Author: Timothy Donahue

  • Organigram Closes 2nd Tranche of BAT Investment

    Organigram Closes 2nd Tranche of BAT Investment

    Photo: krishnadasekm

    Organigram Holdings closed the second of three tranches of a CAD124.56 million ($92.2 million) equity investment by British American Tobacco’s BT DE Investments subsidiary.

    Pursuant to the second tranche closing, the investor acquired 4,429,740 common shares and 8,463,435 Class A preferred shares at a price of CAD3.22 per share for gross proceeds of $30.82 million. The remaining 12,893,175 shares subscribed for are due to be issued at the per share price in the final tranche on or around Feb. 28, 2025.

    “With two tranches of the Jupiter pool now funded, combined with our strong balance sheet and targeted investment strategy, Organigram is well on its way to executing on its ambitious growth plan focusing on international, technological and product expansion,” said Organigram CEP Paolo De Luca in a statement.

    “Our inaugural Jupiter investment in Open Book Extracts marked our second investment in the U.S. market, and our first international investment in Sanity Group represents a significant first step in our ambitions to grow our footprint in the fast-growing German market,” he added.

  • Accorto Joins Global Institute for Novel Nicotine

    Accorto Joins Global Institute for Novel Nicotine

    Accorto Regulatory Solutions has joined the Global Institute for Novel Nicotine (GINN), an organization dedicated to advancing tobacco harm reduction through supporting the research and development of non-vaporized tobacco alternatives for adult smokers. The GINN also promotes compliance standards, focusing on youth access prevention, responsible marketing and product quality.

    Accorto Chief Scientific Officer Vince Angelico will join the GINN’s science and standards committee, which helps shape regulatory recommendations for the industry.

    “Becoming a member of GINN is a pivotal move in our ongoing commitment to advancing public health through robust, evidence-based regulation,” said Accorto Regulatory Solutions CEO Tom Beaudet in a statement. “GINN’s dedication to upholding industry integrity and prioritizing consumer safety mirrors our own values. We are eager to collaborate with fellow members to drive impactful progress in the tobacco harm reduction space.”

    Through this collaboration, Accorto Regulatory Solutions aims to contribute to the development of comprehensive, science-driven regulations that will enhance public health outcomes and promote responsible industry practices. Additionally, Accorto says it is dedicated to helping GINN members with novel, science-backed reduced-risk products fortify their regulatory applications, enabling these products to reach the market.

    “Accorto Regulatory Solutions joining GINN marks a significant step forward in our shared mission to advance tobacco harm reduction through evidence-based regulation,” said GINN Director Shem Baldeosingh. “Accorto’s deep expertise in regulatory compliance and their commitment to public health align perfectly with GINN’s core values. We are particularly excited about Dr. Vince Angelico’s involvement in our science and standards committee, as it will further enhance our ability to develop comprehensive, science-driven regulatory frameworks that support the safe and responsible marketing of reduced-risk nicotine products.”

  • Research Grant to Study Biopesticides for Hemp

    Research Grant to Study Biopesticides for Hemp

    Credit: Mex Chriss

    The economic importance of hemp is increasing globally and in the United States. However, because federal laws restricted hemp growth and research until recently, commercial hemp production lacks best practices for cultivation, including effective and safe pest and disease management.

    The Foundation for Food & Agriculture Research’s (FFAR) Hemp Research Consortium is providing Cornell University with a $210,000 grant to identify biologically derived crop protection products—biopesticides—to control hemp’s major pest and disease threats.

    BioWorks and the University of Kentucky (UK) are participating in the research, and BioWorks is providing matching funds for a total investment of $420,000.

    “Research on hemp production is still in its infancy, and pests and disease can be an overwhelming challenge for many growers,” said Kathy Munkvold, FFAR scientific program director. “This project is providing actionable knowledge that will help the hemp production industry thrive.”

    Companies developing crop protection products currently focus on fruit, vegetable, and commodity crops such as corn and soy, rather than newer crops like hemp. This project seeks to fill that gap through a partnership between academic institutions and industry, according to a press release.

