Litigation relevant to regulation of novel and emerging nicotine and tobacco products: case summaries

Case summaries A Benn McGrady and Kritika Khanijo COMPARISON ACROSS JURISDICTIONS LITIGATION RELEVANT TO REGULATION OF NOVEL AND EMERGING NICOTINE AND TOBACCO PRODUCTS CASE SUMMARIES Case summaries B Case summaries C LITIGATION RELEVANT TO REGULATION OF NOVEL AND EMERGING NICOTINE AND TOBACCO PRODUCTS CASE SUMMARIES Litigation relevant to regulation of novel and emerging nicotine and tobacco products: case summaries ISBN 978-92-4-002418-2 (electronic version) ISBN 978-92-4-002419-9 (print version) © World Health Organization 2021 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. 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The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. Introduction INTRODUCTION Novel and emerging tobacco products have presented a number of challenges for regulators, including the risk that regulation may lead to litigation. The report titled ‘Litigation Relevant to Regulation of Novel and Emerging Nicotine and Tobacco Products’ analyses litigation concerning tobacco and nicotine product regulation across jurisdictions, with the aim of highlighting the legal arguments advanced and the reasoning of courts relevant to novel and emerging nicotine and tobacco products. In this regard, 89 cases between 2008-2020 were identified as relevant. The report identifies two broad categories of litigation. The first concerns measures addressing product characteristics and disclosures. This group of cases concerns legal challenges against measures which prescribe the form that a product may or may not take, including, classification of these products under national legislation, proportionality of product prohibi- tions, and flavour bans. The second category of cases concerns health claims and advertising, promotion and sponsorship. These concern application of laws to different products, including enforcement actions concerning misleading conduct and restrictions on advertising, promotion, and sponsorship. This document contains summaries of the cases identified as relevant, including those described in the report. This docu- ment describes the facts, legal issues, arguments advanced, and reasoning of the courts. Case summaries F Case summaries 1 AUSTRALIA 1. Hawkins v Van Heerden1 Facts Issue Arguments Advanced 60 packages of electronic cigarettes were found with Mr. Van Heerden (accused) and he was charged under s 106 (a) of the Tobacco Products Control Act 2006 (Act), which states: ‘A person must not sell any food, toy or other prod- uct that is not a tobacco product but is: (a) designed to resemble a tobacco product….’. The accused pleaded not guilty to the charge and was acquitted before the Magistrate Court. The Ld. Magistrate held that the items were ‘other products’ for the purposes of s 106 but not designed to resemble a tobacco product and thus the charge had not been proved. Against this order, an appeal was filed by the Department of Health (Appellant) before the Supreme Court of Western Australia. Whether the overall characteristics of the items resembled a tobacco product and the Ld. Magistrate erred in interpreting the phrase ‘designed to resemble’ in s 106 of the Act? The Appellant contended that the Ld. Magistrate failed to construe the phrase ‘designed to resemble’ in its entirety and confined the analysis to the products’ physical appearance. Decision/Status ‘Other Product’: It was held by the Ld. Magistrate that the items fell within the ambit of ‘other product’ as per s 106 of the Act. This finding was challenged by the accused in the appeal filed as a cross appeal. The Supreme Court was unable to accept the contentions raised by the accused. It was held that a construction of s 106 of the Act which resulted in its application to all products designed to resemble a tobacco product, advanced the purposes of the Act better than a narrow construction which confined it to products similar to food or toys. ‘Designed to resemble’: It was noted that this phrase in s 106 of the Act referred to a product which was intended to have a likeness or similarity to, or to have some feature in common with a tobacco product. Further, the provision was expressly directed to products which were not tobacco products. Whether the product was intended to have a likeness or similarity to, or common features with a tobacco product would be ascertained by taking into account all the features and essential characteristics of the product. The Magistrate’s Court erred in focusing only on the physical appearance of the items to ascertain whether the product was ‘designed to resemble’ a tobacco product under s 106 of the Act. The Court by placing reliance on the evidence of the accused came to the conclusion that the items were essentially elec- tronic inhalers that vaporize a liquid solution into a mist for inhalation, akin to smoke from a cigarette. Reliance was also placed on the user manual of the items where a comparison was drawn with cigarettes. The appeal was allowed and the decision to acquit the accused of the charge was set aside. Status: Decided | 10 April 2014 1 Supreme Court of Western Australia, Hawkins v Van Heerden, [2014] WASC 127, (https://www.tobaccocontrollaws.org/files/live/litigation/1754/AU_ Hawkins%20v.%20Van%20Heerden.pdf, accessed 15 September 2020) Case summaries 2 2. Australian Competition and Consumer Commission v The Joystick Company2 Facts Issue Arguments Advanced It was alleged that the Joystick Company Pty Ltd. (Joystick), in contravention of the provisions of the Australian Consumer Law (ACL), engaged in misleading or deceptive conduct for the sale of its e-cigarettes. Joystick represented on its website that the e-cigarettes: (a) did not contain carcino- gens and toxic substances; (b) did not contain any of the carcinogens and toxic substances found in traditional tobacco cigarettes; (c) did not contain Formaldehyde; and (d) all flavours had received approval from the Australian Competition and Consumer Commission (ACCC), when that was not the case. Alleged violation of the Australian Consumer Law. Joystick and Mr. McDonell (Director of Joystick) accepted the allegations and prayed for a consent order to be passed. Decision/Status Joystick and Mr. Alexander McDonell (Director of Joystick) were directed to pay $50,000 and $10,000 respectively. Further, Mr. McDonell gave an undertaking that for a period of three years he would not engage in the supply, possible supply, sale or promotion of e-cigarette products. Status: Decided | 2 May 2017 Similar Cases3: The Australian Competition and Consumer Commission (ACCC) filed similar complaints against Social- Lites Pty Ltd. and Burden. In both these cases, the companies accepted the allegations. The ACCC imposed penalties and restrained the companies from selling e-cigarettes similar to the Joystick case. 2 Federal Court of Australia, ACCC v The Joystick Company, [2017] FCA 397, (https://www.tobaccocontrollaws.org/files/live/litigation/2541/AU_Australian%20 Competition%20and%20Con.pdf, accessed 15 September 2020) 3 Federal Court of Australia ACCC v Social-Lites Pty Ltd., [2017] FCA 398, (https://www.tobaccocontrollaws.org/files/live/litigation/2542/AU_Australian%20 Competition%20and%20C n.pdf, accessed 15 July 2019) and ACCC v Burden, [2017] FCA 399, (https://www.tobaccocontrollaws.org/files/live/litigation/2543/ AU_Australian%20Competition%20and%20Con.pdf, accessed 15 July 2019) Case summaries 3 BRAZIL 1. Sinditabaco v ANVISA4 Facts Issue Arguments Advanced A Brazilian tobacco lobbying group, Sinditabaco, brought an action to stop the National Health Surveillance Agency, ANVISA, from implementing a rule to ban the use of additives and flavorings in cigarettes. Whether ANVISA had the legal authority to ban the use of addi- tives and flavourings in cigarettes? The group argued that ANVISA did not have the legal authority to make the rule and that the rule was not sup- ported by any scientific evidence as to the health effects of the flavorings. The group claimed the rule would affect over 95% of tobacco users and presented a petition signed by various stakeholders in the tobacco product supply chain claiming that it would cause billions of dollars of losses. The legal representatives of ANVISA were not present at the hearing on the issue. Decision/Status The court agreed to grant the preliminary injunction stopping the implementation of the rule, pending a hearing on the merits of the case.5 Status: Decided | 17 December 2012 2. National Confederation of Industry (Confederação Nacional da Indústria) v ANVISA6 Facts Issue Arguments Advanced In 2012, Brazil banned tobacco additives and flavors, with the exception of sugar. The National Confederation of Industry (Confederação Nacional da Indústria) challenged the ban. - - 4 Federal Court of the Federal District (Brazil), Sinditabaco v ANVISA, [2012] Decision No. 323-B/2012, (https://www.tobaccocontrollaws.org/files/live/ litigation/1098/BR_Sinditabaco%20v.%20ANVISA.pdf, accessed 25 July 2019) 5 Case summary is the original work of the Campaign for Tobacco-Free Kids and directly excerpted from the Tobacco Control Laws Database (https://www. tobaccocontrollaws.org/litigation/decisions/br-20121217-sinditabaco-v.-anvisa, accessed 29 July 2019) 6 Supreme Federal Court of Brazil, National Confederation of Industry (Confederação Nacional da Indústria) v ANVISA, [2018] Direct Action of Unconstitutionality (ADI) 4874, Unique Number: 9984745-20.2012.1.00.000, (https://www.tobaccocontrollaws.org/files/live/litigation/2634/BR_National%20Confederation%20of%20 Indu.pdf, accessed 26 July 2019) Case summaries 4 2. National Confederation of Industry (Confederação Nacional da Indústria) v ANVISA6 Decision/Status The Supreme Federal Tribunal, Brazil’s highest court, upheld the 2012 regulation and affirmed the Brazilian Health Regulatory Agency’s (ANVISA) right to regulate tobacco products. The court held that freedom of enterprise does not prevent Brazil from imposing conditions and limitations on private activities. The court found that while businesses have rights, they must be compatible with other fundamental and constitutional rights. In the case of tobacco control, these fundamental and constitutional rights include the right to health and the right to information. The court further held that the risks associated with tobacco consumption justify the tobacco market being subjected to intense health regulations. Because the court failed to reach a majority (5-5 tie), the decision is not binding on other tribunals, and, by not reaching a majority, the court rejected the constitutionality claim against the ANVISA regulation (“Resolução da Diretoria Colegiada da ANVISA 14/2012”).7 Although the decision is not binding because of a lack of quorum, it is unlikely that subsequent challenges to the regulation would be decided differently. Status: Decided | 1 February 2018 7 Case summary is the original work of the Campaign for Tobacco-Free Kids and directly excerpted from the Tobacco Control Laws Database (https://www. tobaccocontrollaws.org/litigation/decisions/br-20180201-national-confederation-of-indu, accessed 29 July 2019) Case summaries 5 CANADA 1. Zen Cigarette Inc. v Health Canada8 Facts Issue Arguments Advanced In 2011, the Inspectorate Program of Health Canada prohibited importation of Zen’s 200 cartridges, each with 18 mg of nicotine. The prohibition was based on the Food and Drug Regulations, under which it is stipulated that other than a practitioner, a drug manu- facturer, a wholesale druggist, a registered pharmacist, or a resident of a foreign country while a visitor in Canada, shall not import a Schedule ‘F’ drug. Nicotine is a drug identified in Schedule F of the Regulations. Zen oper- ates a business of selling electronic cigarettes and could not legally import and sell electron- ic cigarettes in Canada without an establish- ment licence. Aggrieved by the decision of Health Canada, Zen filed its application for judicial review. Whether Health Canada’s decision to prohibit the entry of electronic cigarettes imported by Zen is reasonable? Arguments advanced by Zen: (i) The electron- ic cigarettes fall under the exception set out in paragraph (d) of Schedule F because the electronic cigarette cartridges deliver 4 mg or less of nicotine per dosage unit; (ii) Electronic cigarettes are not a medicament and thus there is no dosage; (iii) With respect to electronic cig- arettes, the dosage unit should be the dosage delivered per inhalation which does not exceed 4 mg of nicotine. Thus it is submitted that Health Canada’s decision is ultra vires. Arguments advanced by Health Canada: (i) Electronic cigarettes contain nicotine, which modifies organic functions and thus falls under paragraph 2(b) of the Act; (ii) Further, as Zen’s website claims that electronic cigarettes may assist with tobacco cessation, it meets the definition of drug in paragraph 2(a) of the Act; (iii) Zen violated the Regulations because it did not obtain an establishment licence before importing its electronic cigarettes; (iv) The electronic cigarettes do not fall under excep- tion of ‘inhalation device delivering 4 mg or less of nicotine per dosage unit’ in paragraph (d) of Schedule F. Decision/Status Health Canada’s decision to prohibit the entry of electronic cigarettes imported by Zen was held as reasonable on the following grounds: (i) The evidence established that Zen promoted electronic cigarettes for the treatment of nicotine addiction and thus qualified as a drug under Section 2(a) of the Act; (ii) Further, electronic cigarettes are a drug under paragraph 2(b) of the Act because the evidence submitted clearly shows that nicotine modifies organic functions in human beings; (iii) No scientific evidence was produced by Zen to establish that the dosage unit fell under exception (d) of Schedule F of the Regulations; (iv) It was clear that Zen imported electronic cigarettes to sell them in Canada without an establishment licence. Status: Decided | 11 December 2012 8 Federal Court of Canada, Zen Cigarette Inc. v Health Canada, [2012] FC 1465 Case summaries 6 COLOMBIA 1. Director of CPI of SIC v Coltabaca S.A.S et al9 Facts Issue Arguments Advanced The Directorate of Consumer Protection Investigations under the Superintendence of Industry and Commerce initiated an investiga- tion about marketing of IQOS after receiving a complaint that a picnic festival in 2017 was sponsored by IQOS. A direction was sent to Coltabaco and Philip Morris Colombia to sup- ply information about advertising and market- ing plans for the product in Colombia. Whether the IQOS de- vice is subject to the publicity restrictions stipulated under Law No. 1335 of 2009 in Colombia? Submissions by Coltabaco and Philip Morris: (i) Studies prove that the aerosol generated from IQOS contains be- tween 90% and 95% less toxic components compared to the smoke generated by combustion of tobacco. (ii) IQOS is an electronic device and not subject to the authorization by Ministry of Salud. Further, pictograms and warnings issued by the Ministry of health are for cigarettes and not applicable to Heets (insert- ed into the IQOS device) because of different product characteristics. (iii) The company was present at the 2017 Picnic festival to sell IQOS and HEETS but did not sponsor the event. Submissions by the Attorney General’s office: (i) As Heets is a product made from tobacco leaf, it must comply with the norms contemplated in Law No. 1335 of 2009 (principal tobacco legisla- tion) and the pronouncements of the Constitutional Court with respect to publicity, promotion and sponsorship (judgment C-830 of 2010). (ii) Despite a national law that explicitly prohibits advertising, pro- motion and sponsorship of tobacco products, these rules have not been applied to IQOS as it openly advertises and promotes through various channels of communication to potential consumers. (iii) It was requested from the SIC to demand Coltabaco and PMI Colombia S.A to cease any type of advertising, promotion and spon- sorship of the IQOS product in the Colombia territory. Submissions by the Ministry of Health and Social Protection: (i) IQOS devices regardless of how they are turned on are covered by tobacco control legislation. The Ministry demanded that the label- ling and packaging requirements be complied for Heets but not the IQOS device. Decision/Status It was observed by the Directorate that in spite of the authority (article 12 of Decree 4886/2011) to investigate infractions of the provisions contained in the tobacco law (No. 1335 of 2009) and apply sanctions contained therein, the prohibitions with re- spect to advertising, promotion and sponsorship do not apply to the IQOS device as it is not a tobacco product or a derivative. In light of this reasoning, it was decided that IQOS escapes the scope of competence provided by the legislator under Law No. 1335 of 2009. Status: Decided | 27 December 2019 9 The Directorate of Consumer Protection Investigations of the Superintendence of Industry and Commerce (Colombia), Dir. of SIC v Coltabaco S.A.S et al., [2019] No. 17-82520—58-0, (https://www.tobaccocontrollaws.org/litigation/decisions/co-20191227-sic-decision-on-iqos-marketing, accessed 7 July 2020) Case summaries 7 EUROPEAN UNION 1. Pillbox 38 (UK) Ltd. v Secretary of State for Health10 Facts Issue Arguments Advanced Pillbox 38 (UK) Ltd., an e-cigarette manufacturer (Company), sought judicial review against the United Kingdom concerning its intention to implement the TPD into domestic law and claimed that the TPD was not valid. Article 20 of the TPD sets out require- ments for e-cigarettes for all EU Member States. The Company challenged the legality of Article 20 of the TPD. The UK court considered the arguments advanced by the Company as reasonable and referred the question of validity of Article 20 of the TPD to the Court of Justice of the European Union (CJEU). Whether Article 20 of the TPD violated prin- ciples of proportional- ity, legal certainty, and equal treatment? It was submitted that Article 20 of the TPD is invalid on the ground that its pro- visions infringe the principles of propor- tionality, legal certainty, equal treatment, free competition and subsidiarity. A viola- tion of Article 16 (freedom to conduct business) and 17 (right to property) of the Charter of Fundamental Rights of the EU was also alleged. Decision/Status It was concluded that no factor affected the legality of Article 20 of the TPD. Equal Treatment and free competition: It was argued that Article 20 subjects less favourable treatment for e-cigarettes compared to tobacco products, even though e-cigarettes are less harmful than tobacco products. In this regard, the Court highlighted that e-cigarettes display different objective characteristics than tobacco products. Firstly, e-cigarettes are used for the consumption of nicotine. Secondly, their consumption does not require combustion but takes place through a function of electrical or electrochem- ical vaporization of the liquid contained in the refill containers. Thirdly, e-cigarettes are relatively new products whose risks to human health still need to be clarified. Accordingly, e-cigarettes are not in the same situation as tobacco products. Thus, the EU legislature has not infringed the principle of equal treatment. Proportionality and Legal Certainty: In light of mixed evidence on the risks posed by e-cigarettes, it was held that application of the requirements was propor- tional and justified. The specific rules ensured smooth functioning of the internal market, albeit adopting a high level of protection for human health. Violation of Article 16 and 17 of the EU Charter: Article 16 of the Charter offers the freedom to exercise an economic or commercial activity. The issue is whether the pro- hibition on commercial communications as stipulated under Article 20(5) of the TPD interferes with the Company’s right under Article 16 of the Charter. It was held that Article 20(5) was proportional and did not affect the Company’s right to conduct business. Article 17 of the Charter relates to the right of intellectual property. It was concluded that Article 20 of the TPD did not in any way hinder the use of intellectual property in connection with the marketing of the products. Status: Decided | 4 May 2016 10 Court of Justice of the European Union (CJEU), Pillbox 38 (UK) Ltd. v Secretary of Sate for Health, [2016] Case C-477/14, (https://www.tobaccocontrollaws.org/ files/live/litigation/2458/EU_Pillbox%2038%20%28UK%29%20Ltd.%20v.%20Secret.pdf, accessed 14 September 2020) Case summaries 8 2. Republic of Poland v European Parliament & Council of the European Union11 Facts Issue Arguments Advanced The Republic of Poland challenged provisions of the European Union (EU) Tobacco Products Directive (TPD) that pro- hibit the sale of menthol and other flavored ciga- rettes by member states as of May 2020. Whether mentholat- ed tobacco products enjoy a special status compared to other tobacco products with a characterising flavour? Arguments advanced by the Republic of Poland: It was submitted that the EU legislature should have distinguished products con- taining menthol from those with other characterizing flavors for the following reasons: (i) the long-established presence of products containing menthol gave them a ‘traditional’ nature; (ii) menthol products have different qualities as it does not completely eliminate the taste and smell of tobacco; (iii) not as attractive to young people as other tobacco products with a characterizing flavor. Further, it was argued that the EU legislature should have examined other less restrictive measures, such as raising the age limits for mentholated products, prohibition of cross-border sales and a warning stating that those products are as harmful as other tobacco products. Arguments advanced by the Parliament, the Council and the Commission: It was submitted that the concept of ‘characterizing flavour’ is defined in a general and abstract manner to allow Member States to identify products with such flavouring, in accordance with the criteria set out in the EU TPD. It was argued that none of the less restrictive measures advocated by the Republic of Poland are likely to be as effective in achieving the objective sought. Decision/Status The Court upheld the validity of the alleged provisions of the EU TPD for the following reasons: Provisions of the TFEU: It was noted that the EU Legislature was authorized under Article 114 of the TFEU to intervene and take appropriate mea- sures when Member States are about to take, divergent measures with respect to a product or a class of products. Menthol and other characterizing flavors: Tobacco products whether menthol or another flavouring, have similar objectives as regards initiating tobacco consump- tion and sustaining its use. The fact that mentholated tobacco products are a ‘traditional’ product does not alter the finding that their objective characteristics are similar to other tobacco products. The claim that menthol was not as attractive to young people was not found to be conclusive. The underlying utility of all flavouring is that they mask or reduce tobacco smoke’s harshness. Principle of proportionality: It was held that the prohibition was appropriate for ensuring a high level of protection of human health, especially for young people. The less restrictive measures do not appear to be equally suitable for achieving the objective pursued. Status: Decided | 4 May 2016 11 Court of Justice of the European Union (CJEU), Republic of Poland v European Parliament & Council of the European Union, [2016] Case-358/14, (https://www.tobaccocontrollaws.org/files/live/litigation/2456/EU_Republic%20of%20Poland%20v.%20European.pdf, accessed 14 September 2020) Case summaries 9 3. R (on the application of) Philip Morris Brands SARL v Secretary of State for Health12 Facts Issue Arguments Advanced Philip Morris (PMI) and British American Tobacco (BAT) initiated proceedings against the Secretary of Health, United Kingdom, challenging the validity of a number of provisions of the EU TPD and their transposition into national law. It was submitted that the EU TPD infringed provisions of the Treaty on the Functioning of the European Union (TFEU) and the Charter of Fundamental Rights of the European Union. The High Court of Justice of England and Wales found these arguments ‘reasonably argu- able’ and referred questions to the CJEU for a preliminary hearing. [This summary is limited to the challenge raised with respect to the prohibition of menthol cigarettes and tobacco products with a characterizing flavor]. Whether Article 7 of the EU TPD which pro- hibits Members States to place tobacco prod- ucts on the market with a characterizing flavour was valid or not? Arguments advanced by PMI and BAT: It was argued that the directive is invalid as it violated provisions of the TFEU, the Charter and principles of proportionality. Decision/Status It was noted that the EU legislature adopted uniform rules for all tobacco products containing a characterizing flavor, as these products could facilitate initiation of tobacco consumption or affect consumption patterns. Further, the EU legislature took into account the Partial Guidelines for implementation of Articles 9 and 10 of the FCTC, which called out for the removal of ingredients that increase palatability of tobacco products. The impact assessment for the EU TPD reflected that there were significant discrepancies between the regulatory regimes of the member states and each had established different lists of permitted or prohibited flavorings. Thus, in the absence of measures at EU level, the relevant national rules could develop in divergent ways, including with regard to the use of menthol, and create obstacles to the free movement of goods. Accordingly, no factor affected the validity of Article 7 of the TPD. On the ground of proportionality, it was held that a high level of protection for human health was appropriate, and partic- ularly in the case for young people. The argument that menthol was not attractive to young people was not tenable. It was concluded that the objective of protection could not be called into question solely with respect to a particular flavoring. Thus, the prohibition laid down in Article 7 cannot be regarded as manifestly inappropriate for achieving smooth function- ing of the internal market for tobacco and related products. Notably, the EU legislature weighed the economic consequences of the prohibition against a high level of protection for human health, and sought to give the tobacco industry and consumers time to adapt. This ensured that the impact of the prohibition was not disproportionate. Status: Decided | 4 May 2016 12 Court of Justice of the European Union (CJEU), The Queen on the Application of Philip Morris Brands SARL et al. v. Secretary of State for Health, [2016] Case C-547/14, (https://www.tobaccocontrollaws.org/files/live/litigation/2457/EU_R%20%28on%20the%20Application%20of%29%20Phil.pdf, accessed 25 July 2019) Case summaries 10 4. Swedish Match AB v Secretary of State for Health13 Facts Issue Arguments Advanced The 2014 EU Tobacco Products Directive obliges EU Member States to prohibit tobacco for oral use, in- cluding snus. Sweden is exempt from this obligation, as is Norway, which is not an EU Member States, but implements the EU TPD as part of the European Economic Area. In Case C-151/17 Swedish Match, challenged the ban despite the fact an earlier ban been found valid in an earlier case (C-210/03). The 2017 challenge was presented in light of new evi- dence on the harmfulness of snus from Sweden and Norway, as well as the introduction of electronic nic- otine delivery systems (ENDS), such as e-cigarettes, and other novel tobacco products into the EU. Whether the pro- hibition on suns violated principles of equal treatment and proportionality? Swedish Match argued that the prohi- bition on snus violated the principle of equal treatment i.e. that comparable situations must not be treated differently unless objectively justified. The company argued that this principle was violated because other smokeless products, ciga- rettes, ENDS and novel tobacco products were permitted on the market. It was also argued that the obligation to prohibit snus was invalid as it violated the principle of proportionality. Decision/Status The European Court of Justice (ECJ) rejected this argument, concluding that the: (i) evidence suggests snus would be attractive to young people and has considerable potential for market expansion, thereby justifying different treatment from cigarettes and smokeless products; (ii) objective characteristics of ENDS differ from tobacco products, justifying different treatment; and (iii) effects of novel tobacco products on health could not be observed when the EU TPD was adopted, whereas the effects of snus had been scientifically substantiated; (iv) The prohibition was not manifestly inappropriate. The Court noted the relevance of the precautionary principle and based its conclusion partly on the risk that the attractiveness of snus to young people might create a gateway effect. Having rejected the argument concerning equal treatment, the court also rejected the argument that the different treat- ment of other products showed the prohibition on snus to be disproportionate. Status: Decided | 22 November 2018 13 Court of Justice of the European Union (CJEU), Swedish Match AB v Secretary of State for Health, [2018] Case C-151/17, (http://curia.europa.eu/juris/celex. jsf?celex=62017CJ0151&lang1=en&type=TXT&ancre=, accessed 14 September 2020) Case summaries 11 5. Planta Tabak-Manufaktur Dr. Manfred Obermann GmbH & Co. KG v Land Berlin14 Facts Issue Arguments Advanced Planta Tabak, manufactures and markets tobacco products, in particular flavoured roll-your-own tobacco. After Germany transposed the EU TPD into its national law (The Gesetz über Tabakerzeugnisse und verwandte Erzeugnisse/Law on Tobacco products and related products), Planta Tabak filed an application seeking a declaration that certain provisions of the new law, were not applicable to its products. The referring court found merit in Planta Tabak’s ar- guments, in particular, with respect to Article 7(14) of the EU TPD, which states that manufacturers of flavored tobacco products with an EU-wide sales volume of 3% or more in a particular product cate- gory were given until May 2020 to comply with the ban on flavorings, while manufacturers of flavored products with a smaller sales volume were required to comply as of May 2016. It was observed that the tobacco manufacturers were not in a position to obtain information on sales volumes at EU level, and this created uncertainty about the application of the prohibition. Whether Article 7 of the EU TPD violat- ed the principle of legal certainty and proportionality? Arguments advanced by Planta Tabak: It was argued that Article 7(1) and 7(7) [prohibition of flavourings in tobacco products] of the EU TPD infringed pri- mary EU law, in particular the princi- ples of legal certainty, equal treatment and proportionality. Decision/Status The Court held that Article 7(14) does not infringe the principle of legal certainty. It was noted that it was for the member states to choose a reliable method capable of ensuring compliance with the requirement. While the Court admitted that the ban was a restriction on the EU’s free movement of goods, “it was justified by the balancing of its economic conse- quences against the requirement to ensure a high level of protection of human health.” The difference in treatment of products based on sales volume was intended to give consumers adequate time to switch to other products and was, therefore, objectively justified.  Status: Decided | 30 January 2019 14 Court of Justice of the European Union (CJEU), Planta Tabak-Manufaktur Dr. Manfred Obermann GmbH & Co. KG v Land Berlin, [2019] Case C-220/17, (https://www.tobaccocontrollaws.org/files/live/litigation/2653/EU_Planta%20Tabak-Manufaktur%20Dr.%20Ma.pdf, accessed 25 July 2019) Case summaries 12 FINLAND 1. SKA Liquids Case15 Facts Issue Arguments Advanced The City of Kotka Environmental Board, pursuant to s. 96 of the Tobacco Act, prohibited the sale of fla- vouring liquids (including food flavorings) to be sold in vape shops. This prohibition was challenged by a nicotine-free liquid manufacturer before the Finland Administrative Court. It was contended by the manu- facturer that the prohibition violates EU law. What are the nico- tine-free e-liquids with a characteristic taste that can be prohibited under the Tobacco Act? Whether a ban on the sale of food through a particular sales channel could be justified under EU law? Arguments advanced by the manu- facturer/distributor: It was argued by the manufacturer that food flavour concentrates did not fall within the ambit of Article 2(20) of the Tobacco Act i.e. nicotine free e-liquid. The flavour concentrates at issue are used, inter alia, in confectioneries and in flavouring lem- onades. Moreover, it was pointed out that these products were commonly available in grocery stores. Arguments advanced by the City Board: In a speciality cigarette shop, the flavour- ing liquid is subject to the provisions of the Tobacco Act because of its likely use, despite the fact that flavouring liquids are marketed for use in food baking. Decision/Status The Court held that food flavorings and flavorings prohibited for sale in the vape shops are nicotine-free liquids, suitable for use as food as well as vaporization. Thereby, the City of Kotka Board had the legitimate authority to prohibit the shop from selling such liquids. Status: Decided | 15 May 2019 Aggrieved, SKA Liquids filed an appeal against this decision. The Supreme Administrative Court16 held that Finland’s Ministry of Employment and Economy’s failed to notify the EU Commission with the final text of the regulation of nico- tine-free liquids and flavourings of electronic cigarettes. Section 25 of the Tobacco Act, which prohibits characterizing flavour or aroma for nicotine-free liquids intended for vaporisation is a technical regulation which had not been notified to the Commission in accordance with Article 5 (3) of the Technical Regulations Directive (2015/1535 / EU). Thus, it was held by the Supreme Administrative Court that section 25 of the Tobacco Act is not applicable to SKA Liquids Oy and annulled the decision of the lower Court. Status: Decided | 24 June 2020 15 ITA Finland Administrative Court, 19/0482/1, [2019] 16 Supreme Administrative Court of Finland, KHO:2020:77, (https://www.kho.fi/fi/index/paatokset/vuosikirjapaatokset/1592891459008.html, accessed 3 November 2020) Case summaries 13 2. Striker Finland Oy17 Facts Issue Arguments Advanced The Health Inspectorate of the City of Pori prohibited the sale of nicotine free liquids for vaporisation in the Scandi Vape electric cigarette shop of Striker Finland (Company). The Environmental Health Division ordered the Company to comply with the decision of the health inspector and to remove liquids, a penalty of EUR 5,000 was also imposed on the Company. The Company challenged this prohibi- tion before the Administrative Court of Turku. Whether food flavour- ing can be regarded as nicotine-free liquids for evaporation within the meaning of the Tobacco Act? Whether a ban on the sale of nicotine free liquids could be enforced on the basis of the location of the sale of the product? Arguments advanced by the Company: It was submitted that the ban on flavour- ings in the Tobacco Act did not cover food flavourings sold in the company’s store for e-cigarettes. The flavour con- centrates sold in the shops are not in- tended to be vaporised and not marketed for such use. Further, the regulation of the tobacco law is contrary to the free- dom of movement provided for in Article 24 of the EU TPD. Prohibitions should be in accordance with the principle of proportionality and not be a means for arbitrary discrimination or a disguised restriction on trade between member States. Decision/Status The Administrative Court noted that the issue at hand required a substantive interpretation of the national rule on flavour- ings for e-cigarettes contained in the Tobacco Act and a reference for preliminary ruling on the interpretation of European Union law was not necessary to resolve the case. It was noted that the Company’s store is a specialty store within the meaning of section 71 (2) of the Tobacco Act, which specializes in e-cigarettes and nicotine liquids. If the sale of flavorings takes place in such a specialty store, it must be considered probable, on the basis of the store’s product range, that the consumer considers that the flavorings on sale are suitable for vaporization by means of an e-cigarette. It was held that the decision of the Environmental Health Division was not contrary to the principle of proportionality and does not discriminate against the Company. Status: Appeal Pending | 20 December 2019 17 Decision of the Administrative Court of Turku, 19/0345/1, [2019] Case summaries 14 3. Salon Höyry Oy18 Facts Issue Arguments Advanced The Construction and Environment Board in the City of Salo prohibited Salon Höyry (company) from selling or otherwise disposing various liquids with characterizing flavours that can be used by mixing with other liquids. Whether food flavour- ing can be regarded as nicotine-free liquids for evaporation within the meaning of the Tobacco Act? Arguments advanced by the Company: The interpretation of the Tobacco Act by the Environment Board broadens the scope of the Tobacco Act and infring- es the principle of legal certainty. The prohibition of characteristic odor or taste applies only to liquids intended for vaporisation. Food flavourings and e-cigarette products are also sold at the same point of sale in grocery stores and online stores. Decision/Status According to the inspection report of the Environment Board, the sales list available to customers describes the taste of those liquids as follows, inter alia: ‘vanilla light cigar’; ‘cool mint tobacco’; Psycho Flavors - “soft cigar flavor with a hint of cherry”. The descriptions of these liquids suggest that they are intended to be nicotine-free flavours for vaporization. The Court noted that Section 25 in conjunction with Section 24 (1) and Section 11 (1) of the Tobacco Act required that a nicotine-free liquid with a characteristic odor or taste may not be sold or otherwise disposed of to the consumer. It was held that the permissibility of sale of the liquid food flavour concentrates was to be assessed based on the condi- tions and context of supply of the products. In a specialty e-cigarette shop, as food flavours could be used as a flavour for e-cigarettes, sale was prohibited. The decision of the Environment Board was upheld. Status: Decided | 20 March 2020 18 Decision of the Administrative Court of Turku, 20/0056/1, [2020] Case summaries 15 GERMANY 1. Menthol Capsule Case19 Facts Issue Arguments Advanced The Plaintiff, a tobacco product manufacturer in- tended to market a cigarette in Germany which con- tained menthol flavoring embedded in the capsule of the cigarette filter (product). Among other things, the capsule contained, gelatin, gellan gum, sorbitol, glycerin, sodium citrate, brilliant blue, FCF, tar- tazine and medium-chain triglycerides. The German Preliminary Tobacco Act (Act) does not approve of these substances as additives for cigarette filters. The Plaintiff filed a petition before the Federal Office of Consumer Protection and Food Safety (agency) to issue a general decree under s 47a of the Act for the import and marketing of these cigarettes. The petition was rejected on the ground that menthol would soften the unpleasant properties of tobacco smoke and thus lead to increased consumption. The Plaintiff objected to this decision by the agency and argued that the product was not a novelty but a further development of menthol cigarettes already being sold in the German market. Aggrieved, the Plaintiff filed a suit to challenge the decision of the agency. Whether the menthol capsule embedded in the cigarette filter complied with the tobacco legislation of Germany and should be authorized to be imported? The Plaintiff argued that the product delivered the same menthol transfer ef- ficiency as traditional menthol cigarettes and was not a novel or different product. Decision/Status The Court upheld the agency’s decision. It was held that in order to protect consumer health, there were compelling rea- sons to reject the Plaintiff’s request. The contents of the product do not comply with the tobacco regulations in Germany. It was noted that there was information that the product showed greater harmfulness or risk addiction compared to tra- ditional cigarettes. It was also highlighted that the attractiveness of smoking the product was significantly increased with the new capsule technology, and thus violated the WHO Framework Convention on Tobacco Control (FCTC). Status: Decided | 26 September 2012 19 Chamber of the Administrative Court (Germany), Menthol Capsule Case, [2012] File Number 5A 206/11, (https://www.tobaccocontrollaws.org/files/live/ litigation/2267/DE_Menthol%20Capsule%20Case.pdf, accessed 25 July 2019) Case summaries 16 INDIA 1. Ankur Gutkha v Indian Asthma care Society & Ors.20 21 Facts Issue Arguments Advanced Ankur Gutkha appealed against a High Court deci- sion in which the Indian Asthma Society sought to ban the sale of gutkha and prohibit the use of plastic sachet packaging for gutkha. - - Decision/Status The Supreme Court, among other things, restrained gutkha, tobacco, and pan masala manufacturers from using plastic materials in the sachets of their products and requested that a study be conducted on the harmful effects of gutkha tobac- co, pan masala and similar articles. Status: Pending (Motion hearing) 2. Yadav et al. v State of Bihar22 Facts Issue Arguments Advanced The Petitioner is a distributor of Pan Masala, Gutka and Zarda (products). This case challenged the notification issued by the Commissioner of Food Safety in the State of Bihar, to prohibit manufacture, store, sell, or distribute products containing tobacco or nicotine. Whether the Commissioner of Food Safety was empow- ered to issue the impugned notification? The Petitioner alleged that the no- tification violated Article 14 of the Constitution, as it imposed restrictions only on Gutka and Paan Masala con- taining tobacco or nicotine but excluded other harmful tobacco products. Decision/Status The Court noted that the notification by the Commissioner of Food Safety was within the provisions of the Food Act, and it was within the Commissioner’s discretion to choose products that were to be brought within the purview of the ban. No error was found in the exercise of power by the Commissioner of Food. Status: Decided | 10 July 2012 20 Supreme Court of India, Ankur Gutkha v Indian Asthama Care Society and Ors., [2010] SLP(C) No. 16308/2007, (https://www.tobaccocontrollaws.org/files/live/ litigation/237/IN_Ankur%20Gutkha%20v.%20Indian%20Asthama.pdf, accessed 22 July 2019) 21 See also Supreme Court of India, Ankur Gutkha v Indian Asthama Care Society and Ors, [2013] SLP(C) No. 16308/2007, (https://www.tobaccocontrollaws.org/ files/live/litigation/1523/IN_Ankur%20Gutkha%20v.%20India%20Asthma%20C.pdf, accessed 17 September 2020) 22 High Court of Patna, Yadav v State of Bihar, [2012] No. 10297, https://www.tobaccocontrollaws.org/files/live/litigation/903/IN_Yadav%20et%20al.%20v.%20 State%20of%20Bihar.pdf Case summaries 17 3. S.J.J Exports Company v Food Safety Commissioner23 Facts Issue Arguments Advanced The Petitioner (an exporter), through this petition chal- lenged a notification dated 19 July 2012 (prohibited the manufacture, storage, distribution or sale of Pan Masala and Gutkha) issued by the Commissioner of Food Safety, State of Maharashtra, and an order by the Assistant Commissioner which called upon the Superintendent of Customs not to allow any consignments of gutka or pan Masala for export and import. Petitioner’s boxes contain- ing gutka sachets were seized by Customs Officers. The Petitioner prayed for directions to quash and set aside the seizure of goods. Whether the 19 July prohibition was only for domestic sales or whether it was also applicable to exports? The Petitioner argued that notification dated 19 July 2012 only prohibited do- mestic distribution and sale of gutka and pan masala, and did not extend to the export of these goods. Decision/Status The details of the goods confiscated reflected that the consignment was not manufactured for export. In fact, the Petitioner did not possess the license for exporting gutka. The Court held that merely because s 3(n) of the Food Act did not refer to export, it did not mean that the Act and the regulations were not intended to regulate the export of food items of this nature. Status: Decided | 21 January 2013 4. Ghodawat Pan Masala v State of Karnataka24 Facts Issue Arguments Advanced The Petitioners are manufacturers of tobacco products, particularly Pan Masala. The Petitioners are aggrieved by Regulation 2.3.4 of the Food Safety and Standard (Prohibition and Restriction on Sales) Regulations 2011, which stated that tobacco and nicotine shall not be used as ingredients in any food prod- ucts. On the other hand, s 7(5) of COTPA permitted use of tobacco or nicotine in any tobacco products. Whether the Commissioner had the authority to issue regulations for Pan Masala which is a sched- uled product under the Cigarette and other Tobacco products (Prohibition of Advertisement and Regulation of Trade and Commerce Production, Supply and Distribution) Act, 2003 (COTPA)? It was argued that the COTPA is a comprehensive law on tobacco and the Commissioner of Food Safety was not empowered to pass any order or notification which conflicted with its provisions. 23 High Court of Judicature at Bombay, S.J.J. Exports Company v Food Safety Commissioner, [2013] W.P. No. 2266 of 2012, (https://www.tobaccocontrollaws.org/ files/live/litigation/1657/IN_S.J.J.%20Exports%20Company%20v.%20Food.pdf, accessed 11 July 2019) 24 High Court of Karnataka, Ghodawat Pan Masala v State of Karnataka, [2013] Writ Petition No. 78378-78380 (https://www.tobaccocontrollaws.org/files/live/ litigation/1641/IN_Ghodawat%20Pan%20Masala%20v.%20State%20o.pdf, accessed 10 July 2019) Case summaries 18 4. Ghodawat Pan Masala v State of Karnataka24 Decision/Status It was noted that s 3(1)(j) of the Food Act defined the term ‘food’ and this would undoubtedly include Pan Masala and gutka. Even though, COTPA deals with tobacco and other tobacco products, the Food Act deals with food and other items which includes Pan Masala and Gutka. Further, the Court placed reliance on s 89 of the Food Act, which gives overriding effect to the provisions of the Food Act. Thus, the Food Authority was competent to issue regulations under s 92 of the Food Act. Status: Decided | 25 June 2013 5. M/s Omkar Agency & Ors. v Food Safety & Standards Authority of India25 Facts Issue Arguments Advanced The Petitioners are manufacturers of tobacco products, such as Pan Masala and Zarda (products), and challenged the authority of the Commissioner of Food Safety (Commissioner) to prohibit the manu- facture, storage, distribution or sale of Zarda, Pan Masala and Gutkha. The Commissioner passed this order under Section 30(a) of the Food Safety and Standards Act 2006 (Food Act), which states: “The Commissioner of Food Safety shall perform all or any of the following functions, namely: (a) prohibit in the interest of public health, the man- ufacture, storage, distribution or sale of any article of food, either in the whole of the State or any area or part thereof for such period, not exceeding one year, as may be specified in the order notified in this behalf in the Official Gazette” The core issue in this case was the inher- ent inconsistency between the Food Act and Cigarette and other Tobacco products (Prohibition of Advertisement and Regulation of Trade and Commerce Production, Supply and Distribution) Act, 2003 (COTPA). Also, whether the Commissioner had the authority under s 30 of the Food Act to prohibit manufacture, sale, and production of products. The main ground of challenge was that the prohibition was not permissible as the products were permitted for sale under India’s omnibus tobacco control law, COTPA. The Petitioners also alleged that they were not food business operators under the Food Act and were not required to submit to the Act’s requirements. 