Tobacco Lawsuits: USA

Posted September 7, 2026

September 2026: U.S. Cities Sue Tobacco Companies over Cigarette Litter

A growing wave of municipal legal actions across the United States is seeking to hold major tobacco companies financially responsible for the toxic environmental toll of cigarette butts. Local governments are asserting the “polluter pays” principle, demanding that manufacturers cover the immense municipal costs associated with cleaning up millions of plastic cigarette filters from public streets, waterways, and drainage systems.

The legal trend began in 2022, when Baltimore, Maryland, initiated the first lawsuit of this kind against major tobacco manufacturers. The city argued that cigarette butts – composed primarily of non-biodegradable cellulose acetate plastic – constitute a massive portion of urban litter and force municipalities to spend substantial public funds on cleanup and stormwater maintenance. Building momentum on Baltimore’s precedent, Sacramento County and the city of Fresno, California, committed to this legal path in 2026, filing suit against tobacco companies for the financial burden imposed on local public works.

Lately, Denver, Colorado, has also launched legal proceedings against several major cigarette manufacturers. Denver officials highlighted that the persistent pollution created by plastic filters inflicts significant, recurring costs on local communities. Municipalities point out that filters do not decompose naturally; instead, they break down into microplastics and leach toxic chemicals – such as heavy metals and nicotine – into local ecosystems, requiring continuous street sweeping and water treatment efforts funded by local tax dollars.

Across the Atlantic, European nations are grappling with the same issue through regulatory and legal frameworks. The debate over tobacco industry liability has reached a high point in the Netherlands. Dutch municipalities, regional water authorities, and waste management organizations (such as the NVRD) have publicly called on tobacco manufacturers to pay 100% of the country’s estimated €36 million annual cigarette butt cleanup bill. Under current European Union Extended Producer Responsibility (EPR) guidelines, tobacco firms pay a portion of cleanup costs based on domestic sales. However, due to cross-border purchases, Dutch officials report that manufacturers currently cover only around half the cleanup costs, leaving local taxpayers to foot the remaining bill. In response, Dutch local councils and water boards are pushing to close these legal loopholes and enforce strict “polluter pays” accountability. Furthermore, the Dutch National Institute for Public Health and the Environment (RIVM) has evaluated potential bans on plastic cigarette filters altogether – a measure supported by municipal authorities to tackle the pollution at its source.

As municipal lawsuits mount in the United States and legislative pressure builds across Europe, the tobacco industry faces an unprecedented reckoning over the life cycle and environmental impact of its products.

September 2026: Altria Sues FDA, Seeking Overhaul of U.S. Tobacco Product Review System

Altria has sued the U.S. Food and Drug Administration (FDA) in federal court in Texas, seeking to force the agency to overhaul its tobacco product review process, which the company says has created lengthy delays and put compliant manufacturers at a disadvantage against unauthorized competitors¹.

Under U.S. law, new tobacco products must receive FDA authorization before they can be legally marketed. Altria argues that the agency has failed to meet the statutory requirement to decide applications within 180 days, with some products remaining under review for more than six years. The company specifically cited its On! nicotine pouch applications, including products submitted through the FDA’s recently established fast-track pathway, which remained pending despite the agency’s target of reaching decisions by December 2025.

Altria said the regulatory backlog has allowed foreign manufacturers selling unauthorized vapes and nicotine products to gain market share while companies that comply with FDA requirements are prevented from launching products in a timely manner. The lawsuit, filed by two Altria subsidiaries together with the Texas Food and Fuel Association, asks the court to set aside the current review system and require the FDA to establish a new approach.

The lawsuit represents the latest escalation in the tobacco industry’s efforts to challenge the FDA’s handling of reduced-risk products. Tobacco companies have pursued litigation and lobbying in recent years, contributing to several regulatory changes under the Trump administration, including FDA marketing authorizations for certain flavored vapes, a fast-track pathway for nicotine pouches and an enforcement-discretion policy covering certain unauthorized products. Altria argues that the agency’s recent reforms further demonstrate the need for a broader restructuring of the review system.

The FDA said it remains committed to facilitating access to less harmful alternatives for adult smokers while protecting young people from nicotine addiction and toxic exposure, and that it would carefully review Altria’s legal challenge.

August 2026: Fifth Circuit Re-Ignites Legal Battle Over FDA’s Flavored Vape Bans

The U.S. Court of Appeals for the Fifth Circuit has ordered the Food and Drug Administration (FDA) to reconsider its regulatory rejections for flavored e-cigarettes, dealing a fresh setback to federal enforcement efforts. In an August 19, 2026 ruling, the appellate court vacated marketing denial orders issued to an e-cigarette distributor, finding that the agency unlawfully enforced an unwritten “comparative efficacy” requirement without first conducting formal public notice-and-comment rulemaking.

The conflict originates from the FDA’s ongoing effort under the 2009 Family Smoking Prevention and Tobacco Control Act to curb youth vaping. When evaluating millions of Premarket Tobacco Product Applications (PMTAs) for fruit-, dessert-, and candy-flavored e-liquids, the FDA issued widespread denials. The agency asserted that flavored products posed inherent risks of attracting young people to nicotine and required distributors to provide scientific proof that their flavored vapes were more effective at helping adults quit smoking than plain tobacco-flavored alternatives.

This heightened standard sparked intense litigation across the country:

– The Appellate Majority: A majority of federal appeals courts – including the Second, Fourth, Seventh, Ninth, and D.C. Circuits – consistently sided with the FDA. They ruled that the agency acted within its statutory mandate to protect public health and could set high scientific benchmarks on a case-by-case basis.

– The Fifth Circuit Rejection: The Fifth Circuit diverged from its sister courts, ruling that the FDA had pulled an unfair “regulatory switcheroo” on vape distributors by shifting its evidentiary requirements after applications were submitted.

To resolve this nationwide circuit split, the U.S. Supreme Court reviewed the dispute and reversed the Fifth Circuit’s initial ruling. The High Court unanimously backed the FDA, holding that the agency did not act arbitrarily because its public guidance consistently warned applicants of the steep evidentiary threshold needed to justify flavored vapes. However, the Supreme Court explicitly left open a procedural question under the Administrative Procedure Act (APA): whether the FDA’s comparative efficacy standard constituted a binding, substantive rule that required a formal notice-and-comment period before implementation.

That unaddressed procedural question laid the foundation for the Fifth Circuit’s latest ruling. Seizing on the open issue, the court concluded that the FDA’s standard functioned as an across-the-board substantive rule rather than mere informal guidance. Because the APA requires federal agencies to allow public notice and input before enacting binding rules, the court instructed the FDA to “rethink” its approach and vacate the distributor’s marketing denials. The ruling re-establishes a sharp division among federal courts, guaranteeing that the legal battle over federal vape regulations will remain ongoing.

August 2026: Fifth Circuit Rules FDA Exceeded Authority with 11 Graphic Cigarette Warnings

A federal appeals court has ruled against the U.S. Food and Drug Administration, holding that the agency overstepped its statutory authority by attempting to mandate 11 graphic health warning labels on cigarette packaging and advertisements. A three-judge panel of the New Orleans-based 5th U.S. Circuit Court of Appeals affirmed a lower court’s preliminary injunction halting the FDA rule. Writing for the unanimous panel, U.S. Circuit Judge emphasized that Congress, through the 2009 Family Smoking Prevention and Tobacco Control Act, explicitly authorized nine specific statutory warnings. “The FDA may require the nine warnings Congress prescribed – no more,” the Judge wrote.