    Researchers at Cornell, BioWorks and UK, led by Christine Smart, director of Cornell AgriTech, are determining the effectiveness of biopesticides against several hemp diseases and investigating the tolerance of hemp crops to these products.

    They are also studying the compatibility of biopesticides with other crop protection products used in hemp production. In addition, the team is examining how long the microbes in bioproducts remain on the plant, which is important for product application timing and post-harvest hemp microbial testing required for some hemp products.

    The research will broaden the understanding of how to effectively manage the pests and diseases that undermine hemp production and inform recommendations for controlling those threats. Ultimately, growers will save money through the proper use of inputs and higher crop yield, and consumers will gain more comprehensive access to safe, high-quality hemp products, according to a press release.

    “Hemp growers are looking for information on pest and disease control, and I am enthusiastic that this project will enable improved management strategies,” said Smart.

    To learn more about this grant, visit the Evaluating Biopesticides for the Treatment of Hemp page on FFAR’s website.

  • Advocacy Group Warns of Harm Vape Ban May Cause

    Advocacy Group Warns of Harm Vape Ban May Cause

    Credit: Gustavo Frazeo

    The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) celebrates New Zealand’s remarkable progress towards its Smokefree 2025 goal, while cautioning that proposed legislative changes, including a ban on disposable vapes, could undermine its regional leadership. 

    “New Zealand stands on the cusp of an historic public health victory,” CAPHRA executive coordinator Nancy Loucas stated. “Thanks to progressive policies supporting vaping and other reduced-risk products, the country is poised to reach its target of less than 5 percent of the population smoking well ahead of schedule. 

    “Recent data shows smoking rates have plummeted to just over 6 percent, down from 16.4 percent in 2011/12 when the Smokefree 2025 goal was set. This remarkable decline is largely attributed to New Zealand’s embrace of tobacco harm reduction strategies, which have served as a model for other countries in the Asia Pacific region. 

    “New Zealand’s success story is built on a foundation of evidence-based policies that recognize the potential of less harmful alternatives to help smokers quit,” Loucas explained. “Countries like Malaysia, the Philippines, Indonesia, and Thailand have looked to New Zealand’s regulatory framework to shape their own approaches to tobacco harm reduction. 

    “However, CAPHRA expresses serious concern over proposed amendments to the Smokefree Environments and Regulated Products Amendment Bill 2024, particularly the ban on closed system vapes:” 

    According to a press release, CAPHRA recommends a balanced approach that: 

        • Maintains access to a variety of vaping products, including closed systems 

        • Implements reasonable regulations without outright bans 

        • Further expands support for reduced-risk alternatives 

        • Increases education on the benefits of switching to less harmful products 

      “New Zealand has become a global leader in tobacco harm reduction, inspiring countries across the Asia Pacific to follow suit. We urge the government to build on this success rather than risk undermining it,” Loucas stated. “With thoughtful policies that preserve access to all types of vaping products, New Zealand can cross the Smokefree 2025 finish line and continue to serve as an inspiration for countries worldwide.”

    • BAT Agrees to Host 2024 CORESTA Congress

      BAT Agrees to Host 2024 CORESTA Congress

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      The UK-based company will host the 2024 CORESTA Congress in Edinburgh, UK, from 13 – 17 Oct.

      • The Congress will bring together leading scientists, tobacco and related product experts, and regulators from over 165 member organizations to focus on the theme of “Advancing Tobacco Harm Reduction through Scientific Collaboration.”
      • Participants will share, discuss, and collaborate on tobacco and related product
        science.

      BAT has volunteered to host the upcoming Cooperation Centre for Scientific Research Relative
      to Tobacco (CORESTA) Congress 2024, set to take place from 13 – 17 October at the Edinburgh
      International Convention Centre, UK.

      This year’s congress will bring together over 165 member organizations, from over 30 countries
      and non-members, including companies, research institutes, laboratories, associations, and
      regulatory bodies under the theme of “Advancing Tobacco Harm Reduction through Scientific
      Collaboration”.

      Formed in 1956, CORESTA is committed to exploring the latest scientific research to facilitate
      positive change in the tobacco industry. This year’s iteration continues this ambition, specifically
      seeking to advance the knowledge and understanding of the science related to Tobacco Harm
      Reduction (THR) among its membership and attendees.

