Accepted Manuscript Title: WHAT TO CONSIDER WHEN REGULATING ELECTRONIC CIGARETTES: PROS, CONS AND UNINTENDED CONSEQUENCES Author: Pasquale Caponnetto Daniela Saitta David Sweanor Riccardo Polosa PII: DOI: Reference:
S0955-3959(15)00068-7 http://dx.doi.org/doi:10.1016/j.drugpo.2015.03.001 DRUPOL 1533
To appear in:
International Journal of Drug Policy
Received date: Revised date: Accepted date:
9-11-2014 3-3-2015 7-3-2015
Please cite this article as: Caponnetto, P., Saitta, D., Sweanor, D., and Polosa, R.,WHAT TO CONSIDER WHEN REGULATING ELECTRONIC CIGARETTES: PROS, CONS AND UNINTENDED CONSEQUENCES, International Journal of Drug Policy (2015), http://dx.doi.org/10.1016/j.drugpo.2015.03.001 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
WHAT TO CONSIDER WHEN REGULATING ELECTRONIC CIGARETTES: PROS, CONS AND UNINTENDED CONSEQUENCES
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Pasquale Caponnetto1,2, Daniela Saitta2, David Sweanor3, Riccardo Polosa1,2 1
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Centro per la Prevenzione e Cura del Tabagismo, Azienda Ospedaliero-Universitaria “PoliclinicoV. Emanuele”, Via S. Sofia 78, 95123 Catania, Italy 2 Dipartimento di Medicina Clinica e Sperimentale, Università di Catania, Via Palermo 636, 95121 Catania, Italy 3 Faculty of Law, University of Ottawa, 75 Laurier Avenue East, Ottawa ON K1N 6N5, Canada
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Corresponding author: Pasquale Caponnetto Centro per la Prevenzione e Cura del Tabagismo, Azienda Ospedaliero-Universitaria “Policlinico-V. Emanuele” Via S. Sofia 78, 95123 Catania, Italy [email protected]; Tel: +39 0953781537; Fax: +39 0953781567
Keywords: electronic cigarettes, regulation, public health.
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Total Word Count (3792)
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Abstract (127 words)
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Many public health experts, medical research societies, large health organizations and policy makers have expressed concerns about the increased popularity of electronic cigarettes and have pushed for more restrictive measures ranging from complete bans to tight regulations of these products either as medicines or as tobacco products. But these concerns have never been adequately qualified nor quantified. Without judicious assessment and thorough evaluation, regulations may have unintended consequences that can do more damage than good in public health terms.
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In this article, we will appraise the existing prominent regulatory frameworks for e-cigarettes, namely, general consumer product, medicinal product and tobacco product regulation, to highlight their pros and cons. Moreover, we provide concrete examples of the unintended consequences which may arise from inappropriate regulatory action. Introduction
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Electronic cigarettes (e-cigarettes) are battery-operated devices designed to turn a liquid solution into an aerosol ("vapor") to simulate the act of smoking. The base of the liquid solution is propylene glycol and/or vegetable glycerin. The liquid also contains water and flavorings, and may or may not contain nicotine. Puffing activates a heating element in the atomizer and the resulting vapor is inhaled.
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The original models were designed to closely resemble a regular cigarette, down to an orange LED at the tip that glows when the consumer activates the unit by inhaling. Now, however, many different models are available. Some look like traditional cigarettes, cigars, or pipes. Others look similar to a pen, and some even look like small flashlights. Some have LED lights, and some don't. Some are single-use disposables, or use prefilled cartridges, and others have refillable cartridges. They come in numerous shapes and sizes and have different features as a very large number of companies seek a marketplace advantage in catering to those who wish to distance themselves from anything resembling a traditional cigarette or want a longer battery life, and/or better performance, and/or the personal satisfaction of having cutting-edge technology. The success of e-cigarettes as a tobacco cigarette substitute is such that these products have been rapidly gaining on conventional cigarettes (Adelman et al., 2013). According to a recent Wells Fargo prediction analysis, e-cigarette consumption could surpass conventional cigarettes within the next decade (Mangan, 2013). The popularity of e-cigarettes’ appears in large part to be related to the fact that they share many similarities with smoking in the behavioural aspect of use (Caponnetto et al., 2012; Caponnetto et al., 2013b). Users are predominantly smokers, who report using them long term to reduce cigarette consumption or quit smoking, to relieve tobacco withdrawal symptoms, and to continue having a ‘smoking’ experience (Farsalinos et al., 2014; 2 Page 2 of 17
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Farsalinos et al., 2013), but with much reduced health risks (Farsalinos and Polosa, 2014). Data from clinical trials (Polosa et al., 2011; Polosa et al., 2013; Caponnetto et al., 2013a; Bullen et al., 2013) have confirmed that e-cigarettes may help smokers quit smoking or reduce their tobacco consumption long term, thus reducing overall exposure to toxins and carcinogens. Moreover, the popularity of e-cigarettes appears to be associated with the fact that they can be used in many smoke-free areas, their prices are competitive, and they are perceived as a much less harmful smoking alternative (Etter, 2010; Heavner, 2010; CASAA, 2013; Etter and Bullen, 2011, Siegel et al., 2011).
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In the face of the growing popularity of e-cigarettes among users, many public health experts, medical societies, large health organizations and policy makers have expressed concerns. These concerns can be essentially classified into two main categories: concerns for individual health risks, and concerns for population effects.
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Specifically, they include: a) Individual health risks: - whether e-cigarette (long-term) use results in higher overall absorption of nicotine/nicotine overdose, or some as-yet-unknown health risks associated with vapor constituents; - whether e-cigarettes perpetuate smokers’ addiction to nicotine;
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b) Population effects: - whether the use of e-cigarettes serves as a gateway to smoking for non-users, particularly youth; - whether e-cigarettes make smoking socially acceptable again, thus undermining current nosmoking policies. Scientific evidence that seems to provide reassuring answers to these questions is already accumulating (Hajek et al., 2014; Abrams et al., 2014). Nevertheless, international health organizations and regulatory authorities in many countries – by invoking a very constraining version of the precautionary principle – have hurriedly recommended and introduced restrictions on the manufacturing, import, sale and advertising of e-cigarettes. In this article, we will analyze the three possible regulatory classifications for e-cigarettes under existing regulatory frameworks, critically appraising their pros and cons. Moreover, we will try to elucidate some possible unintended consequences that may arise from the application of certain regulatory action.