25 High Court of Patna, M/s Omkar Agency & Ors. v Food Safety & Standards Authority of India, [2015] Civil Writ Jurisdiction Case No. 3805 (https://www.tobaccocontrollaws.org/files/live/litigation/2493/IN_M_s%20Omkar%20Agency%20v.%20Food%20Safet.pdf, accessed 26 July 2019) Case summaries 19 5. M/s Omkar Agency & Ors. v Food Safety & Standards Authority of India25 Decision/Status The Court set aside and quashed the order of prohibition passed by the Commissioner, for the following reasons: i. Scope of Power of the Food Commissioner under Section 30 of the Food Act The Court examined the provisions and framework of the Food Act and concluded that an order to prohibit Pan Masala could only be passed if objective evidence was found that a particular brand was not conforming to standards. It was not permissible to ban all brands of Pan Masala by a blanket order. Notably, s 30(a) stipulates a maximum period of one year for prohibition. It was noted that the Commissioner had issued notifications (dated 7.11.2014 and 06.11.2015) from time to time which resulted in exceeding this period and amounted to an arbitrary exercise of power. ii. Applicable Law: Food Act or COTPA To answer this question, the Court examined whether tobacco would classify as ‘food’. It was noted that the Food Products Standards and Food Additives Regulations 2011 did not define tobacco. The Supreme Court in ITC Ltd. V. Agricultural Produce Market Committee (2002) 9 SCC 232 also held that tobacco is not a foodstuff. Accordingly, it was held that COTPA is the exclusive law which dealt with tobacco products. Only Regulations which prohibited mixing food with tobacco could be passed under the Food Act. Status: Decided | 19 July 2016 6. Central Arecanut Marketing Co. v Union of India26 Facts Issue Arguments Advanced As observed from the above cases, 23 states and 5 Union Territories in India had prohibited the manufacture and sale of Gutka and Pan Masala with tobacco or nicotine under the Food Act. Different manufacturers across the country challenged this ban, and eventually transfer petitions were filed for transferring these cases to the Supreme Court. The Ministry of Health & Family Welfare submitted be- fore the Supreme Court that in order to circumvent the ban, manufacturers were selling Pan Masala (without tobacco) along with flavoured chewing tobacco in separate sachets. Essentially, instead of ready to consume mixes, chewing tobacco compa- nies were selling the product in twin packs to be mixed as one. The central question in these petitions is whether there is any inherent consistency between the provi- sions of the Food Act and the COTPA. - 26 The Supreme Court of India, Central Arecanut Co. & Ors. v Union of India, [2010] Transfer Case (Civil)/Diary No. 60005/2010, (https://www.tobaccocontrollaws. org/files/live/litigation/2620/IN_Central%20Arecanut%20Marketing%20Com.pdf, accessed 30 June 2019) Case summaries 20 6. Central Arecanut Marketing Co. v Union of India26 Decision/Status The Supreme Court directed that representatives of the States and Union Territories that had not prohibited the manufacture and sale of such smokeless products to indicate why no action had been taken. The Court also directed that all States and Union Territories representatives file affidavits regarding their total compliance with the ban before the next date of hearing. Order date: 23 September 2016 Status: Pending 7. M/s Focus Brands & Anr. v Directorate General of Health Services and Ors.27 Piyush Ahluwalia v Union of India (W.P (C) 2735/2019) Litejoy International Pvt. Ltd. v Union of India & Ors. (W.P.(C) 2351/2019) Facts Issue Arguments Advanced An advisory was issued by the Ministry of Health & Family Welfare (MoH) in August 2018 to States/Union Territories to ensure that Electronic Nicotine Delivery systems (ENDS) including e-cigarettes, heat-not burn devices, vape, e-sheesha, e-nicotine flavored hookah, and the like devices that enable nicotine delivery are not sold (including online sale), manufactured, distributed, traded, imported and advertised in their jurisdictions, except for the purpose and in the manner and to the extent, as may be approved under the Drugs and Cosmetics Act 1940 and Rules made thereunder. In connection therewith, a circular dated 27.11.18 was issued to all the Customs Authorities to ensure that the advisory issued by MoH was implement- ed for all import consignments of ENDS. The Petitioners filed writ petitions before the High Court of Delhi against the advisory and communication dated 27.11.18. Whether ENDS qualifies as a ‘drug’ under the Drugs and Cosmetics Act? The Petitioners contended that ENDS, including e-cigarettes are substitutes to smoking combustible cigarettes. It was also argued that these prod- ucts are healthier than combustible cigarettes and could be used as a replacement therapy. Decision/Status Relevant Order: After a plain reading of s 3(b) of the Drugs and Cosmetics Act, the Court was of the opinion that the prod- ucts do not fall within the definition of ‘drug’ and stayed the advisory and communication. In September, 2019, the Central Government promulgated an ordinance to prohibit electronic cigarettes. Thereafter, the Petitioners withdrew the petition with liberty to file afresh and challenge the ordinance. Status: Decided | 18 March 2019 27 The High Court of Delhi, M/s Focus Brands v Directorate of Health Services and Ors, [2019] Writ Petition (Civil) 2688/2019, (http://delhihighcourt.nic.in/ dhcqrydisp_o.asp?pn=60136&yr=2019, accessed 3 May 2019) Case summaries 21 8. Plume Vapour Pvt. Ltd. & Anr. v Union of India28 M/s Woke Vapors Pvt. Ltd. v Union of India Facts Issue Arguments Advanced The two writ petitions were filed to challenge the ordinance passed by the Central Government to ban production, manufacture, import, export, transport, sale, distribu- tion, storage and advertisement of e-cigarettes. Whether the ordi- nance infringes the right of a user to choose a less harm- ful alternative (i.e. ENDS) compared to combustible tobacco cigarettes? The Petitioners prayed for an interim measure claim- ing that e-cigarettes are less harmful than combustible tobacco. In fact, it was emphasized that ENDS could be a method to aid existing smokers to quit smoking. It was contended that a verbal imagery was being drawn to attach fear to the product through the ordinance. It was also submitted that the executive action was manifestly arbitrary, disproportionate and excessive. The Government submitted that there were materials ne- cessitating issuance of the ordinance due to the growing popularity of e-cigarettes across the country. Attempts to classify the chemicals in e-cigarettes as drugs had been stayed by judicial intervention. Further, it was submitted that in the upcoming session of Parliament the ordinance would be taken up for discussion. Decision/Status The Court noted that the Bill passed scrutiny before both Houses, to become an Act of Parliament. In the circumstances, nothing remained for adjudication in the writ petitions and they were dismissed. Status: Decided | 12 December 2019 28 The High Court of Calcutta, Plume Vapour Private Ltd. & Anr. v Union of India & Ors. and M/s Woke Vapors Pvt. Ltd. v Union of India & Ors., [2019] A.S.T 40 and 41, (https://www.calcuttahighcourt.gov.in/Order-Judgment-PDF/A/AST_40_2019_26092019_O_239.pdf, accessed 3 October 2019) Case summaries 22 ISRAEL 1. E-Cig Ltd. v Ministry of Health29 Facts Issue Arguments Advanced In April 2012, the Petitioner Company wished to import and market electronic cigarettes and related products in Israel. Under Chapter F of the Pharmacists Ordinance (Ordinance), a product containing nicotine intended for swallowing, suck- ing, chewing or inhaling, could not be marketed in Israel without proper registration. The Petitioner Company approached the Director-General of the Ministry of Health and the Director of Pharmacy in the Ministry (Respondents), to request permission to import electronic cigarettes and related products. The request was rejected on the ground that it was prohibited to import or market nicotine-containing electronic cigarettes “unless the efficacy and safety of the product was proven, and nicotine was record- ed as an ingredient in the order”. Aggrieved by the rejection of this request, the Petitioner Company filed a petition before the Supreme Court. Whether the Respondents had the authority to prohibit the import and mar- keting of electronic cigarettes on the basis of the provisions of the Ordinance. The government submitted that the Ministry had the power to supervise electronic cigarettes in accordance with the provisions of Chapter G of the Ordinance. Also, in the interest of public health, the prohibition on the import and marketing of electronic cigarettes was justified. To this extent, the Ministry had initiated the process to implement the prohibition by passing new legislation. In light of this, it was prayed that the Court would refrain from ruling on the petition and grant additional time for the comple- tion of the legislative process. Decision/Status The Court examined the provisions of the Ordinance and held that its provisions were designed to protect public health from unprofessional or careless treatment of drugs and their constituent substances. The Ordinance regulated the profes- sion of pharmacy and limits of its activity. Chapter VII titled ‘Consumer Goods’ was added to the Ordinance by an amend- ment in 1993. This authorized the Minister of Health to impose control over consumer goods in order to prevent health risks from consumer products containing toxic substances (discovery of nitrosamines in the pacifiers). It was held that the Respondent’s decision to ban import of electronic cigarettes based on the provision of Chapter VII, and in particular s 49 of the Ordinance, was without any authority. It was also observed that the Respondents’ decision signifi- cantly restricted the Petitioner’s freedom of occupation. The Petitioner’s petition was allowed, and Respondents’ were directed to bear the Petitioner’s expenses. Status: Decided | 3 December 2014 29 The Israel Supreme Court, E-Cig Ltd. v Ministry of Health, [2014] HCJ 6665/12, (https://www.tobaccocontrollaws.org/files/live/litigation/2217/IL_E-Cig%20 Ltd.%20v.%20Ministry%20of%20Heal.pdf, accessed 16 September 2020) Case summaries 23 2. Smoke Free-Israel v Ministry of Health (High Court 2951/19)30 Tel Aviv Chamber of Commerce (High Court 4657/19) Juul Labs (High Court 1532/19) Facts Issue Arguments Advanced The three Petitioners in these cases challenged provisions of the Restriction of Advertising and mar- keting of Tobacco Products Law (Amendment No. 7). This law stipulated restrictions and prohibition on the advertising of electronic cigarettes. Juul Labs Inc. filed three lawsuits against the legislation: (i) August 2018: Against the injunction prohibiting the marketing of electronic cigarettes with nicotine concentrations above 20 milligrams per millilitre; (ii) January 2019 - against regulations under the Pharmacy Ordinance prohibiting the marketing of electronic cigarettes with nicotine concentrations above 20 milligrams per millilitre; (iii) February 2019 - against the Prohibition of Advertising and Restriction of Marketing of Tobacco and Smoking Law, with reference to all sections of the law relating to electronic cigarettes, including the section prohibiting the marketing of electronic cigarettes with nicotine concentrations above 20 milligrams per millilitre. Whether tobacco related restrictions could be extended to ENDS? The importers argued that there was a difference between tobacco products and electronic cigarettes, the latter category of products had a harm reduction poten- tial and required a separate legislation. Decision/Status JUUL Labs withdrew the petition a few days before the hearing. After a consultation, the Tel Aviv Chamber also decided to withdraw its petition. Status: Decided | 25 November 2019 30 The Israel Supreme Court, Tel Aviv Chamber of Commerce v Israeli Knesset & Ors., [2019] HC 4657/19 and HC 1532/19, (https://www.tobaccocontrollaws.org/ files/live/litigation/2711/IL_The%20Tel%20Aviv%20Chamber%20of%20Commer.pdf, accessed 16 September 2020) Case summaries 24 ITALY 1. National Council of Consumers and Users (Associzione dei Consumatori) v two electronic cigarette manufacturers (names redacted)31 Facts Issue Arguments Advanced One of the leading consumer associations i.e. the National Council of Consumers and Users petitioned the court for an injunction to revoke the advertising campaign promoted by two electronic cigarette manufacturers. Whether Art 21 of the national legislation and Art 20 of the EU TPD prohibited commercial commu- nications that directly or indirectly promoted electronic cigarettes and cartridges? Arguments advanced by the Consumer Association: The Association argued that Article 21 of Legislative Decree No. 6 of 12 January 2016 prohibited all forms of advertising and/or sponsorship of electronic cigarettes. Arguments advanced by the electronic cigarette manufacturers: The electronic cigarette manufacturers argued that the publication of mere informational content and/or images related to their products cannot be considered advertis- ing/promotional activity and thus not in violation of the current legislation. Decision/Status After a perusal of all the provisions of the national decree and the EU TPD, the Court noted that in essence the definition of commercial communication should be understood as any form of message with commercial content that has the direct or indirect purpose of promoting the sale of goods or services to consumers. It was held that in view of the restrictive approach to the advertising of electrotonic cigarettes and liquid refill containers taken in the EU TPD, the argument of the manufacturers that commercial communications on its social media pages be excluded from the scope of information society services was dismissed. Information about a product should be provided in a correct manner and not with promotional intent. With respect to user-generated content, it was held that though the manufacturers could not be held responsible for it, they could not republish or promote even through links such posts or images on their own social media channels. The Court held that there were sufficient reasons to direct the manufacturers to cease all commercial communications aimed at promoting the sale of electronic cigarettes and refill cartridges and remove all unlawful content from their websites and social media pages within 15 days from the date of the judgment. It was also ordered that the manufacturers would be fined €500 for each violation and for each day of delay in the execution of the order. Status: Decided | 4 November 2019 31 Civil action n. 57714/2019, XVII Civil Division, Court of Rome, (https://www.tobaccocontrollaws.org/files/live/litigation/2706/IT_National%20Council%20of%20 Consumers%20.pdf, accessed 27 January 2020) Case summaries 25 MEXICO 1. Neri, José Armando Contreras v Mexico32 Facts Issue Arguments Advanced The Federal Commission for the Protection against Sanitary Risks (Cofepris) imposed a fine of more than 60 thousand pesos on Neri, José Armando Contreras (merchant) who offered electronic ciga- rettes in a commercial establishment. The merchant filed a lawsuit against Article 16 of the General Law on Tobacco Control, which stated: “It is prohibited to trade, sell, distribute, exhibit, promote or produce any object that is not a tobacco product, that con- tains any of the elements of the brand or any type of design or auditory signal that identifies it with tobacco products.” Whether Article 16 of General Law of Tobacco Control violated the guaran- tee of equality under Article 1 of the Federal Constitution? It was submitted that Article 16 stipulat- ed unequal and discriminatory treatment to substances that were not tobacco products. It was argued that on one hand sale of tobacco products were permitted subject to compliance with labelling provisions. On the other hand, it was pro- hibited to trade, sell, distribute, display, promote or produce any object that was not a tobacco product. Decision/Status At the heart of the analysis, the Court had to balance right of health on the one hand, and the right to conduct business on the other. It was noted that the legislator sought to pursue a legitimate objective to protect public health, but by imposing an absolute prohibition on trade, the provision could not be considered proportional, taking into account that products that came from tobacco were allowed to be part of trade provided they complied with packaging and labelling restrictions. It was held that Article 16 was excessive and affected constitutionally protected property rights. Status: Decided | 2 October 2015 32 Supreme Court of Justice of the Nation (Mexico), Neri, José Armando Contreras v Mexico, [2015] Revision 513/2015, (https://www.tobaccocontrollaws.org/files/ live/litigation/2642/MX_Neri%2C%20Jos%C3%A9%20Armando%20Contreras%20.pdf, accessed 27 June 2019) Case summaries 26 NETHERLANDS 1. X [Company selling e-cigarettes] v The Netherlands33 Facts Issue Arguments Advanced The Plaintiff operated a business of e-cigarettes. In October 2007, the Health Care Inspectorate (IGZ) informed the plaintiffs that the electronic cigarettes and nicotine containing cartridges were classified as ‘medicine’ and could not be traded or promoted without a permit. Whether the Minister unlawfully prohibited the Plaintiff from pro- moting its products? It was argued by the Plaintiffs that the Minister assumed that because the e-cigarettes contained nicotine, it could be classified as a medicine. It was submitted that the same logic would apply to caffeine, which like nicotine is a stimulant. The Ministry of Health submitted that the nicotine from e-cigarettes had a calming and stimulating effect. Decision/Status Reliance was placed on Article 84 of the Medicines Act which prohibited advertisement of a medicine for which no market- ing authorization had been granted. It was noted that the Minister of Health did not want to allow businesses to actively promote e-cigarettes through advertising, as long as there was insufficient knowledge about the safety of the product. Thus, it was held that e-cigarettes were rightly classified as a ‘medicine’ within the meaning of the Medicines Act, allowing the Health Ministry to regulate promotional activities. Status: Decided | 8 February 2008 2. United Tobacco Vapor Group Inc. v The Netherlands34 Facts Issue Arguments Advanced United Tobacco Vapor Group (UTVG) is a manufacturer and importer of e-cigarettes, with products available at various doses. At the end of 2007, the State provisionally qualified e-cigarettes as a medicine and applied a propor- tional enforcement policy. This meant that e-cigarettes could be imported without a marketing authorization from the Medicines Evaluation Board (MEB) but any promotion or advertising was not permitted. In December 2011, the Minister of Health, Welfare & Sport classified e-cigarettes as a medicine under the Dutch Medicines Act. This implied that a license would be required from the MEB for the trade and advertisement of e-cigarettes. Against this decision, UTGV approached the District Judge seeking a preliminary injunc- tion against the classification of e-cigarettes as ‘medicine’. Whether e-ciga- rettes could be classified as ‘med- icine’ under the Dutch Medicines Act? It was argued that the State unlawfully classified e-cigarettes as a medicine under the Medicines Act. The State should provide scientific evidence that the nicotine contained in e-cigarettes has a different pharmacological effect than the consumption of a reasonable amount of normal cigarettes. 33 The District Court of Hague, X [Company selling e-cigarettes] v The Netherlands, [2008] Case No: KG 08-136,(https://www.tobaccocontrollaws.org/files/live/ litigation/2126/NL_X%20%5BCompany%20selling%20e-cigarette.pdf, accessed 15 September 2020) 34 The District Court of Hague, United Tobacco Vapor Group Inc. v The Netherlands, [2012] Case No.: 414117-KG ZA 12-209, (https://www.tobaccocontrollaws.org/ files/live/litigation/2128/NL_United%20Tobacco%20Vapor%20Group%20Inc.pdf, accessed 17 September 2020) Case summaries 27 2. United Tobacco Vapor Group Inc. v The Netherlands34 Decision/Status It was held that the State did not discharge the burden of proof to establish grounds for classification of e-cigarettes as a medicine. The State should have scientifically demonstrated the pharmacological effects of e-cigarettes to classify it as a medicine under the Medicines Act. Thus, it was held that the Minister’s decision to classify e-cigarettes was contrary to the law and principle of legal certainty. Status: Decided | 13 March 2012 3. The Netherlands v United Tobacco Vapor Group Inc.35 Facts Issue Arguments Advanced [The facts are the same as the case above and are not repeated in the interest of brevity]. The District Judge passed an order in favour of UTVG holding that its e-cigarette cannot be classified as a medi- cine. Aggrieved, the State filed an appeal against the decision of the District Court. Whether e-cigarettes could be classified as ‘medicine’ under the Dutch Medicines Act? The State argued that the e-cigarettes resembled a nicotine inhaler which was designated as a medicinal product in 1996. Decision/Status The State acknowledged that e-cigarettes did not present an acute danger to public health (para 8.3). In fact, any risks associated with e-cigarettes are smaller than the risks associated with the use of regular cigarette. It was noted that application of the Medicines Act resulted in obstacles to the free movement of goods and that was disproportionate to the objective of protecting public health. The Court concluded that the e-cigarette did not cross the threshold to be classified as a medicine under the Medicines Act. Status: Decided | 26 June 2012 35 The Hague Court of Appeal, The Netherlands v United Tobacco Vapor Group, [2012] Case No.: 200.105.395-01,(https://www.tobaccocontrollaws.org/files/live/ litigation/2130/NL_The%20Netherlands%20v.%20United%20Toba.pdf, accessed 21 July 2019) Case summaries 28 NEW ZEALAND 1. New Zealand Ministry of Health (MoH) v Philip Morris (New Zealand) Ltd.36 Facts Issue Arguments Advanced Philip Morris Limited was charged by the Ministry of Health (MoH) for selling a tobacco product called ‘Heets’ (product/used by heating in a device referred to as IQOS), in contraven- tion with s 29(2) of the Smoke-free Environment Act 1990 (Act). The product was labelled as suitable for chewing or any other oral use (other than smoking). Section 29(2) of the Act stipulated: “No person shall import for sale, sell, pack or distribute any tobacco product labelled or other- wise described as suitable for chewing, or for any other oral use (other than smoking).” Whether the sale of the product was pro- hibited under s 29(2) of the Act? Arguments advanced by MoH: The MoH submitted that the product would squarely fall within the ambit of s 29 of the Act because the aerosol emanated from it was inhaled through the mouth. Reference was also made to the enlargement of the scope of toxic substances under the Toxic Substances Act 1979. At the time of enactment of the 1979 Act, toxic substances were defined as: ‘any tobacco prepared for smoking, chewing, or snuffing’. In 1986, the definition was expanded by the addition of ‘or any other oral use’. It was the intention of the Parliament to capture prod- ucts for ‘any other oral use’, and it was this expanded definition that was included in s 29(2) of the Act. Section 29 was included in Part 2 of the Act, under the heading ‘Control of smoking products’. The objectives for Part 2 of the Act were set out in s 21 of the Act. Most importantly, it was to reduce the social approval of tobacco use particularly among young people by imposing controls on the marketing, advertising or promotion of tobacco products. The MoH submitted that this sup- ported the interpretation with respect to ‘Heets’ qualifying as a product under s 29 of the Act. It was emphasized by the MoH that the relative harm argument of the product being less harmful than cigarettes was irrelevant for the purposes of interpretation of s 29 of the Act. Arguments advanced by Philip Morris Limited: It was submitted that the present prosecution by the MoH was misconceived as s 29 of the Act was enacted to combat chewing tobacco and other kinds of tobacco taken orally. Thus, the product did not fall within the ambit of s 29 of the Act. Decision/Status The Court agreed with the interpretation of Philip Morris Limited and held that the product did not fall within the ambit of s 29(2) of the Act. The Court applied the rule of ejusdem generis to establish that the term ‘or for any other oral use’ was confined to a tobacco product used for chewing or an activity similar to chewing. The Court also relied on the evidence provided by a UK Physician that the act of burning tobacco resulted in the forma- tion of majority of harmful chemicals. While there are risks associated with the use of the product, it is not as harmful or potentially harmful as ordinary cigarette use. Thus, the product would not be caught within the ambit of s 29(2) of the Act. Status: Decided | 12 March 2018 36 District Court at Wellington, Ministry of Health v Phillip Morris (New Zealand) Limited, [2018] NZDC 4478, (https://www.tobaccocontrollaws.org/files/live/ litigation/2632/NZ_New%20Zealand%20MOH%20v.%20PMI.pdf, accessed 15 September 2020) Case summaries 29 NORWAY 1. Swedish Match v The Ministry of Health & Care Services Facts Issue Arguments Advanced Swedish Match filed a petition before the Oslo County Court seeking an injunction against the implementation of plain packaging regulations for snuff (snus) sold in Norway. The Ministry of Health and Care Services presented a proposal to amend the Tobacco Harm Act (for the implementation of the European Tobacco Products Directive 2014/40/EU). It was stated in the proposal that snus products have been introduced on the market with untraditional designs, which has contributed to the product’s increased appeal amongst youth. Thus, the Ministry considered it important to stan- dardize snus packaging. Whether standardized packaging applicable for snus was a neces- sary and proportional measure? Arguments advanced by Swedish Match: It was con- tended that the standardized packaging was adopted on a faulty factual basis. The State solely relied on the Norwegian Institute of Public Health’s report on the health risks associated with using snus. No separate risk as- sessment related to the use of snus was conducted by the State. Instead, the State mixed epidemiological studies of the risk of snus use with epidemiological studies of other tobacco products. Further, the State did not demonstrate that standardized packaging would have a positive effect on public health. It was also contended that the standardized packaging could have a negative effect on public health because snus is a harm-limiting alternative to cigarettes. The State imposed standardized packaging on snuff and lifted the ban on the sale of e-cigarettes at the same time, but with- out imposing standardized packaging on e-cigarettes. The State had not established that snus has greater appeal to children and youth than compared with e-cigarettes. In fact, e-cigarettes are already used by youth and this shows that the State has not followed a consistent and systematic approach for this measure. Arguments advanced by the State: The standardized packaging measure was imposed in a consistent and sys- tematic manner. The State submitted that e-cigarettes did not specifically appeal to youth and its use was not wide- spread. Standardized packaging may also be introduced for e-cigarettes, if the market conditions for it change. Further, the States enjoy a margin of appreciation in the selection of measures and there was no need to positively establish that no other measure would have achieved the consideration with equal effectiveness. The main objec- tive of the measure was to prevent the use of tobacco, especially among children and adolescents. Finally, the interests of Swedish Match were of an economic na- ture and could be compensated but the State sought to avoid irreversible consequences in terms of exposure to health risks. Case summaries 30 1. Swedish Match v The Ministry of Health & Care Services Decision/Status The State would have fulfilled the evidentiary requirement if it was established that the measure was appropriate and necessary to achieve the objective. i. Whether the measure met the proportionality principle? The Court noted that the State enjoyed a wide margin of ap- preciation in the area of health. In fact, scientific uncertainty about the potential for damage and the risk of the products to which the restrictions apply, provided a larger margin of discretion than would otherwise be available. ii. Whether the standardized snus packages are an appropriate measure? The Court noted that undoubtedly there was a health risk associated with the use of snus. The only disagreement related to the extent of this risk, and whether the use of snus could lead to cancer. The Court examined the report on the use of smokeless tobacco products by the Norwegian Institute of Public Health. It was concluded that the report was accurate with respect to the conclusions drawn by the Ministry. The Court observed no factual errors underlying the measure adopted by the Ministry. iii. Whether the measure was appropriate on the basis of differential treatment of snuff and e-cigarettes? The Court noted that e-cigarettes were a new product category and little research was available on any harm related to its use at this point. Further, there were no corresponding similarities between snus and e-cigarettes. The Ministry acknowledged that standardized packaging would be introduced for e-cigarettes if extensive use was detected amongst youth. The Court concluded that the differential treatment between e-cigarettes and snuff must be regarded as fair and justifiable. Accordingly, the State proved that the introduction of standardized packaging for snus was a necessary measure and that the objectives could not be attained by using less comprehensive measures or restrictions. The petition for temporary injunction filed by Swedish Match was denied and the State was awarded costs. Swedish Match filed an appeal against this order, which was dismissed by the Oslo Court of Appeal. Status: Decided | 6 November 2017 Case summaries 31 PHILIPPINES 1. Green Puff Electronic Cigarettes Inc, v The Department of Health37 Facts Issue Arguments Advanced The Department of Health issued an administra- tive order (No 2019-0007), under which electronic cigarettes were classified as health or consumer products under the jurisdiction of the FDA. The AO served to act as a guide to all individuals, enter- prises and businesses which seek to manufacture, distribute, import, export ENDS/ENNDS products. The Petitioner filed a petition of certiorari seeking to annul and set aside the DoH administrative order as being invalid and unconstitutional before a regional trial court. Whether the admin- istrative order was constitutional and valid? The Petitioners submitted that the AO issued by the DoH was unconstitutional as it should have been passed by the Congress and not the head of the DoH. ENDS and ENNDS are not covered by the Food and Drug Administration Act (R.A. No. 9711) and thus could not be placed under the purview of the FDA by an exercise of rule-making power. Decision/Status - Status: Pending 37 Regional Trial Court (National Capital Judicial Region), Green Puff Electronic Cigarettes Inc. v The Department of Health, [2019] R-MNL-19-07810-SC Case summaries 32 REPUBLIC OF KOREA 1. Korea Electronic Cigarette Association v Ministry of Health and Welfare38 Facts Issue Arguments Advanced In October 2019, the Minister of Health and Welfare strongly recommended that liquid e-cigarettes be discontinued until the safety management and hazard verification is completed. In December 2019, the Minister of Health and Welfare announced that research of the e-cigarette components was required to understand the causal relationship with lung damage and death, until then it was strongly recommended to discontinue use of liquid e-ciga- rettes. The said measures would be maintained until the first-half of 2020, when human toxicity studies would be announced. The Korea Electronic Cigarette Association chal- lenged the Ministry of Health and Welfare’s Recommendation. Whether the Ministry of Health and Welfare’s recommen- dation violates the claimant association’s right to equality? - Decision/Status It was held that Ministry of Health and Welfare’s Directive was only recommendatory in nature and not compulsory. Thus, it did not have a direct legal effect on the rights and obligations of the claimant. Status: Decided | 17 March 2020 38 The Constitutional Court of South Korea, Korea Electronic Cigarette Association v the Ministry of Health, Cases 2020 Heungma 365, (https://www.tobaccocontrollaws.org/litigation/decisions/kr-20200317-korea-electronic-cigarette-ass, accessed 17 September 2020) Case summaries 33 SPAIN 1. Altadis v Philip Morris39 Facts Issue Arguments Advanced Spain’s Advertising law prohibits all kinds of ad- vertising and promotion of tobacco products in all media and other means (Article 9 r/w Article 2 of law 28/2005). Altadis filed a lawsuit against Philip Morris Spain alleging that the US Company was illegally advertising IQOS along with ‘Heets’. Whether advertising the IQOS device is prohibit- ed under the provisions of Law 28/2005? - Decision/Status The Court directed Philip Morris to cease its campaigning of these products. It was held that in the field of tobacco, if the purpose or effect of the communication is direct or indirect promotion of a tobacco product, then it is violative of the law. The isolated advertising of the IQOS device has no other purpose than the use of tobacco and would be caught within the ambit of Law 28/200540. Status: Decided | 30 September 2019 39 Commercial Court of Madrid, Altadis v. Philip Morris, [2018] Roj: SJM M 1157/2019 - ECLI: ES:JMM:2019:1157 40 Spain | Law 28/2005 | Health measures regarding smoking and its sales regulation, supply, use and advertising of tobacco products, (https://www.tobaccocontrollaws.org/files/live/Spain/Spain%20-%20Law%2028_2005.pdf, accessed 18 December 2019) Case summaries 34 SWITZERLAND 1. GmbH v Customs Inspectorate Basel41 Facts Issue Arguments Advanced The Court assessed the constitutionality and legality of an import ban on white snus in this case. The importer filed a complaint when 42 cartons (244.8 kg) of white snus were withheld by the Customs Inspectorate. The importer submitted before the Court that ‘white snus’ did not fall within Article 5 of the Tobacco Products and Smokers’ Products with Tobacco Substances Regulation (Tobacco Ordinance) i.e. a provision that prohibited tobacco products for oral use. Whether the import ban on snus was constitutional? The importer argued that the rejection of white snus by the custom authorities constituted an interference with the economic freedom of the importer. Decision/Status The Court examined the constitutionality and legality of Article 5 of the Tobacco Ordinance on the touchstone of economic freedom. The Court inspected provisions of the Foodstuff and Utility Articles Act (aLMG) which also applied to tobacco and other tobacco products. The analysis of the aLMG led the Court to conclude that semi-luxury foods (alcohol and nicotine) inevitably involved inherent risks and could not justifiably be banned. People who drank and smoked in excess, conscious- ly damaged their health. It was held that semi-luxury goods could only be banned if in their normal use, they endangered health directly or in unexpected ways. Further, the health hazards of tobacco products, especially nicotine were well known today. The risks were inherent in the consumption of the good and according to the provisions of the aLMG should not be banned on this basis. Thus, Art 5 of the Tobacco Ordinance was illegal. The Court also observed that as the provision was illegal, explanations on the grounds of public interest and proportionality were superfluous. On the argument of comparative risk between snus and cigarettes, the Court held that it was arbitrary and illegal to prohibit snus when more dangerous products like cigarettes were not prohibited. Even in the European Union, the ban on snus did not apply to all states (exception: Sweden). Thus, it was unclear why a ban on snus would be required in Switzerland, for which EU law is not even binding. Status: Decided | 27 May 2019 41 Federal Court of Switzerland, Gmbh v Customs Inspectorate Basel, [2019] 2C_718/2018, (https://www.bger.ch/ext/eurospider/live/de/php/aza/http/index. php?highlight_docid=aza%3A%2F%2Faza://27-05-2019-2C_718-2018&lang=de&zoom=&type=show_document, accessed 27 June 2019) Case summaries 35 UNITED KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND 1. ASA Adjudication on Cigirex42 Facts Issue Arguments Advanced A national press ad, for CIGIREX, was headed “ATTENTION SMOKERS: a new product with less nic- otine, no tobacco or tar, but the same satisfaction!”. Text stated “... a breakthrough on how nicotine is delivered to your bloodstream without tar, tobacco and thousands of carcinogens associated with tradi- tional cigarettes ... CIGIREX removes these harmful ingredients associated with traditional cigarettes and delivers a no tobacco, tar free method of how nicotine is delivered into your system ... CIGIREX, a carcinogen-free nicotine oral delivery system with cartomizer technology. CIGIREX looks, feels and smokes just like a real tobacco cigarette with none of the tar or tobacco found in a regular tobacco ciga- rette ... Today is the first day of rest [sic] of your life. It is time to say NO to being addicted to tobacco cig- arettes. If you are among this group, then take your first steps to taking charge of your life, your destiny and your future. CIGIREX along with Together Against Cancer ... invites you to take the CIGIREX Challenge to live tobacco and tar free! ... They will send you ... a special certificate that commemorates the day that you took your first step to freedom and living tobacco-free ... [CIGIREX] may help you stop smoking tobacco cigarettes in a very short period of time with none of the side effects ... Remember with this product no prescription is required ...”. Whether the adver- tisement misleadingly implied that: (i) the product had no detrimental effects of smoking tobacco cigarettes and (ii) the advertisement made medicinal claims for an unautho- rized product. CIGIREX submitted that the advertise- ment made no medicinal claims, or implied claims, that the product would heal or cure any pre-existing condition or improve any health concerns. Decision/Status The ASA noted that no scientific evidence was provided to support the impression that Cigirex had none of the damaging effects of smoking tobacco cigarettes. The advertisement exaggerated the benefits of the product and was thus mis- leading. Further, Cigirex did not hold relevant marketing authorization to make medicinal claims. On this point also the advertisement was misleading. Status: Decided | 22 December 2010 42 ASA Adjudication on CIGIREX, [2010] Complaint Ref: 136940, (https://www.tobaccocontrollaws.org/files/live/litigation/1686/GB_ASA%20Adjudication%20on%20 CIGIREX.pdf, accessed 28 June 2019) Case summaries 36 2. ASA Adjudication on Cigirex Ltd.43 Facts Issue Arguments Advanced A national press advertisement for an electronic nicotine dispenser, which appeared on 24 November 2011 was headlined “LOOKS, SMOKES, TASTES & SATISIFIES like a cigarette”. Text appearing on what appeared to be a cigarette packet stated “CIGIREX. Contains Nicotine, Zero Tobacco, Zero Tar, Zero Tobacco Smoke, Zero chemicals, Zero odour ... 100% Satisfying. 100% Safe”. The advertisement compared Cigirex to cigarettes and provided further informa- tion about the product and information on how to buy the product. Whether the claims: (i) zero chemicals and (ii) 100% safe were misleading and could be substantiated. It was submitted that the claim “100% Safe” related to the fact that Cigirex did not contain any tobacco or carcino- gens which were recognised to be the cause of smoking related ailments and diseases. Decision/Status ASA noted that Cigirex had not provided suitable evidence to establish that its e-cigarette did not contain propylene glycol. It was held that the claim ‘zero chemicals’ had not been substantiated and was misleading. The test reports of the product stated that the product was equivalent to “mild smoking cigarettes” or “very mild smoking cigarettes”. The test reports also indicated that Cigirex contained tar and that implied that Cigirex delivered tobacco to the user- an ingredient which the ad claimed were not present in Cigirex. The advertisement clearly stated that the product contained nicotine and contradicted the claim that Cigirex was 100% safe. Thus, the claim had not been substantiated and was misleading. Status: Decided | 28 March 2012 43 ASA Adjudication on Cigirex Ltd, [2012] Complaint Ref: A11-179572, (https://www.tobaccocontrollaws.org/files/live/litigation/1687/GB_ASA%20Adjudication%20 on%20Cigirex%20Lt.pdf, accessed 28 June 2019) Case summaries 37 3. ASA Adjudication on Desert Point Ltd44 Facts Issue Arguments Advanced The website www.clearsmoke.co.uk, which offered a trial of electronic cigarettes, was headed “ClearSmoke” and featured the logos of the BBC, Sky News and itv1 with the statement “e-Cigs advertised on”. Under the heading “THE SMART SMOKERS [sic] CHOICE”. The ad stated “SMOKE ANYWHERE. ClearSmoke electronic cigarettes are smoke-free and flame-free, meaning you can enjoy them safely, anywhere you want”. Under the heading “Electronic Cigarettes in the Media” the ad included quotations from national newspapers and television broadcasters. The quotation from the Guardian stated “The government’s ‘nudge unit’ wants to encourage the use of smokeless nicotine cigarettes - in an attempt to reduce the numbers killed in the UK by smoking diseases each year”. The quotation from the Daily Telegraph stated “Electronic cigarettes mimic the act of smoking and include nicotine, but do not emit the same type of odour or ash”. The ad also stated “QUALITY ASSURANCE. All ClearSmoke products are subjected to strict quality control and industry assess- ments”. It then listed “CE A mandatory conformance mark on products in the European Economic Area - RoHS Restriction of Hazardous Substances - SGS The global leader and innovator in inspection, verification, testing & certification”. The ad also stated “ClearSmoke has the following certifications: CE ... RoHS - SGS”. Whether: (i) the claim that the product had been advertised by the BBC, SKY News and itv1 could be substantiated; (ii) the claim “…you can enjoy them safely, any- where you want” was misleading and could not be substantiated; (iii) the quotation under the heading “Electronic Cigarettes in the Media” were misleading because they had been taken out of context; and (iv) the claims under qual- ity assurance were misleading because they suggested that the product had been medically approved. It was submitted that “e-cigs advertised on” referred to the product type as a whole and not the ClearSmoke brand specifically. Additionally, the website contained a disclaimer which stated, “The use of references to statements made by news organizations and quotes from experts in the field does not mean that these organisations and/or experts in any way endorse the ClearSmoke (TM) product”. Decision/Status ASA noted: (i) Whether the claim referred to the ClearSmoke brand or e-cigarettes generally. No explanation had been provided on the context in which the product had been advertised or featured on BBC, Sky News and itv1. Accordingly, the claim was misleading. (ii) The policy on usage of e-cigarettes varied between organizations, employers etc. While it might not be illegal to use e-cigarettes, it was not always allowed in all situations. Thus, the claim “…you can enjoy them safely, anywhere you want” was misleading. (iii) The quotations in this section suggested that the authors or organizations were strongly in favour of the use of e-ciga- rettes as an alternative to smoking conventional cigarettes. While the full articles adopted a more cautious approach on the usage of e-cigarettes, the extracts were taken out of context. It was concluded that the use of quotations was misleading. (iv) E-Cigarettes were not regulated by the MHRA and were not approved by them. Thus, the text, “All ClearSmoke prod- ucts are subjected to strict quality control and industry assessment” was ambiguous and was misleading. Status: Decided | 24 October 2012 44 ASA Adjudication on Desert Point Ltd, [2012] Complaint Ref: A12-199372, (https://www.tobaccocontrollaws.org/files/live/litigation/1426/GB_ASA%20 Adjudication%20on%20Desert%20Poi.pdf, accessed 28 June 2019) Case summaries 38 4. ASA Adjudication on Nicocigs Ltd45 Facts Issue Arguments Advanced Claims on the website www.nicolitesonline.co.uk, for electronic cigarettes, included “Although the vapour inhaled and exhaled when using Nicolite resembles smoke, it’s simply a completely harmless vapour. The vapour has no odour and does not linger the way tobac- co smoke does. So there’s no danger of passive smok- ing posed to those around ‘vapers,’ as e-cig users are called. It’s the tobacco that’s harmful, not the nicotine, which is mildly addictive but poses no health hazard …”. Whether the website misleadingly claimed that the product was not harmful? Nicolite submitted that the ingredi- ents in their liquid which was heated to create a vapour had been subject to a toxicology risk assessment. The report confirmed that all of the ingredi- ents were safe and the vapour caused no harm. Decision/Status The ASA perused the evidence submitted by Nicolite, in the form of literature reviews or references to individual ingre- dients in the product. It was noted that the toxicology risk assessment did not take the form of a controlled clinical trial and concluded that e-cigarettes were unlikely to pose a risk to health over and above that of cigarettes. However, the advertisement implied that the product would pose no risks to health at all. It was concluded that the advertisement was misleading as the claim that the product was not harmful had not been substantiated. Status: Decided | 16 January 2013 5. ASA Adjudication on Nicocigs Ltd.46 Facts Issue Arguments Advanced A website for electronic cigarettes, www.nicolitesonline. co.uk, claimed that although the vapour inhaled and exhaled when using Nicolite resembled smoke, it was completely harmless vapour. Further, the website stat- ed that tobacco was harmful and not nicotine, which was mildly addictive but posed no health hazard. Whether the website misleadingly claimed that the product was not harmful as the claim could not be substantiated? Nicolites submitted a safety report of the inhaled aerosol, wherein it was observed that “it was safe relative to cigarettes and also safe in absolute terms on all measurements applied”. Decision/Status The evidence submitted by Nicolites was examined by ASA. It was concluded that no assessment was submitted to substantiate the claim that that the vapour from e-cigarettes was “completely harmless” and “posed no health hazard”. Thus, the advertisement was held to be misleading under the Committee of Advertising Practice (CAP) Code. Nicolites was directed to ensure that the advertisement should not appear in its current form. Status: Decided | 16 January 2013 45 ASA Adjudication on Nicocigs Ltd, [2013] Complaint Ref: A12-207775, (https://www.tobaccocontrollaws.org/files/live/litigation/1396/GB_ASA%20Adjudication%20 on%20Nicocigs%20L.pdf, accessed 28 June 2019) 46 ASA Ruling on Nicocigs Ltd., [2013] Complaint Ref: A12-207775, (https://www.tobaccocontrollaws.org/files/live/litigation/1396/GB_ASA%20Adjudication%20 on%20Nicocigs%20L.pdf, accessed 27 June 2019) Case summaries 39 6. ASA Adjudication on Nicocigs Ltd47 Facts Issue Arguments Advanced A national press ad for Nicolites electronic ciga- rettes included the text, “THE SAFER SMOKING ALTERNATIVE” and “HEALTHIER. No tobacco, tar or carbon monoxide”. Whether the health claims in the adver- tisement implied that the product was not harmful? Nicocigs stated that the advertisement was misleading. Decision/Status ASA noted that Nicocigs did not submit evidence to support its claims and it was concluded that the advertisement was misleading. Status: Decided | 15 May 2013 7. ASA Adjudication on Easylife Group Ltd48 Facts Issue Arguments Advanced A catalogue enclosed in a national newspaper and claims on the website www.dailymailselect.com promoted an electronic cigarette: a. The catalogue stated, “The cigarette you can smoke anywhere you like ... Unaffected by smoking bans - so they’re legal in pubs and restaurants ...”