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Type of Tobacco Product: E-cigarettes and other ENDS products

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BAT Uganda Ltd v. Attorney General & Center for Health, Human Rights and Development [Uganda] [May 28, 2019]

British American Tobacco Uganda (BATU), a subsidiary of British American Tobacco, filed a lawsuit in the Constitutional Court of Uganda in 2016 challenging the constitutionality of several key provisions in the Tobacco Control Act, 2015. The Court dismissed the Petition in its entirety and awarded costs to the government. The Court found that the Petition appeared to have been misconceived or brought in bad faith as part of a global strategy to fight tobacco control legislation. The challenged provisions upheld by the Court include provisions:

- requiring 65% or larger picture health warnings;
- banning smoking in all indoor public places and workplaces, on all means of public transport, and in specified outdoor public places;
- banning all tobacco advertising, promotion, and sponsorship, including product displays at points of sale;
- prohibiting the sale of tobacco products in specified places (health institutions, schools, prisons, and other places);
- prohibiting the import, manufacture, distribution, and sale of electronic nicotine delivery systems, and shisha, smokeless, and flavored tobacco;
- banning the sale of tobacco products through vending machines and through remote means of sale (e.g., mail, internet); and
- implementing WHO FCTC Article 5.3.

American Academy of Pediatrics, et al. v. FDA, et al. [United States] [May 15, 2019]

The Campaign for Tobacco-Free Kids, in conjunction with other public health and medical organizations and several individual pediatricians, challenged the U.S. Food and Drug Administration decision to allow e-cigarettes to remain on the market until 2022 before applying for FDA authorization and permitting products to remain on the market during review. The FDA also delayed the deadline for cigar manufacturers to file such applications until 2021. The court found that the FDA had exceeded its legal authority and the FDA’s delay had played a role in the skyrocketing youth use of e-cigarettes. The court gave the plaintiffs 14 days to submit additional briefing regarding a remedy and the FDA 14 days to respond.

Nicopure Labs, LLC v. Food and Drug Administration [United States] [July 21, 2017]

A manufacturer of e-cigarette devices and liquids challenged a federal regulation that deemed e-cigarettes to be “tobacco products.” This rule subjects e-cigarettes to the same federal laws as traditional cigarettes under the Tobacco Control Act (TCA). The manufacturer argued that the Food and Drug Administration (FDA), which issued the regulations, did not have the authority to regulate empty e-cigarettes or nicotine free e-liquids, because they were not made or derived from tobacco. The company also argued that the TCA’s ban on distributing free samples and pre-approval for modified risk statements was arbitrary and violated their First Amendment rights.

In this decision, the District Court upheld the FDA’s rule. The TCA gives the FDA the power to regulate “components” of tobacco products. The court found empty e-cigarettes and nicotine-free e-liquids are “components” of a tobacco product because together they make up an electronic nicotine delivery system. Further, the court found that the rule did not violate the manufacturers’ First Amendment rights because the ban on free samples was regulating conduct, not speech. The court also held that pre-approval for modified risk statements did not violate the First Amendment because it does not ban modified risk statements, it only requires the claims be substantiated. Finally, the court found because of the public health risks associated with nicotine and increasing rates of e-cigarette use in adolescents and adults, the decision to subject e-cigarettes to the TCA was not arbitrary. 

Australian Competition and Consumer Commission v. The Joystick Company Pty Ltd. [Australia] [May 02, 2017]

The Australian Competition and Consumer Commission successfully took action against an e-cigarette company for making false and misleading statements in violation of the Australian Consumer Law. The e-cigarette company stated on its website and in a YouTube video that its products did not contain carcinogens and toxic substances found in traditional tobacco cigarettes. 

In this decision, the court accepted the Commission’s recommendations and ordered the company to stop making statements that its products do not contain carcinogens and toxic substances for a period of three years. The court found that the company had no evidence to support its statements, which had the potential to mislead consumers who might not have purchased the products if they had known about the presence of these chemicals. Additionally, the court ordered the company to include information on its website about this decision for 90 days. Finally, the court fined the company $50,000 and its director $10,000. 

Australian Competition and Consumer Commission v. Social-Lites Pty Ltd [Australia] [May 02, 2017]

The Australian Competition and Consumer Commission successfully took action against an e-cigarette company for making false and misleading statements in violation of the Australian Consumer Law. The e-cigarette company stated on its website and in a YouTube video that its products did not contain carcinogens and toxic substances found in traditional tobacco cigarettes. 

In this decision, the court accepted the Commission’s recommendations and ordered the company to stop making statements that its products do not contain carcinogens and toxic substances for a period of three years. The court found that the company had no evidence to support its statements, which had the potential to mislead consumers who might not have purchased the products if they had known about the presence of these chemicals. Additionally, the court ordered the company to include information on its website about this decision for 90 days. Finally, the court fined the company $50,000 and its director $10,000. 

Australian Competition and Consumer Commission v. Burden [Australia] [May 02, 2017]

The Australian Competition and Consumer Commission successfully took action against an e-cigarette company for making false and misleading statements in violation of the Australian Consumer Law. The e-cigarette company stated on its website that its products did not contain harmful chemicals and carcinogens found in traditional tobacco cigarettes. 

In this decision, the court accepted the Commission’s recommendations and ordered the company to stop making statements that its products do not contain harmful chemicals and carcinogens for a period of three years. The court found that the company had no evidence to support its statements, which had the potential to mislead consumers who might not have purchased the products if they had known about the presence of these chemicals. Additionally, the court ordered the company to include information on its website about this decision for 90 days. Finally, the court fined the company $40,000 and its director $15,000. 

