Author: Marissa Dean

  • UK to Raise Cigarette Consumption Age

    UK to Raise Cigarette Consumption Age

    Image: premiumdesign

    The U.K. prime minister, Rishi Sunak, wants to raise the legal age for consuming cigarettes, gradually increasing it one year at a time until the next generation is no longer legally allowed to purchase the products, reports Bloomberg.

    According to Sunak, the move would make it so that “a 14-year-old today would never legally be sold a cigarette.” Sunak spoke on the age increase at a Conservative Party conference in Manchester Wednesday, where plans to restrict availability of vapes and look at packaging and flavors of vapor products were also discussed.

    Simon Clark, director of smokers’ rights group Forest, responded to the move, saying, “These are desperate measures by a desperate prime minister.

    “Raising the age of sale of tobacco is creeping prohibition, but it won’t stop young people smoking because prohibition doesn’t work. Anyone who wants to smoke will buy tobacco abroad or from illicit sources.

    “This is the opposite of leveling up; it’s dumbing down. Future generations of adults who are considered old enough to vote, pay taxes, drive a car and drink alcohol are going to be treated like children and denied the right to buy a product that can be purchased legally by people a year older than them.

    “This is now a conservative government in name only because the prime minister has just taken a wrecking ball to the principles of choice and personal responsibility,” Clark said.

  • Sinditabaco Attends ESG Experience

    Sinditabaco Attends ESG Experience

    Image: SindiTabaco

    Ricardo Voltolini, CEO and founder of the consultancy Ideia Sustentavel, gave the opening lecture of the first edition of ESG Experience on Oct. 3 at the University of Santa Cruz do Sul (UNISC) Memorial Auditorium in Santa Cruz do Sul, according to SindiTabaco. Promoted by ACI, the event was attended by several business leaders from the region.

    Voltolini portrayed the challenges and trends of sustainability and environmental, social and governance (ESG). “Today it is a trendy topic, but it has existed for many years. It has been called private social investment, corporate social responsibility, sustainability—in two versions—and, more recently, ESG, a concept that was born in 2004, but only in 2019 did companies bring up the discussion that it is necessary to put purpose ahead profit,” he said.

    According to him, there has never been so much talk about sustainability because there have never been so many pressure factors, especially climate change, and the new generations that are beginning to take power. “Millennials already come with a pro-sustainability generational chip. This new way of seeing the business can accelerate changes,” he highlighted.

    In the afternoon, ESG cases focused on the environmental area were discussed with the participation of representatives from the three largest cigarette companies installed in Brazil (Philip Morris, BAT and Japan Tobacco International), CORSAN and Azul Conecta. Sustainability and innovation for a smoke-free future; advances in the protection of biodiversity; sustainable agriculture for small properties; payment program for environmental services and innovation focused on sustainability were the topics discussed by the panelists.

    Iro Schuenke, president of the Interstate Tobacco Industry Union (SindiTabaco), participated in the moment focused on governance cases, together with three other panelists: Jorge Hoelzel Neto, management facilitator and president of the Mercur advisory board; Luiz Motta, CEO at Excelsior Alimentos; and Fabiola Eggers, institutional relations manager at Fruki.

    In his presentation, Schuenke detailed the tobacco sector’s initiatives within the scope of ESG and highlighted the importance of the Integrated Tobacco Production System to achieve effective results in the different pillars of ESG: environmental, social and governance. “Our integration model is a competitive differentiator that unites the links in the production chain with the purpose of delivering a product of quality and integrity, but more than that, together, these links activate good ESG practices, often in an innovative way and pioneering,” he said.

    During the event, the Pact for Regional Environmental Valorization was signed between the Vale do Rio Pardo Intermunicipal Services Consortium (Cisvale), the Santa Cruz do Sul Commercial and Industrial Association (ACI), the Brazilian Tobacco Growers Association (Afubra) and SindiTabaco. The signing was accompanied by the mayor of Santa Cruz do Sul, Helena Hermany, and the vice rector of UNISC, Andreia Valim. The pact aims to identify and develop socio-environmental actions, taking into account the principles highlighted by the region and integrating public authorities, associations, entities, communities, companies and public control bodies to promote the integration of environmental actions and consolidate long-lasting short term, medium term and long term. The following principles guide collective actions: commitment to environmental sustainability; biodiversity conservation; climate change and resilience; sustainable resource use; environmental education and public engagement; partnerships and collaboration; monitoring and evaluation; transparency and accountability; innovation and problem-solving; and heritage for future generations.

