Pillbox 38 (UK) Ltd. v. Secretary of State for Health
A challenge to the validity of the e-cigarette regulations in the European Union’s (EU) Tobacco Products Directive (TPD) 2014 was dismissed on all grounds by the Court of Justice of the European Union (CJEU). Pillbox 38 (UK) Ltd. (trading under the name "Totally Wicked"), an e-cigarette manufacturer, brought a judicial review against the UK government challenging its intention to implement the TPD into domestic law on the basis that it claimed the TPD was not valid. The TPD Article 20 sets out requirements for e-cigarettes for all EU Member States. The UK court hearing the case asked the CJEU for a reasoned opinion on the validity of Article 20.
The CJEU found the TPD to be valid and upheld all of the e-cigarette requirements, including health warnings; a ban on most e-cigarette advertising; a limit on nicotine levels and amounts and e-liquid container sizes; a requirement to notify the government before introducing a new product; and the requirement to include a leaflet with the product containing information such as a list of ingredients. Firstly, because the purpose of the Directive is to harmonise regulations across the EU, the court found that there were significant divergences between the regulations in different Member States which justified the EU regulating the market. The court found that it was permissible to regulate e-cigarettes differently than other tobacco products in part because e-cigarettes are novel products and there is insufficient information on their health effects. The identified and potential risks linked to the use of e-cigarettes means the EU may act according to the precautionary principle.
Pillbox 38 (UK) Ltd. v. Secretary of State for Health, Case C-477/14, Court of Justice of the European Union (2016).
Tobacco companies or front groups may challenge any legislative or regulatory measure that affects their business interests. Unlike public interest litigation, these cases seek to weaken health measures. These cases frequently involve the industry proceeding against the government. For example, a group of restaurant owners challenging a smoke free law as unconstitutional.
Measures to regulate the marketing on tobacco packages. This includes both bans on false, misleading, deceptive packaging, as well as required health warnings on packaging.
(See FCTC Art. 11)
Electronic and/or battery-operated devices designed to deliver an inhaled dose of nicotine or other substances. Examples include electronic cigarettes (e-cigarettes), electronic cigars, electronic cigarillos, electronic hookah, vaporizers, and vape pens. ENDS does not include any device or medication approved by the government as nicotine replacement therapy.
Limitations regarding the use of quotes The quotes provided here reflect statements from a specific decision. Accordingly, the International Legal Consortium (ILC) cannot guarantee that an appellate court has not reversed a lower court decision which may influence the applicability or influence of a given quote. All quotes have been selected based on the subjective evaluations undertaken by the ILC meaning that quotes provided here may not accurately or comprehensively represent a given court’s opinion or conclusion, as such quotes may have originally appeared alongside other negative opinions or accompanying facts. Further, some quotes are derived from unofficial English translations, which may alter their original meaning. We emphasize the need to review the original decision and related decisions before authoritatively relying on quotes. Using quotes provided here should not be construed as legal advice and is not intended to be a substitute for legal counsel on any subject matter in any jurisdiction. Please see the full limitations at https://www.tobaccocontrollaws.org/about.
"It should be stated in this connection that the effects of electronic cigarettes on human health are a source of controversy internationally, as the WHO notes in a report of 1 September 2014 entitled ‘Electronic nicotine delivery systems’ (‘the ENDS report’). That report states that some experts are in favour of those products, describing them as a means of reducing tobacco consumption, while others consider that those products could ‘undermine efforts to denormalise tobacco use’. In the words of that report, electronic nicotine delivery systems represent ‘an evolving frontier, filled with promise and threat for tobacco control’. However, the ENDS report notes the existence of certain health risks related to the inhalation of nicotine and toxicants in aerosol and to nicotine exposure by means other than inhalation, in particular for children, adolescents, pregnant women and women of reproductive age.
The ENDS report also states that the scientific evidence for the effectiveness of electronic nicotine delivery systems as a method for quitting tobacco smoking is limited and does not allow conclusions to be reached. Likewise, the evidence available does not allow an affirmation or rejection of the ‘gateway’ and ‘renormalisation’ effects associated with the use of those delivery systems. In its written observations, Pillbox acknowledges that the liquid and vapour of electronic cigarettes contain toxic and carcinogenic components, but at lower levels than those present in tobacco products, and that additional scientific studies are necessary.
