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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.