Commentary
Is there any legal and scientific basis for classifying electronic cigarettes as medications?

https://doi.org/10.1016/j.drugpo.2014.03.003Get rights and content

Abstract

The rapid growth in the use of electronic cigarettes has been accompanied by substantial discussions by governments, international organisations, consumers and public health experts about how they might be regulated. In the European Union they are currently regulated under consumer legislation but new legislation will regulate them under the Tobacco Products Directive. However, several countries have sought to regulate them under medicines regulations. These claims have been successfully challenged in 6 court cases in European states. Under European legislation a product may be deemed to be a medicine by function if it is used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. It is a medicine by presentation if it is presented (e.g. by a manufacturer or distributor) as having properties for treating or preventing disease in human beings. We assess the legal and scientific basis for the claim that electronic cigarettes should be regulated as medicines. We conclude that they are neither medicine by function nor necessarily by presentation The main reason for their existence is as a harm reduction product in which the liking for and/or dependence on nicotine is maintained, and adoption of use is as a substitute for smoking and not as a smoking cessation product. In reality, they are used as consumer products providing pleasure to the user. They are not used to treat nicotine addiction or other disease, but to enable continued use of nicotine. Their use is adjusted individually by each consumer according to his or her perceived pleasure and satisfaction. Gaps in current regulation regarding safety and quality can be met by tailored regulations.

Introduction

Electronic cigarettes have been gaining in popularity in recent years. First introduced into many counties around 2006, there has been a rapid rise in sales: in the US for example sales were valued at $20m US in 2009, and have more than doubled each year to over $1b in 2013 (Natalie Robehmed, 2013). According to Eurobarometer data from 2012, it is estimated that there are seven millions users in Europe (European Commission, 2012a). They can be considered tobacco harm reduction products, in that they provide an alternative less harmful product to tobacco cigarettes (Rodu, 2011). As in any other kind of harm reduction approach, tobacco harm reduction is appropriate for smokers who want to give up smoking but find it hard to give up nicotine due to the limited efficacy and appeal of currently approved therapeutic options to treat nicotine and cigarette dependence. Moreover, there is a substantial proportion of smokers who are unwilling to be deprived of the positive experience of nicotine or the act of using cigarettes but would prefer an alternative product to maintain perceived pleasure but reduce harm (Bell, 2013, Britton and Edwards, 2008).

Current medications consist of nicotine replacement therapies (NRT – mostly in the form of gums and patches), oral medications (bupropion and varenicline) and psychological support. The efficacy of these medicinal products is disappointing. In randomized controlled trials, NRTs have a 1-year success rate of approximately 7%, which is much less when psychological support is not included (Moore et al., 2009). In cohort studies of real world quit attempts over-the-counter use NRT in self-initiated quit attempts confers no advantage over stopping without any aid (Kotz, Brown, & West, 2014). There is no evidence for the effect of NRT at a population level. The efficacy of oral medications is lower than 20% even in well-designed medical studies (Rigotti et al., 2009), while in every-day clinical practice it is considerably lower (Casella, Caponnetto, & Polosa, 2010). Moreover, oral medications are hindered by serious adverse neuropsychiatric effects (Hays & Ebbert, 2010). As a result, the majority of smokers are unable to quit smoking with currently available methods. Additionally, those who want to continue experiencing the positive effects of the smoking habit are unlikely to use any kind of medication since these do not substitute the pleasure perceived from smoking.

Electronic cigarettes consist of a lithium battery, an atomizer, and a fluid filled cartridge. There is no tobacco and no combustion. The atomizer comprises of a storage part for liquid, a resistance and a wick. The liquid evaporates when heated, by activating the battery part of the device which delivers electrical current to the resistance. There is a huge variability of electronic cigarette devices: small “first generation” devices which look similar to a tobacco cigarette, second generation devices which do not resemble cigarettes and are filled by the user and third generation devices which incorporate adjustable electronic circuits that affect taste and performance. The liquid in electronic cigarettes contains nicotine, propylene glycol or vegetable glycerin, and flavorings. There is a large choice of electronic cigarette liquids, with a wide range of flavorings and nicotine levels from 0 up to 36 mg/ml (and more in some cases). Electronic cigarettes are used similarly to tobacco cigarettes: the user takes puffs of aerosol (instead of smoke) and exhales visible aerosol (that resembles smoke in appearance). The difference with electronic cigarettes is that, instead of combustion which produces the smoke in tobacco cigarettes, the aerosol (commonly referred to as “vapor”) is produced by heating the liquid at 5–10 times lower temperatures compared to tobacco cigarettes (Laugesen, 2009).

The introduction of electronic cigarettes has led to considerable uncertainty as to how the devices and their contents should be regulated. In the European Union they are currently covered by 17 EU directives and regulations covering for example general product safety, packaging and labeling, chemical safety, electrical safety and weights and measures. Under new legislation which will take effect in 2016, they will be regulated under the Tobacco Products Directive. Several governments, including the UK, Sweden, Germany and Greece have proposed that they should be regulated as medical products and devices. Medicinal regulation was proposed in the draft European Tobacco Products Directive (European Commission, 2012b) but this was rejected by the European Parliament in favor of a consumer model of regulation. According to a briefing from the Library of the European Parliament (Library of the European Parliament, 2013), there have been 6 court cases successfully challenging the classification of electronic cigarettes as medicinal products (1 in USA, 1 in Estonia, 1 in the Netherlands and 3 in Germany), and additionally a recent case in Hungary. In all these cases, the court rulings prohibited the regulation of electronic cigarettes as medications.

In this commentary we examine the legal and scientific basis for the claim that they are medicines. The commentary originated in expert testimony by one of the authors (KF) to the Court of the 2nd and 3rd district of Budapest, Hungary. The Hungarian Customs seized nicotine-containing products and subsequently an electronic cigarette vendor was prosecuted for violating laws of medicines policy. The Hungarian court ruling determined that electronic cigarettes cannot be classified as medicines.

Section snippets

Legal perspective

According to Article 1 of the Directive 2004/27/EC of the European Parliament and of the Council (31 March 2004), a medicinal product is: (a) any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis, or (b) any substance or combination of substances presented as having properties

Further considerations

Several scientific aspects of the issue of whether electronic cigarettes should be regulated as medications have been addressed above as relevant to the legal definitional issues. However, there are some additional aspects of electronic cigarette use that distinguishes it from the use of medications.

Regulatory options

The “risk” of applying medicinal regulation is that electronic cigarettes will be transformed into another form of pharmaceutical nicotine inhaler; currently there is no need for such a product and it will not be accepted in the same way as electronic cigarettes are currently accepted by consumers. Additionally, strict medicinal regulation will give electronic cigarettes a disadvantage compared to the main competitor, which is the tobacco cigarette. The cost of performing the extensive testing

Conclusions

In conclusion, currently available scientific evidence and observations of the use of electronic cigarettes by consumers in the real world clearly show that electronic cigarettes are not used as medications and are not used as a treatment – they are neither medicine by function nor necessarily by presentation. The main reason for their existence is as a tobacco harm reduction product (similar to the use of snus in Sweden), which means that the liking for and/or dependence on nicotine is

Conflict of interest statement

K.F. is a researcher at Onassis Cardiac Surgery Center. For some of his studies, the institution has received financial compensation from electronic cigarette companies to cover the cost of experiments. A company of which G.S. is a director has received a research feasibility grant from an electronic cigarette company developing a new nicotine delivery device.

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