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Topic: Packaging and Labeling Measures

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Search Results Results 1-10 of 202

La Republicana S.A. v. State - Executive Branch [Uruguay] [July 24, 2019]

Compañía Industrial de Tabacos Montepaz S.A. and La Republicana S.A. challenged Decree No. 120/2019, issued by the executive branch, that requires plain packaging of tobacco products. The Court rejected the challenge and found that the decree is not clearly illegitimate, and therefore, the plaintiffs did not meet the required standard. The Court further held that Congress was the appropriate institution to approve plain packaging and impose restrictions on the tobacco industry (done via Law No. 19.723), and therefore, the executive branch did not exceed its authority when it issued Decree No. 120/2019. Additionally, the Court found that even though the implementation timeline might be strict (one year), the industry had prior knowledge given that there was a previous decree and a pending bill in Congress.

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 [United States] [March 05, 2019]

In 2016, the Campaign for Tobacco-Free Kids in conjunction with seven other health organizations, medical groups, and several individual pediatricians, filed a lawsuit to force the FDA to issue a final rule requiring graphic health warnings on cigarette packing and marketing, as mandated by the 2009 Family Smoking Prevention and Tobacco Control Act. In September 2018, the District Court ruled in favor of the health groups finding that the FDA had both “unlawfully withheld” and “unreasonably delayed” agency action to require the graphic health warnings.  

In March 2019, the District Court ordered that the FDA must issue a final rule by March 2020 for graphic health warnings on cigarette packaging and marketing.  The ruling also requires the FDA to finish its study on the labels by April 15, 2019, and submit its proposed rule by August 15, 2019.

For the earlier decision, see: American Academy of Pediatrics, et al. v. U.S. Food & Drug Admin., No. 1:16-cv-11985 (D. Mass. 2018).

Planta Tabak-Manufaktur Dr. Manfred Obermann GmbH & Co. KG v. Land Berlin [European Union] [January 30, 2019]

Planta Tabak, a Berlin-based tobacco company that primarily manufactures and markets flavored roll-your-own tobacco, challenged provisions of the EU Tobacco Products Directive (Directive 2014/40/EU) that prohibit characterizing flavors in cigarettes and roll-your-own tobacco and prohibit packaging from alluding to flavors, among others. The plaintiffs sought a declaration that these provisions were not applicable to its products and alleged that they violated the principles of legal certainty, equal treatment, and proportionality. Planta Tabak objected to the fact that manufacturers of flavored tobacco products with an EU-wide sales volume of 3% or more in a particular product category were given until May 2020 to comply with the ban on flavorings, while manufacturers of flavored products with a smaller sales volume must comply as of May 2016.

The Court held that flavored tobacco products were particularly attractive to young people and facilitate the initiation of tobacco consumption. 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 consequences against the requirement to ensure a high level of protection of human health." Further, the Court found that 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. The Court also upheld the ban on any indication of flavor on the product packaging and labeling.

The case now reverts to Berlin's administrative court, where Planta Tabak filed its initial challenge.

B.A.T. v. Executive Branch [Uruguay] [October 11, 2018]

British American Tobacco (BAT) challenged an executive decree requiring plain packaging of tobacco products. While an administrative tribunal (Tribunal de lo Contencioso Administrativo) is considering the initial challenge, BAT also filed a rapid constitutional challenge, called an “amparo,” requesting suspension of the decree until the administrative challenge is decided (which may take up to one year). With regard to the amparo, the Administrative First Instance Court decided in favor of BAT because the plain packaging policy was approved through a decree instead of a law passed by Congress.

Here, the government appealed the decision by the Administrative First Instance Court, and the Court of Appeals ruled in favor of the government. The Court of Appeals found that the amparo was not the proper mechanism for the challenge, because there is a pending administrative claim. This decision was final, and BAT cannot appeal the decision. The decision does not address the merits as to whether the policy is constitutional, only that the President did not have the power to enact the policy by way of executive order.

