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Topic: Packaging and Labeling Measures

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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).

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.

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, 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. 

Japan Tobacco International and Others v. Ministry of Health (plain packaging laws) [France] [December 23, 2016]

Legal challenges to the plain packaging of tobacco products laws dismissed. 

On December 23, 2016 the Conseil d’Etat (the Council of State, the highest administrative jurisdiction in France) dismissed six legal challenges that were brought against the tobacco products plain packaging laws. Previously, in January 2016, the Constitutional Council had also upheld the law as in accordance with the constitution, on a referral from members of parliament.

In brief, six cases were brought challenging the regulations - four by the tobacco companies, one from the confederation of tobacco retailers, and one from a tobacco paper manufacturer. The Conseil d'Etat dismissed all the claims and held that:

1. The ban on using figurative, semi-figurative signs, and logos on packaging of tobacco products was valid because the brand and variant name is still permitted allowing the identification of the product.
2. Plain packaging constitutes an infringement of property rights, but that this infringement is justified in the light of the objective pursued (public health) and because the measure regulates the use of trademarks but does not completely ban them.
3. There was no 'deprivation' of property rights.
4. For the same reasons, the Conseil d'État held that the national legislation is a quantitative restriction on the importation of goods but this is in conformity with European Union law because the introduction of such restrictions is permitted where they are justified by a public health objective and the protection of human life. The court held that in this case, the challenged provisions must be considered as unable to do anything other than, over time, reduce the consumption of tobacco. The evidence in the case file also showed that neutral packaging would reduce the attractiveness of tobacco products. The measures were therefore proportionate and justified.

A summary of the decisions from the two separate courts is attached in French and English in the section on "Related Documents".