  • PMI Joins We Card

    PMI Joins We Card

    Image: Tobacco Reporter archive

    Philip Morris International has joined the We Card Program, a national nonprofit serving the nation’s retailers of age-restricted products. The company’s Swedish Match affiliate will serve on We Card’s manufacturer advisory council.

    Independent retail establishments and large retail chains utilize We Card’s educational and training services for their compliance efforts with federal, state and local laws aimed at preventing age-restricted product sales to minors.

    National and state retail trade associations, government officials, community groups and others also support We Card’s ongoing efforts to raise awareness of responsible retailing and age verification requirements and to educate and train retail employees to identify and prevent underage attempts to purchase age-restricted products.

    “As we enter the U.S. market, our ambition is twofold: to be the market leader across America for innovative smoke-free products that are a better choice than continued cigarette use and to ensure that youth cannot access these products, which are intended only for adults who smoke or use another nicotine product,” said Stacey Kennedy, president of the Americas and CEO of the PMI U.S. business. “Joining We Card reflects the commitment shared by PMI and Swedish Match to further enhance youth access prevention programs in close cooperation with our retail partners.”

    “The We Card Program has long been a vital tool for retailers, and we look forward to working with them to expand the program’s suite of tools to reflect the growing range of innovative nicotine products, including oral pouches,” Kennedy added.

    “We Card is pleased to have Swedish Match join our manufacturer advisory council. This will help us further our mission to prevent underage access to nicotine products and work to address the problem of the social sourcing of those products,” said Doug Anderson, president of the We Card Program.

  • JTI Malaysia Appoints Juliana Mohd Yahaya

    JTI Malaysia Appoints Juliana Mohd Yahaya

    Image: peach_adobe

    Japan Tobacco International Malaysia appointed Juliana Mohd Yahaya as managing director effective Oct. 1, according to The Edge Malaysia.

    Yahaya will take the place of Khoo Bee Leng, who will retire after 30 years with the company.

    “[Yahaya] brings a wealth of experience to the role, having assumed various leadership positions at Japan Tobacco International’s (JTI) global center as well as in markets,” said JTI Malaysia.

    Yahaya joined JTI Malaysia in 2000, and she has held various roles in marketing and sales. She also worked at JTI’s Geneva headquarters and in leadership roles across Asia and Europe. Yahaya has been leading the Belgium and Luxembourg markets since 2020.

    “JTI Malaysia would also like to take this opportunity to thank Khoo Bee Leng for her dedicated service and leadership, and we wish her a happy retirement,” the company said. Leng started in the role of managing director on Jan. 1, 2021.

  • Flavor Bans Boost Combustible Sales

    Flavor Bans Boost Combustible Sales

    Image: DoraZett

    A new study has found that flavor bans boost sales of traditional combustible cigarettes. The study, E-Cigarette Flavor Restrictions’ Effects on Tobacco Product Sales, concluded that restrictions on the sale of flavored nicotine vaping products could lead to significant increases in traditional cigarette sales.

    Given that combustible cigarettes are widely recognized as more harmful than vaping, the study’s findings raise pressing questions about the public health implications of such policies, according to a release from the Canadian Vaping Association (CVA). The group “urges Canadian governments to review the study’s findings and ensure that vapor product regulations are in line with harm reduction and Canada’s Drugs and Substances Strategy.”

    Key highlights from the study include:

    Substitution to cigarettes: For every 1 fewer 0.7 mL pod sold due to flavor restrictions, there’s an increase of 15 additional cigarettes purchased.

    Rise in cigarette sales over time: While the short-term effects are less clear, the long-term correlation between vaping flavor policies and a surge in cigarette sales is robust. This surge occurs especially when such policies have been in place for a year or more.

