Category: Litigation

  • Tobacco Firms Settle MSA Dispute

    Tobacco Firms Settle MSA Dispute

    Image: mehaniq41

    Tobacco companies will pay Massachusetts hundreds of millions of dollars to settle a dispute about how much the cigarette manufacturers owe the state.

    The deal ends a dispute stemming from the 1998 Master Settlement Agreement (MSA) in which tobacco companies agreed to pay states billions of dollars each year to offset medical expenses stemming from smoking.

    Claiming that some MSA signatories withheld “substantial funds,” the Massachusetts attorney general’s office sent disputes over hundreds of millions of dollars into arbitration.

    Monday’s announced deal resolves seven of those past disputes for 2005 through 2011, the office said, and will result in $600 million being paid to the commonwealth this year and “tens of millions” each year going forward.

    “The country’s major tobacco manufacturers have pushed smoking products to young people for decades—and this settlement is evidence of our ongoing commitment to hold these companies accountable for their actions that caused irreparable harm to public health and safety,” said Massachusetts Attorney General Andrea Joy Campbell in a statement.

  • Top Court Upholds FDA Authority in Philippines

    Top Court Upholds FDA Authority in Philippines

    Photo: natatravel

    The Supreme Court of the Philippines upheld its 2021 decision to grant the country’s Food and Drug Administration regulatory authority over the health aspects of tobacco products, reports the Inquirer.

    “All products affecting health, including tobacco products, are covered by the FDA’s mandate to ensure the safety, efficacy, purity, and quality of health products,” the Supreme Court said.

    “Thus, the inclusion of tobacco products in the implementing rules of the FDA Act is in accordance with the law,” it added.

    The case stemmed from an attempt to stop the enforcement of the FDA implementing rules and regulations. In a case filed in 2011 before the Regional Trial Court of Las Pinas City, the Philippine Tobacco Institute (PTI) alleged that those rules improperly expanded Republic Act No. 9711 by classifying tobacco products as health products.

    The PTI argued that under the Tobacco Regulation Act of 2003, the Inter-Agency Committee on Tobacco (IACT) had exclusive jurisdiction over tobacco products.

    In 2012, the Las Pinas court ruled in favor of PTI and nullified the provisions of the FDA implementing rules and regulations relating to tobacco.

    The Department of Health and the FDA then petitioned the Supreme Court for review, which overturned the Las Pinas court decision in 2021. The PTI then challenged the high tribunal’s ruling, but was rebuffed.

    The denial of the motions for consideration means the IACT and the FDA will continue to share authority over tobacco, with each overseeing different aspects of the trade.

    Under the Tobacco Regulation Act, the IACT is chaired by the trade secretary with the health secretary as vice chair and includes a representative of the tobacco industry as a member. The PTI previously held the position of representing the tobacco industry in the committee.

  • Russia Sues Dutch Owner of Megapolis

    Russia Sues Dutch Owner of Megapolis

    Image: somemeans

    The Russia government is seeking to suspend the corporate rights of Megapolis Distribution, the Dutch owner of Russian tobacco distributor Megapolis Group, reports Interfax.

    On July 18, Russia’s Industry and Trade Ministry filed a lawsuit against Megapolis Distribution in the Arbitration Court of the Moscow Region, according to records.

    The Russian company was earlier included in Russia’s list of economically significant organizations.

    The court has agreed to hear the lawsuit, and the first hearing is scheduled for August 8.

    Shortly after Russia’s invasion of Ukraine in February 2022 and just before the EU imposed sanctions on him, Russian billionaire Igor Kasaev, who owns 40 percent of Megapolis, funneled €8 million ($8.71 million) through the Netherlands, according to the NL Times.

    Kasaev is known to have ties to the Kremlin and the Russian arms industry. He keeps his shares in Megapolis, the largest distributor of cigarettes in Russia, in the letterbox company registered in The Hague. The sanctions froze Kesaev’s assets in his Hague company, “trapping” some €650 million in assets in the Netherlands.

