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Tag: Vuse

  • 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.

  • BAT COO Says Korea Key to Smokeless Expansion

    BAT COO Says Korea Key to Smokeless Expansion

    British American Tobacco (BAT) said it is focusing on South Korea as a strategic hub for its global smokeless transformation, citing the country’s tech-savvy consumers, dynamic regulatory landscape, and innovation-driven ecosystem. BAT Group Chief Operating Officer Johan Vandermeulen said Korea plays a vital role beyond sales, acting as a testing ground for the company’s next-generation products, during an interview with The Korea Herald.

    “Korea offers a unique blend of sophisticated consumers, cutting-edge technology, and a dynamic regulatory environment that makes it an ideal testing ground for our next-generation products,” said Vandermeulen.

    Vandermeulen called the company’s Sacheon facility “one of the best” in the global BAT network, and said with Korea now the second-largest heated tobacco market in the world (behind Japan), BAT is accelerating investments in product innovation, localization, and advanced manufacturing. BAT is also expanding its vapor brand VUSE in Korea with strict ingredient and marketing standards, while eyeing future opportunities for nicotine pouches, its fastest-growing category globally.

    Vandermeulen emphasized that tobacco harm reduction, responsible marketing, and clear, fair regulation are central to the company’s vision, but warned about the dangers of illicit vaping products, which he said undermine public trust and legitimate efforts.

    “We believe vaping has a vital role in encouraging adult smokers, who would otherwise continue smoking, to switch completely to smokeless alternatives,” Vandermeulen said. “But the category can only thrive if market order is preserved.”

  • BAT’s Vuse Out of Malaysia by Q3 2025

    BAT’s Vuse Out of Malaysia by Q3 2025

    Today (April 28), British American Tobacco Malaysia Bhd said it will phase out its vapor products from the Malaysian market by the third quarter of 2025 to comply with the new Control of Smoking Products for Public Health Act 2024 (Act 852).

    “In order to comply with the new regulatory requirements for vapor products as set out in Act 852 and its regulations that will take effect on Oct 1, 2025, the company will be transitioning out its current range of Vuse products in the third quarter of 2025,” BAT Malaysia said in a filing.

    The company said the transition will undertake commercial assessments of Vuse products while adhering to the new regulations, with a continued focus on “delivering combustible value growth.” BAT Malaysia expects that the exit will have a minimal impact on its financial performance for the financial year ending Dec 31, 2025. Vuse, the No. 1 global vaping brand by market share, is currently the only vapor product sold by BAT Malaysia.

    Last week, Health Minister Datuk Seri Dr Dzulkefly Ahmad said the government will intensify enforcement and regulation of electronic cigarettes and vape products under Act 852. Act 852, which first came into effect in October of last year, specifically targets individuals under the age of 18, who are prohibited from purchasing or using any smoking products, including e-cigarettes and vape devices, in Malaysia.

    In FY2024, BAT Malaysia’s gross profit margin slipped 1.2 percentage points to 23.4% or RM541 million ($124.4 million), from RM568 million ($130.6 million) in FY2023, largely due to lower margins from vapor products. 

  • PMI Retains European Vape Patent

    PMI Retains European Vape Patent

    European patent officials tossed a challenge from a British American Tobacco subsidiary allowing Philip Morris to retain its patent for a type of power supply for electronic vapes.

    The patent from PMI primarily describes a power supply system for an e-vaping device, including a sensor and a sensor holder designed to regulate airflow and house a power source. Nicoventures claimed the patent was not new because it used similar features in three older patents for its “Vuse Solo.” The BAT side argued that there were several features in the older patents that effectively served as sensor holders similar to the PMI design.

    In a Feb. 20 decision that was published yesterday (March 5), the appellate board at the European Patent Office upheld an earlier decision dismissing Nicoventures’ opposition because Philip Morris’ power supply design contains a unique structure.

