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Tag: Reynolds

  • FDA Pushed on ‘De Facto’ Vape Ban by 5th Circ.

    FDA Pushed on ‘De Facto’ Vape Ban by 5th Circ.

    A panel of the U.S. Court of Appeals for the Fifth Circuit signaled skepticism yesterday (January 6) toward the Food and Drug Administration’s claim that it has not effectively banned flavored refillable e-cigarette products, suggesting the agency’s near-total rejection of applications amounts to a de facto prohibition. During oral arguments, Judge Cory T. Wilson noted that the FDA has approved only six applications out of hundreds of thousands of premarket tobacco product applications (PMTAs), remarking that “if you’re effectively at 100% denial on a certain class of products, then it is a de facto ban.”

    The case was brought by VDX Distro Inc., which is challenging the FDA’s refusal to authorize its menthol-flavored refillable vaping products. Government attorney Ben Lewis argued that no ban exists because some products have been approved, but judges pressed the agency on whether it has ever approved a flavored e-cigarette without evidence showing it provides greater smoking cessation benefits than tobacco-flavored products. Counsel for VDX argued the FDA violated the Tobacco Control Act by imposing new, unwritten standards without notice-and-comment rulemaking, effectively blocking all open-system refillable devices.

    Industry amici echoed those concerns, with an attorney for R.J. Reynolds Vapor Co. arguing the FDA applies stricter standards to flavored vaping products than to other nicotine products, such as pouches. The panel did not rule from the bench, but the pointed questioning underscores growing judicial scrutiny of FDA tobacco regulation, with potential implications for future authorization pathways for flavored vaping products closely watched by the tobacco and nicotine industries.

  • BAT Pauses Vuse One Vape Launch Amid FDA Scrutiny

    BAT Pauses Vuse One Vape Launch Amid FDA Scrutiny

    Yesterday (October 28), Reuters reported that BAT paused its pilot launch of the Vuse One disposable vape in the U.S., highlighting the regulatory hurdles in the rapidly growing nicotine products market, news that was confirmed by a spokesperson for Reynolds American, BAT’s U.S. subsidiary. The pilot will be postponed while the company focuses on its existing portfolio, including a nicotine pouch currently under PMTA review that FDA has promised to fast-track.

    “We will bring Vuse One to market at the appropriate time,” the spokesperson said. “Vuse One is one of the few disposable vapor products that meet the in-market and PMTA-deadline requirements that Congress established in 2022. We have communicated with our customers to ensure that they are fully informed about our decision.”

    The move follows increased U.S. Food and Drug Administration (FDA) enforcement against unapproved vapes, many imported from China, which have eroded profits in the $22 billion U.S. smoking alternatives sector. Earlier this year, it was reported that several manufacturers, frustrated by the lack of progress within the FDA, were considering launching products prior to official approval, similar to those already available on the market.

    The pause underscores the industry’s broader push for reforms to streamline FDA approvals, which often take years. Philip Morris International and Altria are also navigating similar challenges, balancing regulatory compliance with the competitive pressure from unlicensed products. The FDA has signaled intentions to accelerate applications, though public health groups warn that any loosening of review standards could undermine safety and oversight.

    The FDA recently sent a letter to “remind” manufacturers that selling new nicotine products without authorization is unlawful.

  • RJR Seeks Dismissal of ‘Carbon Neutral’ Vape Lawsuit

    RJR Seeks Dismissal of ‘Carbon Neutral’ Vape Lawsuit

    R.J. Reynolds Vapor Co. has asked a California federal judge to dismiss a proposed class-action lawsuit accusing the company of misleading consumers by advertising its Vuse e-cigarettes as “the world’s first carbon neutral vape brand.” In its filing with the U.S. District Court for the Northern District of California, the company said its statements were backed by independent third-party certifications from Verra and Vertis Environmental Finance Ltd., insisting that its carbon-neutral claims were accurate, verified, and aligned with recognized environmental standards. R.J. Reynolds argued that it did not exaggerate its emissions data and said plaintiffs failed to prove any economic loss tied to the marketing claim.

    According to ClassAction.org, the lawsuit, filed on May 28, 2025, seeks $5 million in damages and alleges that British American Tobacco (BAT) and its subsidiary R.J. Reynolds misled consumers with a deceptive sustainability campaign. Plaintiffs argue that the “carbon neutral” label relied on flawed carbon offset projects, including Uruguay’s Guanaré Forest Plantations Project, which an independent review found had no measurable climate benefit. The complaint claims the company continued to use the “carbon neutral” slogan even after learning of issues with the offset program, calling the campaign a marketing strategy aimed at enhancing brand loyalty rather than environmental responsibility.