Existing regulatory frameworks for e-cigarettes In most jurisdictions, there are essentially three possible regulatory classifications for e-cigarettes under existing regulatory frameworks: as a general consumer product, a medicinal product or a tobacco product. The product classifications will drive both the strategy for bringing the products to market and the manner in which companies can commercialise them, including the claims the company can make on the packaging and in other commercial communications. 3 Page 3 of 17
General consumer products
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Many refer to general consumer products as being “unregulated” consumer products. That is often a misnomer. Many jurisdictions do regulate consumer products by subjecting them to general safety requirements, such as those found in the European Union General Product Safety Directive 2001/95/EC (GPSD). Often a patchwork of other more specific rules would apply, such as rules governing electrical safety and compatibility contained in the Low Voltage Directive 2006/95/EC and the Electromagnetic Compatibility Directive 2004/108/EC, which apply to electronic components of an e-cigarette.
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In general terms, the GPSD requires that producers only place safe products on the market. A product will be “safe” if it “does not present any risk or only the minimum risks compatible with the product’s use.” In determining whether a product is to be regarded as “safe,” the following considerations are relevant:
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the characteristics of the product, including its composition, packaging and instructions; the effect of the product on other products, where it is reasonably foreseeable that it will be used with other products; and
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the presentation of the product, including labelling, warnings and instructions.
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Pursuant to the GPSD, a product may be deemed safe when it conforms with relevant EU and national laws and, in the absence of such laws, with: (i) voluntary national standards; (ii) European Commission recommendations setting out guidelines on the assessment of product safety; (iii) codes of good practice as regards health and safety; (iv) the current state of the art; and (v) the consumers’ safety expectations. There are no EU-wide standards on e-cigarettes. However, in the UK, the British Standards Institute (BSI), with input from the Electronic Cigarette Industry Trade Association (ECITA), is developing a Publicly Available Specification (PAS) providing guidance for the importation and sale of electronic cigarettes and directly related products. The PAS represents the first UK attempt to prepare a voluntary standard for e-cigarettes. It covers product safety and quality, packaging and labelling, and testing methodologies (ECITA, 2014). BSI is expected to publish the PAS in March 2015. Consumer products are subject to general advertising laws, requiring that advertisements be substantiated, factual, balanced and not misleading. There is, however, potential for national advertising regulators to set standards and deem certain types of claim to be inappropriate or unsubstantiated for certain categories of products. In the UK, for example, the Committee of Advertising Practice (CAP) and the Broadcast Committee of Advertising Practice (BCAP) have adopted new rules governing the marketing of e-cigarettes (CAP, 2014). The rules do not have the force of law. However, companies are expected to comply with them when marketing their products in the UK. Non-compliance can have negative consequences, including possible referral 4 Page 4 of 17
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to OFCOM or the Office of Fair Trading (OFT), although this is rare in practice. The rules are intended as an interim measure until the Tobacco Products Directive is implemented into UK law. Among other things, the rules require that companies make clear in their marketing communications that the product is an e-cigarette and not a tobacco product and that such communications do not contain health or medicinal claims unless the MHRA has authorised the product for such purposes.
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The general requirement that products must be safe, coupled with other consumer protection laws may provide for a flexible, proportionate approach. The creation and enforcement of standards for particular products allows the creation of detailed technical requirements, covering both quality, performance and safety. The voluntary nature of most standards, of the selective application of parts of standards relevant to the product, allows for innovation. E-cigarettes can be advertised freely, subject to the need to ensure that claims are substantiated, are fair, balanced and not misleading. Advertising regulators may provide additional guidance on the types of claims and substantiation required. Medicinal claims, e.g. that the products can assist with smoking cessation or alleviate the symptoms of nicotine withdrawal, may trigger regulation as a medicine.
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Pros & Cons of Consumer Product Regulation
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Cons • Relative lack of legal clarity or certainty, e.g. in terms of standards for product safety, performance and quality. • While it is possible to establish relatively sophisticated safety, quality and performance standards and to control advertising within this regime, based on standards and guidance documents, enforcement can be challenging unless laws make standards mandatory. • No dedicated system of pre-market notification or review. • No clear system for post-market monitoring and surveillance, except perhaps in the event of a product recall. • No clear regulation of manufacturing quality or practices, unless reflected in applicable standards. Medicinal Product Regulation While it is possible to achieve a relatively high level of technical regulation via general consumer product rules, the lack of pre-market regulatory review and approval and gaps in the regulation of the quality of the manufacturing and supply chain, coupled with deficiencies in post-market monitoring and surveillance, means that some legislators and regulators have sought to regulate ecigarettes as medicines.
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For example, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) favoured regulating all nicotine-containing products that are not tobacco products as medicinal products by function, irrespective of whether the manufacturer made any medicinal claims linked to smoking cessation or alleviation of the symptoms of nicotine withdrawal. To do so, it had to argue that ecigarettes fall within the definition of a medicinal product under EU, and hence UK, law. EU law, namely the Medicines Directive 2001/83/EC (EC, 2001), defines a “medicinal product” as: (a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
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(b) 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.
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The MHRA faced a number of challenges with this definition, in that few if any e-cigarette manufactures make smoking cessation, nicotine withdrawal or disease prevention claims.
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There is also some ambiguity in the operative part of the medicines definition under EU and UK law dealing with the function of the product. One might argue, as the MHRA has done, that nicotine exerts a pharmacological effect and that nicotine delivery products are medicinal. Alternatively, one could argue that many substances exert a pharmacological effect, including alcohol and chocolate, and that the purpose for which they are administered is key. This is position that appears to be prevailing in the judgments of the Court of Justice of the European Union.
