Category: Litigation

  • Oregon Court Strikes Down Vape Packaging Law

    Oregon Court Strikes Down Vape Packaging Law

    Image: Alexander Berdyugin

    The Oregon Court of Appeals on Oct. 16 struck down a law restricting the packaging of vape and cannabis products on the grounds that the legislation unconstitutionally restricts free speech, reports Keller & Heckman.

    The contested law prohibited an “inhalant delivery system” from being packaged “in a manner that is attractive to minors.” Subsequently, the Oregon Health Authority banned the use of cartoons, celebrities and other representations that are likely to appeal to minors.

    It also restricted descriptive words for flavors that are likely to appeal to minors, such as tart, tangy or sweet. In addition to a comprehensive list of items explicitly prohibited from packaging, the rule includes a general catch-all restriction to include any presentation, shape, graphic, coloring or writing that is likely to appeal to minors.

    Plaintiffs Paul Bates and No Moke Daddy argued that the packaging restrictions were overly broad and unconstitutionally vague and infringed on their right to free speech by prohibiting truthful, non-misleading communication.

    the Oregon Court of Appeals reversed a lower court’s dismissal of the challenge, noting that the law violates free speech as outlined in the Oregon Constitution.

    The Court of Appeals explained that selling products is a form of communicative behavior that may involve protected speech. The court stated that the law restricting “attractive” packaging is reasonably interpreted to refer to the communicative aspects of the packaging and not its functionality. Thus, the packaging restrictions are a direct restriction on expressive speech.

  • Tobacco Industry Nears Settlement of Litigation

    Tobacco Industry Nears Settlement of Litigation

    Image: ink drop

    Canada’s three leading cigarette manufacturers will pay CAD32.5 billion ($23.6 billion) to settle a long-running lawsuit as part of a court-appointed mediator’s proposed plan, Philip Morris International announced on Oct. 18.

    In 2015, a Quebec court award damages to some 100,000 smokers and ex-smokers who alleged the companies failed to warn consumers about the health risks of smoking, which they had known about since the 1950s.

    The verdict was upheld in 2019, forcing the Canadian subsidiaries of PMI, BAT and Japan Tobacco International to seek bankruptcy protection.

    The subsidiaries have been under a court-supervised mediation process negotiating a possible settlement since then.

    The allocation of the aggregate settlement amount between the tobacco giants remains unresolved, according to Philip Morris.

    “Although important issues with the plan remain to be resolved, we are hopeful that this legal process will soon conclude, allowing RBH [Rothmans, Benson & Hedges] and its stakeholders to focus on the future,” said PMI CEO Jacek Olczak.

    “Today marks an important step towards a potential settlement,” said Eric Gagnon, vice president, corporate and regulatory affairs for BAT’s Imperial Tobacco Canada subsidiary in a statement. “The plan resolves all Canadian tobacco litigation and provides a full and comprehensive release to Imperial, BAT and all related entities for all tobacco claims.”

    The Lung Health Foundation (LHF), too, welcomed the prospect of a settlement. “This is a meaningful first step in acknowledging decades of harm,” noted LHF President and CEO Jessica Buckley in a statement. “But financial restitution can’t make up for the loss of life. It can’t make up for the experiences of Canadians who have suffered through lung cancer and COPD.”

    Buckley called for the funds to be reinvested into vaping and smoking prevention and cessation support, mental health and addiction initiatives, and improved access to screening and care for conditions like lung cancer and COPD.”

  • Industry Group Files Amicus Brief in Triton Case

    Industry Group Files Amicus Brief in Triton Case

    This week, the Coalition of Manufacturers of Smoking Alternatives (CMSA), a trade coalition that represents a diverse array of members who manufacture and distribute smoking harm reduction products, filed an amicus curiae brief before the Supreme Court of the United States supporting White Lion Investments, dba as Triton Distribution, in its case against the U.S. Food and Drug Administration.

    In its brief, CMSA argues that FDA violated the Family Smoking Prevention and Tobacco Control Act (TCA) in its wholesale rejection of applications for flavored vaping products by applying a surprise and improperly adopted standard and foregoing the required notice-and-comment process. The brief emphasizes that the U.S. Congress specifically requires the FDA to undergo a transparent rulemaking process before imposing any restriction that amounts to a “tobacco product” standard.