B.A.T. v. State - Executive Branch [Uruguay] [September 18, 2018]

British American Tobacco (BAT) challenged an executive decree requiring plain packaging of tobacco products. While an administrative tribunal (Tribunal de lo Contencioso Administrativo) is considering the initial challenge, BAT also filed a rapid constitutional challenge, called an “amparo,” requesting suspension of the decree until the administrative challenge is decided (which may take up to one year). With regard to the amparo, the court decided in favor of BAT because the plain packaging policy was approved through a decree instead of a law passed by Congress. The decision does not address the merits as to whether the policy is constitutional, only that the President did not have the power to enact the policy by way of executive order.

Note: The government appealed this decision, and the Court of Appeals ruled in favor of the government. The Court of Appeals found that the amparo was not the proper mechanism for the challenge, because there is a pending administrative claim. That decision was final and the case cannot be appealed by BAT.

American Academy of Pediatrics et al. v. U.S. Food and Drug Administration [United States] [September 05, 2018]

In a lawsuit filed by eight public health and medical groups and several individual pediatricians, plaintiffs filed suit to force the U.S. Food and Drug Administration (FDA) to issue a final rule requiring pictorial health warnings on cigarette packs and advertising, as mandated by the 2009 Family Smoking Prevention and Tobacco Control Act. The FDA's previous final rule was struck down in August 2012 by the U.S. Court of Appeals for the D.C. Circuit, which ruled that the proposed warnings violated the First Amendment. Ruling in a separate case in March 2012, the U.S. Court of Appeals for the Sixth Circuit upheld the law’s requirement for pictorial health warnings, finding that this provision did not violate the First Amendment. That court found the warnings “are reasonably related to the government’s interest in preventing consumer deception and are therefore constitutional.” The U.S. Supreme Court declined to hear a tobacco industry appeal of this ruling. Taken together, these two federal court decisions meant the FDA was still legally obligated to require pictorial health warnings, and the agency was free to use different images than those struck down by the D.C. Circuit in 2012. The FDA stated in March 2013 that it planned to issue a new rule, but had yet to act when plaintiffs filed suit.

The judge agreed with the health groups that the FDA has both “unlawfully withheld” and “unreasonably delayed” agency action to require the pictorial warnings. The judge set a deadline of September 26, 2018, for the FDA to provide an expedited schedule for the proposal, review, and issuance of final pictorial health warnings in accordance with the law.

Australia - Tobacco Plain Packaging [Australia] [June 28, 2018]

In 2012 and 2013, Honduras, Indonesia, Cuba and Dominican Republic brought complaints in the World Trade Organization (WTO) claiming that Australia's tobacco plain packaging laws breached the WTO agreements. The complaining countries argued that Australia’s law breached the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) by failing to provide required protections to trademarks rights and because it is an unjustifiable encumbrance on the use of tobacco trademarks; and the Agreement on Technical Barriers to Trade (TBT Agreement) because it is more trade-restrictive than necessary to fulfill a legitimate objective.

This long anticipated ruling by the WTO rejected all grounds of complaint against Australia's plain packaging laws in a 900 page ruling. The panel's authoritative ruling should be powerful in persauding governments to move forward with tobacco plain packaging and can be used to resist many of the flawed arguments the tobacco industry puts forward to oppose the policy. The WTO considered extensive evidence from Australia and the complaining countries and found the evidence demonstrates tobacco plain packaging works to reduce tobacco use. The panel re-affirmed that states have the right to regulate for public health under WTO law and the policy does not interfere with international trademark rights. The panel made strong findings of fact which undermine many of the other arguments that the tobacco industry tries to use to oppose plain packaging laws. These are detailed in the briefing document that can be downloaded under the 'additional documents' tag. 

Health for Millions Trust v. Union of India [India] [January 08, 2018]

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.  After months of hearings, a two judge bench of the Karnataka High Court struck down the 2014 rules, and the Government and public health groups appealed the matter to the Supreme Court. The Supreme Court stayed implementation of the Karnataka High Court order and set final disposal of the matter for March 12, 2018. The Court stated: "[W]e are inclined to think that health of a citizen has primacy and he or she should be aware of that which can affect or deteriorate the condition of health. We may hasten to add that deterioration may be a milder word and, therefore, in all possibility the expression ‘destruction of health’ is apposite." India’s 85% graphic health warning rules accordingly remain in effect for now.

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.