. b. The website contained the same claim. Whether the claim “unaffected by smoking bans- so they’re legal in pubs and restaurants” was misleading, because many pubs and restaurants did not allow the use of elec- tronic cigarettes? It was submitted that the advertisement implied that there was no government directive to ban use of e-cigarettes in pubs and restaurants. The claim was not misleading because it was the choice of individual pubs and restaurants, if at all to ban use of e-cigarettes. Decision/Status The ASA noted that e-cigarettes did not fall within the scope of the laws restricting smoking in an enclosed public place. Nevertheless, some pubs and restaurants had chosen not to allow their use. The claim in the advertisement was specific to the restrictions imposed on smoking by UK law and did not imply that all pubs and restaurants would allow the use of e-cigarettes. Thus, the claim was not misleading. Status: Decided | 21 August 2013 47 ASA Adjudication on Nicocigs Ltd, [2013] Complaint Ref: A13-219974, (https://www.tobaccocontrollaws.org/files/live/litigation/1407/GB_ASA%20Adjudication%20 on%20Nicocigs%20L.pdf, accessed 28 June 2019) 48 ASA Adjudication on Easylife Group Ltd, [2013] Complaint Ref: A13-230302, (https://www.tobaccocontrollaws.org/files/live/litigation/1397/GB_ASA%20 Adjudication%20on%20Easylife%20G.pdf, accessed 28 June 2019) Case summaries 40 8. ASA Adjudication on Nicocigs Ltd49 Facts Issue Arguments Advanced A website, www.nicolitesonline.co.uk, for Nicolite Electronic Cigarettes, featured three rotating images at the top of the “Benefits” page. One of the images showed a woman holding a cigarette and a glass. Text beside the image stated, “Cheaper Than Traditional Cigarettes. Electronic Cigarettes work out to be up to three times cheaper than traditional cigarettes”. The final paragraph was titled “Less Expensive than Conventional Cigarettes” and displayed text that stated “Nicolite can be significantly less expensive than tobacco cigarettes. Once you’ve bought the starter kit, all that needs replacing is the carto- miser that contains liquid nicotine. A cartridge is equivalent to about twenty tobacco cigarettes. If you smoke five cigarettes a day, you stand to save nearly £400 per year if you switch to Nicolite. If you smoke twenty cigarettes a day, the saving would be about £1500 per year. With all these benefits to recom- mend them, aren’t Nicolite e-cigs worth a try?”. Beneath that appeared a table, which displayed figures of the savings consumers could achieve if they replaced conventional cigarettes with Nicolite Electronic Cigarettes. The table showed that a per- son who smoked 20 cigarettes a day would spend £2,372.52 a year on ‘ordinary’ cigarettes or £845.60 on Nicolite Electronic Cigarettes, which represented a yearly saving of £1,526.92. Whether a cartridge is equivalent to about twenty tobacco cigarettes was mis- leading and could be substantiated? The manufacturer conducted tests after receiving the complaint from ASA. The test established that each cartomiser lasted for at least 20 cigarettes. Decision/Status The ASA noted that Nicolite conducted a test to substantiate the claim after the complaint had been filed. On this basis alone, the test was inadmissible to support the claim at the time the advertisement appeared. Further, the test report submitted by Nicolite did not contain a detailed methodology and the robustness of the test could not be assessed. As the claim could not be substantiated, it breached the Code. Status: Decided | 11 September 2013 49 ASA Adjudication on Nicocigs Ltd, [2013] Complaint Ref: A13-231073, (https://www.tobaccocontrollaws.org/files/live/litigation/1685/GB_ASA%20Adjudication%20 on%20Nicocigs%20L.pdf, accessed 28 June 2019) Case summaries 41 9. ASA Adjudication on Sorse Distribution Ltd.50 Facts Issue Arguments Advanced A television advertisement for e-cigarettes, viewed at various times between 9 pm and 1 am, began with on- screen text that stated, “5 COLORS” and a voice-over that said, “Five Colors. What’s your flavour? The ad showed a number of young adults jumping in the air while fruits, including strawberries, apples and grapes, appeared and exploded in the background. Onscreen text visible throughout the ad stated “5colors.co.uk 0844 XXX XXXX”. In the final scenes a voice-over said, “It’s time to come in from the cold. Five Colors.” Whether the adver- tisement was: (i) mis- leading as it did not clarify the characteris- tics of the product; (ii) irresponsible as it would encourage young adults and children to take up smoking. It was submitted that the advertise- ment was purposefully vague and did not include references to smoking or any imagery that could be mis- construed as being linked to tobacco products. Decision/Status ASA noted that the nature of the product was not clear through the advertisement and could mislead a consumer. It was important that such advertisements clarified the nature of the product and whether or not it contained nicotine. Thus, the advertisement breached the BCAP Code rules 3.1. and 3.2. At the same time, the advertisement was cleared with an ‘ex-kids’ restriction and would not be broadcasted around pro- grammes of particular appeal to children. The advertisement did not include any reference to nicotine or tobacco prod- ucts and thus would not encourage young adults and children to start smoking. Status: Decided | 25 September 2013 10. ASA Adjudication on Zulu Ventures Ltd.51 Facts Issue Arguments Advanced A television advertisement for e-cigarettes, viewed at around 7.15 pm, showed scenes of young adults undertaking various day-to-day activities. On-screen text during the advertisement stated “www.sky- start.co.uk 0800 XXX XX XX” and “SKYSTART only available to those over 18yrs of age”. A voice-over said, “Life is not about tomorrow nor is it about yes- terday. Life is about the moment, the now. Whoever you are, whatever you do, life only asks you one question - who will you share it with? Skystart.” Whether the advertise- ment was: (i) mislead- ing as it did not clarify the characteristics of the product; and (ii) irresponsible as it would encourage young adults and children to take up smoking. It was submitted that because an elec- tronic cigarette was reminiscent of a traditional cigarette, the advertisement did not specify characteristics of the product. 50 ASA Adjudication on Sorse Distribution Ltd, [2013] Complaint Ref: A13-219212, (https://www.tobaccocontrollaws.org/files/live/litigation/1431/GB_ASA%20 Adjudication%20on%20Sorse%20Dist.pdf, accessed 28 June 2019) 51 ASA Adjudication on ZULU Ventures Ltd, [2013] Complaint Ref A13-219713, (https://www.tobaccocontrollaws.org/files/live/litigation/1432/GB_ASA%20 Adjudication%20on%20ZULU%20Ventu.pdf, accessed 28 June 2019) Case summaries 42 10. ASA Adjudication on Zulu Ventures Ltd.51 Decision/Status ASA noted that the advertisement did not share material information about the product which was necessary for viewers if they wished to find out more. In fact, inquisitive consumers were likely to have visited the website during the adver- tisement, thus resulting in an action that many would not otherwise have taken if they were aware of the nature of the product. As the advertisement did not clarify that the product being advertised contained nicotine, it was concluded that the advertisement was misleading and breached the BCAP Code. The advertisement did not glamourize the nicotine product nor encouraged its excessive or inappropriate use. Further, the advertisement did not include any reference to tobacco products and did not encourage people of any age to start smok- ing cigarettes. Thus, the advertisement was not irresponsible or harmful. Status: Decided | 25 September 2013 11. ASA Adjudication on Ten Motives Ltd52 Facts Issue Arguments Advanced A television advertisement for electronic cigarettes, featured a ‘£’ symbol next to animated images of various day-to-day activities and objects such as a beach holiday and a television. The ad also featured animated images of cycling and a young family. The voice-over stated, “What’s my motive? Finding them is easy as 1, 2, 3. I have more freedom, to be the real me, and do all the things I haven’t done in a long time. Enjoying life with the people that matter most. Ten motives. What’s your motive?” On-screen text stated “www.tenmotives.com What’s your motive?”. Whether the adver- tisement was: (i) misleading because it encouraged young adults and children to visit the website but did not make clear the characteristics of the product; and (ii) was irresponsible and harmful because it promoted a nico- tine-based product. It was submitted that at no point in the advertisement was a viewer encouraged to visit the website. The advertisement was targeted towards adults. Decision/Status ASA noted that the advertisement did not identify the type of product being promoted and inquisitive viewers were likely to visit the website to find out more about the product. It was important that such advertisements clearly spelled out the nature of the product and whether or not it contained nicotine. Thus, it was held that the advertisement was misleading. The advertisement did not encourage the harmful use of a nicotine product and thus was not socially irresponsible. Status: Decided | 25 September 2013 52 ASA Adjudication on Ten Motives Ltd, [2013] Complaint Ref: A13-230598, (https://www.tobaccocontrollaws.org/files/live/litigation/1406/GB_ASA%20 Adjudication%20on%20Ten%20Motive.pdf, accessed 28 June 2019) Case summaries 43 12. ASA Adjudication on Zandera Ltd.53 Facts Issue Arguments Advanced A radio ad, a television ad, an internet banner ad, a poster at a bus-stop and a display ad on the side of a bus, for electronic cigarettes formed the basis of this complaint. a. The radio ad featured three scenes of vital mo- ments: a wedding; an award ceremony; and the birth of a child. In each scene a key participant was obviously missing and someone asked “Where’s Dave?”. A voice-over then stated, “What are you miss- ing when you pop out for a cigarette? By switching to E-Lites you can legally smoke indoors with no tobacco, no smell and around seventy per cent less cost. Find E-Lites in store or at e-lites.co.uk. E-Lites, smoking reinvented.” b. The TV ad showed a family gathering in which a number of adults were admiring an infant child. One of the men then got up, tapped his shirt pocket, nod- ded to the woman holding the baby and left the room. The baby then began to toddle towards one of the other women, but stopped in the middle of the room and performed several dance moves from the music video for the song Gangnam Style, before sitting down. The man who had left the room then returned, clapped his hands and said, “So, what have I missed?” while the other adults were shown frozen with shock. On-screen text stated “E-Lites. What are you missing? E-Lites.co.uk”. c. The internet banner ad had text which stated “NO TAR. NO TOBACCO. 70% CHEAPER. 100% LEGAL” and had a picture of an e-cigarette. The image then changed to show two product packages alongside the text, “The satisfying smoking alternative learn more”. At the bottom of the ad was the product logo and the text “E-Lites UK’S BEST ELECTRONIC CIGARETTE”. d. The poster ad at the bus-stop stated “WHAT ARE YOU MISSING? No tar. No tobacco. No odour”. It showed an open packet of E-Lites with the two sep- arate parts of an individual electronic cigarette lying next to it. e. The poster on the bus showed an open product pack next to text which stated “WHAT ARE YOU MISSING? No tar, no tobacco and legal indoors. E-Lites SMOKING REINVENTED”. The complaints against each of the advertisements de- scribed above are: (i) Whether advertise- ment (a) promoted a nicotine based product and encouraged and normalized tobacco smoking; (ii) Whether advertise- ment (a) and (b) were misleading due to the omission of material information about the product, specifically its ingredients and that it contained nicotine; (iii) Whether adver- tisement (b), (c), (d) and (e) promoted a nicotine-based product and encour- aged and normalized smoking or the use of E-Lites. Zandera made the following submis- sions before ASA: - The radio advertisement did not promote nicotine, nor encouraged or normalised traditional smoking. - Advertisement (b) showed a website address where further information could be found on the product and its ingredients. It was submitted that the advertisement did not normalise the act of smoking and was not irresponsi- ble or harmful in any way. 53 ASA Adjudication on Zandera Ltd, [2013] Complaint Ref: A13-219706, (https://www.tobaccocontrollaws.org/files/live/litigation/1427/GB_ASA%20Adjudication%20 on%20Zandera%20Lt.pdf, accessed 28 June 2019) Case summaries 44 12. ASA Adjudication on Zandera Ltd.53 Decision/Status (i) Advertisement (a) presented smoking in a negative light and did not encourage or normalize tobacco smoking. (ii) E-cigarettes were a new product in the UK and it was important that the nature of the product was advertised clearly along with full material disclosure. Thus, advertisements (a) and (b) were misleading and breached the code. (iii) Nicotine-containing electronic cigarettes could be sold legally in the UK and were not a prohibited category under the CAP Code. The three advertisements promoted an alternative to tobacco smoking and were unlikely encouraging or normalizing tobacco smoking. Status: Decided | 25 September 2013 13. ASA Adjudication on Zulu Ventures Ltd.54 Facts Issue Arguments Advanced A poster on a train for electronic cigarettes was headlined “Feel the difference”. The advertisement featured an image of three packs of the product, which resembled tobacco cigarettes. Further text stated “SKYCIG Combines industry-leading technol- ogy with a name you can trust to give you the most realistic smoking experience possible. SKYCIG cus- tomers also save up to 80% compared to smoking traditional cigarettes so why not give SKYCIG a try today? EQUIVALENT TO 40 CIGARETTES”. Whether the untarget- ed poster advertise- ment was irrespon- sible because it was placed in a location where it was likely to be seen by children? Zulu Ventures contended that the aver- age commuter on the train fell into the 25-34 years of age bracket. Decision/Status The ASA noted that the advertisement appeared on a route which did not carry a high percentage of children. Further, the advertisement was mostly comprised of text and did not contain any image or content that was likely to be attractive to children. The text clearly stated that the advertisement was for a non-tobacco product and did not encourage or normalize tobacco smoking among children or adults. Status: Decided | 20 November 2013 54 ASA Adjudication on ZULU Ventures Ltd, [2013] Complaint Ref: A13-240201, (https://www.tobaccocontrollaws.org/files/live/litigation/1628/GB_ASA%20 Adjudication%20on%20ZULU%20Ventu.pdf, accessed 28 June 2019) Case summaries 45 14. ASA Adjudication on UKVapes Ltd.55 Facts Issue Arguments Advanced A radio advertisement for electronic cigarettes featured a voice-over that stated, “Do you smoke? Want to save money? Well, with electronic cigarettes from UKVapes, save money and enjoy the sensation of smoking, with- out the anti-social side effects [a coughing sound effect was heard]. They don’t contain tobacco and because they only create vapour, you can use them almost anywhere. Electronic cigarettes come in a variety of vapour flavours too - there’s the ‘fruities,’ like cherry and banana or the ‘yummies,’ like cola or ice mint.” Whether the adver- tisement was irre- sponsible because of its reference to a range of flavours that could encourage children to use the product? It was submitted that the advertise- ment was targeted at existing smokers who wanted to try e-cigarettes. Decision/Status ASA noted that the advertisement started with the statement, “Do you smoke?”, which clearly established that it was tar- geted towards existing smokers. The flavours referenced were common to many products and not only those that would appeal to children. Thus, the advertisement was not irresponsible and did not breach the Code. Status: Decided | 20 November 2013 15. ASA Adjudication on CN Creative Ltd.56 Facts Issue Arguments Advanced A national press advertisement for e-cigarettes included an image of a number of packages of the product alongside text that stated “A BIG DEAL FOR SMOKERS. Finally, there’s an e-cigarette that can deliver a truly re- alistic experience and a smooth, satisfying taste. Try the Vype e-cigarette FREE at goVype.com/guardian”. Small print at the bottom of the ad stated “Contains nicotine. Always read the label. Terms and conditions apply”. Whether the ad- vertisement was irresponsible and could encourage non-smokers and former smokers to take up smoking? It was submitted that the key message of the advertisement was to encourage smokers to try e-cigarettes as an alter- native to traditional cigarettes. Decision/Status The ASA noted that the advertisement was clearly for an electronic cigarette and addressed towards current smokers. It disassociated the product from traditional tobacco cigarettes. Thus, it was observed that the advertisement would unlikely encourage tobacco smoking amongst non-smokers. Status: Decided | 8 January 2014 55 ASA Adjudication on UKVapes Ltd, [2013] Complaint Ref: A13-239752, (https://www.tobaccocontrollaws.org/files/live/litigation/1627/GB_ASA%20 Adjudication%20on%20UKVapes%20Lt.pdf, accessed 28 June 2019) 56 ASA Adjudication on CN Creative Ltd, [2014] Complaint Ref: A13-243944, (https://www.tobaccocontrollaws.org/files/live/litigation/1625/GB_ASA%20 Adjudication%20on%20CN%20Creativ.pdf, accessed 27 June 2019) Case summaries 46 16. ASA Adjudication on Dardam Services Ltd.57 Facts Issue Arguments Advanced A national press advertisement, for an electron- ic cigarette, was titled “Stub it out for good”. It discussed the national stop smoking campaign Stoptober and was headed “Switchtober 2013”. It featured an image of a calendar page with the first day marked with the No Match logo, which was a match with a cross through it. Whether the adver- tisement was mislead- ing and implied that the product could be used as a smoking cessation device? The company submitted that every effort was taken to ensure that their products were not confused with smoking cessa- tion devices. Decision/Status The ASA noted the similarity between the phrases “Switchtober” and the NHS campaign “Stoptober”. This could lead the consumers to believe that the product was suitable as a smoking cessation device but the product was not licensed by the MHRA for that purpose. Thus, the advertisement breached the Code in that regard. Status: Decided | 29 January 2014 17. ASA Adjudication on Nicocigs Ltd.58 Facts Issue Arguments Advanced A poster for Nicolites electronic cigarettes stated, “KICKS BUTT”. The accompanying smaller text stated, “UK’S FAVOURITE ELECTRONIC CIGARETTE. A SMOOTH, SATISFYING FLAVOUR THAT HITS THE SPOT!”. The advertisement also featured an image of the product. Whether the adver- tisement was mislead- ing because it implied that the product could be used as a smoking cessation aid? It was submitted that the phrase “Kicks Butt” was not intended to imply that the product could be used as a smoking ces- sation aid. Therefore, the product did not require and did not have any marketing authorization from MHRA. Decision/Status ASA noted that the advertisement implied that the consumers could use the product to kick the habit because of the phrase “Kicks Butt”. However, the product was not licensed by the MHRA for that purpose, the advertisement breached the Code. Nicocigs Ltd was directed not to imply that their product could be used as a smoking cessation aid in the future. Status: Decided | 5 February 2014 57 ASA Adjudication on Dardam Services Ltd, [2014] Complaint Ref: A13-245512, (https://www.tobaccocontrollaws.org/files/live/litigation/1631/GB_ASA%20 Adjudication%20on%20Dardam%20Ser.pdf, accessed 27 June 2019) 58 ASA Adjudication on Nicocigs Ltd, [2014] Complaint Ref: A13-245645, (https://www.tobaccocontrollaws.org/files/live/litigation/1690/GB_ASA%20Adjudication%20 on%20Nicocigs%20L.pdf, accessed 27 June 2019) Case summaries 47 18. ASA Adjudication on Zandera Ltd.59 Facts Issue Arguments Advanced A magazine advertisement for e-lites, elec- tronic cigarettes, featured a penguin with various e-cigarette paraphernalia. The ad stated “Don’t get left out in the cold this Christmas ... ‘smoke’ inside without wor- rying about nasty odours, passive smoke, harmful tar or carbon monoxide”. Whether the advertisement was irresponsible because it: (i) appeared in a magazine that appealed to children; and (ii) included an image of a pen- guin and the word ‘Christmas’, which could appeal to children. Zandera contended that the magazine was not targeted at children and its core audience was of men over 40 years of age. Decision/Status The ASA noted that the magazine was targeted towards adults and not children. It contained no visuals or wording that were likely to appeal to children. It was held that the advertisement was not irresponsible. Status: Decided | 12 February 2014 19. ASA Adjudication on 1111 EC Services Ltd.60 Facts Issue Arguments Advanced A national press advertisement for V2 electronic cigarettes stated “USA’s #1 now in the UK. Feel the quality. Taste the difference ... For FREE ...”. Halfway down the page, the text stated “For Stoptober ... To get your Express Starter Kit, ... use promo-code ‘STOPTOBER’...”. Whether the advertisement implied that: (i) it was suitable as a smoking cessation device; (ii) misleadingly implied that the product was associated with the NHS “Stoptober” campaign. The company submitted that nothing in the advertisement made reference to cessation. Decision/Status The ASA was concerned that the advertisement used “Stoptober” and the consumers were likely to understand that the product was associated or endorsed by the NHS campaign. Since this was not the case and the product had not been licensed by the MHRA as a cessation device, ASA concluded that the advertisement breached the Code. Status: Decided | 12 February 2014 59 ASA Adjudication on Zandera Ltd., [2014] Complaint Ref: A13-251599, (https://www.tobaccocontrollaws.org/files/live/litigation/1630/GB_ASA%20 Adjudication%20on%20Zandera%20Lt.pdf, accessed 27 June 2019) 60 ASA Adjudication on 1111 EC Services Ltd, [2014] Complaint Ref: A13-250336, (https://www.tobaccocontrollaws.org/files/live/litigation/1629/GB_ASA%20 Adjudication%20on%201111%20EC%20Se.pdf, accessed 27 June 2019) Case summaries 48 20. ASA Adjudication on Must Have Ltd t/a VIP Electronic Cigarette61 Facts Issue Arguments Advanced Two advertisements that appeared on television and the advertiser’s YouTube channel formed the basis of 1, 156 complaints. The first TV ad showed a woman speaking directly to the camera, she stated, “I want you to get it out, I want to see it, feel it, hold it Put it in my mouth I want to see how great it tastes.” Onscreen text stat- ed, “www.vipecig.co.uk Contains Nicotine”. A symbol also appeared that indicated the product was not suitable for those aged under 18 years. Further on-screen text stated “THE GREAT TASTE OF VIP” and “VIP E-cigarettes & E-liquids”. An accompany- ing female voice-over stated, “If you’re gonna Vape, Vape with VIP.” The second TV ad showed a man speaking directly to the camera, he stated, “Do you want to see it? I can get it out if you’d like. You can feel it, hold it, put it in your mouth. And see how great it tastes.” On-screen text stated “www.vipecig.co.uk Contains Nicotine”. A symbol also appeared that indicated the product was not suitable for those aged under 18. Further on-screen text stated “THE GREAT TASTE OF VIP” and “VIP E-cigarettes & E-liquids”. An accom- panying female voice-over stated “If you’re gonna Vape, Vape with VIP”. Whether the ad- vertisements were irresponsible as they sexualized and glam- ourized e-cigarettes and smoking? The company argued that the advertise- ments employed double entendre. The suggestiveness in the advertisement was a reference to an e-cigarette. Further, it was submitted that the advertisement carried an appropriate health warning associated with nicotine products. Decision/Status The ASA acknowledged the complaints’ concerns that the presentation of the ads included implied references to oral sex. Although, the advertisement had been cleared with a post 21:00 timing restriction, it was noted that the same was not sufficient and a post 23:00 timing restriction should have been applied. It was noted that while the ads were sexual in tone, they did not glamourize the nicotine product nor did they encourage excessive or inappropriate use. It was concluded that the ads did not encourage smoking or the harmful use of a nicotine product. Status: Decided | 26 February 2014 61 ASA Adjudication on Must Have Ltd., [2014] Complaint Ref: A13-249268 (https://www.tobaccocontrollaws.org/files/live/litigation/1688/GB_ASA%20 Adjudication%20on%20Must%20Have%20.pdf, accessed 27 June 2019) Case summaries 49 21. ASA Adjudication on Ten Motives Ltd.62 Facts Issue Arguments Advanced A leaflet for e-cigarettes, featured the Ten Motives disposable electronic cigarette and pictured two versions of the product, which stated “The healthier smoking alternative”, and “... because it contains no tar or cancerous toxins, you can still enjoy smoking without worrying about the effects on your health”. Whether the health claims made were misleading and could be substantiated? Ten Motives submitted that the MHRA had confirmed that it was acceptable to refer to their product as a healthier alternative. Decision/Status The ASA observed that the claims “healthier smoking alternative” and “you can still enjoy smoking without worrying about the effects on your health” were likely to be understood to mean Ten Motives products featured in the advertisement were less harmful than smoking, or that the products were not harmful. The advertisers had not provided any documentation from the Medicines and Healthcare Products Regulatory Agency (MHRA) in support of their claims. In the absence of any supporting evidence, the advertisements were held to be misleading. Status: Decided | 12 March 2014 22. ASA Adjudication on Vapourlites Ltd.63 Facts Issue Arguments Advanced A complaint was filed against a regional press advertisement and claims advanced on a website for electronic cigarettes. The regional press adver- tisement showed the product, which resembled a conventional cigarette above an outstretched hand. The hand was dressed in a red sleeve with a white fur cuff and a white glove. The text along with it stat- ed, “Lighter on your pocket, Lighter on your Health. Recommended by Santa & Pharmacies nationwide www.vapourlites.com. Electronic cigarettes contain nicotine which is addictive, you must be over 18 to purchase.” Additional text on the pack stated, “A harm reduction alternative to smoking”. Small print at the bottom of the ad indicated that the product was not a smoking cessation aid. Similar claims were made on the website www.vapourlites.com. Whether the ad- vertisements were irresponsible and would appeal to young children because of a reference to Santa? Additionally, whether the claim “recommended by pharmacies nation- wide” and “a harm reduction alternative to smoking” was mis- leading and could be substantiated. Vapourlites stated that Santa’s hand was not used to attract children but to embrace the spirit of Christmas. The advertisement clarified that the product contained nicotine and could only be purchased by consumers aged over 18 years. 62 ASA Adjudication on Ten Motives Ltd., [2014] Complaint Ref: A13-250753, (https://www.tobaccocontrollaws.org/files/live/litigation/1714/GB_ASA%20 Adjudication%20on%20Ten%20Motive.pdf, accessed 27 June 2019) 63 ASA Adjudication on Vapourlites Ltd, [2014] Complaint Ref: A13-252488, (https://www.tobaccocontrollaws.org/files/live/litigation/1926/GB_ASA%20 Adjudication%20on%20Vapourlite.pdf, accessed 27 June 2019) Case summaries 50 22. ASA Adjudication on Vapourlites Ltd.63 Decision/Status The ASA noted that the advertisement was not shown in media targeted at children and only depicted Santa’s hand. Thus, the advertisement was not irresponsible. Vapourlites submission that it was the largest supplier of electronic cigarettes to independent pharmacies did not sub- stantiate the claim “recommended by pharmacies nationwide”. This claim suggested that the products were endorsed or promoted by both independent pharmacies and pharmacy chains. On this point, the claim breached the CAP Code. Further, no clinical evidence was submitted to support the claim that their electronic cigarettes were a ‘harm reduction alternative to smoking’ and therefore ASA held that it was misleading and unsubstantiated. Status: Decided | 2 April 2014 23. ASA Adjudication on E-Cigilicious64 Facts Issue Arguments Advanced A national press advertise- ment, was headed “Help your loved ones change their life this Christmas”. Further text stated “E-Cigs make the perfect present - a safer, cheaper, odorless [sic] alternative to smoking!” The ad- vertisement featured an image of a young woman wearing a Santa hat, holding an e-cigarette near her face. (i) whether the image used in the adver- tisement was irresponsible because it would likely appeal to children; (ii) whether the claim that e-cigarettes were a ‘safer’ alternative to smoking was misleading and could be substantiated; and (iii) whether the claim ‘help your loved ones change their life this Christmas’ implied that the product could be used as a smoking cessation device. E-Cigilicious submitted that they did not promote e-cigarettes as a smoking cessation device but as an alternate to smoking. Decision/Status ASA observed that the image and theme of Christmas was likely to be used for a variety of products, rather than products exclusively aimed at children. Thus, the advertisement was not irresponsible. E-Cigilicious had not provided documentary evidence from MHRA to support its claim that e-cigarettes were a safer alternative to smoking. As the claim had not been substantiated it was misleading and violated the CAP Code. Similarly, E-Cigilicious had no evidence to substantiate that the product could be used as a smoking cessation device. E-Cigilicious was directed not to make cessation claims in the future, unless they could provide robust evidence to sub- stantiate these claims. Status: Decided | 2 April 2014 64 ASA Adjudication on E-Cigilicious, [2014] Complaint Ref: A13-252279, (https://www.tobaccocontrollaws.org/files/live/litigation/1927/GB_ASA%20Adjudication%20 on%20E-Cigilici.pdf, accessed 26 June 2019) Case summaries 51 24. ASA Adjudication on NJOY Innovation Ltd.65 Facts Issue Arguments Advanced Two advertisements for NJOY electronic cigarettes were assessed in this complaint. The first one featured a mon- tage of scenes, which documented the friendship between two men and was set to a soundtrack. A voiceover stated “For everything friends do for each other. Return the fa- vour. Give a friend an NJOY King electronic cigarette. Made to satisfy”. On-screen text stated “Contains nicotine. 18+ to purchase”. In a final scene, the friends were having dinner in a restaurant with their partners and one friend was seen giving the other the product. An end frame featured the NJOY branding with a strapline stating “Made to satisfy”. The second advertisement featured the same scenes, soundtrack and on-screen text as the first advertise- ment. However, the voiceover stated “For everything friends do for each other. Return the favour. Friends don’t let friends smoke. Give them an NJOY King elec- tronic cigarette. Made to satisfy”. Whether the adver- tisements mis- leadingly implied that smoking the product was health- ier than smoking tobacco cigarettes? NJOY submitted that there was no reference to health benefits in the advertisement. Decision/Status The ASA concluded that neither the audio, visuals or on-screen text contained any express health claims relating to the product. No express claims were made that smoking the product was healthier than smoking tobacco cigarettes. Thus, the advertisement was not misleading. Status: Decided | 16 July 2014 25. ASA Adjudication on Nicofresh66 Facts Issue Arguments Advanced A billboard poster appeared in various locations in Belfast, and featured an elderly white woman sitting on a sofa alongside a young black man. The man had his arms around the woman and his eyes were closed, whilst the woman held an electronic cigarette and was looking directly at the camera. Text alongside the image stated “NO TOBACCO. NO TABOO”. Whether the adver- tisement was offen- sive on the grounds of race and age? It was submitted that the advertise- ment asserted that e-cigarettes were socially permissible and did not carry the same taboo as traditional smoking. 65 ASA Adjudication on NJOY Innovations Ltd., [2014] Complaint Ref: A14-258948, (https://www.tobaccocontrollaws.org/files/live/litigation/1928/GB_ASA%20 Adjudication%20on%20NJOY%20Innov.pdf, accessed 27 June 2019) 66 ASA Adjudication on Nicofresh, [2014] Complaint Ref: A14-268557 (https://www.tobaccocontrollaws.org/files/live/litigation/1930/GB_ASA%20Adjudication%20 on%20Nicofresh.pdf, accessed 27 June 2019) Case summaries 52 25. ASA Adjudication on Nicofresh66 Decision/Status The ASA observed that the consumers were likely to interpret the ad to imply that smoking e-cigarettes was not a taboo. Further, as the ad represented a relationship between an older and younger individual of a different race as something unusual or socially unacceptable, it was likely to cause widespread offence on the grounds of race and age. Status: Decided | 6 August 2014 26. ASA Adjudication on E&L Distributors67 Facts Issue Arguments Advanced A poster ad, on a bus shelter, for a brand of e-ciga- rettes. Text in the ad stated “E-CIGARETTES HAVE EVOLED. LEOLITES.COM. LOVE YOUR LUNGS”. Whether there was ev- idence to substantiate that the product was not harmful and that its use was beneficial to the health of users’ lungs? It was submitted that there was no health claim being made with the statement: “Love Your Lungs”. This claim could not be construed to imply that the product was harmless or beneficial to the health of consumers’ lungs. Decision/Status It was noted that the wording of the advertisement implied that Leolites e-cigarettes contained properties that were not harmful to its users’ lungs. However, no evidence had been submitted to demonstrate that Leolites products were beneficial to the health of users’ lungs or that the products were less harmful than traditional cigarettes or other brands of e-cigarettes. On this basis, it was concluded that the claim “Love Your Lungs” had not been substantiated and was misleading. Status: Decided | 13 August 2014 67 ASA Adjudication on E&L Distribution Ltd, [2014] Complaint Ref: A14-266193, (https://www.tobaccocontrollaws.org/files/live/litigation/1903/GB_ASA%20 Adjudication%20on%20E%26L%20Distri.pdf, accessed 1 July 2019) Case summaries 53 27. ASA Adjudication on Must Have Ltd.68 Facts Issue Arguments Advanced A television advertisement for VIP e-cigarettes featured a woman in a black dress, who spoke to the camera and said, “You know that feeling you get, when something’s great? You can touch it, hold it, even see it. Well, now you can taste it.” As she spoke she ran her hand over her thigh. The voice-over stated, “Choose the great taste of VIP e-cigarettes and e-liquids. Quality assured since 2009, with a variety of flavours and nicotine strengths from 0 to 24 mg. VIP.” Whether the adver- tisement was overtly sexual and irrespon- sibly sexualised e-cigarette use. Also, whether the claim ‘quality assured since 2009’ was mislead- ing and could be substantiated. It was submitted that there was mild innuendo but the advertisement did not sexualise e-cigarettes. Additionally, VIP provided the ASA with a range of reports showing product testing and analysis dating back to 2009. Decision/Status The ASA noted that the woman was depicted touching her leg in a sensual manner and that some viewers would find the advertisement distasteful, the sexual references were not explicit and could not be regarded as irresponsible. However, the sexuality though not overt was unsuitable for even older children and the advertisement should have been aired only post 9 PM. The range of reports submitted by the company established that the e-cigarettes conformed to the product testing and analysis since 2009. Thus, the quality claim assurance was substantiated. Status: Decided | 24 September 2014 28. ASA Adjudication on Cygnet UK Trading Ltd.69 Facts Issue Arguments Advanced A television advertisement depicted young adults setting up a party in an abandoned warehouse. It showed the group dancing to upbeat music played by a DJ. On-screen text and voice over stated, “Freedom for taking Blu e-cigarettes and e-liquids”. On-screen text stated, “Contains nicotine. 18+ only. Blu e-cigarettes are not a smoking cessation prod- uct and have not been evaluated by the MHRA”. Whether the ad- vertisement was irresponsible as it promoted a nico- tine-based product to young people? It was submitted that the product was advertised responsibly and did not encourage individuals under 18 to use the product. 68 ASA Adjudication on Must Have Ltd., [2014] Complaint Ref: A14-267854, (https://www.tobaccocontrollaws.org/files/live/litigation/1967/GB_ASA%20 Adjudication%20on%20Must%20Have%20.pdf, accessed 27 June 2019) 69 ASA Adjudication on Cygnet UK Trading Ltd., [2014] Complaint Ref: A14-275161, (https://www.tobaccocontrollaws.org/files/live/litigation/2159/GB_ASA%20 Adjudication%20on%20Cygnet%20UK%20.pdf, accessed 27 June 2019) Case summaries 54 28. ASA Adjudication on Cygnet UK Trading Ltd.69 Decision/Status It was noted that advertisers could legitimately advertise e-cigarettes, provided the advertisements were responsible and compliant with the Code. The party scenes in the advertisement were quite generic in nature. The on-screen text clearly stated that the product contained nicotine and consumers over the age of 18 years were able to exercise their own reasonable judgment whether to purchase the product or not. It was concluded that the advertisement did not breach the BCAP Code. Status: Decided | 15 October 2014 29. ASA Adjudication on E-Cig Ltd.70 Facts Issue Arguments Advanced A poster, for Neo e-cigarettes, showed an image of a woman using an e-cigarette and blowing va- pour into a man’s face. Headline text stated “neo E-CIGARETTE”, followed by the claim “SMOKING, REDEFINED”. The poster also included images of the packaged product in the bottom left-hand corner. Whether the adver- tisement was irre- sponsible because it promoted tobacco smoking? The word “E-Cigarette” featured promi- nently on the product logo. Further, the product depicted was in stark contrast to tobacco cigarettes. It was submitted that the advertisement did not promote or glamourize tobacco smoking. Decision/Status The most prominent text on the poster stated, “SMOKING, REDEFINED”. The main focus of the poster was the “smoke” and in combination with the headline text, the image, created a strong association with traditional tobacco smoking. Further, the woman was holding the e-cigarette in an elegant manner and these elements gave the advertisement a sultry and glamourous tone. Irrespective of whether the consumers recognised that the product was an e-cigarette, the glamorous presentation indirectly promoted tobacco smoking. Thus, it breached the CAP Code and was held to be irresponsible. Status: Decided | 12 November 2014 70 ASA Adjudication on E-Cig Ltd., [2014] Complaint Ref: A14-278009, (https://www.tobaccocontrollaws.org/files/live/litigation/2163/GB_ASA%20Adjudication%20 on%20E-Cig%20Ltd.pdf, accessed 27 June 2019) Case summaries 55 30. ASA Adjudication on Vape Nation Ltd.71 Facts Issue Arguments Advanced A television advertisement for KiK electronic cig- arettes (“e-cigarettes”) showed a group of adults using and discussing the products in an outdoor restaurant. One man in the group said, “I used to smoke normal cigarettes, but after I quit, I tried these. I actually prefer them.” Whether the adver- tisement breached the Code as it was likely to encourage non-smokers and particularly former smokers, to use the product? It was contended that the advertisement was aimed at current smokers and did not encourage non-smokers to take up e-cigarettes. Decision/Status ASA noted that the advertisement was in line with the CAP Code as it included actors who appeared to be over 25 years of age. Further, the visuals and comments clarified that the advertised product was an e-cigarette. However, the man’s statement could be understood by the consumers to mean that he had stopped smoking and thereaf- ter started using KiK e-cigarettes. This could encourage non-smokers to take up using e-cigarettes and thus the adver- tisement was irresponsible and breached rule 33.1 and 33.8 of the BCAP Code. Vape Nation was directed not to encourage ex-smokers or non-nicotine users to use e-cigarettes. Status: Decided | 24 December 2014 31. ASA Adjudication on Must Have Ltd.72 Facts Issue Arguments Advanced Complaints were filed against two television advertisements for VIP electronic cigarettes. The first one showed a woman using an e-cigarette and exhaling vapour. A voice-over stated, “Find out why 89% of our consumers said they pre- ferred VIP over other brands. VIP e-cigarettes and e-liquids. Quality assured since 2009. VIP.” The second one showed the same depiction of the woman using an e-cigarette. A voice-over stated, “The great taste of VIP. E-cigarettes and e-liquids. VIP.” The advertisements were challenged on four grounds: (a) promoted the use of tobacco products; (b) were overtly sexual and offensive; (c) appealed to people under 18 years of age and were irrespon- sible; and (d) encour- aged non-smokers or non-nicotine users to use e-cigarettes. The company submitted that it was clear that the product was an e-ciga- rette and was being used by a woman over 25 years of age. 71 ASA Adjudication on Vape Nation Ltd., [2014] Complaint Ref: A14-284845, (https://www.tobaccocontrollaws.org/files/live/litigation/2167/GB_ASA%20 Adjudication%20on%20Vape%20Natio.pdf, accessed 27 June 2019) 72 ASA Adjudication on Must Have Ltd., [2014] Complaint Ref: A14-284650, (https://www.tobaccocontrollaws.org/files/live/litigation/2165/GB_ASA%20 Adjudication%20on%20Must%20Have%20.pdf, accessed 27 June 2018) Case summaries 56 31. ASA Adjudication on Must Have Ltd.72 Decision/Status Out of the four grounds, ASA upheld the contention about promotion of tobacco products. The advertisements breached the CAP code as they indirectly promoted the use of tobacco products. It was observed that the advertisement created a strong association with traditional tobacco smoking by the manner in which the woman appeared to be using the product. The woman featured in the advertisement appeared to be over 25 years of age and did not breach the Code. Further, no explicit encouragement for non-smokers or non-nicotine users to use e-cigarettes was found. Status: Decided | 24 December 2014 32. ASA Adjudication on Mirage Cigarettes Ltd.73 Facts Issue Arguments Advanced A television advertisement, for electronic cigarettes, showed a man handing a woman an electronic cigarette. Several shots, included on-screen text that stated “CHOICE”, “FLAVOUR” and then “FREEDOM”. In the final scene, the couple was featured in va- pour-like clouds. Whether the adver- tisement glamourized smoking of tobacco products? Mirage Cigarettes submitted that the advertisement did not make any refer- ence to tobacco products. In fact, the products displayed in the advertisement were larger than tobacco cigarettes. The objective was to make consumers aware of the brand. Decision/Status The prominence of heavy vapour throughout the advertisement, in conjunction with the music and shots of the couple, contributed to the sultry and glamorous tone of the advertisement. Even though, it was clear that the products shown were electronic cigarettes, a strong association with traditional tobacco smoking was created. Thus, the advertisement indirectly promoted the use of tobacco products and breached the CAP Code. Mirage Cigarettes Limited were directed to ensure that their advertisements did not promote the use of tobacco products. Status: Decided | 29 April 2015 73 ASA Ruling on Mirage Cigarettes Ltd., [2015] Complaint Ref: A15-292291, (https://www.tobaccocontrollaws.org/files/live/litigation/2360/GB_ASA%20 Adjudication%20on%20Mirage%20Cig.pdf, accessed 27 June 2019) Case summaries 57 33. ASA Adjudication on Hubbly Bubbly74 Facts Issue Arguments Advanced Claims on the website www.hubblybubbly.uk.com were challenged by the Medicines & Healthcare products regu- latory Authority (MHRA). The content of the five advertise- ments promoting electronic cigarettes was as follows: a. The website listed famous celebrities who enjoyed using electronic cigarettes, like Leonardo DiCaprio, Katherine Heigl, and Johnny Depp. b. The Twitter page of Hubbly Bubbly had a banner image on top which depicted two young women using e-cigarettes. c. A tweet posted by Hubbly Bubbly showed an image of two young people using e-cigarettes standing in front of a row of spirit bottles. The accompanying text stated, “End of a very productive week at HB. Ready to kickoff the weekend! #TGIF”. d. Another tweet posted by Hubbly Bubbly showed a black-and-white image of a young woman holding an e-cigarette in a bar. Text stated, “Hubbly Bubbly - getting you through the midweek slump! #ECIG”. The Youtube video featured scenes including bars, clubs and a music concert. Product shots showing Hubbly Bubbly-branded packaging were interspersed with crowd scenes and individual shots of young people dancing, drinking and using e-cigarettes. Whether these five advertisements irresponsibly promoted the use of electron- ic cigarettes among youth and breached the CAP Code. Hubbly Bubbly after receiving noti- fication of the complaint from ASA voluntarily removed all of the adver- tisements under investigation and made the following submissions: - All the celebrities listed in the ad were adults and would not appeal to those under the age of 18. - The women depicted in advertise- ment (b) were adults and not behaving in an adolescent or juvenile manner. Decision/Status The CAP Code stated that marketing communications must state clearly if an advertised product contained nicotine. The ASA assessed the five advertisements in the following manner: a. The first advertisement under the heading “Famous E-Cigarettes Fans” appeared on the “social” page of the Hubbly Bubbly website. ASA concluded that the content was presented within a wider context and clearly stated that the products contained nicotine. However, the inclusion of celebrity names in the marketing communication created an association with youth culture and the advertisement was irresponsible in that context. b. The banner image on Twitter served to promote the whole range of products available on Hubbly Bubbly. However, some of Hubbly Bubbly’s products contained nicotine and this information was not clearly presented to the consumers along with the image. Thus, this advertisement breached the code. c. The Code stipulated that people shown using e-cigarettes or playing a significant role in the marketing communication for e-cigarettes must neither be, nor seem to be under the age of 25. On this point advertisements (b), (c) and (d) breached the CAP Code. d. The YouTube video was reminiscent of a rave scene, in which e-cigarettes featured prominently and would appeal to those aged under 18. Thus, the video advertisement also breached the CAP Code. Hubbly Bubbly was directed to ensure that its advertisements did not appeal to people under 18 years of age and did not feature people who were or seemed to be, under 25 years of age. Status: Decided | 10 June 2015 74 ASA Adjudication on Hubbly Bubbly, [2015] Complaint Ref: A15-300973, (https://www.tobaccocontrollaws.org/files/live/litigation/2337/GB_ASA%20 Adjudication%20on%20Hubbly%20Bub.pdf, accessed 27 June 2019) Case summaries 58 34. ASA Adjudication on Fontem Ventures75 Facts Issue Arguments Advanced ASA received 13 complaints objecting to a wrap- around press advertisement of Blu electronic cig- arettes published in the London Evening Standard. The front cover showed an image of the back of a nude woman with her head turned to look back towards the camera holding an electronic ciga- rette. The text alongside stated, ‘Just you & blu e-cigarettes’. Whether the ad- vertisement was offensive and overtly sexual to be placed on the front page of a regional newspaper? It was submitted that the Evening Standard was an appropriate publication for the ad because it had predominantly adult readership. Decision/Status The advertisement was considered sensual and sexually suggestive but was not sexually explicit. Thus, it was held that it did not breach the CAP Code and was not placed inappropriately. Status: Decided | 29 June 2016 75 ASA Ruling on Fontem Ventures BV, [2016] Complaint Ref: A16-340739, (https://www.tobaccocontrollaws.org/files/live/litigation/2553/GB_ASA%20 Adjudication%20on%20Fontem%20Ven.pdf, accessed 27 June 2019) Case summaries 59 35. ASA Adjudication on British American Tobacco UK Ltd.76 Facts Issue Arguments Advanced Seven Instagram posts by Vype were challenged before the ASA: i. A post on Instagram, from 10 February 2019, showed an e-cig- arette with the text “FROM ONE WINNER TO ANOTHER. WELL DONE” and “RAMI MALEK BOHEMIAN RHAPSODY LEADING ACTOR”. The post included the caption “And the winner is… #epen3 #vype #productoftheyear #vapecommunity. Oh and…#ramimalek #bohe- mianrhapsody #baftas #bestactor #baftas2019. Vype e-cigarettes contain nicotine. 