  • Biden Asks Judge to Drop Menthol Ban Suit

    Biden Asks Judge to Drop Menthol Ban Suit

    TR Archive

    The Biden administration asked a federal judge to dismiss a lawsuit by anti-smoking groups demanding that it end nearly a year of delay and ban menthol cigarettes, which are used disproportionately by Blacks and younger people.

    In a court filing late last week, the U.S. Food and Drug Administration said the delay was not unreasonable because it had yet to determine that a ban was “appropriate for the protection of the public health.”

    The FDA also said the plaintiffs had no direct stake in a ban, having alleged at most “a setback to their abstract social interests,” and therefore had no standing to sue,” according to Reuters.

    It cited the U.S. Supreme Court’s June 13 rejection of a bid by anti-abortion groups and doctors to restrict access to a widely used abortion pill.

    The lawsuit was filed on April 2 in the Oakland, California federal court by the American Medical Association, the African American Tobacco Control Leadership Council, Action on Smoking and Health and the National Medical Association.

    Last month, the FDA authorized four menthol NJOY products through the premarket tobacco product application (PMTA) pathway.

    The FDA issued marketing granted orders to NJOY, an Altria subsidiary, for two pods for its Ace closed e-cigarette device, which was authorized in April of 2022, and two disposable e-cigarettes—NJOY DAILY Menthol 4.5%, and NJOY DAILY EXTRA Menthol 2.4%.

  • U.S. Supreme Court Overturns Chevron

    U.S. Supreme Court Overturns Chevron

    The U.S. Supreme Court on June 28 overturned the “Chevron deference,” a doctrine that requires courts to defer to federal agencies when sorting out ambiguities in law. The 6-3 majority ruling could impact the U.S. Food and Drug Administration and its premarket tobacco product authorization process. According to critics, the Chevron deference often gives agencies leeway to reach beyond the limits of a statute’s plain language, often bypassing the rulemaking process otherwise required under the Administrative Procedure Act and making it more difficult to challenge an agency action in court.

    Chris Howard, executive vice president, external affairs & new product compliance for Swisher, welcomed the ruling, saying that for decades federal agencies have had too much power. “That ended today with the Supreme Court’s decision overturning the long-standing Chevron Doctrine,” said Howard. “The decision marks a significant shift in the judicial landscape, correcting the balance of power between federal agencies and the judiciary. It fundamentally alters how courts rule on agency statutory interpretation. As the majority states, courts will no longer be restrained by the need to provide deference.

    “Instead, ‘Courts must exercise their independent judgment in deciding whether an agency has acted within its statutory authority, as the APA requires.’ This transformation will likely lead to significantly less regulatory flexibility and increased judicial scrutiny. The implications of this decision will resonate across industries, including the tobacco industry, influencing regulatory practices and shaping the future of administrative law. Regulatory overreach will become the exception as opposed to the norm and enable courts to fulfill their duty to interpret the law.”

    In the years since electronic nicotine delivery systems (ENDS) became subject to FDA regulation, the vast majority of courts reviewing ENDS industry challenges to premarket application denials, as well as FDA rulemakings and guidance documents, have rubber-stamped the agency’s interpretation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the “appropriate for the protection of the public health” standard.

    Critics contend that the Chevron deference has enabled the FDA to impermissibly interpret the TCA to implement a de facto ban on all nontobacco-flavored ENDS products without any requisite notice and comment rulemaking or congressional amendments to the TCA.

    “For far too long, unelected bureaucrats at the FDA have been making up the law to suit their own ulterior agenda and Today, the Supreme Court has thankfully put a stop to it once and for all,” said Allison Boughner, vice president of the American Vapor Manufacturers Association. “No longer will it be good enough for prohibitionists in Congress to write vague, Crayola language and then connive behind closed doors with FDA to impose arbitrary policies on the American public that could never withstand the light of day.”

    It has been nearly 40 years since the Supreme Court indicated in Chevron v. Natural Resources Defense Council that courts should defer to an agency’s reasonable interpretation of an ambiguous statute.

    The court’s ruling could have ripple effects across the federal government, where agencies frequently use highly trained experts to interpret and implement federal laws, according to SCOTUSblog. Although the doctrine as relatively noncontroversial when it was first introduced in 1984, in recent years conservatives—including some members of the Supreme Court—have called for it to be overruled.