    Young population at risk: The relation between vaping flavor restrictions and increased cigarette sales isn’t limited to a particular age group. Alarmingly, there’s also a surge in sales for cigarette brands popular among underage youth.

    The research firmly underscores the unintended consequences of restricting flavored product sales, according to the CVA. While the research indicated that these policies do achieve their goal of reducing flavored product use, they inadvertently boost the sales of traditional cigarettes across all age groups.

    Given the stark difference in health risks between cigarettes and vaping, the study contends that the overall health benefits of such policies may be minimal or even potentially harmful in the broader perspective.

  • The Therapeutic Track

    The Therapeutic Track

    Photo: goodmanphoto

    Key considerations for designing vapes as medical devices

    By Pete Lomas

    To further support the transition from smoking to reduced-risk nicotine products, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) is encouraging next-generation nicotine product manufacturers to consider the marketing authorization application (MAA) route to market. Nicotine products, such as vape devices, authorized via this regulatory pathway can be marketed as smoking cessation tools and prescribed by healthcare professionals.

    This article discusses how manufacturers can design vapes to improve their chances of MAA approval, giving a particular focus to delivered dose uniformity (DDU), which is a critical parameter for any authorized medical inhalation device.

    Medicinal vapes will be classified in a similar way as conventional pressurized metered dose inhalers (pMDIs), meaning they must meet similar criteria for approval. One key criteria is DDU, a measure used to ensure patients are getting the same amount of drug delivery both within and between devices.

    Achieving DDU is challenging in vapes for several reasons. Most consumer vapes rely on traditional coil and wick technology. The wick is saturated with e-liquid, and when the coil heats up, the wick releases vapor for the user to inhale. Coil-based and wick-based vapes are prone to inconsistency caused by a variety of issues, such as variation in battery life, power delivery and temperature, to highlight a few.

    The MHRA recognizes that vapes are fundamentally different from pMDIs and has made some concessions related to DDU. However, manufacturers must achieve nine out of 10 doses within 25 percent of the mean and all doses within 35 percent of the mean. In addition, the mean of 10 puffs must fall within 15 percent of the label claim. To have the best chance of MAA approval, manufacturers should design vapes well within these limits. Manufacturers can achieve this by adapting existing vape designs or by turning to novel technology.

    Adapting Existing Technology

    Several areas of product development influence DDU, including airflow, e-liquid properties, test methods, e-liquid delivery, packaging, production and power delivery. Ceramic heating elements are one example of a way manufacturers are changing their designs to improve DDU. Ceramic elements improve the consistency of power delivery while more accurately controlling the wicking rate via engineering of the wick’s pore size.

    Another way a design can be adapted is with the introduction of thermocontrols that regulate power delivery and therefore the temperature of the coil. Thermocontrols help ensure the same amount of vapor is being released with each inhale by setting a temperature limit that applies to the wick no matter the battery level of the device. Vape manufacturers can also consider the influence of the airflow path on DDU, such as tightening manufacturing tolerances.

    Photo: makcoud

    Emerging Technologies

    Alternatively, vape manufacturers can make use of emerging electronic nicotine-delivery system technologies to improve dosage consistency. Better control of droplet size can be achieved with devices based on piezo ceramic meshes, a similar technology to that used in medical nebulizers. E-cigarette devices based on piezo technology use mechanical forces, in the form of ultrasonic waves, to convert the e-liquid into vapor in a process known as atomization. The droplet size and dosage can be predefined through the mesh dimensions, allowing for uniformity in the vapor.

    Another emerging technology is microfluidic liquid delivery. This technology uses the surface tension of the liquid to transport it along micro channels for “wicking” and is a more engineered solution than conventional wicks.

    Regulatory Insight

    Businesses with products undergoing the premarket tobacco product application process can reuse this data to reduce the number of new studies required for an MAA. However, MAA applicants should expect the process to be extended. Working with a scientific and regulatory compliance partner that can support you through the process, from product design to regulatory approval, can increase your chances of success.