    A BAT spokesperson previously said that Vuse’s carbon-neutral status was independently verified in 2021 and that related marketing materials were discontinued by the end of 2023, according to Law360.

  • Reynolds American Names New Senior CIO

    Reynolds American Names New Senior CIO

    Reynolds American Inc. appointed Dawn-Marie Hutchinson as senior vice president and Chief Information Officer, effective October 1, 2025. In her new role, Hutchinson will oversee technology strategy and operations, including digital workplace, core platforms, data and analytics, cybersecurity, and IT service delivery, while serving on the Reynolds American Leadership Team.

    Hutchinson joined Reynolds’ parent company BAT in 2021 after holding global CISO roles at GSK and Urban Outfitters Group. At BAT, she expanded the global cybersecurity program, launched a Cyber Defense Centre, and transformed governance, risk, and compliance functions. In her new role, she will focus on modernizing IT systems, enhancing operational resilience, and leveraging data and AI across Reynolds’ operating companies.

  • FDA Launches Pilot to Fast-Track Nicotine Pouch Reviews

    FDA Launches Pilot to Fast-Track Nicotine Pouch Reviews

    The U.S. Food and Drug Administration is set to fast-track reviews of nicotine pouches from Philip Morris International, Altria, Reynolds American, and Turning Point Brands in a pilot program launching Monday, according to Reuters. According to transcripts of an agency meeting last Friday, the agency aims to complete assessments by December, providing a quicker path to market for products like Zyn, on!, Velo, Fre, and Alp. The initiative comes amid pressure from the Trump administration to accelerate approvals and streamline the review process for the fastest-growing category of U.S. tobacco alternatives.

    The pilot program will reportedly feature reduced and expedited reviews, more frequent communication between FDA staff and companies, and a focus on essential scientific and safety data, including product characterization, manufacturing consistency, and abuse-liability information. For products already on the market without full authorization, the process could remove uncertainty over legality and potential enforcement actions. Tobacco firms have long lobbied for a faster FDA authorization route, noting that lengthy reviews have allowed competitors to capture market share in the meantime.

    “Adult nicotine and tobacco consumers are increasingly seeking nicotine pouches as a smoke-free alternative, and the industry is rapidly growing in response,” said Laura Leigh Oyler, vice president of U.S. Regulatory Affairs at Haypp Group, who will be speaking at GTNF 2025 in Brussels on the U.S. regulatory landscape. “These consumers deserve a marketplace of FDA-reviewed product choices to support their journey away from more harmful products. 

    “It makes sense that our government should also work to meet the demands of citizens, supporting a regulatory regime that quickly reviews well-designed and well-tested products from responsible and compliant manufacturers. This is a positive step not just for the regulator and the regulated industry, but for the millions of American adults looking for products they can trust.”

  • Philip Morris Gets Wash. Tobacco Deal Fight Sent o Arbitrator

    Philip Morris Gets Wash. Tobacco Deal Fight Sent o Arbitrator

    A Washington state judge ordered R.J. Reynolds Tobacco Co. to arbitrate rival Philip Morris USA Inc.’s claims that it breached a 2017 deal delineating billions of dollars in annual payments. Ruling from the bench on September 3, King County Superior Court Judge Michael Scott granted the motion to force arbitration, contending Philip Morris’ breach-of-contract claim against R.J. Reynolds and the other tobacco producers “clearly arises” out of the 2017 agreement and therefore must be arbitrated.

    The conflict centers on longstanding disagreements over the annual Master Settlement Agreement (MSA) payments to the state. RJR and fellow plaintiffs claim PM USA aims to derail a separate 2025 settlement signed between RJR and Washington by attempting to enforce an arbitration clause dating back to the 2017 agreement. They argue PM USA is improperly interfering in a deal it is not directly part of.

    In June, PM USA submitted its motion to compel arbitration, asserting that RJR and the other defendants are bound by the 2017 arbitration clause and that the court must defer to this private resolution mechanism.

  • Vape Industry Seeks to Block NC Law “Backed by Big Tobacco”

    Vape Industry Seeks to Block NC Law “Backed by Big Tobacco”

    Vape industry groups are urging the Fourth Circuit Court of Appeals to temporarily block enforcement of a new North Carolina law that could ban many e-cigarettes from the market. In an emergency filing, the groups claim the law was heavily influenced by Reynolds American Inc. and is designed to eliminate competition from vaping products that help smokers quit.

    The law prohibits the sale of vapor products that lack full FDA authorization, even though many remain under scientific review. Critics say this effectively bans nearly all independent vape brands in favor of a few tobacco-owned products that have gained approval.

