Tag: news

  • Medad Pioneers Ultrasound Water Pipe for Shisha

    Medad Pioneers Ultrasound Water Pipe for Shisha

    Image: Studio217

    Medad Technology has developed a shisha pipe that it says is less harmful to health than traditional hookah, reports The National.

    Unveiled at the recent World Vape Show in Dubai, the company’s Nesta pipe delivers a nicotine hit via ultrasonic vibrations, which could cut cancer risk from inhaling toxic fumes, according to Medad Technology.

    The device’s patented algorithm reportedly produces mist droplets containing nicotine that are evenly distributed as they are inhaled.

    Misting is distinct from vaping as it uses ultrasound technology rather than heat. The absence of charcoal and tobacco means the product generates none of the harmful carbon emissions or toxic fumes that are usually inhaled by users of traditional hookah pipes, according to the company.

    “The challenge was to develop real, alternative products that were safer than shisha and e-cigarettes, not categorized under vaping, so a completely new product,” Medad Holding CEO Mohammed Al Mazrouei was quoted as saying.

    The device has been approved by the European Union Medical Agency and by the U.K.’s Medicines and Healthcare Products Regulatory Agency, according to Medad Holding.  

    It is under review by UAE authorities. The company is planning to also apply for approval by the U.S. Food and Drug Administration.

    An estimated 100 million people use shisha, or similar water pipes, on a daily basis around the world.

     

  • Juul Expected to be Pulled From Market Soon

    Juul Expected to be Pulled From Market Soon

    Let the shock settle in. The U.S. Food and Drug Administration is preparing to order Juul Labs to take its e-cigarettes off the market in the United States, the Wall Street Journal reported on Wednesday, citing people familiar with the matter.

    Todd Cecil, deputy director for the FDA’s Center for Tobacco Products’ Office of Science, told Vapor Voice during the Next Generation Nicotine Delivery seminar in Miami that he could not make a comment on the Juul decision until the FDA formerly issues a marketing denial order (MDO).

    The news sent Altria’s stock (MO) on a massive drop, falling more than 10 percent once the news broke.

    Wells Fargo analyst Bonnie Herzog wrote in an email that while the news comes as a bit of a surprise, she doesn’t believe all is lost for Altria and the company has several options it can pursue, adding that the sell-off today is overdone with the stock having lost an estimated $7 billion of market capital.

    “First, assuming the FDA does in fact issue an MDO for Juul, we believe the impact is far from certain given Juul’s likely options to appeal or challenge it (via a court decision similar to Kaival Brands’ approach for Bidi Vapor Sticks and IMB’s use of the appeals process for myblu), revise its [premarket tobacco product application] PMTA application, or sue the FDA altogether,” wrote Herzog. “Also, with no detail yet on the FDA’s rationale, it is tough to know how the agency is thinking about an MDO on Juul in the context of its broader efforts to encourage adult smokers to quit and/or move down the continuum of risk to less harmful alternatives (e.g., e-vapor, heat-not-burn, oral nicotine pouches, etc) especially given Juul’s critical leadership in e-cigs.

    “While it is unclear how the FDA is thinking about the remaining PMTAs that are pending (especially the popular VUSE Alto line), we have a hard time imagining the FDA would categorically remove highly popular e-cig brands without ensuring a suitable off-ramp for users (that isn’t back to combustible cigs).”

    It is expected that Juul will receive the MDO in a response to its PMTA because of its product’s potential to appeal to youth. The company has also seen a slump in sales recently, and has been taken over by RJ Reynolds Vapor Company’s Vuse brand e-cigarette in Nielsen rankings for the last two quarters.

    “We expect the company to appeal, with the products remaining on the market,” Vivien Azer, managing director for cannabis, consumer beverages and tobacco at Cowen Inc., New York, said in a research note.

    George Cassels-Smith, CEO of Tobacco Technologies, says Juul receiving an MDO is ridiculous. “For a company that has that has been a standard in this industry and has some of the highest quality products on the market, its shocking,” he said. “The company has tried hard to move past its early issues of appealing to youth. This isn’t appropriate for the protection of public health and it isn’t good for the industry. It hurts adult smokers because Juul is a product that is successful in helping smokers switch.”

    The decision is likely celebrated by some anti-nicotine groups who say Juul is the cause of the rise in teen vaping. That rise has also declined dramatically over the last 2-3 years. Recently, Juul Labs also settled several lawsuits related to youth marketing. Juul Labs — until recently the market leader in e-cigarette product sales — admitted to no wrongdoing in any of its settlements.

    Tony Abboud, executive director of the Vapor Technology Association (VTA) said that he was surprised by the news because Juul was always expected to get an approval order.