      To achieve this goal, leading scientists from across the world will attend and present their work, bringing their expertise in a diverse range of disciplines to allow participants to explore all aspects of THR. Thanks to the collaborative work of the most experienced scientists in their field, CORESTA has gained international recognition.

      With increasing regulatory requirements, CORESTA’s scientific work and outputs have become a worldwide reference point for tobacco policymaking and support the development of testing standards, such as ISO Standards.

      As host, BAT looks forward to facilitating the conversations necessary to grasp the public health opportunity presented by THR to significantly reduce the risks for the estimated 1bn consumers who smoke and address misperceptions of alternative tobacco and nicotine products with the potential to reduce risks compared to cigarettes.

      To learn more about the event and request an invitation, visit the official congress website: www.corestacongress2024.com. Registration is open until Sept. 20, 2024.

    • Lawmakers File Amicus Brief in SCOTUS Vape Case

      Lawmakers File Amicus Brief in SCOTUS Vape Case

      supreme court of US
      VV Archives

      A group of congressional lawmakers urged the Supreme Court of the United States to overturn a lower court ruling that blocked federal regulators from rejecting certain e-cigarette products. They argued that the move could hinder government efforts to keep illegal vaping products off store shelves.

      The Supreme Court is set to tackle the FDA’s power to regulate vape sales altogether this term, in FDA v. Wages and White Lion Investments, LLC. The forthcoming case challenges a January ruling from the Fifth Circuit, which found that the FDA overstepped its authority when it rejected marketing applications from two manufacturers looking to sell flavored liquids for e-cigarettes, according to Courthouse News.

      In an amicus brief filed with the Supreme Court Monday, the group of legislators — led by Senate Majority Whip Dick Durbin, Oregon Senator Jeff Merkley and New Jersey Representative Frank Pallone — argued that the FDA’s decision to reject these marketing applications was “carefully” reasoned.

      “Guided by Congress’ chief directive — to deny such authorization unless a product under review would be ‘appropriate for the protection of the public health’ … FDA has been appropriately mindful of children and teenagers, the most vulnerable pool of non-tobacco users,” the lawmakers wrote.

      They contended that judicial oversight of the agency’s authority had been “generally consistent” until the Fifth Circuit’s ruling and had not impeded it from accomplishing its regulatory responsibilities.

      The legislatures told the high court that allowing the lower court’s ruling to stand would not only force the FDA to waste resources reevaluating the rejected marketing applications but could also invite other manufacturers previously rejected by the FDA to relitigate their own marketing requests.

      “While those applications are once again pending FDA review, the tobacco products they cover would continue to be sold, despite the law’s clear pre-market authorization regime,” the lawmakers said. That provides a “powerful financial incentive” for manufacturers to reapply for FDA approval, even if they know the agency will ultimately deny their applications.

    • Supreme Court Urged to Overturn Triton Ruling

      Supreme Court Urged to Overturn Triton Ruling

      Image: hafakot

      Ten U.S. public health medical and community organizations have filed an amicus brief supporting the Food and Drug Administration in asking the U.S. Supreme Court to overturn a recent Fifth Circuit Court of Appeals decision forcing the FDA to reconsider several marketing denying orders (MDOs) issued vaping companies.

      In their brief, the groups explain why they believe that allowing the decision in Food and Drug Administration v. Wages and White Lion Investments, LLC, d/b/a Triton Distribution to stand would undermine the FDA’s ability to protect young people from the health harms of flavored e-cigarettes.

      In September 2020, the FDA denied Triton’s applications for approval of a variety of flavored e-liquids for use in e-cigarettes. Triton appealed to the Fifth Circuit, which struck down the FDA’s marketing denial orders. In July, the Supreme Court agreed to hear the FDA’s appeal of that decision.

      According to amici, “E-cigarettes pose unique health risks for youth, as adolescent brains are more susceptible to nicotine’s effects due to ongoing neural development” and “[t]he tobacco industry has long known that flavors are important to its ability to successfully market its products to young people.”

