Tag: Vuse

  • FDA OKs Vuse Alto Tobacco-Flavor Pods, Device

    FDA OKs Vuse Alto Tobacco-Flavor Pods, Device

    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. 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.

  • Reynolds Files PMTA for Age-Gated Vuse Pro System

    Reynolds Files PMTA for Age-Gated Vuse Pro System

    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.”

  • Vuse’s Market Share Lead Stays Static in December

    Vuse’s Market Share Lead Stays Static in December

    Credit: RJR Vapor Co.

    The latest Nielsen report shows that the market share of R.J. Reynolds’ top-selling Vuse e-cigarette remained flat at 42 percent in December at convenience stores.

    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.

  • Vuse Market-Share Lead Over Juul Continues to Grow

    Vuse Market-Share Lead Over Juul Continues to Grow

    Credit: Konstiantyn Zapylaie

    R.J. Reynolds’ top-selling Vuse electronic cigarette saw an increase in market share after a recent small decline, according to the latest Nielsen convenience store report for the four-week period ending Dec. 2.

    Vuse’s market share rose from 41.5 percent to 42 percent, surpassing No. 2 Juul which dropped from 24.7 percent to 24.3 percent.

    In May 2019, Juul held a dominant 74.6 percent share of the U.S. e-cigarette market, but regulatory actions led to a decrease in product availability.

    Despite Altria Group’s ownership of No. 3 NJoy, their market share remained stagnant at 2.6 percent.

    Fontem Ventures’ blu eCigs, affiliated with Imperial Brands Plc, also had no change in market share at 1.2 percent. Overall, the e-cigarette category saw an 8 percent decline during this period.

  • Vuse Continues to Grow Market Share Over Juul

    Vuse Continues to Grow Market Share Over Juul

    Credit: RJR Vapor Co.

    The latest Nielsen convenience store report covering the period ending November 4th shows the market share for R.J. Reynolds Vapor Co.’s Vuse electronic cigarette continues to grow over rival Juul.

    Vuse’s market share rose from 41.8% to 42.1%, compared with No. 2 Juul being unchanged at 24.4%.

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

    Meanwhile, Altria Group’s ownership of No. 3 NJoy hasn’t resulted in a meaningful market-share increase so far. It remained unchanged at 2.5%, according to the Winston-Salem Journal.

    Fontem Ventures’ blu eCigs, an affiliate of Imperial Brands Plc, was unchanged at 1.3%.

    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.

    Altria Group and British American Tobacco have issued a warning about the surge in “illicit” synthetic nicotine electronic cigarettes in the U.S. vaping market. Both companies have estimated those synthetic products represent about half of the overall domestic market.

    In July, BAT’s president and chief executive Tadeu Marroco expressed his frustration to analysts about the proliferation of “unauthorized products” in the U.S. vapor market.

    Marroco’s concerns come in large part because of the pivotal revenue role Vuse is playing toward BAT achieving its fiscal 2024 goal of achieving annual profitability for its new-category products and its 2025 goal of at least $6.4 billion in new-category product revenue.

    By comparison, Reynolds’ Vuse was down 1% in the latest report, while NJoy was down 13.7% and blu eCigs were down 15%. The overall e-cigarette category was down 8.1%.

    The recent heightened pressure on overall tobacco industry volumes and sales remained steady over the four-week period.

    The Nielsen report reflects the banning of traditional menthol cigarettes in California in December, which represents about 8% of the national marketplace.

  • Study Finds Nearly Half of Vuse Alto Users Quit Smoking

    Study Finds Nearly Half of Vuse Alto Users Quit Smoking

    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.

  • Reynolds ITC Complaint Could Destroy Vape Industry

    Reynolds ITC Complaint Could Destroy Vape Industry

    The implications could be far-reaching. R.J. Reynolds 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 Vapor Voice that if the ITC agrees with Reynolds, all flavored disposable vaping devices without a U.S. Food and Drug Administration 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.

    Reynolds owns the Vuse vaping brand, including the Vuse Alto. Last week, the FDA issued a marketing denial order (MDO), 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.

    Reynolds also 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.

  • FDA Denies Marketing Order for Flavored Vuse Alto Pods

    FDA Denies Marketing Order for Flavored Vuse Alto Pods

    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% 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.

  • BAT Launches New Vuse 800 Disposable in Korea

    BAT Launches New Vuse 800 Disposable in Korea

    BAT Rothmans, the Korean unit of BAT, debuted Vuse 800 in Korea, marking the first launch in Asia, according to The Korea Herald.

    The battery-powered e-liquid cigarette product allows up to 800 puffs without charging. There are four flavor options available.

    In the U.S., Vuse accounts for nearly half the market.

    Vuse’s U.S. market share declined from 42.2 percent to 41.8 percent, compared with Juul declining from 26.1 percent to 26 percent.

    In March of this year, Altria Group announced it had entered into an agreement to acquire Njoy Holdings for approximately $2.75 billion in cash.

    Altria said it had multiple sources of funding for the deal, including cash from a $2.7 billion agreement with Philip Morris International last year for IQOS. 

    A day before the Njoy announcement, Altria Group announced it had exchanged its entire investment in Juul Labs for a non-exclusive, irrevocable global license to certain of Juul’s heated tobacco intellectual property.

  • Vuse and Juul Both See Slight Dip in Market Share

    Vuse and Juul Both See Slight Dip in Market Share

    A slight dip in the market-share lead of R.J. Reynolds Vapor Co.’s Vuse vaping system was announced in the latest Nielsen convenience store report released last week.

    Vuse’s market share declined from 42.2 percent to 41.8 percent, compared with Juul declining from 26.1 percent to 26 percent.

    The latest Nielsen analysis covers the four-week period ending April 22.

    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. Local vape shops are not included in the data.

    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, according to media reports.

    No. 3 NJoy was unchanged at 2.7 percent, while Fontem Ventures’ blu eCigs was unchanged at 1.4 percent.

    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 22.6 percent decline in the latest report.

    By comparison, Reynolds’ Vuse was up 23.1 percent in the latest report, while NJoy was down 8.1 percent, blu eCigs down 35.1 percent and Japan Tobacco’s Logic up 4.9 percent.

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

    In March of this year, Altria Group announced it had entered into an agreement to acquire Njoy Holdings for approximately $2.75 billion in cash. Altria said it had multiple sources of funding for the deal, including cash from a $2.7 billion agreement with Philip Morris International last year for IQOS. 

    A day before the Njoy announcement, Altria Group announced it had exchanged its entire investment in Juul Labs for a non-exclusive, irrevocable global license to certain of Juul’s heated tobacco intellectual property.