    “The board concurs with the respondent’s arguments [that] the structure of the e-vaping device in [the older inventions] and the patent are not identical,” the Technical Board of Appeal said.

    PMI further argued that Nicoventures failed to prove that Vuse Solo “was available to the public before it filed its own patent application, therefore Nicoventures cannot argue that its design is not new,” Law360 wrote.

  • FDA OKs Vuse Alto Tobacco-Flavored Pods

    FDA OKs Vuse Alto Tobacco-Flavored Pods

    Photo: Postmodern Studio

    Today, the U.S. Food and Drug Administration authorized the marketing of seven e-cigarette products in the United States through the premarket tobacco product application (PMTA) pathway. Following an extensive scientific review, FDA issued marketing granted orders to R.J. Reynolds Vapor Co. (RJRVC) for the Vuse Alto Power Unit and six Vuse Alto tobacco-flavored pods, which are sealed, pre-filled, and non-refillable:

    • Vuse Alto Pod Golden Tobacco 5%
    • Vuse Alto Pod Rich Tobacco 5%
    • Vuse Alto Pod Golden Tobacco 2.4%
    • Vuse Alto Pod Rich Tobacco 2.4%
    • Vuse Alto Pod Golden Tobacco 1.8%
    • Vuse Alto Pod Rich Tobacco 1.8%

    While the FDA says it remains concerned about the risk of youth use of all e-cigarettes, youth are less likely to use tobacco‐flavored e-cigarette products compared to other flavors. According to the 2023 National Youth Tobacco Survey, Vuse was among the most commonly reported brands used by middle and high school students currently using e-cigarettes.

    However, only 6.4 percent of students who currently used e-cigarettes reported using tobacco‐flavored products. To further mitigate youth use of these products, FDA has placed stringent marketing restrictions on the new products in an effort to prevent youth access and exposure.

    The FDA has received applications for nearly 27 million deemed products and has made determinations on more than 26 million of those applications. To date, the agency has authorized 34 e-cigarette products and devices, including the seven authorized today.

    A list of all authorized e-cigarette products is available here.

    Tadeu Marroco, CEO of RJRVC’s parent company, British American Tobacco, welcomed the authorizations. “With authorizations for Alto, Vibe, Ciro and Solo, all in tobacco flavors, BAT now has the largest portfolio of vapor market authorizations provided to any U.S. organization for premarket tobacco product applications,” he said in a statement.

    However, Tadeu noted that the success of the authorized products would depend on the FDA’s progress in tackling the thriving illicit marketplace of vapor products in the United States.

    BAT also vowed it would continue to challenge the FDA’s marketing denial orders for Alto’s Menthol and Mixed Berry flavors, which were issued in October 2023. These orders have been stayed in court, which means they remain available pending resolution of the litigation.

  • Reynolds Files PMTA for Age-Gated Vuse Pro

    Reynolds Files PMTA for Age-Gated Vuse Pro

    R.J. Reynolds Vapor Co. has filed the final pre-market tobacco product application submissions with the U.S. Food and Drug Administration for its Vuse Pro age-gated device. The electronic nicotine delivery system device platform connects to a mobile application that verifies the consumer’s age through a third-party provider.

    Once verified, the device will unlock. It uses a unique design to only allow compatible Vuse Pro pods to be used. The technology and mobile application also enable features such as auto-lock and proximity lock to further secure device access.

    “Our PMTA submissions to the FDA underscore our commitment to both offering adult tobacco and vapor consumers choices as well as underage access prevention,” said Reynolds Executive Vice President of Scientific Research and Development Tim Nestor in a statement. “We don’t want our products in the hands of youth, period. The Vuse Pro ENDS platform provides a solution that limits access to adult consumers while also offering flavors that appeal to current adult smokers and a unique vapor experience.”