    “Importantly, this process tasks FDA with considering the broader public health effects of any such standard, ‘such as creating demand for and increasing the use of unregulated black-market products,’ or other harmful consequences,” the CMSA states. “In its efforts to unilaterally reject flavored vapor product applications based on a new and heightened standard, FDA unlawfully sidestepped this critical regulatory check and operated outside the bounds of its authority.”

    The CMSA states that the FDA circumvented the very procedures Congress imposed to check the arbitrary or unreasonable exercise of such delegated power, and causes real harms as the FDA “misleads and whipsaws” manufacturers seeking to provide a robust set of options for consumers seeking to quit smoking,” the CMSA wrote in its brief. Further adding that “the long delays in FDA’s review of the many PMTAs (premarket tobacco product applications) it has received, coupled with the moving goal posts imposed via the review process, creates a level of uncertainty that severely deters investment and innovation in new products with harm-reduction potential.”

    Earlier this week, 13 members of Congress, including U.S. Senator Roger Marshall and U.S. Representative Andy Harris, filed an amicus brief supporting the position of Triton Distribution and CMSA. In their brief, the members of Congress write, “There is a clear lack of authority for such a ban. Congress has specifically prohibited the FDA from banning products. Despite this, the FDA imposed a categorical prohibition.”

    Also, the Global Action to End Smoking wrote in its amicus brief to SCOTUS that the FDA strayed from a “sensible, science-based harm-reduction approach, adopting an all-or-nothing stance that exalts outright cessation and all but ignores the harm-reduction strategy that Congress mandated…. [ignoring the] overwhelming scientific evidence that e-cigarettes containing flavor additives have an important role to play in moving adult smokers down the continuum of risk.”

    SCOTUS announced Dec. 2, 2024 as the date for the U.S. Food and Drug Administration v. Wages and White Lion Investments, LLC, d/b/a Triton Distribution hearing.

  • Taxpayer Group Files Amicus Brief

    Taxpayer Group Files Amicus Brief

    Image: hafakot

    The Taxpayers Protection Alliance (TPA) submitted an amicus curiae brief to the U.S. Supreme Court in support of the Wages and White Lion Investments case, challenging the Food and Drug Administration’s regulation of e-cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA). The TPA argues that the FDA’s actions have been arbitrary, capricious and detrimental to public health.

    The brief contends that the TCA’s standard for determining what is “appropriate for the protection of the public health” is unconstitutionally vague, providing insufficient guidance to regulated entities and delegating excessive authority to the FDA. This vagueness has led to unpredictable enforcement, adversely affecting both taxpayers and adults who smoke and are seeking safer alternatives to conventional cigarettes.

    Furthermore, the TPA criticizes the FDA for failing to recognize the significant benefits of e-cigarettes as a smoking cessation tool, as acknowledged by leading health organizations such as Public Health England. According to the TPA, the TCA is clear on the need for the FDA to consider the impact of e-cigarettes on smoking cessation, yet the agency has abjectly failed to undertake this analysis. The TPA highlights the FDA’s stringent regulatory approach and high denial rates for new e-cigarette products, which the group says stifle market diversity and limit consumer choice, particularly harming adults who smoke and who might benefit from less harmful alternatives.

    The TPA also notes the FDA’s disregard for market realities and consumer preferences, particularly the benefits of open-system e-cigarettes that allow for customization and have been shown to be more effective for quitting smoking.

    The TPA urges the Supreme Court to uphold the 5th Circuit’s decision, affirming that the FDA’s regulatory approach under the TCA is arbitrary and capricious and violates due process. The TPA calls for a regulatory framework that adequately considers the benefits of e-cigarettes and gives regulated parties fair notice of how their products will be evaluated.

  • Imperial Sued Over Zone Trademark

    Imperial Sued Over Zone Trademark

    Photo: Olivier Le Moal

    2ONE Labs and Performance Plus Marketing have filed both a trademark infringement lawsuit and a preliminary injunction against Imperial Brand subsidiaries Zone nicotine pouch trademark.

