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Argument: Procedural Defect

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M/S Marvelous Creations v. Deputy Commissioner of Customs [India] [May 08, 2019]

M/S Marvelous Creations (Marvelous) seeks release of a consignment containing such items as hookah flavorings, e-sheesha pens and e-liquid.  The government retained these items because of Marvelous' failure to follow the procedures set out in the November 27, 2018 Drugs Controller General order calling for enforcement of an e-cigarettes ban.  Marvelous asserted, however, that the November 2018 order had been stayed by the Delhi High Court and the government's retention of its consignment is due only to the pendency of this writ petition.  The court ordered the release of Marvelous' consignment.  

Manjinder Singh Sirsa v. Union of India [India] [January 19, 2019]

Manjinder Singh Sirsa requests the court to direct government authorities to prevent air pollution in restaurants and bars. Mr. Sirsa specifically alleges that hookahs contain hazardous substances and that the Delhi Pollution Control Committee should take action under the Air (Prevention and Control of Pollution) Act, 1981. By contrast, the government contends that hookahs are not hazardous. Noting that hookah is listed in the tobacco products schedule contained in India's omnibus tobacco control law, COTPA, the court dismissed the matter, finding that it did not possess jurisdiction to hear the application as its jurisdiction extends only to environmental questions.


J. Anbazhagan v. Union of India [India] [April 26, 2018]

J. Anbazhagan, a member of the legislative assembly in the State of Tamil Nadu, filed a writ petition to highlight the illegal manufacture and sale of gutka and pan masala in the state and to urge the High Court of Madras to order an independent investigation into the matter. Mr. Anbazhagan alleged such sales were carried out in collusion with several high dignitaries and bureaucrats, such as central excise officials, central government officials, officials from different state governments, including the Government of Tamil Nadu, councilors of the Chennai Corporation, and officials of the food safety department, among others. The Court observed that it was compelled to take up the case as the issues involved the right to health and directed that the Central Bureau of Investigation investigate the matter, since, among other reasons, central government officials allegedly were involved.  In response to arguments made by the respondents, the Court also clarified that the definition of “food” under Section 3(j) of the Food Safety Act includes any substance, whether processed, partially processed or unprocessed, which is intended for human consumption and that the definition undoubtedly was wide enough to include gutka, and other forms of chewable tobacco/nicotine products intended for human consumption. The Court further clarified that India’s omnibus tobacco control law, COTPA, and the Food Safety Act were not in conflict, but were meant to be read in conjunction with each other as COTPA does not contain a non-obstante clause that excludes operation of other laws.

Ghumman v. National Health Services, Regulation and Coordination [Pakistan] [December 18, 2017]

Public health organization, Pakistan National Heart Association, through its General Secretary, Sana Ullah Ghumman, filed a complaint in the office of the Federal Ombudsman alleging that the Federal Board of Revenue (FBR) and the Ministry of Health made inappropriate tax decisions which resulted in a reduction in price for certain tobacco products.  The Ombudsman ruled that the government's departure from established practice amounted to maladministration under Article 2(1)(a) of President Order No. 1 of 1983. The Ombudsman directed the government to either mandatorily comply with Articles 6 and 15 of the FCTC, or intimate reasons for non-compliance under Article 11(2) of the President Order No. 1 of 1983, both within thirty days.  The FBR appealed to the President's Secretariat. The Secretariat set aside the Federal Ombudsman's decision, finding that the Ombudsman did not possess jurisdiction to hear the matter as taxation strategy cannot be reviewed for maladministration and a tax bill passed by Parliament is not an act of an agency as required by the President's Order establishing Federal Ombudsman jurisdiction. The Secretariat further held that compliance with treaty obligations is a government policy issue and cannot be reviewed by judicial or quasi-judicial bodies like the Federal Ombudsman.

Karnataka Beedi Industry Association v. Union of India [India] [December 15, 2017]

Using the powers conferred by India’s omnibus tobacco control law, the government introduced new graphic health warnings in October 2014 that, among other things, increased the graphic health warning size from 40 percent of one side to 85 percent of both sides of tobacco product packaging and amended the rotation scheme of the warnings.  The Karnataka Beedi Industry Association, the Tobacco Institute of India, and other pro-tobacco entities challenged the validity of the 2014 pack warning rules in five cases in the Karnataka High Court – Bengaluru, and the court initially stayed the implementation of the warnings via interim orders.  Following a petition by tobacco control advocates, the court lifted the stays, and a division bench of the court affirmed the decision on appeal.  The association and others challenged this ruling in the Supreme Court.  Paving the way for immediate implementation of the warnings, the Supreme Court, on May 4, 2016, directed that the matter be decided within six weeks in the Karnataka High Court by a bench constituted by the Karnataka Chief Justice and that any stays of the warnings in other high courts not be given effect until the conclusion of the matter.  The Supreme Court identified pending pack warning challenges in courts throughout India (more than 27 in number) and transferred these cases to Karnataka. After months of hearings, a two judge bench of the Karnataka High Court struck down the 2014 rules. One judge found the rules illegal, holding that the Ministry of Health did not possess authority to act unilaterally. Both judges found the rules to be arbitrary and unreasonable.

