07.18.13

Safety and efficacy of electronic cigarettes to quit smoking are not scientifically demonstrated says WHO – A clear answer to a (not so) complicated problem?

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Electronic cigarettesThis post was written by Florian Kastler (Global Health LL.M. 2011), visiting researcher at Georgetown University Law Center. Any comments or questions about this post can be directed to florian.kastler@gmail.com.

Last week, on 9 July 2013, the World Health Organization (WHO) updated its Questions and answers on electronic cigarettes or electronic nicotine delivery systems (ENDS) concluding that “consumers should be strongly advised not to use (…) electronic cigarettes.”  Despite its limited legal impact, this statement is not trivial as it clearly positions the WHO against electronic cigarettes, while the discussions regarding the health benefits and the regulatory framework are still ongoing.

The WHO describes electronic cigarettes or electronic nicotine delivery systems (ENDS) as “devices whose function is to vaporize and deliver to the lungs of the user a chemical mixture typically composed of nicotine, propylene glycol and other chemicals, although some products claim to contain no nicotine.” Further “each device contains an electronic vaporization system, rechargeable batteries, electronic controls and cartridges of the liquid that is vaporized.” According to the WHO, “the manufacturers report that the cartridges typically contain between 6 and 24 mg of nicotine, but sometimes can contain more than 100 mg.”

In its statement, the WHO answered the two following questions: Are electronic cigarettes or ENDS safe? Are they an effective method for quitting tobacco smoking? In both situations, WHO clearly considered that that it was not scientifically demonstrated that electronic cigarettes were safe and effective to quit smoking. This factual analysis may be nuanced but for now the decision of the WHO seems to be the appropriate one.

The stakes are high. According to the Centers for Disease Control and Prevention (CDC), in 2011, about 21 percent of adults who smoke traditional cigarettes had used electronic cigarettes, which amounts to a 10% increase compared to 2010. Overall, about six percent of all adults have tried e-cigarettes, with estimates nearly doubling from 2010. This study is the first to report changes in awareness and use of e-cigarettes between 2010 and 2011. Further, at an economic level, according to David Sweanor, law professor at the Univeristy of Ottawa, the market for e-cigarettes will surpass $10 billion in the U.S. by 2017 and e-cigarettes will outsell regular cigarettes within a decade. Indeed, the use of ENDS is likely to continue increasing rapidly as their price falls, they are about “20% cheaper than cigarettes at the moment.”

Electronic cigarettes are not (scientifically) safe, yet?

In the argument provided by the WHO, the statement explains that “the potential risks ENDS pose for health of users remain undetermined”. The approach taken by the WHO is one of precaution. Indeed, they consider that the risks associated with electronic cigarettes are “undetermined”. Further, WHO criticizes the content of electronic cigarettes and the lack of information to the consumer on the amount of nicotine and other chemicals, stating that “most ends contain large concentrations of propylene glycol, which is a known irritant when inhaled.” WHO also insists on the health risks related to nicotine especially for vulnerable persons “either inhaled, ingested or in direct contact with the skin”. Finally, ENDS give an illusive impression of safety, compared to tobacco, even though the “chemicals used in electronic cigarettes have not been fully disclosed and there are no adequate data on their emissions.”

Nonetheless, some commentators recklessly consider that e-cigs are “incredible cigarettes that don’t cause cancer.” The argument, as highlighted by Leo Hickman, is that it is safer because there is no tar, smoke and cocktail of other harmful compound chemicals that are responsible for the “vast majority of harm in a regular cigarette.” With electronic cigarettes the nicotine is delivered to the lungs via a spritz of water vapored from a tiny canister contained within the battery operated plastic “cigarette.” It is argued that this avoids inhaling the carcinogens and toxic chemicals found in tobacco smoke.

However, so far, there is a scientific consensus that the current state of science does not demonstrate whether electronic cigarettes are safe or not. In other words, doubt exists as to the potential side effects of e-cigs. The international community calls for further research and study in order to assess the safety of electronic cigarettes. It seems reasonable, in the mean time, to regulate electronic cigarettes and dissuade people from using them. However one can argue that it is only a matter of time before industry comes up with safe electronic cigarettes. For instance, Britain seems to trust manufactures as they have decided that e-cigarettes and other nicotine products will be licensed starting in 2016 as a medicine, giving manufacturers time to ensure that their products comply with all standards for medicines, safety being a key requirement.

