Author: Staff Writer

  • U.S. FDA Sends Another Round of Warning Letters

    U.S. FDA Sends Another Round of Warning Letters

    The U.S. Food and Drug Administration (FDA) issued warning letters to 18 manufacturers selling unauthorized e-liquids. The companies did not submit premarket tobacco product applications (PMTAs) by the Sept. 9, 2020, deadline. It’s the second time in February 2021 that the agency has sent warning letters for illegal e-liquids.

    peanut butter crunch e-liquid bottle
    Peanut Butter Crunch Time from California Vaping Co.

    The companies that received warning letters include Square Vape Labs, The Vapor Emporium, Tally Ho Vapor Tonic, The Vape Corner., Dripco d/b/a Dripco Vape Co., VaporIce, Vapor Maven E-Juice, Vapor City Plus, Vapor Invasion, Vaporatory, Chuckin’ Clouds Vape Shop, Black Dog Reserve, California Vaping Company, The Chubby Baker, Smooth, Bulldog Vapor, Adore eLiquid and E-Cig Outlet.

    While each warning letter issued cites specific products as examples, collectively these companies have listed a combined total of more than 234,000 products with the FDA.

    Per a court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-liquids—were required to be submitted to the FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, the FDA generally intends to continue to defer enforcement for up to one year pending review unless there is a negative action taken by the FDA on the application.

    The FDA recently published an update on its progress on the processing and review of the applications received by Sept. 9, including a list of companies that submitted timely applications.

  • P.E.I. Flavor Ban for Vapor Products Starts Today

    P.E.I. Flavor Ban for Vapor Products Starts Today

    Flavored vaping products are banned on Prince Edward Island in Canada. The regulation changes were passed by cabinet in August of last year. It comes as part of a private members bill from PC MLA Cory Deagle, which received unanimous support from the legislature in 2019, to crack down on nicotine use among young people.

    man holding flavored vape products
    Manager J-K Thorne holds some of the flavored products that are no longer available at Wild Impulse vape shop. (Shane Hennessey/CBC – image credit)

    “The only flavor you’ll be able to use would be tobacco flavored so all those other flavors will be gone,” Deagle said. “This is probably one of the biggest steps that we’re going to see trying to get rid of, or at least reduce, the amount of youth that are vaping.”

    Vendors were notified of the upcoming ban on flavored products in August 2020, in a letter distributed by the Department of Health and Wellness, according to the CBC. The letter said the department believed that with six month advance notice, “tobacconist shops have sufficient time to deplete their inventory of flavored electronic smoking device products.”

    At Wild Impulse, a vape shop in Charlottetown, the shelves were still full of flavored products last Friday afternoon, with the ban just days away. Manager J-K Thorne said the store carries more than 45 flavors for vaping, but as of March 1st, they will only be able to sell ones that are tobacco flavored, flavorless or labelled clear, adding that the flavor ban is also pushing former smokers back to combustible cigarettes.

    “Customers are a little disappointed. They feel that they have something to lean on if they wanted to get off cigarettes,” Thorne said. “They found that the tobacco flavor actually reminded them of cigarettes, but it wasn’t good enough, and it actually brought them back to buying cigarettes, which is a little unfortunate.”

  • Kaival Expands Distribution for Bidi Stick to 46,000 Stores

    Kaival Expands Distribution for Bidi Stick to 46,000 Stores

    Kaival Brands has three new distribution partners for its Bidi Vapor products: Smoker Friendly International, Avail Vapor and Hilmes Distributing. These three additional distributors push the potential U.S. store count for Bidi Vapor products above 46,000, up from 10,000 in 2020.

    According to Bidi Vapor, distributor interest in its products has increased greatly following its receipt of a premarket tobacco product application filing letter from the Food and Drug Administration. As the company’s product moves into the substantive review phase, Bidi Vapor anticipates it will continue to update investors on additional new distribution agreements.