    “The reported denial of Juul’s PMTA application is stunning. While the company has certainly been at the epicenter of conflict, the amount of rigorous, peer reviewed science supporting their products’ ability to help smokers quit, raises serious questions about the FDA’s subjective balancing test, and whether public pressure campaigns will steer science policy,” said Abboud.

    Americans for Tax Reform (ATR) strongly condemned the decision. Tim Andrews, ATR’s director of consumer issues, said the Juul MDO will devastate public health across the country, and lead to easily preventable deaths.

    “Juul’s reduced risk tobacco alternatives are critical tools of smoking cessation that have been proven to help cigarette smokers across the U.S. save their lives through transitioning away from deadly combustible tobacco,” he said. ““This is a decision grounded in ideology, not science. It is a decision that will cause countless deaths that could have otherwise been prevented. For the sake of public health, it is a decision we hope will be overturned in the courts on appeal.”

    In 2018, Altria spent nearly $13 billion taking a 35 percent stake in Juul. The company has taken non-cash charges on the investment as regulatory scrutiny of Juul and its marketing practices have impacted sales. As of March 31, Altria said the estimated fair value of its investment in Juul was $1.6 billion.

    In 2019, Juul Labs announced it was suspending its print, broadcast and online advertising in the United States. That same year it halted the sale of its fruit and dessert flavors — including mango, creme brulee and cucumber — that were seen as a significant lure for teen users. The FDA also recently instituted a proposed rule to place a ban on menthol combustible cigarettes and flavored cigars. The menthol ban will not yet cover next-generation tobacco products, such as e-cigarettes, but the FDA has the authority to include them if it sees fit.

    Juul Labs submitted its PMTAs in July 2020. At the time, the company said its submission included comprehensive scientific evidence for the Juul device and Juul pods in Virginia Tobacco and Menthol flavors at nicotine concentrations of 5.0 percent and 3.0 percent, as well as information on its data-driven measures to address underage use of its products.

    Juul will not join NJOY as the only FDA-approved closed system, pod-style vaping device. The FDA is expected to make decisions on additional vaping brands that submitted timely PMTAs soon.

    Now that at the FDA has approved a quality vaping product in Njoy, many tobacco harm reduction groups are hoping the FDA publicly clarifies that vaping is a less risky alternative to smoking combustible. A recent Rutgers University study found that more than 60 percent of all doctors incorrectly believe all tobacco products are equally harmful, making them less likely to recommend e-cigarettes for people trying to quit smoking.

  • Sweden: Lawmakers Reject Vapor Flavor Ban

    Sweden: Lawmakers Reject Vapor Flavor Ban

    Photo: WDnet Studio

    Sweden’s Parliament, the Riksdag, rejected a ban on sales of flavored vaping products, with 177 lawmakers voting against the proposal and 126 lawmakers voting in favor, reports Vaping360.

    Introduced by the government’s Ministry of Social Affairs in late February, the new rules would have taken effect next January, and would have prohibited flavors other than tobacco in all e-liquid, including zero-nicotine vape juice.

    In rejecting the proposal, lawmakers heeded the advice of the Riksdag’s social affairs committee, which had recommended adopting proposed regulations for nicotine pouches and synthetic nicotine but eliminating the flavor ban.

    Seven other European countries have banned non-tobacco vape flavors. In Denmark, Estonia, Finland, Hungary and Ukraine, flavored vape restrictions are currently in place. Lithuania’s flavor ban will take effect July 1. In the Netherlands, the flavor prohibition scheduled to begin in July has been postponed until January 2023.

    No European country has banned vaping products outright.

  • Bidi Parent Kaival Brands Reports Quarterly Results

    Bidi Parent Kaival Brands Reports Quarterly Results

    Photo: Song about Summer

    Kaival Brands’ revenues decreased by approximately $15.7 million in the second quarter of fiscal year 2022, compared to the same period of fiscal year 2021. Compared with the first quarter of 2022, however, revenues rose 11 percent.

    Gross profit in the second quarter of fiscal year 2022 was approximately $387,700, or approximately 12.7 percent of revenues, net, compared to approximately $6.3 million gross profit, or approximately 34.6 percent of revenues, net, for the second quarter of fiscal year 2021.

    In February 2022, Bidi Vapor was granted a judicial stay on the marketing denial order (MDO) previously issued by the U.S. Food and Drug Administration prohibiting the marketing and sale of nontobacco flavored Bidi Sticks, which had significantly impacted Kaival Brands’ revenues in previous quarters.

    As a result of the grant of the judicial stay of the MDO, the company’s revenues increased in the second quarter of fiscal 2022, as compared to first quarter of fiscal 2022. Kaival Brands expect this trend to continue as renewed distribution ramps up and sales of nontobacco flavored Bidi Sticks increase, subject to the court ruling in Bidi Vapor’s favor in the pending merits-based case, and subject to the FDA’s enforcement discretion.

