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Edited by Lukasz Gruszczynski

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Lukasz Gruszczynski

This chapter introduces the theme of the book. In this context, it looks at the variety of approaches taken by regulators around the globe with respect to e-cigarettes, as well as at the science that stands behind specific regulatory choices. It also delimits the scope of the book and clarifies terminological nuances. Against this background, the chapter summarizes and critically assesses the findings of the individual authors relating to: (i) the factors that influence the particular paths taken in different jurisdictions; (ii) general features of an optimal regulatory model for e-cigarettes; and (iii) constraints imposed by international and European rules on regulators in this policy space. The chapter also offers some general observations as to the possible future directions of e-cigarette regulation.

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Mateusz Zatoński and Allan M. Brandt

The adoption of the Framework Convention on Tobacco Control in 2003 came about during a period of great optimism about tobacco control. New therapeutic approaches promised novel ways to support those wanting to quit, while the industry was culturally marginalized and lost its place at the regulatory table. At the same time, experiments with new technologies were largely unsuccessful. It seemed that tobacco companies would be unable to develop a viable alternative to the combustible cigarette. Then came the advent of the e-cigarette. Today, one of the looming challenges for health advocacy is the appropriate regulation of e-cigarettes. This debate comprises several of the recurring themes in the history of tobacco control. These include the tensions between harm reduction approaches and the precautionary principle, and the challenges posed by disruptive innovation as the dissemination of technological advances outstrips the knowledge context. The aim of this chapter is to critically address these issues.

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Charlie A. Smith, Aleksandra Herbeć and Lion Shahab

Electronic Nicotine Delivery Systems (ENDS) have divided the tobacco control community. Although some e-liquids and the aerosols produced by e-cigarettes have been found to contain a number of potentially harmful toxins, they are at substantially lower levels than those present in tobacco, and humans’ actual exposure is at levels similar to medically licensed nicotine replacement therapies. As a result, Public Health England has declared ENDS to be around 95 percent less harmful than combustible cigarettes. Moreover, while the evidence is currently too weak to draw firm conclusions regarding ENDS’ impact on smoking cessation, findings from population studies and a handful of clinical trials indicate there appears to be a benefit in this regard. This chapter summarizes and critically assesses the current scientific knowledge on the use of ENDS, particularly with regard to their safety and efficacy as a cessation or harm reduction device.

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Lukasz Gruszczynski

The Framework Convention on Tobacco Control (FCTC) is an international treaty that sets global standards for national tobacco control measures. It is widely seen as a major achievement of the global community in the area of public health. However, the emergence of e-cigarettes poses serious conceptual challenges for the Parties as to their proper classification (and subsequent legal treatment) under the Convention. In this context, the chapter investigates whether and to what extent the FCTC disciplines apply to e-cigarettes and whether the mandate enjoyed by the FCTC Conference of the Parties (COP) is sufficiently broad to deal with these products. It concludes that due to the formulation of the relevant provisions, the complex nature of e-cigarettes, and the COP’s unwillingness to take a decisive stance on their status, the Convention regime currently has only a limited impact on the development of legal standards in this policy space.

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Marie Elske C. Gispen and Jacquelyn D. Veraldi

Tobacco control clearly falls within the remit of human rights law. Yet the potential for the regulation of e-cigarettes is understudied from a human rights perspective. This chapter shows that there are good reasons to assume that the use of e-cigarettes may pose certain health risks and possibly undermine the regulatory efforts directed against use of conventional tobacco products. Employing doctrinal legal research, the chapter explores different approaches to the regulation of e-cigarettes in terms of the right to the highest attainable standard of health included in Art. 12 of the 1966 International Covenant on Economic, Social, and Cultural Rights and the 1989 Convention on the Rights of the Child. It develops a human rights framework applicable to regulating e-cigarettes as a device harmful to health, as a potential harm reduction tool, and as a gateway product.

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Marina Foltea and Bryan Mercurio

Some countries regulate ENDS in the same way as traditional tobacco products, while others classify them as medicinal products or create a sui generis category subject to unique rules. A number of countries have simply prohibited their sale and possession. Although ENDS definitely require a regulatory response, applying highly trade restrictive measures to them may potentially damage business operators, while governments may be missing an opportunity to tackle the tobacco epidemic. Just as with any other product, highly trade restrictive measures may not be allowable under the system established by the WTO. Against this background, this chapter examines the applicability of the WTO nondiscrimination provisions to cases where a general ban on trade in ENDS is adopted. It is argued that so long as cigarettes are traded freely across borders, it is not at all obvious that a ban on ENDS will be compliant with the WTO rules.

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Anna Pudło and Lukasz Gruszczynski

The market for e-cigarettes has recently been harmonized at the European Union (EU) level by the 2014 Tobacco Products Directive (TPD). To some, the TPD establishes a golden regulatory standard for the treatment of e-cigarettes - one which can be replicated in the future in other jurisdictions - while for others it is an example of an overprotective regulation that stifles innovation, which in the end may have a negative impact on public health protection. The aim of this chapter is twofold. First, it analyzes the legislative process that led to the adoption of the new EU regulatory framework for e-cigarettes, at the same time identifying the factors that have had an impact on its ultimate shape and presenting its main features. Second, the chapter assesses the legality of the relevant TPD provisions under applicable EU rules in light of the Pillbox 38 (UK) Ltd v Secretary of State for Health judgment.

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Giancarlo A. Ferro and Costanza Nicolosi

Current state practice still lacks a uniform approach to vaping regulation. The discrepancies are, at least in part, due to the uncertainties about the potential risks to human health resulting from vaping. In this context, the most plausible criteria justifying a given regulation are often rooted in the precautionary principle, which concentrates on “potential risks.” However, in the case of vaping regulation the assessment of potential risks has not been considered from the standpoint of a comparison with the well-known risks deriving from the consumption of traditional cigarettes. The EU Tobacco Products Directive, which provides for the harmonization of rules regarding e-cigarettes, is a good example of such an approach. In this chapter the authors, following a brief analysis of the features of the precautionary principle in the international and EU legal systems, investigate some of the distortions that appear when the precautionary principle is applied to vaping regulations.

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Chuan-Feng Wu, Ching-Fu Lin and Mao-Wei Lo

In light of the scientific evidence confirming that tobacco consumption poses a higher risk of cancer and deaths, and therefore constitutes a significant threat to global public health, Taiwan has implemented a myriad of tobacco control measures under its Tobacco Hazards Prevention Act (THPA) in light of the WHO Framework Convention on Tobacco Control. However, the THPA faces new legal challenges raised by the emergence of e-cigarettes. This chapter examines Taiwan’s current regulatory framework relating to e-cigarettes and explores the regulatory gaps by identifying the key legal and ethical issues. By closely scrutinizing the proposed e-cigarette regulations and the justifications put forward by the government, the chapter assesses multiple policy options and endeavors to determine an optimal institutional design for a more rounded approach to e-cigarette control policies. Where relevant, the chapter also offers a contextual analysis of China’s e-cigarette regulation (or lack thereof) as well as key issues on tobacco control.