    The plea to overturn the Chevron doctrine came to the court in two cases challenging a rule, issued by the National Marine Fisheries Service, that requires the herring industry to bear the costs of observers on fishing boats. Applying Chevron, both the U.S. Court of Appeals for the District of Columbia Circuit and the U.S. Court of Appeals for the 1st Circuit upheld the rule, finding it to be a reasonable interpretation of federal law.

    The fishing companies came to the Supreme Court, asking the justices to weigh in on the rule itself but also to overrule Chevron. Roman Martinez, representing one group of fishing vessels, told the justices that the Chevron doctrine undermines the duty of courts to say what the law is and violates the federal law governing administrative agencies, which similarly requires courts to undertake a fresh review of legal questions.

    Under the Chevron doctrine, he observed, even if all nine Supreme Court justices agree that the fishing vessels’ interpretation of federal fishing law is better than the NMFS’s interpretation, they would still be required to defer to the agency’s interpretation as long as it was reasonable. Such a result, Martinez concluded, is “not consistent with the rule of law.”

  • U.S. Top Court May Tame ‘Chevron Doctrine’

    U.S. Top Court May Tame ‘Chevron Doctrine’

    Photo: maurice norbert

    The U.S. Supreme Court may overturn a legal doctrine that according to some vapor industry advocates has allowed the Food and Drug Administration to reach beyond its legal authority, reports Reuters, citing legal scholars.

    Known as Chevron deference, the doctrine calls for judges to defer to federal agency interpretations of U.S. laws that are deemed to be ambiguous. This doctrine, among the most important principles in administrative law, arose from a 1984 Supreme Court ruling involving oil company Chevron.

    It is opposed by conservatives and business interests but supported by liberals who favor robust corporate regulation. Vaping activists contend that the Chevron doctrine has, among other things, enabled the FDA to essentially ban all nontobacco-flavored e-cigarettes.

    The U.S. Chamber of Commerce, which represents more than 300,000 businesses, has argued that Chevron deference has let Congress “outsource core policy decisions (particularly controversial ones) to agencies through broadly worded statutes.” That has given the agencies, it added, “free rein to enact their own new regulatory requirements through sweeping rulemakings or after-the-fact enforcement actions.”

    Many legal scholars expect the Supreme Court, which has a 6-3 conservative majority, to scale back or overturn the Chevron doctrine in a case in which fishing companies are seeking to avoid bearing costs associated with a government-run program to monitor for overfishing of herring off New England’s coast. The suit is part of a broader conservative project to strip away regulatory power from federal agencies.

    The justices heard arguments in the case on Jan. 17 and are expected to rule on the case by the end of June.

  • Court Refuses to Hear Health Label Challenge

    Court Refuses to Hear Health Label Challenge

    Photo: William A. Morgan

    The U.S. Court of Appeals for the 5th Circuit has refused to hear the tobacco industry’s challenge to graphic health warnings required by a 2020 Food and Drug Administration rule.

    In March, a three-judge panel of the same court ruled that the federal requirement for cigarette packs and advertising, which includes graphic images of the effects of smoking, including images of smoke-damaged lungs and blackened feet, does not violate the First Amendment of the Constitution, reports AP News.

    The March ruling affirmed that the FDA’s graphic cigarette warnings are both scientifically and legally sound. Proponents say these graphic warnings are critically needed as the current text-only warnings have become stale and unnoticed since they were last updated in 1984.

    The three-judge panel ruling overturned a lower court order from a Texas federal district court, which ruled that the requirements violate the First Amendment.

    Congress first mandated the graphic health warnings as part of the 2009 Family Smoking Prevention and Tobacco Control Act, which required graphic warnings covering the top half of the front and back of cigarette packs and 20 percent of cigarette advertisements.

    Anti-smoking activists welcomed the appeals court’s refusal to hear the industry’s challenge.

    “Because of the tobacco industry’s repeated legal challenges, the U.S. currently ranks last in the world in the size of its cigarette warnings and has fallen behind the rest of the world in implementing graphic warnings, which are now required by 138 countries and territories,” said Yolonda C. Richardson, president and CEO of the Campaign for Tobacco-Free Kids, in a statement.