    “These new partners will become a large new revenue stream for Bidi and Kaival,” said Niraj Patel, CEO of Kaival Brands, in a statement. “It is important to note our 2020 sales of just under $100 million were achieved with a distribution network of 10,000 stores and in less than 10 months of operation.

    “Today’s new distribution partner announcements bring our network to over 46,000 store locations. The strength and breadth of these partnerships fuels our confidence in our ability to meet or exceed our 2021 projection of $400 [million] to 450 million in sales.”

  • U.S. Senator Romney Calls for Federal Flavor Ban

    U.S. Senator Romney Calls for Federal Flavor Ban

    Utah Sen. Mitt Romney on Thursday pushed for flavored vaping products to be pulled from shelves across the United States. Romney introduced legislation in Sept. 2019 that would have banned the sale of all flavored vape products except tobacco flavors, but it was never taken up for a vote.

    Credit: Office of Mitt Romney

    Romney’s comments during the confirmation hearing for President Joe Biden’s nominee for surgeon general, Vivek Murthy, echo similar statements the senator has made in the past, according to kutv.com.

    “The analysis shows that nearly one fourth of high school kids are vaping on a regular basis — tobacco products — and in many cases marijuana, as well,” Romney said, adding that the government needs to do everything it can to stop the sale of flavored vaping products and implement a robust public education campaign to warn kids about the dangers of vaping.

    In Oct. 2019, the Utah Department of Health issued an emergency order banning the sale of flavored vape products in Utah, which was met swiftly with a lawsuit from tobacco retailers. The products remain available for sale today.

    In 2019, the legal age to purchase tobacco products in the U.S. was raised from 18 to 21.

  • TPE Still Planned for May 12-14 in Las Vegas

    TPE Still Planned for May 12-14 in Las Vegas

    The vapor industry may find a semblance of normalcy in Las Vegas this Spring. The Tobacco Plus Expo (TPE) tradeshow is scheduled to take place May 12-14. The TPE is traditionally been the first vapor and alternative products tradeshow of the year.

    Team Innokin / Credit: TS Donahue

    The industry only show includes numerous vaping nicotine hardware and e-liquid suppliers, as well as numerous members of the cannabis industry. Owned by Kretek International Inc., the TPE was originally to be held in January.
     
    A press release states that the show will be following Covid-19 protocols to ensure the safety of both exhibitors and attendees. Masks will be mandatory on the show floor (meaning attendees cannot walk around and vape) and there will be temperature checks, sanitizing stations and social distancing.

    Exhibitors will be permitted to vape at their booths, and there will be designated vaping areas for those attending the show. For more information, visit tobaccoplusexpo.com.

  • Vuse Alto Going National Across United States

    Vuse Alto Going National Across United States

    The Vuse vapor brand announced today a national expansion in the United States of Vuse Alto Golden Tobacco 5.0 percent and Alto Menthol 5.0 percent four-pod packs and the national release of Vuse Alto Golden Tobacco 2.4 percent and Alto Menthol 2.4 percent four-pod packs.

    vuse alto
    Credit: RJR Vapor Co.

    The four-pod packs provide adult vapor consumers with three Vuse Alto configuration options as they can now choose from single-pod, two-pod or four-pod packs. The national availability of four-pod packs gives Vuse the most expansive portfolio of choice for adult vapor consumers with three flavors, in three nicotine strengths across three configuration formats, as well as the many options for device customization with a range of device colors, wraps and engraving options.

    “Done responsibly, our ambition is to make Vuse the No. 1 vapor brand in the U.S. market,” said Christy Canary-Garner, vice president—Vuse commercial development at R.J. Reynolds Vapor Co, in a statement.  “This portfolio expansion provides us with the opportunity to better compete and enhances our price competitiveness to drive conversion among existing adult vapor consumers and boost loyalty.

    “The four-pod pack configuration is the most popular among competitive pod-mod vapor products and 4-pod packs enable Vuse Alto to compete against competitors on a per-pod price point. The new four-pod packs are available to all retail outlets.

    vuse alto
    Credit: RJR Vapor Co.