WHO is right. The safety of ENDS has not been scientifically demonstrated yet and further studies must be made to better assess the potential health risks. Conversely, WHO analysis of the absence of efficacy of ENDS to quit smoking might be more questionable.

Electronic cigarettes are not (scientifically) effective, really?

WHO state that ENDS, which are “touted as tobacco replacements, smoking alternatives or smoking cessation aids”, do not provide instructions developed for each product through scientific testing. For the WHO there is no doubt as to the lack of scientific evidence to prove the effectiveness of using ENDS as replacements or to quit smoking stating that “the implied health benefits associated with these claims are unsubstantiated or may be based on inaccurate or misleading information.” The statement explains that ENDS “deliver nicotine directly to the lungs” with unknown effects. It is interesting to note that despite talking about the efficacy of ENDS to quit smoking, WHO relates to the role of nicotine and the dangerousness it might cause for the lungs. Thus, the risk of health hazard associated to the electronic cigarettes is used to explain that it does not help quit tobacco smoking. How is that really relevant? If you take aside the nicotine related health hazard, all WHO is saying is that the health benefits are unsubstantiated, not necessarily that the efficacy is untrue.

Indeed, defenders of e-cigs have argued not only that the electronic cigarettes are safe but they could help smokers quit smoking cigarettes. Compared to other methods used to quit smoking, e-cigs let smokers continue the “habitual act of holding a small white stick between their fingers and then inhaling a dose of nicotine”. As WHO states “most ENDS are shaped to look like their conventional (tobacco) counterparts (e.g. cigarettes, cigars, cigarillos, pipes, hookahs or shishas).” They are also “sometimes made to look like everyday items such as pens and USB memory sticks, for people who wish to use the product without other people noticing.” Further, the consumption of e cigarettes is not referred to as smoking but as “vaping” (due to the fact that the user is inhaling vapor and not smoke), marking the difference between regular cigarettes and electronic cigarettes and thus proving that what they are doing is not smoking anymore…

This argument is reinforced by the perception users have of electronic cigarettes. In a recent online survey, people who use the devices think of them as a safer alternative to tobacco and a means to break the smoking habit. Indeed, 76% said they started using their device to replace cigarettes entirely and only 7% used the devices for stopping smoking (6% for health reasons and 3% to get around smoking restrictions). A line is drawn between quitting smoking and quitting smoking cigarettes. To be honest, I have friends using ENDS, and they all say that they use it to try and quit smoking and a lot of them actually only “vape” e-cigs and have stopped, or at least, this has helped them diminish the consumption of regular cigarettes.

Finally, scientifically, an Italian study published in PLoS One concluded that “in smokers not intending to quit, the use of e-cigarettes, with or without nicotine, decreased cigarette consumption and elicited enduring tobacco abstinence without causing significant side effects.” Indeed, among Italian smokers with no desire to quit using tobacco at the outset, up to 13% of participants were not smoking regular cigarettes at all a year later. However, these results are not entirely reliable, considering the scientific method used, and they have been criticized. For instance, the Center for tobacco control research and education of UCSF argues that there was no control group of smokers who were not using e-cigarettes. Thus it is hard to determine how many smokers would have quit smoking on their own by the end of the 12-month period (i.e. spontaneous quitting). It also raises issue regarding the statistical analysis and concludes that “these data cannot be used to support any statement about the efficacy of e-cigarettes for stimulating smoking cessation one way or the other.”

This confirms that so far, all studies have been challenged for lack of scientific rigor including flawed cohort therefore diminishing the scientific soundness of the results. Nonetheless, electronic cigarettes could have the potential of helping consumers quit smoking. It has to be safe first though, which is not the case. Thus further scientific studies must be undertaken to better assess the risks related to electronic cigarettes.

How can electronic cigarettes be regulated?

This decision, despite its lack of legal authority, could have a broader impact both on the qualification and the regulation of electronic cigarettes. Without qualifying ENDS explicitly, by this statement, WHO implies that they cannot be considered as a medical device and should be considered as a tobacco product or at least as an unhealthy product, which should not be consumed. Indirectly, recommending the ban of e-cigarettes until further studies are carried out to guarantee their safety and efficacy. WHO’s approach is radical and is not always the view followed by its Member States.

