Category: Also in TR

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  • James Murphy Makes a Case for Consensus

    James Murphy Makes a Case for Consensus

    Photo: pavelkant

    A global alignment on health policy is necessary to make a smokeless world a reality.

    By James Murphy

    With renewed attention on smoking and vaping regulation around the world, now is the time for action that will realize global smoke-free ambitions and ensure cigarettes become a thing of the past.

    Achieving this vision requires a global consensus on the most effective approach to create sustained and lasting changes to consumer behavior—tobacco harm reduction (THR).

    THR is one the greatest public health opportunities today, representing a pathway for hundreds of millions of smokers who would not otherwise quit to transition from combustible tobacco products to smokeless alternatives.

    Countries that have recognized the opportunity THR presents, and which have adopted supportive policies, have seen striking success in reducing their smoking rates. The U.S., U.K. and Japan are all currently witnessing their lowest smoking rates on record while Sweden is on track to declare themselves smoke-free this year—defined as having less than 5 percent daily smokers in the population—16 years ahead of the 2040 EU target.

    These remarkable transformations have been driven by widespread THR acceptance from policymakers, regulators, health officials and consumers in these markets, enabling and encouraging smokers to migrate from combustible tobacco products such as cigarettes to vapor, oral nicotine pouches, snus and heated-tobacco or herbal products.

    The widespread accessibility of smokeless products is essential for the success of THR. However, at present, this is being hamstrung by many countries limiting access to these alternative tobacco and nicotine products. For example, 60 percent of the world’s population live in just 15 countries. Of these, only about 40 percent permit the sale of smokeless products, leaving millions who would otherwise continue to smoke without the option to switch to such alternatives.

    In order to fully realize the public health potential of THR and significantly reduce the more than 8 million deaths attributed to smoking cigarettes each year, regulators around the world should embrace evidence-based science to drive positive public health outcomes. This means implementing a supportive regulatory framework that encourages adult smokers who would otherwise continue to smoke to switch while also protecting consumers with stringent safety standards and preventing underage use.

    In addition, the global success of THR depends on governments and regulators correcting persistent misperceptions of smokeless products compared to cigarettes.

    A University College London-led study published earlier this year highlighted that most smokers in England wrongly believe vaping is at “least as harmful as smoking,” with 57 percent of respondents saying they thought vaping was “equally” or “more harmful.” This echoes trends reported in the U.S., with research showing that perceptions of e-cigarettes as more harmful than cigarettes doubled year on year between 2018 and 2020. Not only are these misperceptions flawed, but they also have significant implications for public health by actively discouraging smokers who would otherwise continue to smoke from making the switch to smokeless products.

    Greater efforts are needed to counter these misperceptions—something that BAT is trying to tackle. As the world’s largest vapor company and a leader in smokeless products, BAT is committed to producing innovative products backed by world-class science and industry-leading product safety and quality standards. BAT’s THR approach is based on the growing body of research and weight of evidence approach that substantiates its belief of the reduced-risk profile of these products compared to cigarettes, which have been accepted by many international public health bodies. BAT publishes its science research to increase understanding of THR and raise awareness with stakeholders.

    Indeed, the industry developing and producing these products has a critical role to play. But to achieve the conditions required to make a success of THR, an inclusive, open and honest dialogue with all stakeholders is required. That includes policymakers, regulators and the healthcare and medical communities. Unfortunately, this is not yet the case, with the industry all too often excluded.

    We have an opportunity to usher in a new smokeless world, grounded in scientific research and a firm commitment to public health. The solutions are available today. All that is required is for the relevant stakeholders to actively work together to prioritize THR and the well-being of millions of people worldwide.

    James Murphy is the director of research and science at BAT.
  • Navigating the Fog: Brazil’s Battle Over Vaping

    Navigating the Fog: Brazil’s Battle Over Vaping

    Image: VlaDee/pavlofox

    Brazilian lawmakers mull regulation of e-cigarettes.

