The cases below provide examples of how tobacco product ingredients regulation has been challenged since the WHO FCTC came into force; how parties have framed their defences to such challenges; and how courts have considered the issues at stake. The list is not exhaustive but rather shows examples of how issues have been framed in different legal challenges.

Ação Direta de Inconstitucionalidade 4.874 / DF, Supreme Federal Court of Brazil, 1 February 2018 (Brazil, 2018)

The National Confederation of Industry challenged Brazil's ban on tobacco product additives, arguing that ANVISA, the health regulatory agency, did not have the authority to regulate tobacco products and that the ban constrained freedom of enterprise. The Supreme Federal Court of Brazil found that ANVISA did have authority to regulate tobacco products, and it also found that freedom of enterprise did not prevent conditions and limitations on private activities, in light of the public interest in protecting and promoting health, and the right of consumers to information. The findings in this decision have since been affirmed in several lower court decisions.

C-358/14 – Republic of Poland v European Parliament and Council of the European Union (European Union, 2016)

The Court of Justice of the European Union upheld the validity of the prohibition on all characterizing flavours including menthol in the Tobacco Products Directive (Directive 2014/40).

The Court found that the Directive was validly adopted. It had a valid legal basis because it aimed to improve the functioning of the internal market by partially harmonising product requirements so as to ensure consistent rules across the internal market and remove an obstacle to trade, while still ensuring a high level of health protection. (The relevant EU bodies have the power to adopt rules to ensure the functioning of the internal market, but not for health protection as an independent basis).

The flavouring ban was proportionate to this aim of ensuring a functioning internal market while ensuring a high level of health protection. The Court noted that the characterizing flavour ban took into account recommendations in the Guidelines to Articles 9 and 10 of the WHO FCTC, which are intended to assist the parties in the implementation of binding obligations under the Convention and are based on the best available scientific evidence and should therefore be considered ‘of particularly high evidential value’. The Partial Guidelines recommended the prohibition of characterizing flavours without drawing distinctions between them, and specifically mentioned menthol as a flavour which contributes to increased palatability and attractiveness of tobacco products. It was therefore within the broad discretion conferred on the relevant EU bodies to prohibit all characterizing flavours including menthol. Less restrictive measures suggested by Poland, such as age limits or health warnings specific to flavoured tobacco products, were not equally suitable for achieving the aim of ensuring a high level of health protection for all consumers by reducing the attractiveness of tobacco products, because restricting access or providing further information did not function in the same way as making the products themselves less attractive.

The characterizing flavour ban was also consistent with the principle of subsidiarity (which requires the EU to act only when the objective of an action cannot be achieved by national legislatures alone). The risk of divergent regulations on characterizing flavours and the need to ensure consistent regulation of tobacco products within the internal market meant that the aims were better achieved at the EU than the member state level.

Planta Tabak-Manufaktur Dr Manfred Obermann GmbH & Co KG v Land Berlin, Case C-220/17 (Court of Justice of the European Union, 2019)

The Court of Justice of the European Union upheld provisions in the EU Tobacco Products Directive which prohibited cigarettes and roll-your-own tobacco from containing a characterizing flavour, and prohibited labels and packaging of all tobacco products from referring to taste, smell, and any flavourings or additives.

Planta Tabak, a flavoured roll-your-own tobacco manufacturer, sought a declaration that did not apply to its products and packaging, and argued that the measures infringed the principles of legal certainty, equal treatment, proportionality, and the free movement of goods under EU law.

The Court held that the prohibition on flavoured cigarettes and roll-your-own tobacco did not infringe the principle of legal certainty because an EU legislative act did not have to provide technical details to provide legal certainty. It held that the prohibition did not infringe the principle of equal treatment because, among other things, the criteria for phasing out flavoured tobacco did not target tobacco products containing a specific flavouring and was neutral with respect to manufacturers. The measure was proportional because it was appropriate to prohibit tobacco products with a characterizing flavour to ensure a high level of protection of human health. The Court noted that tobacco flavourings are particularly attractive to young people and facilitate initiation of tobacco consumption. Finally, the Court held that prohibiting references to flavours on packages and labels also prohibited the display of information relating to permitted ingredients which imparted a characterizing flavour on those packages and labels.

Judgement 5 A 206/11, 26 Sept 2012, Chamber of the Administrative Court of Germany (Germany, 2012)

A German tobacco product manufacturer, which sought to make a cigarette containing menthol flavouring embedded in the capsule of the cigarette filter, filed a petition with the Federal Office of Consumer Protection and Food Safety (Federal Office) requesting it to issue a general decree for the import and sale of this product. The menthol capsule cigarettes did not comply with the German Preliminary Tobacco Act which bans various flavouring substances as additives for cigarette filters. The Federal Office rejected the petition on the basis that menthol would decrease the unpleasant properties of tobacco smoke and, therefore, increase consumption of flavoured tobacco products. The tobacco manufacturer appealed this decision to the 5th Chamber of the Administrative Court of Germany. It argued that the product was not a novelty but a further development of menthol cigarettes already being sold in Germany.

The Federal Office’s decision was upheld by the Court which held that, in order to protect consumer health, there were compelling reasons for the Federal Office to not issue the decree. The Court also found that the product and its contents, which do not comply with tobacco regulations in Germany under the Act, showed greater harmfulness or risk addiction compared to traditional cigarettes. The Court also noted that the attractiveness of smoking the product was significantly increased with the new capsule technology. The Court held that this was in breach of Article 9 of the WHO FCTC and its Guidelines for Implementation which state that “there is no justification for permitting the use of ingredients, such as flavouring agents, which help make tobacco products attractive”.