The lawsuit was brought by R.J. Reynolds Tobacco, the U.S. subsidiary of British American Tobacco (BAT), alongside co-plaintiffs ITG Brands and JTI Liggett. The manufacturers challenged the FDA’s 2020 rule, which required color graphic depictions covering 50% of the front and back of cigarette packages and 20% of print advertisements. The agency’s proposed 11 images illustrated health risks including bladder, head, and neck cancers, fatal lung disease, stunted fetal growth, cataracts, and type 2 diabetes.

While the 5th Circuit had previously addressed First Amendment claims in earlier litigation, this ruling focuses on the agency’s statutory bounds under the Administrative Procedure Act, establishing that the FDA cannot unilaterally add to the number of warnings set by Congress. The decision marks the latest setback in the FDA’s decades-long effort to implement graphic health disclaimers on U.S. commercial tobacco products.

August 2026: Altria Asks Appeals Court to Declare ITC Patent Cases Unconstitutional

Altria Group and its vaping subsidiary NJOY Inc. have launched a major constitutional challenge against the U.S. International Trade Commission, asking a federal appeals court to dismantle the administrative agency’s power to judge patent infringement disputes. In filings before the U.S. Court of Appeals for the Fourth Circuit, Altria argues that the ITC’s administrative process for adjudicating Section 337 patent cases violates the U.S. Constitution. The challenge targets both the structure of the agency’s administrative law judges and the tribunal’s overall authority to resolve private intellectual property conflicts.

At the center of Altria’s appeal are two core constitutional arguments. First, the company contends that the ITC’s administrative law judges operate in violation of Article II’s Appointments Clause because they are shielded from presidential oversight by double-layer tenure protections. Second, Altria asserts that resolving private patent rights and issuing import bans belongs exclusively in federal court under Article III, rather than within an administrative executive agency.

The high-stakes legal battle stems from a broader, ongoing patent war between rival e-cigarette manufacturers. Juul Labs previously petitioned the ITC to secure an import exclusion order that would effectively block the sale and distribution of NJOY’s flagship “ACE” vaping devices in the United States.

Rather than waiting for the internal agency trial to run its course, Altria and NJOY mounted a collateral lawsuit in a Virginia federal district court aimed at halting the ITC proceeding entirely. After the district court declined to freeze the agency’s proceedings, Altria appealed to the Fourth Circuit, seeking an emergency injunction to block the administrative tribunal from moving forward.

The lawsuit comes amid a broader wave of corporate challenges against federal regulatory authority, following recent landmark rulings by the U.S. Supreme Court that reined in administrative power. If Altria succeeds in the Fourth Circuit, the decision could undermine the ITC’s Section 337 tribunal – long considered one of the fastest and most influential venues for technology and consumer product companies seeking to block allegedly infringing imports at the border.

August 2026: Federal Appeals Court Upholds FDA Ban on Flavored and Zero-Nicotine Vapes

A federal appeals court has delivered another major setback to the e-cigarette industry, affirming the U.S. Food and Drug Administration’s authority to block the sale of dozens of flavored e-liquids and zero-nicotine vaping products. In a unanimous decision, a three-judge panel for the U.S. Court of Appeals for the Ninth Circuit denied a petition for review brought by an e-liquid manufacturer. The ruling leaves intact the FDA’s Marketing Denial Orders (MDOs) covering dozens of fruit- and candy-flavored products, reinforcing the strict public health standard required for vape makers to remain on store shelves.

Under the Family Smoking Prevention and Tobacco Control Act, any new tobacco product must demonstrate that its market availability is “appropriate for the protection of the public health.” To meet this threshold, manufacturers must prove that the potential benefit to adult smokers – specifically helping them switch completely away from combustible cigarettes – outweighs the known risks of youth initiation and addiction.

The dispute arose after the FDA rejected Premarket Tobacco Product Applications (PMTAs) for dozens of flavored e-liquids submitted by the manufacturer. The regulatory agency concluded that the company failed to provide sufficient scientific evidence, such as randomized controlled trials or long-term observational studies, showing that its flavored offerings provided a unique benefit to adult smokers compared to traditional tobacco flavors.

The vape manufacturer challenged the denial in federal court, raising several legal arguments: (1) Shifting Regulatory Demands: The company argued the FDA acted arbitrarily by requiring comparative scientific studies without giving manufacturers sufficient advance notice; (2) Overlooked Access Controls: The manufacturer claimed the agency ignored its proposed age-verification and marketing restriction plans designed to prevent underage access; (3) Zero-Nicotine Products: The company contended that zero-nicotine e-liquids were improperly grouped into the blanket denial without individual evaluation.

The Ninth Circuit panel rejected each of the company’s claims, siding firmly with the regulator. Writing for the court, the judges held that requiring robust comparative evidence is fully consistent with the FDA’s statutory mandate. Given the high appeal of sweet and fruity flavors among teenagers, the court noted that the agency was well within its rights to demand high-caliber proof that such flavors offer a distinct public health benefit for adult cessation.

Addressing the manufacturer’s proposed youth-access plans, the court ruled that any failure by the FDA to individually evaluate those controls constituted harmless error. Strict marketing rules and age checks alone, the judges noted, cannot substitute for scientific proof that a product actually helps adult smokers switch away from cigarettes. The court also affirmed the FDA’s treatment of zero-nicotine e-liquids, noting that because the company bundled those products within its broader e-cigarette product lines, the agency properly evaluated the submission as a whole.

The ruling represents another significant legal victory for federal regulators as they continue to clamp down on unauthorized flavored vaping products. By upholding the FDA’s evidentiary standards, the Ninth Circuit joins several other federal appeals courts in cementing a high bar for e-cigarette manufacturers seeking regulatory approval. Unless appealed to the U.S. Supreme Court, the decision leaves the manufacturer unable to legally market or distribute the impacted flavored and zero-nicotine e-liquids nationwide.

July 2026: U.S. Appeals Court Revives Class Action Against BAT Over Natural American Spirit Marketing

A U.S. federal appeals court has ruled that British American Tobacco (BAT) must face a proposed class action alleging that the marketing and labeling of Natural American Spirit cigarettes misled consumers into believing the products were safer than other cigarettes. The decision revives claims that had previously been rejected by a lower court and allows the litigation to proceed on behalf of consumers in 12 U.S. states.

The lawsuit challenges the use of descriptors such as “100% Additive-Free,” “Natural” and “Organic,” arguing that these claims led consumers to believe the cigarettes posed lower health risks despite containing the same harmful constituents as conventional cigarettes. The plaintiffs contend they paid premium prices based on these allegedly misleading representations.

In a split decision, the 10th U.S. Circuit Court of Appeals held that the lower court had improperly evaluated the merits of the claims when deciding whether to certify the class. The case will now return to the district court for further proceedings. A BAT spokesperson declined to comment, citing the company’s policy of not discussing ongoing litigation.

July 2026: FDA and Imperial Brands Strike Agreement to Terminate Regulatory Lawsuit

Imperial Brands subsidiary, Fontem US and the U.S. Food and Drug Administration (FDA) have reached a settlement agreement to resolve federal court litigation challenging the agency’s marketing decision on ZONE oral nicotine pouch products. Under the terms of the joint stipulation filed in federal court, the manufacturer has agreed to voluntarily dismiss its lawsuit in exchange for the regulatory body rescinding or staying its administrative denial order to conduct a renewed scientific review of the products.

As part of the settlement, Imperial Brands will drop all active legal claims against the agency in federal court. In return, the FDA will place the company’s Premarket Tobacco Product Applications (PMTAs) back under review and re-examine the submitted scientific, toxicological, and behavioral data. While this re-evaluation is ongoing, the affected nicotine pouch products are expected to remain on the market without facing immediate regulatory enforcement tied to the previous order.