    By Claudio Teixteira

    In the face of growing concerns about public health, the expansion of the illicit market, and the persistent inaction of the Health Agency in assuming its regulatory responsibilities, the Federal Senate of Brazil has taken matters into its own hands with a bill for the regulation of electronic cigarettes in the country. This initiative, driven by Senator Soraya Thronicke, seeks to fill a legal loophole that has favored organized crime for over a decade and ensure adequate consumer protection. The bill under discussion in Brazil has the potential to mark a before and after in the vaping policy of the largest market in Latin America. Below, some fundamental aspects of this project are detailed, and the perspectives of experts on the subject are gathered.

    Nearly 15 years have passed since the Brazilian National Health Surveillance Agency (ANVISA) banned commercial activities related to electronic cigarettes, and the discussion about this measure remains as relevant as it was at the beginning.

    Although the current law does not restrict personal use or possession of vaping devices, the ANVISA’s decision in 2022 to maintain the ban, after an exhaustive review process and public consultation, has generated a polarized debate among the Brazilian population. The consultation conducted last February has revealed considerable interest from consumers and various social sectors in reviewing and softening the current rules, favoring a more open and evidence-based policy.

    The ANVISA’s decision not to engage in the regulation of vaping products has spurred a significant legislative reaction from the Federal Senate. This situation highlights a critical moment in Brazil’s public health policy, marking a possible turning point in how the country addresses the regulation of these contemporary and widely debated products.

    In this context, Bill No. 5,008 of 2023, promoted by Thronicke, emerges. This legislative initiative is proposed as a direct response to the ANVISA’s inaction and seeks to establish a comprehensive regulatory framework for electronic cigarettes and similar devices in Brazil. The project covers many aspects, including production, marketing, importation and exportation as well as the regulation and specific supervision of these consumer products.

    Intending to establish precise requirements for their control, this bill represents a comprehensive effort to manage the presence and distribution of vaping devices in the Brazilian market, ensuring proper regulation from their manufacture to their promotion.

    Benefiting Organized Crime

    The senator has expressed concern that Brazil, unlike 84 percent of Organization for Economic Cooperation and Development countries, lacks specific legislation to regulate electronic cigarettes. According to her, this omission leaves consumers vulnerable, facing a proven ineffective ban that does not align with the more advanced legal and regulatory standards adopted globally.

    Thronicke emphasizes that the protection of public health must be the priority, with a particular focus on the safety of young people. She proposes implementing strict regulations covering all aspects from production to marketing, promotion and consumption of these products. The senator maintains that adopting such measures is essential to minimize the risks associated with the use of electronic cigarettes and ensure a market supply that is responsible and regulated.

    The senator has expressed her deep dissatisfaction with Brazil’s current lack of regulation of electronic cigarettes. In an interview with Poder360, she pointed out how this legislative gap directly benefits organized crime. She highlighted the critical need to be held accountable for this omission and wondered who truly benefits from this legal void.

    “I wish those responsible for this omission face the consequences. I need to know who is behind this and who is facilitating organized crime operations. In this legal limbo scenario, the only beneficiaries are, without a doubt, criminal groups,” emphasized the senator, underscoring the importance of addressing and closing this legislative gap to combat the advancement of organized crime in this sector effectively.

    The senator’s concern extends to the quality and safety of vaping products in the Brazilian market. Many of these products evade regulations and contain components of unknown composition, posing a significant risk to public health. Furthermore, she criticizes the current prohibitive policies for their inconsistency, banning potential alternatives in favor of products whose dangers are already widely documented.

    Thronicke argues that if bans are to be implemented, they should be applied equitably, including traditional tobacco products. “If the decision is made to ban electronic devices, then conventional cigarettes should also face prohibition. It takes courage to do so, especially when nicotine is legal in Brazil, and electronic cigarettes represent just another way of consuming it.”