18+ only. Read leaflet in pack”. ii. A post on Instagram, from 14 February 2019, showed an image of Lily Allen holding an e-cigarette with text which stated “LFW HOUSE OF HOLLAND CATWALK 16.02.19”. The post included the caption “The latest #HoHxVape collection will be revealed this weekend at #LFW, with @lilyallen and @houseofholland #govype #vape #vapecommu- nity #vapenation #vapelife #vaper #vapestagram #instavape #lon- donfashionweek #LilyAllen #HenryHolland #HouseOfHolland” and “Vype e-cigarettes contain nicotine. 18+ only. Read leaaet in pack”. iii. An Instagram story, from 16 February 2019, showed a woman us- ing an e-cigarette and included text which stated “Vype e-cigarettes contain nicotine. 18+ only. Read leaflet in pack”. iv. A post on Instagram, from 20 February 2019, showed Lily Allen holding an e-cigarette. The post included the caption “Wishing our friend #lilyallen the very best at tonight’s #BritAwards where she’s nominated for Best British Female Solo Artist! #vype #govype #vape #vapecommunity #vapenation #vapelife #vaper #vapestagram #instavape #lilyallen #bestbritishfemalesoloartist #britawards2019 Vype ecigarettes contain nicotine. 18+ only. Read leaflet in pack”. v. A post on Instagram, from 21 February 2019, showed Lily Allen behind DJ decks with a Vype banner in the background. The post was tagged with the location ‘Menagerie Restaurant & Bar’ and included the caption “We’ve taken #LFW to #Manchester. Great night with @lilyallen on the decks and @houseofholland partying with us. Were you there? #vype #epen3 #govype #vape #vapecommunity #HoHxVype” and “Vype e-cigarettes contain nicotine. 18+ only. Read leaflet in pack”. vi. A post on Instagram, from 21 February 2019, showed Olivia Jade Attwood smoking an e-cigarette with the caption “We’ve taken #LFW to #Manchester. Great night with @lilyallen on the decks and @houseofholland partying with us. Were you there? #vype #epen3 #govype #vape #vapecommunity #HoHxVype” and “Vype eciga- rettes contain nicotine. 18+ only. Read leaflet in pack”. vii. A post on Instagram, from 7 March 2019, showed a person’s hand holding an e-cigarette marked with ‘HOUSE OF HOLLAND’ and ‘vype’, while wearing an event admission bracelet with ‘HOUSE OF HOLLAND’. The post included the caption “Who could forget the time we took Vype to #LFW with our good friends @houseofhol- land. See more from #behindthescenes in our stories. #HoHxVype #ThrowbackThursday #vype #govype #vape #vapecommunity #vape- nation #vapelife #vaper #vapestagram #instavape and “Vype e-ciga- rettes contain nicotine. 18+ only. Read leaflet in pack”. Whether the detailed advertisements breached the code by promoting unlicensed, nic- otine-containing e-cigarettes on Instagram? Whether the advertisements breached the Code by featuring some- one who appeared to be under 25 years of age? BAT submitted that the information provided was factual in nature by ensur- ing that the content of their posts related to the prod- uct. Further, Vype related content only appeared in the feeds of Instagram users who sought out information regarding e-cigarettes. It was also submitted that the use of product-focused hashtags, as well as broad- er hashtags, only allowed information about Vype to reach users actively seeking it or users seeking information around vaping in general. 76 ASA Ruling on British American Tobacco UK Ltd., [2019], (https://www.tobaccocontrollaws.org/files/live/litigation/2710/GB_ASA%20Ruling%20on%20British%20 American.pdf, accessed 27 January 2020) Case summaries 60 35. ASA Adjudication on British American Tobacco UK Ltd.76 Decision/Status ASA examined whether the advertisements directly or indirectly promoted a nicotine-containing e-cigarette. Each ad- vertisement categorically stated that Vype e-cigarettes contained nicotine. Thus, the advertisements directly promoted unlicensed nicotine-containing e-cigarettes and violated rule 22.12 of the CAP Code. It was observed that content on an Instagram page was not similar to content on a marketers’ website, as there were mechanisms on social media to push content to consumers. In any case, the advertisements contained content that went beyond factual information about their product. BAT was directed not to publish marketing communications with the direct or indirect effect of promoting nicotine-contain- ing e-cigarettes and their components which were not licensed as medicines. Status: Decided | 18 December 2019 Case summaries 61 UNITED STATES OF AMERICA 1. Smoking Everywhere, Inc. & Ors. v FDA77 Facts Issue Arguments Advanced Smoking Everywhere and inter- venor plaintiff, Sottera, Inc. are distributors of electronic cigarettes (collectively referred as Plaintiffs). The inbound shipments of the two companies were denied entry into the United States, or detained under an order passed by the Food and Drug Administration on the ground that electronic cigarettes were an unapproved drug-device combi- nation under the Federal Food, Drug, and Cosmetic Act (FDCA). The Plaintiffs sought a preliminary in- junction barring FDA from refusing entry to its products into the United States on the basis that those prod- ucts are unapproved drug-device combinations under the FDCA. Whether FDA has the authority under the FDCA to regulate electronic cigarettes as a drug/device combination? Arguments advanced by Plaintiffs: It was asserted that electronic cigarettes qualified as a tobacco product and could not be regulated as a drug/device under the FDCA. Arguments advanced by FDA: It was submitted that electronic cigarettes fall beyond the scope of Brown & Williamson Tobacco case, and are subject to regulation under the FDCA as a drug-device combination. The defini- tion of ‘tobacco product’ under the Tobacco Act excludes “any article that is a drug, device, or a combination product under the FDCA”. Reliance was also placed on Smoking Everywhere’s promotional materials which state that its electronic cigarettes are intended to have a therapeutic effect. In particular, the materials state that electronic ciga- rettes provide a ‘healthier way’ to obtain effects of nicotine. Thus, electronic cigarettes would satisfy the definition of drug-device combination as an article “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” under s 321 (g) (1) (B) of the FDCA. Decision/Status Definition of tobacco product: The Court reasoned that it was illogical to classify electronic cigarettes as a drug-device combination on the basis that these devices delivered nicotine and had the same effect on the structure and function of the body as cigarettes, and thereby exclude them from the definition of “tobacco product”. This interpretation dismantles the regulatory wall erected by the Congress between tobacco products and drug-device combinations. It was inferred that the Congress enacted the Tobacco Act with the intent to permit nicotine use, whether from unforeseen, non-traditional sources (like e-cigarettes) or from well-established traditional sources (like regular cigarettes). Most importantly, the Court highlighted the expansive definition of tobacco products under the Tobacco Act as “any product made or derived from tobacco that is intended for human consumption”. Therapeutic claims: FDA’s argument that the product was marketed as a device to treat withdrawal symptoms of nicotine addiction was un- supported by substantial evidence. In fact, Smoking Everywhere’s promotional material was aimed, not toward preventing, mitigating, or treating nicotine addiction and the effects of withdrawal, but towards encouraging nicotine use. The over- arching theme of the marketing campaign highlighted that smoking electronic cigarettes was fun and exciting, and the product should be used at the same frequency as traditional cigarettes. The Plaintiffs’ motions were granted and it was held that the FDA did not have the authority to regulate e-cigarettes as a drug/device combination under the FDCA. Status: Decided | 14 January 2010 77 United States District Court, Smoking Everywhere Inc. v FDA, [2010] 680 F.Supp. 2d 62 (Columbia), (https://www.tobaccocontrollaws.org/files/live/ litigation/1493/US_Smoking%20Everywhere%20v.%20Food%20and.pdf, accessed 25 July 2019) Case summaries 62 2. Sottera, Inc. v FDA78 Facts Issue Arguments Advanced The Food and Drug Administration appealed against the order passed by the District Court (summarized above). Case law and Legislative Overview: In 1996, the FDA promulgated regulations affecting tobacco products as customarily marketed, i.e., ones sold without therapeutic claims. The agency argued that nicotine affected the structure and function of the body and that cigarettes and smokeless tobacco were drug/device combinations falling under the FDA’s regulatory purview, even without therapeutic claims. In FDA v. Brown & Williamson, the Supreme Court rejected FDA’s authority to regulate tobacco products as customarily marketed under the pro- visions of the FDCA. In 2009, the Congress passed the Tobacco Act bestowing FDA with the authority to regulate tobacco products. The Tobacco Act defined tobacco products to include all consumption products derived from tobacco except articles that qualify as drugs, devices, or drug-device combina- tions under the FDCA. Whether the source of authority for the Food and Drug Administration (FDA) to regulate electronic cigarettes stemmed from the drug/device provisions of the FDCA or from the Family Smoking Prevention and Tobacco Control Act of 2009. The only difference in the two acts is that the former gives the FDA the authority to ban them while the later regulates tobacco products. Arguments advanced by the Company: It was argued that the FDA could regulate e-cigarettes only under the Tobacco Act, based on the decision of the Supreme Court in the Brown & Williamson case which foreclosed FDCA drug/device jurisdiction over tobacco products marketed without claims of therapeutic effect. Further, it was submitted that the e-cigarettes were derived from natu- ral tobacco plants and marketed and labelled for “smoking pleasure”, rather than as a therapeutic or smoking cessa- tion product. Arguments advanced by FDA: It was submitted that Brown & Williamson took a statute-specific approach, and excluded the FDA from regulating only those tobacco products (cigarettes and smokeless tobacco) that had been the subject of the federal legislation. The FDCA preserves regulation under the FDCA for any product “made or derived from tobacco” that Brown & Williamson did not carve out of the FDCA’s coverage i.e. electronic cigarettes. Decision/Status It was held that FDA’s authority to regulate e-cigarettes stemmed from the Tobacco Control Act and not the FDCA. It was noted that the Brown & Williamson case and the Tobacco Act established that the FDA cannot regulate customarily marketed tobacco products under the FDCA’s drug/device provisions, that it can regulate tobacco products marketed for therapeutic purposes under FDCA provisions, and that it can regulate customarily marketed tobacco products under the Tobacco Act, including e-cigarettes. Status: Decided | 24 January 2011 78 United States Court of Appeals, Sottera, Inc. v FDA, [2010] 627 F.3d 891 (Columbia), (https://www.tobaccocontrollaws.org/files/live/litigation/1032/US_ Sottera%20v.%20Food%20%26%20Drug%20Adminis.pdf, accessed 27 June 2019) Case summaries 63 3. United States-Clove Cigarettes79 Facts Issue Arguments Advanced Indonesia brought a claim before the WTO against the United States concerning a law that prohibits cigarettes containing a constituent that is a charac- terizing flavour of tobacco or tobacco smoke, other than menthol or tobacco. Whether the US law discriminated against cigarettes produced in Indonesia? Among other things, Indonesia argued that the: (i) law is discriminatory because it treats clove cigarettes (primarily produced in Indonesia) less favourably than like menthol cigarettes (primarily of United States origin), in violation of Article 2.1 of the TBT Agreement; and (ii) prohibition is not necessary to achieve a legitimate objective, such as protection of human life or health, and that accordingly, the measure results in violation of Article 2.2 of the TBT Agreement. Decision/Status The WTO panel found that the US law discriminated against cigarettes produced in Indonesia in favour of cigarettes pro- duced in the US. In upholding the Panel Report, the Appellate Body found that the law fell heaviest on imported products and was not based solely on a legitimate regulatory distinction between the two product classes. In the latter respect, the Appellate Body emphasized that clove and menthol each mask the harshness of tobacco and that clove and menthol cigarettes are each attractive to youth. The Panel also rejected Indonesia’s argument that the prohibition of clove flavoured cigarettes was more trade restrictive than necessary under Article 2.2 of the TBT Agreement. This aspect of the Panel Report was not appealed. Status: Decided | 24 April 2012 79 World Trade Organization, Panel Report- United States- Measures affecting the production and sale of clove cigarettes, [2011] WT/DS406/R (https://docs.wto. org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/WT/DS/406R-01.pdf&Open=True, accessed 17 September 2020); World Trade Organization, Appellate Body Report- United States- Measures affecting the production and sale of clove cigarettes, [2012] WT/DS406/AB/R (https://docs.wto.org/dol2fe/Pages/SS/directdoc. aspx?filename=Q:/WT/DS/406ABR.pdf&Open=True, accessed 17 September 2020) Case summaries 64 4. U.S. Smokeless Tobacco Mfg. Co. v City of New York80 Facts Issue Arguments Advanced Plaintiffs (U.S. Smokeless Tobacco Manufacturing Company LLC and U.S. Smokeless Tobacco Brands Inc.) manufacture and distribute smokeless tobacco products, including flavoured smokeless tobacco. In 2009, the Plaintiffs filed a suit challenging the validity of a New York City ordinance which prohib- ited the sale of flavoured tobacco products except in a tobacco bar. It was alleged that the ordinance was preempted by the Family Smoking Prevention and Tobacco Control Act (Act) and sought an injunction against its enforcement. The trial court decided in favour of the Defendant. Aggrieved, the Plaintiffs filed an appeal against that order. Whether the New York ordinance was preempted by the FSPTCA (Act)? The Plaintiffs argued that the New York City ordinance was artfully crafted to evade express federal pre-emption. Decision/Status The Act prohibited FDA from banning entire categories of tobacco products throughout the country but did not constrain the power of state and local governments to impose restrictions. On the contrary, the preservation clause of s 916 of the Act expressly preserved localities’ traditional power to adopt any “measure relating to or prohibiting the sale” of tobacco products. Thus, the ordinance represented an exercise of local police power that Congress specifically allowed when it enacted the Act, and thus it is not preempted. Status: Decided | 26 February 2013 80 United States Court of Appeals, U.S. Smokeless Tobacco Mfg. Co., et al. v City of New York, [2013] 11-5167-cv (2d Cir. 2013)., (https://www.tobaccocontrollaws. org/files/live/litigation/1106/US_U.S.%20Smokeless%20Tobacco%20Mfg.%20v..pdf, accessed 22 July 2019) Case summaries 65 5. State of Vermont v R.J. Reynolds Tobacco Co.81 Facts Issue Arguments Advanced R.J. Reynolds (Company) on their website advertised a “saf- er” cigarette, ‘Eclipse’. The slogan for Eclipse stated, “The best choice for smokers worried about their health is to quit- the next best choice is to switch to Eclipse”. Other claims made by the Company on its website were: “Extensive scientific studies show that, compared to other cigarettes [Eclipse] May present less risk of cancer associated with smoking Because Eclipse primarily heats rather than burns tobacco, its smoke chemistry is fundamentally different, and the tox- icity of its smoke is dramatically reduced compared to other cigarettes.” The State filed the action against the Company on the ground that no medical or scientific studies were conduct- ed to prove these claims. The principal advertising state- ment challenged was part of a print advertisement of the Company: “Eclipse is “[a] cigarette that may present less risk of cancer, chronic bronchitis, and possibly emphysema”. The marketing plan of the Company was to feature prominently and aggressively promote the health benefits to existing smokers of switching to this non-traditional cigarette. In this case, the Court determined civil penalties to be awarded against the Company and any injunctive relief to be awarded to the State with respect to any future marketing or advertising. Whether each health claim in every re- gional advertisement constituted a sepa- rate violation of the Vermont Consumer Fraud (CFA), or a single violation. Arguments advanced by State: The Company deliberately made health claims about the Eclipse which implied that smokers would improve their chances of not developing tobacco related diseases. It was submitted that each and every instance of such claim should be counted as a violation under the CFA. Arguments advanced by the Company: The marketing and sales campaign for the Eclipse cigarettes was in view of an uninterrupted effort to promote the “less risk” claims. It was submitted that the sales of Eclipse in Vermont were only $12,000 in gross revenue. Thus, it should be liable to a maxi- mum amount of $10,000 in civil monetary penalties. Decision/Status It was held that each instance of deceptive marketing or promotional statement would constitute a separate violation. Thus, the Court accepted the State’s count of 6776 separate instances of deliberate and unsubstantiated health claims about Eclipse. It was noted that the Company acted deliberately and intentionally to pursue an extensive marketing cam- paign for Eclipse which featured “less risk” health claims. The Company spent $16.656 million on advertising and other marketing and promotional expenses for Eclipse. The Court assessed that the Company could be forced to take a charge back of 50% of the advertisement expense i.e. $ 8.328 million for its deceptive conduct. It was noted that the Company had stopped selling the Eclipse in 2007. However, its business endeavours focussed on researching innovative smoke-free products. This could provide the Company an opportunity to make deceptive state- ments of a similar nature as in the case of the Eclipse cigarette. Accordingly, a permanent injunction was issued against the Company prohibiting it from the marketing, sale, distribution, promotion or advertisement of a potentially reduced exposure product unless a long-term, epidemiological study “unequivocally” supported the health claims. Status: Decided | 3 June 2013 81 Vermont Superior Court, Civil Division, [2013] Docket No. S1087-05 CnC, (https://www.tobaccocontrollaws.org/files/live/litigation/1159/US_State%20of%20 Vermont%20v.%20R.J.%20Reyno.pdf, accessed 27 June 2019) Case summaries 66 6. National Association of Tobacco Outlets, Inc. et al v City of Providence, Rhode Island, et al82 Facts Issue Arguments Advanced The City of Providence adopted two ordinances con- cerning the sale of tobacco products. This summary is restricted to the ordinance that restricted sale of certain flavored tobacco products other than cigarettes. The Flavor Ordinance prohibited retailers from selling flavored tobacco products (other than cigarettes), such as flavored “cigars, pipe tobacco, snuff, chewing tobacco, dipping tobacco”, and other flavored tobacco products. The National Association of tobacco outlets filed a suit in the district court and alleged that the ordinances violated both federal and state law. Whether the Flavour Ordinance was pre-empted by the FSPTCA? It was submitted that the Flavor Ordinance was preempted by the Family Smoking Prevention and Tobacco Control Act (FSPTCA). Decision/Status The Court held that the “Flavour Ordinance” was not pre-empted by the Family Smoking Prevention and Tobacco Control Act. The Court placed reliance on the reasoning of U.S. Smokeless Tobacco Manufacturing Case. Status: Decided | 30 September 2013 7. Independents Gas & Serv. Stations Associations & Anr. v City of Chicago83 Facts Issue Arguments Advanced The Chicago City Council passed an ordinance that regulated the sale of flavoured tobacco products. The ordinance defined “flavoured tobacco product” as “any tobacco product that contains a constituent that im- parts a characterizing flavour”. The objective of the or- dinance was to reduce flavoured tobacco retail around schools. The Plaintiffs were, an association of small business owners and operators of gasoline service stations holding tobacco licenses in the City of Chicago, along with Quick Pick Food Mart a convenience store that sells flavoured tobacco products. The Plaintiffs sued the City of Chicago and inter alia challenged that the ordinance was pre-empted by the federal Family Smoking Prevention and Tobacco Control Act (FSPTCA). Whether the Ordinance was pre-empted by the FSPTCA? The Plaintiffs argued that the ordi- nance was a manufacturing regulation disguised as a sales regulation because it would reduce production of flavoured tobacco products. 82 US Court of Appeals for the First Circuit, National Association of Tobacco Outlets, Inc. et al v City of Providence, Rhode Island, et al [2013] No. 13-1053, F.3d (1st Cir.) (https://www.tobaccocontrollaws.org/files/live/litigation/1292/US_National%20Association%20of%20Tobacc.pdf, accessed 25 July 2019) 83 United States District Court, Illinois, Eastern Division, [2015] 112 F.Supp.3d 749 (N.D. Ill., 2015), (https://www.tobaccocontrollaws.org/files/live/litigation/2531/ US_Independents%20Gas%20%26%20Service%20Sta.pdf, accessed 25 July 2019) Case summaries 67 7. Independents Gas & Serv. Stations Associations & Anr. v City of Chicago83 Decision/Status It was noted that the State’s police powers are not pre-empted by the federal law unless clearly intended by the Congress. A bare reading of Section 387p(a)(1) indicates that the local government’s authority to adopt and enforce laws involv- ing the sale of tobacco products is preserved. Further, as in the U.S. Smokeless Tobacco case, the Court noted that the Chicago ordinance regulated flavoured tobacco products without stipulating manufacturing standards. It was concluded that the ordinance enacted by the Chicago City Council was not pre-empted as it did not stipulate any product standards. Status: Decided | 29 June 2015 8. In re NJOY, INC. Consumer Class Action Litigation84 Facts Issue Arguments Advanced The Plaintiffs filed a class action suit85, alleging that: (i) NJOY engaged in false and misleading advertis- ing, conveying that its electronic cigarettes are safer than regular tobacco cigarettes; (ii) NJOY omitted material information from its packaging, including both an ingredient list and the potential risks associated with certain ingredients. Whether the Plaintiffs satisfied the condi- tions for a class action suit? Relevant provision of Law: Under Rule 23(a), a class action is only proper if: (1) the class is so numerous that joinder of all members is impracti- cable; (2) there are questions of law or fact common to the class; (3)  the claims or defenses of the representative parties are typical of the claims or defenses of the class; and (4)  the representative parties will fairly and adequately protect the interests of the class. Decision/Status The Court concluded that the Plaintiffs failed to meet their burden of demonstrating that questions of law or fact common to class members predominate over any questions affecting only individual members. Further, the Plaintiffs did not offer a model capable of calculating damages on a class wide basis. Status: Decided | 2 February 2016 84 United States District Court, Central District of California, [2016] CV 14-428-JFW, (https://www.tobaccocontrollaws.org/files/live/litigation/2430/US_In%20re%20 NJOY%2C%20Inc.%20Consumer%20Clas.pdf, accessed 5 May 2019) 85 The Plaintiffs filed a motion to certify two statewide classes of purchasers of NJOY e-cigarettes: (1) a California class with claims based on both the alleged affirmative misrepresentations in NJOY’s advertising and the alleged omissions from NJOY’s packaging; and (2) a Florida class with claims based on alleged omissions from NJOY’s packaging. Case summaries 68 9. Nicopure Labs, LLC v Food and Drug Administration86 Facts Issue Arguments Advanced On May 10, 2016, the FDA exercised its discretion to deem e-cigarettes87 to be classified as “tobacco products” and sub- ject them to the set of federal laws that govern the promotion and marketing of conventional cigarettes (Rule). The Rule applied to “components” and “parts” of the newly deemed to- bacco products. Nicopure Labs, Inc. (Plaintiff), a distributor of open-system e-cigarettes and manufacturer of e-liquids, filed a suit to challenge FDA’s Rule. The ground for the challenge was three-fold: (i) FDA exceeded its authority by applying the Rule to empty cartridges and nicotine free e-liquids; (ii) it was arbitrary and capricious for the FDA to enact a rule that requires e-cigarette manufacturers to undergo premarket review; and (iii) The restriction on modified risk-statements prohibits manufacturers from making truthful and non-mis- leading statements about their products and ban on distribu- tion of free samples violates Plaintiff’s right to free speech. The Plaintiff prayed that the Rule be vacated and declared unlawful. Through a separate action, several state-wide trade associations88 representing the ENDS industry also chal- lenged FDA’s Rule on similar grounds. Whether the FDA exceeded its au- thority in applying the Rule to regulate open-system devices sold without any liquid and e-liquids that do not contain nicotine? Arguments advanced by the Plaintiff: It was submitted that the term “component” in the Tobacco Control Act was defined to “refer to items inseparable from the product made or derived from tobacco”. An empty ENDS device contains nei- ther tobacco nor anything derived from tobacco. Argument advanced by FDA: It was argued that the Rule applied to nicotine free e-liquids only in three circumstances: (i) when e-liquids claiming to be nicotine-free actual- ly contained high levels of nicotine; (ii) when the e-liquids were tobacco flavoured; and (iii) when the e-liq- uids are reasonably expected to be mixed with liquid nicotine and form a component of a tobacco product. Decision/Status The Court upheld the Rule stipulated by the FDA for the following reasons: FDA acted within the scope of its authority: The Court concluded that the agency acted within the scope of its statutory authority, it was legally permitted to regulate e-liquids and to consider refillable electronic nicotine delivery systems to be a ‘component’ of a tobacco product and therefore subject to regulation. The Plaintiff’s argument that a component or part must be physically connected to the whole, otherwise it would not be a component of an e-cigarette was found illogical. FDA’s authority to regulate nicotine free e-liquids: FDA does not derive its authority to regulate nicotine-free liquids by classifying them as a “tobacco product”, instead as a “component” that gets added to the mix. FDA’s rule was not arbitrary and capricious: It was not arbitrary and capricious for the FDA to decide to take action with respect to e-cigarettes. Evidence established that e-cigarettes deliver as much nicotine as other tobacco products. An alarming rise in e-cigarette use by middle and high school students was also reported. It was noted that given the prolif- eration of ENDS, there was significant variability in the concentration of chemicals amongst the products. Onerous compliance of pre-market review on ENDS: The Tobacco Control Act requires that all tobacco products undergo some kind of premarket review. In fact, in the regulatory impact analysis of the Rule, it was observed that the premar- ket review would result in fewer harmful or addictive products from reaching the market than would be the case in the absence of the Rule. It was held that FDA carefully assessed the costs and benefits of the Rule to the entire ENDS industry and did not make a “clear error of judgment”. Marketing restrictions in the Tobacco Control Act do not violate the First Amendment: After an analysis of relevant case law, the Court came to the conclusion that the Rule regulated conduct not speech. Distribution of free samples and regula- tion of modified risk statements did not violate the First Amendment rights of the Plaintiffs. Aggrieved by the District Court judgment, an appeal was filed. The United States Court of Appeals for the District of Columbia affirmed the judgment of the District Court.89 Status: Decided | 21 July 2017 86 U.S. District Court, District of Columbia, Nicopure Labs, LLC v Food and Drug Administration, [2017] F.Supp.3d, (https://www.tobaccocontrollaws.org/files/live/ litigation/2558/US_Nicopure%20Labs%2C%20LLC%20v.%20Food%20and.pdf, accessed 1 July 2019) 87 Exercised authority conferred upon in 21 U.S.C § 387 a(b). 88 The Right to be Smoke Free Coalition, American Vaping Association, Electronic Vaping Coalition of America, Georgia Smoke Free Association, Kentucky Vaping Retailers Association, Inc., Louisiana Vaping Association, Maryland Vaping Professionals, LLC, Ohio Vapor Association, Tennessee Smoke Free Association, and the New Jersey Retailers Coalition (collectively, “RSF”). 89 United States Court of Appeals for the District of Columbia Circuit, Nicopure Labs, LLC v FDA, [2019] No. 17-5196 Case summaries 69 10. American Academy of Pediatrics, et al v FDA, et al.90 Facts Issue Arguments Advanced The Campaign for Tobacco-Free Kids, in conjunction with other public health and medical organizations (Plaintiff Organizations), challenged the U.S. Food and Drug Administration’s decision to allow e-cig- arettes to remain on the market until 2022 before applying for FDA pre-market authorization (August 2017 Guidance). The FDA also delayed the deadline for cigar manufacturers to file such applications until 2021. The Plaintiffs challenged the August 2017 Guidance on three counts: (i) it was unlawful and exceeded FDA’s statutory authority; (ii) it was a deliberate ab- dication of FDA’s responsibilities under the Tobacco Control Act; (iii) it was arbitrary and capricious and not the product of reasoned decision making. Whether the FDA has the authority to issue the August 2017 Guidance? Arguments advanced by the Plaintiff Organizations: The August 2017 Guidance violates the Tobacco Control Act’s requirement of premarket review of newly deemed products before they are distributed to consumers. Arguments advanced by FDA: Firstly, it was argued that the Plaintiff Organizations lacked standing to bring the lawsuit as the August 2017 Guidance caused no cognizable harm to them. Secondly, the FDA had unreviewable discretion in deciding how to enforce the Tobacco Control Act and its rules. Thirdly, the August 2017 Guidance was not final agency action and was beyond the reach of judicial review. Decision/Status The Court held that the FDA through the August 2017 Guidance abdicated its statutory duty to review new tobacco prod- ucts in a prompt fashion. Accordingly, the August 2017 guidance was vacated for the following reasons: Plaintiff Organizations standing to bring the lawsuit: It was noted that the Plaintiff Organizations had standing to bring the lawsuit as the August 2017 Guidance impacted their mission of increasing awareness about tobacco addiction and efforts to avert the creation of new generations of addicted children and adults. Further the Guidance, denied the Plaintiff Organizations access to information required by the Tobacco Control Act. Scientific data on the contents of novel tobacco products and their physiological consequences are crucial to the American Cancer Society Cancer Action Network’s (ACS CAN) ability to identify effective and feasible product standards. The situation forces ACS CAN to invest more resources in monitoring the market and the products on the to determine where the greatest risks for public health were arising. Traceable Injury: It was noted that the FDA had not issued any orders on premarket tobacco product applications since 2015 or taken any final action on any premarket tobacco product applications since June 2017. The Plaintiff Organizations injuries arise from the FDA’s actions to exempt certain products from premarket review for years. Judicial Review of Non-enforcement decision: It was noted that the language of the Tobacco Control Act with respect to consideration of premarket applications was mandatory and not discretionary. Thus, FDA’s decision not to undertake premarket review was subject to judicial review. The August 2017 Guidance expressed the definitive legal position by FDA to delay the premarket review requirement. Tobacco Control Act’s Provisions and Extent of FDA’s Statutory Authority: The August 2017 Guidance defeated the purpose of the Tobacco Act by providing a five-year compliance safe harbour for newly deemed tobacco products. Status: Decided | 15 May 2019 90 United States District Court, District of Maryland, American Academy of Pediatrics, et al v FDA, [2019] Case No. PWG-18-883, (https://www.tobaccocontrollaws. org/files/live/litigation/2645/US_American%20Academy%20of%20Pediatrics.pdf, accessed 27 June 2019) Case summaries 70 11. Junaid & Areeb Corp v Morris91 Facts Issue Arguments Advanced The Plaintiffs, a group of convenience store owners in Walpole, Massachusetts, challenge Walpole Board of Health’s regulation prohibiting convenience stores and other retails from selling mint, menthol, and wintergreen fla- voured tobacco products and flavoured e-cigarettes. Those products would be sold in adult-only retail tobacco shops. Whether the regu- lation passed by the Health Board is arbi- trary and capricious? Arguments advanced by the Plaintiff: It is alleged that the regulation is arbitrary, capricious, and not rationally related to the Board’s stated purpose of prevent- ing underage tobacco use. Decision/Status The Plaintiffs motion for preliminary injunction was denied. It was held that there was sufficient evidence before the Court that the Board based the regulation on information and research that gave rise to grave concerns about teen tobacco and e-cigarette use and that flavoured tobacco products are the most common entry point for such potentially addictive use. Status: Decided | 1 August 2019 12. Cumberland Farms Inc. v Bd. Of Health of Barnstable92 Facts Issue Arguments Advanced The Plaintiff owns and operates a chain of retail conve- nience stores in six cities and towns in Massachusetts. The Defendants in this case are elected boards of health in the six cities and towns that issued regulations that limit the sale of flavoured tobacco products to adult-only smoke shops and/or adult-only smoking bars. It is alleged by the Plaintiffs that the regulations implemented by the Defendants’ are be- yond the scope of their constitutional authority and violate the equal protection clause and due process rights. Whether the regula- tions implemented by the Defendant Health Boards violate the Massachusetts Declaration of Rights? Arguments advanced by the Plaintiffs: Removing flavoured ENDS from convenience stores will harm the public because the product represents a safer alter- native to combustible tobacco and serves as a means for smokers to reduce or quit tobacco. Decision/Status It was held that the inclusion of flavoured ENDS in the municipal bans is rational because ENDS have been linked as a gateway to subsequent tobacco use. Convenience stores, absent the regulations, could serve as a recruitment venue for youths not already interested in buying flavoured tobacco products. Accordingly, the Plaintiffs motion for preliminary injunctions was denied. Status: Decided | 29 August 2019 91 Superior Court of Massachusetts, Junaid & Areeb Corporation v William Morris et al., [2019] 36 Mass. L. Rep. 53 92 Superior Court of Massachusetts, Cumberland Farms, Inc v Board of Health of the Town of Barnstable et al., [2019] 36 Mass L. Rep 21 Case summaries 71 13. Vapor Tech Association v Baker93 Facts Issue Arguments Advanced During the EVALI outbreak, an emergency order was passed prohibiting the sale or display of all vaping products to consumers until January 25, 2020, in Massachusetts.94 The Plaintiffs challenged this order on the ground that it was reflective of executive overreach and sought injunctive relief to invalidate the order. Whether the Public Health Council (Council) overstepped its authority in adopt- ing the emergency regulation? Arguments advanced by Plaintiffs: The Council did not have the legislative power to adopt an emergency order of this nature and thus violated separation of governmental powers. Arguments advanced by the Defendants: Upon declaration of a public health emergency by a Governor, the Public Health Council may take such action as he may deem necessary to assure the maintenance of public health and the prevention of disease. Decision/Status It was held that the Order was promulgated without consideration and in disregard of facts and circumstances from the public and affected persons. The Plaintiffs have established irreparable harm because the Order puts many companies out of business for four months and have a likelihood of success in establishing that the Order exceeded any authority delegated by the legislature. The Court also noted that an immediate injunction against the entire order would contravene public interest. Thus, the Health Commissioner is directed to pass the emergency order after curing the defects indicated in the order. Status: Decided | 21 October 2019 93 Superior Court of Massachusetts, Vaor Tech Association v Baker, [2019] WL 6050041 94 The Order’s operative paragraph read: The sale or display of all vaping products to consumers in retail establishments, online and through any other means, including all non-flavoured and flavoured vaping products, including mint and menthol, including tetrahydrocannabinol (THC) and any other cannabinoid, is prohibited in the Commonwealth. Case summaries 72 14. Vapor Tech Association v Raimondo95 Facts Issue Arguments Advanced In September 2019, Governor Raimondo issued an executive order titled “Protecting Rhode Island Youth Against the Harms of Vaping”. The Executive Order, inter alia, directed the DOH to “promulgate emergency regulations to prohibit the sale of fla- voured ENDS. Accordingly, emergency regulations were issued that completely ban “the manufacture, distribution, sale, or offer for sale of, or the pos- session with intent to manufacture, distribute, sell, or offer for sale flavoured ENDS to consumers”. The regulation carves out an exception for tobacco flavoured or unflavoured vaping products. The Plaintiffs challenged the enforcement of the emergency regulations and sought declaratory and injunctive relief. Whether the emergen- cy regulations passed violate the separation of powers doctrine? Arguments advanced by the Plaintiffs: It is submitted that a restraining order should be passed against the emergency regulations because it may cause former smokers to return to cigarettes or turn to the unregulated black market. Arguments advanced by the Defendants: In light of the public health crisis asso- ciated with vaping, it weighs in favour of public interest to temporarily ban flavoured vaping products. Smokers that intend to quit will still have access to to- bacco flavoured or unflavoured nicotine vaping products. Decision/Status It was held that the Defendant’s determination of an imminent peril and the enactment of emergency regulations was proper, expedient and necessary to combat the youth vaping crisis. Thus, the Plaintiff’s failed to carry their burden for the issuance of a temporary restraining order. Status: Decided | 5 November 2019 15. Matter of Vapor Tech Association v Cuomo96 Facts Issue Arguments Advanced During the EVALI outbreak in the United States, Governor Cuomo through an executive order in September, 2019 banned possession, manufacture, distribution, sale or offer to sell any flavoured e-liq- uids and related products in New York. The ban ap- plied to flavoured e-liquids whether they contained nicotine or not. The ban did not apply to tobacco flavoured, menthol flavoured, or flavourless liquids. The emergency regulation was challenged by the Petitioners, a vapor technology association. Whether the Public Health and Health Planning Council (Council) overstepped its authority in adopt- ing the emergency regulation? Arguments advanced by Petitioner: It is submitted that 90% of the e-liquids cur- rently sold by the Petitioners fall within the definition of the products banned by the emergency regulation, and would render it impossible for their businesses to continue operation in New York. Arguments advanced by the Respondents: The goal of the emergency regulation was to reduce the attraction of vaping for younger consumers. 95 Superior Court of Rhode Island, Vapor Tech Association v Raimondo, [2019] C.A. No. PC-2019-10370 96 Supreme Court of New York, Matter of Vapor Tech. Assn. v Cuomo, [2020] 118 N.Y.S. 3d 397 Case summaries 73 15. Matter of Vapor Tech Association v Cuomo96 Decision/Status The Court held that the Council overstepped its authority in adopting the emergency regulation, as the regulation was a statement of public policy instead of an exercise of technical expertise. The emergency regulation carved out an exception for tobacco and menthol flavoured e-liquids, without any evidence that these flavours had been eliminated from the list of substances shown to trigger the spate of pulmonary diseases in New York. It was also noted that the emergency regulation was less of an effort at filing in the blanks left by a broad legislation and more of an attempt to set a State policy limiting the availability of vaping products in New York. This action is constitution- ally reserved for the Legislature and not the executive branch of the government. Accordingly, the Court granted the Petitioner’s motion for preliminary injunction because it would save businesses without hampering the government action through constitutionally appropriate legislative channels. Status: Decided | 8 January 2020 16. Jooce & Ors. v FDA97 Facts Issue Arguments Advanced E-cigarette manufactures and retailers challenge the Deeming Rule issued by the FDA that classifies e-cigarettes as ‘tobacco products’ and subject to regulation under the Family Smoking Prevention and Tobacco Control Act. Whether the deem- ing rule violates the Appointments Clause and the First Amendment? Arguments advanced by the Plaintiffs: The pre-clearance requirement in the Tobacco Control Act violates the First Amendment because it places the burden on manufacturers to show that certain of their marketing claims are truthful and not misleading. Decision/Status It was held that placing the burden on manufacturers to substantiate their marketing claims does not violate the First Amendment as held in the Nicopure Labs case. Thus, the Tobacco Control Act’s premarket review provisions do not imper- missibly burden speech. Status: Decided | 11 February 2020 97 United States District Court for the District of Columbia, Jooce v FDA, [2020] Case No. 18-cv-203 (CRC) Case summaries 74