    “Our results demonstrate strong execution and resiliency in our business, as revenues in the second quarter of fiscal year 2022 rose 11 percent as compared to revenues in the first quarter of fiscal year 2022,” said Kaival Brands founder and CEO Niraj Patel in a statement.

    “The recently announced international licensing agreement with Philip Morris Products, a wholly owned affiliate of Philip Morris International, is a major milestone in the company’s efforts to expand the global sales and distribution of the Bidi Stick. From a balance sheet perspective, the international licensing agreement has the potential to generate substantial returns on capital for the company, given the low cash investment needed to reach a significant number of potential new consumers.”

  • Canada Proposes New Vapor Disclosure Requirements

    Canada Proposes New Vapor Disclosure Requirements

    Photo: DD Images

    The Canadian government wants vapor product manufacturers to disclose information about their sales  and the ingredients used in their products.

    On June 17, Minister of Mental Health and Addictions and Associate Minister of Health Carolyn Bennett announced the launch of a 45-day public consultation period on the proposed rules.

    “Canada’s vaping market is evolving rapidly,” Health Canada wrote in a press release. “A large number of vaping substances are available across the country and new formulations are frequently introduced with new flavors. Health Canada is restricted in its capacity to properly track market trends due to limited access to information on vaping products sales and composition.”

    According to Health Canada, the proposed regulations are the first step of a gradual approach to introducing vaping product reporting requirements. Health Canada is considering additional reporting requirements for implementation in the future similar to those already in place for tobacco products. This could include reporting on information related to research and development as well as promotional activities. It could also include disclosing some information to the public which would increase industry transparency.

    “As the vaping market continues to evolve rapidly and entice Canadians, including young people, to use vaping products, we are taking action to better protect everyone in Canada by more fully understanding the impact of these products on their health,” said Bennett. “The proposed regulations will help us educate Canadians about the health harms while furthering research aimed at reducing the amount of people impacted by harms related to tobacco and vaping product use across the country.” 

    The proposed regulations have been published in the Canada Gazette. Stakeholders can submit comments to mailto:mpregs@hc-sc.gc.ca until Aug. 2.

  • CAPHRA Condemns Anti-Vaping Campaign

    CAPHRA Condemns Anti-Vaping Campaign

    “By stirring up anti-vaping hysteria, New Zealand’s Asthma and Respiratory Foundation will only send more minors back to smoking and put the country’s decade long Smokefree 2025 ambition in jeopardy,” says Nancy Loucas, executive coordinator of the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA).

    Loucas’ comments follow the Asthma and Respiratory Foundation (ARFNZ) launching a video series titled, “Spotlight on Vaping.” The campaign claims New Zealand is experiencing an “epidemic” of youth vaping. Together with the Secondary Principals’ Association of NZ (SPANZ), it also claims over a quarter of students have vaped in the past week.

    “What these sensationalized numbers don’t take into account is, if 26 percent of school students had in fact vaped in the past week, many would only be trying it, and secondly, almost all of them would’ve been smoking deadly cigarettes a generation ago,” says Loucas.

    CAPHRA says while smoking-related illnesses kill around 5,000 New Zealanders every year, vaping has not reportedly caused one death in the country. In fact, vaping been widely attributed for positively contributing to New Zealand’s plummeting smoking rate. The overall adult daily smoking rate has fallen from 18 percent in 2006/07 to 9.4 percent in 2020-2021.

    “What ARFNZ fails to mention is [that] the 2021 ASH Year 10 Snapshot survey that they selectively refer to confirms that vaping is not hooking nonsmokers. In that survey, just 3 percent of those who vape daily have never smoked. What’s more, while many may try it, very few ever become regular vapers, particularly non-smoking students,” she says.

    Loucas says while ARFNZ attract headlines by alleging a “youth vaping epidemic,” University of Auckland researchers in 2020 came to a different conclusion: “Our findings do not support the notion of a so-called vaping epidemic in New Zealand or a large youth population dependent on vaping,” the researchers wrote

    “While no one wants youth vaping, we are not seeing an ‘epidemic’ as ARFNZ would have the public believe.

     

  • Senator Durbin Continues Cries to FDA Over PMTAs

    Senator Durbin Continues Cries to FDA Over PMTAs

    Dick Durbin
    Credit: Durbin.gov

    U.S. Senate Majority Whip Dick Durbin today met virtually with six public health organizations regarding what he calls a failure of the U.S Food and Drug Administration to fulfill its obligation to regulate e-cigarettes under the Tobacco Control Act.