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. 

BAT v. UK Department of Health (Appeal) [United Kingdom] [November 30, 2016]

An appeal against the earlier High Court judgment which upheld the UK's Standardised Packaging of Tobacco Products Regulations 2015.

British American Tobacco, Japan Tobacco International and Imperial Tobacco, together with the tipping paper company Tannpapier, appealed the High Court judgment of May 2016. The Appeal Court rejected all grounds of appeal. 

The appeal concerned the nature of the claimants' trade mark rights, the extent to which the Regulations interfere with those rights and the lawfulness of any interference. The Claimants also appealed the High Court judgment on the proportionality of the Regulations. The case concerned issues of European Union law and the European Convention on Human Rights (the right to property in Article 1 of Protocol 1), as well as domestic common law. 

The Appeal Court confirmed that a positive 'right to use' a registered trade mark did not exist in either domestic law, European Union law or international law. The Court also confirmed that the Regulations amounted to a control on the use of the tobacco trade marks and did not amount to a deprivation of those marks. The Regulations were a proportionate response to the public health objectives and struck a fair balance between the objectives and the interference with the claimant's rights. 

RJR Nabisco et al. v. European Community et al. [United States] [June 20, 2016]

The U.S. Supreme Court ruled that RJR Nabisco could not be sued under the federal Racketeer Influenced and Corrupt Organizations (RICO) Act for its conduct abroad. The European Union (known as the European Community in this case) sued RJR Nabisco claiming that the company directed and managed a global smuggling and money-laundering scheme with organized crime groups in violation of the RICO law. In this decision, the Supreme Court ruled that certain elements of RICO can apply to conduct that occurs outside of the United States. However, the Court also found that a private entity— this case, a foreign government­—cannot sue under RICO in the United States unless it has suffered a domestic injury. Because the European Union had earlier waived its claims of a domestic injury, the Court was forced to dismiss the EU’s remaining claims. 

Tobacco Institute of India v. Union of India [India] [March 11, 2016]

The Union of India and Health For Millions filed an interim application seeking vacation of the High Court’s December 4, 2015 stay (and January 6, 2016 modification) of a 2014 Ministry of Health notification establishing pack warnings on 85% of both sides of tobacco product packaging.  They alleged that a May 2009 Supreme Court order in a pack warnings matter (W.P. 549/2008) still pending before the Supreme Court directed that no court in India may pass orders inconsistent with the May 2009 order and that this May order was not considered in the High Court’s December 4, 2015 ruling.  The Karnataka Beedi Association and others maintained that the May 2009 Supreme Court order pertains to implementation of the 2008 pack warning rules and not the October 2014 rules.  They argued that the order thus cannot be relied upon in this matter.  Noting, among other things, that Health For Millions has filed an application for rigorous enforcement of the 2014 rules in W.P. 549/2008, the court observed that the May 2009 Supreme Court order is applicable to the writ petitions in the Karnataka High Court as issues relating to both the 2008 and 2014 rules are before the Supreme Court.  For this reason, the court held that the December 4, 2015 stay of the 2014 pack warnings rules must be lifted.  The Karnataka Beedi Association and others appealed, arguing that the constitutional validity of neither the 2008 nor the 2014 rules was at issue in the Supreme Court.  Instead, they maintain that the Supreme Court was adjudicating a writ of mandamus for the rules’ implementation.  Accordingly, the association argues that the high court must review the constitutional validity of the rules.  The high court disagreed and upheld the judge’s order lifting the stay.  The court also invited the association to approach the Supreme Court for further clarity so that the court can proceed further in these matters.

Tobacco Institute of India v. Union of India [India] [February 24, 2016]

The Union of India and Health For Millions filed an interim application seeking vacation of the High Court’s December 4, 2015 stay (and January 6, 2016 modification) of a 2014 Ministry of Health notification establishing pack warnings on 85% of both sides of tobacco product packaging.  They alleged that a May 2009 Supreme Court order in a pack warnings matter (W.P. 549/2008) still pending before the Supreme Court directed that no court in India may pass orders inconsistent with the May 2009 order and that this May order was not considered in the High Court’s December 4, 2015 ruling.  The Karnataka Beedi Association and others maintained that the May 2009 Supreme Court order pertains to implementation of the 2008 pack warning rules and not the October 2014 rules.  They argued that the order thus cannot be relied upon in this matter.  Noting, among other things, that Health For Millions has filed an application for rigorous enforcement of the 2014 rules in W.P. 549/2008, the court observed that the May 2009 Supreme Court order is applicable to the writ petitions in the Karnataka High Court as issues relating to both the 2008 and 2014 rules are before the Supreme Court.  For this reason, the court held that the December 4, 2015 stay of the 2014 pack warnings rules must be lifted.