    “Coupled with our release of single-pods in November of 2020, this national rollout of four-pod packs now gives adult Vuse consumers more options than any other brand.”

    The national expansion of the four-pod packs will begin this week.

  • Vermont Revives Bill to Ban Flavored Vape Products

    Vermont Revives Bill to Ban Flavored Vape Products

    The U.S. state of Vermont is once again floating the idea of proposing legislation that seeks to ban the sale of flavored vaping products. Support for the bill is gaining traction in the state’s senate and would also ban flavored combustible tobacco, including menthol cigarettes.Flavored nicotine products

    The ban was originally proposed in early 2020 as a way to prevent youth use, but was sidelined after the Covid-19 pandemic began to impact the country. Ginny Lyons, chair of the Senate Committee on Health and Welfare, said in an interview this week that she’d like the Senate to pass the bill, S.24, “as quickly as possible.” She said use of nicotine products by young people has increased during the Covid-19 pandemic, according to vtdigger.com

    If Vermont approved a ban on flavored e-cigarettes, it would be the third state to do so. Massachusetts banned flavored vapes and tobacco products in 2019, and California followed suit last year. However, California’s law was blocked after the tobacco industry moved successfully to have voters decide on the ban in a statewide referendum next year.

    “During the pandemic, we’ve seen a real fallback from all the progress we’ve made on limiting youth access to tobacco and other flavored products, so it seems more important than ever to move forward with this bill,” Lyons said. “If we were only to eliminate all the other flavors and leave menthol on the market, we would see a transition of people to those menthol products, and we would be backsliding again.”

  • Juul Labs: Dual Use Often Ends in Transition to Vapor

    Juul Labs: Dual Use Often Ends in Transition to Vapor

    Photo: Juul Labs

    Juul Labs announced findings from its science and research program at the 2021 Annual Meeting of the Society for Research on Nicotine & Tobacco (SRNT), which was held virtually. The studies presented covered a wide range of topics that contribute to the growing body of scientific evidence on ENDS products, including information about their harm reduction potential as well as rates of complete switching to ENDS among adult smokers.

    To better understand patterns of tobacco product use among adult smokers, Juul Labs has developed an extensive behavioral research program that includes measurements of complete switching from combustible cigarettes to the Juul System among adult smokers. Among the data presented at SRNT are the results of a longitudinal study which found that more than 50 percent of adult smokers who purchased the Juul System reported complete switching at a 12-month follow-up assessment. Complete switching was defined as no cigarette smoking in the past 30 days.

    Another new study presented this week examined trends in dual use of the Juul System and cigarettes among adult smokers who recently purchased Juul products, as well as any changes in cigarette consumption among these dual-users. While dual use of Juul products and cigarettes was initially high, it declined over time, and most adult smokers who began by dual-using ultimately switched completely away from cigarettes 12 months after initial purchase. Additionally, over 60 percent of dual-users at 12 months substantially reduced their average daily cigarette consumption. Researchers concluded that dual use is often a transitional stage characterized by reductions in cigarette consumption followed by complete switching away from cigarettes.

  • UK Health Group: Vapor Works as Quit-Smoking Aid

    UK Health Group: Vapor Works as Quit-Smoking Aid

    Nicotine vaping products were the most popular quit-smoking aids (27.2 percent) in England in 2020, according to Public Health England’s (PHE) seventh independent report on vaping, carried out by researchers at King’s College London. Using a vaping product as part of a quit attempt in local stop smoking services had some of the highest quit success rates—between 59.7 percent and 74 percent in 2019 and 2020. An estimated 50,000 smokers stopped smoking with the aid of a vaping product in 2017.

    Despite these trends, 38 percent of smokers in 2020 believed that vaping is as harmful as smoking; with 15 percent believing that vaping is more harmful

    The coronavirus pandemic is likely to have had an impact on smoking and vaping behaviors in both adults and young people. However, it is still too early to assess the full effect of the pandemic, with much of the data examined in this report being pre-pandemic.

