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Search Results Results 1-10 of 128

British American Tobacco Ltd v. Ministry of Health [Kenya] [February 17, 2017]

British American Tobacco appealed a 2016 court decision, which upheld nearly all elements of Kenya’s Tobacco Control Regulations. The appeals court ruled that the tobacco company’s appeal had no merit and affirmed the decision of the lower court. The earlier ruling upheld nearly all elements of the Regulations, which are designed to implement the Tobacco Control Act, including:

  • a 2% annual contribution by the tobacco industry to help fund tobacco control education, research, and cessation;
  • graphic health warnings;
  • ingredient disclosure;
  • smoke-free environments in streets, walkways, and verandas adjacent to public places and in private vehicles where children are present;
  • disclosure of annual tobacco sales and other industry disclosures; and
  • regulations limiting interaction between the tobacco industry and public health officials.

The appeals court agreed with the lower court that the tobacco company had been given adequate opportunities for participation in the development of the regulations and that the regulations do not violate the tobacco company’s constitutional rights. 

Republic of Poland v. European Parliament & Council of the European Union [European Union] [May 04, 2016]

Poland challenged the provisions of a European Union (EU) Tobacco Products Directive (TPD) that prohibit the sale of menthol and other flavored cigarettes by member states as of May 2020. The Court of Justice of the European Union (CJEU) dismissed the claim, finding that it was appropriate for the EU to adopt a directive in order to prevent barriers to the trade of such products if different member states have different laws. The court noted that the TPD is also designed to protect public health. The Court rejected Poland’s argument that the EU should have adopted less restrictive measures, such as an age-related restriction on the use of menthol products, or that the regulation of such products should have been left to individual member states to regulate, as such alternative measures did not appear to be equally suitable for achieving the objective pursued. The Court also rejected the argument that the measure breached the principle of subsidiarity (which requires that the EU should not regulate on matters that are within the competence of individual Member States). 

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 labelling, 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 28 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 labelling 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. 

British American Tobacco Kenya Ltd. v. Ministry of Health [Kenya] [March 24, 2016]

British American Tobacco's Kenyan subsidiary filed a lawsuit claiming that Kenya’s Tobacco Control Regulations are unconstitutional. The court ruled against the tobacco company, finding that the process of developing the regulations was lawful and conducted with sufficient participation by the tobacco industry. The court upheld nearly all elements of the Regulations, which are designed to implement the Tobacco Control Act, including:

  • a 2% annual contribution by the tobacco industry to help fund tobacco control education, research, and cessation;

  • graphic health warnings;

  • ingredient disclosure;

  • smoke-free environments in streets, walkways, verandas adjacent to public places;

  • disclosure of annual tobacco sales and other industry disclosures; and

  • regulations limiting interaction between the tobacco industry and public health officials.

The court specifically noted that the Tobacco Control Act and Regulations are intended to comply with the Framework Convention on Tobacco Control. Additionally, the court acknowledged the harm caused by tobacco products and stated it would make its decision within the context of a public health system balanced against the commercial rights of the tobacco company.

The court struck down a few minor elements of the regulations, ruling that (1) the tobacco industry is not required to provide evidence of its market share to the government; and (2) that penalties for violation cannot exceed the maximums authorized by law.

The court ruled that the regulations should take effect six months after the date of the decision. 

R.J. Reynolds v. United States Food and Drug Administration [United States] [January 15, 2016]

Tobacco companies challenged the composition of the Tobacco Products Scientific Advisory Committee (TPSAC), which was established by the U.S. Food and Drug Administration (FDA) to advise the agency on scientific issues related to tobacco products, including the use of menthol in cigarettes. The tobacco companies alleged that three of the scientific members of the Committee had both an actual and a perceived conflict of interest because each consulted with companies that developed nicotine replacement therapies and testified as expert witnesses in lawsuits against tobacco manufacturers. The court ruled in favor of the tobacco companies, finding that the challenged committee members had both financial conflicts of interest and an appearance of conflicts of interest, which fatally tainted the composition of the Committee and its work product, including the 2011 Committee report on menthol in cigarettes. The court issued an order requiring the FDA to reconstitute the Committee’ membership to comply with ethics laws and barred the agency from using the Committee’s menthol report, which had recommended removing menthol cigarettes from the marketplace.  The FDA appealed, and a three-judge panel of the appeals court unanimously reversed the lower court ruling, finding that plaintiffs had not shown imminent injury from the appointment or the actions of challenged Committee members.

M/s Prabhat Zarda Factory India v. The State of Bihar [India] [December 23, 2014]

The government of Bihar issued a one-year ban on the sale, manufacture, or storage of certain flavored tobacco products, such as beetelnut. A number of manufacturers challenged the ban. In this decision, the court ruled that Pan Masala is not subject to the ban and that it may be sold, manufactured, or stored, so long as the companies comply with the Food Safety and Standards Regulations. The court also ruled that Zarda is not subject to the ban because it is a flavored tobacco product and not a food product or food additive. 

Lorillard v. United States Food and Drug Administration [United States] [July 21, 2014]

Tobacco companies challenged the composition of the Tobacco Products Scientific Advisory Committee (TPSAC), which was established by the U.S. Food and Drug Administration (FDA) to advise the agency on scientific issues related to tobacco products, including the use of menthol in cigarettes. The tobacco companies alleged that three of the scientific members of the Committee had both an actual and a perceived conflict of interest because each consulted with companies that developed nicotine replacement therapies and testified as expert witnesses in lawsuits against tobacco manufacturers. The court ruled in favor of the tobacco companies, finding that the challenged committee members had both financial conflicts of interest and an appearance of conflicts of interest, which fatally tainted the composition of the Committee and its work product, including the 2011 Committee report on menthol in cigarettes. The court concluded that if a Committee member stands to profit from the sale of tobacco cessation devices then he faces a conflict in his duty to render impartial advice regarding the regulation of menthol cigarettes. The court issued an order requiring the FDA to reconstitute the Committee’ membership to comply with ethics laws and barred the agency from using the Committee’s menthol report, which had recommended removing menthol cigarettes from the marketplace.

Dharmendra Kansal v. Union of India [India] [June 03, 2014]

A public interest lawsuit requested that cigarette manufacturers and the Indian government comply with the provisions of the Cigarette and Other Tobacco Products Act (COTPA) regarding tar and nicotine levels. Specifically, the law requires manufacturers to provide the tar and nicotine content of cigarettes on the label. The law also requires the government to set maximum permissible limits for tar and nicotine, which are also to be displayed on cigarette packs.  The court said that it did not have the power to compel the government to implement this provision of the law, even though the government had failed to set maximum tar and nicotine levels for cigarettes in the 11 years since the law was adopted. Instead, the court banned the sale of cigarettes in the State of Uttarakhand, effective one year after the date of the decision. The court said that the ban will not take effect if the government prescribes maximum nicotine and tar limits and manufacturers provide this information on their labels. Additionally, the court ordered that all loose cigarettes must be sold with the specified warning label on the cigarette or the packaging, effective six months from the date of the decision.

The Libra India v. Union of India [India] [January 12, 2014]

A public interest organization sued the government asking it to prohibit the sale, manufacture, and storage of all forms of tobacco and to study the contents of cigarettes, beedis, and other products for smoking tobacco. The court took note of the extensive information submitted by the petitioner about the huge loss of life and impacts on health due to tobacco use. The court noted that although the petition had been filed nearly a year earlier, the government had not yet provided a response. The court ordered the government to respond to the petition within six weeks from the date of the decision. 

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