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In November 2014, the German Supreme Administrative Court (Bundesverwaltungsgericht, “BVerwG”) ruled that nicotine-containing liquids that are vaporised and inhaled via e-cigarettes are not medicines and therefore e-cigarettes are not medical devices. The BVerwG found that the liquids are not medicines by function. Although nicotine is a substance that appreciably influences human physiological functions through a pharmacological action, the assessment of a product as a medicine by function must follow on a case-by-case basis and take into account all characteristics of the product. On this basis, the BVerwG ruled that such liquids do not possess any medicinal properties. These liquids do not have a therapeutic ability because use of e-cigarettes as an aid for a long-term smoking and nicotine withdrawal is not scientifically proven. As a result, consumers do not attribute any medicinal purpose to nicotine-containing liquids but use them as consumer goods. Ultimately, the debate has been resolved in the EU by Article 20 of the new Tobacco Products Directive 2014/40/EU, which provides that the Directive does not apply to e-cigarettes that are subject to an authorisation requirement under the Medicines Directive 2001/83/EC. In accordance with the Medicines Directive, a product will be classified as a medicinal product if it is associated with medicinal claims.
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In the United States, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) regulates only e-cigarettes that are marketed for therapeutic purposes. Ecigarettes that do not make medicinal claims are currently unregulated.
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Under the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), the FDA Center for Tobacco Products (CTP) currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The FDCA also permits the FDA to issue regulations deeming other “tobacco products” (defined, in pertinent part, as “any product made or derived from tobacco that is intended for human consumption”) not named in the Tobacco Control Act to be subject to the FDCA. FDA has recently issued a proposed rule, known as the Deeming Regulation, that would extend the CTP’s tobacco authority to cover additional products that meet this definition, including e-cigarettes, cigars, pipe tobacco and waterpipe tobacco.
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Consistent with currently regulated tobacco products, these additional products will be subject to regulatory scrutiny, including a requirement for manufacturers to register with the FDA and report product and ingredient listings, and a restriction on the ability to make reduced risk claims. The Deeming Regulation will also impose minimum age restrictions on sales and requirements to include health warnings on product packages and in advertisements.
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In the UK, companies required to seek approval of e-cigarettes as medicines or that voluntarily decide to do so would face greater developmental and regulatory hurdles. There appears to be some acceptance within key medicines regulators, such as the MHRA, that a pragmatic approach to the regulation of e-cigarettes as medicines is necessary. The MHRA has indicated that it “will use the flexibilities within the existing licensing framework to enable products that meet medicinal standards to be available”, but the words “that meet medicinal standards” are telling (MHRA, 2013). The standards for the approvability of medicines are set out in laws and guidelines adopted at the EU level and national medicines agencies have only have so much discretion to deviate from them.
Pros and Cons of Medicines Regulation Pros •
Generally the highest standards for the protection of public health.
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Well-established regime, concepts and standards.
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The ability to advertise non-prescription medicines to both members of the healthcare professions and the general public, provided that the advertising is consistent with the marketing authorisation. 7 Page 7 of 17
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No health warnings on packaging or restrictions on comparative safety claims, provided that the advertising is consistent with the marketing authorisation.
Cons Extensive regulatory burdens, both pre- and post-authorisation.
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Significant costs and barriers to market entry.
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It is far from clear that many current e-cigarette technologies will meet with pharmaceutical standards, particularly as regards the performance of the devices against pharmaceutical standards for inhaled products.
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Supply chain may be restricted to pharmacies in some jurisdictions.
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The final regulatory option is to regulate e-cigarettes as tobacco products. Although nicotine is usually manufactured from tobacco, pure nicotine does not contain tobacco per se, which is a feature of many legal definitions of tobacco products. Under such circumstances, bringing ecigarettes within the scope of the tobacco rules may require legislation, such as the FDA’s proposed Deeming Regulation discussed above. At EU level, the Tobacco Products Directive 2014/40/EU establish a specific regime for such products. The Directive provides the following definition:
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‘electronic cigarette’ means a product that can be used for consumption of nicotinecontaining vapour via a mouth piece, or any component of that product, including a cartridge, a tank and the device without cartridge or tank. Electronic cigarettes can be disposable or refillable by means of a refill container and a tank, or rechargeable with single use cartridges. Electronic cigarettes that do not make medicinal claims and contain nicotine at a level below 20 mg/ml will be regulated under Article 20 of the Tobacco Products Directive 2014/40/EU. Article 20 allows the marketing of e-cigarettes, subject to certain nicotine content, volume and dose, quality and performance requirements, an obligation to notify the relevant Member State before marketing and a number of other conditions and restrictions. Even though the threat of medicines regulation appears removed for products that satisfy these conditions, the regime largely mirrors medicines regulation without the benefits, namely, without the ability to advertise the product. This is because the Directive expressly prohibits any commercial communications (and indeed private interactions with individuals) that are aimed, directly or indirectly, at, promoting electronic cigarettes and refill containers (other than trade advertising) (Art. 20(5)). In addition, it is possible that such products could be subject to “plain 8 Page 8 of 17
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packaging” and display bans that operate (or may operate in the future) in relation to other tobacco products. This would reduce further the access to e-cigarettes despite the clear public health benefit in making these products widely available. In contrast, nicotine-inhaled products that are licensed as medicines, such as the Nicorette Inhalator and the recently approved Voke, may be advertised (and displayed) to the general public (at least in the UK).
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The very strict standards required by the EU Directive are unlikely to be met by many existing ecigarette operators, leaving it to those organisations with the largest resources to develop products that can satisfy these requirements. Indeed, that is why there is currently an application pending before the Court of Justice of the European Union seeking the annulment of Article 20. A key plank of the application is that the data requirements and also the inability to advertise e-cigarettes are disproportionate given the potential health benefits. The application, brought by Totally Wicked, a manufacturer of e-cigarettes, argues that the assumption made by the Commission in enacting the legislation – i.e., that they present an equivalent health risk to tobacco products – is flawed, and is not supported by the available scientific evidence.
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Clarity of regime, concepts and standards. Pre-market regulatory review.
Essentially medicines-like regulation and standards without the benefits Extensive regulatory burdens, both pre- and post-authorisation. Significant costs and barriers to market entry. It is far from clear that many current e-cigarette technologies will be able to comply, particularly as regards the dose reproducibility requirement.
