Tag: Vuse

  • 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.

  • Court Stays Vuse Alto MDO

    Court Stays Vuse Alto MDO

    Photo: fotofabrika

    The U.S. Court of Appeals for the Fifth Circuit granted R.J. Reynolds Vapor Co. (RJRV) an emergency administrative stay of the Food and Drug Administration’s marketing denial order for menthol flavored Vuse Alto e-cigarette products.

    “We are pleased that the Fifth Circuit Court of Appeals has granted our emergency motion for temporary administrative stay of FDA’s marketing denial order for menthol flavored Vuse Alto e-cigarette products. This decision allows Reynolds to continue offering Vuse Alto Menthol e-cigarette products to adult nicotine consumers age 21+ without interruption,” Reynolds wrote in an e-mailed statement.

    “We believe appropriately regulated flavored vaping products—including menthol—are critical in supporting adult smokers who migrate from combustible cigarettes. We remain confident in the quality of Reynolds’ applications and believe there is ample evidence for FDA to determine that the marketing of these products is appropriate for the protection of public health.”

    RJRV will now apply for a formal stay and challenge the denial of its premarket tobacco product application for Vuse Alto Menthol Pods.

  • Marketing Denials for Flavored Vuse Alto

    Marketing Denials for Flavored Vuse Alto

    Image: Rangizz

    The U.S. Food and Drug Administration on Oct. 12 issued marketing denial orders (MDOs) to R.J. Reynolds Vapor Co. for six flavored e-cigarette products under its Vuse Alto brand. This includes three menthol-flavored and three mixed berry-flavored products, with each flavor being offered in three nicotine strengths.

    After reviewing the company’s PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.

    Specifically, evidence submitted by the applicant did not demonstrate that the menthol- and mixed berry-flavored products provided an added benefit for adults who smoke cigarettes—in terms of complete switching or significant smoking reduction—relative to that of tobacco-flavored products that is sufficient to outweigh the known risks to youth, according to the agency.

    “We review each application on its own merits, and it’s the responsibility of the applicant to provide sufficient science to support the product they’re seeking to market,” said Matthew Farrelly, director of the FDA’s Center for Tobacco Product’s Office of Science. “If an application contained sufficient scientific evidence to meet the necessary public health standard, including a non-tobacco-flavored product, we’d authorize the product. But such evidence was lacking in this case.” 

    Vuse is the most commonly sold e-cigarette brand in the U.S., with Vuse Alto being its most popular sub-brand. Further, findings from the National Youth Tobacco Survey (NYTS) show that Vuse e-cigarettes, which are cartridge-based products, have been the second most commonly reported e-cigarette brand used by youth in the U.S. since 2021.  

    These actions are among many the FDA has taken to ensure any tobacco products that are marketed in the U.S. undergo science-based review and receive marketing authorizations by the agency. The FDA has received applications for more than 26 million deemed products and has made determinations on 99 percent of these applications.

    To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are the only e-cigarettes that currently may be lawfully sold or distributed in the U.S. These authorizations include other products under the Vuse brand, including tobacco-flavored Vuse Vibe and Vuse Ciro devices and accompanying cartridges. Applications for six tobacco-flavored Vuse Alto products remain under FDA review.

  • World Vape Day:

    World Vape Day:

    Photo: BAT

    A new scientific study on Vuse underscores the contribution vapor products can make toward tobacco harm reduction.

    By James Murphy

    Almost 20 years ago, I joined BAT as a scientist motivated by the positive change that tobacco harm reduction (THR) can achieve. We have made great strides since then, and on days like World Vape Day, it is encouraging to see continued innovation in this area. This ambition to support THR is embodied by BAT’s release today of one of the largest vapor product studies ever conducted, further supporting the role that Vuse, BAT’s flagship vapor brand, can play in tobacco harm reduction.

    Science and research have been fundamental to the progress that I have witnessed over almost two decades at BAT. Together, they form the cornerstone of consumer and regulatory confidence in our brands. This confidence is essential for our new-category products to be able to both support THR and provide reduced-risk*† alternatives for consumers who would otherwise smoke.

    Early in my career, I had the opportunity to lead product development for BAT’s first vapor product, which would subsequently turn into Vuse: a billion-pound brand and the No. 1 global vaping brand by market share.1 Now, in 2023, there is wide acceptance that vaping continues to grow in importance as adult smokers seek reduced-risk alternatives to continued smoking.

    As director of research and science at BAT, my priority is to develop and publish science-based information needed to better understand the real-world impacts of our products. 

    Our latest study, published today in the peer-reviewed journal Internal and Emergency Medicine, is intended to do just that. By comparing clinical measurements from exclusive Vuse consumers with current smokers, the results of the study show that adult consumers using BAT’s vapor brand Vuse2 had significantly better results for biomarkers relevant to smoking-related diseases than smokers.

    For priority cigarette smoke toxicants identified by the World Health Organization, levels of exposure were significantly lower in the Vuse consumers compared to the smokers. Additionally, favorable differences between the Vuse consumers and smokers were found across all seven measured biomarkers of potential harm relevant to smoking-related diseases.

