Category: Featured

  • FDA Tobacco Authority Deemed Constitutional

    FDA Tobacco Authority Deemed Constitutional

    Photo: Tierney

    A lawsuit challenging the constitutionality of the U.S. Food and Drug Administration’s (FDA) authority over vapor products has failed following the Supreme Court’s refusal to review a lower court’s ruling on the issue.

    The suit was filed on Aug. 19, 2019, by Big Time Vapes and United States Vaping Association in the U.S. District Court for the Southern District of Mississippi.

    The suit challenged the Tobacco Control Act, claiming that Congress unconstitutionally ceded its legislative authority to the FDA when it gave the agency the power to “deem” products as tobacco products that were not specified in the 2009 legislation.

    The complaint was dismissed in December 2019 and failed on appeal in the Fifth Circuit Court of Appeals last year. On June 25, 2020, the Court of Appeals found that Congress’ delegation of authority to the Secretary of Health and Human Services to deem additional products subject to the Tobacco Control Act was constitutional, upholding the district court’s decision.

    The Supreme Court referred the case back to a lower court. Since the court did not accept the petition, the lower court’s decision stands.

    The petition is the first case involving e-cigarettes to be heard by the Supreme Court, which accepts only between 100–150 of the more than 7,000 cases that it is asked to review each year, according to its website.

  • BAT: Sales of Noncombustibles Up

    BAT: Sales of Noncombustibles Up

    Photo: BAT

    BAT added more than 1.4 million noncombustible product consumers in the first quarter of 2021 to reach a total of 14.9 million, CEO Jack Bowles announced in a trading update.

    “We are investing and building strong, fast-growing international brands in each segment, rapidly accelerating our reach and consumer acquisition, thanks to our digitalization and our multi-category consumer-centric approach, supported by the right resources and products and our agile organization,” said Bowles.

    “Our portfolio of noncombustible products is tailored to meet the needs of adult consumers. We are growing New Categories at pace, encouraging more smokers to switch to scientifically substantiated reduced-risk alternatives.”

    The company’s New Category products are now sold in 74 markets across 53 countries. Its Vuse/Vype vapor devices have been gaining value share in all Top 5 markets. Vuse is even approaching global leadership in vapor, reaching 31.4 percent category value share in the Top 5 vapor markets year-to-date in April, according to Bowles.

    We are growing New Categories at pace, encouraging more smokers to switch to scientifically substantiated reduced-risk alternatives.

    BAT’s Glo tobacco-heating product (THP) recorded positive volume share momentum in many markets, including Japan. The device achieved 16.2 percent category volume share in the Top 9 THP markets year-to-date in April.

    According to Bowles, BAT has also been consolidating its international volume share leadership in Modern Oral, with strong Velo volume share growth in the U.S. The company’s category share of Modern Oral in the Top 5 markets reached 40.2 percent year-to-date in April.

    BAT’s combustibles segment was characterized by strong pricing and robust volume, the company said. Group value and volume share were both up 10 base points year-to-date, with full-year industry volume expected to be down about 3 percent.

    For 2021, BAT now anticipates constant currency revenue growth of above 5 percent, ahead of its 3 percent to 5 percent guidance.

  • 22nd Century Keen to Maximize Opportunities

    22nd Century Keen to Maximize Opportunities

    Photo: felix brönnimann

    22nd Century Group has announced new initiatives to strengthen and maximize revenue opportunities in its hemp/cannabis franchise. Included in these developments are strategic partnerships with two plant breeders in the northern and southern hemispheres, providing the company with year-round growing capabilities, close partnership activities with Aurora Cannabis and the establishment of a newly created Canadian subsidiary.

    “The addition of breeders who specialize in alkaloid-based plant cultivation to our network of strategic partnerships provides us with the competitive edge to commercialize our second-generation IP and technologies,” said James A. Mish, CEO of 22nd Century Group, in a statement. “As cannabis regulation evolves, we believe that companies able to control the traits and consistency of the plants will command a premium price and margin in the marketplace. 22nd Century is well positioned to capitalize on the tremendous potential in the global legal cannabis space by creating hemp/cannabis plants that have stable, specific cannabinoid levels at commercial scale for various end-use markets.

    “As a matter of preparedness, earlier we announced a $40 million registered direct offering through Cowen and Company,” Mish continued. “Cowen is well-known as a pioneer in the cannabis institutional markets, and with this registered direct placement, 22nd Century is now squarely positioned in the mainstream of the cannabis equity space. Proceeds from this offering will be used as needed for future strategic growth opportunities as our hemp/cannabis market activity continues to increase. With the Special Equities Group as our financial advisor on this transaction to the company, we now have ample financial flexibility for this franchise as we advance our revenue-generating initiatives later this year.”