    Vaping has plateaued in adults and young people since the last PHE report in March 2020. Around 4.8 percent of young people (aged 11 to 18 years) reported vaping at least once a month—the same as last year—and most of these were either current or former smokers (only 0.8 percent of young people who had never smoked currently vape). Smoking prevalence among young people, including those who smoked sometimes or more than once a week, was 6.7 percent in March 2020, similar to March 2019, at 6.3 percent.

    Similar to last year, around 6 percent of adults are current vapers, equating to about 2.7 million adult vapers in England. Smoking prevalence continues to fall and is between 13.8 percent and 16 percent depending on the survey. Vaping prevalence was between 17.5 percent and 20.1 percent among current smokers, around 11 percent among former smokers and between 0.3 percent and 0.6 percent among those who have never smoked. The proportion of vapers who also smoke, or “dual users,” has declined since 2012.

    “Our report draws together findings from randomized controlled trials, stop-smoking services and population studies and concludes that nicotine vaping products are an effective way of successfully quitting smoking,” said Ann McNeill, professor of tobacco addiction at King’s College London.

    “What is concerning is that smokers, particularly those from disadvantaged groups, incorrectly and increasingly believe that vaping is as harmful as smoking. This is not true and means fewer smokers try vaping.

    “The goal for 2030 is to be smokefree in England. The development of a new Tobacco Control Plan and this year’s review of the Tobacco and Related Products Regulations 2016 is an opportunity to ensure that the regulations around vaping are appropriate. The regulations are also hoped to help smokers to quit, while not attracting people who have never smoked.”

  • Bidi Vapor PMTA Moves to Substantive Review Phase

    Bidi Vapor PMTA Moves to Substantive Review Phase

    Kaival Brands Innovations Group, the global distributor of all Bidi Vapor products, announced its premarket tobacco product application (PMTA) has moved the substantive review phase of the regulatory process. Bidi’s disposable e-cigarettes, Bidi Stick, comes in 11 flavor varieties, according to a press release.

    Substantive Review is where the scientific review of the U.S. FDA’s regulatory process is undertaken. The company received its acceptance letter, the first step, on Feb. 9. The FDA will determine if Bidi products meet the criteria for “appropriate for the protection of the public health” established in the Tobacco Control Act. The agency issues marketing orders that authorize the continued marketing and sale of products meeting the criteria.

    “Seeking an order for the continued marketing of Bidi Sticks in the United States is a long process. But it was always our goal to provide a premium vaping experience and an option to traditional, combustible tobacco that meets the needs of every adult smoker,” said Niraj Patel, the president and CEO of Kaival Brands. “This substantive review phase is where months of extensive information collection and hard work gathering together 285,000 pages of science-based evidence will pay off, as we continually put consumer health and the environment first.”

    Bidi Vapor also announced they have discontinued their online direct-to-consumer (DTC) sales through its website as of February 22, 2021. The company will allow sales through gopuff.com. “With a long history of distribution of alcoholic beverages, goPuff has pioneered a very stringent and dynamic compliance program and age-gating process,” the release states.

    “We are extremely excited to partner with one of the fastest growing and most secure online delivery services in the country,” stated Kaival Brands’ Chief Executive Officer, Niraj Patel. “More importantly, goPuff’s commitment to protecting minors and stringent procedural implementations will allow Kaival Brands to focus on our rapidly developing additional wholesaler distribution agreements.”

    While Kaival Brands will continue its business-to-business (B2B) online sales to retailers, it believes its decision to halt online DTC sales specifically through www.bidivapor.com will set an example for the industry and help reduce the larger problem of underage access to vaping devices. “The decision also bolsters its commitment to brick-and-mortar retail, which Kaival Brands believes to be a stronger age-verification distribution model than online sales,” the release states.