    The suit alleges that Imperial’s Zone products willfully infringe the 2ONE nicotine pouch brand. In addition to seeking an award for damages, 2ONE is also seeking cancellation of Imperial’s Zone mark.

    According to the plaintiffs, the 2ONE brand has been continuously marketed and sold to adult consumers through thousands of U.S. convenience chain and independent grocery and smoke shop stores for the last five years.

    The suit alleges Imperial Brands made false statements by claiming a significantly earlier use of their mark in commerce than had occurred. The suit further alleges the false statements allowed Zone to be granted a fraudulent mark.

    “We have experienced numerous instances of consumer confusion since Imperial launched its Zone brand in 2024 and we intend to vigorously fight this type of blatant infringement, no matter how big the corporate bully,” said 2ONE Labs founder and partner Vincent Schuman in a statement.

    The case is before the U.S. District Court for the Central District of California.

  • PMI Seeks Dismissal of Zyn Lawsuit

    PMI Seeks Dismissal of Zyn Lawsuit

    Photo: PMI

    Philip Morris International and its Swedish Match North America subsidiary have asked a U.S. federal judge in Connecticut to dismiss a lawsuit claiming they falsely marketed nicotine pouches as safe and targeted adolescents, according to the USA Herald.

    In July, Florida resident Ethan Norris filed a court case claiming that Philip Morris and Swedish Match marketed Zyn nicotine pouches to adolescents by promoting them as a healthy alternative to tobacco. The lawsuit suggests the companies misled consumers by highlighting the pouches’ “food-grade flavorings” and “natural additives.” Norris further alleges that the companies employed social media influencers to target younger consumers.

    In its motion filed Sept. 24, PMI argues that the lawsuit is preempted by federal law as the labeling of its Zyn nicotine pouches is approved by the U.S. Food and Drug Administration.

    In a separate motion, Swedish Match North America made a similar argument and added that because Norris is a Florida resident who purchased and used the products in Florida, the case has no direct connection to Connecticut.

    PMI urged the court to dismiss the lawsuit or require Norris to provide a more specific complaint.

  • Supreme Court Urged to Overturn Triton Ruling

    Supreme Court Urged to Overturn Triton Ruling

    Image: hafakot

    A group of congressional lawmakers urged the Supreme Court of the United States to overturn a lower court ruling that blocked federal regulators from rejecting certain e-cigarette products, reports, reports Courthouse News.

    They argued that the move could hinder government efforts to keep illegal vaping products off store shelves.

    The Supreme Court is set to tackle the FDA’s power to regulate vape sales altogether this term, in FDA v. Wages and White Lion Investments, LLC. The forthcoming case challenges a January ruling from the Fifth Circuit, which found that the FDA overstepped its authority when it rejected marketing applications from two manufacturers looking to sell flavored liquids for e-cigarettes.

    In an amicus brief filed with the Supreme Court Sept. 2, the group of legislators—led by Senate Majority Whip Dick Durbin, Oregon Senator Jeff Merkley and New Jersey Representative Frank Pallone—argued that the FDA’s decision to reject these marketing applications was “carefully” reasoned.

    “Guided by Congress’ chief directive—to deny such authorization unless a product under review would be ‘appropriate for the protection of the public health’ … FDA has been appropriately mindful of children and teenagers, the most vulnerable pool of nontobacco users,” the lawmakers wrote.

    They contended that judicial oversight of the agency’s authority had been “generally consistent” until the Fifth Circuit’s ruling and had not impeded it from accomplishing its regulatory responsibilities.

    The legislatures told the high court that allowing the lower court’s ruling to stand would not only force the FDA to waste resources reevaluating the rejected marketing applications but could also invite other manufacturers previously rejected by the FDA to relitigate their own marketing requests.

    “While those applications are once again pending FDA review, the tobacco products they cover would continue to be sold, despite the law’s clear pre-market authorization regime,” the lawmakers said. That provides a “powerful financial incentive” for manufacturers to reapply for FDA approval, even if they know the agency will ultimately deny their applications.