    Incorporated in April 2021, 22nd Century’s Canadian subsidiary will serve as a base for the company’s expanded activities in tobacco, hemp/cannabis and its yet-to-be announced third franchise.

    22nd Century Canada will also serve as a hub for expanded reduced-nicotine tobacco activities in Canada, to include a possible future launch of VLN and the potential expansion of its reduced nicotine tobacco-growing programs.

  • MPs Urged to Champion Vaping During Debate

    MPs Urged to Champion Vaping During Debate

    Photo: Gerry

    The U.K. Vaping Industry Association (UKVIA) is asking Members of Parliament to champion the public health benefits of vaping as the Department of Health and Social Care looks to publish a new Tobacco Control Plan (TCP) later this year to support the government’s smoke-free 2030 ambition.

    The U.K. House of Commons will debate the “Recommendations for the forthcoming Tobacco Control Plan” on June 10.

    According to the UKVIA, the upcoming debate is a huge opportunity to refocus efforts in ensuring that England achieves its aim of becoming smoke-free by 2030. The U.K. is estimated to have a smoking prevalence of 14.1 percent, and the forthcoming Tobacco Control Plan is a chance to see this number decrease further, particularly in light of an uptake during the pandemic period, the association writes in template letter to local MPs.

    The UKVIA letter urges MPs to make the following points during the debate:

    • The government must seize the opportunity presented by the U.K. having left the European Union. With the ongoing review of the Tobacco and Related Products Regulations (TRPR) and the forthcoming TCP, the government has the opportunity to diverge from EU law governing tobacco and nicotine policy to level up on health inequalities across the U.K. Independence allows for U.K. regulations to stay relevant, be easily adapted to changing consumer trends and any market and technological developments, with greater ease and less bureaucracy.
    • The government’s forthcoming TCP should be based on the significant and growing body of evidence showing vaping to be an effective alternative for smokers looking to quit and should cement the concept of harm reduction, placing the U.K. as the global leader in tobacco harm reduction. Vaping is twice as effective as other nicotine-replacement therapies, such as gum and patches. Research from University College London has found that e-cigarettes, in one year alone, helped an additional 50,000–70,000 smokers in England quit. Despite the overwhelming and growing evidence in support of e-cigarettes, perceptions of harm from vaping among smokers are increasingly incorrect and out of line with the evidence. This is despite ONS data from Great Britain showing that over half of smokers want to quit.
    • Misinformation and misperceptions about the relative risk of e-cigarettes must be challenged at every opportunity. To do so, the government must work with industry leaders to develop a series of policies that can help the vaping industry communicate directly with existing adult smokers. It is suggested that approved health claims and switching messages, alongside nicotine health warnings, should be available to vape manufacturers and retailers to communicate the facts about vaping. Such claims and messages could be used on both device and e-liquid packaging as well as on posters and leaflets. Similar proposals have been made by the governments of New Zealand and Canada.
    • In light of the University of East Anglia’s study to trial e-cigarettes in NHS A&E departments, greater support is also needed for medical practitioners. The new TCP should support medical professionals by ensuring that clinicians are signposted to the latest clinical evidence on e-cigarettes and that local stop-smoking clinics adopt a consistent approach to the advice given to smokers looking to switch to less harmful alternatives and/or quit smoking combustible cigarettes.

    “Whilst on one hand the current regulations and the existing TCP have allowed the vaping industry in the U.K. to flourish, on the other, they have hindered the ability of the vaping sector to promote vaping as an effective way of switching to a less harmful alternative, thereby preventing the government achieving the aims set out in the Tobacco Control Plan,” the UKVIA wrote. “Parliamentarians should therefore be advocating for fair and proportionate policies and regulations of e-cigarettes to help reduce inequalities and improve public health.”

  • Crafton Joins Swisher as VP of Innovation

    Crafton Joins Swisher as VP of Innovation

    Zack Crafton (Photo: Swisher)

    Swisher has appointed Zack Crafton as vice president of corporate innovation. In this position, Crafton will be working to diversify Swisher’s products and brands.

    “This is a significant appointment for our company, and we welcome Zack’s wealth of innovation experience and leadership that will move Swisher to drive the implementation of our strategic objectives and expand our portfolio of products,” said John Miller, president and CEO of Swisher, in a statement. “Our first corporate innovation VP reflects our commitment to growth and the future of Swisher.”

    Crafton has extensive experience and leadership in categories including wine, beer, cannabis and regulated e-commerce. Before joining Swisher, Crafton was CEO of the first online dispensary in California’s recreational cannabis market, paving the way for emerging cannabis brands and direct-to-consumer platforms across the cannabis industry. Prior to entering the California cannabis market, Crafton helped launch NakedWines.com where he built the largest online winery in the world as chief operating officer.

    We welcome Zack’s wealth of innovation experience and leadership that will move Swisher to drive the implementation of our strategic objectives and expand our portfolio of products.