The agreement highlights the continuing friction between manufacturers and the FDA’s Center for Tobacco Products (CTP) regarding evaluation standards for new nicotine product alternatives. Over the past two years, numerous manufacturers of e-vapor and oral nicotine pouch products have turned to federal courts, arguing that the FDA’s application of premarket rules was arbitrary and capricious. Oral nicotine pouches represent one of the fastest-growing categories in the tobacco alternative space, and similar administrative resolutions provide a non-litigious path forward for regulatory re-evaluation.

June 2026: Court Hands FDA Major Victory, Upholding Block on Menthol Vape Marketing

In a significant legal victory for federal tobacco regulators, a U.S. appeals court has upheld the Food and Drug Administration’s (FDA) decision to block the marketing of menthol-flavored e-cigarette products. The U.S. Court of Appeals for the Fifth Circuit ruled against two vape manufacturers, affirming the FDA’s denial of their Premarket Tobacco Product Applications (PMTAs). The court found that the agency acted reasonably when it concluded that the potential benefits of the flavored products – namely helping adult smokers transition away from traditional cigarettes – did not outweigh the documented risks of attracting youth users.

At the heart of the ruling is the regulatory standard that mandates all new tobacco and nicotine products prove they are “appropriate for the protection of public health” before hitting store shelves. The Fifth Circuit’s decision reinforces the FDA’s authority to demand rigorous, robust evidence from manufacturers showing a net public health benefit before flavored vaping products can be legally marketed. The ruling delivers a substantial blow to the flavored vape industry, which has frequently challenged the FDA’s strict PMTA review process in federal court, while handing public health advocates a major win in the ongoing effort to curb youth nicotine addiction.

June 2026: Fifth Circuit Questions FDA’s Flavored Vape Approval Standard

The U.S. Court of Appeals for the Fifth Circuit heard arguments in a closely watched dispute over whether the FDA lawfully required flavored vape manufacturers to prove that their products are more effective than tobacco-flavored alternatives at helping smokers switch away from cigarettes. The cases involve companies whose applications for flavored e-liquids were denied after the FDA concluded they failed to provide sufficient comparative-efficacy evidence.

The hearing is particularly significant because the Fifth Circuit has developed a reputation for taking a more skeptical view of federal agency actions than many other appellate courts. The court has previously ruled against the FDA in several vaping-related cases, finding that the agency acted arbitrarily or failed to provide adequate notice regarding its product review standards, although it has not uniformly sided with the tobacco and nicotine industry.

During oral arguments, several judges appeared receptive to industry claims that the FDA may have imposed the comparative-efficacy requirement without first undertaking the formal notice-and-comment rulemaking process required under the Administrative Procedure Act. Judges questioned whether the requirement effectively amounts to a new tobacco product standard that should have been formally adopted before being applied to applicants.

The FDA countered that the requirement is not a new rule but rather part of its case-by-case evaluation of whether a product is “appropriate for the protection of public health” under the Tobacco Control Act. The agency maintains that applicants were already on notice that strong scientific evidence would be needed to demonstrate that the benefits of flavored products outweigh the risks, particularly given concerns about youth uptake.

The outcome could have major implications for future FDA reviews of flavored vaping products. A ruling in favor of manufacturers could require the agency to formally codify parts of its authorization framework and would represent another high-profile challenge to FDA tobacco regulation in a court that has frequently scrutinized the agency’s approach to vaping products.

June 2026: U.S. Appeals Court Allows Altria–Juul Antitrust Case to Move Forward During Ongoing Appeal

A U.S. federal appeals court has allowed the antitrust class action against Altria and Juul Labs to proceed while the companies pursue an appeal of a class certification order. The underlying case alleges that Altria’s 2018 investment in Juul and related conduct effectively reduced competition in the e-cigarette market by sidelining rival products and consolidating market power. Plaintiffs are seeking damages on behalf of both direct and indirect purchasers of Juul products.

The Ninth Circuit previously granted Altria and Juul permission to appeal the district court’s decision certifying multiple purchaser classes, a key procedural step that allows the case to proceed as a class action. At the same time, the appeals court has now declined to fully halt district court proceedings during the appeal, meaning the litigation can continue in parallel unless further relief is granted.

Altria and Juul have argued that the class certification raises serious legal and jurisdictional issues, while plaintiffs maintain that the alleged coordination between the companies harmed competition and inflated prices. The dispute remains in early appellate and pre-trial stages, with potential exposure estimated in the billions depending on class scope and liability findings.

May 2026: Texas Supreme Court Upholds Tax Treatment of VELO Nicotine Pouches, Case Sent Back for Further Review

The Texas Supreme Court has ruled against British American Tobacco (BAT) subsidiary, RJ Reynolds Vapor Company, in a dispute over state taxation of its VELO nicotine pouch products, clearing the way for further proceedings in a lower court. The case stems from a determination by the Texas Comptroller that VELO pouches should be classified as “tobacco products” under the state’s Cigars and Tobacco Products Tax, making them subject to excise taxation. RJ Reynolds challenged the classification after arguing that its nicotine pouches should be treated more like nicotine-replacement therapies, which are not subject to the same tax regime under Texas law. The company further claimed that taxing VELO while exempting certain cessation-oriented products violates the state’s constitutional requirement for equal and uniform taxation.

While the Texas Supreme Court did not resolve the underlying constitutional question, it sided with the state on the classification issue and sent the case back to a lower court to determine whether the tax treatment creates an unlawful disparity under Texas’s tax framework. The outcome could have broader implications for how modern oral nicotine products are treated compared with traditional tobacco items and cessation aids.

May 2026: U.S. Judge Dismisses BAT North Korea Sanctions Case

A U.S. federal judge has dismissed the criminal case against British American Tobacco (BAT) related to violations of U.S. sanctions on North Korea, closing a major legal case that had been hanging over the company since 2023. The dismissal came after the U.S. Department of Justice confirmed that BAT had fully complied with the terms of a three-year deferred prosecution agreement reached in April 2023. Under that agreement, BAT strengthened its compliance systems and paid roughly $630 million in fines and forfeitures, one of the largest sanctions-related penalties involving North Korea.

The case centered on allegations that BAT continued selling cigarettes to North Korea between 2007 and 2017 through a Singapore-based third-party structure, despite publicly stating it had exited the market. BAT subsidiary BAT Marketing Singapore previously pleaded guilty to conspiracy charges tied to the scheme. U.S. authorities argued the transactions helped generate revenue for North Korea despite extensive international sanctions designed to restrict funding for the country’s weapons and nuclear programs.

U.S. District Judge approved the Justice Department’s request to dismiss the case after the company satisfied the agreement’s conditions. The ruling removes a significant legal overhang for BAT, although the company still faces separate civil litigation linked to its historical North Korea business activities.

March 2026: Imperial Brands To Refile FDA Lawsuit in Washington

Fontem U.S., a subsidiary of Imperial Brands, has withdrawn its lawsuit against the U.S. Food and Drug Administration (FDA) and plans to refile the case in Washington, D.C., after jurisdictional issues arose from the original filing in Texas. The company, which markets ZONE nicotine pouches, initially filed the lawsuit in Texas, alleging that the FDA unlawfully delayed or mishandled regulatory decisions related to its nicotine pouch products. However, the court determined that the case should be heard in the District of Columbia, where many federal regulatory cases are handled. Following this decision, Fontem voluntarily dismissed the Texas case and intends to refile the same claims in Washington, D.C.