    A group of health organizations has filed a separate amicus brief, making similar arguments, in the case.

  • Switzerland to Tighten Tobacco Rules

    Switzerland to Tighten Tobacco Rules

    Photo: Heorshe

    Switzerland will strengthen its restriction on tobacco advertising and nicotine product notification requirements effective Oct. 1, reports Swissinfo.

    The new rules include a nationwide ban on sales to people under the age of 18 and stricter advertising restrictions, for example on posters, on public transport, in cinemas, in publicly accessible buildings such as train stations and airports and on sports grounds.

    Existing smoking bans will now also apply to heated products and electronic cigarettes.

    Sponsorship of events with an international character or for an underage audience is no longer permitted.

    Cigarette manufacturers will also be required to print pictorial warnings on tobacco packaging

  • Top Court Urged to Review Graphic Labels

    Top Court Urged to Review Graphic Labels

    Images: FDA

    Cigarette manufacturers have asked the U.S. Supreme Court to review a lower court ruling affirming a Food and Drug Administration rule mandating graphic health warnings on cigarette packaging and advertisements, reports Law360.

    In March, the U.S. 5th Circuit Court of Appeals rejected industry arguments that FDA’s plans violates companies’ free speech rights and that the requirement overpowers branding and messaging on packages and advertisements due to the size of the images and lettering.

    Earlier, a district court had found that the new labels were provocative, value-laden messages that burdened tobacco companies’ free speech, but the Fifth Circuit disagreed, concluding that the warnings are undisputedly factual and the images “are no different from those a medical student might see in a textbook.”

    On Aug. 19, R.J. Reynolds Tobacco Co., ITG Brands and other tobacco companies urged the nation’s top court to review the appeals court’s decision, arguing that the proposed warnings are “massive, provocative and misleading.”

    They also noted that the Fifth Circuit’s finding are at odds with other court rulings that found “far smaller warnings were unduly burdensome.”

    “The Fifth Circuit’s opinion, if permitted to stand, would authorize the government to require similar massive and grotesque admonitions on virtually any disfavored consumer product—from fast food, candy and wine to plastic straws, firearms and gas stoves,” the petition said.

    The FDA released the final rule in March 2020 requiring new graphic warnings for cigarettes that feature some of the lesser-known but still serious health risks of smoking, such as diabetes, on the top half of the front and back of cigarette packages and at least 20 percent of the area on the top of cigarette advertisements.

  • U.S. Court Reverses ‘Elf’ Trademark Suit

    U.S. Court Reverses ‘Elf’ Trademark Suit

    Image: Olivier Le Moal

    A ban on a Chinese company selling “Elfbar” vapes can’t stand because a district court failed to analyze whether the rightsholder’s use of “Elf” on an illegal product negated its trademark rights, the Federal Circuit court stated.

    “Elfbar” seller Shenzhen Weiboli Technology Co. Ltd. argued the “unlawful use doctrine” precluded a preliminary injunction as plaintiff VPR Brands LP failed to clear its “new tobacco product” with the government as required under federal law, according to Bloomberg.

    The U.S. Court of Appeals stated in its opinion that the district court wrongly dismissed the defense without considering the propriety of the doctrine, a proper standard or Weiboli’s evidence.

    The Federal Circuit ruled that the district judge who ordered the injunction “misread” precedent and relied on a “deficient” legal analysis.

    A U.S. federal judge on Feb. 23 ordered Shenzhen Weiboli Technology to stop marketing its Elfbar e-cigarettes in the U.S., finding that VPR Brands, which makes and sells Elf brand vapes, is likely to succeed on its claims that the Elfbar vapes infringe its trademark.

    According to U.S. District Judge Aileen M. Cannon, VPR has shown there is a likelihood of confusion and the company stands to suffer harm if its Chinese competitor is allowed to keep selling the Elfbar vapes.

    In November, VPR asked for an injunction blocking Shenzhen Weiboli from continuing to use the Elfbar mark, arguing the alleged infringement is costing VPR about $100 million because of the effect on future sales.

    VPR claims Shenzhen Weiboli is not only infringing VPR’s Elf trademark but also its patent for its e-cigarette device.