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Pros • • Cons • • • •
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Pros and Cons of the EU Tobacco Regulation of e-Cigarettes
Possible unintended consequences The health consequences of combustible cigarettes obviously represent a great challenge for regulators, and those seeking to influence them to focus on health-oriented, science-based approaches aimed at moving nicotine use as far down the spectrum of risk as can be achieved. Existing evidence-based approaches should be applied when designing a sensible and coherent regulatory framework for electronic cigarettes (Polosa and Caponnetto, 2013b). Taking action to limit hypothetical risks can have unintended consequences that work against achieving the ultimate goal: saving lives by reducing the morbidity and mortality caused by smoking. We propose a framework of these possible unintended consequences (see table 1), correlated to a certain regulatory action settled to resolve a specific issue.
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Table 1: Possible unintended consequences of regulatory action
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Concluding Remarks
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Given the enormous health and economic losses due to cigarette smoking, the presence of approximately one and a half billion people who obtain nicotine through the inhalation of the products of combustion, the realization that ‘people smoke for the nicotine but die from the smoke’ (Russell, 1976), and the relatively low success rates using traditional quitting methods, it is clear that a different, more effective approach is needed to reduce the harm from cigarette smoking. It is therefore imperative to provide e-cigarette regulation with a legal framework that maximizes the impact of these alternative products as a low-risk replacement for smoking conventional cigarettes.
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Involving consumers in the regulatory process, getting and acting on the best available science, and treating combustion-based delivery as the health emergency it is will help policy makers determine which concerns represent real problems and may point out potential unintended consequences of any proposed actions that policy makers might overlook.
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On the basis of current knowledge of benefits and harms and in line with consumers' desires, future regulatory measures should primarily address safety and quality standards, child-proof caps on liquid containers, verification of accurate nicotine levels and product ingredients, complete and accurate package labeling and safety warnings, and post-marketing surveillance (Saitta et al., 2014; Polosa and Caponnetto, 2013a).
Conflict of Interest
None of the authors have any competing financial interests to declare, with the exception of Riccardo Polosa. Riccardo has received lecture fees and research funding from Pfizer and GlaxoSmithKline, manufacturers of stop smoking medications. He has also served as a consultant for Pfizer, Global Health Alliance for treatment of tobacco dependence, Arbi Group Srl (the Italian distributor for Categoria electronic cigarettes), and ECITA (Electronic Cigarette Industry Trade Association, in the UK). Lectures fees from a number of European electronic cigarette industry and trade associations (including FIVAPE in France and FIESEL in Italy) were directly donated to vaper advocacy organizations. He is currently scientific advisor for LIAF, Lega Italiana Anti Fumo (Italian acronym for Italian Anti Smoking League).
Acknowledgements 12 Page 11 of 17
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Pasquale Caponnetto is Senior Research Fellow at the CPCT – Centro per la Prevenzione e Cura del Tabagismo (Italian acronym for Smoking Prevention and Cessation Centre) of the University of Catania, and he is supported by the same University. Daniela Saitta is Expert of Health Communication at the Department of Clinical and Experimental Medicine and she is supported by the University of Catania, Italy. David Sweanor is a self-supporting adjunct Professor at the Faculty of Law of the University of Ottawa, Canada. Riccardo Polosa is tenured full Professor of Internal Medicine and he is supported by the University of Catania, Italy. His research on smoking, electronic cigarettes and tobacco regulation is currently supported by University of Catania and LIAF – Lega Italiana Anti Fumo (Italian acronym for Italian Anti Smoking League).
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It is imperative to provide e-cigs regulation that maximizes their impact as a low-risk replacement for smoking cigarettes Involving consumers in the regulatory process, will help policy makers determine which concerns represent real problems
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Involving consumers will help policy makers point out unintended consequences of any actions that they might overlook
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Future regulatory measures should primarily address safety and quality standards, child-proof caps on liquid containers
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Should primarily address verification of nicotine levels and ingredients, accurate package labeling and safety warnings
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Regulatory Action Desired Outcome
Possible Unintended Consequences
Risk of unsafe devices and liquids
Extensive testing and approval process
Higher quality products
Expense of compliance may drive all except large corporations out of the industry Lag time in bringing new, less hazardous products to market, meanwhile smokers keep smoking Reduction in product innovation
Risk of nicotine overdose
Limit on nicotine concentration
Reduce abuse liability
Risk of e-cigarette use by adolescents
Ban on nontobacco flavors
Reduce attraction to children
If children really are not attracted by flavors, may have no effect on child uptake Prevent extinguishment of liking for "tobacco" flavor
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Regulatory Issue
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Table 1: Possible unintended consequences of regulatory action
Reduce acceptability as a substitute for smoking fewer smokers quit
Risk of e-cigarette use by never smokers
Ban or limit on advertising
Prevent new user uptake
Prevent switching by smokers due to lack of product knowledge
Risk of secondhand exposure
Restrict use to smoking zone
Protect bystanders from second-hand exposure
Instead of staying inside adult-only venues, smokers and vapers go outside where they are more easily seen
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Restrict use to smoking zone
Avoid renormalization of the smoking habit
Expose former smokers to chemicals in smoke Eliminate one benefit of switching Tempt a relapse to smoking
Risk of modeling by children
Restrict use to smoking zone
Protect children from viewing activity that looks like smoking
Instead of staying inside adult-only venues, smokers and vapers go outside where they are more easily seen
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Prevent never smokers and children uptake
Fewer smokers switch due to lack of financial benefit Increased movement to black market sources
Prevent sale of unsafe products Prevent sales to children
Lack of access to products keeps adult smokers smoking
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Outlaw Internet Sales
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Risk of e-cigarette High Taxes use by never smokers Risk of e-cigarette use by children and adolescents Unregulated sale of uncontrolled products Risk of Internet sale to minors
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Risk of renormalization of the smoking habit
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S0955-3959(15)00068-7 http://dx.doi.org/doi:10.1016/j.drugpo.2015.03.001 DRUPOL 1533
To appear in:
International Journal of Drug Policy
Received date: Revised date: Accepted date:
9-11-2014 3-3-2015 7-3-2015
Please cite this article as: Caponnetto, P., Saitta, D., Sweanor, D., and Polosa, R.,WHAT TO CONSIDER WHEN REGULATING ELECTRONIC CIGARETTES: PROS, CONS AND UNINTENDED CONSEQUENCES, International Journal of Drug Policy (2015), http://dx.doi.org/10.1016/j.drugpo.2015.03.001 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
WHAT TO CONSIDER WHEN REGULATING ELECTRONIC CIGARETTES: PROS, CONS AND UNINTENDED CONSEQUENCES
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Pasquale Caponnetto1,2, Daniela Saitta2, David Sweanor3, Riccardo Polosa1,2 1
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Centro per la Prevenzione e Cura del Tabagismo, Azienda Ospedaliero-Universitaria “PoliclinicoV. Emanuele”, Via S. Sofia 78, 95123 Catania, Italy 2 Dipartimento di Medicina Clinica e Sperimentale, Università di Catania, Via Palermo 636, 95121 Catania, Italy 3 Faculty of Law, University of Ottawa, 75 Laurier Avenue East, Ottawa ON K1N 6N5, Canada
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Corresponding author: Pasquale Caponnetto Centro per la Prevenzione e Cura del Tabagismo, Azienda Ospedaliero-Universitaria “Policlinico-V. Emanuele” Via S. Sofia 78, 95123 Catania, Italy [email protected]; Tel: +39 0953781537; Fax: +39 0953781567
Keywords: electronic cigarettes, regulation, public health.
