The cases below provide some examples of legal challenges to novel tobacco and nicotine products. The list is not exhaustive but rather shows examples of how issues related to novel and emerging tobacco and nicotine products have been framed and addressed in different legal challenges.

Plume Vapour Private Ltd v Union of India & Anr. (Calcutta High Court, 2019)

An importer of ENDS/ENNDS, Plume Vapour, and another company, Woke Vapour, challenged a government ordinance passed by the Central Government which bans the production, manufacture, import, export, transport, sale, distribution, storage and advertisement of ENDS/ENNDS and HTPs. The petitioners sought a stay on the implementation of the ban. They claimed that ENDS are less harmful than combustible tobacco and that ENDS could be a method to aid existing smokers to quit smoking. They argued that the ban was manifestly arbitrary, disproportionate and excessive. The Government submitted that the issuance of the ordinance was necessary due to the growing popularity of ENDS/ENNDS, and HTPs across India and that the ban was part of a wider effort to reduce the consumption of ENDS/ENNDS and HTPs.

The Calcutta High Court noted that the Bill passed scrutiny before both Houses to become an Act of Parliament and refused to stay the ban. The Court dismissed the petitions.

BAT Uganda Ltd v Attorney General, et al. No. 46 of 2016 (Constitutional Court of Uganda, 2019)

The Constitutional Court of Uganda unanimously rejected a legal challenge brought by British American Tobacco (BAT) against the Tobacco Control Act 2015 of Uganda. BAT challenged the Act as a whole including provisions that prohibit the import, manufacture, distribution, and sale of ENDS/ENNDS, water pipe tobacco delivery systems, smokeless tobacco, and flavoured tobacco. BAT argued that the Act fails to provide any basis for identifying and measuring what amounts to a ‘flavoured tobacco product’ and, therefore, imposes a vague, uncertain and unreasonable restriction. BAT argued that the prohibition on all flavoured tobacco products deprived it of its property and economic rights by being prohibited from selling certain brands, and using the trademarks associated with those brands. BAT claimed that the ban would severely restrict its ability to compete with other tobacco companies through product differentiation by distorting market competition. BAT also argued that the ban on flavoured tobacco products violated its constitutional right to practice a lawful trade and business.

The Court comprehensively rejected BAT’s arguments, finding in favour of the Republic of Uganda and the civil society intervener, the Centre for Health, Human Rights and Development, on all grounds. Among the Court’s findings were that the Act was enacted by Uganda with the objective of implementing the WHO FCTC and meeting its duties under the right to life and that Uganda was putting into effect the provisions of its Constitution which protect the rights of its citizens. The Court held that the objective of protecting health and life under the Tobacco Control Act is sufficiently important to warrant limiting BAT’s right to engage in lawful occupation, trade or business.

Swedish Match AB v Secretary of State for Health (Court of Justice of the European Union, 2018)

Swedish Match, a manufacturer of snus – a smokeless oral tobacco product, challenged Directive 2014/40/EU of the European Union (EU), known as the Tobacco Products Directive, which requires EU Member States to prohibit tobacco for oral use, including snus. Swedish Match argued that the ban on snus violated the principle of equal treatment because it bans tobacco products for oral use while permitting the marketing of other smokeless tobacco products, cigarettes, ENDS and novel tobacco products. It also argued that the ban violated the principle of proportionality.

The Court of Justice of the European Union (CJEU) rejected these arguments. It found that if oral smokeless tobacco products were allowed to be introduced onto the EU market, they would be novel compared with other smokeless tobacco products and smoked tobacco products, including cigarettes, and would therefore be attractive to young people. Consequently, the CJEU held that it was justified to treat snus differently from cigarettes and smokeless tobacco products given the considerable potential for market expansion.

The CJEU also found that the harmful effects of oral tobacco products, such as snus, had been scientifically proven in contrast to other novel tobacco products. Additionally, the Court noted that the attractiveness of snus to young people might create a gateway effect, for example, leading some to later use smoked tobacco products. The CJEU found that the different treatment of other tobacco and related products compared to snus was proportionate. It ultimately upheld the validity of the ban.

Pillbox 38 (UK) Ltd v Secretary of State for Health (Court of Justice of the European Union, 2016)

Pillbox 38 (UK) Ltd. (Pillbox), a manufacturer of ENDS/ENNDS, brought a judicial review application in the High Court of Justice of England and Wales (High Court) against the UK Government, which intended to implement ENDS regulations into domestic law in accordance with the Directive 2014/40/EU of the European Union (EU), known as the Tobacco Products Directive (TPD). Article 20 of the TPD sets out requirements for all EU Member States to regulate ‘electronic cigarettes’ (defined as “a product that can be used for consumption of nicotine-containing vapour via a mouth piece, or any component of that product”) which includes nicotine limits for ENDS, health warnings, notification requirements, and a ban on most forms of advertising, promotion, and sponsorship for such products. Pillbox claimed that Article 20 of that TPD is invalid on the ground that it infringes the principles of proportionality, legal certainty, equal treatment, free competition and subsidiarity, as well as Articles 16 (freedom to conduct business) and Article 17 (right to property) of the Charter of Fundamental Rights of the European Union (the EU Charter). The High Court decided to stay the proceedings and refer the question of the validity of Article 20 of the TPD to the Court of Justice of the European Union (CJEU) for a preliminary ruling.

In relation to equal treatment and free competition, the CJEU rejected Pillbox’s argument that Article 20 subjects ENDS to less favourable treatment compared to tobacco products. The CJEU found that ENDS display different objective characteristics than tobacco products and that they are relatively new products whose risks to human health are unknown. The CJEU found that ENDS are, therefore, not comparable to tobacco products and that the principle of equal treatment, and the principle of free competition in respect of which Pillbox made similar arguments, had not been infringed. The CJEU also held that application of the ENDS requirements in the TPD was proportional and justified to ensuring the smooth functioning of the internal EU market while protecting human health.

In relation to Article 16 of the EU Charter, the CJEU held that the ENDS requirements in Article 20 of the TPD were proportional and did not affect Pillbox’s right to conduct business. The CJEU found that Article 20 of the TPD does not affect the essence of the freedom to conduct a business or prevent economic operators from manufacturing and marketing ENDS and refill containers in compliance with the TPD. In addition, the CJEU found that Article 20 of the TPD did not hinder the use of intellectual property in connection with the marketing of ENDS products and, therefore, did not breach article 17 of the EU Charter.

The CJEU upheld the validity of all ENDS requirements in Article 20 of the TPD.