    Pete Lomas is a managing consultant at Broughton, a global scientific consultancy-based contract research organization serving customers operating in the pharmaceuticals, next-generation nicotine-delivery products and cannabinoids industries. Among other services, the company offers support with the MAA pathway. For more information, visit www.broughton-group.com/maa-regulatory-support-and-submission-service.

  • PMI Launches Tobacco-Free Heat Stick

    PMI Launches Tobacco-Free Heat Stick

    Image: Reuters

    Philip Morris International unveiled a zero-tobacco stick for use with its heat-not-burn device IQOS, which may help the company avoid tax and other regulations that affect its tobacco products in some markets, according to Reuters.

    The new sticks, called LEVIA, do not contain tobacco but rather a “nontobacco substrate” infused with nicotine. It offers flavors including tobacco, menthol with blueberry and peppermint.

    LEVIA may avoid the heavy taxes or other controls imposed on other tobacco products, according to CEO Jacek Olczak. He said it “may not be subject to flavor regulations in some jurisdictions” and that it “doesn’t fit” in existing fiscal categories.

    A PMI spokesperson declined to comment on when and where LEVIA would launch or what substance replaces the tobacco.

  • UKVIA Launches Vape Recycling Info Hub

    UKVIA Launches Vape Recycling Info Hub

    Image: jpgon

    The U.K. Vaping Industry Association (UKVIA) has announced that it is launching a new web-based information hub, as well as a special Sustainable Vaping Week campaign during October, designed to get vapers, the vaping industry and those outlets that sell vapes to act now for the benefit of the environment.

    While the sector is making progress in limiting its impact on the environment, including the development of more recyclable product innovations and the introduction of collection schemes, a recent report by Material Focus highlights that some 5 million single use vapes are thrown away each week, according to a UKVIA release.

    The new resource hub and week-long campaign will provide vapers with information on the dos and don’ts of recycling single use vapes as well as access to locations where they can dispose of their devices in an environmentally considerate way. Retailers and other outlets, such as pubs and clubs, will also be able to download educational resources to educate their customers about recycling single use vapes across the week and throughout the year.

    There will also be guidance provided for those responsible for producing, importing, distributing and selling vape devices to ensure they are operating legally at all times when it comes to meeting environmental regulations and are working closely and effectively with reputable waste management companies.

    “There have been calls for the banning of single use vapes in part due to their environmental impact,” said John Dunne, director general of the UKVIA. “However, a ban is not the answer—firstly disposable vapes are proven to be hugely effective in getting smokers to switch from their habits to considerably less harmful vapes, due to their ease of use, convenience and low entry price points. They are the main reason why smoking is currently at record low levels across the U.K. In addition, through the collective efforts of a range of stakeholders, we can reverse the current impact on the environment arising from vapers throwing them away.

    “The initiatives we are announcing will play a key role in this process by educating vapers about how they can play a critical role in being environmentally considerate when disposing of their vapes. They will also give much needed guidance to the vaping industry and other sectors, such as hospitality and general retail, about what they need to be doing to support the collection of vape waste, thereby enabling significantly higher recycling rates than we are currently seeing for these devices.”

    The Sustainable Vaping Week will take place beginning Oct. 16, following International E-Waste Day on Oct. 14. The resource hub will become a permanent source of information on vaping and the environment.

    The UKVIA will be providing a range of content for all of its members and the wider industry to promote and share via their offline and online retail stores as well as through their communications channels to educate vapers about how they can make a positive difference to the environment as a result of changing their throwaway behaviors.

  • Malawi Extends Tobacco Farmer Registration

    Malawi Extends Tobacco Farmer Registration

    Image: Tobacco Commission

    Malawi’s Tobacco Commission has extended tobacco farmer registration and licensing to Oct. 31, 2023, according to The Nyasa Times. The end date was originally scheduled for Sept. 30, 2023.

    “We have decided to extend the exercise by one month, giving enough period to them [stakeholders and growers] without charging any fee or penalty to them,” said Tobacco Commission CEO Joseph Chidanti Malunga.

