By Ann Wendling, MD, MPH
Medical Director, Tobacco Cessation, Healthways
In just a few years, e-cigarettes have advanced from difficult-to-find novelty to readily available commodity widely marketed as a healthier alternative to cigarettes. But with research and regulatory action struggling to keep pace, what do we really know about e-cigarettes?
Food for thought
E-cigarettes, whether manufactured in China or the United States, are not subject to production and content regulation, leading to a multitude of products with inconsistent nicotine delivery and complicating any research on safety and effectiveness.
Usage is increasing dramatically among both youth and adults – about 7% for both in 2012. Alarmingly, a Legacy for Health February 2014 survey found current e-cigarette use at 9% for ages 13-17 and 29% for ages 18-21. Dual use with conventional cigarettes predominates.
Limited population studies and clinical trails have not shown quit efficacy or effectiveness. However, recent data from a survey of almost 6,000 recently quit smokers in England, published on May 21, suggested a promising real-world effectiveness of 1.6 times for e-cigarettes compared to over-the-counter nicotine replacement therapy (NRT) and 1.4 times compared to unaided cessation.
Safety studies have had variable results:
- We know ultrafine particles, dependent on the presence of nicotine, are small enough to reach deep into the lungs and subsequently the systemic circulation.
- Cytotoxicity is variable among products and can be related to the concentration and number of flavorings.
- Exposure to e-cigarette aerosol, often containing glycerin or propylene glycol, can cause throat and mouth irritation, cough, nausea, vomiting and increased airway resistance. No long-term safety data have yet been collected.
- Secondhand exposure to nicotine as well as other toxins in the vapor has been detected in several studies, albeit usually at lower concentrations than secondhand smoke.
The public health effect
If indeed smoking cessation were as simple as switching from conventional cigarettes to e-cigarettes, undoubtedly there would be significant benefit to the public’s health. But it is not this simple.
Up to a third of youth have only used e-cigarettes. Will this set them on a trajectory toward a lifelong addiction to nicotine and eventually conventional cigarettes?
In addition, most adults are dual users – are they using e-cigarettes to vape in smoke-free environments or to cut down on more costly conventional cigarettes, believing they are at less risk for smoking-related disease? Data do not necessarily support the latter premise. If e-cigarettes delay total abstinence, the health burden may actually increase.
Until clean indoor air policies universally include bans on e-cigarette use (only three states have them to date), there is increasing risk for social acceptance/normalization of smoking/vaping behavior. Fortunately, more states are on board with limiting sales to minors.
What's on the horizon?
If we follow the same course as the past couple years, we can expect continuing exponential growth in e-cigarette consumption. Fortunately, on April 24, 2014, the U.S. Food and Drug Administration (FDA) took the first step toward regulation by proposing a Deeming Regulation to assert jurisdiction over other tobacco products, including e-cigarettes. Unfortunately, the regulation does not include limits on marketing/advertising and flavor additives attractive to youth and will take up to several years for some of the regulations to take effect.
The Patient Protection and Affordable Care Act, according to recently released guidance, requires most health plans to cover FDA-approved smoking cessation products and counseling without any out-of-pocket cost to consumers. E-cigarettes, not proven or approved as cessation tools, will not be covered. This may not be a significant barrier to the escalating use unless more states tax e-cigarettes at a level comparable to conventional cigarettes.
Many questions remain unanswered. How will e-cigarettes be viewed by health plans and employers? Will vapers be considered tobacco users and pay higher healthcare premiums?
The next several years will yield much needed data on the safety and efficacy of e-cigarettes while we observe a natural experiment of "free-range" marketing, easy access and escalating use and wait for guidance and regulation. Until then, the evidence supports a combination of behavioral therapy and FDA-approved cessation aides to assist tobacco users in quitting.
Grana R, Benowitz N, and Glantz SA. "E-Cigarettes: A Scientific Review." Circulation 129:1972-1986, 2014.
Brown J, Beard E, Kotz D, Michie S and West R. "Real-world effectiveness of e-cigarettes when used to aid smoking cessation: A cross-sectional population study." Addiction 109: doi: 10.1111/add.12623, 2014.
Legacy for Health. "Vaporized: E-Cigarettes, Advertising, and Youth." Report. May 2014.
Andrews M. "E-Cigarette Users May End Up Paying More For Insurance." Kaiser Health News. May 20, 2014.