Case summaries A Benn McGrady and Kritika Khanijo COMPARISON ACROSS JURISDICTIONS LITIGATION RELEVANT TO REGULATION OF NOVEL AND EMERGING NICOTINE AND TOBACCO PRODUCTS CASE SUMMARIES Case summaries B Case summaries C LITIGATION RELEVANT TO REGULATION OF NOVEL AND EMERGING NICOTINE AND TOBACCO PRODUCTS CASE SUMMARIES Litigation relevant to regulation of novel and emerging nicotine and tobacco products: case summaries ISBN 978-92-4-002418-2 (electronic version) ISBN 978-92-4-002419-9 (print version) © World Health Organization 2021 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. 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The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. Introduction INTRODUCTION Novel and emerging tobacco products have presented a number of challenges for regulators, including the risk that regulation may lead to litigation. The report titled ‘Litigation Relevant to Regulation of Novel and Emerging Nicotine and Tobacco Products’ analyses litigation concerning tobacco and nicotine product regulation across jurisdictions, with the aim of highlighting the legal arguments advanced and the reasoning of courts relevant to novel and emerging nicotine and tobacco products. In this regard, 89 cases between 2008-2020 were identified as relevant. The report identifies two broad categories of litigation. The first concerns measures addressing product characteristics and disclosures. This group of cases concerns legal challenges against measures which prescribe the form that a product may or may not take, including, classification of these products under national legislation, proportionality of product prohibi- tions, and flavour bans. The second category of cases concerns health claims and advertising, promotion and sponsorship. These concern application of laws to different products, including enforcement actions concerning misleading conduct and restrictions on advertising, promotion, and sponsorship. This document contains summaries of the cases identified as relevant, including those described in the report. This docu- ment describes the facts, legal issues, arguments advanced, and reasoning of the courts. Case summaries F Case summaries 1 AUSTRALIA 1. Hawkins v Van Heerden1 Facts Issue Arguments Advanced 60 packages of electronic cigarettes were found with Mr. Van Heerden (accused) and he was charged under s 106 (a) of the Tobacco Products Control Act 2006 (Act), which states: ‘A person must not sell any food, toy or other prod- uct that is not a tobacco product but is: (a) designed to resemble a tobacco product….’. The accused pleaded not guilty to the charge and was acquitted before the Magistrate Court. The Ld. Magistrate held that the items were ‘other products’ for the purposes of s 106 but not designed to resemble a tobacco product and thus the charge had not been proved. Against this order, an appeal was filed by the Department of Health (Appellant) before the Supreme Court of Western Australia. Whether the overall characteristics of the items resembled a tobacco product and the Ld. Magistrate erred in interpreting the phrase ‘designed to resemble’ in s 106 of the Act? The Appellant contended that the Ld. Magistrate failed to construe the phrase ‘designed to resemble’ in its entirety and confined the analysis to the products’ physical appearance. Decision/Status ‘Other Product’: It was held by the Ld. Magistrate that the items fell within the ambit of ‘other product’ as per s 106 of the Act. This finding was challenged by the accused in the appeal filed as a cross appeal. The Supreme Court was unable to accept the contentions raised by the accused. It was held that a construction of s 106 of the Act which resulted in its application to all products designed to resemble a tobacco product, advanced the purposes of the Act better than a narrow construction which confined it to products similar to food or toys. ‘Designed to resemble’: It was noted that this phrase in s 106 of the Act referred to a product which was intended to have a likeness or similarity to, or to have some feature in common with a tobacco product. Further, the provision was expressly directed to products which were not tobacco products. Whether the product was intended to have a likeness or similarity to, or common features with a tobacco product would be ascertained by taking into account all the features and essential characteristics of the product. The Magistrate’s Court erred in focusing only on the physical appearance of the items to ascertain whether the product was ‘designed to resemble’ a tobacco product under s 106 of the Act. The Court by placing reliance on the evidence of the accused came to the conclusion that the items were essentially elec- tronic inhalers that vaporize a liquid solution into a mist for inhalation, akin to smoke from a cigarette. Reliance was also placed on the user manual of the items where a comparison was drawn with cigarettes. The appeal was allowed and the decision to acquit the accused of the charge was set aside. Status: Decided | 10 April 2014 1 Supreme Court of Western Australia, Hawkins v Van Heerden, [2014] WASC 127, (https://www.tobaccocontrollaws.org/files/live/litigation/1754/AU_ Hawkins%20v.%20Van%20Heerden.pdf, accessed 15 September 2020) Case summaries 2 2. Australian Competition and Consumer Commission v The Joystick Company2 Facts Issue Arguments Advanced It was alleged that the Joystick Company Pty Ltd. (Joystick), in contravention of the provisions of the Australian Consumer Law (ACL), engaged in misleading or deceptive conduct for the sale of its e-cigarettes. Joystick represented on its website that the e-cigarettes: (a) did not contain carcino- gens and toxic substances; (b) did not contain any of the carcinogens and toxic substances found in traditional tobacco cigarettes; (c) did not contain Formaldehyde; and (d) all flavours had received approval from the Australian Competition and Consumer Commission (ACCC), when that was not the case. Alleged violation of the Australian Consumer Law. Joystick and Mr. McDonell (Director of Joystick) accepted the allegations and prayed for a consent order to be passed. Decision/Status Joystick and Mr. Alexander McDonell (Director of Joystick) were directed to pay $50,000 and $10,000 respectively. Further, Mr. McDonell gave an undertaking that for a period of three years he would not engage in the supply, possible supply, sale or promotion of e-cigarette products. Status: Decided | 2 May 2017 Similar Cases3: The Australian Competition and Consumer Commission (ACCC) filed similar complaints against Social- Lites Pty Ltd. and Burden. In both these cases, the companies accepted the allegations. The ACCC imposed penalties and restrained the companies from selling e-cigarettes similar to the Joystick case. 2 Federal Court of Australia, ACCC v The Joystick Company, [2017] FCA 397, (https://www.tobaccocontrollaws.org/files/live/litigation/2541/AU_Australian%20 Competition%20and%20Con.pdf, accessed 15 September 2020) 3 Federal Court of Australia ACCC v Social-Lites Pty Ltd., [2017] FCA 398, (https://www.tobaccocontrollaws.org/files/live/litigation/2542/AU_Australian%20 Competition%20and%20C n.pdf, accessed 15 July 2019) and ACCC v Burden, [2017] FCA 399, (https://www.tobaccocontrollaws.org/files/live/litigation/2543/ AU_Australian%20Competition%20and%20Con.pdf, accessed 15 July 2019) Case summaries 3 BRAZIL 1. Sinditabaco v ANVISA4 Facts Issue Arguments Advanced A Brazilian tobacco lobbying group, Sinditabaco, brought an action to stop the National Health Surveillance Agency, ANVISA, from implementing a rule to ban the use of additives and flavorings in cigarettes. Whether ANVISA had the legal authority to ban the use of addi- tives and flavourings in cigarettes? The group argued that ANVISA did not have the legal authority to make the rule and that the rule was not sup- ported by any scientific evidence as to the health effects of the flavorings. The group claimed the rule would affect over 95% of tobacco users and presented a petition signed by various stakeholders in the tobacco product supply chain claiming that it would cause billions of dollars of losses. The legal representatives of ANVISA were not present at the hearing on the issue. Decision/Status The court agreed to grant the preliminary injunction stopping the implementation of the rule, pending a hearing on the merits of the case.5 Status: Decided | 17 December 2012 2. National Confederation of Industry (Confederação Nacional da Indústria) v ANVISA6 Facts Issue Arguments Advanced In 2012, Brazil banned tobacco additives and flavors, with the exception of sugar. The National Confederation of Industry (Confederação Nacional da Indústria) challenged the ban. - - 4 Federal Court of the Federal District (Brazil), Sinditabaco v ANVISA, [2012] Decision No. 323-B/2012, (https://www.tobaccocontrollaws.org/files/live/ litigation/1098/BR_Sinditabaco%20v.%20ANVISA.pdf, accessed 25 July 2019) 5 Case summary is the original work of the Campaign for Tobacco-Free Kids and directly excerpted from the Tobacco Control Laws Database (https://www. tobaccocontrollaws.org/litigation/decisions/br-20121217-sinditabaco-v.-anvisa, accessed 29 July 2019) 6 Supreme Federal Court of Brazil, National Confederation of Industry (Confederação Nacional da Indústria) v ANVISA, [2018] Direct Action of Unconstitutionality (ADI) 4874, Unique Number: 9984745-20.2012.1.00.000, (https://www.tobaccocontrollaws.org/files/live/litigation/2634/BR_National%20Confederation%20of%20 Indu.pdf, accessed 26 July 2019) Case summaries 4 2. National Confederation of Industry (Confederação Nacional da Indústria) v ANVISA6 Decision/Status The Supreme Federal Tribunal, Brazil’s highest court, upheld the 2012 regulation and affirmed the Brazilian Health Regulatory Agency’s (ANVISA) right to regulate tobacco products. The court held that freedom of enterprise does not prevent Brazil from imposing conditions and limitations on private activities. The court found that while businesses have rights, they must be compatible with other fundamental and constitutional rights. In the case of tobacco control, these fundamental and constitutional rights include the right to health and the right to information. The court further held that the risks associated with tobacco consumption justify the tobacco market being subjected to intense health regulations. Because the court failed to reach a majority (5-5 tie), the decision is not binding on other tribunals, and, by not reaching a majority, the court rejected the constitutionality claim against the ANVISA regulation (“Resolução da Diretoria Colegiada da ANVISA 14/2012”).7 Although the decision is not binding because of a lack of quorum, it is unlikely that subsequent challenges to the regulation would be decided differently. Status: Decided | 1 February 2018 7 Case summary is the original work of the Campaign for Tobacco-Free Kids and directly excerpted from the Tobacco Control Laws Database (https://www. tobaccocontrollaws.org/litigation/decisions/br-20180201-national-confederation-of-indu, accessed 29 July 2019) Case summaries 5 CANADA 1. Zen Cigarette Inc. v Health Canada8 Facts Issue Arguments Advanced In 2011, the Inspectorate Program of Health Canada prohibited importation of Zen’s 200 cartridges, each with 18 mg of nicotine. The prohibition was based on the Food and Drug Regulations, under which it is stipulated that other than a practitioner, a drug manu- facturer, a wholesale druggist, a registered pharmacist, or a resident of a foreign country while a visitor in Canada, shall not import a Schedule ‘F’ drug. Nicotine is a drug identified in Schedule F of the Regulations. Zen oper- ates a business of selling electronic cigarettes and could not legally import and sell electron- ic cigarettes in Canada without an establish- ment licence. Aggrieved by the decision of Health Canada, Zen filed its application for judicial review. Whether Health Canada’s decision to prohibit the entry of electronic cigarettes imported by Zen is reasonable? Arguments advanced by Zen: (i) The electron- ic cigarettes fall under the exception set out in paragraph (d) of Schedule F because the electronic cigarette cartridges deliver 4 mg or less of nicotine per dosage unit; (ii) Electronic cigarettes are not a medicament and thus there is no dosage; (iii) With respect to electronic cig- arettes, the dosage unit should be the dosage delivered per inhalation which does not exceed 4 mg of nicotine. Thus it is submitted that Health Canada’s decision is ultra vires. Arguments advanced by Health Canada: (i) Electronic cigarettes contain nicotine, which modifies organic functions and thus falls under paragraph 2(b) of the Act; (ii) Further, as Zen’s website claims that electronic cigarettes may assist with tobacco cessation, it meets the definition of drug in paragraph 2(a) of the Act; (iii) Zen violated the Regulations because it did not obtain an establishment licence before importing its electronic cigarettes; (iv) The electronic cigarettes do not fall under excep- tion of ‘inhalation device delivering 4 mg or less of nicotine per dosage unit’ in paragraph (d) of Schedule F. Decision/Status Health Canada’s decision to prohibit the entry of electronic cigarettes imported by Zen was held as reasonable on the following grounds: (i) The evidence established that Zen promoted electronic cigarettes for the treatment of nicotine addiction and thus qualified as a drug under Section 2(a) of the Act; (ii) Further, electronic cigarettes are a drug under paragraph 2(b) of the Act because the evidence submitted clearly shows that nicotine modifies organic functions in human beings; (iii) No scientific evidence was produced by Zen to establish that the dosage unit fell under exception (d) of Schedule F of the Regulations; (iv) It was clear that Zen imported electronic cigarettes to sell them in Canada without an establishment licence. Status: Decided | 11 December 2012 8 Federal Court of Canada, Zen Cigarette Inc. v Health Canada, [2012] FC 1465 Case summaries 6 COLOMBIA 1. Director of CPI of SIC v Coltabaca S.A.S et al9 Facts Issue Arguments Advanced The Directorate of Consumer Protection Investigations under the Superintendence of Industry and Commerce initiated an investiga- tion about marketing of IQOS after receiving a complaint that a picnic festival in 2017 was sponsored by IQOS. A direction was sent to Coltabaco and Philip Morris Colombia to sup- ply information about advertising and market- ing plans for the product in Colombia. Whether the IQOS de- vice is subject to the publicity restrictions stipulated under Law No. 1335 of 2009 in Colombia? Submissions by Coltabaco and Philip Morris: (i) Studies prove that the aerosol generated from IQOS contains be- tween 90% and 95% less toxic components compared to the smoke generated by combustion of tobacco. (ii) IQOS is an electronic device and not subject to the authorization by Ministry of Salud. Further, pictograms and warnings issued by the Ministry of health are for cigarettes and not applicable to Heets (insert- ed into the IQOS device) because of different product characteristics. (iii) The company was present at the 2017 Picnic festival to sell IQOS and HEETS but did not sponsor the event. Submissions by the Attorney General’s office: (i) As Heets is a product made from tobacco leaf, it must comply with the norms contemplated in Law No. 1335 of 2009 (principal tobacco legisla- tion) and the pronouncements of the Constitutional Court with respect to publicity, promotion and sponsorship (judgment C-830 of 2010). (ii) Despite a national law that explicitly prohibits advertising, pro- motion and sponsorship of tobacco products, these rules have not been applied to IQOS as it openly advertises and promotes through various channels of communication to potential consumers. (iii) It was requested from the SIC to demand Coltabaco and PMI Colombia S.A to cease any type of advertising, promotion and spon- sorship of the IQOS product in the Colombia territory. Submissions by the Ministry of Health and Social Protection: (i) IQOS devices regardless of how they are turned on are covered by tobacco control legislation. The Ministry demanded that the label- ling and packaging requirements be complied for Heets but not the IQOS device. Decision/Status It was observed by the Directorate that in spite of the authority (article 12 of Decree 4886/2011) to investigate infractions of the provisions contained in the tobacco law (No. 1335 of 2009) and apply sanctions contained therein, the prohibitions with re- spect to advertising, promotion and sponsorship do not apply to the IQOS device as it is not a tobacco product or a derivative. In light of this reasoning, it was decided that IQOS escapes the scope of competence provided by the legislator under Law No. 1335 of 2009. Status: Decided | 27 December 2019 9 The Directorate of Consumer Protection Investigations of the Superintendence of Industry and Commerce (Colombia), Dir. of SIC v Coltabaco S.A.S et al., [2019] No. 17-82520—58-0, (https://www.tobaccocontrollaws.org/litigation/decisions/co-20191227-sic-decision-on-iqos-marketing, accessed 7 July 2020) Case summaries 7 EUROPEAN UNION 1. Pillbox 38 (UK) Ltd. v Secretary of State for Health10 Facts Issue Arguments Advanced Pillbox 38 (UK) Ltd., an e-cigarette manufacturer (Company), sought judicial review against the United Kingdom concerning its intention to implement the TPD into domestic law and claimed that the TPD was not valid. Article 20 of the TPD sets out require- ments for e-cigarettes for all EU Member States. The Company challenged the legality of Article 20 of the TPD. The UK court considered the arguments advanced by the Company as reasonable and referred the question of validity of Article 20 of the TPD to the Court of Justice of the European Union (CJEU). Whether Article 20 of the TPD violated prin- ciples of proportional- ity, legal certainty, and equal treatment? It was submitted that Article 20 of the TPD is invalid on the ground that its pro- visions infringe the principles of propor- tionality, legal certainty, equal treatment, free competition and subsidiarity. A viola- tion of Article 16 (freedom to conduct business) and 17 (right to property) of the Charter of Fundamental Rights of the EU was also alleged. Decision/Status It was concluded that no factor affected the legality of Article 20 of the TPD. Equal Treatment and free competition: It was argued that Article 20 subjects less favourable treatment for e-cigarettes compared to tobacco products, even though e-cigarettes are less harmful than tobacco products. In this regard, the Court highlighted that e-cigarettes display different objective characteristics than tobacco products. Firstly, e-cigarettes are used for the consumption of nicotine. Secondly, their consumption does not require combustion but takes place through a function of electrical or electrochem- ical vaporization of the liquid contained in the refill containers. Thirdly, e-cigarettes are relatively new products whose risks to human health still need to be clarified. Accordingly, e-cigarettes are not in the same situation as tobacco products. Thus, the EU legislature has not infringed the principle of equal treatment. Proportionality and Legal Certainty: In light of mixed evidence on the risks posed by e-cigarettes, it was held that application of the requirements was propor- tional and justified. The specific rules ensured smooth functioning of the internal market, albeit adopting a high level of protection for human health. Violation of Article 16 and 17 of the EU Charter: Article 16 of the Charter offers the freedom to exercise an economic or commercial activity. The issue is whether the pro- hibition on commercial communications as stipulated under Article 20(5) of the TPD interferes with the Company’s right under Article 16 of the Charter. It was held that Article 20(5) was proportional and did not affect the Company’s right to conduct business. Article 17 of the Charter relates to the right of intellectual property. It was concluded that Article 20 of the TPD did not in any way hinder the use of intellectual property in connection with the marketing of the products. Status: Decided | 4 May 2016 10 Court of Justice of the European Union (CJEU), Pillbox 38 (UK) Ltd. v Secretary of Sate for Health, [2016] Case C-477/14, (https://www.tobaccocontrollaws.org/ files/live/litigation/2458/EU_Pillbox%2038%20%28UK%29%20Ltd.%20v.%20Secret.pdf, accessed 14 September 2020) Case summaries 8 2. Republic of Poland v European Parliament & Council of the European Union11 Facts Issue Arguments Advanced The Republic of Poland challenged provisions of the European Union (EU) Tobacco Products Directive (TPD) that pro- hibit the sale of menthol and other flavored ciga- rettes by member states as of May 2020. Whether mentholat- ed tobacco products enjoy a special status compared to other tobacco products with a characterising flavour? Arguments advanced by the Republic of Poland: It was submitted that the EU legislature should have distinguished products con- taining menthol from those with other characterizing flavors for the following reasons: (i) the long-established presence of products containing menthol gave them a ‘traditional’ nature; (ii) menthol products have different qualities as it does not completely eliminate the taste and smell of tobacco; (iii) not as attractive to young people as other tobacco products with a characterizing flavor. Further, it was argued that the EU legislature should have examined other less restrictive measures, such as raising the age limits for mentholated products, prohibition of cross-border sales and a warning stating that those products are as harmful as other tobacco products. Arguments advanced by the Parliament, the Council and the Commission: It was submitted that the concept of ‘characterizing flavour’ is defined in a general and abstract manner to allow Member States to identify products with such flavouring, in accordance with the criteria set out in the EU TPD. It was argued that none of the less restrictive measures advocated by the Republic of Poland are likely to be as effective in achieving the objective sought. Decision/Status The Court upheld the validity of the alleged provisions of the EU TPD for the following reasons: Provisions of the TFEU: It was noted that the EU Legislature was authorized under Article 114 of the TFEU to intervene and take appropriate mea- sures when Member States are about to take, divergent measures with respect to a product or a class of products. Menthol and other characterizing flavors: Tobacco products whether menthol or another flavouring, have similar objectives as regards initiating tobacco consump- tion and sustaining its use. The fact that mentholated tobacco products are a ‘traditional’ product does not alter the finding that their objective characteristics are similar to other tobacco products. The claim that menthol was not as attractive to young people was not found to be conclusive. The underlying utility of all flavouring is that they mask or reduce tobacco smoke’s harshness. Principle of proportionality: It was held that the prohibition was appropriate for ensuring a high level of protection of human health, especially for young people. The less restrictive measures do not appear to be equally suitable for achieving the objective pursued. Status: Decided | 4 May 2016 11 Court of Justice of the European Union (CJEU), Republic of Poland v European Parliament & Council of the European Union, [2016] Case-358/14, (https://www.tobaccocontrollaws.org/files/live/litigation/2456/EU_Republic%20of%20Poland%20v.%20European.pdf, accessed 14 September 2020) Case summaries 9 3. R (on the application of) Philip Morris Brands SARL v Secretary of State for Health12 Facts Issue Arguments Advanced Philip Morris (PMI) and British American Tobacco (BAT) initiated proceedings against the Secretary of Health, United Kingdom, challenging the validity of a number of provisions of the EU TPD and their transposition into national law. It was submitted that the EU TPD infringed provisions of the Treaty on the Functioning of the European Union (TFEU) and the Charter of Fundamental Rights of the European Union. The High Court of Justice of England and Wales found these arguments ‘reasonably argu- able’ and referred questions to the CJEU for a preliminary hearing. [This summary is limited to the challenge raised with respect to the prohibition of menthol cigarettes and tobacco products with a characterizing flavor]. Whether Article 7 of the EU TPD which pro- hibits Members States to place tobacco prod- ucts on the market with a characterizing flavour was valid or not? Arguments advanced by PMI and BAT: It was argued that the directive is invalid as it violated provisions of the TFEU, the Charter and principles of proportionality. Decision/Status It was noted that the EU legislature adopted uniform rules for all tobacco products containing a characterizing flavor, as these products could facilitate initiation of tobacco consumption or affect consumption patterns. Further, the EU legislature took into account the Partial Guidelines for implementation of Articles 9 and 10 of the FCTC, which called out for the removal of ingredients that increase palatability of tobacco products. The impact assessment for the EU TPD reflected that there were significant discrepancies between the regulatory regimes of the member states and each had established different lists of permitted or prohibited flavorings. Thus, in the absence of measures at EU level, the relevant national rules could develop in divergent ways, including with regard to the use of menthol, and create obstacles to the free movement of goods. Accordingly, no factor affected the validity of Article 7 of the TPD. On the ground of proportionality, it was held that a high level of protection for human health was appropriate, and partic- ularly in the case for young people. The argument that menthol was not attractive to young people was not tenable. It was concluded that the objective of protection could not be called into question solely with respect to a particular flavoring. Thus, the prohibition laid down in Article 7 cannot be regarded as manifestly inappropriate for achieving smooth function- ing of the internal market for tobacco and related products. Notably, the EU legislature weighed the economic consequences of the prohibition against a high level of protection for human health, and sought to give the tobacco industry and consumers time to adapt. This ensured that the impact of the prohibition was not disproportionate. Status: Decided | 4 May 2016 12 Court of Justice of the European Union (CJEU), The Queen on the Application of Philip Morris Brands SARL et al. v. Secretary of State for Health, [2016] Case C-547/14, (https://www.tobaccocontrollaws.org/files/live/litigation/2457/EU_R%20%28on%20the%20Application%20of%29%20Phil.pdf, accessed 25 July 2019) Case summaries 10 4. Swedish Match AB v Secretary of State for Health13 Facts Issue Arguments Advanced The 2014 EU Tobacco Products Directive obliges EU Member States to prohibit tobacco for oral use, in- cluding snus. Sweden is exempt from this obligation, as is Norway, which is not an EU Member States, but implements the EU TPD as part of the European Economic Area. In Case C-151/17 Swedish Match, challenged the ban despite the fact an earlier ban been found valid in an earlier case (C-210/03). The 2017 challenge was presented in light of new evi- dence on the harmfulness of snus from Sweden and Norway, as well as the introduction of electronic nic- otine delivery systems (ENDS), such as e-cigarettes, and other novel tobacco products into the EU. Whether the pro- hibition on suns violated principles of equal treatment and proportionality? Swedish Match argued that the prohi- bition on snus violated the principle of equal treatment i.e. that comparable situations must not be treated differently unless objectively justified. The company argued that this principle was violated because other smokeless products, ciga- rettes, ENDS and novel tobacco products were permitted on the market. It was also argued that the obligation to prohibit snus was invalid as it violated the principle of proportionality. Decision/Status The European Court of Justice (ECJ) rejected this argument, concluding that the: (i) evidence suggests snus would be attractive to young people and has considerable potential for market expansion, thereby justifying different treatment from cigarettes and smokeless products; (ii) objective characteristics of ENDS differ from tobacco products, justifying different treatment; and (iii) effects of novel tobacco products on health could not be observed when the EU TPD was adopted, whereas the effects of snus had been scientifically substantiated; (iv) The prohibition was not manifestly inappropriate. The Court noted the relevance of the precautionary principle and based its conclusion partly on the risk that the attractiveness of snus to young people might create a gateway effect. Having rejected the argument concerning equal treatment, the court also rejected the argument that the different treat- ment of other products showed the prohibition on snus to be disproportionate. Status: Decided | 22 November 2018 13 Court of Justice of the European Union (CJEU), Swedish Match AB v Secretary of State for Health, [2018] Case C-151/17, (http://curia.europa.eu/juris/celex. jsf?celex=62017CJ0151&lang1=en&type=TXT&ancre=, accessed 14 September 2020) Case summaries 11 5. Planta Tabak-Manufaktur Dr. Manfred Obermann GmbH & Co. KG v Land Berlin14 Facts Issue Arguments Advanced Planta Tabak, manufactures and markets tobacco products, in particular flavoured roll-your-own tobacco. After Germany transposed the EU TPD into its national law (The Gesetz über Tabakerzeugnisse und verwandte Erzeugnisse/Law on Tobacco products and related products), Planta Tabak filed an application seeking a declaration that certain provisions of the new law, were not applicable to its products. The referring court found merit in Planta Tabak’s ar- guments, in particular, with respect to Article 7(14) of the EU TPD, which states that manufacturers of flavored tobacco products with an EU-wide sales volume of 3% or more in a particular product cate- gory were given until May 2020 to comply with the ban on flavorings, while manufacturers of flavored products with a smaller sales volume were required to comply as of May 2016. It was observed that the tobacco manufacturers were not in a position to obtain information on sales volumes at EU level, and this created uncertainty about the application of the prohibition. Whether Article 7 of the EU TPD violat- ed the principle of legal certainty and proportionality? Arguments advanced by Planta Tabak: It was argued that Article 7(1) and 7(7) [prohibition of flavourings in tobacco products] of the EU TPD infringed pri- mary EU law, in particular the princi- ples of legal certainty, equal treatment and proportionality. Decision/Status The Court held that Article 7(14) does not infringe the principle of legal certainty. It was noted that it was for the member states to choose a reliable method capable of ensuring compliance with the requirement. While the Court admitted that the ban was a restriction on the EU’s free movement of goods, “it was justified by the balancing of its economic conse- quences against the requirement to ensure a high level of protection of human health.” The difference in treatment of products based on sales volume was intended to give consumers adequate time to switch to other products and was, therefore, objectively justified.  Status: Decided | 30 January 2019 14 Court of Justice of the European Union (CJEU), Planta Tabak-Manufaktur Dr. Manfred Obermann GmbH & Co. KG v Land Berlin, [2019] Case C-220/17, (https://www.tobaccocontrollaws.org/files/live/litigation/2653/EU_Planta%20Tabak-Manufaktur%20Dr.%20Ma.pdf, accessed 25 July 2019) Case summaries 12 FINLAND 1. SKA Liquids Case15 Facts Issue Arguments Advanced The City of Kotka Environmental Board, pursuant to s. 96 of the Tobacco Act, prohibited the sale of fla- vouring liquids (including food flavorings) to be sold in vape shops. This prohibition was challenged by a nicotine-free liquid manufacturer before the Finland Administrative Court. It was contended by the manu- facturer that the prohibition violates EU law. What are the nico- tine-free e-liquids with a characteristic taste that can be prohibited under the Tobacco Act? Whether a ban on the sale of food through a particular sales channel could be justified under EU law? Arguments advanced by the manu- facturer/distributor: It was argued by the manufacturer that food flavour concentrates did not fall within the ambit of Article 2(20) of the Tobacco Act i.e. nicotine free e-liquid. The flavour concentrates at issue are used, inter alia, in confectioneries and in flavouring lem- onades. Moreover, it was pointed out that these products were commonly available in grocery stores. Arguments advanced by the City Board: In a speciality cigarette shop, the flavour- ing liquid is subject to the provisions of the Tobacco Act because of its likely use, despite the fact that flavouring liquids are marketed for use in food baking. Decision/Status The Court held that food flavorings and flavorings prohibited for sale in the vape shops are nicotine-free liquids, suitable for use as food as well as vaporization. Thereby, the City of Kotka Board had the legitimate authority to prohibit the shop from selling such liquids. Status: Decided | 15 May 2019 Aggrieved, SKA Liquids filed an appeal against this decision. The Supreme Administrative Court16 held that Finland’s Ministry of Employment and Economy’s failed to notify the EU Commission with the final text of the regulation of nico- tine-free liquids and flavourings of electronic cigarettes. Section 25 of the Tobacco Act, which prohibits characterizing flavour or aroma for nicotine-free liquids intended for vaporisation is a technical regulation which had not been notified to the Commission in accordance with Article 5 (3) of the Technical Regulations Directive (2015/1535 / EU). Thus, it was held by the Supreme Administrative Court that section 25 of the Tobacco Act is not applicable to SKA Liquids Oy and annulled the decision of the lower Court. Status: Decided | 24 June 2020 15 ITA Finland Administrative Court, 19/0482/1, [2019] 16 Supreme Administrative Court of Finland, KHO:2020:77, (https://www.kho.fi/fi/index/paatokset/vuosikirjapaatokset/1592891459008.html, accessed 3 November 2020) Case summaries 13 2. Striker Finland Oy17 Facts Issue Arguments Advanced The Health Inspectorate of the City of Pori prohibited the sale of nicotine free liquids for vaporisation in the Scandi Vape electric cigarette shop of Striker Finland (Company). The Environmental Health Division ordered the Company to comply with the decision of the health inspector and to remove liquids, a penalty of EUR 5,000 was also imposed on the Company. The Company challenged this prohibi- tion before the Administrative Court of Turku. Whether food flavour- ing can be regarded as nicotine-free liquids for evaporation within the meaning of the Tobacco Act? Whether a ban on the sale of nicotine free liquids could be enforced on the basis of the location of the sale of the product? Arguments advanced by the Company: It was submitted that the ban on flavour- ings in the Tobacco Act did not cover food flavourings sold in the company’s store for e-cigarettes. The flavour con- centrates sold in the shops are not in- tended to be vaporised and not marketed for such use. Further, the regulation of the tobacco law is contrary to the free- dom of movement provided for in Article 24 of the EU TPD. Prohibitions should be in accordance with the principle of proportionality and not be a means for arbitrary discrimination or a disguised restriction on trade between member States. Decision/Status The Administrative Court noted that the issue at hand required a substantive interpretation of the national rule on flavour- ings for e-cigarettes contained in the Tobacco Act and a reference for preliminary ruling on the interpretation of European Union law was not necessary to resolve the case. It was noted that the Company’s store is a specialty store within the meaning of section 71 (2) of the Tobacco Act, which specializes in e-cigarettes and nicotine liquids. If the sale of flavorings takes place in such a specialty store, it must be considered probable, on the basis of the store’s product range, that the consumer considers that the flavorings on sale are suitable for vaporization by means of an e-cigarette. It was held that the decision of the Environmental Health Division was not contrary to the principle of proportionality and does not discriminate against the Company. Status: Appeal Pending | 20 December 2019 17 Decision of the Administrative Court of Turku, 19/0345/1, [2019] Case summaries 14 3. Salon Höyry Oy18 Facts Issue Arguments Advanced The Construction and Environment Board in the City of Salo prohibited Salon Höyry (company) from selling or otherwise disposing various liquids with characterizing flavours that can be used by mixing with other liquids. Whether food flavour- ing can be regarded as nicotine-free liquids for evaporation within the meaning of the Tobacco Act? Arguments advanced by the Company: The interpretation of the Tobacco Act by the Environment Board broadens the scope of the Tobacco Act and infring- es the principle of legal certainty. The prohibition of characteristic odor or taste applies only to liquids intended for vaporisation. Food flavourings and e-cigarette products are also sold at the same point of sale in grocery stores and online stores. Decision/Status According to the inspection report of the Environment Board, the sales list available to customers describes the taste of those liquids as follows, inter alia: ‘vanilla light cigar’; ‘cool mint tobacco’; Psycho Flavors - “soft cigar flavor with a hint of cherry”. The descriptions of these liquids suggest that they are intended to be nicotine-free flavours for vaporization. The Court noted that Section 25 in conjunction with Section 24 (1) and Section 11 (1) of the Tobacco Act required that a nicotine-free liquid with a characteristic odor or taste may not be sold or otherwise disposed of to the consumer. It was held that the permissibility of sale of the liquid food flavour concentrates was to be assessed based on the condi- tions and context of supply of the products. In a specialty e-cigarette shop, as food flavours could be used as a flavour for e-cigarettes, sale was prohibited. The decision of the Environment Board was upheld. Status: Decided | 20 March 2020 18 Decision of the Administrative Court of Turku, 20/0056/1, [2020] Case summaries 15 GERMANY 1. Menthol Capsule Case19 Facts Issue Arguments Advanced The Plaintiff, a tobacco product manufacturer in- tended to market a cigarette in Germany which con- tained menthol flavoring embedded in the capsule of the cigarette filter (product). Among other things, the capsule contained, gelatin, gellan gum, sorbitol, glycerin, sodium citrate, brilliant blue, FCF, tar- tazine and medium-chain triglycerides. The German Preliminary Tobacco Act (Act) does not approve of these substances as additives for cigarette filters. The Plaintiff filed a petition before the Federal Office of Consumer Protection and Food Safety (agency) to issue a general decree under s 47a of the Act for the import and marketing of these cigarettes. The petition was rejected on the ground that menthol would soften the unpleasant properties of tobacco smoke and thus lead to increased consumption. The Plaintiff objected to this decision by the agency and argued that the product was not a novelty but a further development of menthol cigarettes already being sold in the German market. Aggrieved, the Plaintiff filed a suit to challenge the decision of the agency. Whether the menthol capsule embedded in the cigarette filter complied with the tobacco legislation of Germany and should be authorized to be imported? The Plaintiff argued that the product delivered the same menthol transfer ef- ficiency as traditional menthol cigarettes and was not a novel or different product. Decision/Status The Court upheld the agency’s decision. It was held that in order to protect consumer health, there were compelling rea- sons to reject the Plaintiff’s request. The contents of the product do not comply with the tobacco regulations in Germany. It was noted that there was information that the product showed greater harmfulness or risk addiction compared to tra- ditional cigarettes. It was also highlighted that the attractiveness of smoking the product was significantly increased with the new capsule technology, and thus violated the WHO Framework Convention on Tobacco Control (FCTC). Status: Decided | 26 September 2012 19 Chamber of the Administrative Court (Germany), Menthol Capsule Case, [2012] File Number 5A 206/11, (https://www.tobaccocontrollaws.org/files/live/ litigation/2267/DE_Menthol%20Capsule%20Case.pdf, accessed 25 July 2019) Case summaries 16 INDIA 1. Ankur Gutkha v Indian Asthma care Society & Ors.20 21 Facts Issue Arguments Advanced Ankur Gutkha appealed against a High Court deci- sion in which the Indian Asthma Society sought to ban the sale of gutkha and prohibit the use of plastic sachet packaging for gutkha. - - Decision/Status The Supreme Court, among other things, restrained gutkha, tobacco, and pan masala manufacturers from using plastic materials in the sachets of their products and requested that a study be conducted on the harmful effects of gutkha tobac- co, pan masala and similar articles. Status: Pending (Motion hearing) 2. Yadav et al. v State of Bihar22 Facts Issue Arguments Advanced The Petitioner is a distributor of Pan Masala, Gutka and Zarda (products). This case challenged the notification issued by the Commissioner of Food Safety in the State of Bihar, to prohibit manufacture, store, sell, or distribute products containing tobacco or nicotine. Whether the Commissioner of Food Safety was empow- ered to issue the impugned notification? The Petitioner alleged that the no- tification violated Article 14 of the Constitution, as it imposed restrictions only on Gutka and Paan Masala con- taining tobacco or nicotine but excluded other harmful tobacco products. Decision/Status The Court noted that the notification by the Commissioner of Food Safety was within the provisions of the Food Act, and it was within the Commissioner’s discretion to choose products that were to be brought within the purview of the ban. No error was found in the exercise of power by the Commissioner of Food. Status: Decided | 10 July 2012 20 Supreme Court of India, Ankur Gutkha v Indian Asthama Care Society and Ors., [2010] SLP(C) No. 16308/2007, (https://www.tobaccocontrollaws.org/files/live/ litigation/237/IN_Ankur%20Gutkha%20v.%20Indian%20Asthama.pdf, accessed 22 July 2019) 21 See also Supreme Court of India, Ankur Gutkha v Indian Asthama Care Society and Ors, [2013] SLP(C) No. 16308/2007, (https://www.tobaccocontrollaws.org/ files/live/litigation/1523/IN_Ankur%20Gutkha%20v.%20India%20Asthma%20C.pdf, accessed 17 September 2020) 22 High Court of Patna, Yadav v State of Bihar, [2012] No. 10297, https://www.tobaccocontrollaws.org/files/live/litigation/903/IN_Yadav%20et%20al.%20v.%20 State%20of%20Bihar.pdf Case summaries 17 3. S.J.J Exports Company v Food Safety Commissioner23 Facts Issue Arguments Advanced The Petitioner (an exporter), through this petition chal- lenged a notification dated 19 July 2012 (prohibited the manufacture, storage, distribution or sale of Pan Masala and Gutkha) issued by the Commissioner of Food Safety, State of Maharashtra, and an order by the Assistant Commissioner which called upon the Superintendent of Customs not to allow any consignments of gutka or pan Masala for export and import. Petitioner’s boxes contain- ing gutka sachets were seized by Customs Officers. The Petitioner prayed for directions to quash and set aside the seizure of goods. Whether the 19 July prohibition was only for domestic sales or whether it was also applicable to exports? The Petitioner argued that notification dated 19 July 2012 only prohibited do- mestic distribution and sale of gutka and pan masala, and did not extend to the export of these goods. Decision/Status The details of the goods confiscated reflected that the consignment was not manufactured for export. In fact, the Petitioner did not possess the license for exporting gutka. The Court held that merely because s 3(n) of the Food Act did not refer to export, it did not mean that the Act and the regulations were not intended to regulate the export of food items of this nature. Status: Decided | 21 January 2013 4. Ghodawat Pan Masala v State of Karnataka24 Facts Issue Arguments Advanced The Petitioners are manufacturers of tobacco products, particularly Pan Masala. The Petitioners are aggrieved by Regulation 2.3.4 of the Food Safety and Standard (Prohibition and Restriction on Sales) Regulations 2011, which stated that tobacco and nicotine shall not be used as ingredients in any food prod- ucts. On the other hand, s 7(5) of COTPA permitted use of tobacco or nicotine in any tobacco products. Whether the Commissioner had the authority to issue regulations for Pan Masala which is a sched- uled product under the Cigarette and other Tobacco products (Prohibition of Advertisement and Regulation of Trade and Commerce Production, Supply and Distribution) Act, 2003 (COTPA)? It was argued that the COTPA is a comprehensive law on tobacco and the Commissioner of Food Safety was not empowered to pass any order or notification which conflicted with its provisions. 23 High Court of Judicature at Bombay, S.J.J. Exports Company v Food Safety Commissioner, [2013] W.P. No. 2266 of 2012, (https://www.tobaccocontrollaws.org/ files/live/litigation/1657/IN_S.J.J.%20Exports%20Company%20v.%20Food.pdf, accessed 11 July 2019) 24 High Court of Karnataka, Ghodawat Pan Masala v State of Karnataka, [2013] Writ Petition No. 78378-78380 (https://www.tobaccocontrollaws.org/files/live/ litigation/1641/IN_Ghodawat%20Pan%20Masala%20v.%20State%20o.pdf, accessed 10 July 2019) Case summaries 18 4. Ghodawat Pan Masala v State of Karnataka24 Decision/Status It was noted that s 3(1)(j) of the Food Act defined the term ‘food’ and this would undoubtedly include Pan Masala and gutka. Even though, COTPA deals with tobacco and other tobacco products, the Food Act deals with food and other items which includes Pan Masala and Gutka. Further, the Court placed reliance on s 89 of the Food Act, which gives overriding effect to the provisions of the Food Act. Thus, the Food Authority was competent to issue regulations under s 92 of the Food Act. Status: Decided | 25 June 2013 5. M/s Omkar Agency & Ors. v Food Safety & Standards Authority of India25 Facts Issue Arguments Advanced The Petitioners are manufacturers of tobacco products, such as Pan Masala and Zarda (products), and challenged the authority of the Commissioner of Food Safety (Commissioner) to prohibit the manu- facture, storage, distribution or sale of Zarda, Pan Masala and Gutkha. The Commissioner passed this order under Section 30(a) of the Food Safety and Standards Act 2006 (Food Act), which states: “The Commissioner of Food Safety shall perform all or any of the following functions, namely: (a) prohibit in the interest of public health, the man- ufacture, storage, distribution or sale of any article of food, either in the whole of the State or any area or part thereof for such period, not exceeding one year, as may be specified in the order notified in this behalf in the Official Gazette” The core issue in this case was the inher- ent inconsistency between the Food Act and Cigarette and other Tobacco products (Prohibition of Advertisement and Regulation of Trade and Commerce Production, Supply and Distribution) Act, 2003 (COTPA). Also, whether the Commissioner had the authority under s 30 of the Food Act to prohibit manufacture, sale, and production of products. The main ground of challenge was that the prohibition was not permissible as the products were permitted for sale under India’s omnibus tobacco control law, COTPA. The Petitioners also alleged that they were not food business operators under the Food Act and were not required to submit to the Act’s requirements. 