    The Tobacco Commission wants farmers to produce as much tobacco crop as possible because there is more demand for higher volumes from traditional and international buyers.

    It is illegal in Malawi for farmers to grow tobacco without being licensed.

  • Snatching Defeat from the Jaws of Victory?

    Snatching Defeat from the Jaws of Victory?

    Will the European Union enable or obstruct the market-based demise of the cigarette?

    By Clive Bates

    There are so many genuinely terrible ways to regulate combustible tobacco and smoke-free nicotine products that achieving one of the less terrible ways is a triumph. Unlike the United States, the European Union hasn’t imposed gigantic regulatory burdens that choke the life out of all but the largest companies, relentlessly favoring tobacco majors over their smaller rivals. Unlike Australia, the EU pulled back from regulating vapes as if they were medicines. Australia was once a leader in tobacco control, but now it has become a chaotic fiasco of sluggish declines in smoking and a massive black market. Despite the prohibition campaigns of the World Health Organization, the EU has resisted most forms of prohibition, though with the inexplicable exception of snus. To state the obvious, prohibition doesn’t cause banned products to disappear; it merely removes law-abiding suppliers and hands the residual market to criminals and unregulated informal traders.

    In contrast, the EU has developed a range of measures to address tobacco and nicotine risks that are not especially disproportionate or discriminatory, reasonably precautionary and not particularly prone to harmful unintended consequences. As a result, the EU has a diverse range of lawfully available safer alternatives to smoking and, therefore, the regulatory basis for tobacco harm reduction for the member states that wish to pursue it. By international standards, it is a modest success.

    European elections will be held in June 2024, and a new legislative program will emerge a few months later, with the most intensive legislative activity expected in 2025. So, the question is where next? I am sorry to report that the Brussels hive mind of bureaucrats, politicians and interest groups is on course to turn a modest success into a conspicuous failure, putting millions of lives at risk.

    The EU’s Public Health Aims are Focused on Reducing Disease

    There is a renewed impetus behind EU tobacco policy. In 2021, the EU launched its plan for addressing cancer, Europe’s Beating Cancer Plan. In 2022, it launched a separate plan for addressing noncommunicable diseases other than cancer, known as Healthier Together. Both place considerable emphasis on tobacco, and both stress the “tobacco-free generation” objective to reduce tobacco use to less than 5 percent of adults by 2040 compared to around 25 percent today.

    Regulatory Instruments

    To deliver this agenda, the EU has three main instruments to regulate tobacco and related products, such as e-cigarettes. These are in the form of “directives,” or legally binding agreements that member states will implement in domestic legislation that complies with the terms of the directive.

    1. The Tobacco Products Directive (TPD: 2014/40/EU) governs standards for products, packaging, warnings and several aspects of commerce in tobacco products. This directive also provides for the regulation of e-cigarettes, including advertising and promotion of these safer alternatives. The TPD is under active review following an evaluation of the legislative framework for tobacco control, and a new European Commission (EC) proposal is expected late in 2024.
    2. The Tobacco Advertising Directive (TAD: 2003/33/EC) bans tobacco advertising, promotion and sponsorship with a potential cross-border reach. Member states control fixed advertising, such as billboards. The TAD will likely be revised alongside the TPD to create a unified approach to tobacco and related products, such as e-cigarettes.
    3. The Tobacco Excise Directive (TED: 2011/64/EU) provides a framework for harmonizing tobacco tax design. Member states generally set the levels of excise duty but are subject to minimum levels set in the directive. The TED has been subject to a lengthy review process since 2016. Taxation matters are sensitive with the member states, and each has a veto on any proposals. Controversy struck on Dec. 7, 2022, when new proposals were pulled from publication, as several Eastern European nations noticed that it would create large increases in tobacco prices for them.

    The EU, as a party to the Framework Convention on Tobacco Control, will also form a common position to take into the November negotiations at the 10th Conference of the Parties to the Framework Convention on Tobacco Control in Panama. By endorsing the positions of the WHO, the EU will build momentum for further regulation aligned with the WHO approach.