  • Nicotine Market Shares Flat in December

    Nicotine Market Shares Flat in December

    Tobacco Reporter Archive

    Consumer demand for nicotine products has fluctuated due to inflation and rising cigarette prices over the past 13-19 months. However, the Neilsen report covering the four-week period ending Dec. 30 shows that market shares are holding steady for both next-generation and traditional tobacco brands.

    The market share of R.J. Reynolds’ top-selling Vuse e-cigarette remained flat at 42 percent in December at convenience stores, according to the report. While Vuse’s market share was unchanged, No. 2 Juul dropped from 24.3 percent to 24.2 percent for the report covering the four-week period ending Dec. 30.

    As recently as May 2019, Juul held a 74.6 percent share in the U.S. electronic cigarette market. That’s when a series of regulatory actions led to product-reduction concessions, according to media reports.

    Meanwhile, Altria Group’s ownership of No. 3 NJoy hasn’t resulted in a meaningful market-share increase so far. Nielsen cited a research error by why it did not include an update for NJoy in the latest report. It was at 2.6 percent in the previous report.

    Fontem Ventures’ blu eCigs, an affiliate of Imperial Brands Plc, was unchanged at 1.2 percent.

    The overall e-cigarette category was down 9.9 percent.

    In traditional cigarettes, Philip Morris’ top market share was at 50.6 percent in the latest Nielsen report with top-selling Marlboro representing 45.6 percent of overall market share.

    Meanwhile, Reynolds was at 33.2 percent with Newport at 12.9 percent and followed by Camel (7.8 percent), Natural American Tobacco (3.7 percent) and Pall Mall (3.7 percent).

    ITG was at 8.5 percent overall, although ITG has said its market share is closer to 10 percent. Its No. 7 Winston brand remained at 2 percent, while Kool and Maverick remained tied for No. 8 at 1.8 percent.

    Goldman Sachs analyst Bonnie Herzog said that “in terms of specific company trends, total nicotine sales declines improved across the board for Altria, BAT, Imperial and Juul, while decelerating for all other manufacturers broadly in the latest period.”

    The decline in cigarette sales continues at a strong pace, said David Sweanor, an adjunct law professor at the University of Ottawa and the author of several e-cigarette and health studies.

    “Yet, as Altria results showed and Barclays recently highlighted, much of this is due to cross-category migration,” Sweanor said.

    “People are switching to far lower-risk options. But disposable vaping products appear to currently be the greatest factor in this migration.”

    TD Cowen analyst Vivian Azer said consumers’ cigarette “downtrading to discount and deep discount continues to benefit Imperial’s share trends.”

  • Nearly Half of Alto Users Quit Smoking: Study

    Nearly Half of Alto Users Quit Smoking: Study

    Nearly 45 percent of participants who use Vuse Alto in a study completely switched away from cigarettes, according to the interim results of research conducted by Reynolds American Inc. (RAI).

    The proportion of Vuse users who reported completely switching was higher for young adults aged 21–29 versus those who were 30 years or older; the proportion of Vuse users who reported completely switching was higher among minority demographics versus those who identified as non-Hispanic white; and the proportion of Vuse users who reported completely switching was higher among those who use menthol-flavored Vuse products versus those who use tobacco-flavored Vuse products.

    For adults who smoke and had yet to switch completely, there was a greater reduction in cigarettes smoked per day for participants who used menthol-flavored Vuse products than those who used tobacco-flavored Vuse products.

    The findings are part of a 24-month study, termed the Longitudinal Tobacco Use and Transitions Survey (LTTS), in support of RAI’s premarket tobacco product application for Vuse Alto.

    Reynolds presented a summary of the interim results through the first year of the LTTS at the Food and Drug Law Institute Tobacco and Nicotine Regulatory Product Science Symposium on March 30, 2023, to an audience that included senior officials from the U.S. Food and Drug Administration’s Center for Tobacco Products as well as several prominent public health researchers.

    James Murphy, global director of research and science, and Chris Junker, vice president of science and regulatory affairs, provided an overview of the study’s importance and interim results in a video.