R (on the Application of) Philip Morris Brands SARL et al. v. Secretary of State for Health [European Union] [May 04, 2016]

A challenge to the validity of the European Union’s (EU) Tobacco Products Directive (TPD) 2014 brought by Philip Morris and British American Tobacco was dismissed on all grounds by the Court of Justice of the European Union (CJEU). The amended TPD was adopted in April 2014 and provides a wide range of requirements relating to emissions, reporting, 65% pictorial health warnings, packaging and labeling, a ban on characterising flavors and other additives, and regulates e-cigarettes. Article 24(4) permits member states to adopt further requirements to standardise packaging. The TPD applies to all countries within the EU.

In this case, Philip Morris and BAT brought a judicial review against the United Kingdom based on the government’s intention to implement the TPD requirements in UK legislation. The tobacco companies claimed that parts of the TPD and the Directive as a whole, were invalid because it was incompatible with the EU Treaties; was not proportionate or supported by evidence; was not sufficiently harmonising in nature; and contravened the principle of subsidiarity.  The UK court hearing the case referred questions on the interpretation of EU law to the CJEU. The CJEU upheld all aspects of the TPD, including provisions to require pictorial warning labels, to prohibit menthol cigarettes, and to allow countries to prohibit cross-border sales and to adopt additional packaging restrictions, such as plain packaging. The court noted that the EU may act to prevent obstacles to the trade of tobacco products while also ensuring a high level of public health protection. The court found that the packaging and labeling requirements were proportionate and did not go beyond what were necessary and appropriate. 

In addition the court highlighted the importance of the FCTC as a tool for interpretation and stated that it could have a 'decisive influence' on the interpretation of both EU law and Member States' tobacco control legislation. 

EU Member States are obliged, under the TPD, to implement most provisions of the TPD into domestic law by May 20, 2016 (although a number of states have been late in their implementation).

Pillbox 38 (UK) Ltd. v. Secretary of State for Health [European Union] [May 04, 2016]

A challenge to the validity of the e-cigarette regulations in the European Union’s (EU) Tobacco Products Directive (TPD) 2014 was dismissed on all grounds by the Court of Justice of the European Union (CJEU). Pillbox 38 (UK) Ltd. (trading under the name "Totally Wicked"), an e-cigarette manufacturer, brought a judicial review against the UK government challenging its intention to implement the TPD into domestic law on the basis that it claimed the TPD was not valid. The TPD Article 20 sets out requirements for e-cigarettes for all EU Member States. The UK court hearing the case asked the CJEU for a reasoned opinion on the validity of Article 20.

The CJEU found the TPD to be valid and upheld all of the e-cigarette requirements, including health warnings; a ban on most e-cigarette advertising; a limit on nicotine levels and amounts and e-liquid container sizes; a requirement to notify the government before introducing a new product; and the requirement to include a leaflet with the product containing information such as a list of ingredients. Firstly, because the purpose of the Directive is to harmonise regulations across the EU, the court found that there were significant divergences between the regulations in different Member States which justified the EU regulating the market. The court found that it was permissible to regulate e-cigarettes differently than other tobacco products in part because e-cigarettes are novel products and there is insufficient information on their health effects. The identified and potential risks linked to the use of e-cigarettes means the EU may act according to the precautionary principle. 

In re NJOY, Inc. Consumer Class Action Litigation [United States] [February 02, 2016]

A court ruled that a lawsuit against e-cigarette maker NJOY could not proceed as a class action. Potential class members had asserted that NJOY: (1) conducted misleading advertising indicating that e-cigarettes are safer than regular cigarettes; and (2) omitted information on its packaging about product ingredients and the risks of such ingredients. The court affirmed an earlier ruling prohibiting the lawsuit from proceeding as a class action, saying that class members failed to demonstrate how damages can be proven for the entire class. Specifically, the court said that the class was not able to show how it could calculate the difference between the price paid by consumers of NJOY and the true market price that reflects the impact of the unfair or fraudulent business practices. Although the ruling means that the case may not proceed as a class action, individuals may sue NJOY independently.  

Neri, José Armando Contreras v. Mexico [Mexico] [October 02, 2015]

The Supreme Court of Justice of the Nation (SCJN) determined that the sale of products related to tobacco, such as electronic cigarettes, can not be prohibited. The Ministers of the Second Chamber decided that it is unconstitutional to prohibit the sale of these items while, on the other hand, the sale of tobacco in our country is allowed. The case reached the Court after in 2012, the Federal Commission for the Protection against Sanitary Risks (Cofepris) imposed a fine of more than 60 thousand pesos to a merchant who offered electronic cigarettes in a commercial establishment. Unhappy with the sanction, seller José Armando Contreras Neri filed a lawsuit against Article 16 of the General Law on Tobacco Control which states: "It is prohibited to Trade, Sell, distribute, exhibit, promote or produce any object that is not a tobacco product, that contains any of the elements of the brand or any type of design or auditory signal that identifies it with tobacco products." The case reached the maximum court that on Wednesday he decided that despite the fact that the law seeks to protect health, this can not be done at the cost of an excessive affectation of other goods and rights. The Ministers agreed that prohibiting the sale of these products to protect public health and the environment violates the right to equality, since at the same time the sale of tobacco is allowed. Thus, they revoked the judgment that prohibited the merchant from selling electronic cigarettes and the fine imposed by Cofepris. The seller may continue with the offer of electronic cigarettes as long as it does so in accordance with the laws that regulate the sale of common cigarettes. AGHO