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Abstract (127 words)
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Many public health experts, medical research societies, large health organizations and policy makers have expressed concerns about the increased popularity of electronic cigarettes and have pushed for more restrictive measures ranging from complete bans to tight regulations of these products either as medicines or as tobacco products. But these concerns have never been adequately qualified nor quantified. Without judicious assessment and thorough evaluation, regulations may have unintended consequences that can do more damage than good in public health terms.
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In this article, we will appraise the existing prominent regulatory frameworks for e-cigarettes, namely, general consumer product, medicinal product and tobacco product regulation, to highlight their pros and cons. Moreover, we provide concrete examples of the unintended consequences which may arise from inappropriate regulatory action. Introduction
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Electronic cigarettes (e-cigarettes) are battery-operated devices designed to turn a liquid solution into an aerosol ("vapor") to simulate the act of smoking. The base of the liquid solution is propylene glycol and/or vegetable glycerin. The liquid also contains water and flavorings, and may or may not contain nicotine. Puffing activates a heating element in the atomizer and the resulting vapor is inhaled.
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The original models were designed to closely resemble a regular cigarette, down to an orange LED at the tip that glows when the consumer activates the unit by inhaling. Now, however, many different models are available. Some look like traditional cigarettes, cigars, or pipes. Others look similar to a pen, and some even look like small flashlights. Some have LED lights, and some don't. Some are single-use disposables, or use prefilled cartridges, and others have refillable cartridges. They come in numerous shapes and sizes and have different features as a very large number of companies seek a marketplace advantage in catering to those who wish to distance themselves from anything resembling a traditional cigarette or want a longer battery life, and/or better performance, and/or the personal satisfaction of having cutting-edge technology. The success of e-cigarettes as a tobacco cigarette substitute is such that these products have been rapidly gaining on conventional cigarettes (Adelman et al., 2013). According to a recent Wells Fargo prediction analysis, e-cigarette consumption could surpass conventional cigarettes within the next decade (Mangan, 2013). The popularity of e-cigarettes’ appears in large part to be related to the fact that they share many similarities with smoking in the behavioural aspect of use (Caponnetto et al., 2012; Caponnetto et al., 2013b). Users are predominantly smokers, who report using them long term to reduce cigarette consumption or quit smoking, to relieve tobacco withdrawal symptoms, and to continue having a ‘smoking’ experience (Farsalinos et al., 2014; 2 Page 2 of 17
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Farsalinos et al., 2013), but with much reduced health risks (Farsalinos and Polosa, 2014). Data from clinical trials (Polosa et al., 2011; Polosa et al., 2013; Caponnetto et al., 2013a; Bullen et al., 2013) have confirmed that e-cigarettes may help smokers quit smoking or reduce their tobacco consumption long term, thus reducing overall exposure to toxins and carcinogens. Moreover, the popularity of e-cigarettes appears to be associated with the fact that they can be used in many smoke-free areas, their prices are competitive, and they are perceived as a much less harmful smoking alternative (Etter, 2010; Heavner, 2010; CASAA, 2013; Etter and Bullen, 2011, Siegel et al., 2011).
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In the face of the growing popularity of e-cigarettes among users, many public health experts, medical societies, large health organizations and policy makers have expressed concerns. These concerns can be essentially classified into two main categories: concerns for individual health risks, and concerns for population effects.
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Specifically, they include: a) Individual health risks: - whether e-cigarette (long-term) use results in higher overall absorption of nicotine/nicotine overdose, or some as-yet-unknown health risks associated with vapor constituents; - whether e-cigarettes perpetuate smokers’ addiction to nicotine;
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b) Population effects: - whether the use of e-cigarettes serves as a gateway to smoking for non-users, particularly youth; - whether e-cigarettes make smoking socially acceptable again, thus undermining current nosmoking policies. Scientific evidence that seems to provide reassuring answers to these questions is already accumulating (Hajek et al., 2014; Abrams et al., 2014). Nevertheless, international health organizations and regulatory authorities in many countries – by invoking a very constraining version of the precautionary principle – have hurriedly recommended and introduced restrictions on the manufacturing, import, sale and advertising of e-cigarettes. In this article, we will analyze the three possible regulatory classifications for e-cigarettes under existing regulatory frameworks, critically appraising their pros and cons. Moreover, we will try to elucidate some possible unintended consequences that may arise from the application of certain regulatory action.