Today, we see countries struggling to qualify ENDS, hesitating between a tobacco product and a medical device. In most countries, governments have not anticipated the rapidly growing market of ENDS. Thus there is no national legislation restricting the sale of e-cigarettes and discussions are ongoing as to how they should be tackled. Taking advantage of this legislative gaps, allowing the sale of electronic cigarettes, manufacturers have started selling in e-cigarettes in shops with not specific restrictions such as on age or regarding informational warnings. We have observed a multiplication of selling point in both Europe and the United States. In Paris, the last store to open offers more than 60 flavors of nicotine liquid including Marlboro and Lucky Strike flavors…

However, governments are trying to catch up and regulate ENDS. One approach is to consider electronic cigarettes as tobacco product thus subjecting them to the same restrictions. For instance, the Health Minister of France, Marisol Touraine, has announced that ENDS will be banned from all public places as regular cigarettes. A similar approach is followed in the United States, with the Washington, D.C Council, which is considering adding electronic cigarettes to the indoor smoking ban. In New York, it was decided that ENDS should not be sold to anyone under 18 and that it is illegal to smoke them within 100 feet of entrances to public or private schools.

Another approach is to consider electronic cigarettes as medical devices requiring the device to be safe and effective. This approach was argued by the FDA, which tried to block the importation of electronic cigarettes from China. However, the U.S Court of Appeals for the District of Columbia, in a decision on January 24, 2011, stated that e-cigarette manufacturers proved that their products are marketed for smoking pleasure and not cessation falling short of the medical device qualification and thus of the FDA’s competence to regulate. Nonetheless, in Denmark, e-cigs containing nicotine are considered as medicinal products requiring authorization to be sold and marketed. So far no authorization has been given. Further, the United Kingdom will license and regulate as an aid to quit smoking from 2016 qualifying it as medicine. Finally, the European Union (EU), who has no laws on the devices, is starting to tackle the issue. For instance, the European Parliament has recently voted to classify all electronic cigarettes as medicinal product, regardless of the nicotine content. This still has to be adopted by the European Commission. The EU health ministers rather argue that ENDS should be considered as medicinal products from 2017 onward. The debate is still ongoing.

The diversity in the approaches followed by the countries, especially in the EU and in the US, shows that there is a lack of uniformity as to how to regulate ENDS. Clearly, further work has to be achieved to avoid confusion. However, whatever regulation is favored, the WHO statement reinforces the idea that ENDS are not scientifically safe and effective yet. That should be factored in as governments develop new regulations.

Conclusion

Both the safety and the efficacy of e-cigarettes are unknown and WHO has no other choice but to recommend people to avoid using e-cigarettes. When a public policy authority is faced with uncertainty, the application of the precautionary principle is required. How could WHO had done otherwise? How could WHO encourage the use of e-cigarettes when there is a risk that it could damage your health with no guaranteed results?

Some professionals argue that, considering the tobacco consumption in the world and the health related risks, the health benefice (quit smoking) of e-cigarettes consumption outweigh the health hazard (potential damage caused by the nicotine). Indeed, they consider that “the potential prize is too great to risk extinguishing.” They consider ENDS as a “massive opportunity.” This is not a position WHO can defend. It cannot compromise with one’s health. Industry can do better. Research and development can do better than offering an alternative to regular cigarettes, which has not been proven safe nor effective. Medically, one should not replace an addiction by another addiction.

In its statement, WHO does explain that “until such time as a given ENDS is deemed safe and effective and of acceptable quality by a competent national regulatory body,” consumers should be strongly advised not to use them. In other words, once the risk analyzed, the safety and efficacy proven of ENDS, then WHO will reconsider its position. This opens the door to potential recommendation in favor of ENDS. Until then though, the knowledge of e-cigarettes is not clear, and the decision taken by WHO was obvious. WHO has taken its responsibility by taking a much-awaited clear-cut decision based on the most accurate and recent knowledge the scientific community can provide. WHO made the right call. That is all, for now.

 

 

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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.

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