The dispute centers on the FDA’s Premarket Tobacco Product Application (PMTA) process, which is required for nicotine products to be placed on the market legally. Companies have increasingly challenged FDA delays and regulatory uncertainty, arguing that slow regulatory decisions create business uncertainty and competitive disadvantages. Importantly, this is a procedural move rather than a change in legal strategy. Fontem is not dropping the case but instead restarting the legal process in the correct jurisdiction, meaning the legal dispute with the FDA over the regulation of new nicotine products is expected to continue.

March 2026: Imperial Brands Challenges FDA’s Refusal-to-File Decision on Nicotine Pouch Applications

Fontem U.S., a subsidiary of Imperial Brands, has filed a federal lawsuit against the U.S. Food and Drug Administration (FDA), contesting the agency’s refusal-to-file (RTF) decision for premarket tobacco product applications (PMTAs) related to its ZONE nicotine pouches. The case was filed in a Texas federal court and also names the Department of Health and Human Services as a defendant.

At the center of the dispute is the FDA’s RTF determination, which prevents an application from advancing to full scientific review. Fontem argues that this action unlawfully blocked its products from being assessed under the statutory public health standard required for market authorization. The company states that its PMTAs, submitted in May 2022, were not reviewed within the legally mandated 180-day timeframe. Instead, the FDA issued an initial RTF letter in December 2025, followed by a revised version in March 2026, maintaining that the applications lacked sufficient information – particularly regarding ingredient data used in bridging analyses.

Fontem’s complaint challenges both the legal basis and the process behind the FDA’s decision. It argues that the Tobacco Control Act does not provide for “refuse-to-file” actions, but instead requires the agency to either approve or deny applications following substantive review. The lawsuit also alleges inconsistent regulatory standards, failure to adequately consider submitted evidence, and procedural shortcomings, including questions about the authority of the official who issued the decision. As relief, Fontem is seeking to have the RTF decision declared unlawful and set aside, along with an injunction to prevent its enforcement while the case proceeds.

The case highlights ongoing tensions between regulators and manufacturers of next-generation nicotine products, particularly in the nicotine pouch category, where companies increasingly argue that regulatory expectations remain unclear and inconsistently applied.

March 2026: U.S. Court Certifies Direct Purchaser Class in Juul–Altria Antitrust Litigation

A U.S. federal court in California has granted class certification to a group of direct purchasers of Juul Labs products in a major antitrust lawsuit targeting Altria Group. The plaintiffs contend that Altria’s $12.8 billion investment in 2018 for a 35% stake in Juul led the company to materially reduce its involvement in the e-cigarette market, allegedly limiting product variety and enabling higher prices by stifling competition. U.S. District Judge found that “common, predominant questions” about antitrust impact and damages justified resolving these claims as a class rather than through individual suits, while still allowing class members the choice to opt out. The certified class covers wholesalers and others who purchased Juul products directly from October 5, 2018, to the present, and the court also approved additional classes for indirect purchasers and resellers under certain state laws.

The litigation at the heart of this decision stems from longstanding legal challenges to Altria’s strategic involvement with Juul and its effects on the closed-system e-cigarette market, including prior scrutiny from the Federal Trade Commission (FTC). The FTC initially challenged the 2018 deal as anticompetitive but dropped its case in 2023 after Altria divested its stake in Juul, even as private plaintiffs continued to press claims under federal and state antitrust statutes. Critics of the certification had argued that differing contracts, pricing terms and individual purchasing arrangements would make class treatment inappropriate; however, the Judge ruled that these differences did not undermine the typicality or adequacy of the named plaintiffs to represent the broader class. The case is part of a broader series of consolidated actions alleging violations of antitrust and competition laws by Juul and Altria, with class certification now advancing a key procedural milestone ahead of anticipated further litigation.

February 2026: Philip Morris USA Sues Reynolds Over Alleged $100 Million Settlement Windfall

Philip Morris USA, a unit of Altria, has sued Reynolds American Inc., a unit of British American Tobacco, alleging unjust enrichment by retaining more than $100 million from a prior legal dispute with ITG Brands LLC, a unit of Imperial Brands, that Philip Morris USA says should have been paid to it. The dispute stems from a previous lawsuit over how the sale of certain tobacco brands affected settlement payments to the state of Florida; Philip Morris USA contends the earlier ruling did not properly account for “profit adjustment” amounts, leaving it on the hook for the nine-figure expense while Reynolds benefited financially. In its complaint, Philip Morris USA argues that Reynolds is “double-dipping” by keeping the settlement windfall, and is seeking recovery of the funds it believes were wrongly retained.

January 2026: Lawsuit Alleges BAT Operations Helped Fund North Korea’s Weapons Programme

A group of U.S. military personnel, civilians and family members filed a civil lawsuit alleging that British American Tobacco (BAT) and related entities indirectly financed terrorism by doing business in North Korea. The plaintiffs argue that revenues generated from cigarette manufacturing and sales in the country were used to support North Korea’s weapons programmes, with some of those weapons later deployed in attacks against U.S. forces in the Middle East. The lawsuit seeks damages under U.S. anti-terrorism legislation that allows victims to pursue claims against companies accused of aiding or abetting terrorist activity².

The case revisits BAT’s long-running involvement in North Korea. In 2001, BAT formed a joint venture with a North Korean company to manufacture cigarettes locally. The venture continued quietly even as the U.S. government publicly warned that North Korea was funding terrorism and imposed sanctions on the country. In 2007, amid mounting international pressure, BAT said it was ending its business in North Korea. However, the U.S. justice department later said the company secretly continued operations through a subsidiary.

According to findings disclosed by the U.S. justice department in 2023, BAT’s North Korean venture generated around $418 million in banking transactions, generating revenue used to advance North Korea’s weapons program. The current civil lawsuit builds on earlier enforcement actions, including a 2023 settlement in which BAT and its subsidiary agreed to pay substantial fines to resolve criminal charges and sanctions violations. BAT stated that the conduct is related to historical activities and it has since strengthened its compliance and governance controls.

January 2026: Fifth Circuit Court Questions Whether FDA Has Effectively Banned Flavored Refillable Vapes

A federal appeals court panel from the U.S. Fifth Circuit expressed serious doubts about the U.S. Food and Drug Administration (FDA)’s claim that it has not imposed a “de facto ban” on flavored refillable e-cigarette products, noting that the agency has approved only a minuscule number of applications out of hundreds of thousands submitted by manufacturers seeking authorization to sell such devices. During oral arguments in the case brought by VDX Distro Inc., judges pointed out that near-100% denial rates for this class of products suggest an effective prohibition in practice, with critics arguing the FDA is imposing unwritten rules and potentially violating procedural requirements under the Family Smoking Prevention and Tobacco Control Act; the Government, however, counters that some approvals exist and therefore no outright ban is in place.

November 2025: TJP Labs Sues Imperial Brands for Alleged Breach of ZONE Volume Targets

Canadian nicotine-pouch manufacturer, TJP Labs sued Imperial Brands in a U.S. court, according to a recent complaint. TJP alleges that Imperial Brands – specifically its U.S. affiliate, ITG Brands – is refusing to honor the binding “minimum purchase” clauses in their deal, recasting them as non-binding forecasts instead. Because of that reinterpretation, TJP says Imperial won’t book the volumes needed to trigger certain deferred payments, effectively denying TJP the money it expected under the contract.