Existing regulatory frameworks for e-cigarettes In most jurisdictions, there are essentially three possible regulatory classifications for e-cigarettes under existing regulatory frameworks: as a general consumer product, a medicinal product or a tobacco product. The product classifications will drive both the strategy for bringing the products to market and the manner in which companies can commercialise them, including the claims the company can make on the packaging and in other commercial communications. 3 Page 3 of 17
General consumer products
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Many refer to general consumer products as being “unregulated” consumer products. That is often a misnomer. Many jurisdictions do regulate consumer products by subjecting them to general safety requirements, such as those found in the European Union General Product Safety Directive 2001/95/EC (GPSD). Often a patchwork of other more specific rules would apply, such as rules governing electrical safety and compatibility contained in the Low Voltage Directive 2006/95/EC and the Electromagnetic Compatibility Directive 2004/108/EC, which apply to electronic components of an e-cigarette.
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In general terms, the GPSD requires that producers only place safe products on the market. A product will be “safe” if it “does not present any risk or only the minimum risks compatible with the product’s use.” In determining whether a product is to be regarded as “safe,” the following considerations are relevant:
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the characteristics of the product, including its composition, packaging and instructions; the effect of the product on other products, where it is reasonably foreseeable that it will be used with other products; and
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the presentation of the product, including labelling, warnings and instructions.
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Pursuant to the GPSD, a product may be deemed safe when it conforms with relevant EU and national laws and, in the absence of such laws, with: (i) voluntary national standards; (ii) European Commission recommendations setting out guidelines on the assessment of product safety; (iii) codes of good practice as regards health and safety; (iv) the current state of the art; and (v) the consumers’ safety expectations. There are no EU-wide standards on e-cigarettes. However, in the UK, the British Standards Institute (BSI), with input from the Electronic Cigarette Industry Trade Association (ECITA), is developing a Publicly Available Specification (PAS) providing guidance for the importation and sale of electronic cigarettes and directly related products. The PAS represents the first UK attempt to prepare a voluntary standard for e-cigarettes. It covers product safety and quality, packaging and labelling, and testing methodologies (ECITA, 2014). BSI is expected to publish the PAS in March 2015. Consumer products are subject to general advertising laws, requiring that advertisements be substantiated, factual, balanced and not misleading. There is, however, potential for national advertising regulators to set standards and deem certain types of claim to be inappropriate or unsubstantiated for certain categories of products. In the UK, for example, the Committee of Advertising Practice (CAP) and the Broadcast Committee of Advertising Practice (BCAP) have adopted new rules governing the marketing of e-cigarettes (CAP, 2014). The rules do not have the force of law. However, companies are expected to comply with them when marketing their products in the UK. Non-compliance can have negative consequences, including possible referral 4 Page 4 of 17
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to OFCOM or the Office of Fair Trading (OFT), although this is rare in practice. The rules are intended as an interim measure until the Tobacco Products Directive is implemented into UK law. Among other things, the rules require that companies make clear in their marketing communications that the product is an e-cigarette and not a tobacco product and that such communications do not contain health or medicinal claims unless the MHRA has authorised the product for such purposes.
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The general requirement that products must be safe, coupled with other consumer protection laws may provide for a flexible, proportionate approach. The creation and enforcement of standards for particular products allows the creation of detailed technical requirements, covering both quality, performance and safety. The voluntary nature of most standards, of the selective application of parts of standards relevant to the product, allows for innovation. E-cigarettes can be advertised freely, subject to the need to ensure that claims are substantiated, are fair, balanced and not misleading. Advertising regulators may provide additional guidance on the types of claims and substantiation required. Medicinal claims, e.g. that the products can assist with smoking cessation or alleviate the symptoms of nicotine withdrawal, may trigger regulation as a medicine.
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Pros & Cons of Consumer Product Regulation
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Cons • Relative lack of legal clarity or certainty, e.g. in terms of standards for product safety, performance and quality. • While it is possible to establish relatively sophisticated safety, quality and performance standards and to control advertising within this regime, based on standards and guidance documents, enforcement can be challenging unless laws make standards mandatory. • No dedicated system of pre-market notification or review. • No clear system for post-market monitoring and surveillance, except perhaps in the event of a product recall. • No clear regulation of manufacturing quality or practices, unless reflected in applicable standards. Medicinal Product Regulation While it is possible to achieve a relatively high level of technical regulation via general consumer product rules, the lack of pre-market regulatory review and approval and gaps in the regulation of the quality of the manufacturing and supply chain, coupled with deficiencies in post-market monitoring and surveillance, means that some legislators and regulators have sought to regulate ecigarettes as medicines.
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For example, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) favoured regulating all nicotine-containing products that are not tobacco products as medicinal products by function, irrespective of whether the manufacturer made any medicinal claims linked to smoking cessation or alleviation of the symptoms of nicotine withdrawal. To do so, it had to argue that ecigarettes fall within the definition of a medicinal product under EU, and hence UK, law. EU law, namely the Medicines Directive 2001/83/EC (EC, 2001), defines a “medicinal product” as: (a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
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(b) 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.
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The MHRA faced a number of challenges with this definition, in that few if any e-cigarette manufactures make smoking cessation, nicotine withdrawal or disease prevention claims.
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There is also some ambiguity in the operative part of the medicines definition under EU and UK law dealing with the function of the product. One might argue, as the MHRA has done, that nicotine exerts a pharmacological effect and that nicotine delivery products are medicinal. Alternatively, one could argue that many substances exert a pharmacological effect, including alcohol and chocolate, and that the purpose for which they are administered is key. This is position that appears to be prevailing in the judgments of the Court of Justice of the European Union.
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In November 2014, the German Supreme Administrative Court (Bundesverwaltungsgericht, “BVerwG”) ruled that nicotine-containing liquids that are vaporised and inhaled via e-cigarettes are not medicines and therefore e-cigarettes are not medical devices. The BVerwG found that the liquids are not medicines by function. Although nicotine is a substance that appreciably influences human physiological functions through a pharmacological action, the assessment of a product as a medicine by function must follow on a case-by-case basis and take into account all characteristics of the product. On this basis, the BVerwG ruled that such liquids do not possess any medicinal properties. These liquids do not have a therapeutic ability because use of e-cigarettes as an aid for a long-term smoking and nicotine withdrawal is not scientifically proven. As a result, consumers do not attribute any medicinal purpose to nicotine-containing liquids but use them as consumer goods. Ultimately, the debate has been resolved in the EU by Article 20 of the new Tobacco Products Directive 2014/40/EU, which provides that the Directive does not apply to e-cigarettes that are subject to an authorisation requirement under the Medicines Directive 2001/83/EC. In accordance with the Medicines Directive, a product will be classified as a medicinal product if it is associated with medicinal claims.