25 High Court of Patna, M/s Omkar Agency & Ors. v Food Safety & Standards Authority of India, [2015] Civil Writ Jurisdiction Case No. 3805 (https://www.tobaccocontrollaws.org/files/live/litigation/2493/IN_M_s%20Omkar%20Agency%20v.%20Food%20Safet.pdf, accessed 26 July 2019) Case summaries 19 5. M/s Omkar Agency & Ors. v Food Safety & Standards Authority of India25 Decision/Status The Court set aside and quashed the order of prohibition passed by the Commissioner, for the following reasons: i. Scope of Power of the Food Commissioner under Section 30 of the Food Act The Court examined the provisions and framework of the Food Act and concluded that an order to prohibit Pan Masala could only be passed if objective evidence was found that a particular brand was not conforming to standards. It was not permissible to ban all brands of Pan Masala by a blanket order. Notably, s 30(a) stipulates a maximum period of one year for prohibition. It was noted that the Commissioner had issued notifications (dated 7.11.2014 and 06.11.2015) from time to time which resulted in exceeding this period and amounted to an arbitrary exercise of power. ii. Applicable Law: Food Act or COTPA To answer this question, the Court examined whether tobacco would classify as ‘food’. It was noted that the Food Products Standards and Food Additives Regulations 2011 did not define tobacco. The Supreme Court in ITC Ltd. V. Agricultural Produce Market Committee (2002) 9 SCC 232 also held that tobacco is not a foodstuff. Accordingly, it was held that COTPA is the exclusive law which dealt with tobacco products. Only Regulations which prohibited mixing food with tobacco could be passed under the Food Act. Status: Decided | 19 July 2016 6. Central Arecanut Marketing Co. v Union of India26 Facts Issue Arguments Advanced As observed from the above cases, 23 states and 5 Union Territories in India had prohibited the manufacture and sale of Gutka and Pan Masala with tobacco or nicotine under the Food Act. Different manufacturers across the country challenged this ban, and eventually transfer petitions were filed for transferring these cases to the Supreme Court. The Ministry of Health & Family Welfare submitted be- fore the Supreme Court that in order to circumvent the ban, manufacturers were selling Pan Masala (without tobacco) along with flavoured chewing tobacco in separate sachets. Essentially, instead of ready to consume mixes, chewing tobacco compa- nies were selling the product in twin packs to be mixed as one. The central question in these petitions is whether there is any inherent consistency between the provi- sions of the Food Act and the COTPA. - 26 The Supreme Court of India, Central Arecanut Co. & Ors. v Union of India, [2010] Transfer Case (Civil)/Diary No. 60005/2010, (https://www.tobaccocontrollaws. org/files/live/litigation/2620/IN_Central%20Arecanut%20Marketing%20Com.pdf, accessed 30 June 2019) Case summaries 20 6. Central Arecanut Marketing Co. v Union of India26 Decision/Status The Supreme Court directed that representatives of the States and Union Territories that had not prohibited the manufacture and sale of such smokeless products to indicate why no action had been taken. The Court also directed that all States and Union Territories representatives file affidavits regarding their total compliance with the ban before the next date of hearing. Order date: 23 September 2016 Status: Pending 7. M/s Focus Brands & Anr. v Directorate General of Health Services and Ors.27 Piyush Ahluwalia v Union of India (W.P (C) 2735/2019) Litejoy International Pvt. Ltd. v Union of India & Ors. (W.P.(C) 2351/2019) Facts Issue Arguments Advanced An advisory was issued by the Ministry of Health & Family Welfare (MoH) in August 2018 to States/Union Territories to ensure that Electronic Nicotine Delivery systems (ENDS) including e-cigarettes, heat-not burn devices, vape, e-sheesha, e-nicotine flavored hookah, and the like devices that enable nicotine delivery are not sold (including online sale), manufactured, distributed, traded, imported and advertised in their jurisdictions, except for the purpose and in the manner and to the extent, as may be approved under the Drugs and Cosmetics Act 1940 and Rules made thereunder. In connection therewith, a circular dated 27.11.18 was issued to all the Customs Authorities to ensure that the advisory issued by MoH was implement- ed for all import consignments of ENDS. The Petitioners filed writ petitions before the High Court of Delhi against the advisory and communication dated 27.11.18. Whether ENDS qualifies as a ‘drug’ under the Drugs and Cosmetics Act? The Petitioners contended that ENDS, including e-cigarettes are substitutes to smoking combustible cigarettes. It was also argued that these prod- ucts are healthier than combustible cigarettes and could be used as a replacement therapy. Decision/Status Relevant Order: After a plain reading of s 3(b) of the Drugs and Cosmetics Act, the Court was of the opinion that the prod- ucts do not fall within the definition of ‘drug’ and stayed the advisory and communication. In September, 2019, the Central Government promulgated an ordinance to prohibit electronic cigarettes. Thereafter, the Petitioners withdrew the petition with liberty to file afresh and challenge the ordinance. Status: Decided | 18 March 2019 27 The High Court of Delhi, M/s Focus Brands v Directorate of Health Services and Ors, [2019] Writ Petition (Civil) 2688/2019, (http://delhihighcourt.nic.in/ dhcqrydisp_o.asp?pn=60136&yr=2019, accessed 3 May 2019) Case summaries 21 8. Plume Vapour Pvt. Ltd. & Anr. v Union of India28 M/s Woke Vapors Pvt. Ltd. v Union of India Facts Issue Arguments Advanced The two writ petitions were filed to challenge the ordinance passed by the Central Government to ban production, manufacture, import, export, transport, sale, distribu- tion, storage and advertisement of e-cigarettes. Whether the ordi- nance infringes the right of a user to choose a less harm- ful alternative (i.e. ENDS) compared to combustible tobacco cigarettes? The Petitioners prayed for an interim measure claim- ing that e-cigarettes are less harmful than combustible tobacco. In fact, it was emphasized that ENDS could be a method to aid existing smokers to quit smoking. It was contended that a verbal imagery was being drawn to attach fear to the product through the ordinance. It was also submitted that the executive action was manifestly arbitrary, disproportionate and excessive. The Government submitted that there were materials ne- cessitating issuance of the ordinance due to the growing popularity of e-cigarettes across the country. Attempts to classify the chemicals in e-cigarettes as drugs had been stayed by judicial intervention. Further, it was submitted that in the upcoming session of Parliament the ordinance would be taken up for discussion. Decision/Status The Court noted that the Bill passed scrutiny before both Houses, to become an Act of Parliament. In the circumstances, nothing remained for adjudication in the writ petitions and they were dismissed. Status: Decided | 12 December 2019 28 The High Court of Calcutta, Plume Vapour Private Ltd. & Anr. v Union of India & Ors. and M/s Woke Vapors Pvt. Ltd. v Union of India & Ors., [2019] A.S.T 40 and 41, (https://www.calcuttahighcourt.gov.in/Order-Judgment-PDF/A/AST_40_2019_26092019_O_239.pdf, accessed 3 October 2019) Case summaries 22 ISRAEL 1. E-Cig Ltd. v Ministry of Health29 Facts Issue Arguments Advanced In April 2012, the Petitioner Company wished to import and market electronic cigarettes and related products in Israel. Under Chapter F of the Pharmacists Ordinance (Ordinance), a product containing nicotine intended for swallowing, suck- ing, chewing or inhaling, could not be marketed in Israel without proper registration. The Petitioner Company approached the Director-General of the Ministry of Health and the Director of Pharmacy in the Ministry (Respondents), to request permission to import electronic cigarettes and related products. The request was rejected on the ground that it was prohibited to import or market nicotine-containing electronic cigarettes “unless the efficacy and safety of the product was proven, and nicotine was record- ed as an ingredient in the order”. Aggrieved by the rejection of this request, the Petitioner Company filed a petition before the Supreme Court. Whether the Respondents had the authority to prohibit the import and mar- keting of electronic cigarettes on the basis of the provisions of the Ordinance. The government submitted that the Ministry had the power to supervise electronic cigarettes in accordance with the provisions of Chapter G of the Ordinance. Also, in the interest of public health, the prohibition on the import and marketing of electronic cigarettes was justified. To this extent, the Ministry had initiated the process to implement the prohibition by passing new legislation. In light of this, it was prayed that the Court would refrain from ruling on the petition and grant additional time for the comple- tion of the legislative process. Decision/Status The Court examined the provisions of the Ordinance and held that its provisions were designed to protect public health from unprofessional or careless treatment of drugs and their constituent substances. The Ordinance regulated the profes- sion of pharmacy and limits of its activity. Chapter VII titled ‘Consumer Goods’ was added to the Ordinance by an amend- ment in 1993. This authorized the Minister of Health to impose control over consumer goods in order to prevent health risks from consumer products containing toxic substances (discovery of nitrosamines in the pacifiers). It was held that the Respondent’s decision to ban import of electronic cigarettes based on the provision of Chapter VII, and in particular s 49 of the Ordinance, was without any authority. It was also observed that the Respondents’ decision signifi- cantly restricted the Petitioner’s freedom of occupation. The Petitioner’s petition was allowed, and Respondents’ were directed to bear the Petitioner’s expenses. Status: Decided | 3 December 2014 29 The Israel Supreme Court, E-Cig Ltd. v Ministry of Health, [2014] HCJ 6665/12, (https://www.tobaccocontrollaws.org/files/live/litigation/2217/IL_E-Cig%20 Ltd.%20v.%20Ministry%20of%20Heal.pdf, accessed 16 September 2020) Case summaries 23 2. Smoke Free-Israel v Ministry of Health (High Court 2951/19)30 Tel Aviv Chamber of Commerce (High Court 4657/19) Juul Labs (High Court 1532/19) Facts Issue Arguments Advanced The three Petitioners in these cases challenged provisions of the Restriction of Advertising and mar- keting of Tobacco Products Law (Amendment No. 7). This law stipulated restrictions and prohibition on the advertising of electronic cigarettes. Juul Labs Inc. filed three lawsuits against the legislation: (i) August 2018: Against the injunction prohibiting the marketing of electronic cigarettes with nicotine concentrations above 20 milligrams per millilitre; (ii) January 2019 - against regulations under the Pharmacy Ordinance prohibiting the marketing of electronic cigarettes with nicotine concentrations above 20 milligrams per millilitre; (iii) February 2019 - against the Prohibition of Advertising and Restriction of Marketing of Tobacco and Smoking Law, with reference to all sections of the law relating to electronic cigarettes, including the section prohibiting the marketing of electronic cigarettes with nicotine concentrations above 20 milligrams per millilitre. Whether tobacco related restrictions could be extended to ENDS? The importers argued that there was a difference between tobacco products and electronic cigarettes, the latter category of products had a harm reduction poten- tial and required a separate legislation. Decision/Status JUUL Labs withdrew the petition a few days before the hearing. After a consultation, the Tel Aviv Chamber also decided to withdraw its petition. Status: Decided | 25 November 2019 30 The Israel Supreme Court, Tel Aviv Chamber of Commerce v Israeli Knesset & Ors., [2019] HC 4657/19 and HC 1532/19, (https://www.tobaccocontrollaws.org/ files/live/litigation/2711/IL_The%20Tel%20Aviv%20Chamber%20of%20Commer.pdf, accessed 16 September 2020) Case summaries 24 ITALY 1. National Council of Consumers and Users (Associzione dei Consumatori) v two electronic cigarette manufacturers (names redacted)31 Facts Issue Arguments Advanced One of the leading consumer associations i.e. the National Council of Consumers and Users petitioned the court for an injunction to revoke the advertising campaign promoted by two electronic cigarette manufacturers. Whether Art 21 of the national legislation and Art 20 of the EU TPD prohibited commercial commu- nications that directly or indirectly promoted electronic cigarettes and cartridges? Arguments advanced by the Consumer Association: The Association argued that Article 21 of Legislative Decree No. 6 of 12 January 2016 prohibited all forms of advertising and/or sponsorship of electronic cigarettes. Arguments advanced by the electronic cigarette manufacturers: The electronic cigarette manufacturers argued that the publication of mere informational content and/or images related to their products cannot be considered advertis- ing/promotional activity and thus not in violation of the current legislation. Decision/Status After a perusal of all the provisions of the national decree and the EU TPD, the Court noted that in essence the definition of commercial communication should be understood as any form of message with commercial content that has the direct or indirect purpose of promoting the sale of goods or services to consumers. It was held that in view of the restrictive approach to the advertising of electrotonic cigarettes and liquid refill containers taken in the EU TPD, the argument of the manufacturers that commercial communications on its social media pages be excluded from the scope of information society services was dismissed. Information about a product should be provided in a correct manner and not with promotional intent. With respect to user-generated content, it was held that though the manufacturers could not be held responsible for it, they could not republish or promote even through links such posts or images on their own social media channels. The Court held that there were sufficient reasons to direct the manufacturers to cease all commercial communications aimed at promoting the sale of electronic cigarettes and refill cartridges and remove all unlawful content from their websites and social media pages within 15 days from the date of the judgment. It was also ordered that the manufacturers would be fined €500 for each violation and for each day of delay in the execution of the order. Status: Decided | 4 November 2019 31 Civil action n. 57714/2019, XVII Civil Division, Court of Rome, (https://www.tobaccocontrollaws.org/files/live/litigation/2706/IT_National%20Council%20of%20 Consumers%20.pdf, accessed 27 January 2020) Case summaries 25 MEXICO 1. Neri, José Armando Contreras v Mexico32 Facts Issue Arguments Advanced The Federal Commission for the Protection against Sanitary Risks (Cofepris) imposed a fine of more than 60 thousand pesos on Neri, José Armando Contreras (merchant) who offered electronic ciga- rettes in a commercial establishment. The merchant filed a lawsuit against Article 16 of the General Law on Tobacco Control, which stated: “It is prohibited to trade, sell, distribute, exhibit, promote or produce any object that is not a tobacco product, that con- tains any of the elements of the brand or any type of design or auditory signal that identifies it with tobacco products.” Whether Article 16 of General Law of Tobacco Control violated the guaran- tee of equality under Article 1 of the Federal Constitution? It was submitted that Article 16 stipulat- ed unequal and discriminatory treatment to substances that were not tobacco products. It was argued that on one hand sale of tobacco products were permitted subject to compliance with labelling provisions. On the other hand, it was pro- hibited to trade, sell, distribute, display, promote or produce any object that was not a tobacco product. Decision/Status At the heart of the analysis, the Court had to balance right of health on the one hand, and the right to conduct business on the other. It was noted that the legislator sought to pursue a legitimate objective to protect public health, but by imposing an absolute prohibition on trade, the provision could not be considered proportional, taking into account that products that came from tobacco were allowed to be part of trade provided they complied with packaging and labelling restrictions. It was held that Article 16 was excessive and affected constitutionally protected property rights. Status: Decided | 2 October 2015 32 Supreme Court of Justice of the Nation (Mexico), Neri, José Armando Contreras v Mexico, [2015] Revision 513/2015, (https://www.tobaccocontrollaws.org/files/ live/litigation/2642/MX_Neri%2C%20Jos%C3%A9%20Armando%20Contreras%20.pdf, accessed 27 June 2019) Case summaries 26 NETHERLANDS 1. X [Company selling e-cigarettes] v The Netherlands33 Facts Issue Arguments Advanced The Plaintiff operated a business of e-cigarettes. In October 2007, the Health Care Inspectorate (IGZ) informed the plaintiffs that the electronic cigarettes and nicotine containing cartridges were classified as ‘medicine’ and could not be traded or promoted without a permit. Whether the Minister unlawfully prohibited the Plaintiff from pro- moting its products? It was argued by the Plaintiffs that the Minister assumed that because the e-cigarettes contained nicotine, it could be classified as a medicine. It was submitted that the same logic would apply to caffeine, which like nicotine is a stimulant. The Ministry of Health submitted that the nicotine from e-cigarettes had a calming and stimulating effect. Decision/Status Reliance was placed on Article 84 of the Medicines Act which prohibited advertisement of a medicine for which no market- ing authorization had been granted. It was noted that the Minister of Health did not want to allow businesses to actively promote e-cigarettes through advertising, as long as there was insufficient knowledge about the safety of the product. Thus, it was held that e-cigarettes were rightly classified as a ‘medicine’ within the meaning of the Medicines Act, allowing the Health Ministry to regulate promotional activities. Status: Decided | 8 February 2008 2. United Tobacco Vapor Group Inc. v The Netherlands34 Facts Issue Arguments Advanced United Tobacco Vapor Group (UTVG) is a manufacturer and importer of e-cigarettes, with products available at various doses. At the end of 2007, the State provisionally qualified e-cigarettes as a medicine and applied a propor- tional enforcement policy. This meant that e-cigarettes could be imported without a marketing authorization from the Medicines Evaluation Board (MEB) but any promotion or advertising was not permitted. In December 2011, the Minister of Health, Welfare & Sport classified e-cigarettes as a medicine under the Dutch Medicines Act. This implied that a license would be required from the MEB for the trade and advertisement of e-cigarettes. Against this decision, UTGV approached the District Judge seeking a preliminary injunc- tion against the classification of e-cigarettes as ‘medicine’. Whether e-ciga- rettes could be classified as ‘med- icine’ under the Dutch Medicines Act? It was argued that the State unlawfully classified e-cigarettes as a medicine under the Medicines Act. The State should provide scientific evidence that the nicotine contained in e-cigarettes has a different pharmacological effect than the consumption of a reasonable amount of normal cigarettes. 33 The District Court of Hague, X [Company selling e-cigarettes] v The Netherlands, [2008] Case No: KG 08-136,(https://www.tobaccocontrollaws.org/files/live/ litigation/2126/NL_X%20%5BCompany%20selling%20e-cigarette.pdf, accessed 15 September 2020) 34 The District Court of Hague, United Tobacco Vapor Group Inc. v The Netherlands, [2012] Case No.: 414117-KG ZA 12-209, (https://www.tobaccocontrollaws.org/ files/live/litigation/2128/NL_United%20Tobacco%20Vapor%20Group%20Inc.pdf, accessed 17 September 2020) Case summaries 27 2. United Tobacco Vapor Group Inc. v The Netherlands34 Decision/Status It was held that the State did not discharge the burden of proof to establish grounds for classification of e-cigarettes as a medicine. The State should have scientifically demonstrated the pharmacological effects of e-cigarettes to classify it as a medicine under the Medicines Act. Thus, it was held that the Minister’s decision to classify e-cigarettes was contrary to the law and principle of legal certainty. Status: Decided | 13 March 2012 3. The Netherlands v United Tobacco Vapor Group Inc.35 Facts Issue Arguments Advanced [The facts are the same as the case above and are not repeated in the interest of brevity]. The District Judge passed an order in favour of UTVG holding that its e-cigarette cannot be classified as a medi- cine. Aggrieved, the State filed an appeal against the decision of the District Court. Whether e-cigarettes could be classified as ‘medicine’ under the Dutch Medicines Act? The State argued that the e-cigarettes resembled a nicotine inhaler which was designated as a medicinal product in 1996. Decision/Status The State acknowledged that e-cigarettes did not present an acute danger to public health (para 8.3). In fact, any risks associated with e-cigarettes are smaller than the risks associated with the use of regular cigarette. It was noted that application of the Medicines Act resulted in obstacles to the free movement of goods and that was disproportionate to the objective of protecting public health. The Court concluded that the e-cigarette did not cross the threshold to be classified as a medicine under the Medicines Act. Status: Decided | 26 June 2012 35 The Hague Court of Appeal, The Netherlands v United Tobacco Vapor Group, [2012] Case No.: 200.105.395-01,(https://www.tobaccocontrollaws.org/files/live/ litigation/2130/NL_The%20Netherlands%20v.%20United%20Toba.pdf, accessed 21 July 2019) Case summaries 28 NEW ZEALAND 1. New Zealand Ministry of Health (MoH) v Philip Morris (New Zealand) Ltd.36 Facts Issue Arguments Advanced Philip Morris Limited was charged by the Ministry of Health (MoH) for selling a tobacco product called ‘Heets’ (product/used by heating in a device referred to as IQOS), in contraven- tion with s 29(2) of the Smoke-free Environment Act 1990 (Act). The product was labelled as suitable for chewing or any other oral use (other than smoking). Section 29(2) of the Act stipulated: “No person shall import for sale, sell, pack or distribute any tobacco product labelled or other- wise described as suitable for chewing, or for any other oral use (other than smoking).” Whether the sale of the product was pro- hibited under s 29(2) of the Act? Arguments advanced by MoH: The MoH submitted that the product would squarely fall within the ambit of s 29 of the Act because the aerosol emanated from it was inhaled through the mouth. Reference was also made to the enlargement of the scope of toxic substances under the Toxic Substances Act 1979. At the time of enactment of the 1979 Act, toxic substances were defined as: ‘any tobacco prepared for smoking, chewing, or snuffing’. In 1986, the definition was expanded by the addition of ‘or any other oral use’. It was the intention of the Parliament to capture prod- ucts for ‘any other oral use’, and it was this expanded definition that was included in s 29(2) of the Act. Section 29 was included in Part 2 of the Act, under the heading ‘Control of smoking products’. The objectives for Part 2 of the Act were set out in s 21 of the Act. Most importantly, it was to reduce the social approval of tobacco use particularly among young people by imposing controls on the marketing, advertising or promotion of tobacco products. The MoH submitted that this sup- ported the interpretation with respect to ‘Heets’ qualifying as a product under s 29 of the Act. It was emphasized by the MoH that the relative harm argument of the product being less harmful than cigarettes was irrelevant for the purposes of interpretation of s 29 of the Act. Arguments advanced by Philip Morris Limited: It was submitted that the present prosecution by the MoH was misconceived as s 29 of the Act was enacted to combat chewing tobacco and other kinds of tobacco taken orally. Thus, the product did not fall within the ambit of s 29 of the Act. Decision/Status The Court agreed with the interpretation of Philip Morris Limited and held that the product did not fall within the ambit of s 29(2) of the Act. The Court applied the rule of ejusdem generis to establish that the term ‘or for any other oral use’ was confined to a tobacco product used for chewing or an activity similar to chewing. The Court also relied on the evidence provided by a UK Physician that the act of burning tobacco resulted in the forma- tion of majority of harmful chemicals. While there are risks associated with the use of the product, it is not as harmful or potentially harmful as ordinary cigarette use. Thus, the product would not be caught within the ambit of s 29(2) of the Act. Status: Decided | 12 March 2018 36 District Court at Wellington, Ministry of Health v Phillip Morris (New Zealand) Limited, [2018] NZDC 4478, (https://www.tobaccocontrollaws.org/files/live/ litigation/2632/NZ_New%20Zealand%20MOH%20v.%20PMI.pdf, accessed 15 September 2020) Case summaries 29 NORWAY 1. Swedish Match v The Ministry of Health & Care Services Facts Issue Arguments Advanced Swedish Match filed a petition before the Oslo County Court seeking an injunction against the implementation of plain packaging regulations for snuff (snus) sold in Norway. The Ministry of Health and Care Services presented a proposal to amend the Tobacco Harm Act (for the implementation of the European Tobacco Products Directive 2014/40/EU). It was stated in the proposal that snus products have been introduced on the market with untraditional designs, which has contributed to the product’s increased appeal amongst youth. Thus, the Ministry considered it important to stan- dardize snus packaging. Whether standardized packaging applicable for snus was a neces- sary and proportional measure? Arguments advanced by Swedish Match: It was con- tended that the standardized packaging was adopted on a faulty factual basis. The State solely relied on the Norwegian Institute of Public Health’s report on the health risks associated with using snus. No separate risk as- sessment related to the use of snus was conducted by the State. Instead, the State mixed epidemiological studies of the risk of snus use with epidemiological studies of other tobacco products. Further, the State did not demonstrate that standardized packaging would have a positive effect on public health. It was also contended that the standardized packaging could have a negative effect on public health because snus is a harm-limiting alternative to cigarettes. The State imposed standardized packaging on snuff and lifted the ban on the sale of e-cigarettes at the same time, but with- out imposing standardized packaging on e-cigarettes. The State had not established that snus has greater appeal to children and youth than compared with e-cigarettes. In fact, e-cigarettes are already used by youth and this shows that the State has not followed a consistent and systematic approach for this measure. Arguments advanced by the State: The standardized packaging measure was imposed in a consistent and sys- tematic manner. The State submitted that e-cigarettes did not specifically appeal to youth and its use was not wide- spread. Standardized packaging may also be introduced for e-cigarettes, if the market conditions for it change. Further, the States enjoy a margin of appreciation in the selection of measures and there was no need to positively establish that no other measure would have achieved the consideration with equal effectiveness. The main objec- tive of the measure was to prevent the use of tobacco, especially among children and adolescents. Finally, the interests of Swedish Match were of an economic na- ture and could be compensated but the State sought to avoid irreversible consequences in terms of exposure to health risks. Case summaries 30 1. Swedish Match v The Ministry of Health & Care Services Decision/Status The State would have fulfilled the evidentiary requirement if it was established that the measure was appropriate and necessary to achieve the objective. i. Whether the measure met the proportionality principle? The Court noted that the State enjoyed a wide margin of ap- preciation in the area of health. In fact, scientific uncertainty about the potential for damage and the risk of the products to which the restrictions apply, provided a larger margin of discretion than would otherwise be available. ii. Whether the standardized snus packages are an appropriate measure? The Court noted that undoubtedly there was a health risk associated with the use of snus. The only disagreement related to the extent of this risk, and whether the use of snus could lead to cancer. The Court examined the report on the use of smokeless tobacco products by the Norwegian Institute of Public Health. It was concluded that the report was accurate with respect to the conclusions drawn by the Ministry. The Court observed no factual errors underlying the measure adopted by the Ministry. iii. Whether the measure was appropriate on the basis of differential treatment of snuff and e-cigarettes? The Court noted that e-cigarettes were a new product category and little research was available on any harm related to its use at this point. Further, there were no corresponding similarities between snus and e-cigarettes. The Ministry acknowledged that standardized packaging would be introduced for e-cigarettes if extensive use was detected amongst youth. The Court concluded that the differential treatment between e-cigarettes and snuff must be regarded as fair and justifiable. Accordingly, the State proved that the introduction of standardized packaging for snus was a necessary measure and that the objectives could not be attained by using less comprehensive measures or restrictions. The petition for temporary injunction filed by Swedish Match was denied and the State was awarded costs. Swedish Match filed an appeal against this order, which was dismissed by the Oslo Court of Appeal. Status: Decided | 6 November 2017 Case summaries 31 PHILIPPINES 1. Green Puff Electronic Cigarettes Inc, v The Department of Health37 Facts Issue Arguments Advanced The Department of Health issued an administra- tive order (No 2019-0007), under which electronic cigarettes were classified as health or consumer products under the jurisdiction of the FDA. The AO served to act as a guide to all individuals, enter- prises and businesses which seek to manufacture, distribute, import, export ENDS/ENNDS products. The Petitioner filed a petition of certiorari seeking to annul and set aside the DoH administrative order as being invalid and unconstitutional before a regional trial court. Whether the admin- istrative order was constitutional and valid? The Petitioners submitted that the AO issued by the DoH was unconstitutional as it should have been passed by the Congress and not the head of the DoH. ENDS and ENNDS are not covered by the Food and Drug Administration Act (R.A. No. 9711) and thus could not be placed under the purview of the FDA by an exercise of rule-making power. Decision/Status - Status: Pending 37 Regional Trial Court (National Capital Judicial Region), Green Puff Electronic Cigarettes Inc. v The Department of Health, [2019] R-MNL-19-07810-SC Case summaries 32 REPUBLIC OF KOREA 1. Korea Electronic Cigarette Association v Ministry of Health and Welfare38 Facts Issue Arguments Advanced In October 2019, the Minister of Health and Welfare strongly recommended that liquid e-cigarettes be discontinued until the safety management and hazard verification is completed. In December 2019, the Minister of Health and Welfare announced that research of the e-cigarette components was required to understand the causal relationship with lung damage and death, until then it was strongly recommended to discontinue use of liquid e-ciga- rettes. The said measures would be maintained until the first-half of 2020, when human toxicity studies would be announced. The Korea Electronic Cigarette Association chal- lenged the Ministry of Health and Welfare’s Recommendation. Whether the Ministry of Health and Welfare’s recommen- dation violates the claimant association’s right to equality? - Decision/Status It was held that Ministry of Health and Welfare’s Directive was only recommendatory in nature and not compulsory. Thus, it did not have a direct legal effect on the rights and obligations of the claimant. Status: Decided | 17 March 2020 38 The Constitutional Court of South Korea, Korea Electronic Cigarette Association v the Ministry of Health, Cases 2020 Heungma 365, (https://www.tobaccocontrollaws.org/litigation/decisions/kr-20200317-korea-electronic-cigarette-ass, accessed 17 September 2020) Case summaries 33 SPAIN 1. Altadis v Philip Morris39 Facts Issue Arguments Advanced Spain’s Advertising law prohibits all kinds of ad- vertising and promotion of tobacco products in all media and other means (Article 9 r/w Article 2 of law 28/2005). Altadis filed a lawsuit against Philip Morris Spain alleging that the US Company was illegally advertising IQOS along with ‘Heets’. Whether advertising the IQOS device is prohibit- ed under the provisions of Law 28/2005? - Decision/Status The Court directed Philip Morris to cease its campaigning of these products. It was held that in the field of tobacco, if the purpose or effect of the communication is direct or indirect promotion of a tobacco product, then it is violative of the law. The isolated advertising of the IQOS device has no other purpose than the use of tobacco and would be caught within the ambit of Law 28/200540. Status: Decided | 30 September 2019 39 Commercial Court of Madrid, Altadis v. Philip Morris, [2018] Roj: SJM M 1157/2019 - ECLI: ES:JMM:2019:1157 40 Spain | Law 28/2005 | Health measures regarding smoking and its sales regulation, supply, use and advertising of tobacco products, (https://www.tobaccocontrollaws.org/files/live/Spain/Spain%20-%20Law%2028_2005.pdf, accessed 18 December 2019) Case summaries 34 SWITZERLAND 1. GmbH v Customs Inspectorate Basel41 Facts Issue Arguments Advanced The Court assessed the constitutionality and legality of an import ban on white snus in this case. The importer filed a complaint when 42 cartons (244.8 kg) of white snus were withheld by the Customs Inspectorate. The importer submitted before the Court that ‘white snus’ did not fall within Article 5 of the Tobacco Products and Smokers’ Products with Tobacco Substances Regulation (Tobacco Ordinance) i.e. a provision that prohibited tobacco products for oral use. Whether the import ban on snus was constitutional? The importer argued that the rejection of white snus by the custom authorities constituted an interference with the economic freedom of the importer. Decision/Status The Court examined the constitutionality and legality of Article 5 of the Tobacco Ordinance on the touchstone of economic freedom. The Court inspected provisions of the Foodstuff and Utility Articles Act (aLMG) which also applied to tobacco and other tobacco products. The analysis of the aLMG led the Court to conclude that semi-luxury foods (alcohol and nicotine) inevitably involved inherent risks and could not justifiably be banned. People who drank and smoked in excess, conscious- ly damaged their health. It was held that semi-luxury goods could only be banned if in their normal use, they endangered health directly or in unexpected ways. Further, the health hazards of tobacco products, especially nicotine were well known today. The risks were inherent in the consumption of the good and according to the provisions of the aLMG should not be banned on this basis. Thus, Art 5 of the Tobacco Ordinance was illegal. The Court also observed that as the provision was illegal, explanations on the grounds of public interest and proportionality were superfluous. On the argument of comparative risk between snus and cigarettes, the Court held that it was arbitrary and illegal to prohibit snus when more dangerous products like cigarettes were not prohibited. Even in the European Union, the ban on snus did not apply to all states (exception: Sweden). Thus, it was unclear why a ban on snus would be required in Switzerland, for which EU law is not even binding. Status: Decided | 27 May 2019 41 Federal Court of Switzerland, Gmbh v Customs Inspectorate Basel, [2019] 2C_718/2018, (https://www.bger.ch/ext/eurospider/live/de/php/aza/http/index. php?highlight_docid=aza%3A%2F%2Faza://27-05-2019-2C_718-2018&lang=de&zoom=&type=show_document, accessed 27 June 2019) Case summaries 35 UNITED KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND 1. ASA Adjudication on Cigirex42 Facts Issue Arguments Advanced A national press ad, for CIGIREX, was headed “ATTENTION SMOKERS: a new product with less nic- otine, no tobacco or tar, but the same satisfaction!”. Text stated “... a breakthrough on how nicotine is delivered to your bloodstream without tar, tobacco and thousands of carcinogens associated with tradi- tional cigarettes ... CIGIREX removes these harmful ingredients associated with traditional cigarettes and delivers a no tobacco, tar free method of how nicotine is delivered into your system ... CIGIREX, a carcinogen-free nicotine oral delivery system with cartomizer technology. CIGIREX looks, feels and smokes just like a real tobacco cigarette with none of the tar or tobacco found in a regular tobacco ciga- rette ... Today is the first day of rest [sic] of your life. It is time to say NO to being addicted to tobacco cig- arettes. If you are among this group, then take your first steps to taking charge of your life, your destiny and your future. CIGIREX along with Together Against Cancer ... invites you to take the CIGIREX Challenge to live tobacco and tar free! ... They will send you ... a special certificate that commemorates the day that you took your first step to freedom and living tobacco-free ... [CIGIREX] may help you stop smoking tobacco cigarettes in a very short period of time with none of the side effects ... Remember with this product no prescription is required ...”. Whether the adver- tisement misleadingly implied that: (i) the product had no detrimental effects of smoking tobacco cigarettes and (ii) the advertisement made medicinal claims for an unautho- rized product. CIGIREX submitted that the advertise- ment made no medicinal claims, or implied claims, that the product would heal or cure any pre-existing condition or improve any health concerns. Decision/Status The ASA noted that no scientific evidence was provided to support the impression that Cigirex had none of the damaging effects of smoking tobacco cigarettes. The advertisement exaggerated the benefits of the product and was thus mis- leading. Further, Cigirex did not hold relevant marketing authorization to make medicinal claims. On this point also the advertisement was misleading. Status: Decided | 22 December 2010 42 ASA Adjudication on CIGIREX, [2010] Complaint Ref: 136940, (https://www.tobaccocontrollaws.org/files/live/litigation/1686/GB_ASA%20Adjudication%20on%20 CIGIREX.pdf, accessed 28 June 2019) Case summaries 36 2. ASA Adjudication on Cigirex Ltd.43 Facts Issue Arguments Advanced A national press advertisement for an electronic nicotine dispenser, which appeared on 24 November 2011 was headlined “LOOKS, SMOKES, TASTES & SATISIFIES like a cigarette”. Text appearing on what appeared to be a cigarette packet stated “CIGIREX. Contains Nicotine, Zero Tobacco, Zero Tar, Zero Tobacco Smoke, Zero chemicals, Zero odour ... 100% Satisfying. 100% Safe”. The advertisement compared Cigirex to cigarettes and provided further informa- tion about the product and information on how to buy the product. Whether the claims: (i) zero chemicals and (ii) 100% safe were misleading and could be substantiated. It was submitted that the claim “100% Safe” related to the fact that Cigirex did not contain any tobacco or carcino- gens which were recognised to be the cause of smoking related ailments and diseases. Decision/Status ASA noted that Cigirex had not provided suitable evidence to establish that its e-cigarette did not contain propylene glycol. It was held that the claim ‘zero chemicals’ had not been substantiated and was misleading. The test reports of the product stated that the product was equivalent to “mild smoking cigarettes” or “very mild smoking cigarettes”. The test reports also indicated that Cigirex contained tar and that implied that Cigirex delivered tobacco to the user- an ingredient which the ad claimed were not present in Cigirex. The advertisement clearly stated that the product contained nicotine and contradicted the claim that Cigirex was 100% safe. Thus, the claim had not been substantiated and was misleading. Status: Decided | 28 March 2012 43 ASA Adjudication on Cigirex Ltd, [2012] Complaint Ref: A11-179572, (https://www.tobaccocontrollaws.org/files/live/litigation/1687/GB_ASA%20Adjudication%20 on%20Cigirex%20Lt.pdf, accessed 28 June 2019) Case summaries 37 3. ASA Adjudication on Desert Point Ltd44 Facts Issue Arguments Advanced The website www.clearsmoke.co.uk, which offered a trial of electronic cigarettes, was headed “ClearSmoke” and featured the logos of the BBC, Sky News and itv1 with the statement “e-Cigs advertised on”. Under the heading “THE SMART SMOKERS [sic] CHOICE”. The ad stated “SMOKE ANYWHERE. ClearSmoke electronic cigarettes are smoke-free and flame-free, meaning you can enjoy them safely, anywhere you want”. Under the heading “Electronic Cigarettes in the Media” the ad included quotations from national newspapers and television broadcasters. The quotation from the Guardian stated “The government’s ‘nudge unit’ wants to encourage the use of smokeless nicotine cigarettes - in an attempt to reduce the numbers killed in the UK by smoking diseases each year”. The quotation from the Daily Telegraph stated “Electronic cigarettes mimic the act of smoking and include nicotine, but do not emit the same type of odour or ash”. The ad also stated “QUALITY ASSURANCE. All ClearSmoke products are subjected to strict quality control and industry assess- ments”. It then listed “CE A mandatory conformance mark on products in the European Economic Area - RoHS Restriction of Hazardous Substances - SGS The global leader and innovator in inspection, verification, testing & certification”. The ad also stated “ClearSmoke has the following certifications: CE ... RoHS - SGS”. Whether: (i) the claim that the product had been advertised by the BBC, SKY News and itv1 could be substantiated; (ii) the claim “…you can enjoy them safely, any- where you want” was misleading and could not be substantiated; (iii) the quotation under the heading “Electronic Cigarettes in the Media” were misleading because they had been taken out of context; and (iv) the claims under qual- ity assurance were misleading because they suggested that the product had been medically approved. It was submitted that “e-cigs advertised on” referred to the product type as a whole and not the ClearSmoke brand specifically. Additionally, the website contained a disclaimer which stated, “The use of references to statements made by news organizations and quotes from experts in the field does not mean that these organisations and/or experts in any way endorse the ClearSmoke (TM) product”. Decision/Status ASA noted: (i) Whether the claim referred to the ClearSmoke brand or e-cigarettes generally. No explanation had been provided on the context in which the product had been advertised or featured on BBC, Sky News and itv1. Accordingly, the claim was misleading. (ii) The policy on usage of e-cigarettes varied between organizations, employers etc. While it might not be illegal to use e-cigarettes, it was not always allowed in all situations. Thus, the claim “…you can enjoy them safely, anywhere you want” was misleading. (iii) The quotations in this section suggested that the authors or organizations were strongly in favour of the use of e-ciga- rettes as an alternative to smoking conventional cigarettes. While the full articles adopted a more cautious approach on the usage of e-cigarettes, the extracts were taken out of context. It was concluded that the use of quotations was misleading. (iv) E-Cigarettes were not regulated by the MHRA and were not approved by them. Thus, the text, “All ClearSmoke prod- ucts are subjected to strict quality control and industry assessment” was ambiguous and was misleading. Status: Decided | 24 October 2012 44 ASA Adjudication on Desert Point Ltd, [2012] Complaint Ref: A12-199372, (https://www.tobaccocontrollaws.org/files/live/litigation/1426/GB_ASA%20 Adjudication%20on%20Desert%20Poi.pdf, accessed 28 June 2019) Case summaries 38 4. ASA Adjudication on Nicocigs Ltd45 Facts Issue Arguments Advanced Claims on the website www.nicolitesonline.co.uk, for electronic cigarettes, included “Although the vapour inhaled and exhaled when using Nicolite resembles smoke, it’s simply a completely harmless vapour. The vapour has no odour and does not linger the way tobac- co smoke does. So there’s no danger of passive smok- ing posed to those around ‘vapers,’ as e-cig users are called. It’s the tobacco that’s harmful, not the nicotine, which is mildly addictive but poses no health hazard …”. Whether the website misleadingly claimed that the product was not harmful? Nicolite submitted that the ingredi- ents in their liquid which was heated to create a vapour had been subject to a toxicology risk assessment. The report confirmed that all of the ingredi- ents were safe and the vapour caused no harm. Decision/Status The ASA perused the evidence submitted by Nicolite, in the form of literature reviews or references to individual ingre- dients in the product. It was noted that the toxicology risk assessment did not take the form of a controlled clinical trial and concluded that e-cigarettes were unlikely to pose a risk to health over and above that of cigarettes. However, the advertisement implied that the product would pose no risks to health at all. It was concluded that the advertisement was misleading as the claim that the product was not harmful had not been substantiated. Status: Decided | 16 January 2013 5. ASA Adjudication on Nicocigs Ltd.46 Facts Issue Arguments Advanced A website for electronic cigarettes, www.nicolitesonline. co.uk, claimed that although the vapour inhaled and exhaled when using Nicolite resembled smoke, it was completely harmless vapour. Further, the website stat- ed that tobacco was harmful and not nicotine, which was mildly addictive but posed no health hazard. Whether the website misleadingly claimed that the product was not harmful as the claim could not be substantiated? Nicolites submitted a safety report of the inhaled aerosol, wherein it was observed that “it was safe relative to cigarettes and also safe in absolute terms on all measurements applied”. Decision/Status The evidence submitted by Nicolites was examined by ASA. It was concluded that no assessment was submitted to substantiate the claim that that the vapour from e-cigarettes was “completely harmless” and “posed no health hazard”. Thus, the advertisement was held to be misleading under the Committee of Advertising Practice (CAP) Code. Nicolites was directed to ensure that the advertisement should not appear in its current form. Status: Decided | 16 January 2013 45 ASA Adjudication on Nicocigs Ltd, [2013] Complaint Ref: A12-207775, (https://www.tobaccocontrollaws.org/files/live/litigation/1396/GB_ASA%20Adjudication%20 on%20Nicocigs%20L.pdf, accessed 28 June 2019) 46 ASA Ruling on Nicocigs Ltd., [2013] Complaint Ref: A12-207775, (https://www.tobaccocontrollaws.org/files/live/litigation/1396/GB_ASA%20Adjudication%20 on%20Nicocigs%20L.pdf, accessed 27 June 2019) Case summaries 39 6. ASA Adjudication on Nicocigs Ltd47 Facts Issue Arguments Advanced A national press ad for Nicolites electronic ciga- rettes included the text, “THE SAFER SMOKING ALTERNATIVE” and “HEALTHIER. No tobacco, tar or carbon monoxide”. Whether the health claims in the adver- tisement implied that the product was not harmful? Nicocigs stated that the advertisement was misleading. Decision/Status ASA noted that Nicocigs did not submit evidence to support its claims and it was concluded that the advertisement was misleading. Status: Decided | 15 May 2013 7. ASA Adjudication on Easylife Group Ltd48 Facts Issue Arguments Advanced A catalogue enclosed in a national newspaper and claims on the website www.dailymailselect.com promoted an electronic cigarette: a. The catalogue stated, “The cigarette you can smoke anywhere you like ... Unaffected by smoking bans - so they’re legal in pubs and restaurants ...”