The underlying deal stems from a June 2023 transaction in which Imperial acquired a portfolio of nicotine pouches from TJP Labs in order to enter the U.S. modern oral nicotine market. After consumer testing, ITG Brands rebranded and launched these pouches in February 2024 under the ZONE brand name in the U.S., while TJP continues to manufacture them under contract.

TJP’s lawsuit, filed in Delaware’s Chancery Court, argues that Imperial’s refusal to meet its volume-based obligations amounts to a repudiation of the deal. By treating performance obligations as mere targets, TJP claims Imperial is sidestepping its payment commitments and undermining the financial structure they originally agreed upon.

November 2025: Philip Morris International Faces Lawsuit Over Alleged Abandonment of Inhalable Aspirin Innovation

The lawsuit, filed in the Delaware Chancery Court, alleges that Philip Morris International (PMI) purchased a late-stage inhalable aspirin product called Asprihale from OtiTopic, a pharmaceutical-industry startup, and effectively abandoned the project, despite its potential to deliver a life-saving form of aspirin for heart-attack patients. The complaint, filed by OtiTopic’s founder accuses PMI of breaching the acquisition contract by failing to advance or commercialise the product.

According to the complaint, Asprihale was designed to deliver aspirin via inhalation, enabling much faster onset of action than the standard chewable or oral aspirin required in acute myocardial infarction treatment. The quick delivery was framed as critical because heart-attack patients currently face a time lag (on the order of 30 minutes) before conventional aspirin becomes fully effective. The lawsuit asserts that PMI acquired OtiTopic in 2021 for around $38 million cash plus costs and contingent payments, and recorded the purchase as in-process R&D.

OtiTopic now contends that after acquisition, PMI did not prioritise the inhaler’s development, and ultimately stopped advancing the product. The plaintiff argues this neglect deprived the inhaler of needed development, marketing, or commercialisation steps, thereby violating terms of the purchase agreement. The complaint seeks to recover contractual damages for what is characterized as mismanagement and abandonment of a valuable therapy.

October 2025: Judge signals likely class certification in Altria-JUUL antitrust case

In 2018, Altria invested $12.8 billion in JUUL, gaining 35% stake in the rapidly rising e-cigarette company. As part of this acquisition, Altria agreed to withdraw its own competing e-cigarette products, sold under the MarkTen brand, and provide JUUL with favourable retail shelf space, thereby reducing competition and product variety in the U.S. e-cigarette market. Plaintiffs, both direct purchasers and indirect purchasers/resellers, alleged that this conduct ran afoul of U.S. antitrust laws – in particular a conspiracy to restrict competition in the relevant market. The initial consolidation of class action complaints occurred in the Northern District of California under docket “In re Juul Labs, Inc. Antitrust Litigation”.

In October 2025, U.S. District Judge signalled a tentative decision favoring certification of both direct‐purchaser and indirect‐purchaser classes in the case. The judge indicated that the plaintiffs share sufficient common issues to justify class certification, despite the defendants’ argument that substantial legal and factual differences among the 31 states implicated would make class treatment impracticable. Altria warned of the danger of creating what they termed a “Frankenstein’s monster” of damages – i.e., a complex patchwork of state laws and damage regimes applied across different jurisdictions. The judge, however, appears inclined to move forward, subject to resolving outstanding structural issues around class definitions, choice of law, and trial bifurcation (liability first, damages later).

If the class certification is formally entered, this will significantly raise the stakes for Altria and JUUL and may accelerate settlement negotiations or intensify trial preparation. Certification means potential exposure to large aggregated damages claims spanning multiple states and both consumer and reseller segments. The defendants’ concern about managing disparate state‐law regimes remains salient: even with certification, the court will need to structure the class in a way that addresses variation in statutes of limitation, damage multipliers (e.g., treble damages under California’s Cartwright Act), and other state‐specific legal issues.

From a business perspective, resolution of this case has implications beyond the parties themselves: it signals regulatory and litigation risk for similar transactional structures in which a large incumbent invests in or acquires a disruptive rival and then retreats from direct competition. Companies pursuing such deals may face heightened antitrust scrutiny and downstream class-action risk. For the defence side, setting up a robust damages model that can accommodate multi‐state claims will be critical; trial strategy may hinge on whether liability and damages phases are bifurcated, how distribution channels are analysed, and how product variety (and alleged restriction thereof) is proven. For the plaintiffs, a certified class offers leverage in negotiating global settlements and may broaden the ability to recover aggregate damages across jurisdictions rather than via piecemeal individual suits. In short, the broader business community will be watching this case closely as an indicator of how the courts will treat antitrust litigation involving multi-state classes, complex purchase chains (direct vs indirect purchasers), and big-ticket strategic investments in fast-moving sectors.

October 2025: Altria Settles with Elf Bar Owner iMiracle in California Flavored Disposable Vape Case

Altria’s e-cigarette subsidiary NJOY filed suit in late 2023 against 34 manufacturers, distributors, and retailers, accusing them of illegally marketing flavored disposable vape products in California in violation of the state’s flavor ban and federal regulations. The original complaint argued that NJOY was placed at a competitive disadvantage because flavored devices such as Elf Bar, produced by China-based iMiracle, diverted consumer demand away from NJOY’s FDA-authorized tobacco-flavored offerings. In early 2024, a U.S. court dismissed most of the defendants due to improper joinder, leaving Elf Bar’s parent company, iMiracle, as the principal remaining target.

The parties later entered settlement negotiations and, in October 2025, jointly asked the court to issue a legally binding order permanently restricting certain actions by iMiracle (a “permanent injunction”). Under the publicly disclosed terms, iMiracle agreed to withdraw all flavored disposable vape products from California, ceasing their sale or shipment into the state. The injunction also prohibits shipments into other jurisdictions if the products are likely to end up in California – a provision designed to prevent circumvention. Notably, iMiracle continues to deny liability but accepts that any breach of the injunction may be treated as contempt of court. Should iMiracle or its distributors violate the agreement, NJOY could seek enforcement or penalties without filing a new lawsuit.

The settlement is conditioned on the continued existence of California’s flavor ban; if that law is repealed or materially altered, the injunction may no longer apply. By resolving the case through a permanent injunction rather than a liability judgment or monetary award, both sides avoid protracted litigation while allowing the court to retain oversight. The injunction formally marks iMiracle’s withdrawal from one of the largest vape markets in the U.S., reducing its exposure to legal risks, but underscores the tightening regulatory landscape for flavored vape producers.

September 2025: A federal judge vacated the FDA’s graphic health warning rule

A federal judge in the Southern District of Georgia vacated the FDA’s final rule requiring graphic health warnings on cigarette packs and ads in Philip Morris USA Inc., et al. v. FDA. In an August 29, 2025 order, the Judge held that, while the rule did not violate the Tobacco Control Act (TCA) and was not arbitrary or capricious, the Agency failed to follow Administrative Procedure Act (APA) procedures during rulemaking. Specifically, the court found FDA relied on studies without making the underlying raw data available for public comment, a prejudicial omission that required setting the rule aside. The court granted summary judgment to Philip Morris USA and Georgia retail plaintiffs and directed the clerk to close the case.

The decision pauses implementation of the 2020 graphic-warning regime and introduces fresh regulatory uncertainty for cigarette manufacturers and retailers that had been preparing for FDA’s previously stated enforcement timeline. It also sits against a complex litigation backdrop: a Fifth Circuit panel had earlier upheld the rule on First Amendment grounds and the U.S. Supreme Court declined review in November 2024, yet multiple district-court challenges persisted, culminating in this APA-based vacatur and other injunction activity in 2025. An appeal to the Eleventh Circuit is likely; until then, companies can treat the Georgia ruling as removing any immediate federal obligation to change packaging and advertising, while monitoring appellate developments and potential FDA procedural re-proposals.