      The groups argue that, contrary to the vaping companies’ protestations, the FDA’s decision to issue MDOs in this case was not arbitrary or capricious, because the applicants did not present evidence that their products would benefit the public health

      The brief cites notes that over 2.1 million U.S. youth, including 10 percent of high schoolers, reported current e-cigarette use in 2023, and nearly 30 percent of high school users reported daily use.

      The brief was submitted by the American Academy of Family Physicians, the American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the American Medical Association, the American Thoracic Society, the Campaign for Tobacco-Free Kids, the Louisiana State Medical Society, Parents Against Vaping E-cigarettes and the  Truth Initiative.

    • Study: Troubled Teens Likely to Start Vaping

      Study: Troubled Teens Likely to Start Vaping

      A new study has found that Australian high school students with symptoms of severe depression or poor well-being are twice as likely to have tried vaping.

      The study also found one-fifth of students in 7th and 8th grade had moderate to severe depression symptoms and demonstrated the need for early intervention targeting both mental health and vaping, experts said.

      In 2023, more than 5,000 students aged 12 to 14 were surveyed for the study as part of the OurFutures vaping prevention program led by the University of Sydney’s Matilda Centre, according to media reports.

      The results, published in the Australian and New Zealand Journal of Psychiatry, showed one-third of the cohort reported poor well-being, another third had high stress, and one-fifth had high anxiety.

      Students who reported moderate or high stress levels were 74% or 64% more likely to have tried vaping, respectively, than those who reported low levels of stress, though anxiety levels seemed to have little relationship with vape use.

      According to Michelle Jongenelis, an associate professor at the University of Melbourne, the results demonstrated the importance of early effective mental health support for young teenagers.

      The study added to previous research suggesting a connection between nicotine use and mental health issues but could not offer an explanation as data was drawn from a single point in time.

    • Durbin Blames Police for Illegal Flavored Vape Surge

      Durbin Blames Police for Illegal Flavored Vape Surge

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      Illinois Senator Dick Durbin strongly condemned top health and law enforcement officials for their inadequate efforts in combating the surge of illegal disposable e-cigarettes among young people in the U.S.

      Industry analysts estimate disposable vapes make up 30 percent to 40 percent of the roughly $7 billion vaping market. The two best-selling disposables—Breeze and Elf Bar—generated more than $500 million in sales last year, according to Nielsen retail sales data analyzed by Goldman Sachs, according to media reports.

      Both brands have been sanctioned by FDA regulators but remain widely available, in some cases with new names, logos, and flavors. More than half of the 2.8 million U.S. teens who vaped last year said they used Elf Bar.

      Overall, teen vaping has fallen 60 percent since its all-time high in 2019, following the COVID-19 pandemic and new age restrictions and flavor bans on e-cigarettes and other tobacco products.

      “Nearly all e-cigarettes are sold in violation of federal law, yet 2 million kids report vaping,” Durbin tweeted.

      Using its own authorities, the FDA has sent hundreds of warning letters to vape shops and e-cigarette manufacturers in recent years. But the letters have done little to dissuade companies from flouting FDA rules and introducing new vapes.

    • South Africa Tobacco Control Bill Not Up in Smoke

      South Africa Tobacco Control Bill Not Up in Smoke

      Credit: Pavlo Fox

      A leftover bill from the previous administration seeking to tighten tobacco and vaping product regulations is back before South Africa’s Parliament’s health committee.

      However, the business community believes it needs to be properly consulted on its potential impact, media outlets have reported.

      Minister of Health Aaron Motsoaledi is set to reintroduce the Tobacco Control & Electronic Delivery Systems Control Bill to the portfolio committee on health on Wednesday.

      The government is pressing on in its efforts to align South Africa’s smoking restrictions with World Health Organisation (WHO) standards.

      Vaping advocates previously said the bill would destroy the vapor industry if it became law.

      The Vapour Products Association of South Africa (VPASA) warned that, among other provisions, the Tobacco Products and Electronic Delivery Systems Control Bill opens an avenue for the government to ban the sale of flavored e-liquids, which tobacco harm advocates insist are key to entice smokers away from cigarettes.