    We believe these results underscore the contribution that vapor products can make toward tobacco harm reduction and how, by using a robust evidence base to substantiate the role of reduced-risk* products, we can give adult smokers who would otherwise continue to smoke access to satisfactory reduced-risk* alternatives.

    While World Vape Day brings together a global community to converse and learn about tobacco harm reduction, there are significant barriers and challenges facing companies involved in the vaping industry. I believe a core component to overcoming these barriers is evidence-led and science-backed regulation and leadership. These two areas are key to ensuring that reduced-risk* products are only made available to adult consumers and that consumers feel confident about the quality and safety standards governing the development of alternatives like vapor products.

    In countries where the concept of tobacco harm reduction has been embraced, we have seen accelerated declines in smoking rates as smokers migrate to noncombustible products. Sweden, for instance, is on the cusp of becoming the first European country to become officially smoke-free—with smoking rates at just 5.6 percent—a 51 percent drop in a decade. Low smoking rates have also had direct benefits for Swedish public health, with cancer rates that are 41 percent lower than the rest of Europe. However, many countries are yet to offer consumers legal access to reduced-risk* products as alternatives to widely available conventional cigarettes.

    I am more convinced than ever that tobacco harm reduction has the potential to be transformative for our consumers and significantly lower currently projected smoking rates worldwide.

    There is a clear opportunity to use the scientific evidence we now have available to substantiate the benefits of reduced-risk* products for those who would otherwise smoke. Looking ahead, I am increasingly confident that the quality of ongoing research from us, other manufacturers, academics and public health authorities—combined with open and honest debate with a diverse range of political, regulatory and public health stakeholders—will accelerate tobacco harm reduction.

    James Murphy is the director of research and science at BAT.

    * Based on the weight of evidence and assuming a complete switch from cigarette smoking. These products are not risk-free and are addictive.

    † Our products as sold in the U.S., including Vuse, Velo, Grizzly, Kodiak and Camel Snus, are subject to FDA regulation, and no reduced-risk claims will be made as to these products without agency clearance.

    1 Based on Vype/Vuse estimated value share from recommended retail price in measured retail for vapor (i.e., total vapor category value in retail sales) in the U.S., Canada, France, the U.K. and Germany. These five markets cover an estimated 77 percent of global vapor closed-system net turnover, calculated in June-July 2021.

    2 The study focused on self-reported exclusive users of commercially available Vuse ePod or Vuse ePen3. Thus, references to “Vuse” in the context of the study means either Vuse ePod or Vuse ePen3.

  • Vuse Market Share Grows While Juul Drops

    Vuse Market Share Grows While Juul Drops

    Image: Tobacco Reporter archive

    R.J. Reynolds Vapor Co. has continued to expand Vuse’s market share gap with Juul, according to the latest Nielsen convenience store report.

    Vuse’s market share rose from 41.5 percent in the previous report to 42.2 percent compared with Juul declining to 26.1 percent.

    The latest Nielsen analysis covers the four-week period ending March 25, according to media reports.

    According to Barclays, Nielsen largely covers the big chains. For the smaller chains, the group extrapolates trends, which is why trend changes don’t appear immediately in Nielsen.

    Consumer demand for tobacco products has ebbed and flowed over the past 12 months, mostly from the impact of inflation and recent upticks in traditional cigarette prices.

    No. 3 Njoy was unchanged at 2.7 percent while Fontem Ventures’ blu eCigs were unchanged at 1.4 percent.

    On March 6, Altria Group Inc. delivered another shake-up to the tobacco industry by confirming it would pay $2.75 billion in cash to take full ownership of Njoy.

    Altria cleared the way for the Njoy purchase by exiting its minority stake in No. 2 e-cigarette company Juul while acquiring global licensing rights.

    Juul’s four-week dollar sales in the latest report have dropped from a 50.2 percent increase in the Aug. 10, 2019, report to a 23.9 percent decline in the latest report.

    By comparison, Reynolds’ Vuse was up 31.1 percent in the latest report while Njoy was down 10.9 percent, blu eCigs were down 37.4 percent and Japan Tobacco’s Logic was up 5.2 percent.

    As recently as May 2019, Juul held a 74.6 percent U.S. e-cigarette market share.

  • Vuse Menthol Pods Granted Stay

    Vuse Menthol Pods Granted Stay

    Image: Tobacco Reporter archive

    Two menthol Vuse flavors that received a marketing denial order (MDO) can continue to be marketed by R.J. Reynolds Vapor Co. after the federal 5th Circuit Court of Appeals issued a stay.

    Last week, the U.S. Food and Drug Administration denied Reynolds Vapor’s premarket tobacco product applications for the Vuse replacement cartridge Menthol 4.8 percent G1 and the Vuse replacement cartridge Menthol 4.8 percent G2.

    As a result, Reynolds would be prohibited from marketing or distributing the products domestically or risk FDA enforcement action. However, the appeals court’s decision allows the products to stay in the marketplace.

    In October last year, the FDA issued MDOs for several menthol-flavored vaping products marketed by Logic Technology Development. It was the first time the FDA issued MDOs for menthol products after receiving a scientific review.

    A few days after the order was issued, Logic obtained a court order from the U.S. Circuit Court of Appeals for the 3rd Circuit that temporarily stayed the order.