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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.
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.
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;
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.
Karnataka Beedi Industry Association v. Union of India [India] [December 08, 2015]
The Karnataka Beedi Industry Association challenged the legality (as it relates to beedis) of an October 2014 Ministry of Health notification establishing pack warnings on 85% of both sides of tobacco product packaging. Without ruling on the merits of the case, the court stayed the implementation of the pack warnings notification in a preliminary order.
Whistle Stop Inn, Inc. & Louise Liford, d/b/a Thirsty Turtle v. City of Indianapolis et al. [United States] [June 24, 2015]
An Indianapolis smoking ordinance contained an exception allowing smoking in “satellite” facilities for off-track gambling. The court ruled that the exception was unconstitutional because it treated satellite facilities differently from bars and restaurants without a sufficient reason. The court struck down the exception for satellite facilities but allowed the remainder of the ordinance to continue in effect.
FIC Argentina v. Buenos Aires City Government [Argentina] [August 15, 2014]
A tobacco control NGO sued the Buenos Aires city government arguing that the lack of implementation of the local tobacco control law, with regards to smoke-free environments, violated the right to health. Furthermore, considering the violations of the law were higher in places like bars and night clubs, the NGO argued that workers in those places had lower standards of protection of their right to health. The judge rejected the lawsuit considering there was no illegal or arbitrary act from the local government. In addition, the judge stated that courts should not replace political decisions.
Charles McCann v. State Hospital Board of Scotland [United Kingdom] [August 12, 2014]
The Hospital Board decided to prohibit smoking and the possession of tobacco on the ground of a government-run hospital. The lower court ruled that the decision was unlawful in regards to the plaintiff, because it violated his right to private and family life, discriminated against him, and did not conform with the principles of the Mental Health Care Act. In this decision, the appeals court reversed the lower court judgment. The appeals court ruled that the hospital had the authority to prohibit smoking, and the decision did not violate the provisions of the European Convention on Human Rights.
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.
Paul Stieler Enterprises, Inc. v. City of Evansville and Evansville Common Council [United States] [February 11, 2014]
A number of bars and fraternal organizations sued the city of Evansville challenging its ordinance prohibiting smoking in bars and restaurants but exempting riverboat casinos. The state Supreme Court overturned an earlier decision and struck down the ordinance. The court said that the ordinance violates the Equal Privileges and Immunities Clause of the state constitution because it gives an advantage to the riverboat casino – an exemption from the smoking ban – that is not provided to similarly situated bars and clubs. Because the court found that the exemption for riverboat casinos could not be separated from the main ordinance it struck down the entire ordinance as unconstitutional.
Goodpaster et al. v. City of Indianapolis [United States] [November 25, 2013]
In 2012 the City of Indianapolis and Marion County expanded a local smoking ordinance to include bars and taverns. A number of bar owners sued, seeking a preliminary and a permanent injunction to prohibit the ordinance from taking effect. The bar owners claimed that the ordinance violated their rights to due process, freedom of association, and equal protection and constituted a taking under the federal and state Constitutions. The appeals court affirmed an earlier ruling upholding the local smoking ordinance. The court found that all of the bar owners claims failed. In particular, the court found that the government could have had a rational reason for adopting the law and for continuing to exclude cigar and hookah bars from the ordinance.