TobaccoReporter logo

Tag: lawsuit

  • Altria Sues FDA Over Product Review System 

    Altria Sues FDA Over Product Review System 

    Altria announced that it has filed a lawsuit against the U.S. FDA in federal court, seeking to force the agency to overhaul its tobacco product review system, which the company says has become a major barrier to growth in the U.S. market. Altria argues that lengthy review delays, including applications remaining pending for years, disadvantage compliant manufacturers while unauthorized products continue to gain market share. 

    The lawsuit is the latest industry challenge to the FDA’s premarket review regime, which requires new tobacco products to demonstrate a net public health benefit before sale. Altria says the agency has failed to meet the statutory 180-day review deadline and argues that recent FDA changes—including a fast-track pathway for nicotine pouches—still have not resolved the backlog. 

  • Ohio Weighs Authority to Enforce Illegal Vape Sales

    Ohio Weighs Authority to Enforce Illegal Vape Sales

    The Ohio Supreme Court heard arguments over whether the state can use its consumer protection laws to take action against retailers selling unauthorized flavored e-cigarettes, a case that could define the extent of state authority alongside federal tobacco regulation. The lawsuits, originally filed in 2024 against several Ohio tobacco retailers, allege the stores sold flavored vaping products that lacked U.S. FDA marketing authorization.

    Retailers argued that enforcement of federal tobacco marketing laws rests exclusively with the FDA, while Ohio officials contended the state has the authority to protect consumers from illegal product sales. The case comes as Ohio also awaits a separate Supreme Court ruling on whether cities can enforce their own flavored tobacco restrictions after the state enacted a law preempting local regulations.

  • RJR Seeks to Overturn $34.5M Verdict

    RJR Seeks to Overturn $34.5M Verdict

    R.J. Reynolds Tobacco Co. asked Florida’s Third District Court of Appeal to overturn a $34.5 million wrongful death verdict awarded to the widow of a smoker who died at age 38, arguing the plaintiff failed to prove the smoker relied on any fraudulent statements by the company regarding the health risks of cigarettes. Reynolds contends Florida Supreme Court precedent requires Engle-progeny plaintiffs pursuing fraud-based claims to demonstrate reliance on specific misleading statements, and that the evidence presented at trial did not meet that standard.

    The appeal is the latest in a series of post-Engle tobacco cases in Florida, where cigarette manufacturers continue to challenge large jury awards on issues including fraud, jury instructions, and comparative fault. Recent appellate decisions have shown Florida courts closely scrutinizing whether trial courts properly instructed juries and whether plaintiffs satisfied the evidentiary requirements for fraudulent concealment claims, making the outcome of the appeal potentially significant for future Engle litigation.

  • Judge Signals Uphill Battle for Vapes Challenge PA Registry Law

    Judge Signals Uphill Battle for Vapes Challenge PA Registry Law

    A federal judge indicated that vape companies challenging Pennsylvania’s new e-cigarette registry law will need to distinguish their case from recent appellate rulings that largely upheld similar laws in North Carolina and Iowa. During proceedings, the judge directed the plaintiffs to address decisions by the Fourth and Eighth U.S. Circuit Courts of Appeals, both of which rejected key arguments that state registry laws tied to the FDA’s premarket authorization process are preempted by federal law.

    Pennsylvania’s law, enacted in 2025, establishes a directory of manufacturers whose products may be legally sold in the state, effectively limiting sales to products meeting specified federal regulatory criteria. Retailers challenging the measure argue it improperly enforces the federal Tobacco Control Act, conflicts with the FDA’s enforcement discretion, and would force the removal of millions of dollars in inventory from store shelves. Similar “PMTA registry” laws have been adopted in more than a dozen states as lawmakers seek to curb sales of unauthorized vaping products.

    The court’s comments suggest Pennsylvania’s case could hinge on whether the plaintiffs can identify meaningful legal distinctions from the North Carolina and Iowa precedents.

  • Decision Nears in Brazil’s Tobacco Health-Cost Lawsuit

    Decision Nears in Brazil’s Tobacco Health-Cost Lawsuit

    A landmark lawsuit filed by Brazil’s Office of the Attorney General in 2019 seeking to recover public healthcare costs linked to smoking has reached the decision stage. All legal submissions have been completed, including an opinion from the Federal Public Prosecutor’s Office supporting the government’s claims. The Federal Court in Porto Alegre will now decide whether the country’s largest cigarette manufacturers are liable for health damages associated with the marketing and sale of their products.

    The case targets BAT Brazil and Philip Morris Brazil, and their parent companies, British American Tobacco and Philip Morris International, seeking compensation for tobacco-related healthcare expenditures. The lawsuit estimates that smoking causes about 177,000 deaths annually in Brazil and R$75 billion ($15 billion) in healthcare costs.