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In the United States, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) regulates only e-cigarettes that are marketed for therapeutic purposes. Ecigarettes that do not make medicinal claims are currently unregulated.
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Under the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), the FDA Center for Tobacco Products (CTP) currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The FDCA also permits the FDA to issue regulations deeming other “tobacco products” (defined, in pertinent part, as “any product made or derived from tobacco that is intended for human consumption”) not named in the Tobacco Control Act to be subject to the FDCA. FDA has recently issued a proposed rule, known as the Deeming Regulation, that would extend the CTP’s tobacco authority to cover additional products that meet this definition, including e-cigarettes, cigars, pipe tobacco and waterpipe tobacco.
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Consistent with currently regulated tobacco products, these additional products will be subject to regulatory scrutiny, including a requirement for manufacturers to register with the FDA and report product and ingredient listings, and a restriction on the ability to make reduced risk claims. The Deeming Regulation will also impose minimum age restrictions on sales and requirements to include health warnings on product packages and in advertisements.
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In the UK, companies required to seek approval of e-cigarettes as medicines or that voluntarily decide to do so would face greater developmental and regulatory hurdles. There appears to be some acceptance within key medicines regulators, such as the MHRA, that a pragmatic approach to the regulation of e-cigarettes as medicines is necessary. The MHRA has indicated that it “will use the flexibilities within the existing licensing framework to enable products that meet medicinal standards to be available”, but the words “that meet medicinal standards” are telling (MHRA, 2013). The standards for the approvability of medicines are set out in laws and guidelines adopted at the EU level and national medicines agencies have only have so much discretion to deviate from them.
Pros and Cons of Medicines Regulation Pros •
Generally the highest standards for the protection of public health.
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Well-established regime, concepts and standards.
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No health warnings on packaging or restrictions on comparative safety claims, provided that the advertising is consistent with the marketing authorisation.
Cons Extensive regulatory burdens, both pre- and post-authorisation.
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Significant costs and barriers to market entry.
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It is far from clear that many current e-cigarette technologies will meet with pharmaceutical standards, particularly as regards the performance of the devices against pharmaceutical standards for inhaled products.
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Supply chain may be restricted to pharmacies in some jurisdictions.
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The final regulatory option is to regulate e-cigarettes as tobacco products. Although nicotine is usually manufactured from tobacco, pure nicotine does not contain tobacco per se, which is a feature of many legal definitions of tobacco products. Under such circumstances, bringing ecigarettes within the scope of the tobacco rules may require legislation, such as the FDA’s proposed Deeming Regulation discussed above. At EU level, the Tobacco Products Directive 2014/40/EU establish a specific regime for such products. The Directive provides the following definition:
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‘electronic cigarette’ means a product that can be used for consumption of nicotinecontaining vapour via a mouth piece, or any component of that product, including a cartridge, a tank and the device without cartridge or tank. Electronic cigarettes can be disposable or refillable by means of a refill container and a tank, or rechargeable with single use cartridges. Electronic cigarettes that do not make medicinal claims and contain nicotine at a level below 20 mg/ml will be regulated under Article 20 of the Tobacco Products Directive 2014/40/EU. Article 20 allows the marketing of e-cigarettes, subject to certain nicotine content, volume and dose, quality and performance requirements, an obligation to notify the relevant Member State before marketing and a number of other conditions and restrictions. Even though the threat of medicines regulation appears removed for products that satisfy these conditions, the regime largely mirrors medicines regulation without the benefits, namely, without the ability to advertise the product. This is because the Directive expressly prohibits any commercial communications (and indeed private interactions with individuals) that are aimed, directly or indirectly, at, promoting electronic cigarettes and refill containers (other than trade advertising) (Art. 20(5)). In addition, it is possible that such products could be subject to “plain 8 Page 8 of 17
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packaging” and display bans that operate (or may operate in the future) in relation to other tobacco products. This would reduce further the access to e-cigarettes despite the clear public health benefit in making these products widely available. In contrast, nicotine-inhaled products that are licensed as medicines, such as the Nicorette Inhalator and the recently approved Voke, may be advertised (and displayed) to the general public (at least in the UK).
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The very strict standards required by the EU Directive are unlikely to be met by many existing ecigarette operators, leaving it to those organisations with the largest resources to develop products that can satisfy these requirements. Indeed, that is why there is currently an application pending before the Court of Justice of the European Union seeking the annulment of Article 20. A key plank of the application is that the data requirements and also the inability to advertise e-cigarettes are disproportionate given the potential health benefits. The application, brought by Totally Wicked, a manufacturer of e-cigarettes, argues that the assumption made by the Commission in enacting the legislation – i.e., that they present an equivalent health risk to tobacco products – is flawed, and is not supported by the available scientific evidence.
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Clarity of regime, concepts and standards. Pre-market regulatory review.
Essentially medicines-like regulation and standards without the benefits Extensive regulatory burdens, both pre- and post-authorisation. Significant costs and barriers to market entry. It is far from clear that many current e-cigarette technologies will be able to comply, particularly as regards the dose reproducibility requirement.
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Pros • • Cons • • • •
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Pros and Cons of the EU Tobacco Regulation of e-Cigarettes
Possible unintended consequences The health consequences of combustible cigarettes obviously represent a great challenge for regulators, and those seeking to influence them to focus on health-oriented, science-based approaches aimed at moving nicotine use as far down the spectrum of risk as can be achieved. Existing evidence-based approaches should be applied when designing a sensible and coherent regulatory framework for electronic cigarettes (Polosa and Caponnetto, 2013b). Taking action to limit hypothetical risks can have unintended consequences that work against achieving the ultimate goal: saving lives by reducing the morbidity and mortality caused by smoking. We propose a framework of these possible unintended consequences (see table 1), correlated to a certain regulatory action settled to resolve a specific issue.
