Tobacco substitute
Electronic cigarettes are proving more effective than conventional nicotine-replacement products. Perhaps that’s why they are meeting so much resistance.
By John Luik
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When I last discussed electronic cigarettes in these columns (“Inconveniently Effective,” Tobacco Reporter, May 2010), the U.S. Food and Drug Administration was furiously trying to prohibit their entry and distribution into the United States. In January, however, Judge Richard Leon ordered the FDA to release the impounded products of two distributors, NJOY and Smoking Everywhere.
The FDA’s position was based on two arguments. First, there was the claim that e-cigarettes should be considered drug-delivery devices—as opposed to tobacco products—and thus subject to FDA regulation. Second, there was claim that e-cigarettes were not safe. In a study, the FDA had examined e-cigarettes from both NJOY and Smoking Everywhere and found carcinogenic nitrosamines in half of the samples. In one sample from Smoking Everywhere, FDA tests found a trace amount of diethylene glycol, a chemical found in antifreeze.
Since this initial skirmish, the e-cigarette industry has continued to win in court. In December 2010, a federal appeals court in Washington ruled in the industry’s favor, and an FDA request to overturn this decision was rejected by the full appeals court in January.
Deeper issues
The entire case against e-cigarettes, however, goes beyond the concerns about safety and the question of whether they are drug devices or tobacco products. The U.K. public health charity Action on Smoking and Health (ASH), for example, advances three arguments against e-cigarettes. According to ASH, e-cigarette users exhale a cloud of “smoke” comprised of chemicals that are toxic and addictive. Second, there is no evidence that e-cigarettes, irrespective of their impact on third parties, are safe for their users. Third, according to ASH, e-cigarettes might lead people to believe that they are safer than conventional cigarettes and may thus recruit new smokers and increase nicotine addiction.
Part of the answer to the health worries surrounding e-cigarettes can be found in two studies. The first was conducted by Dr. Thomas Eissenberg of the Virginia Commonwealth University and funded by the U.S. National Cancer Institute. The second is by Zachary Cahn and Michael Siegel, of the University of California at Berkeley and Boston University, respectively (“Electronic cigarettes as a harm reduction strategy for tobacco control: A step forward or a repeat of past mistakes?” Journal of Public Health Policy, 2010)
Cahn and Siegel located 16 studies that have looked at the components found in the e-cigarette liquid and vapor. They write that the primary components of electronic cigarette cartridges are propylene glycol, glycerin and nicotine. Two of the studies found TSNAs at trace levels—8.2ng/g, which compares with a TSNA level of 8 ng in a typical nicotine patch. More crucially, TSNA levels are significantly lower in e-cigarettes than in regular cigarettes. Aside from TSNAs, Cahn and Siegel note that few, if any, chemicals at levels detected in electronic cigarettes raise serious health concerns. “Although the existing research does not warrant a conclusion that electronic cigarettes are safe in absolute terms, and further clinical studies are needed to comprehensively assess the safety of electronic cigarettes, a preponderance of the available evidence shows them to be much safer than tobacco cigarettes and comparable in toxicity to conventional nicotine replacement products,” the researchers write.
And this is surely the relevant point of comparison. It is not whether e-cigarettes are absolutely safe but whether they are safer than traditional cigarettes and comparable in safety to typical nicotine replacement products.
Eissenberg comes to the e-cigarette issue from a slightly different perspective. His objective was to find out how e-cigarettes affect smokers’ nicotine levels, cigarette cravings and heart rates when compared with tobacco cigarettes.
In the test, 16 smokers who had never used e-cigarettes and who had not smoked for 12 hours smoked either a fake-cigarette, their usual brand or an e-cigarette. The smokers were told to puff normally 10 times. Following this their craving and nicotine levels were assessed for an hour, after which the procedure was repeated.
The results were striking. The nicotine levels in the e-cigarette smokers were not noticeably different than those who smoked fake cigarettes. The mean nicotine level of e-cigarettes smokers was 3.5 ng/ml, while the mean nicotine level of tobacco smokers was 20 ng/ml.
They work
While the media has focused on the fact that the e-cigarettes in this study didn’t appear to deliver much nicotine—with some anti-tobacco activists arguing this is yet another reason to ban them—the more interesting fact about Eissenberg’s research has been ignored: Even though they fail to deliver significant amounts of nicotine, e-cigarettes appear to satisfy smokers’ cravings for cigarettes.
So, contrary to the anti-tobacco lobby’s claim that e-cigarettes increase nicotine addiction, they appear to lessen such addiction. And even if there were an increase in nicotine addiction, it is not nicotine addiction that is the lethal component of conventional cigarettes. Just as methadone prevents some of the horrible effects of heroin addiction without curing the addiction, so e-cigarettes might well prevent some of the risks of cigarette smoking even while leaving smokers addicted.
This leaves only the third claim against e-cigarettes—that they may lead smokers to think that these new products are safer than conventional cigarettes. Given the findings of the mentioned studies, the question is why should this be a problem? Why would the agency regulating cigarettes want smokers to believe that all tobacco and nicotine products carry the same risk? After all, nicotine-replacement products (NRP) are freely sold over the counter and recommended by the anti-tobacco movement and the government as safer alternatives to smoking. How are e-cigarettes different from other NRPs, aside from the fact that they are not manufactured by the pharmaceutical industry, which has hugely supported the anti-smoking movement?
But here, of course, we come to the crux of the issue, as Cahn and Siegel note in their paper. E-cigarettes appear to present no significant risks to their users, or certainly no risks comparable to those presented by conventional smoking. Moreover, they appear to satisfy a smoker’s craving without providing him anywhere near the amount of nicotine found in regular tobacco products. Finally, they look to satisfy the non-pharmacological aspects of smoking by mimicking the “real” smoking experience. One would think this was a rare but complete win-win.
But it is precisely these qualities that doom e-cigarettes with the FDA and the anti-tobacco movement.
First, the anti-tobacco movement and much of the FDA is dominated by individuals who are opposed to harm reduction. A product that reduces tobacco-related harm while still satisfying smokers goes against the prevailing mantra—that the only acceptable option is to quit smoking altogether. Whatever their ability to satisfy the cravings of smokers without delivering much nicotine, e-cigarettes are simply too much like conventional cigarettes.
Second, and more perversely, the anti-tobacco movement will continue to oppose e-cigarettes as a smoking-cessation device because it is captive to the pharmaceutical industry, which provides many of its funds. The main competitors to e-cigarettes are the NRP devices made and marketed by Big Pharma—devices that have proven highly ineffective in sustaining smoking cessation.
The last thing Big Pharma wants is a public health community promoting e-cigarettes as a conventional smoking-cessation device. The real opposition to e-cigarettes then has nothing to do with safety but with competitors’ fears that they might work and compromise their market.
The fact that e-cigarettes might benefit both smokers and public health is a consideration of little or no consequence to them. For a movement that always claims the moral high ground, that’s quite a position.