    These statements underline the urgency and complexity of formulating precise and compelling regulations for electronic cigarettes and other reduced-risk products in Brazil, focusing on safeguarding public health and combating illegality.

    Her concerns are evident when she points out how the absence of regulation benefits organized crime through the illicit trade of these products. She also highlights the risks of using unregulated devices and liquids whose ingredients are unknown and potentially harmful. “What is currently sold in Brazil evades any regulation. In Brazil, it’s simple to adulterate these products. The substances used for refilling or containing are made up of unknown ingredients, representing a serious health risk,” the senator emphasized.

    Knowing the Bill

    • The bill proposes that companies wishing to manufacture or import electronic cigarettes in Brazil register their products with the ANVISA. This process would include paying a “sanitary surveillance and inspection fee” set at BRL100,000 ($20,000) for each registration application or renewal.
    • Additionally, registering these products with the Brazilian Federal Revenue service will be required. As part of the process, interested parties must also submit a toxicological evaluation report to the ANVISA that should comprehensively analyze the additives and materials used in the products. This measure seeks to ensure rigorous control over the quality and safety of electronic cigarettes available in the Brazilian market to protect public health and ensure that only safe and regulated products are accessible to consumers.
    • The National Institute of Metrology, Quality and Technology and the National Telecommunications Agency will play crucial roles in establishing technical and safety criteria for the proper functioning of vaping devices. These guidelines will include regulations on safety in the charging process and standards for the wireless communication of devices, aiming to ensure that their use is safe and effective.
    • On the other hand, the bill introduces rigorous regulations for liquids containing nicotine, establishing a maximum volume limit of 22 mL and a maximum nicotine concentration of 35 mg per milliliter.
    • Additionally, the devices must be designed to prevent inappropriate tampering and ensure that they are inaccessible to children as part of a comprehensive effort to increase the safety of these products and primarily protect minors.
    • For heated-tobacco products and their respective packaging, the legislative project specifies that each package must contain 20 units, with a nicotine emission that does not exceed 1 mg per tobacco stick.
    • Product packages must include an informative leaflet covering essential aspects for the consumer, including instructions for use and storage, contraindications, possible adverse effects and warnings directed at at-risk groups.
    • The products must detail their ingredients, the nicotine concentration, the batch number and production and expiration dates. In addition, they must incorporate warning messages about health risks and the obligation to keep these products away from children and adolescents.
    • The products must display explicit warnings about several critical aspects of consumer safety and health. Firstly, they must prominently indicate the prohibition of their sale to minors under 18 years of age along with a strong recommendation against their use by nonsmokers. The need to keep the product out of reach of pets will also be emphasized.
    • Specific contraindications will be detailed to ensure that consumers are fully informed about situations in which the use of the product is not recommended or can be risky. This includes warnings focused on high-risk groups, such as pregnant women, people with diabetes and patients with heart conditions, reinforcing the project’s commitment to public health protection and the promotion of responsible consumption.
    • The product label must provide detailed information on the possible adverse effects of using the product and warnings about the risks of dependency and toxicity arising from its prolonged use.
    • The products will include detailed contact information, such as the company’s legal registry and the manufacturer’s or importer’s address, to ensure effective communication with consumers and facilitate the submission of complaints if necessary. According to the senator, this set of requirements promotes high transparency and accountability, encouraging these devices’ safe and informed use.
    • The packaging of electronic cigarette products must clearly and visibly display on their exterior a series of crucial information for the consumer. This includes a detailed list of ingredients, categorized explicitly and understandably by the type of additives and nicotine concentration. It is also crucial to include the batch identification, the production date and the product’s expiration date.
    • A prominent warning that the product must remain out of reach of children and adolescents is essential, along with a message about the health risks that must occupy at least 20 percent of the packaging surfaces most visible to the consumer.
    • Regarding the wording of the products, a specific prohibition will be implemented on using numbers, expressions or graphic elements that evoke flavors associated with desserts, sweets or any other element that may attract children and adolescents.
    • The ANVISA will determine the substances whose use will be prohibited, thus ensuring thorough control over the components of these products to safeguard public health.
    • The advertising of electronic cigarettes and related products will be subject to a rigorous ban in all media, including television, radio, billboards, print publications and digital platforms, such as social networks. The only exception allowed will be promoting these products within physical sales points or through e-commerce platforms, provided that strict age control is implemented to prevent minors from accessing them.
    • Expressly, any direct or indirect reference to youth culture is prohibited, including images of people who may be perceived as under 25 years of age, to deter interest in these products from this age group. These measures aim to reduce the appeal of electronic cigarettes and similar products among young people, safeguarding their health and well-being.
    • A robust age verification system will be required at the point of sale to confirm that the purchaser is over 18 years old, using biometrics or other equivalents.
    • Sales points must also comply with regulations prohibiting placing electronic cigarettes near products intended for children, such as candies and toys, thus avoiding any association that may be appealing to minors.
    • Furthermore, an explicit ban will be imposed on the free distribution of electronic cigarettes by manufacturers, importers or traders for promotional purposes to prevent encouraging consumption among new users, particularly young people.