Under such circumstances, the EU legislature had to take account of the precautionary principle, according to which, where there is uncertainty as to the existence or extent of risks to human health, protective measures may be taken without having to wait until the reality and seriousness of those risks become fully apparent. Where it proves to be impossible to determine with certainty the existence or extent of the alleged risk because of the insufficiency, inconclusiveness or imprecision of the results of studies conducted, but the likelihood of real harm to public health persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures (judgment in Neptune Distribution, C‑157/14, EU:C:2015:823, paragraphs 81 and 82)."
"The Court has consistently held that the principle of equal treatment requires that comparable situations must not be treated
differently and different situations must not be treated in the same way unless such treatment is objectively justified...It should, in that regard, be noted that electronic cigarettes display different objective characteristics from those of tobacco products.
First, the elements included in their respective composition are significantly different in several respects. Thus, according to Article 2(4) of Directive 2014/40, tobacco products are products that can be consumed and consist, even partly, of tobacco, whether genetically modified or not. By contrast, an electronic cigarette does not contain tobacco but is, as set out in Article 2(16) of that directive, a product that can be used for consumption of nicotine-containing vapour via a mouth piece, or any component of that product, including a cartridge, a tank and the device without cartridge or tank. In addition, electronic cigarettes can be disposable or refillable by means of a refill container and a tank, or rechargeable with single use cartridges. Refill containers are described, in the words of Article 2(17) of that directive, as a receptacle that contains a nicotine-containing liquid, which can be used to refill an electronic cigarette. Secondly, it is common ground that the pattern of consumption of electronic cigarettes is also substantially different from the pattern of consumption of tobacco products. While tobacco products are consumed by the combustion of tobacco, electronic cigarettes function by the electrical or electromechanical vaporisation of the liquid contained in their refill containers. Thirdly, unlike tobacco products, electronic cigarettes are relatively new products, whose risks to human health still need to be clarified. Accordingly, it must be held that electronic cigarettes are not in the same situation as tobacco products for the purposes of the case-law cited in paragraph 35 of the present judgment. Therefore, by submitting those cigarettes to a separate legal regime which is, moreover, less strict than the one applicable to tobacco products, the EU legislature cannot be said to have infringed the principle of equal treatment."
Limitations regarding the use of quotes The quotes provided here reflect statements from a specific decision. Accordingly, the International Legal Consortium (ILC) cannot guarantee that an appellate court has not reversed a lower court decision which may influence the applicability or influence of a given quote. All quotes have been selected based on the subjective evaluations undertaken by the ILC meaning that quotes provided here may not accurately or comprehensively represent a given court’s opinion or conclusion, as such quotes may have originally appeared alongside other negative opinions or accompanying facts. Further, some quotes are derived from unofficial English translations, which may alter their original meaning. We emphasize the need to review the original decision and related decisions before authoritatively relying on quotes. Using quotes provided here should not be construed as legal advice and is not intended to be a substitute for legal counsel on any subject matter in any jurisdiction. Please see the full limitations at https://www.tobaccocontrollaws.org/about.
A challenge to the validity of the e-cigarette regulations in the European Union’s (EU) Tobacco Products Directive (TPD) 2014 was dismissed on all grounds by the Court of Justice of the European Union (CJEU). Pillbox 38 (UK) Ltd. (trading under the name "Totally Wicked"), an e-cigarette manufacturer, brought a judicial review against the UK government challenging its intention to implement the TPD into domestic law on the basis that it claimed the TPD was not valid. The TPD Article 20 sets out requirements for e-cigarettes for all EU Member States. The UK court hearing the case asked the CJEU for a reasoned opinion on the validity of Article 20.
The CJEU found the TPD to be valid and upheld all of the e-cigarette requirements, including health warnings; a ban on most e-cigarette advertising; a limit on nicotine levels and amounts and e-liquid container sizes; a requirement to notify the government before introducing a new product; and the requirement to include a leaflet with the product containing information such as a list of ingredients. Firstly, because the purpose of the Directive is to harmonise regulations across the EU, the court found that there were significant divergences between the regulations in different Member States which justified the EU regulating the market. The court found that it was permissible to regulate e-cigarettes differently than other tobacco products in part because e-cigarettes are novel products and there is insufficient information on their health effects. The identified and potential risks linked to the use of e-cigarettes means the EU may act according to the precautionary principle.