    “It is time for the U.S. to catch up with the rest of the world in implementing this best-practice policy to reduce tobacco use and save lives.”

  • Panama Vape Ban Ruled Unconstitutional

    Panama Vape Ban Ruled Unconstitutional

    The Supreme Court of Justice in Panama has ruled unanimously that Panama’s ban on the sale of all vaping products is unconstitutional.

    According to several media reports, the ruling, announced last week, was in response to a lawsuit brought by the Asociación por la Reducción de Daños del Tabaquismo de Panamá (ARDT Panama), a vaping consumer advocacy group.

    The court found that Law 315 violated parliamentary procedures spelled out in Article 170 of the Panamanian constitution, according to Panama America.

    Law 315 prohibited the sale and import of all vaping and heated tobacco products, with or without nicotine. It also banned online sales, prohibited vaping in any place where smoking is not allowed, and gave customs authorities the right to inspect, detain, and seize shipments into the Central American country.

    The law passed the National Assembly in 2021, and was given assent by Panamanian President Laurentino Cortizo nearly a year later, on June 30, 2022. Panama had previously prohibited vape sales under a 2014 health ministry decree.

    The ARDT Panama lawsuit challenged the vaping ban on the basis that it violated the constitutional right to health (depriving people who smoke of a lower-risk substitute). Also, it alleged that the National Assembly violated technical parliamentary rules in passing the law.

    According to El Capital Financiero, the legal challenge was also supported by the Association of Smokers and Families for a Smoke-Free Panama and the Medicinal Cannabis Association of Panama.

    It’s unclear if the high court also weighed in on the health-based challenge.

  • Outdoor Smoking Bans Constitutional

    Outdoor Smoking Bans Constitutional

    Photo: J. studio

    South Korea’s law designating public facilities, including crowded outdoor plazas, as nonsmoking areas is constitutional, according to the Constitutional Court.

    In an April 25 ruling, reported by the Korea JoongAng Daily, the court held that the National Health Promotion Act, which requires all public facilities, including outdoor spaces, to be designated as nonsmoking areas, does not violate the Constitution.

    Article 9 of the National Health Promotion Act designates public facilities that are 1,000 square meters or more as nonsmoking areas.

    The law was challenged after a smoker fined for lighting up outside of the Bexco convention center in Busan filed a legal case arguing that it was excessive to designate such open areas as nonsmoking areas.

    The case eventually made its way to the Constitutional Court, which held that even public outdoor areas can’t be considered completely free from the risk of secondhand smoke, noting that it is difficult to completely block cigarette smoke even if there are separate nonsmoking and smoking areas.

    The court noted that the need to protect people who do not want to breathe in secondhand smoke is greater than the need to guarantee smokers’ freedom to smoke.

  • NCLA Weighs in on Cigar Rules Litigation

    NCLA Weighs in on Cigar Rules Litigation

    Photo: Alfazet Chronicles

    The New Civil Liberties Alliance (NCLA) has filed an amicus curiae brief in Cigar Association of America v. FDA, urging the U.S. Court of Appeals for the District of Columbia Circuit to reject the “remand without vacatur” legal doctrine. This practice allows administrative agencies to continue enforcing rules that the court has just declared unlawful.

    In August 2023, the U.S. District Court for the District of Columbia concluded that the U.S. Food and Drug Administration’s final deeming rule regulating tobacco products was “arbitrary and capricious” with respect to premium cigars because the FDA failed to account for evidence regarding the potentially differential health effects between premium cigars and other tobacco products.

    The court then set the rule aside to the extent that it addresses premium cigars. The FDA now asks the D.C. Circuit to either reverse the district court’s ruling or to at least allow it to continue enforcing the remaining unlawful rule under the “remand without vacatur” doctrine while it considers its options.

    Without taking a position on whether the FDA’s conduct was arbitrary and capricious, the NCLA argues that the Administrative Procedure Act requires courts to set aside unlawfully promulgated rules completely. According to the group, this duty necessarily follows from basic principles underlying both the rule of law and the U.S. constitution.