    In 2020, Swisher announced a new corporate identity, purpose, mission, vision and strategic framework to develop new businesses, products and experiences while building on the legacies and strengths of existing products.

    “I’m thrilled to join Swisher, and I look forward to building a robust innovation platform, unique capabilities and a durable plan to support Swisher’s growth and diversification goals into innovative categories,” said Crafton. “This is an exciting time where we look to diversify Swisher’s product and capability portfolio while helping to shape the future for adult consumers.”

  • BAT Laments Inaction Against ‘Menthol’

    BAT Laments Inaction Against ‘Menthol’

    Photo: kasetch

    BAT has admonished Ireland’s tobacco regulator for failing to take action against competitors selling new products that may be in breach of the EU ban on menthol cigarettes, reports The Irish Times.

    There is “no rationale for the HSE to further delay” its action against tobacco companies that may be breaching the ban, BAT wrote in a letter to the Health Service Executive (HSE) this week. “We are concerned that inaction is leading to more products appearing on the market.”

    The HSE said a year ago that it would investigate tobacco companies for allegedly breaching the Europe-wide ban on menthol flavors, which some have allegedly tried to circumvent with techniques exploiting loopholes while marketing them as menthol substitutes.

    Japan Tobacco International, for example, launched Silk Cut Choice Green, which it admitted still contained traces of menthol. The company insists Silk Cut Choice Green complies with rules because the cigarettes don’t taste or smell of menthol. Philip Morris, the maker of Marlboro, also launched a new brand targeted at smokers of its old Marlboro Green but says the new product is legal and menthol-free. BAT did not launch a menthol substitute.

    Despite its year-long investigation, the HSE’s Tobacco Control Office has yet to issue any findings.

    Ireland’s market for the flavored cigarettes was worth up to €250 million ($304.92 million) before the ban came into force last May.

    Tobacco Reporter detailed the industry’s efforts to serve former menthol smokers in the EU with alternative products in June 2020.

  • Clifford Douglas: Let’s End War on Vaping

    Clifford Douglas: Let’s End War on Vaping

    Photo: pavelkant

    It is time to end the internecine warfare over vaping, according to Clifford Douglas, former vice president of Tobacco Control at the American Cancer Society and founder of the Center for Tobacco Control.

    In a recently published commentary, Douglas writes that the U.S. tobacco control community is “letting down tens of millions of adult smokers, their families and friends, healthcare providers and government decision-makers.”

    “I refer to my community’s approach to dealing with electronic cigarettes,” Douglas writes. “We are now neck-deep in intractable internecine warfare between the mainstream tobacco control community, whose primary focus is on protecting youth from the dangers of vaping, and the tobacco harm reduction (THR) community, some of whose scientists are also committed participants in mainstream tobacco control efforts. The THR community emphasizes the potential benefits of vaping for adult smokers who cannot or will not quit smoking otherwise. It seems that ne’er the twain shall meet.”

    There are ways to prevent youth use that won’t inflict harm on adult smokers.

    Vapor advocates welcomed Douglas’ comments.

    “The Canadian Vaping Association (CVA) commends Douglas for trying to bridge the gap between tobacco control and vape advocates,” the CVA wrote in a press note. “In the end, we all have the same goal of a tobacco-free society. The past practices of tobacco companies have caused distrust of the vape industry with regulators and the public. It is important to remember that this industry was created by smokers, for smokers. We don’t want youth vaping and have proposed many reasonable solutions. There are ways to prevent youth use that won’t inflict harm on adult smokers,” said Darryl Tempest, executive director of the CVA.

    Douglas has also formerly served as a special counsel on tobacco issues in the U.S. House of Representatives, as a tobacco control policy advisor for the U.S. Assistant Secretary for Health and the U.S. Surgeon General, and as a lawyer representing injured smokers and state attorneys general in litigation against the tobacco industry.

  • Plant-Based Vaccines to Exceed $584 Million

    Plant-Based Vaccines to Exceed $584 Million

    Photo: Baiya Phytopharm

    The global plant-based vaccines market, currently valued at $43.7 million, will expand at a compound annual growth rate of nearly 50 percent from 2021 to 2028, according to Coherent Market Insights.

    Key trends in the market include increasing research and development activities, increasing cases of influenza, ongoing clinical trials on plant-based vaccine and inorganic activities, such as collaborations by the market players.

    Coherent Market Insights expects increasing research and development activities to bolster growth of the plant-based vaccines market. For instance, on Nov. 10, 2020, Medicago started conducting clinical trials for a plant-based Covid-19 vaccine. Medicago is also developing a VLP Quadrivalent plant-based vaccine for seasonal influenza. Currently, the influenza vaccine is in Phase II of the clinical trial. In both the cases, the company uses Nicotiana benthamiana, an Australian tobacco plant, to produce the vaccine.

