R. J. Reynolds Vapor Co.

Company Must Stop Marketing Unauthorized Products The company must not market or distribute these products in the U.S. or they risk FDA enforcement action. (Credit: CDC on Unsplash) Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company under the Vuse Solo brand. The currently marketed products include the Vuse Replacement Cartridge Menthol 4.8% G1 and the Vuse Replacement Cartridge Menthol 4.8% G2. The company must not market or distribute these products in the U.S. or they risk FDA enforcement action. The company may resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs. The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the risks and benefits of the product on the population as a whole. After reviewing the company’s PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health, which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. Specifically, evidence submitted by the applicant did not demonstrate that its menthol-flavored e-cigarettes provide an added benefit for adult smokers relative to tobacco-flavored e-cigarettes. “The FDA is a data driven agency and science remains the cornerstone of our tobacco product regulatory activities,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “The science has guided – and will always guide – the FDA’s decision making on premarket tobacco product applications, including today’s marketing denial orders.” Existing evidence, including data from the 2022 National Youth Tobacco Survey (NYTS), shows that non-tobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, have a known and substantial risk with regard to youth appeal, uptake and use. In contrast, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk. Given these existing differences in youth risk, applicants need to provide robust evidence to demonstrate that using their menthol-flavored e-cigarette products are likely to promote complete switching or are likely to significantly reduce combustible cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarettes. NYTS data also found Vuse to be the second most common brand youth e-cigarette users reported “usually” using. These products cannot be legally introduced into interstate commerce in the U.S. without risking FDA enforcement. In addition to ensuring that the manufacturer complies with this order, as with unauthorized products generally, the FDA intends to ensure compliance by distributors and retailers. Retailers should contact R.J. Reynolds Vapor Company with any questions about products in their inventory. Source: Company Press Release

Dublin, Aug. 18, 2021 (GLOBE NEWSWIRE) -- The "Hot Tobacco Global Market Report 2021: COVID-19 Growth and Change to 2030" report has been added to ResearchAndMarkets.com's offering. The global hot tobacco market is expected to grow from $7.53 billion in 2020 to $10.63 billion in 2021 at a compound annual growth rate (CAGR) of 41.2%. The market is expected to reach $42.41 billion in 2025 at a CAGR of 41%. Hot Tobacco Global Market Report 2021 provides the strategists, marketers and senior management with the critical information they need to assess the global hot tobacco products market. Major players in the hot tobacco products market are Philip Morris International, Japan Tobacco International (JTI), British American Tobacco, Imperial Brands, KT&G Corp., Eli Lilly and Company, RJ Reynolds Vapor Company (RJRVC), Shenzhen AVBAD Technology Company Ltd., Pax Labs and Vapor Tobacco Manufacturing.The hot tobacco products market consists of sales of hot tobacco products and its related services. Hot tobacco is also known as heated tobacco or heat-not-burn tobacco or hybrid tobacco. Heated Tobacco Products (HTPs) produce aerosols containing nicotine and other chemicals, which are inhaled by users through the mouth. These use specific tobacco products to be heated at temperatures below combustion levels. Hot tobacco products release flavors with nicotine and allow the user to enjoy tobacco without combustion. The approvals by the government bodies are anticipated to drive the demand for the hot tobacco products market during the period. For instance, in April 2019, the U.S. Food and Drug Administration (FDA) have authorized the marketing of new heating tobacco products, iQOS, manufactured by Philips Morris International.The increasing popularity of e-cigarettes is projected to limit the growth of the hot tobacco market. E-cigarettes are battery-powered devices and are considered less harmful as they do not contain tobacco. These devices vaporize liquid which contains nicotine to imitate conventional smoking. Thus, the growing popularity of vape products and e-cigarettes are projected to hinder the growth of the hot tobacco products market in the near future. The hot tobacco products market covered in this report is segmented by product type into HNB tobacco devices; direct/indirect heating HNB tobacco; infused/hybrid HNB tobacco devices; HNB tobacco consumables; HNB tobacco sticks; HNB tobacco capsules and cartridges. It is also segmented by type into devices; capsules; vaporizers and by distribution channel into retail stores; online websites.The launch of new heated tobacco products across the globe is a leading trend driving the growth of the hot tobacco products market. For instance, in September 2019, British American Tobacco (BAT), cigarette and tobacco manufacturing company based in London, England, announced the launch of two new heating tobacco products- Glo Nano and Glo Pro in Japan market, under its Glo Bran. Similarly, in October 2019, Altria Group, Inc., engaged in producing and marketing of tobacco, cigarettes and related products, announced the launch of IQOS tobacco device in the USA. IQOS is a device that heats tobacco without burning it in order to give a similar experience to the user as smoking with fewer toxins. Therefore, the continuous launch of new hot tobacco products in the market is projected to be a major trend in the market over the approaching years.Key Topics Covered: 1. Executive Summary 2. Hot Tobacco Products Market Characteristics 3. Hot Tobacco Products Market Trends and Strategies 4. Impact of COVID-19 on Hot Tobacco Products 5. Hot Tobacco Products Market Size and Growth 5.1. Global Hot Tobacco Products Historic Market, 2015-2020, $ Billion 5.1.1. Drivers of the Market 5.1.2. Restraints on The Market 5.2. Global Hot Tobacco Products Forecast Market, 2020-2025F, 2030F, $ Billion 5.2.1. Drivers of the Market 5.2.2. Restraints on the Market 6. Hot Tobacco Products Market Segmentation 6.1. Global Hot Tobacco Products Market, Segmentation By Product, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion 6.2. Global Hot Tobacco Products Market, Segmentation By Type, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion 6.3. Global Hot Tobacco Products Market, Segmentation By Distribution Channel, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion 7. Hot Tobacco Products Market Regional and Country Analysis 7.1. Global Hot Tobacco Products Market, Split By Region, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion 7.2. Global Hot Tobacco Products Market, Split By Country, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion Companies Mentioned For more information about this report visit