August 2025: Texas ban on Chinese vape products can take effect

Texas Governor signed Senate Bill 2024 (SB 2024) into law in June 2025, banning “e-cigarette products” manufactured in China. An “e-cigarette product” is defined in the law as any substance [containing nicotine from any source that is] intended for use in an e-cigarette, regardless of whether the substance contains nicotine. The law will come into effect on September 1, 2025.

In a complaint filed in the US District Court for the Southern District of Texas, a group of vape companies claimed that the Texas state law is unconstitutional as it constitutes an “impermissible exercise of state power in a realm reserved for the federal government” under the US Constitution’s foreign commerce clause.

Subsequently, at an emergency hearing, a federal judge ruled that the new Texas law banning the sale of e-cigarettes containing any components manufactured in China can take effect on September 1, 2025 as planned. The judge denied a request for a temporary restraining order and underlined the short notice period to form a judgment on whether the law infringes on the federal government’s authority to regulate commerce.

August 2025: Altria sues U.S. FDA and Department of Health and Human Services

Altria’s NJOY LLC subsidiary, together with retailers with presence in the state of Louisiana, initiated legal proceedings against the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS), including officials such as FDA Commissioner Martin Makary and HHS Secretary Robert F. Kennedy Jr. The lawsuit, filed on August 21, 2025, in the U.S. District Court for the Western District of Louisiana³, concerns FDA’s protracted delay in ruling on NJOY’s appeal regarding the marketing denial orders (MDOs) issued by the U.S. FDA for NJOY flavored vapes – including Blue/Blackberry, Watermelon and Tropical Twist flavors. NJOY states that these products are identical in composition to previously approved tobacco and menthol variants. NJOY contends that the delay significantly exceeds statutory review period and has caused illicit flavored products to proliferate in the market.

NJOY’s supervisory appeal to the MDOs has been pending since October 2022, for nearly three years, whereas the U.S. law calls for a decision within 180 days. The company highlights strong evidence supporting its case, including longitudinal cohort data from over 3,600 adult users showing heightened switching rates with flavored vapes, youth perception studies indicating low interest among adolescents, and robust safeguards such as stringent age-verification protocols and sales restrictions. NJOY also underscores internal FDA staff assessments that reportedly validated its data. The complaint accuses FDA of applying inconsistent standards, ignoring scientific evidence and safeguards, and effectively imposing a “de facto flavor ban” through unreasonable delay in review timeline.

August 2025: A group of vape companies challenged the new Texas law

August 2025: Court rules that FDA CTP’s Civil Money Penalty against a vape retailer is unconstitutional

In a case brought by a Texas-based vape retailer, U.S. District Court for the Northern District of Texas ruled that Civil Money Penalty (CMP) issued by the Food and Drug Administration (FDA)’s Center for Tobacco Products (CTP) is unconstitutional, violating the Seventh Amendment’s right to a jury trial. Under the Tobacco Control Act, Congress gave the FDA the authority to issue CMPs to companies and individuals who are found to violate rules. FDA CTP typically issues CMP to a retailer, manufacturer or distributor in case of continued violation despite receiving a warning letter. As a final enforcement action, following the CMPs, FDA could issue no-sale orders, which would ban the business from selling tobacco or vape products. A jury trial is not offered as part of the CMP enforcement; however, CMPs can be challenged in front of an administrative law judge and, subsequently, appealed at a federal court.

The ruling in Texas only enjoined CTP from enforcing CMP against the plaintiff and did not grant a broader nationwide injunction that would have prevented CTP from collecting any CMPs. However, as the ruling sets a clear precedent, other vape companies are likely to use the ruling in their defense against CMPs. U.S. FDA is forced to react to the ruling as it endangers one of its most noted enforcement actions.

June 2025: Supreme Court allows “forum-shopping” for vape manufacturers

The U.S. Supreme Court, in a 7–2 decision, ruled that companies affected by the U.S. FDA’s denials of e‑cigarette marketing applications can choose where to sue. The case centered on British American Tobacco (BAT)’s U.S. subsidary, R.J. Reynolds “handpicking” conservative 5th Circuit to challenge the FDA’s rejection of menthol/berry-flavored Vuse Alto vapes and partnering with Texas and Mississippi retailers to do so. The Supreme Court interpreted the Tobacco Control Act’s “adversely affected” language broadly, granting both manufacturers and retailers flexibility in selecting venues such as their home circuit or D.C.

“Adversely affected” language explained:

The “adversely affected” language refers to a provision in the Tobacco Control Act – the law that governs how the FDA regulates tobacco and nicotine products. The law says that any party “adversely affected” by an FDA decision (like denying a product’s marketing application) has the right to challenge that decision in court. The Supreme Court interpreted this term broadly, meaning not just the manufacturer directly denied by the FDA, but also retailers or partners of that manufacturer can be considered “adversely affected” and thus eligible to sue. This interpretation matters because it expands who can challenge the FDA, and more importantly, where they can bring that legal challenge. The practical result is greater flexibility in choosing the venue – the location of the court where the case is heard. So, if a retailer based in Texas is affected by an FDA denial, the case can be filed in the 5th Circuit Court of Appeals (which is considered more industry-friendly), even if the manufacturer is located elsewhere. This opens the door for strategic “forum shopping”, where companies pick courts likely to be more favorable to their case, potentially weakening centralized oversight.

Two Liberal Justices dissented, warning that this decision undermines Congress’s intent to prevent forum‑shopping and could weaken FDA oversight. They criticized the ruling as allowing manufacturers to “make an end run” around venue constraints by aligning with retailers in more favorable jurisdictions. Public health advocates echoed these concerns, arguing the decision may embolden vape firms to continue promoting flavored products that have been linked to youth uptake.

While the ruling addresses procedural venue rights – not the substance of the FDA’s regulatory authority – it comes on the heels of an earlier April Supreme Court decision that upheld the FDA’s refusal to authorize sweet‑flavored vapes. Industry groups welcomed the decision, noting it ensures broader access to judicial review. Meanwhile, anti‑tobacco advocates caution it complicates the regulatory environment by giving manufacturers more legal leeway to challenge flavor‑related denials and potentially delay enforcement.

June 2025: Court of Appeals rejects a challenge to U.S. FDA’s menthol vape denial

The Eighth Circuit Court of Appeals rejects a challenge from SWT Global Supply Inc. to the U.S. Food and Drug Administration (FDA)’s denial of its application to market menthol-flavored e-cigarettes. The Court rules that U.S. FDA’s decision to refuse SWT’s marketing plan (on the basis that SWT’s proposed sales point restrictions were not sufficient for youth access prevention) is not arbitrary or capricious and SWT failed to provide sufficient evidence demonstrating that the product benefits public health. The judge panel also cites a recent U.S. Supreme Court decision (in U.S. FDA v. Triton Distribution and Vapetasia) that largely backs FDA’s denial of flavored vape product applications and covers most of the arguments raised in SWT’s appeal (- see below for further details).

U.S. FDA rejected SWT’s Pre-market Tobacco Product Application (PMTA) in May 2023 due to the lack of sufficient evidence demonstrating that SWT’s menthol-flavored products have potential benefits for adult users that outweigh the risks for youth and SWT’s marketing plan was not effective in restricting youth access to and use of the products. In its appeal, SWT claimed that the FDA made changes to the PMTA standards without prior notification, such as requiring the submission of long-term study data and conducting comparative effectiveness tests, and failed to provide a reasonable explanation for denying its marketing plans, overlooking the differences between open and closed system e-cigarette products.