    British American Tobacco is also developing a Covid-19 vaccine based on tobacco plants, as are researchers in Thailand.

    According to Coherent Market Insights, plant-based vaccines offer several benefits over conventional egg-based vaccine production in terms of efficiency, production time and enhancing the immune system of the patient.

    However, there is no plant-derived vaccine approved to be marketed for human consumption to date. Challenges to develop effective vaccines include selection of antigen and plant expression host, uniformity of dosage and manufacturing of plant vaccines, according to good manufacturing practice procedures, according to Coherent Market Insights.

  • Critics: TPD Proposals Would Ban Most Vapes

    Critics: TPD Proposals Would Ban Most Vapes

    Photo: areporter

    The Independent European Vape Alliance (IEVA) has expressed concern about “the content and the tone” of the European Commission’s recent report on the application of the Tobacco Products Directive (TPD), which suggests that further restrictions on vapers might be proposed.

    According to the IEVA, the effect of the commission’s proposals would be to ban most vaping products on the market today.

    “While the commission is careful not to say it out loud, its proposals would effectively ban most vaping products available today,” the organization wrote in a press release. “It suggests revising all the unjustifiable limits the last TPD set downward, removing most flavors and banning many of the devices commonly used today. Vapers in the EU would lose most of the products they use to stay away from cigarettes today. A flavor ban alone would, according to the commission’s own figures, remove two-thirds of today’s vaping market.”

    The IEVA says the report fails to acknowledge the concept of harm reduction. “The report fails to acknowledge any of the evidence on the relative risks of vaping and smoking,” the IEVA wrote. “This is despite member state governments running campaigns trying to encourage smokers to switch to vaping. Sante Publique France, for example, has launched an anti-smoking campaign called ‘Je choisis la vapotage’ (‘I choose vaping’), which makes clear that ‘you can use vaping products without taking short-term health risks.’ The commission must take account of best practice in the EU, not ignore it.”

    Some of the report’s proposals on vaping, says the IEVA, could also lead to more young people smoking.

    “Shortly after this report was published, Yale University released the first real world study on the effect of flavor bans on youth smoking prevalence,” the IEVA stated. “In the city of San Francisco, flavored vaping products were banned in 2018. Since then, smoking has doubled among high school students in the area relative to trends in districts without the ban, even when adjusting for individual demographics and other tobacco policies. This study was funded by the U.S. Food and Drug Administration’s Center for Tobacco Products. There was no industry involvement in the study.”

    The IEVA says the report insufficiently focuses on the real enemy of public health—smoking. “While the commission does question whether the nicotine threshold for vaping products should be lower, it has brushed aside calls from members of the European Parliament to adapt the method for measuring tar, nicotine and carbon monoxide levels in cigarette smoke,” the IEVA wrote. “This combination of policies would ensure that cigarettes deliver far more nicotine—an addictive substance—than vaping products. While there have been no reported deaths in Europe caused by vaping TPD-regulated products, smoking kills half of its regular users.”

  • AOI Promotes Grower Income Diversification

    AOI Promotes Grower Income Diversification

    Photo: AOI

    Alliance One Brazil has partnered with Bayer Crop Science to provide quality maize seeds and agronomic support to smallholder tobacco farmers in Brazil. Through the partnership, Alliance One Brazil’s goal is to help its contracted farmers diversify their income by strengthening the quality and yield of a crop that is complementary to tobacco.

    “Approximately 75 percent of our contracted Brazilian farmers produce maize along with tobacco,” said Helio Moura, AOI’s global agronomy director, in a statement. “By providing our contracted farmers with a high-quality agronomic package for maize, we are helping them improve the quality and yield of the maize crop.”

    “One of our company’s top priorities is the improvement of farmer livelihoods.”

    During the 2020 growing season, Alliance One Brazil implemented a pilot project with 2,300 farmers to evaluate interest in future program participation.

    The team found that farmers appreciated the support and guidance related to maize in addition to the ongoing support related to tobacco.

    As a result of the positive feedback from the farmers, Alliance One Brazil will implement this project across its full farmer base throughout the 2021 crop season.

    Over the next three years, Alliance One Brazil intends to expand the project to include other crops, and AOI will evaluate how the project could be expanded throughout the company’s global operations.

    By providing the necessary support to enhance the crops that they are already growing, we are providing our contracted farmers with the tools they need to diversify their income.

    “One of our company’s top priorities is the improvement of farmer livelihoods,” Moura added. “By providing the necessary support to enhance the crops that they are already growing, we are providing our contracted farmers with the tools they need to diversify their income. In addition, crop diversification is becoming increasingly important as extreme weather patterns impact crop production. We are excited about the potential for this project and the potential for AOI to scale it at a global level in the future.”

    AOI is profiled in Tobacco Reporter’s June 2021 print edition.