nicotine is a highly addictive drug. Many teens who start with e-cigarettes may be condemned to struggling with a lifelong addiction to nicotine and conventional cigarettes.”

Mayo's Hurt said the question people should be asking is whether e-cigarettes are as effective as traditional nicotine replacement therapies in helping people to quit smoking. “The comparator should not be comparing what's in an e-cigarette with what's in a traditional cigarette,” he said. “The comparator should be with what's in an e-cigarette to a comparable, medicinal nicotine delivery device that's been approved by the Food and Drug Administration as being safe and effective—and that would be the nicotine inhaler.”

Studies on the effectiveness of e-cigarettes as a smoking cessation device are sparse since manufacturers don't want to go that route and haven't sponsored research. A recent study in The Lancet from researchers at the National Institute for Health Innovation at the University of Auckland in New Zealand found e-cigarettes were at least as effective in helping smokers quit as the nicotine patch.

E-cigarette makers have steered clear of claiming their products help people to quit. Such claims would subject them to government regulation as a medical device. “We're not making any cessation claims on this,” said David Sylvia, spokesman for Nu Mark, the manufacturer of MarkTen e-cigarettes and a subsidiary of tobacco maker Altria Group.

While opponents and supporters alike recognize the need for federal regulation on the sale and production of e-cigarettes, the two sides greatly differ on how those rules should look.

Anti-smoking advocates believe the agency should simply impose the same rules on e-cigarettes that it has on tobacco. That would ban TV and radio advertising and place restrictions on where and how they can be sold.

But industry officials are resisting that approach. “We don't believe that the Tobacco (Control) Act is the appropriate regulatory framework for electronic cigarettes,” said Cynthia Cabrera, executive director of the Smoke-Free Alternatives Trade Association, one of the largest trade groups for e-cigarette manufacturers. “The compliance and regulatory burden that being designated a tobacco product would bring with it would wipe out quite a lot of the industry.”

Regulation can have consequences that go beyond restrictions on how e-cigarettes are sold. Treating them like tobacco products could subject them to local and state government “sin taxes,” which would make them more expensive and discourage use.

Moreover, since the ACA does not define what is considered “tobacco use,” designating e-cigarettes as a tobacco product could trigger higher health insurance premiums for users—an assumption already made by some insurers and employers.

The designation would also hurt low-income users who turn to the new exchanges for health insurance. Those receiving a federal subsidy to buy health coverage could be hit with higher out-of-pocket costs because the subsidy would not increase to cover the smoker's premium, which could be 50% higher.

A number of businesses have already begun banning e-cigarette use inside their establishments while some employers have started to prohibit their employees from using them at the workplace.

Helen Darling, president of the National Business Group on Health, said the use of e-cigarettes would be considered tobacco use under the ACA, although the health law does not specifically name e-cigarettes as falling under that designation.

“Any employer that has a tobacco surcharge or penalty of any kind would count e-cigarettes as use of tobacco,” Darling said, “And they will already be counted in however that's treated.”

Boston University's Siegel said the ambiguity over e-cigarettes' status underscores the need for regulation that clearly separates the devices from their tobacco cigarette cousins. “I'm hoping the FDA will recognize that there are major differences in risks between electronic cigarettes and regular cigarettes,” he said. “To regulate them in the exact same way would make no sense at all.”

Follow Steven Ross Johnson on Twitter: @MHSjohnson