The Court underlines that FDA has broad discretion to determine the types of scientific evidence required and denial of applications that do not contain comparisons to tobacco-flavored products is not inconsistent with previous actions. Moreover, the Court recognizes that FDA did not promise to authorize menthol-flavored products even if the Agency publicly commited to prioritize the review and enforcement actions against non-tobacco, non-menthol-flavored products. The Court also determines that menthol-flavored products play an important role in attracting minors and FDA’s decision to treat them the same as other flavored e-cigarette products is reasonable and consistent.

Another case, involving SWT, was submitted to the Supreme Court of the United States and remanded to the Fifth Circuit Court of Appeals. The litigation is still ongoing.

June 2025: British American Tobacco is hit with a class-action lawsuit over VUSE’s carbon neutrality claims

A group of consumers filed a class-action lawsuit in the Northern District Court of California, accusing British American Tobacco (BAT) and its U.S. subsidiary, RJ Reynolds, of falsely promoting VUSE vapes as carbon neutral and seeking $5 million in compensation. The lawsuit alleges that VUSE is marketed as the “world’s first global carbon-neutral vape brand” altough the environmental claims based on carbon credits have not resulted in any actual environmental improvements⁴.

The court filing states that consumers chose Vuse over other products because of these claims, detailing instances in which VUSE was promoted as carbon-neutral and citing a BAT document in which the company described its green credentials as a means of “enhancing consumer buy-in and brand loyalty”. It also alleges that BAT continued to market the VUSE as carbon-neutral even after being made aware of the sham credits: more than one-third of the credits used to offset VUSE emissions came from the Guanaré Forest Plantations Project in Uruguay. The project is an eucalyptus tree farm in Uruguay that was rated zero by an independent rating agency in 2022. The rating means that the credits, which should each represent one tonne of emissions avoided or removed, represent no change whatsoever. The lawsuit argues that this farm and three other forestry projects found to be overstating their sustainability claims, accounted for the vast majority of the credits that enabled Vuse to be declared carbon neutral and companies making environmental claims in their marketing must do their due diligence to substantiate them; thereby, BAT and its subsidiaries were in breach of these duties.

In May 2021, BAT announced that VUSE became the world’s first global carbon-neutral vape brand and this was the latest step in BAT’s ambitious targets to be carbon-neutral in its operations by 2030, and across its wider value chain by 2050. VUSE’s carbon neutrality was claimed to be through carbon offset through reforestation projects. This included a project in Uruguay to plant trees across 21,298 hectares, where intensive cattle grazing has eroded soil and degraded land. As well as removing carbon dioxide and delivering better soil quality and biodiversity, the project also resulted in increased availability and quality of employment opportunities. A BAT spokesperson stated in November 2024 that the “carbon neutral” claim had been independently verified in 2021, and all advertising materials related to carbon neutrality for VUSE were discontinued in December 2023.

March 2025: The U.S. Supreme Court largely backs FDA’s denial of flavored vape product applications

The U.S. Supreme Court (SCOTUS) largely backed the U.S. Food and Drug Administration (FDA)’s refusal to allow the marketing of flavored vape products sold by Triton Distribution and Vapetasia. SCOTUS justices removed a lower court decision that the FDA had failed to follow proper legal procedures under a federal law, called the Administrative Procedure Act, when it rejected the applications of the two vape companies.

In an unanimous ruling, SCOTUS decided that it can’t be concluded that the FDA has improperly changed its position with respect to scientific evidence (i.e. applied regulatory standard is different from published guidance). Moreover, SCOTUS ordered the lower court to reassess FDA’s denial to consider the proposed plans of the two vape companies to restrict underage access and use of their products.

Background information: Triton Distribution and Vapetasia filed PMTA applications for their flavored vape products in 2020. The FDA denied the applications for more than a million flavored vape products from hundreds of vape companies, including Triton and Vapetasia, in 2021. Subsequently, Triton and Vapetasia asked the New Orleans-based 5th U.S. Circuit Court of Appeals to review the FDA’s denial of their applications. The Conservative-leaning 5th Circuit ruled that the FDA had been arbitrary and capricious in violation of the Administrative Procedure Act. However, seven other federal appellate courts had sided with the FDA in similar cases.

March 2025: Imperial Brands is ordered to pay $251.5 million to BAT

A Delaware judge ordered ITG Brands, the US subsidary of Imperial Brands, to pay Reynolds American, the US subsidary of British American Tobacco, $251.5 million in connection to a payment Reynolds made to the state of Florida as part of a settlement agreement that pre-dated ITG’s acquisition of Reynolds’ cigarette brands. The judge decided that the payments Reynolds made to Florida on behalf of ITG-owned brands aren’t excluded under the companies’ purchase agreement. Delaware Chancery Court rejected ITG’s request to reduce the amount due by $112.8 million based on the “profit adjustment” claim and the fact that ITG did not join the Florida settlement.

ITG purchased four cigarette brands (Winston, Salem, Kool, Maverick) and blu eCigs from Reynolds for $7.1 billion in 2015.

January 2025: Judge blocks the US FDA’s graphic health warning requirement for cigarettes

A federal judge in Texas, who was appointed by Republican President-elect Donald Trump during his first term, blocked the U.S. Food and Drug Administration (FDA) from enforcing a pending requirement that cigarette packages and advertisements contain graphic warnings illustrating the health risks of smoking. The U.S. District Judge sided with BAT’s R.J. Reynolds, Imperial Brands’ ITG Brands and Japan Tobacco’s Vector Group (which filed the case in 2020) and found that the US FDA went beyond its authority by requiring packaging and advertising to contain 11 specific graphic health warnings⁵.

He ruled that US FDA adopted two extra warnings beyond the nine warnings specified by the Congress when Tobacco Control Act was passed in 2009 (- offering the US FDA the authority to regulate tobacco products and mandating the adoption of graphic warnings) and used the exact text required by the Congress only in two of the remaining nine warnings.

The Judge delayed the rule’s effective date pending further litigation, preventing the US FDA from proceeding to enforce the graphic health warnings from February 2026.

November 2024: Supreme Court declined to hear the challenge to graphical health warnings

The Supreme Court declined to hear the challenge from major tobacco companies to the US FDA’s requirement to place graphical health warnings on cigarette packages and advertisements⁶. The FDA issued a rule in 2020 that requires health warnings on cigarette packages and advertisements, occupying the top 50% of the area on the front and back panels of packages and at least 20% of the area at the top of cigarette ads. Moreover, the Agency created 11 text-and-image graphics for compliance with the rule.

Several tobacco companies, including British American Tobacco’s U.S. subsidiary Reynolds American, Imperial Brands’ U.S. subsidiary ITG Brands and Vector Group (recently acquired by Japan Tobacco), took the rule to court arguing that the warnings run afoul of the First Amendment and the Agency violated federal rulemaking procedures. A federal judge in Texas initially sided with the tobacco companies and abolished the rule. But the 5th US Circuit Court of Appeals reversed that decision and ruled in favor of the US FDA. In a unanimous ruling issued in March 2024, the Appeals Court stated that the rule “passes constitutional muster” under a decades-old Supreme Court standard that allows the government to compel commercial speech so long as the speech is “purely factual,” “uncontroversial,” “justified by a legitimate state interest” and “not unduly burdensome”. The court sent the case back to the lower court for further review, but the tobacco companies appealed to the Supreme Court before the proceedings could restart. The case will continue to work its way through the lower courts and may reach the high court again in the future.