    The plaintiffs argue the statute undermines federal regulatory authority, disrupts public health harm-reduction efforts, and was crafted to protect big-tobacco corporate interests over consumers. They are seeking an injunction to prevent what they describe as irreparable harm to small businesses and adult nicotine users seeking alternatives to smoking.

    The court has yet to rule on the request.

  • U.S. Supreme Court Backs RJR, Broader Legal Challenges to FDA

    U.S. Supreme Court Backs RJR, Broader Legal Challenges to FDA

    The U.S. Supreme Court ruled 7–2 in favor of R.J. Reynolds Vapor Company, allowing it to challenge FDA denials of e-cigarette marketing applications in the Fifth Circuit, even though the company is based in North Carolina.

    The decision effectively expands who can file lawsuits under the 2009 Family Smoking Prevention and Tobacco Control Act, now including retailers and trade groups affected by product bans, not just manufacturers. This enables tobacco companies to approach conservative-leaning courts like the Fifth Circuit, which has frequently ruled against FDA vaping restrictions.

    The FDA argued that retailers were never meant to be included under the legislation, and that 75% of e-cigarette appeals were being filed in the Fifth Circuit through strategic partnerships with local vape shops and trade groups, undermining consistent enforcement.

    Justice Amy Coney Barrett, writing for the majority, said that retailers are “adversely affected” because they lose potential sales or risk penalties by selling unapproved products. Justice Ketanji Brown Jackson, in dissent, warned the ruling contradicts Congress’s intent, allowing companies to bypass venue restrictions meant to streamline regulation.

    The case specifically involved menthol-flavored Vuse vapes, which the FDA had denied for failing to meet public health standards. The ruling now returns the case to the Fifth Circuit for further review.

  • Judge Rules ITG Owes Reynolds Full $251 Million

    Judge Rules ITG Owes Reynolds Full $251 Million

    Yesterday, a Delaware judge ordered ITG Brands to reimburse Reynolds American the full $251.5 million it paid to the state of Florida as part of a settlement agreement that pre-dated ITG’s acquisition of four cigarette brands a decade ago. ITG was attempting to cut the bill to $130 million by claiming Reynolds saved $112 million because ITG did not join the Florida settlement.

    “The payments Reynolds made to Florida on behalf of ITG-owned brands aren’t excluded under the companies’ purchase agreement, and Reynolds is owed reimbursement of that amount to restore it to the position it held before ITG failed to assume that liability,” Vice Chancellor Lori W. Will of the Delaware Chancery Court wrote.

    In 1997, Reynolds settled with Florida to resolve claims cigarette makers misrepresented the risks associated with smoking. In 2015, RJR sold its Kool, Maverick, Salem, and Winston brands to ITG for $7.1 billion. Florida’s settlement obligations assumingly shifted to ITG, but ITG didn’t sign on, leaving Reynolds to pay the full sum in 2023.

    “ITG was not found liable for failing to join the Florida settlement agreement,” Will said. “I did not hold that it breached any such obligation in the asset purchase agreement. ITG was, instead, found liable for failing to assume the liability imposed on Reynolds by the Florida court.

    “There is a fundamental problem with ITG’s argument. It centers the wrong harm. ITG presumes that the relevant breach is its failure to join the Florida settlement agreement. But I did not find that ITG breached any such obligation. I held only that it failed to assume the Florida judgment liability under [Asset Purchase Agreement] Section 2.01(c)(iv).”

  • Reynolds Launches Non-Nicotine Vape

    Reynolds Launches Non-Nicotine Vape

    Image: Wall Street Journal

    R.J. Reynolds Vapor Company (RJRVC), an operating company of Reynolds American Inc. (Reynolds American), BAT Group’s U.S. subsidiary, is expanding its innovative vapor portfolio with SENSA, a zero-nicotine vapor product.

    As the market leader in vapor with its Vuse products, RJRVC is joining the growing marketplace for zero-nicotine vapor products and aims to establish the highest standards in the industry, according to an emailed press release.

    SENSA products include a locking feature to prevent unintended usage, and adult consumers of the device will have access to Call2Recycle’s battery recycling program, which will facilitate the responsible disposal of SENSA batteries.

    “Adult tobacco and vapor consumers across the retail marketplace are looking for more options,” said Valerie Mras, senior vice president for RJRVC. “Adding a zero-nicotine product to our growing vapor portfolio is driven by deep adult vapor consumer insights and enables us to responsibly compete within a category that is already well established in many countries.”

    The SENSA portfolio of flavors is intended for adult tobacco and vapor consumers and does not include flavors intended to appeal to those who are underage. The product will be responsibly marketed to adult tobacco and vapor consumers consistent with the Reynolds American organization’s marketing practices for tobacco and nicotine products, according to the release. All web properties will be age-gated.