    The regulations surrounding the consumption of harm reduction products will be established in line with the rules applied to traditional cigarettes, including restricting their use in enclosed spaces under existing legislation.

    The controversial prohibition of open-system devices is among the critical challenges to implementing and complying with the proposed regulation. These are characterized by a reservoir that can be refilled and generally offers the option to recharge. In contrast, closed systems comprise devices designed typically for single use, which are nonrechargeable and disposable after use.

    Such devices, due to their customization capability and low cost, present a significant alternative for those users looking to quit smoking by allowing them to adjust the nicotine concentration according to their specific needs.

    However, a critical limitation of the proposed law is that the prohibition significantly restricts the tools available for harm reduction and smoking cessation. This limitation to specific devices poses notable challenges in compliance and effective implementation of the regulation, implying the allocation of resources that could be used more effectively in other tobacco control strategies and in promoting awareness of the associated risks.

    ‘Chemical Weapons’

    The journey of the bill proposed by Thronicke in the Brazilian Senate is anticipated to be full of obstacles. One critic is conservative Senator Eduardo Girao, who has fervently defended the approval of his project, the PL 4.356/2023, which seeks to ratify the prohibitions already imposed by the ANVISA on electronic cigarettes, which he describes as “authentic chemical weapons with a technological varnish.”

    Girao argues that e-cigarettes are designed to attract new consumers, thus compensating for the loss of users that the tobacco industry has experienced in Brazil and globally over the last decades. During a plenary session of the Senate on March 11, he warned about the “serious health consequences in the short [term], medium [term] and long term” that an increase in the consumption of these devices could entail, especially among young people. Among these consequences, he mentioned an increase in the incidence of respiratory diseases, cardiovascular diseases and cancer.

    Despite this opposition, there are voices like that of Deputy Heitor Schuch suggesting that it’s unlikely any bill will succeed without explicit backing or a prior determination by the health agency.

    The scenario underscores the complexity of the legislative and regulatory debate around electronic cigarettes in Brazil, reflecting the divergence of opinions both within the political spectrum and in the academic and medical fields. The situation highlights the need for a deep and balanced analysis that considers both public health and the realities of nicotine consumption in the country. Amid this debate, various voices, including politicians, scientists and civil society representatives, urge Brazil to adopt a coherent and safe regulatory framework for nicotine products.

    With 22 million active smokers and about 3 million vapers, the lack of defined regulation and clear inequality in access to less harmful alternatives underline the urgency of establishing effective regulation through legislation. This measure is essential for promoting public health, social equity and economic stimulus. This raises the question of whether this will be the moment Brazil moves toward a more equitable and effective tobacco control policy.