. b. The website contained the same claim. Whether the claim “unaffected by smoking bans- so they’re legal in pubs and restaurants” was misleading, because many pubs and restaurants did not allow the use of elec- tronic cigarettes? It was submitted that the advertisement implied that there was no government directive to ban use of e-cigarettes in pubs and restaurants. The claim was not misleading because it was the choice of individual pubs and restaurants, if at all to ban use of e-cigarettes. Decision/Status The ASA noted that e-cigarettes did not fall within the scope of the laws restricting smoking in an enclosed public place. Nevertheless, some pubs and restaurants had chosen not to allow their use. The claim in the advertisement was specific to the restrictions imposed on smoking by UK law and did not imply that all pubs and restaurants would allow the use of e-cigarettes. Thus, the claim was not misleading. Status: Decided | 21 August 2013 47 ASA Adjudication on Nicocigs Ltd, [2013] Complaint Ref: A13-219974, (https://www.tobaccocontrollaws.org/files/live/litigation/1407/GB_ASA%20Adjudication%20 on%20Nicocigs%20L.pdf, accessed 28 June 2019) 48 ASA Adjudication on Easylife Group Ltd, [2013] Complaint Ref: A13-230302, (https://www.tobaccocontrollaws.org/files/live/litigation/1397/GB_ASA%20 Adjudication%20on%20Easylife%20G.pdf, accessed 28 June 2019) Case summaries 40 8. ASA Adjudication on Nicocigs Ltd49 Facts Issue Arguments Advanced A website, www.nicolitesonline.co.uk, for Nicolite Electronic Cigarettes, featured three rotating images at the top of the “Benefits” page. One of the images showed a woman holding a cigarette and a glass. Text beside the image stated, “Cheaper Than Traditional Cigarettes. Electronic Cigarettes work out to be up to three times cheaper than traditional cigarettes”. The final paragraph was titled “Less Expensive than Conventional Cigarettes” and displayed text that stated “Nicolite can be significantly less expensive than tobacco cigarettes. Once you’ve bought the starter kit, all that needs replacing is the carto- miser that contains liquid nicotine. A cartridge is equivalent to about twenty tobacco cigarettes. If you smoke five cigarettes a day, you stand to save nearly £400 per year if you switch to Nicolite. If you smoke twenty cigarettes a day, the saving would be about £1500 per year. With all these benefits to recom- mend them, aren’t Nicolite e-cigs worth a try?”. Beneath that appeared a table, which displayed figures of the savings consumers could achieve if they replaced conventional cigarettes with Nicolite Electronic Cigarettes. The table showed that a per- son who smoked 20 cigarettes a day would spend £2,372.52 a year on ‘ordinary’ cigarettes or £845.60 on Nicolite Electronic Cigarettes, which represented a yearly saving of £1,526.92. Whether a cartridge is equivalent to about twenty tobacco cigarettes was mis- leading and could be substantiated? The manufacturer conducted tests after receiving the complaint from ASA. The test established that each cartomiser lasted for at least 20 cigarettes. Decision/Status The ASA noted that Nicolite conducted a test to substantiate the claim after the complaint had been filed. On this basis alone, the test was inadmissible to support the claim at the time the advertisement appeared. Further, the test report submitted by Nicolite did not contain a detailed methodology and the robustness of the test could not be assessed. As the claim could not be substantiated, it breached the Code. Status: Decided | 11 September 2013 49 ASA Adjudication on Nicocigs Ltd, [2013] Complaint Ref: A13-231073, (https://www.tobaccocontrollaws.org/files/live/litigation/1685/GB_ASA%20Adjudication%20 on%20Nicocigs%20L.pdf, accessed 28 June 2019) Case summaries 41 9. ASA Adjudication on Sorse Distribution Ltd.50 Facts Issue Arguments Advanced A television advertisement for e-cigarettes, viewed at various times between 9 pm and 1 am, began with on- screen text that stated, “5 COLORS” and a voice-over that said, “Five Colors. What’s your flavour? The ad showed a number of young adults jumping in the air while fruits, including strawberries, apples and grapes, appeared and exploded in the background. Onscreen text visible throughout the ad stated “5colors.co.uk 0844 XXX XXXX”. In the final scenes a voice-over said, “It’s time to come in from the cold. Five Colors.” Whether the adver- tisement was: (i) mis- leading as it did not clarify the characteris- tics of the product; (ii) irresponsible as it would encourage young adults and children to take up smoking. It was submitted that the advertise- ment was purposefully vague and did not include references to smoking or any imagery that could be mis- construed as being linked to tobacco products. Decision/Status ASA noted that the nature of the product was not clear through the advertisement and could mislead a consumer. It was important that such advertisements clarified the nature of the product and whether or not it contained nicotine. Thus, the advertisement breached the BCAP Code rules 3.1. and 3.2. At the same time, the advertisement was cleared with an ‘ex-kids’ restriction and would not be broadcasted around pro- grammes of particular appeal to children. The advertisement did not include any reference to nicotine or tobacco prod- ucts and thus would not encourage young adults and children to start smoking. Status: Decided | 25 September 2013 10. ASA Adjudication on Zulu Ventures Ltd.51 Facts Issue Arguments Advanced A television advertisement for e-cigarettes, viewed at around 7.15 pm, showed scenes of young adults undertaking various day-to-day activities. On-screen text during the advertisement stated “www.sky- start.co.uk 0800 XXX XX XX” and “SKYSTART only available to those over 18yrs of age”. A voice-over said, “Life is not about tomorrow nor is it about yes- terday. Life is about the moment, the now. Whoever you are, whatever you do, life only asks you one question - who will you share it with? Skystart.” Whether the advertise- ment was: (i) mislead- ing as it did not clarify the characteristics of the product; and (ii) irresponsible as it would encourage young adults and children to take up smoking. It was submitted that because an elec- tronic cigarette was reminiscent of a traditional cigarette, the advertisement did not specify characteristics of the product. 50 ASA Adjudication on Sorse Distribution Ltd, [2013] Complaint Ref: A13-219212, (https://www.tobaccocontrollaws.org/files/live/litigation/1431/GB_ASA%20 Adjudication%20on%20Sorse%20Dist.pdf, accessed 28 June 2019) 51 ASA Adjudication on ZULU Ventures Ltd, [2013] Complaint Ref A13-219713, (https://www.tobaccocontrollaws.org/files/live/litigation/1432/GB_ASA%20 Adjudication%20on%20ZULU%20Ventu.pdf, accessed 28 June 2019) Case summaries 42 10. ASA Adjudication on Zulu Ventures Ltd.51 Decision/Status ASA noted that the advertisement did not share material information about the product which was necessary for viewers if they wished to find out more. In fact, inquisitive consumers were likely to have visited the website during the adver- tisement, thus resulting in an action that many would not otherwise have taken if they were aware of the nature of the product. As the advertisement did not clarify that the product being advertised contained nicotine, it was concluded that the advertisement was misleading and breached the BCAP Code. The advertisement did not glamourize the nicotine product nor encouraged its excessive or inappropriate use. Further, the advertisement did not include any reference to tobacco products and did not encourage people of any age to start smok- ing cigarettes. Thus, the advertisement was not irresponsible or harmful. Status: Decided | 25 September 2013 11. ASA Adjudication on Ten Motives Ltd52 Facts Issue Arguments Advanced A television advertisement for electronic cigarettes, featured a ‘£’ symbol next to animated images of various day-to-day activities and objects such as a beach holiday and a television. The ad also featured animated images of cycling and a young family. The voice-over stated, “What’s my motive? Finding them is easy as 1, 2, 3. I have more freedom, to be the real me, and do all the things I haven’t done in a long time. Enjoying life with the people that matter most. Ten motives. What’s your motive?” On-screen text stated “www.tenmotives.com What’s your motive?”. Whether the adver- tisement was: (i) misleading because it encouraged young adults and children to visit the website but did not make clear the characteristics of the product; and (ii) was irresponsible and harmful because it promoted a nico- tine-based product. It was submitted that at no point in the advertisement was a viewer encouraged to visit the website. The advertisement was targeted towards adults. Decision/Status ASA noted that the advertisement did not identify the type of product being promoted and inquisitive viewers were likely to visit the website to find out more about the product. It was important that such advertisements clearly spelled out the nature of the product and whether or not it contained nicotine. Thus, it was held that the advertisement was misleading. The advertisement did not encourage the harmful use of a nicotine product and thus was not socially irresponsible. Status: Decided | 25 September 2013 52 ASA Adjudication on Ten Motives Ltd, [2013] Complaint Ref: A13-230598, (https://www.tobaccocontrollaws.org/files/live/litigation/1406/GB_ASA%20 Adjudication%20on%20Ten%20Motive.pdf, accessed 28 June 2019) Case summaries 43 12. ASA Adjudication on Zandera Ltd.53 Facts Issue Arguments Advanced A radio ad, a television ad, an internet banner ad, a poster at a bus-stop and a display ad on the side of a bus, for electronic cigarettes formed the basis of this complaint. a. The radio ad featured three scenes of vital mo- ments: a wedding; an award ceremony; and the birth of a child. In each scene a key participant was obviously missing and someone asked “Where’s Dave?”. A voice-over then stated, “What are you miss- ing when you pop out for a cigarette? By switching to E-Lites you can legally smoke indoors with no tobacco, no smell and around seventy per cent less cost. Find E-Lites in store or at e-lites.co.uk. E-Lites, smoking reinvented.” b. The TV ad showed a family gathering in which a number of adults were admiring an infant child. One of the men then got up, tapped his shirt pocket, nod- ded to the woman holding the baby and left the room. The baby then began to toddle towards one of the other women, but stopped in the middle of the room and performed several dance moves from the music video for the song Gangnam Style, before sitting down. The man who had left the room then returned, clapped his hands and said, “So, what have I missed?” while the other adults were shown frozen with shock. On-screen text stated “E-Lites. What are you missing? E-Lites.co.uk”. c. The internet banner ad had text which stated “NO TAR. NO TOBACCO. 70% CHEAPER. 100% LEGAL” and had a picture of an e-cigarette. The image then changed to show two product packages alongside the text, “The satisfying smoking alternative learn more”. At the bottom of the ad was the product logo and the text “E-Lites UK’S BEST ELECTRONIC CIGARETTE”. d. The poster ad at the bus-stop stated “WHAT ARE YOU MISSING? No tar. No tobacco. No odour”. It showed an open packet of E-Lites with the two sep- arate parts of an individual electronic cigarette lying next to it. e. The poster on the bus showed an open product pack next to text which stated “WHAT ARE YOU MISSING? No tar, no tobacco and legal indoors. E-Lites SMOKING REINVENTED”. The complaints against each of the advertisements de- scribed above are: (i) Whether advertise- ment (a) promoted a nicotine based product and encouraged and normalized tobacco smoking; (ii) Whether advertise- ment (a) and (b) were misleading due to the omission of material information about the product, specifically its ingredients and that it contained nicotine; (iii) Whether adver- tisement (b), (c), (d) and (e) promoted a nicotine-based product and encour- aged and normalized smoking or the use of E-Lites. Zandera made the following submis- sions before ASA: - The radio advertisement did not promote nicotine, nor encouraged or normalised traditional smoking. - Advertisement (b) showed a website address where further information could be found on the product and its ingredients. It was submitted that the advertisement did not normalise the act of smoking and was not irresponsi- ble or harmful in any way. 53 ASA Adjudication on Zandera Ltd, [2013] Complaint Ref: A13-219706, (https://www.tobaccocontrollaws.org/files/live/litigation/1427/GB_ASA%20Adjudication%20 on%20Zandera%20Lt.pdf, accessed 28 June 2019) Case summaries 44 12. ASA Adjudication on Zandera Ltd.53 Decision/Status (i) Advertisement (a) presented smoking in a negative light and did not encourage or normalize tobacco smoking. (ii) E-cigarettes were a new product in the UK and it was important that the nature of the product was advertised clearly along with full material disclosure. Thus, advertisements (a) and (b) were misleading and breached the code. (iii) Nicotine-containing electronic cigarettes could be sold legally in the UK and were not a prohibited category under the CAP Code. The three advertisements promoted an alternative to tobacco smoking and were unlikely encouraging or normalizing tobacco smoking. Status: Decided | 25 September 2013 13. ASA Adjudication on Zulu Ventures Ltd.54 Facts Issue Arguments Advanced A poster on a train for electronic cigarettes was headlined “Feel the difference”. The advertisement featured an image of three packs of the product, which resembled tobacco cigarettes. Further text stated “SKYCIG Combines industry-leading technol- ogy with a name you can trust to give you the most realistic smoking experience possible. SKYCIG cus- tomers also save up to 80% compared to smoking traditional cigarettes so why not give SKYCIG a try today? EQUIVALENT TO 40 CIGARETTES”. Whether the untarget- ed poster advertise- ment was irrespon- sible because it was placed in a location where it was likely to be seen by children? Zulu Ventures contended that the aver- age commuter on the train fell into the 25-34 years of age bracket. Decision/Status The ASA noted that the advertisement appeared on a route which did not carry a high percentage of children. Further, the advertisement was mostly comprised of text and did not contain any image or content that was likely to be attractive to children. The text clearly stated that the advertisement was for a non-tobacco product and did not encourage or normalize tobacco smoking among children or adults. Status: Decided | 20 November 2013 54 ASA Adjudication on ZULU Ventures Ltd, [2013] Complaint Ref: A13-240201, (https://www.tobaccocontrollaws.org/files/live/litigation/1628/GB_ASA%20 Adjudication%20on%20ZULU%20Ventu.pdf, accessed 28 June 2019) Case summaries 45 14. ASA Adjudication on UKVapes Ltd.55 Facts Issue Arguments Advanced A radio advertisement for electronic cigarettes featured a voice-over that stated, “Do you smoke? Want to save money? Well, with electronic cigarettes from UKVapes, save money and enjoy the sensation of smoking, with- out the anti-social side effects [a coughing sound effect was heard]. They don’t contain tobacco and because they only create vapour, you can use them almost anywhere. Electronic cigarettes come in a variety of vapour flavours too - there’s the ‘fruities,’ like cherry and banana or the ‘yummies,’ like cola or ice mint.” Whether the adver- tisement was irre- sponsible because of its reference to a range of flavours that could encourage children to use the product? It was submitted that the advertise- ment was targeted at existing smokers who wanted to try e-cigarettes. Decision/Status ASA noted that the advertisement started with the statement, “Do you smoke?”, which clearly established that it was tar- geted towards existing smokers. The flavours referenced were common to many products and not only those that would appeal to children. Thus, the advertisement was not irresponsible and did not breach the Code. Status: Decided | 20 November 2013 15. ASA Adjudication on CN Creative Ltd.56 Facts Issue Arguments Advanced A national press advertisement for e-cigarettes included an image of a number of packages of the product alongside text that stated “A BIG DEAL FOR SMOKERS. Finally, there’s an e-cigarette that can deliver a truly re- alistic experience and a smooth, satisfying taste. Try the Vype e-cigarette FREE at goVype.com/guardian”. Small print at the bottom of the ad stated “Contains nicotine. Always read the label. Terms and conditions apply”. Whether the ad- vertisement was irresponsible and could encourage non-smokers and former smokers to take up smoking? It was submitted that the key message of the advertisement was to encourage smokers to try e-cigarettes as an alter- native to traditional cigarettes. Decision/Status The ASA noted that the advertisement was clearly for an electronic cigarette and addressed towards current smokers. It disassociated the product from traditional tobacco cigarettes. Thus, it was observed that the advertisement would unlikely encourage tobacco smoking amongst non-smokers. Status: Decided | 8 January 2014 55 ASA Adjudication on UKVapes Ltd, [2013] Complaint Ref: A13-239752, (https://www.tobaccocontrollaws.org/files/live/litigation/1627/GB_ASA%20 Adjudication%20on%20UKVapes%20Lt.pdf, accessed 28 June 2019) 56 ASA Adjudication on CN Creative Ltd, [2014] Complaint Ref: A13-243944, (https://www.tobaccocontrollaws.org/files/live/litigation/1625/GB_ASA%20 Adjudication%20on%20CN%20Creativ.pdf, accessed 27 June 2019) Case summaries 46 16. ASA Adjudication on Dardam Services Ltd.57 Facts Issue Arguments Advanced A national press advertisement, for an electron- ic cigarette, was titled “Stub it out for good”. It discussed the national stop smoking campaign Stoptober and was headed “Switchtober 2013”. It featured an image of a calendar page with the first day marked with the No Match logo, which was a match with a cross through it. Whether the adver- tisement was mislead- ing and implied that the product could be used as a smoking cessation device? The company submitted that every effort was taken to ensure that their products were not confused with smoking cessa- tion devices. Decision/Status The ASA noted the similarity between the phrases “Switchtober” and the NHS campaign “Stoptober”. This could lead the consumers to believe that the product was suitable as a smoking cessation device but the product was not licensed by the MHRA for that purpose. Thus, the advertisement breached the Code in that regard. Status: Decided | 29 January 2014 17. ASA Adjudication on Nicocigs Ltd.58 Facts Issue Arguments Advanced A poster for Nicolites electronic cigarettes stated, “KICKS BUTT”. The accompanying smaller text stated, “UK’S FAVOURITE ELECTRONIC CIGARETTE. A SMOOTH, SATISFYING FLAVOUR THAT HITS THE SPOT!”. The advertisement also featured an image of the product. Whether the adver- tisement was mislead- ing because it implied that the product could be used as a smoking cessation aid? It was submitted that the phrase “Kicks Butt” was not intended to imply that the product could be used as a smoking ces- sation aid. Therefore, the product did not require and did not have any marketing authorization from MHRA. Decision/Status ASA noted that the advertisement implied that the consumers could use the product to kick the habit because of the phrase “Kicks Butt”. However, the product was not licensed by the MHRA for that purpose, the advertisement breached the Code. Nicocigs Ltd was directed not to imply that their product could be used as a smoking cessation aid in the future. Status: Decided | 5 February 2014 57 ASA Adjudication on Dardam Services Ltd, [2014] Complaint Ref: A13-245512, (https://www.tobaccocontrollaws.org/files/live/litigation/1631/GB_ASA%20 Adjudication%20on%20Dardam%20Ser.pdf, accessed 27 June 2019) 58 ASA Adjudication on Nicocigs Ltd, [2014] Complaint Ref: A13-245645, (https://www.tobaccocontrollaws.org/files/live/litigation/1690/GB_ASA%20Adjudication%20 on%20Nicocigs%20L.pdf, accessed 27 June 2019) Case summaries 47 18. ASA Adjudication on Zandera Ltd.59 Facts Issue Arguments Advanced A magazine advertisement for e-lites, elec- tronic cigarettes, featured a penguin with various e-cigarette paraphernalia. The ad stated “Don’t get left out in the cold this Christmas ... ‘smoke’ inside without wor- rying about nasty odours, passive smoke, harmful tar or carbon monoxide”. Whether the advertisement was irresponsible because it: (i) appeared in a magazine that appealed to children; and (ii) included an image of a pen- guin and the word ‘Christmas’, which could appeal to children. Zandera contended that the magazine was not targeted at children and its core audience was of men over 40 years of age. Decision/Status The ASA noted that the magazine was targeted towards adults and not children. It contained no visuals or wording that were likely to appeal to children. It was held that the advertisement was not irresponsible. Status: Decided | 12 February 2014 19. ASA Adjudication on 1111 EC Services Ltd.60 Facts Issue Arguments Advanced A national press advertisement for V2 electronic cigarettes stated “USA’s #1 now in the UK. Feel the quality. Taste the difference ... For FREE ...”. Halfway down the page, the text stated “For Stoptober ... To get your Express Starter Kit, ... use promo-code ‘STOPTOBER’...”. Whether the advertisement implied that: (i) it was suitable as a smoking cessation device; (ii) misleadingly implied that the product was associated with the NHS “Stoptober” campaign. The company submitted that nothing in the advertisement made reference to cessation. Decision/Status The ASA was concerned that the advertisement used “Stoptober” and the consumers were likely to understand that the product was associated or endorsed by the NHS campaign. Since this was not the case and the product had not been licensed by the MHRA as a cessation device, ASA concluded that the advertisement breached the Code. Status: Decided | 12 February 2014 59 ASA Adjudication on Zandera Ltd., [2014] Complaint Ref: A13-251599, (https://www.tobaccocontrollaws.org/files/live/litigation/1630/GB_ASA%20 Adjudication%20on%20Zandera%20Lt.pdf, accessed 27 June 2019) 60 ASA Adjudication on 1111 EC Services Ltd, [2014] Complaint Ref: A13-250336, (https://www.tobaccocontrollaws.org/files/live/litigation/1629/GB_ASA%20 Adjudication%20on%201111%20EC%20Se.pdf, accessed 27 June 2019) Case summaries 48 20. ASA Adjudication on Must Have Ltd t/a VIP Electronic Cigarette61 Facts Issue Arguments Advanced Two advertisements that appeared on television and the advertiser’s YouTube channel formed the basis of 1, 156 complaints. The first TV ad showed a woman speaking directly to the camera, she stated, “I want you to get it out, I want to see it, feel it, hold it Put it in my mouth I want to see how great it tastes.” Onscreen text stat- ed, “www.vipecig.co.uk Contains Nicotine”. A symbol also appeared that indicated the product was not suitable for those aged under 18 years. Further on-screen text stated “THE GREAT TASTE OF VIP” and “VIP E-cigarettes & E-liquids”. An accompany- ing female voice-over stated, “If you’re gonna Vape, Vape with VIP.” The second TV ad showed a man speaking directly to the camera, he stated, “Do you want to see it? I can get it out if you’d like. You can feel it, hold it, put it in your mouth. And see how great it tastes.” On-screen text stated “www.vipecig.co.uk Contains Nicotine”. A symbol also appeared that indicated the product was not suitable for those aged under 18. Further on-screen text stated “THE GREAT TASTE OF VIP” and “VIP E-cigarettes & E-liquids”. An accom- panying female voice-over stated “If you’re gonna Vape, Vape with VIP”. Whether the ad- vertisements were irresponsible as they sexualized and glam- ourized e-cigarettes and smoking? The company argued that the advertise- ments employed double entendre. The suggestiveness in the advertisement was a reference to an e-cigarette. Further, it was submitted that the advertisement carried an appropriate health warning associated with nicotine products. Decision/Status The ASA acknowledged the complaints’ concerns that the presentation of the ads included implied references to oral sex. Although, the advertisement had been cleared with a post 21:00 timing restriction, it was noted that the same was not sufficient and a post 23:00 timing restriction should have been applied. It was noted that while the ads were sexual in tone, they did not glamourize the nicotine product nor did they encourage excessive or inappropriate use. It was concluded that the ads did not encourage smoking or the harmful use of a nicotine product. Status: Decided | 26 February 2014 61 ASA Adjudication on Must Have Ltd., [2014] Complaint Ref: A13-249268 (https://www.tobaccocontrollaws.org/files/live/litigation/1688/GB_ASA%20 Adjudication%20on%20Must%20Have%20.pdf, accessed 27 June 2019) Case summaries 49 21. ASA Adjudication on Ten Motives Ltd.62 Facts Issue Arguments Advanced A leaflet for e-cigarettes, featured the Ten Motives disposable electronic cigarette and pictured two versions of the product, which stated “The healthier smoking alternative”, and “... because it contains no tar or cancerous toxins, you can still enjoy smoking without worrying about the effects on your health”. Whether the health claims made were misleading and could be substantiated? Ten Motives submitted that the MHRA had confirmed that it was acceptable to refer to their product as a healthier alternative. Decision/Status The ASA observed that the claims “healthier smoking alternative” and “you can still enjoy smoking without worrying about the effects on your health” were likely to be understood to mean Ten Motives products featured in the advertisement were less harmful than smoking, or that the products were not harmful. The advertisers had not provided any documentation from the Medicines and Healthcare Products Regulatory Agency (MHRA) in support of their claims. In the absence of any supporting evidence, the advertisements were held to be misleading. Status: Decided | 12 March 2014 22. ASA Adjudication on Vapourlites Ltd.63 Facts Issue Arguments Advanced A complaint was filed against a regional press advertisement and claims advanced on a website for electronic cigarettes. The regional press adver- tisement showed the product, which resembled a conventional cigarette above an outstretched hand. The hand was dressed in a red sleeve with a white fur cuff and a white glove. The text along with it stat- ed, “Lighter on your pocket, Lighter on your Health. Recommended by Santa & Pharmacies nationwide www.vapourlites.com. Electronic cigarettes contain nicotine which is addictive, you must be over 18 to purchase.” Additional text on the pack stated, “A harm reduction alternative to smoking”. Small print at the bottom of the ad indicated that the product was not a smoking cessation aid. Similar claims were made on the website www.vapourlites.com. Whether the ad- vertisements were irresponsible and would appeal to young children because of a reference to Santa? Additionally, whether the claim “recommended by pharmacies nation- wide” and “a harm reduction alternative to smoking” was mis- leading and could be substantiated. Vapourlites stated that Santa’s hand was not used to attract children but to embrace the spirit of Christmas. The advertisement clarified that the product contained nicotine and could only be purchased by consumers aged over 18 years. 62 ASA Adjudication on Ten Motives Ltd., [2014] Complaint Ref: A13-250753, (https://www.tobaccocontrollaws.org/files/live/litigation/1714/GB_ASA%20 Adjudication%20on%20Ten%20Motive.pdf, accessed 27 June 2019) 63 ASA Adjudication on Vapourlites Ltd, [2014] Complaint Ref: A13-252488, (https://www.tobaccocontrollaws.org/files/live/litigation/1926/GB_ASA%20 Adjudication%20on%20Vapourlite.pdf, accessed 27 June 2019) Case summaries 50 22. ASA Adjudication on Vapourlites Ltd.63 Decision/Status The ASA noted that the advertisement was not shown in media targeted at children and only depicted Santa’s hand. Thus, the advertisement was not irresponsible. Vapourlites submission that it was the largest supplier of electronic cigarettes to independent pharmacies did not sub- stantiate the claim “recommended by pharmacies nationwide”. This claim suggested that the products were endorsed or promoted by both independent pharmacies and pharmacy chains. On this point, the claim breached the CAP Code. Further, no clinical evidence was submitted to support the claim that their electronic cigarettes were a ‘harm reduction alternative to smoking’ and therefore ASA held that it was misleading and unsubstantiated. Status: Decided | 2 April 2014 23. ASA Adjudication on E-Cigilicious64 Facts Issue Arguments Advanced A national press advertise- ment, was headed “Help your loved ones change their life this Christmas”. Further text stated “E-Cigs make the perfect present - a safer, cheaper, odorless [sic] alternative to smoking!” The ad- vertisement featured an image of a young woman wearing a Santa hat, holding an e-cigarette near her face. (i) whether the image used in the adver- tisement was irresponsible because it would likely appeal to children; (ii) whether the claim that e-cigarettes were a ‘safer’ alternative to smoking was misleading and could be substantiated; and (iii) whether the claim ‘help your loved ones change their life this Christmas’ implied that the product could be used as a smoking cessation device. E-Cigilicious submitted that they did not promote e-cigarettes as a smoking cessation device but as an alternate to smoking. Decision/Status ASA observed that the image and theme of Christmas was likely to be used for a variety of products, rather than products exclusively aimed at children. Thus, the advertisement was not irresponsible. E-Cigilicious had not provided documentary evidence from MHRA to support its claim that e-cigarettes were a safer alternative to smoking. As the claim had not been substantiated it was misleading and violated the CAP Code. Similarly, E-Cigilicious had no evidence to substantiate that the product could be used as a smoking cessation device. E-Cigilicious was directed not to make cessation claims in the future, unless they could provide robust evidence to sub- stantiate these claims. Status: Decided | 2 April 2014 64 ASA Adjudication on E-Cigilicious, [2014] Complaint Ref: A13-252279, (https://www.tobaccocontrollaws.org/files/live/litigation/1927/GB_ASA%20Adjudication%20 on%20E-Cigilici.pdf, accessed 26 June 2019) Case summaries 51 24. ASA Adjudication on NJOY Innovation Ltd.65 Facts Issue Arguments Advanced Two advertisements for NJOY electronic cigarettes were assessed in this complaint. The first one featured a mon- tage of scenes, which documented the friendship between two men and was set to a soundtrack. A voiceover stated “For everything friends do for each other. Return the fa- vour. Give a friend an NJOY King electronic cigarette. Made to satisfy”. On-screen text stated “Contains nicotine. 18+ to purchase”. In a final scene, the friends were having dinner in a restaurant with their partners and one friend was seen giving the other the product. An end frame featured the NJOY branding with a strapline stating “Made to satisfy”. The second advertisement featured the same scenes, soundtrack and on-screen text as the first advertise- ment. However, the voiceover stated “For everything friends do for each other. Return the favour. Friends don’t let friends smoke. Give them an NJOY King elec- tronic cigarette. Made to satisfy”. Whether the adver- tisements mis- leadingly implied that smoking the product was health- ier than smoking tobacco cigarettes? NJOY submitted that there was no reference to health benefits in the advertisement. Decision/Status The ASA concluded that neither the audio, visuals or on-screen text contained any express health claims relating to the product. No express claims were made that smoking the product was healthier than smoking tobacco cigarettes. Thus, the advertisement was not misleading. Status: Decided | 16 July 2014 25. ASA Adjudication on Nicofresh66 Facts Issue Arguments Advanced A billboard poster appeared in various locations in Belfast, and featured an elderly white woman sitting on a sofa alongside a young black man. The man had his arms around the woman and his eyes were closed, whilst the woman held an electronic cigarette and was looking directly at the camera. Text alongside the image stated “NO TOBACCO. NO TABOO”. Whether the adver- tisement was offen- sive on the grounds of race and age? It was submitted that the advertise- ment asserted that e-cigarettes were socially permissible and did not carry the same taboo as traditional smoking. 65 ASA Adjudication on NJOY Innovations Ltd., [2014] Complaint Ref: A14-258948, (https://www.tobaccocontrollaws.org/files/live/litigation/1928/GB_ASA%20 Adjudication%20on%20NJOY%20Innov.pdf, accessed 27 June 2019) 66 ASA Adjudication on Nicofresh, [2014] Complaint Ref: A14-268557 (https://www.tobaccocontrollaws.org/files/live/litigation/1930/GB_ASA%20Adjudication%20 on%20Nicofresh.pdf, accessed 27 June 2019) Case summaries 52 25. ASA Adjudication on Nicofresh66 Decision/Status The ASA observed that the consumers were likely to interpret the ad to imply that smoking e-cigarettes was not a taboo. Further, as the ad represented a relationship between an older and younger individual of a different race as something unusual or socially unacceptable, it was likely to cause widespread offence on the grounds of race and age. Status: Decided | 6 August 2014 26. ASA Adjudication on E&L Distributors67 Facts Issue Arguments Advanced A poster ad, on a bus shelter, for a brand of e-ciga- rettes. Text in the ad stated “E-CIGARETTES HAVE EVOLED. LEOLITES.COM. LOVE YOUR LUNGS”. Whether there was ev- idence to substantiate that the product was not harmful and that its use was beneficial to the health of users’ lungs? It was submitted that there was no health claim being made with the statement: “Love Your Lungs”. This claim could not be construed to imply that the product was harmless or beneficial to the health of consumers’ lungs. Decision/Status It was noted that the wording of the advertisement implied that Leolites e-cigarettes contained properties that were not harmful to its users’ lungs. However, no evidence had been submitted to demonstrate that Leolites products were beneficial to the health of users’ lungs or that the products were less harmful than traditional cigarettes or other brands of e-cigarettes. On this basis, it was concluded that the claim “Love Your Lungs” had not been substantiated and was misleading. Status: Decided | 13 August 2014 67 ASA Adjudication on E&L Distribution Ltd, [2014] Complaint Ref: A14-266193, (https://www.tobaccocontrollaws.org/files/live/litigation/1903/GB_ASA%20 Adjudication%20on%20E%26L%20Distri.pdf, accessed 1 July 2019) Case summaries 53 27. ASA Adjudication on Must Have Ltd.68 Facts Issue Arguments Advanced A television advertisement for VIP e-cigarettes featured a woman in a black dress, who spoke to the camera and said, “You know that feeling you get, when something’s great? You can touch it, hold it, even see it. Well, now you can taste it.” As she spoke she ran her hand over her thigh. The voice-over stated, “Choose the great taste of VIP e-cigarettes and e-liquids. Quality assured since 2009, with a variety of flavours and nicotine strengths from 0 to 24 mg. VIP.” Whether the adver- tisement was overtly sexual and irrespon- sibly sexualised e-cigarette use. Also, whether the claim ‘quality assured since 2009’ was mislead- ing and could be substantiated. It was submitted that there was mild innuendo but the advertisement did not sexualise e-cigarettes. Additionally, VIP provided the ASA with a range of reports showing product testing and analysis dating back to 2009. Decision/Status The ASA noted that the woman was depicted touching her leg in a sensual manner and that some viewers would find the advertisement distasteful, the sexual references were not explicit and could not be regarded as irresponsible. However, the sexuality though not overt was unsuitable for even older children and the advertisement should have been aired only post 9 PM. The range of reports submitted by the company established that the e-cigarettes conformed to the product testing and analysis since 2009. Thus, the quality claim assurance was substantiated. Status: Decided | 24 September 2014 28. ASA Adjudication on Cygnet UK Trading Ltd.69 Facts Issue Arguments Advanced A television advertisement depicted young adults setting up a party in an abandoned warehouse. It showed the group dancing to upbeat music played by a DJ. On-screen text and voice over stated, “Freedom for taking Blu e-cigarettes and e-liquids”. On-screen text stated, “Contains nicotine. 18+ only. Blu e-cigarettes are not a smoking cessation prod- uct and have not been evaluated by the MHRA”. Whether the ad- vertisement was irresponsible as it promoted a nico- tine-based product to young people? It was submitted that the product was advertised responsibly and did not encourage individuals under 18 to use the product. 68 ASA Adjudication on Must Have Ltd., [2014] Complaint Ref: A14-267854, (https://www.tobaccocontrollaws.org/files/live/litigation/1967/GB_ASA%20 Adjudication%20on%20Must%20Have%20.pdf, accessed 27 June 2019) 69 ASA Adjudication on Cygnet UK Trading Ltd., [2014] Complaint Ref: A14-275161, (https://www.tobaccocontrollaws.org/files/live/litigation/2159/GB_ASA%20 Adjudication%20on%20Cygnet%20UK%20.pdf, accessed 27 June 2019) Case summaries 54 28. ASA Adjudication on Cygnet UK Trading Ltd.69 Decision/Status It was noted that advertisers could legitimately advertise e-cigarettes, provided the advertisements were responsible and compliant with the Code. The party scenes in the advertisement were quite generic in nature. The on-screen text clearly stated that the product contained nicotine and consumers over the age of 18 years were able to exercise their own reasonable judgment whether to purchase the product or not. It was concluded that the advertisement did not breach the BCAP Code. Status: Decided | 15 October 2014 29. ASA Adjudication on E-Cig Ltd.70 Facts Issue Arguments Advanced A poster, for Neo e-cigarettes, showed an image of a woman using an e-cigarette and blowing va- pour into a man’s face. Headline text stated “neo E-CIGARETTE”, followed by the claim “SMOKING, REDEFINED”. The poster also included images of the packaged product in the bottom left-hand corner. Whether the adver- tisement was irre- sponsible because it promoted tobacco smoking? The word “E-Cigarette” featured promi- nently on the product logo. Further, the product depicted was in stark contrast to tobacco cigarettes. It was submitted that the advertisement did not promote or glamourize tobacco smoking. Decision/Status The most prominent text on the poster stated, “SMOKING, REDEFINED”. The main focus of the poster was the “smoke” and in combination with the headline text, the image, created a strong association with traditional tobacco smoking. Further, the woman was holding the e-cigarette in an elegant manner and these elements gave the advertisement a sultry and glamourous tone. Irrespective of whether the consumers recognised that the product was an e-cigarette, the glamorous presentation indirectly promoted tobacco smoking. Thus, it breached the CAP Code and was held to be irresponsible. Status: Decided | 12 November 2014 70 ASA Adjudication on E-Cig Ltd., [2014] Complaint Ref: A14-278009, (https://www.tobaccocontrollaws.org/files/live/litigation/2163/GB_ASA%20Adjudication%20 on%20E-Cig%20Ltd.pdf, accessed 27 June 2019) Case summaries 55 30. ASA Adjudication on Vape Nation Ltd.71 Facts Issue Arguments Advanced A television advertisement for KiK electronic cig- arettes (“e-cigarettes”) showed a group of adults using and discussing the products in an outdoor restaurant. One man in the group said, “I used to smoke normal cigarettes, but after I quit, I tried these. I actually prefer them.” Whether the adver- tisement breached the Code as it was likely to encourage non-smokers and particularly former smokers, to use the product? It was contended that the advertisement was aimed at current smokers and did not encourage non-smokers to take up e-cigarettes. Decision/Status ASA noted that the advertisement was in line with the CAP Code as it included actors who appeared to be over 25 years of age. Further, the visuals and comments clarified that the advertised product was an e-cigarette. However, the man’s statement could be understood by the consumers to mean that he had stopped smoking and thereaf- ter started using KiK e-cigarettes. This could encourage non-smokers to take up using e-cigarettes and thus the adver- tisement was irresponsible and breached rule 33.1 and 33.8 of the BCAP Code. Vape Nation was directed not to encourage ex-smokers or non-nicotine users to use e-cigarettes. Status: Decided | 24 December 2014 31. ASA Adjudication on Must Have Ltd.72 Facts Issue Arguments Advanced Complaints were filed against two television advertisements for VIP electronic cigarettes. The first one showed a woman using an e-cigarette and exhaling vapour. A voice-over stated, “Find out why 89% of our consumers said they pre- ferred VIP over other brands. VIP e-cigarettes and e-liquids. Quality assured since 2009. VIP.” The second one showed the same depiction of the woman using an e-cigarette. A voice-over stated, “The great taste of VIP. E-cigarettes and e-liquids. VIP.” The advertisements were challenged on four grounds: (a) promoted the use of tobacco products; (b) were overtly sexual and offensive; (c) appealed to people under 18 years of age and were irrespon- sible; and (d) encour- aged non-smokers or non-nicotine users to use e-cigarettes. The company submitted that it was clear that the product was an e-ciga- rette and was being used by a woman over 25 years of age. 71 ASA Adjudication on Vape Nation Ltd., [2014] Complaint Ref: A14-284845, (https://www.tobaccocontrollaws.org/files/live/litigation/2167/GB_ASA%20 Adjudication%20on%20Vape%20Natio.pdf, accessed 27 June 2019) 72 ASA Adjudication on Must Have Ltd., [2014] Complaint Ref: A14-284650, (https://www.tobaccocontrollaws.org/files/live/litigation/2165/GB_ASA%20 Adjudication%20on%20Must%20Have%20.pdf, accessed 27 June 2018) Case summaries 56 31. ASA Adjudication on Must Have Ltd.72 Decision/Status Out of the four grounds, ASA upheld the contention about promotion of tobacco products. The advertisements breached the CAP code as they indirectly promoted the use of tobacco products. It was observed that the advertisement created a strong association with traditional tobacco smoking by the manner in which the woman appeared to be using the product. The woman featured in the advertisement appeared to be over 25 years of age and did not breach the Code. Further, no explicit encouragement for non-smokers or non-nicotine users to use e-cigarettes was found. Status: Decided | 24 December 2014 32. ASA Adjudication on Mirage Cigarettes Ltd.73 Facts Issue Arguments Advanced A television advertisement, for electronic cigarettes, showed a man handing a woman an electronic cigarette. Several shots, included on-screen text that stated “CHOICE”, “FLAVOUR” and then “FREEDOM”. In the final scene, the couple was featured in va- pour-like clouds. Whether the adver- tisement glamourized smoking of tobacco products? Mirage Cigarettes submitted that the advertisement did not make any refer- ence to tobacco products. In fact, the products displayed in the advertisement were larger than tobacco cigarettes. The objective was to make consumers aware of the brand. Decision/Status The prominence of heavy vapour throughout the advertisement, in conjunction with the music and shots of the couple, contributed to the sultry and glamorous tone of the advertisement. Even though, it was clear that the products shown were electronic cigarettes, a strong association with traditional tobacco smoking was created. Thus, the advertisement indirectly promoted the use of tobacco products and breached the CAP Code. Mirage Cigarettes Limited were directed to ensure that their advertisements did not promote the use of tobacco products. Status: Decided | 29 April 2015 73 ASA Ruling on Mirage Cigarettes Ltd., [2015] Complaint Ref: A15-292291, (https://www.tobaccocontrollaws.org/files/live/litigation/2360/GB_ASA%20 Adjudication%20on%20Mirage%20Cig.pdf, accessed 27 June 2019) Case summaries 57 33. ASA Adjudication on Hubbly Bubbly74 Facts Issue Arguments Advanced Claims on the website www.hubblybubbly.uk.com were challenged by the Medicines & Healthcare products regu- latory Authority (MHRA). The content of the five advertise- ments promoting electronic cigarettes was as follows: a. The website listed famous celebrities who enjoyed using electronic cigarettes, like Leonardo DiCaprio, Katherine Heigl, and Johnny Depp. b. The Twitter page of Hubbly Bubbly had a banner image on top which depicted two young women using e-cigarettes. c. A tweet posted by Hubbly Bubbly showed an image of two young people using e-cigarettes standing in front of a row of spirit bottles. The accompanying text stated, “End of a very productive week at HB. Ready to kickoff the weekend! #TGIF”. d. Another tweet posted by Hubbly Bubbly showed a black-and-white image of a young woman holding an e-cigarette in a bar. Text stated, “Hubbly Bubbly - getting you through the midweek slump! #ECIG”. The Youtube video featured scenes including bars, clubs and a music concert. Product shots showing Hubbly Bubbly-branded packaging were interspersed with crowd scenes and individual shots of young people dancing, drinking and using e-cigarettes. Whether these five advertisements irresponsibly promoted the use of electron- ic cigarettes among youth and breached the CAP Code. Hubbly Bubbly after receiving noti- fication of the complaint from ASA voluntarily removed all of the adver- tisements under investigation and made the following submissions: - All the celebrities listed in the ad were adults and would not appeal to those under the age of 18. - The women depicted in advertise- ment (b) were adults and not behaving in an adolescent or juvenile manner. Decision/Status The CAP Code stated that marketing communications must state clearly if an advertised product contained nicotine. The ASA assessed the five advertisements in the following manner: a. The first advertisement under the heading “Famous E-Cigarettes Fans” appeared on the “social” page of the Hubbly Bubbly website. ASA concluded that the content was presented within a wider context and clearly stated that the products contained nicotine. However, the inclusion of celebrity names in the marketing communication created an association with youth culture and the advertisement was irresponsible in that context. b. The banner image on Twitter served to promote the whole range of products available on Hubbly Bubbly. However, some of Hubbly Bubbly’s products contained nicotine and this information was not clearly presented to the consumers along with the image. Thus, this advertisement breached the code. c. The Code stipulated that people shown using e-cigarettes or playing a significant role in the marketing communication for e-cigarettes must neither be, nor seem to be under the age of 25. On this point advertisements (b), (c) and (d) breached the CAP Code. d. The YouTube video was reminiscent of a rave scene, in which e-cigarettes featured prominently and would appeal to those aged under 18. Thus, the video advertisement also breached the CAP Code. Hubbly Bubbly was directed to ensure that its advertisements did not appeal to people under 18 years of age and did not feature people who were or seemed to be, under 25 years of age. Status: Decided | 10 June 2015 74 ASA Adjudication on Hubbly Bubbly, [2015] Complaint Ref: A15-300973, (https://www.tobaccocontrollaws.org/files/live/litigation/2337/GB_ASA%20 Adjudication%20on%20Hubbly%20Bub.pdf, accessed 27 June 2019) Case summaries 58 34. ASA Adjudication on Fontem Ventures75 Facts Issue Arguments Advanced ASA received 13 complaints objecting to a wrap- around press advertisement of Blu electronic cig- arettes published in the London Evening Standard. The front cover showed an image of the back of a nude woman with her head turned to look back towards the camera holding an electronic ciga- rette. The text alongside stated, ‘Just you & blu e-cigarettes’. Whether the ad- vertisement was offensive and overtly sexual to be placed on the front page of a regional newspaper? It was submitted that the Evening Standard was an appropriate publication for the ad because it had predominantly adult readership. Decision/Status The advertisement was considered sensual and sexually suggestive but was not sexually explicit. Thus, it was held that it did not breach the CAP Code and was not placed inappropriately. Status: Decided | 29 June 2016 75 ASA Ruling on Fontem Ventures BV, [2016] Complaint Ref: A16-340739, (https://www.tobaccocontrollaws.org/files/live/litigation/2553/GB_ASA%20 Adjudication%20on%20Fontem%20Ven.pdf, accessed 27 June 2019) Case summaries 59 35. ASA Adjudication on British American Tobacco UK Ltd.76 Facts Issue Arguments Advanced Seven Instagram posts by Vype were challenged before the ASA: i. A post on Instagram, from 10 February 2019, showed an e-cig- arette with the text “FROM ONE WINNER TO ANOTHER. WELL DONE” and “RAMI MALEK BOHEMIAN RHAPSODY LEADING ACTOR”. The post included the caption “And the winner is… #epen3 #vype #productoftheyear #vapecommunity. Oh and…#ramimalek #bohe- mianrhapsody #baftas #bestactor #baftas2019. Vype e-cigarettes contain nicotine. 