    The EU also has a range of softer instruments, such as the nonbinding 2009 Council Recommendation on Smoke-Free Environments (2009/C 296/02). In July 2022, the EC issued a call for evidence for a proposal for an updated recommendation that would apply to heated-tobacco products and e-cigarettes.

    The Outlook is Bleak

    It is never easy to see the big picture in the EU through the relentless blizzard of initiatives, consultations, reports, working groups and statements. However, some disturbing developments are emerging.

    First, the major error of strategy. The EC sees the newer tobacco and nicotine products (heated tobacco, pouches, e-cigarettes) as a threat rather than as an opportunity to reduce cancer and NCDs. There is no sign that it recognizes or is interested in exploiting the radically different risks to health posed by smoked and smoke-free products. It should be treating tobacco products differently and proportionately according to risk. However, it is moving in the opposite direction toward treating all tobacco and nicotine products as if they were cigarettes. The effect will be to protect the cigarette trade, promote smoking, slow the decline of serious diseases and nurture the criminalization of supply and workarounds.

    Second, instead of reversing the absurd and indefensible ban on snus, rumors suggest that the EC may even try to extend this ban to nicotine pouches. Snus has already reduced adult smoking in Sweden to close to the EU’s 2040 tobacco-free target of 5 percent, with measurable improvements in cancer and cardiovascular outcomes. Encouraging “free movement” of pouches would build on the snus proof-of-concept and help to reduce smoking across the EU. Regulation of purity and total nicotine density in pouches makes sense. However, a ban will simply deny users a significant harm reduction opportunity and create an influx of illicit high-strength pouches.

    Third, there are moves to extend the ban on characterizing flavors in combustible tobacco products to all nicotine products. The EC has already done this for heated-tobacco products and could extend severe ingredient restrictions to vaping products. The government of the Netherlands, in alliance with the public health agency RIVM, has adopted a “whitelist” approach of permitting a few ingredients used chiefly to make artificial tobacco flavors. If adopted by the EU, this system would radically constrain the legal vaping market in which consumers are drawn to the diversity and ever-changing range of flavors as an alternative to smoking. At a December 2022 conference presentation in Paris, an RIVM official, Reinskje Talhout, presented on the Netherlands’ approach. After 33 pages of detailed analysis showing how to create a (short) list of permitted ingredients, she included the following slide on “Possible unintended consequences.”

    The challenge is well summarized on this slide. Yet the advocates of broad flavor bans have no response. They have largely ignored the malign market and behavioral dynamics that they are likely to unleash.

    Fourth, changes in the excise regime will dull the consumer economic incentives to switch from high-risk cigarettes to low-risk, noncombustible products. The minimum tax levels envisaged in leaked proposals are far greater than would be implied by the difference in risk compared to cigarettes. If the excise regime were more proportionate to the risk, the tax take would be outweighed by the costs of tax administration, and it would barely be worth raising excise duties. Member states should insist on their right to set zero minimum taxes on noncombustibles as it is their right to pursue tobacco harm reduction domestically. There would also be a scope for setting maximum tax levels for safer products to maintain a material difference in taxation between the highest-risk products and lowest-risk products.

    Fifth, the EC plans to make it harder for European citizens to learn of safer alternatives to smoking by imposing further controls on advertising and promotion and possibly to willfully mislead consumers with packaging and warnings that implicitly exaggerate the risks of low-risk alternatives to smoking. Again, the regulatory tactic is to treat all products as if they are as harmful as cigarettes when what is required is more nuanced risk communication. If the EU follows the direction of the WHO, it will risk drifting into inappropriate restrictions on free speech and legitimate opinion.

    The question for me is why? What fearful autocratic reflex causes the EC to suppress pro-health innovation and see opportunity as a threat? There is an opportunity here for the free movement of goods and services within a well-functioning internal market to deliver a high level of health and consumer protection. The internal market, if allowed to function as intended, could end the cigarette era and epidemic of smoking-related disease. Yet its most ardent champion, the EC, appears unwilling to let the internal market crush the cigarette trade through the power of consumer preference, competition and creative destruction. What a pity.