By Thomas J. Glynn, PhD
The U.S. Food and Drug Administration (FDA) recently announced that it is taking steps to regulate electronic cigarettes (e-cigarettes) as tobacco products, acting under its authorities in the Family Smoking Prevention and Tobacco Control Act of 2009.
That's got everybody talking about these rather strange devices, which have become increasingly popular over the past few years.
E-cigarettes resemble a standard cigarette but use a battery and an atomizer to heat a solution which, when inhaled, delivers vaporized nicotine to the user. They have been described both as a miracle answer to the devastating effects of cigarette smoking and as a grave danger to public health.
As with so many highly celebrated, or reviled, products, their true nature likely lies somewhere in between. Let's consider what many are saying about these devices.
Those who favor e-cigarettes list as benefits:
- Their ability to deliver nicotine to the user without many of the other 7,000+ chemicals in a regular, burned cigarette;
- Their absence of secondhand cigarette smoke;
- Their resemblance to regular cigarettes, which provide the tactile and visual sensations - holding them in a certain way, a glowing tip, blowing smoke, etc. - that many cigarette smokers have become used to, or even psychologically dependent upon; and
- Their potential for aiding cigarette smokers to who wish to quit to do so.
Those with concerns about e-cigarettes warn of:
- Lack of scientific data about their safety. Simply put, e-cigarette users cannot be sure of what they are inhaling, since e-cigarettes have not been subjected to thorough, independent testing and, due to their manufacture by many different companies, there are no quality assurances in their production processes;
- Lack of scientific data about their effectiveness as quit-smoking aids;
- Lack of scientific data regarding their ability to deliver enough nicotine to satisfy withdrawal effects;
- Lack of scientific data about the effect of secondhand vapor from e-cigarettes;
- Lack of scientific data about whether the use of e-cigarettes encourages smokers who might have otherwise quit to continue smoking and only use e-cigarettes when they are in no-smoking environments; and
- Lack of scientific data about whether youth may use e-cigarettes as an introduction to smoking regular cigarettes.
So, looking at these lists, it is easy to see how e-cigarettes are a source of controversy.
Proponents of e-cigarettes emphasize their potential for expanding the tools available for smokers who want to quit; their comforting similarity to regular cigarettes; the likelihood that they are considerably safer than regular cigarettes; and so on. They urge the public health community and, especially, the FDA, to drop their objections to e-cigarettes, promote their use, and, in the case of the FDA, to take actions to ease their way into the mainstream marketplace.
Those who are urging more caution in their widespread use, however, emphasize what we do not yet know about them: their safety for long-term inhalation; their effectiveness as smoking cessation aids; their appeal to youth; and so on. They urge the public to remain wary of e-cigarette use, the FDA to subject e-cigarettes to the same stringent testing regimen that similar products undergo, and the e-cigarette manufacturers to open their doors to independent safety and effectiveness testing.
The newly announced regulation would give the FDA authority to require e-cigarette manufacturers to register their products with the FDA, list their ingredients, establish (or continue) good manufacturing practices, address impure/untested product additions and misbranding issues, and restrict marketing and sales only to those 18 years and older.
While this new regulation would be a significant step forward in establishing the safety profile of e-cigarettes, what it would not do is establish whether they are effective in helping people quit smoking, whether they discourage some smokers from quitting, and whether youth may use them as gateway products to cigarette smoking.
The answers to those vital questions will need to come from a wide-ranging, independent research agenda, as recently suggested and outlined by a group of international researchers who have themselves been viewed by some to be on both sides of this issue.*
During the time the new FDA regulation is being prepared and e-cigarette research is being conducted, these products will remain controversial - praised by many and looked at with great caution by many others. Many will use them and say they can help people quit smoking cigarettes, and many others will warn of possible harm from their use.
The only solution to bridging this divide - and ultimately improving public health - is, as we have learned from more than two centuries of public health advances, to put science to work, obtain solid, independent data, and then make decisions and recommendations based on those data. To do otherwise, to develop public health policy on the basis of opinions and anecdotes, will not serve the public well and will, ultimately, undermine both points of view.
E-cigarettes may have the potential to make an important contribution to public health by helping some smokers stop. They are not likely to be a "magic bullet" any more than other quit smoking tools have been, at least to date. But their safety and effectiveness, their potential to keep some smokers from quitting, and possibly encourage young people to start smoking, require both investigation and thoughtful behavior and commentary by those on either side of this issue.
Hopefully, the research and regulation processes will move forward quickly. After all, if the e-cigarette is shown to be unsafe and ineffective, we want to move on to other approaches that can lower the appalling toll from cigarette smoking. Or, if they are shown to be both safe and effective, smokers can then add them to their menu of approaches to end their habit and extend their lives.
*(Etter, JF, Bullen, C, Flouris, AD, Laugesen, M, and Eissenberg, T "Electronic Nicotine Delivery Systems: A Research Agenda, Tobacco Control Online First, March 17, 2011 as 10/1136/tc.2010.042168).
Thomas J. Glynn, MA, MS, PhD, is director of Cancer Science and Trends and director of International Cancer Control for the American Cancer Society.