    In early October, the U.S. Food and Drug Administration issued marketing denial orders (MDO) for six flavored Vuse Alto-branded products. At the request of Reynolds, an appeals court stayed the order, allowing Reynolds to continue offering Vuse Alto menthol products pending review of the company’s formal challenge of the order.

  • RJR Complaint Could Wreck Vaping Industry

    RJR Complaint Could Wreck Vaping Industry

    The implications could be far-reaching. Reynolds American Inc. (RAI)  has filed a U.S. International Trade Commission (ITC) complaint charging multiple manufacturers, distributors and retailers of several popular disposable vaping devices with unfair importation. It is one of several recent actions Reynolds has made to remove its competitor’s vaping products from store shelves.

    Reynolds is asking the ITC to investigate and issue an exclusion order preventing further U.S. imports of disposable vaping products. Several legal scholars have told Tobacco Reporter that if the ITC agrees with Reynolds, all flavored disposable vaping devices without marketing authorization could be stopped at the border and prevented from entering the U.S. market.

    Reynolds wants the ITC to issue a permanent “cease and desist order” prohibiting any businesses from selling illegal vaping products. The move would push nearly the entire vaping industry underground, with the exception of products owned by major tobacco companies such as Reynolds that have received marketing orders from the FDA.

    Several businesses were named specifically as “peddlers of illegal disposable vapes” in the Reynolds complaint, including the “manufacturers, importers, distributors and retailers” of Breeze, Elf Bar, Esco Bar, Hyde, Puff Bar, and R&M disposable vapes.

    Also named are several well-known U.S. wholesale and retailers of disposable vapes, including Element Vape, Flawless Vape, Magellan Technology, Mi-One Brands, Price Point Distributors, and Vape Sourcing.

    The ITC complaint accuses what amounts to the manufacturers of all unauthorized vaping products of importing “illegal disposable vapes” in violation of Section 337 of the Tariff Act of 1930. Specifically, Reynolds claims the named businesses either falsely advertised that their products are authorized for sale by the U.S. government, failed to comply with federal laws imposing registration and reporting requirements and limitations on sales, or violated customs laws and regulations.

    “As a result of the relentless influx of illegal vapor products flowing through U.S. borders, Reynolds American Inc. subsidiaries R.J. Reynolds Tobacco Co. and R.J. Reynolds Vapor Co. have filed a complaint with the U.S. International Trade Commission against more than 30 companies involved in illegally importing unregulated, youth appealing flavored disposable vapor products,” RAI wrote in a statement. “Many of the manufacturers of these disposable vapor devices intentionally and systematically market to youth, selling products with dessert and candy flavors and featuring cartoon characters.

    “These illegal disposable vapor devices, which have unknown ingredients and bypass regulations, are jeopardizing public health by refusing to adhere to the laws that regulate the sale of tobacco products. The complaint requests that the ITC institute an investigation into unfair acts in the importation and sale of these Chinese-manufactured, youth appealing flavored disposable vapor devices into the United States.”

    Reynolds owns the Vuse vaping brand, including the Vuse Alto. Last week, the FDA issued a marketing denial order, ordering Alto menthol refill pods off the market. The Alto device and tobacco-flavored pods are still under review by the agency. Two older Vuse vapes, the Solo and Vibe models (and their tobacco-flavored refills) are among the 23 products currently authorized by the FDA. The marketing denial order was subsequently stayed by the Fifth Circuit Court of Appeals.

    In its ITC complaint, Reynolds states it has the capacity to fill any void in the market if the illegal products were removed. “Reynolds has the capacity to replace any increase in demand if the Accused Products were excluded from importation,” the complaint states. “Reynolds is willing to meet any increased demand and can do so in a commercially reasonable time, given that it already supplies the industry with significant quantities of ENDS products, as well as oral tobacco and nicotine products.”

    The ITC has not yet made a decision on the complaint that was filed on Oct. 13.