  • Altria, Juul Ask 9th Circ. To Overturn Antitrust Classes

    Altria, Juul Ask 9th Circ. To Overturn Antitrust Classes

    Altria and Juul Labs are asking the U.S. Court of Appeals for the Ninth Circuit to overturn a lower court’s decision certifying nationwide antitrust classes in litigation challenging Altria’s former investment in Juul. According to Law 360, the companies are arguing that the certified classes improperly combine a wide range of purchasers with differing legal claims under the laws of multiple states, making class treatment inappropriate.

    The underlying lawsuit alleges that Altria’s 2018 acquisition of a 35% stake in Juul reduced competition in the U.S. e-cigarette market after Altria withdrew its own competing vapor products. Plaintiffs claim the transaction allowed Juul to maintain higher prices and limited consumer choice. Altria and Juul deny the allegations and contend the district court erred by certifying classes that they say contain materially different groups of purchasers with varying legal and factual issues.

  • Minnesota AG Sues Local Company for Selling Flavored Vapes

    Minnesota AG Sues Local Company for Selling Flavored Vapes

    Minnesota AG Keith Ellison filed a lawsuit against local e-cigarette manufacturer Maduro Distributors, alleging the company sold banned flavored vape products under its The Loon brand that were marketed in ways appealing to youth. The complaint, filed in Ramsey County District Court, accuses the Fridley-based company of selling products with flavors including cotton candy and blue razz slushy, using “kid-friendly characters” in promotions, and falsely representing some products as FDA-approved.

    The Loon sells disposable and refillable vapes as well as nicotine pouches and previously received an FDA warning letter for marketing unauthorized products, according to The Minnesota Star Tribune. Maduro said it had changed flavor names before Minnesota’s 2024 ban took effect and removed the FDA approval claim from a third-party website, arguing it had cooperated with state officials.

  • Public Health Groups Sueing FDA Over New Vape, Pouch Stance

    Public Health Groups Sueing FDA Over New Vape, Pouch Stance

    A coalition of public health organizations, including the Campaign for Tobacco-Free Kids, American Academy of Pediatrics, American Heart Association, and American Lung Association, filed a federal lawsuit yesterday (July 14) challenging the U.S. Food and Drug Administration’s May 2026 enforcement guidance for e-cigarettes and nicotine pouches. The plaintiffs argue the policy unlawfully allows unauthorized products to remain on the market without the premarket scientific review required under the Tobacco Control Act, creating an enforcement safe-harbor for products that FDA has previously identified as posing significant youth appeal.

    Filed in the U.S. District Court for the District of Maryland, the lawsuit seeks to overturn the guidance, alleging it violates both the Tobacco Control Act and the Administrative Procedure Act, and could have significant implications for manufacturers and retailers by determining whether products with pending marketing applications can continue to be sold while awaiting FDA review.

  • FDA Faces $10M Lawsuit from Cigar Companies Over User Fees

    FDA Faces $10M Lawsuit from Cigar Companies Over User Fees

    Nine premium cigar manufacturers filed a lawsuit in the U.S. Court of Federal Claims seeking at least $10 million plus interest in refunds of FDA user fees paid between 2016 and 2023. The lawsuit follows the cigar industry’s victory in a separate legal challenge that resulted in premium cigars being exempted from FDA regulation, with the companies arguing they should not have been required to pay user fees on products the agency ultimately lacked authority to regulate.

    Arturo Fuente, Ashton, CLE Cigar, J.C. Newman, Oliva, La Flor Dominicana, My Father Cigars, Padrón, and Rocky Patel contend they paid the fees despite premium cigars being excluded from most FDA requirements and are now seeking reimbursement after the FDA stopped collecting user fees on premium cigars following a key 2023 court ruling. Court filings in the earlier litigation suggested the government could face more than $100 million in past user fee refunds. The case has been assigned to Judge Edward H. Meyers, with the plaintiffs represented by Morgan Lewis, including attorney Michael Edney, who led much of the industry’s successful challenge to the FDA’s premium cigar regulations.

  • BAT’s Case for Violating North Korean Sanctions Dropped

    BAT’s Case for Violating North Korean Sanctions Dropped

    A U.S. federal judge dismissed the government’s criminal case against British American Tobacco after the company fulfilled the terms of a three-year deferred prosecution agreement related to sanctions violations involving North Korea. The U.S. Department of Justice said BAT complied fully with the 2023 agreement, including strengthening compliance systems and paying approximately $630 million in penalties, one of the largest sanctions-related fines tied to North Korea.

    The case stemmed from allegations that BAT continued supplying tobacco products to North Korea between 2007 and 2017 through a third-party entity after publicly exiting the market. With the dismissal granted by the court, the matter concludes following the company’s settlement and compliance measures.