October 2024: The US Supreme Court agreed to review vape case venue

The Supreme Court granted a new case which challenges a legal maneuver used by the tobacco and e-cigarette industry to fight US FDA rulings in more sympathetic federal courtroom venues. The case focuses on the US Court of Appeals for the 5th Circuit, one of the most conservative in the US, which has become an attractive venue for the Industry players seeking to oppose regulations⁷.

Federal law states that corporations can challenge FDA policies in Washington, D.C., federal court, or where the company’s place of business is located. But under a rule in the 5th Circuit, plaintiffs have been allowed to bring challenges to that venue so long as a product made by the principal company is sold by a retail store within the 5th Circuit’s jurisdiction, which spans Texas, Mississippi, and Louisiana.

The underlying dispute is based on the FDA’s denial of RJ Reynolds Vapor Company (RJRVC)’s bid to introduce three flavored vapes to the market. According to the FDA ruling, RJRVC, an operating company of Reynolds American Inc. (London-based British American Tobacco’s U.S. subsidiary), failed to meet federal requirements concerning tobacco products’ marketing. However, RJRVC contended that the decision was arbitrary and capricious. As RJRVC sells its products at convenience stores in the three states under the 5th Circuit’s jurisdiction, it was able to take advantage of the appeals court’s looser restrictions. In court filings, U.S. Solicitor General disputed the ability of manufacturers to “forum shop” in administrative law cases by having retailers join the lawsuit.

In a separate case already taken up for the upcoming term, the Supreme Court will review the FDA’s marketing denial orders for flavored vapes and, thereby, FDA’s overall regulatory scheme for vapes. The Supreme Court announced that oral arguments in the case will be heard on December 2, 2024.

Decisions in both cases are expected by Summer 2025.

July 2024: The US Supreme Court agreed to hear the US FDA’s defense on flavored vape denials

The US Supreme Court agreed to hear US FDA’s appeal on a lower court (5th US Circuit Court of Appeals) decision which ruled that the US FDA’s denial of flavored vapes is in violation of a federal law called the Administrative Procedure Act (i.e. failure to follow the proper legal procedures). The Court will hear the Agency’s defense on the marketing denial orders (MDOs) issued to two e-liquid makers for their flavored products; the Agency had determined that these vapes pose risks to the youth. The Supreme Court will hear the case in the next legal term which begins in October 2024.

Two e-liquid makers, Triton Distribution and Vapetasia, filed PMTAs in 2020 for their flavored e-liquid products; these applications are later denied by the US FDA. In 2021, Triton and Vapetasia demanded the New Orleans-based 5th US Circuit Court of Appeals to review the FDA’s MDOs. In January 2024, the 5th Circuit ruled that the US FDA’s decision was arbitrary and capricious as the requests were denied without reviewing the plans submitted by the companies to prevent the underage access and use. The 5th Circuit ruling created a conflict with the other appeal court decisions and prompted the US FDA to appeal to the Supreme Court.

Although the US FDA states that flavored vapes are not categorically banned, the Agency has not yet issued a marketing order for a flavored vape (except for menthol) as, according to the US FDA, these products pose a “known and substantial risk to youth”.

June 2024: The US FDA demands the dismissal of the lawsuit requesting an immediate ban on menthol cigarettes

The US FDA asked a federal judge to dismiss the lawsuit by anti-smoking groups demanding the ban of menthol cigarettes without further delay. In the court filing, the US FDA stated that the delay was not unreasonable because it had yet to determine whether a ban was appropriate for the protection of the public health. The FDA also claimed that the plaintiffs had neither a direct stake in a ban nor a standing to sue while citing the US Supreme Court’s recent rejection of a bid by anti-abortion groups to restrict access to a widely used abortion pill.

The lawsuit was filed in April 2024 in the Oakland, California federal court by the American Medical Association, African American Tobacco Control Leadership Council, Action on Smoking & Health and National Medical Association.

The FDA was planning to announce the final menthol rule in August 2023 before pushing it back multiple times. The latest delay (for an indefinite amount of time) was announced in April 2024 by the FDA’s parent federal agency, Health & Human Services.

January 2024: 5th Circuit Overturns FDA Denial of Flavored E-Cigarette Applications

The 5th U.S. Circuit Court of Appeals has ordered the Food and Drug Administration (FDA) to reconsider its marketing denial orders against two manufacturers of flavored e-cigarettes, reversing a decision the court made in July 2022. The court ruled that the FDA acted “arbitrarily and capriciously” when it rejected Premarket Tobacco Product Applications (PMTAs) from Triton Distribution and Vapetasia LLC without reviewing the companies’ marketing plans. The panel also concluded that the agency violated the fair notice doctrine.

According to the ruling, the FDA failed to provide clear guidance on how it balances marketing plans designed to restrict youth access against scientific studies demonstrating product benefits for adult smokers. Additionally, the court held that the regulator failed to offer fair notice to manufacturers regarding the need to conduct long-term studies on specific flavored products.

Triton and Vapetasia had submitted PMTAs to keep their flavored e-liquids on the market, but the FDA initially rejected them, claiming the manufacturers failed to show that adult benefits outweighed the risks posed to youth. Under the court’s mandate, the FDA must now re-evaluate both applications.

January 2024: The US Supreme Court declined to hear Reynold American’s challenge to flavored tobacco ban in California

The US Supreme Court declined to hear Reynolds American’s challenge to a voter-approved measure in California that banned flavored tobacco products⁸. Reynolds American Inc. is the U.S. subsidiary of London-based British American Tobacco (BAT) Group.

Background: A ban on all flavored tobacco products went into effect in December 2022 in California following the approval of the measure on a ballot by nearly two-thirds of the voters. RJ Reynolds (a subsidiary of BAT) and other plaintiffs filed a lawsuit arguing that the federal Tobacco Control Act preempts state and local laws from banning flavored tobacco products. However, both a Federal Court and a Court of Appeals concluded that the California’s law did not conflict with the federal statute regulating tobacco products. RJ Reynolds appealed the decision to the US Supreme Court.

In December 2022, the US Supreme Court also rejected Reynold American’s request to prevent the California law from taking effect.

February 2023: The US Supreme Court declined to hear Reynold American’s challenge to flavored tobacco ban in Los Angeles County

US Supreme Court declined to hear the Reynolds American’s appeal on flavored-tobacco ban in Los Angeles County⁹. The ban went into effect in June and now stays in force with the Supreme Court decision – which was made without comment. Reynolds American Inc. is the U.S. subsidiary of London-based British American Tobacco (BAT) Group.

Meanwhile, the US FDA appealed the court’s order that found the graphic cigarette health warning rule unconstitutional¹⁰. The court decision was issued in December 2022 on the basis of violating free speech protections under the First Amendment.

October 2022: US Department of Justice seeks permanent injunctions against six e-cigarette companies

US Department of Justice, on behalf of the FDA, sued six companies that reportedly continue to sell e-cigarettes without submitting PMTA¹¹. These cases represent the first time injunction proceedings are initiated to enforce PMTA requirements.

August 2022: A federal appeals court ruled the reconsideration of the marketing denial orders (MDOs) issued to six e-cigarette companies by the US FDA

Six e-cigarette companies petitioned the 11th U.S. Circuit Court of Appeals in 2021 to review the FDA’s denial of their applications to market various flavored e-cigarettes and e-liquids. 11th Circuit ruled that the Agency’s decisions were arbitrary and capricious because of refusal to consider the companies’ plans to prevent their products from being accessed by the minors. Accordingly, the US FDA will have to reconsider its denial of six companies’ applications¹².