    In 2019, the U.S. District Court for the District of Maryland mandated that FDA finalize its premarket tobacco product applications under review by September 9, 2021.

    As FDA has delayed for more than nine months past that deadline on finalizing its reviews.

    During his meeting with these health groups, Durbin discussed his recent statement for FDA Commissioner Robert Califf to “immediately clear the market of unauthorized, kid-friendly e-cigarettes or step aside,” according to River Bender.

    “We know that kids are getting hooked on these flavored e-cigarettes that are specifically targeted to children, like JUUL. Yet FDA has decided to cower to Big Tobacco and ignore the addiction of children as the agency wrings its hands over e-cigarette applications,” said Durbin.

    “I’m grateful for the leadership of these health organizations, and together, we will do our best to ensure there is responsible, active leadership at FDA that will take the issue of nicotine addiction seriously.”

  • Pennsylvania Court Overturns THC Vape Recall

    Pennsylvania Court Overturns THC Vape Recall

    Credit: J Zehnder

    Marijuana vapes are again legal in Pennsylvania.

    A Commonwealth Court judge on Wednesday allowed Pennsylvania medical marijuana companies to resume selling vapes that were taken off the shelves in February in a controversial recall. The state is expected to appeal the ruling.

    “We are thrilled about this decision,” said Judith D. Cassel, an attorney for a group of cannabis companies that sued state regulators in February, alleging that the recall was unfounded, according to the Philadelphia Inquirer.

    “The vapes can go immediately back on the shelves and the grower processors can continue or commence producing these vapes,” said Cassel, a partner at Hawke McKeon & Sniscak LLP in Harrisburg.

    The ruling is a blow to the Pennsylvania Department of Health, which in February mandated a massive recall and ban of 670 types of cannabis concentrates for vaping — 330,000 units — that they had previously approved for sale in Pennsylvania’s more than 150 marijuana dispensaries

  • Jury Awards PMI $10 Million in Vuse Patent  Violation Suit

    Jury Awards PMI $10 Million in Vuse Patent Violation Suit

    Credit: Aleksandar Radovanov

    Philip Morris International was awarded $10.7 million by a jury in Alexandria, Virginia on Wednesday after finding rival R.J. Reynolds Vapor Co’s Vuse e-cigarettes violate its patent rights.

    The federal court jury said RJR’s Vuse Solo and Alto devices infringe two Philip Morris patents covering parts of a vaping device for heating substances and preventing leaks. The case is part of multi-front patent dispute between Philip Morris and RJR parent company BAT.

    A spokesperson for Winston-Salem, N.C.-based RJR said the company was disappointed by the infringement findings and said it may appeal, but was pleased that the jury cleared its Vuse Alto of infringing one of the patents, according to Reuters.

    A Philip Morris spokesperson said the company was “grateful” for the verdict, which “rejects an attempt by BAT to free-ride on our hard work and investment.”

    RJR’s Vuse line is one of the two top-selling e-cigarette brands in the United States, along with Juul. The Tuesday verdict concerned counterclaims in RJR’s ongoing patent lawsuit over Philip Morris’ IQOS heated-tobacco device, which is on hold.

  • NIH, FDA Fund Study to Understand Effect of Flavors

    NIH, FDA Fund Study to Understand Effect of Flavors

    Credit: Feng Yu

    The National Institutes of Health and the U.S. Food and Drug Administration have given the University of Louisville a $3.6 million grant to study the effects of flavorings like mango and bubblegum used in vaping products.

    Researchers at UofL’s Christina Lee Brown Envirome Institute hope to better understand the short-and long-term impacts of flavorings -specifically on the heart- and catalog which are potentially harmful, according to Kentucky Today.

    “E-cigarettes are still relatively new, and we don’t yet fully understand what their health effects are,” said Alex Carll, an assistant professor in the Department of Physiology and co-lead on the project.  “Understanding this could help us make better purchasing and regulatory decisions.”

    The FDA banned flavors used in disposable e-cigarette and has not approved any flvors except tobacco through its premarket tobacco product application (PMTA) process. The agency contends that some flavors could appeal to kids and help fuel rising rates of youth vaping.

    Matthew Nystoriak, an associate professor of medicine and co-lead on the project, said some flavors may seem harmless because they taste like or use the same ingredients as in food. But while those ingredients are safe to eat, they may not be safe to inhale.

    “Our goal is to understand how individual flavoring chemicals impact the heart,” Nystoriak said. “There are many flavor chemicals used in e-cigarettes and if we know which are potentially more harmful than others, it’s possible for people to make more informed decisions about which products they use.”

    Identifying their biological effects also is likely to help the FDA in regulating flavoring additives in e-cigarettes in the future.