18+ only. Read leaflet in pack”. ii. A post on Instagram, from 14 February 2019, showed an image of Lily Allen holding an e-cigarette with text which stated “LFW HOUSE OF HOLLAND CATWALK 16.02.19”. The post included the caption “The latest #HoHxVape collection will be revealed this weekend at #LFW, with @lilyallen and @houseofholland #govype #vape #vapecommu- nity #vapenation #vapelife #vaper #vapestagram #instavape #lon- donfashionweek #LilyAllen #HenryHolland #HouseOfHolland” and “Vype e-cigarettes contain nicotine. 18+ only. Read leaaet in pack”. iii. An Instagram story, from 16 February 2019, showed a woman us- ing an e-cigarette and included text which stated “Vype e-cigarettes contain nicotine. 18+ only. Read leaflet in pack”. iv. A post on Instagram, from 20 February 2019, showed Lily Allen holding an e-cigarette. The post included the caption “Wishing our friend #lilyallen the very best at tonight’s #BritAwards where she’s nominated for Best British Female Solo Artist! #vype #govype #vape #vapecommunity #vapenation #vapelife #vaper #vapestagram #instavape #lilyallen #bestbritishfemalesoloartist #britawards2019 Vype ecigarettes contain nicotine. 18+ only. Read leaflet in pack”. v. A post on Instagram, from 21 February 2019, showed Lily Allen behind DJ decks with a Vype banner in the background. The post was tagged with the location ‘Menagerie Restaurant & Bar’ and included the caption “We’ve taken #LFW to #Manchester. Great night with @lilyallen on the decks and @houseofholland partying with us. Were you there? #vype #epen3 #govype #vape #vapecommunity #HoHxVype” and “Vype e-cigarettes contain nicotine. 18+ only. Read leaflet in pack”. vi. A post on Instagram, from 21 February 2019, showed Olivia Jade Attwood smoking an e-cigarette with the caption “We’ve taken #LFW to #Manchester. Great night with @lilyallen on the decks and @houseofholland partying with us. Were you there? #vype #epen3 #govype #vape #vapecommunity #HoHxVype” and “Vype eciga- rettes contain nicotine. 18+ only. Read leaflet in pack”. vii. A post on Instagram, from 7 March 2019, showed a person’s hand holding an e-cigarette marked with ‘HOUSE OF HOLLAND’ and ‘vype’, while wearing an event admission bracelet with ‘HOUSE OF HOLLAND’. The post included the caption “Who could forget the time we took Vype to #LFW with our good friends @houseofhol- land. See more from #behindthescenes in our stories. #HoHxVype #ThrowbackThursday #vype #govype #vape #vapecommunity #vape- nation #vapelife #vaper #vapestagram #instavape and “Vype e-ciga- rettes contain nicotine. 18+ only. Read leaflet in pack”. Whether the detailed advertisements breached the code by promoting unlicensed, nic- otine-containing e-cigarettes on Instagram? Whether the advertisements breached the Code by featuring some- one who appeared to be under 25 years of age? BAT submitted that the information provided was factual in nature by ensur- ing that the content of their posts related to the prod- uct. Further, Vype related content only appeared in the feeds of Instagram users who sought out information regarding e-cigarettes. It was also submitted that the use of product-focused hashtags, as well as broad- er hashtags, only allowed information about Vype to reach users actively seeking it or users seeking information around vaping in general. 76 ASA Ruling on British American Tobacco UK Ltd., [2019], (https://www.tobaccocontrollaws.org/files/live/litigation/2710/GB_ASA%20Ruling%20on%20British%20 American.pdf, accessed 27 January 2020) Case summaries 60 35. ASA Adjudication on British American Tobacco UK Ltd.76 Decision/Status ASA examined whether the advertisements directly or indirectly promoted a nicotine-containing e-cigarette. Each ad- vertisement categorically stated that Vype e-cigarettes contained nicotine. Thus, the advertisements directly promoted unlicensed nicotine-containing e-cigarettes and violated rule 22.12 of the CAP Code. It was observed that content on an Instagram page was not similar to content on a marketers’ website, as there were mechanisms on social media to push content to consumers. In any case, the advertisements contained content that went beyond factual information about their product. BAT was directed not to publish marketing communications with the direct or indirect effect of promoting nicotine-contain- ing e-cigarettes and their components which were not licensed as medicines. Status: Decided | 18 December 2019 Case summaries 61 UNITED STATES OF AMERICA 1. Smoking Everywhere, Inc. & Ors. v FDA77 Facts Issue Arguments Advanced Smoking Everywhere and inter- venor plaintiff, Sottera, Inc. are distributors of electronic cigarettes (collectively referred as Plaintiffs). The inbound shipments of the two companies were denied entry into the United States, or detained under an order passed by the Food and Drug Administration on the ground that electronic cigarettes were an unapproved drug-device combi- nation under the Federal Food, Drug, and Cosmetic Act (FDCA). The Plaintiffs sought a preliminary in- junction barring FDA from refusing entry to its products into the United States on the basis that those prod- ucts are unapproved drug-device combinations under the FDCA. Whether FDA has the authority under the FDCA to regulate electronic cigarettes as a drug/device combination? Arguments advanced by Plaintiffs: It was asserted that electronic cigarettes qualified as a tobacco product and could not be regulated as a drug/device under the FDCA. Arguments advanced by FDA: It was submitted that electronic cigarettes fall beyond the scope of Brown & Williamson Tobacco case, and are subject to regulation under the FDCA as a drug-device combination. The defini- tion of ‘tobacco product’ under the Tobacco Act excludes “any article that is a drug, device, or a combination product under the FDCA”. Reliance was also placed on Smoking Everywhere’s promotional materials which state that its electronic cigarettes are intended to have a therapeutic effect. In particular, the materials state that electronic ciga- rettes provide a ‘healthier way’ to obtain effects of nicotine. Thus, electronic cigarettes would satisfy the definition of drug-device combination as an article “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” under s 321 (g) (1) (B) of the FDCA. Decision/Status Definition of tobacco product: The Court reasoned that it was illogical to classify electronic cigarettes as a drug-device combination on the basis that these devices delivered nicotine and had the same effect on the structure and function of the body as cigarettes, and thereby exclude them from the definition of “tobacco product”. This interpretation dismantles the regulatory wall erected by the Congress between tobacco products and drug-device combinations. It was inferred that the Congress enacted the Tobacco Act with the intent to permit nicotine use, whether from unforeseen, non-traditional sources (like e-cigarettes) or from well-established traditional sources (like regular cigarettes). Most importantly, the Court highlighted the expansive definition of tobacco products under the Tobacco Act as “any product made or derived from tobacco that is intended for human consumption”. Therapeutic claims: FDA’s argument that the product was marketed as a device to treat withdrawal symptoms of nicotine addiction was un- supported by substantial evidence. In fact, Smoking Everywhere’s promotional material was aimed, not toward preventing, mitigating, or treating nicotine addiction and the effects of withdrawal, but towards encouraging nicotine use. The over- arching theme of the marketing campaign highlighted that smoking electronic cigarettes was fun and exciting, and the product should be used at the same frequency as traditional cigarettes. The Plaintiffs’ motions were granted and it was held that the FDA did not have the authority to regulate e-cigarettes as a drug/device combination under the FDCA. Status: Decided | 14 January 2010 77 United States District Court, Smoking Everywhere Inc. v FDA, [2010] 680 F.Supp. 2d 62 (Columbia), (https://www.tobaccocontrollaws.org/files/live/ litigation/1493/US_Smoking%20Everywhere%20v.%20Food%20and.pdf, accessed 25 July 2019) Case summaries 62 2. Sottera, Inc. v FDA78 Facts Issue Arguments Advanced The Food and Drug Administration appealed against the order passed by the District Court (summarized above). Case law and Legislative Overview: In 1996, the FDA promulgated regulations affecting tobacco products as customarily marketed, i.e., ones sold without therapeutic claims. The agency argued that nicotine affected the structure and function of the body and that cigarettes and smokeless tobacco were drug/device combinations falling under the FDA’s regulatory purview, even without therapeutic claims. In FDA v. Brown & Williamson, the Supreme Court rejected FDA’s authority to regulate tobacco products as customarily marketed under the pro- visions of the FDCA. In 2009, the Congress passed the Tobacco Act bestowing FDA with the authority to regulate tobacco products. The Tobacco Act defined tobacco products to include all consumption products derived from tobacco except articles that qualify as drugs, devices, or drug-device combina- tions under the FDCA. Whether the source of authority for the Food and Drug Administration (FDA) to regulate electronic cigarettes stemmed from the drug/device provisions of the FDCA or from the Family Smoking Prevention and Tobacco Control Act of 2009. The only difference in the two acts is that the former gives the FDA the authority to ban them while the later regulates tobacco products. Arguments advanced by the Company: It was argued that the FDA could regulate e-cigarettes only under the Tobacco Act, based on the decision of the Supreme Court in the Brown & Williamson case which foreclosed FDCA drug/device jurisdiction over tobacco products marketed without claims of therapeutic effect. Further, it was submitted that the e-cigarettes were derived from natu- ral tobacco plants and marketed and labelled for “smoking pleasure”, rather than as a therapeutic or smoking cessa- tion product. Arguments advanced by FDA: It was submitted that Brown & Williamson took a statute-specific approach, and excluded the FDA from regulating only those tobacco products (cigarettes and smokeless tobacco) that had been the subject of the federal legislation. The FDCA preserves regulation under the FDCA for any product “made or derived from tobacco” that Brown & Williamson did not carve out of the FDCA’s coverage i.e. electronic cigarettes. Decision/Status It was held that FDA’s authority to regulate e-cigarettes stemmed from the Tobacco Control Act and not the FDCA. It was noted that the Brown & Williamson case and the Tobacco Act established that the FDA cannot regulate customarily marketed tobacco products under the FDCA’s drug/device provisions, that it can regulate tobacco products marketed for therapeutic purposes under FDCA provisions, and that it can regulate customarily marketed tobacco products under the Tobacco Act, including e-cigarettes. Status: Decided | 24 January 2011 78 United States Court of Appeals, Sottera, Inc. v FDA, [2010] 627 F.3d 891 (Columbia), (https://www.tobaccocontrollaws.org/files/live/litigation/1032/US_ Sottera%20v.%20Food%20%26%20Drug%20Adminis.pdf, accessed 27 June 2019) Case summaries 63 3. United States-Clove Cigarettes79 Facts Issue Arguments Advanced Indonesia brought a claim before the WTO against the United States concerning a law that prohibits cigarettes containing a constituent that is a charac- terizing flavour of tobacco or tobacco smoke, other than menthol or tobacco. Whether the US law discriminated against cigarettes produced in Indonesia? Among other things, Indonesia argued that the: (i) law is discriminatory because it treats clove cigarettes (primarily produced in Indonesia) less favourably than like menthol cigarettes (primarily of United States origin), in violation of Article 2.1 of the TBT Agreement; and (ii) prohibition is not necessary to achieve a legitimate objective, such as protection of human life or health, and that accordingly, the measure results in violation of Article 2.2 of the TBT Agreement. Decision/Status The WTO panel found that the US law discriminated against cigarettes produced in Indonesia in favour of cigarettes pro- duced in the US. In upholding the Panel Report, the Appellate Body found that the law fell heaviest on imported products and was not based solely on a legitimate regulatory distinction between the two product classes. In the latter respect, the Appellate Body emphasized that clove and menthol each mask the harshness of tobacco and that clove and menthol cigarettes are each attractive to youth. The Panel also rejected Indonesia’s argument that the prohibition of clove flavoured cigarettes was more trade restrictive than necessary under Article 2.2 of the TBT Agreement. This aspect of the Panel Report was not appealed. Status: Decided | 24 April 2012 79 World Trade Organization, Panel Report- United States- Measures affecting the production and sale of clove cigarettes, [2011] WT/DS406/R (https://docs.wto. org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/WT/DS/406R-01.pdf&Open=True, accessed 17 September 2020); World Trade Organization, Appellate Body Report- United States- Measures affecting the production and sale of clove cigarettes, [2012] WT/DS406/AB/R (https://docs.wto.org/dol2fe/Pages/SS/directdoc. aspx?filename=Q:/WT/DS/406ABR.pdf&Open=True, accessed 17 September 2020) Case summaries 64 4. U.S. Smokeless Tobacco Mfg. Co. v City of New York80 Facts Issue Arguments Advanced Plaintiffs (U.S. Smokeless Tobacco Manufacturing Company LLC and U.S. Smokeless Tobacco Brands Inc.) manufacture and distribute smokeless tobacco products, including flavoured smokeless tobacco. In 2009, the Plaintiffs filed a suit challenging the validity of a New York City ordinance which prohib- ited the sale of flavoured tobacco products except in a tobacco bar. It was alleged that the ordinance was preempted by the Family Smoking Prevention and Tobacco Control Act (Act) and sought an injunction against its enforcement. The trial court decided in favour of the Defendant. Aggrieved, the Plaintiffs filed an appeal against that order. Whether the New York ordinance was preempted by the FSPTCA (Act)? The Plaintiffs argued that the New York City ordinance was artfully crafted to evade express federal pre-emption. Decision/Status The Act prohibited FDA from banning entire categories of tobacco products throughout the country but did not constrain the power of state and local governments to impose restrictions. On the contrary, the preservation clause of s 916 of the Act expressly preserved localities’ traditional power to adopt any “measure relating to or prohibiting the sale” of tobacco products. Thus, the ordinance represented an exercise of local police power that Congress specifically allowed when it enacted the Act, and thus it is not preempted. Status: Decided | 26 February 2013 80 United States Court of Appeals, U.S. Smokeless Tobacco Mfg. Co., et al. v City of New York, [2013] 11-5167-cv (2d Cir. 2013)., (https://www.tobaccocontrollaws. org/files/live/litigation/1106/US_U.S.%20Smokeless%20Tobacco%20Mfg.%20v..pdf, accessed 22 July 2019) Case summaries 65 5. State of Vermont v R.J. Reynolds Tobacco Co.81 Facts Issue Arguments Advanced R.J. Reynolds (Company) on their website advertised a “saf- er” cigarette, ‘Eclipse’. The slogan for Eclipse stated, “The best choice for smokers worried about their health is to quit- the next best choice is to switch to Eclipse”. Other claims made by the Company on its website were: “Extensive scientific studies show that, compared to other cigarettes [Eclipse] May present less risk of cancer associated with smoking Because Eclipse primarily heats rather than burns tobacco, its smoke chemistry is fundamentally different, and the tox- icity of its smoke is dramatically reduced compared to other cigarettes.” The State filed the action against the Company on the ground that no medical or scientific studies were conduct- ed to prove these claims. The principal advertising state- ment challenged was part of a print advertisement of the Company: “Eclipse is “[a] cigarette that may present less risk of cancer, chronic bronchitis, and possibly emphysema”. The marketing plan of the Company was to feature prominently and aggressively promote the health benefits to existing smokers of switching to this non-traditional cigarette. In this case, the Court determined civil penalties to be awarded against the Company and any injunctive relief to be awarded to the State with respect to any future marketing or advertising. Whether each health claim in every re- gional advertisement constituted a sepa- rate violation of the Vermont Consumer Fraud (CFA), or a single violation. Arguments advanced by State: The Company deliberately made health claims about the Eclipse which implied that smokers would improve their chances of not developing tobacco related diseases. It was submitted that each and every instance of such claim should be counted as a violation under the CFA. Arguments advanced by the Company: The marketing and sales campaign for the Eclipse cigarettes was in view of an uninterrupted effort to promote the “less risk” claims. It was submitted that the sales of Eclipse in Vermont were only $12,000 in gross revenue. Thus, it should be liable to a maxi- mum amount of $10,000 in civil monetary penalties. Decision/Status It was held that each instance of deceptive marketing or promotional statement would constitute a separate violation. Thus, the Court accepted the State’s count of 6776 separate instances of deliberate and unsubstantiated health claims about Eclipse. It was noted that the Company acted deliberately and intentionally to pursue an extensive marketing cam- paign for Eclipse which featured “less risk” health claims. The Company spent $16.656 million on advertising and other marketing and promotional expenses for Eclipse. The Court assessed that the Company could be forced to take a charge back of 50% of the advertisement expense i.e. $ 8.328 million for its deceptive conduct. It was noted that the Company had stopped selling the Eclipse in 2007. However, its business endeavours focussed on researching innovative smoke-free products. This could provide the Company an opportunity to make deceptive state- ments of a similar nature as in the case of the Eclipse cigarette. Accordingly, a permanent injunction was issued against the Company prohibiting it from the marketing, sale, distribution, promotion or advertisement of a potentially reduced exposure product unless a long-term, epidemiological study “unequivocally” supported the health claims. Status: Decided | 3 June 2013 81 Vermont Superior Court, Civil Division, [2013] Docket No. S1087-05 CnC, (https://www.tobaccocontrollaws.org/files/live/litigation/1159/US_State%20of%20 Vermont%20v.%20R.J.%20Reyno.pdf, accessed 27 June 2019) Case summaries 66 6. National Association of Tobacco Outlets, Inc. et al v City of Providence, Rhode Island, et al82 Facts Issue Arguments Advanced The City of Providence adopted two ordinances con- cerning the sale of tobacco products. This summary is restricted to the ordinance that restricted sale of certain flavored tobacco products other than cigarettes. The Flavor Ordinance prohibited retailers from selling flavored tobacco products (other than cigarettes), such as flavored “cigars, pipe tobacco, snuff, chewing tobacco, dipping tobacco”, and other flavored tobacco products. The National Association of tobacco outlets filed a suit in the district court and alleged that the ordinances violated both federal and state law. Whether the Flavour Ordinance was pre-empted by the FSPTCA? It was submitted that the Flavor Ordinance was preempted by the Family Smoking Prevention and Tobacco Control Act (FSPTCA). Decision/Status The Court held that the “Flavour Ordinance” was not pre-empted by the Family Smoking Prevention and Tobacco Control Act. The Court placed reliance on the reasoning of U.S. Smokeless Tobacco Manufacturing Case. Status: Decided | 30 September 2013 7. Independents Gas & Serv. Stations Associations & Anr. v City of Chicago83 Facts Issue Arguments Advanced The Chicago City Council passed an ordinance that regulated the sale of flavoured tobacco products. The ordinance defined “flavoured tobacco product” as “any tobacco product that contains a constituent that im- parts a characterizing flavour”. The objective of the or- dinance was to reduce flavoured tobacco retail around schools. The Plaintiffs were, an association of small business owners and operators of gasoline service stations holding tobacco licenses in the City of Chicago, along with Quick Pick Food Mart a convenience store that sells flavoured tobacco products. The Plaintiffs sued the City of Chicago and inter alia challenged that the ordinance was pre-empted by the federal Family Smoking Prevention and Tobacco Control Act (FSPTCA). Whether the Ordinance was pre-empted by the FSPTCA? The Plaintiffs argued that the ordi- nance was a manufacturing regulation disguised as a sales regulation because it would reduce production of flavoured tobacco products. 82 US Court of Appeals for the First Circuit, National Association of Tobacco Outlets, Inc. et al v City of Providence, Rhode Island, et al [2013] No. 13-1053, F.3d (1st Cir.) (https://www.tobaccocontrollaws.org/files/live/litigation/1292/US_National%20Association%20of%20Tobacc.pdf, accessed 25 July 2019) 83 United States District Court, Illinois, Eastern Division, [2015] 112 F.Supp.3d 749 (N.D. Ill., 2015), (https://www.tobaccocontrollaws.org/files/live/litigation/2531/ US_Independents%20Gas%20%26%20Service%20Sta.pdf, accessed 25 July 2019) Case summaries 67 7. Independents Gas & Serv. Stations Associations & Anr. v City of Chicago83 Decision/Status It was noted that the State’s police powers are not pre-empted by the federal law unless clearly intended by the Congress. A bare reading of Section 387p(a)(1) indicates that the local government’s authority to adopt and enforce laws involv- ing the sale of tobacco products is preserved. Further, as in the U.S. Smokeless Tobacco case, the Court noted that the Chicago ordinance regulated flavoured tobacco products without stipulating manufacturing standards. It was concluded that the ordinance enacted by the Chicago City Council was not pre-empted as it did not stipulate any product standards. Status: Decided | 29 June 2015 8. In re NJOY, INC. Consumer Class Action Litigation84 Facts Issue Arguments Advanced The Plaintiffs filed a class action suit85, alleging that: (i) NJOY engaged in false and misleading advertis- ing, conveying that its electronic cigarettes are safer than regular tobacco cigarettes; (ii) NJOY omitted material information from its packaging, including both an ingredient list and the potential risks associated with certain ingredients. Whether the Plaintiffs satisfied the condi- tions for a class action suit? Relevant provision of Law: Under Rule 23(a), a class action is only proper if: (1) the class is so numerous that joinder of all members is impracti- cable; (2) there are questions of law or fact common to the class; (3)  the claims or defenses of the representative parties are typical of the claims or defenses of the class; and (4)  the representative parties will fairly and adequately protect the interests of the class. Decision/Status The Court concluded that the Plaintiffs failed to meet their burden of demonstrating that questions of law or fact common to class members predominate over any questions affecting only individual members. Further, the Plaintiffs did not offer a model capable of calculating damages on a class wide basis. Status: Decided | 2 February 2016 84 United States District Court, Central District of California, [2016] CV 14-428-JFW, (https://www.tobaccocontrollaws.org/files/live/litigation/2430/US_In%20re%20 NJOY%2C%20Inc.%20Consumer%20Clas.pdf, accessed 5 May 2019) 85 The Plaintiffs filed a motion to certify two statewide classes of purchasers of NJOY e-cigarettes: (1) a California class with claims based on both the alleged affirmative misrepresentations in NJOY’s advertising and the alleged omissions from NJOY’s packaging; and (2) a Florida class with claims based on alleged omissions from NJOY’s packaging. Case summaries 68 9. Nicopure Labs, LLC v Food and Drug Administration86 Facts Issue Arguments Advanced On May 10, 2016, the FDA exercised its discretion to deem e-cigarettes87 to be classified as “tobacco products” and sub- ject them to the set of federal laws that govern the promotion and marketing of conventional cigarettes (Rule). The Rule applied to “components” and “parts” of the newly deemed to- bacco products. Nicopure Labs, Inc. (Plaintiff), a distributor of open-system e-cigarettes and manufacturer of e-liquids, filed a suit to challenge FDA’s Rule. The ground for the challenge was three-fold: (i) FDA exceeded its authority by applying the Rule to empty cartridges and nicotine free e-liquids; (ii) it was arbitrary and capricious for the FDA to enact a rule that requires e-cigarette manufacturers to undergo premarket review; and (iii) The restriction on modified risk-statements prohibits manufacturers from making truthful and non-mis- leading statements about their products and ban on distribu- tion of free samples violates Plaintiff’s right to free speech. The Plaintiff prayed that the Rule be vacated and declared unlawful. Through a separate action, several state-wide trade associations88 representing the ENDS industry also chal- lenged FDA’s Rule on similar grounds. Whether the FDA exceeded its au- thority in applying the Rule to regulate open-system devices sold without any liquid and e-liquids that do not contain nicotine? Arguments advanced by the Plaintiff: It was submitted that the term “component” in the Tobacco Control Act was defined to “refer to items inseparable from the product made or derived from tobacco”. An empty ENDS device contains nei- ther tobacco nor anything derived from tobacco. Argument advanced by FDA: It was argued that the Rule applied to nicotine free e-liquids only in three circumstances: (i) when e-liquids claiming to be nicotine-free actual- ly contained high levels of nicotine; (ii) when the e-liquids were tobacco flavoured; and (iii) when the e-liq- uids are reasonably expected to be mixed with liquid nicotine and form a component of a tobacco product. Decision/Status The Court upheld the Rule stipulated by the FDA for the following reasons: FDA acted within the scope of its authority: The Court concluded that the agency acted within the scope of its statutory authority, it was legally permitted to regulate e-liquids and to consider refillable electronic nicotine delivery systems to be a ‘component’ of a tobacco product and therefore subject to regulation. The Plaintiff’s argument that a component or part must be physically connected to the whole, otherwise it would not be a component of an e-cigarette was found illogical. FDA’s authority to regulate nicotine free e-liquids: FDA does not derive its authority to regulate nicotine-free liquids by classifying them as a “tobacco product”, instead as a “component” that gets added to the mix. FDA’s rule was not arbitrary and capricious: It was not arbitrary and capricious for the FDA to decide to take action with respect to e-cigarettes. Evidence established that e-cigarettes deliver as much nicotine as other tobacco products. An alarming rise in e-cigarette use by middle and high school students was also reported. It was noted that given the prolif- eration of ENDS, there was significant variability in the concentration of chemicals amongst the products. Onerous compliance of pre-market review on ENDS: The Tobacco Control Act requires that all tobacco products undergo some kind of premarket review. In fact, in the regulatory impact analysis of the Rule, it was observed that the premar- ket review would result in fewer harmful or addictive products from reaching the market than would be the case in the absence of the Rule. It was held that FDA carefully assessed the costs and benefits of the Rule to the entire ENDS industry and did not make a “clear error of judgment”. Marketing restrictions in the Tobacco Control Act do not violate the First Amendment: After an analysis of relevant case law, the Court came to the conclusion that the Rule regulated conduct not speech. Distribution of free samples and regula- tion of modified risk statements did not violate the First Amendment rights of the Plaintiffs. Aggrieved by the District Court judgment, an appeal was filed. The United States Court of Appeals for the District of Columbia affirmed the judgment of the District Court.89 Status: Decided | 21 July 2017 86 U.S. District Court, District of Columbia, Nicopure Labs, LLC v Food and Drug Administration, [2017] F.Supp.3d, (https://www.tobaccocontrollaws.org/files/live/ litigation/2558/US_Nicopure%20Labs%2C%20LLC%20v.%20Food%20and.pdf, accessed 1 July 2019) 87 Exercised authority conferred upon in 21 U.S.C § 387 a(b). 88 The Right to be Smoke Free Coalition, American Vaping Association, Electronic Vaping Coalition of America, Georgia Smoke Free Association, Kentucky Vaping Retailers Association, Inc., Louisiana Vaping Association, Maryland Vaping Professionals, LLC, Ohio Vapor Association, Tennessee Smoke Free Association, and the New Jersey Retailers Coalition (collectively, “RSF”). 89 United States Court of Appeals for the District of Columbia Circuit, Nicopure Labs, LLC v FDA, [2019] No. 17-5196 Case summaries 69 10. American Academy of Pediatrics, et al v FDA, et al.90 Facts Issue Arguments Advanced The Campaign for Tobacco-Free Kids, in conjunction with other public health and medical organizations (Plaintiff Organizations), challenged the U.S. Food and Drug Administration’s decision to allow e-cig- arettes to remain on the market until 2022 before applying for FDA pre-market authorization (August 2017 Guidance). The FDA also delayed the deadline for cigar manufacturers to file such applications until 2021. The Plaintiffs challenged the August 2017 Guidance on three counts: (i) it was unlawful and exceeded FDA’s statutory authority; (ii) it was a deliberate ab- dication of FDA’s responsibilities under the Tobacco Control Act; (iii) it was arbitrary and capricious and not the product of reasoned decision making. Whether the FDA has the authority to issue the August 2017 Guidance? Arguments advanced by the Plaintiff Organizations: The August 2017 Guidance violates the Tobacco Control Act’s requirement of premarket review of newly deemed products before they are distributed to consumers. Arguments advanced by FDA: Firstly, it was argued that the Plaintiff Organizations lacked standing to bring the lawsuit as the August 2017 Guidance caused no cognizable harm to them. Secondly, the FDA had unreviewable discretion in deciding how to enforce the Tobacco Control Act and its rules. Thirdly, the August 2017 Guidance was not final agency action and was beyond the reach of judicial review. Decision/Status The Court held that the FDA through the August 2017 Guidance abdicated its statutory duty to review new tobacco prod- ucts in a prompt fashion. Accordingly, the August 2017 guidance was vacated for the following reasons: Plaintiff Organizations standing to bring the lawsuit: It was noted that the Plaintiff Organizations had standing to bring the lawsuit as the August 2017 Guidance impacted their mission of increasing awareness about tobacco addiction and efforts to avert the creation of new generations of addicted children and adults. Further the Guidance, denied the Plaintiff Organizations access to information required by the Tobacco Control Act. Scientific data on the contents of novel tobacco products and their physiological consequences are crucial to the American Cancer Society Cancer Action Network’s (ACS CAN) ability to identify effective and feasible product standards. The situation forces ACS CAN to invest more resources in monitoring the market and the products on the to determine where the greatest risks for public health were arising. Traceable Injury: It was noted that the FDA had not issued any orders on premarket tobacco product applications since 2015 or taken any final action on any premarket tobacco product applications since June 2017. The Plaintiff Organizations injuries arise from the FDA’s actions to exempt certain products from premarket review for years. Judicial Review of Non-enforcement decision: It was noted that the language of the Tobacco Control Act with respect to consideration of premarket applications was mandatory and not discretionary. Thus, FDA’s decision not to undertake premarket review was subject to judicial review. The August 2017 Guidance expressed the definitive legal position by FDA to delay the premarket review requirement. Tobacco Control Act’s Provisions and Extent of FDA’s Statutory Authority: The August 2017 Guidance defeated the purpose of the Tobacco Act by providing a five-year compliance safe harbour for newly deemed tobacco products. Status: Decided | 15 May 2019 90 United States District Court, District of Maryland, American Academy of Pediatrics, et al v FDA, [2019] Case No. PWG-18-883, (https://www.tobaccocontrollaws. org/files/live/litigation/2645/US_American%20Academy%20of%20Pediatrics.pdf, accessed 27 June 2019) Case summaries 70 11. Junaid & Areeb Corp v Morris91 Facts Issue Arguments Advanced The Plaintiffs, a group of convenience store owners in Walpole, Massachusetts, challenge Walpole Board of Health’s regulation prohibiting convenience stores and other retails from selling mint, menthol, and wintergreen fla- voured tobacco products and flavoured e-cigarettes. Those products would be sold in adult-only retail tobacco shops. Whether the regu- lation passed by the Health Board is arbi- trary and capricious? Arguments advanced by the Plaintiff: It is alleged that the regulation is arbitrary, capricious, and not rationally related to the Board’s stated purpose of prevent- ing underage tobacco use. Decision/Status The Plaintiffs motion for preliminary injunction was denied. It was held that there was sufficient evidence before the Court that the Board based the regulation on information and research that gave rise to grave concerns about teen tobacco and e-cigarette use and that flavoured tobacco products are the most common entry point for such potentially addictive use. Status: Decided | 1 August 2019 12. Cumberland Farms Inc. v Bd. Of Health of Barnstable92 Facts Issue Arguments Advanced The Plaintiff owns and operates a chain of retail conve- nience stores in six cities and towns in Massachusetts. The Defendants in this case are elected boards of health in the six cities and towns that issued regulations that limit the sale of flavoured tobacco products to adult-only smoke shops and/or adult-only smoking bars. It is alleged by the Plaintiffs that the regulations implemented by the Defendants’ are be- yond the scope of their constitutional authority and violate the equal protection clause and due process rights. Whether the regula- tions implemented by the Defendant Health Boards violate the Massachusetts Declaration of Rights? Arguments advanced by the Plaintiffs: Removing flavoured ENDS from convenience stores will harm the public because the product represents a safer alter- native to combustible tobacco and serves as a means for smokers to reduce or quit tobacco. Decision/Status It was held that the inclusion of flavoured ENDS in the municipal bans is rational because ENDS have been linked as a gateway to subsequent tobacco use. Convenience stores, absent the regulations, could serve as a recruitment venue for youths not already interested in buying flavoured tobacco products. Accordingly, the Plaintiffs motion for preliminary injunctions was denied. Status: Decided | 29 August 2019 91 Superior Court of Massachusetts, Junaid & Areeb Corporation v William Morris et al., [2019] 36 Mass. L. Rep. 53 92 Superior Court of Massachusetts, Cumberland Farms, Inc v Board of Health of the Town of Barnstable et al., [2019] 36 Mass L. Rep 21 Case summaries 71 13. Vapor Tech Association v Baker93 Facts Issue Arguments Advanced During the EVALI outbreak, an emergency order was passed prohibiting the sale or display of all vaping products to consumers until January 25, 2020, in Massachusetts.94 The Plaintiffs challenged this order on the ground that it was reflective of executive overreach and sought injunctive relief to invalidate the order. Whether the Public Health Council (Council) overstepped its authority in adopt- ing the emergency regulation? Arguments advanced by Plaintiffs: The Council did not have the legislative power to adopt an emergency order of this nature and thus violated separation of governmental powers. Arguments advanced by the Defendants: Upon declaration of a public health emergency by a Governor, the Public Health Council may take such action as he may deem necessary to assure the maintenance of public health and the prevention of disease. Decision/Status It was held that the Order was promulgated without consideration and in disregard of facts and circumstances from the public and affected persons. The Plaintiffs have established irreparable harm because the Order puts many companies out of business for four months and have a likelihood of success in establishing that the Order exceeded any authority delegated by the legislature. The Court also noted that an immediate injunction against the entire order would contravene public interest. Thus, the Health Commissioner is directed to pass the emergency order after curing the defects indicated in the order. Status: Decided | 21 October 2019 93 Superior Court of Massachusetts, Vaor Tech Association v Baker, [2019] WL 6050041 94 The Order’s operative paragraph read: The sale or display of all vaping products to consumers in retail establishments, online and through any other means, including all non-flavoured and flavoured vaping products, including mint and menthol, including tetrahydrocannabinol (THC) and any other cannabinoid, is prohibited in the Commonwealth. Case summaries 72 14. Vapor Tech Association v Raimondo95 Facts Issue Arguments Advanced In September 2019, Governor Raimondo issued an executive order titled “Protecting Rhode Island Youth Against the Harms of Vaping”. The Executive Order, inter alia, directed the DOH to “promulgate emergency regulations to prohibit the sale of fla- voured ENDS. Accordingly, emergency regulations were issued that completely ban “the manufacture, distribution, sale, or offer for sale of, or the pos- session with intent to manufacture, distribute, sell, or offer for sale flavoured ENDS to consumers”. The regulation carves out an exception for tobacco flavoured or unflavoured vaping products. The Plaintiffs challenged the enforcement of the emergency regulations and sought declaratory and injunctive relief. Whether the emergen- cy regulations passed violate the separation of powers doctrine? Arguments advanced by the Plaintiffs: It is submitted that a restraining order should be passed against the emergency regulations because it may cause former smokers to return to cigarettes or turn to the unregulated black market. Arguments advanced by the Defendants: In light of the public health crisis asso- ciated with vaping, it weighs in favour of public interest to temporarily ban flavoured vaping products. Smokers that intend to quit will still have access to to- bacco flavoured or unflavoured nicotine vaping products. Decision/Status It was held that the Defendant’s determination of an imminent peril and the enactment of emergency regulations was proper, expedient and necessary to combat the youth vaping crisis. Thus, the Plaintiff’s failed to carry their burden for the issuance of a temporary restraining order. Status: Decided | 5 November 2019 15. Matter of Vapor Tech Association v Cuomo96 Facts Issue Arguments Advanced During the EVALI outbreak in the United States, Governor Cuomo through an executive order in September, 2019 banned possession, manufacture, distribution, sale or offer to sell any flavoured e-liq- uids and related products in New York. The ban ap- plied to flavoured e-liquids whether they contained nicotine or not. The ban did not apply to tobacco flavoured, menthol flavoured, or flavourless liquids. The emergency regulation was challenged by the Petitioners, a vapor technology association. Whether the Public Health and Health Planning Council (Council) overstepped its authority in adopt- ing the emergency regulation? Arguments advanced by Petitioner: It is submitted that 90% of the e-liquids cur- rently sold by the Petitioners fall within the definition of the products banned by the emergency regulation, and would render it impossible for their businesses to continue operation in New York. Arguments advanced by the Respondents: The goal of the emergency regulation was to reduce the attraction of vaping for younger consumers. 95 Superior Court of Rhode Island, Vapor Tech Association v Raimondo, [2019] C.A. No. PC-2019-10370 96 Supreme Court of New York, Matter of Vapor Tech. Assn. v Cuomo, [2020] 118 N.Y.S. 3d 397 Case summaries 73 15. Matter of Vapor Tech Association v Cuomo96 Decision/Status The Court held that the Council overstepped its authority in adopting the emergency regulation, as the regulation was a statement of public policy instead of an exercise of technical expertise. The emergency regulation carved out an exception for tobacco and menthol flavoured e-liquids, without any evidence that these flavours had been eliminated from the list of substances shown to trigger the spate of pulmonary diseases in New York. It was also noted that the emergency regulation was less of an effort at filing in the blanks left by a broad legislation and more of an attempt to set a State policy limiting the availability of vaping products in New York. This action is constitution- ally reserved for the Legislature and not the executive branch of the government. Accordingly, the Court granted the Petitioner’s motion for preliminary injunction because it would save businesses without hampering the government action through constitutionally appropriate legislative channels. Status: Decided | 8 January 2020 16. Jooce & Ors. v FDA97 Facts Issue Arguments Advanced E-cigarette manufactures and retailers challenge the Deeming Rule issued by the FDA that classifies e-cigarettes as ‘tobacco products’ and subject to regulation under the Family Smoking Prevention and Tobacco Control Act. Whether the deem- ing rule violates the Appointments Clause and the First Amendment? Arguments advanced by the Plaintiffs: The pre-clearance requirement in the Tobacco Control Act violates the First Amendment because it places the burden on manufacturers to show that certain of their marketing claims are truthful and not misleading. Decision/Status It was held that placing the burden on manufacturers to substantiate their marketing claims does not violate the First Amendment as held in the Nicopure Labs case. Thus, the Tobacco Control Act’s premarket review provisions do not imper- missibly burden speech. Status: Decided | 11 February 2020 97 United States District Court for the District of Columbia, Jooce v FDA, [2020] Case No. 18-cv-203 (CRC) Case summaries 74