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Table 1: Possible unintended consequences of regulatory action
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Concluding Remarks
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Given the enormous health and economic losses due to cigarette smoking, the presence of approximately one and a half billion people who obtain nicotine through the inhalation of the products of combustion, the realization that ‘people smoke for the nicotine but die from the smoke’ (Russell, 1976), and the relatively low success rates using traditional quitting methods, it is clear that a different, more effective approach is needed to reduce the harm from cigarette smoking. It is therefore imperative to provide e-cigarette regulation with a legal framework that maximizes the impact of these alternative products as a low-risk replacement for smoking conventional cigarettes.
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Involving consumers in the regulatory process, getting and acting on the best available science, and treating combustion-based delivery as the health emergency it is will help policy makers determine which concerns represent real problems and may point out potential unintended consequences of any proposed actions that policy makers might overlook.
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On the basis of current knowledge of benefits and harms and in line with consumers' desires, future regulatory measures should primarily address safety and quality standards, child-proof caps on liquid containers, verification of accurate nicotine levels and product ingredients, complete and accurate package labeling and safety warnings, and post-marketing surveillance (Saitta et al., 2014; Polosa and Caponnetto, 2013a).
Conflict of Interest
None of the authors have any competing financial interests to declare, with the exception of Riccardo Polosa. Riccardo has received lecture fees and research funding from Pfizer and GlaxoSmithKline, manufacturers of stop smoking medications. He has also served as a consultant for Pfizer, Global Health Alliance for treatment of tobacco dependence, Arbi Group Srl (the Italian distributor for Categoria electronic cigarettes), and ECITA (Electronic Cigarette Industry Trade Association, in the UK). Lectures fees from a number of European electronic cigarette industry and trade associations (including FIVAPE in France and FIESEL in Italy) were directly donated to vaper advocacy organizations. He is currently scientific advisor for LIAF, Lega Italiana Anti Fumo (Italian acronym for Italian Anti Smoking League).
Acknowledgements 12 Page 11 of 17
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Pasquale Caponnetto is Senior Research Fellow at the CPCT – Centro per la Prevenzione e Cura del Tabagismo (Italian acronym for Smoking Prevention and Cessation Centre) of the University of Catania, and he is supported by the same University. Daniela Saitta is Expert of Health Communication at the Department of Clinical and Experimental Medicine and she is supported by the University of Catania, Italy. David Sweanor is a self-supporting adjunct Professor at the Faculty of Law of the University of Ottawa, Canada. Riccardo Polosa is tenured full Professor of Internal Medicine and he is supported by the University of Catania, Italy. His research on smoking, electronic cigarettes and tobacco regulation is currently supported by University of Catania and LIAF – Lega Italiana Anti Fumo (Italian acronym for Italian Anti Smoking League).
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Adelman DJ, Grainger M, Ayala V, Paxton K (2013). Tobacco: New Years’ Resolutions + E-Cigs = Weaker Volumes?. New York: Morgan Stanley Research North America. Bullen C, Howe C, Laugesen M, et al (2013). Electronic cigarettes for smoking cessation: a randomised controlled trial. Lancet, 382(9905):1629-37. Caponnetto P, Campagna D, Papale G, Russo C, Polosa R (2012). The emerging phenomenon of electronic cigarettes. Expert Rev Respir Med, 6(1):63-74. Caponnetto P, Campagna D, Cibella F, et al. (2013a) EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as Tobacco Cigarettes Substitute: A Prospective 12-Month Randomized Control Design Study. PLoS One, 8(6):e66317. Caponnetto P, Russo C, Bruno CM, Alamo A, Amaradio MD, Polosa R. (2013b) Electronic cigarette: a possible substitute for cigarette dependence. Monaldi Arch Chest Dis, 79(1):12-19. Committees of Advertising Practice (CAP) (2014). Electronic Cigarettes, Rule 22. Retrieved 5th February 2015 from http://cap.org.uk/Advertising-Codes/Non13 Page 12 of 17
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It is imperative to provide e-cigs regulation that maximizes their impact as a low-risk replacement for smoking cigarettes Involving consumers in the regulatory process, will help policy makers determine which concerns represent real problems
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Involving consumers will help policy makers point out unintended consequences of any actions that they might overlook
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Future regulatory measures should primarily address safety and quality standards, child-proof caps on liquid containers
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Should primarily address verification of nicotine levels and ingredients, accurate package labeling and safety warnings
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Regulatory Action Desired Outcome
Possible Unintended Consequences
Risk of unsafe devices and liquids
Extensive testing and approval process
Higher quality products
Expense of compliance may drive all except large corporations out of the industry Lag time in bringing new, less hazardous products to market, meanwhile smokers keep smoking Reduction in product innovation
Risk of nicotine overdose
Limit on nicotine concentration
Reduce abuse liability
Risk of e-cigarette use by adolescents
Ban on nontobacco flavors
Reduce attraction to children
If children really are not attracted by flavors, may have no effect on child uptake Prevent extinguishment of liking for "tobacco" flavor
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Regulatory Issue
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Table 1: Possible unintended consequences of regulatory action
Reduce acceptability as a substitute for smoking fewer smokers quit
Risk of e-cigarette use by never smokers
Ban or limit on advertising
Prevent new user uptake
Prevent switching by smokers due to lack of product knowledge
Risk of secondhand exposure
Restrict use to smoking zone
Protect bystanders from second-hand exposure
Instead of staying inside adult-only venues, smokers and vapers go outside where they are more easily seen
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Restrict use to smoking zone
Avoid renormalization of the smoking habit
Expose former smokers to chemicals in smoke Eliminate one benefit of switching Tempt a relapse to smoking
Risk of modeling by children
Restrict use to smoking zone
Protect children from viewing activity that looks like smoking
Instead of staying inside adult-only venues, smokers and vapers go outside where they are more easily seen
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Prevent never smokers and children uptake
Fewer smokers switch due to lack of financial benefit Increased movement to black market sources
Prevent sale of unsafe products Prevent sales to children
Lack of access to products keeps adult smokers smoking
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Outlaw Internet Sales
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Risk of e-cigarette High Taxes use by never smokers Risk of e-cigarette use by children and adolescents Unregulated sale of uncontrolled products Risk of Internet sale to minors
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Risk of renormalization of the smoking habit
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