    However, as several experts, including Schuch, have highlighted, the likelihood of any bill progressing without the endorsement or a preliminary determination by the health agency seems slim. This scenario highlights the complexities surrounding the formulation and implementation of public policies in tobacco control, emphasizing the importance of a consensus among the stakeholders involved to move toward solutions that adequately address the public health challenges in Brazil.

    Finding the Right Balance

    For professor Ingrid Dragan Taricano, a prominent toxicologist, regulating electronic cigarettes is at a decisive moment. Taricano identifies several aspects that underline the urgent need to regulate these devices, covering everything from public health and the protection of minors to environmental implications and risk and safety assessments from a toxicological perspective.

    Following the essential principle of toxicology, which holds that “every substance is toxic; it is the dose that makes the poison,” Taricano highlights the need to carry out rigorous health-risk assessments to establish safe exposure limits to any substance that comes into contact with humans. This approach emphasizes the importance of addressing concerns about toxic substances in electronic cigarettes and raises a crucial question: What is the safe dose for each component of these products?

    Bill PL 5008/2023 incorporates this vision by requiring the submission of toxicological evaluation reports for registering electronic nicotine-delivery devices with the ANVISA. Taricano views this proposal positively, highlighting its relevance within the regulatory framework to ensure a comprehensive evaluation considering the additives used, the manufacturing material and an objective toxicological comparison with traditional cigarettes.

    Taricano emphasizes the importance of toxicology as a cornerstone for developing policies and regulations regarding electronic cigarettes. This scientific discipline provides the foundation for establishing quality and safety criteria, restricting certain ingredients and flavors and adopting measures to prevent young people’s access to these products.

    In nations where effective regulation has been implemented, specific limits for nicotine concentration have been determined, and proven quality components of e-liquid have been required. This scenario contrasts significantly with deregulated markets, where devices can contain dangerous substances without supervision, as Taricano warns.

    She criticizes positions against regulation that focus solely on the presence of harmful elements in electronic devices, overlooking the fundamental toxicological principle that “every substance is toxic, and everything is a matter of dose.” According to Taricano, user safety can only be guaranteed through the appropriate regulation of the quantities and quality of the components.

    Taricano highlights the complexity of establishing balanced regulation that protects public health without inhibiting innovation or individual freedom. For her, it’s fundamental that regulatory decisions are supported by a solid scientific base, ensuring that both the risks and benefits of using electronic cigarettes are considered. In this sense, science must be the beacon that guides toward informed and effective regulation, always with consumer well-being as the highest priority.

    ‘An Obstacle to Quitting’

    Alexandro Lucian, a renowned expert in harm reduction associated with smoking and leader of the Directory of Information for Tobacco Harm Reduction, a nongovernmental organization dedicated to improving anti-tobacco policies, highlights the bill’s importance as an essential tool to address current issues of smuggling, tax evasion and the indiscriminate use of products attractive to young people.

    Lucian points out that this project seeks to ensure that consumers have access to products that comply with appropriate health regulations and are adequately informed about the risks involved in their use.

    However, Lucian emphasizes that the bill requires significant reforms. He criticizes the imposition of an annual registration fee of BRL100,000 and the misclassification of electronic cigarettes as tobacco derivatives, which could hinder the legalization of numerous existing initiatives, thus fostering the illegal market and posing a risk to public health. “This fee will prevent most of the initiatives already existing in the country from becoming legal, fueling illegal trade and bringing incalculable risks to public health,” he says.

    He also underscores the need to review the project section that suggests banning open systems, which many users prefer. He argues that restricting legal access to these systems could further stimulate illegal trade. Lucian highlights that these systems, by offering the possibility to adjust the nicotine dose, facilitate the process for traditional cigarette smokers to migrate to electronic ones and, over time, give up the smoking habit.

    ‘An Obstacle for Small Businesses’

    From the consumer’s perspective, Ignacio Leiva, leader of ASOVAPE Chile and coordinator of the “Vaping Is Not Smoking” campaign, is a recognized activist who has significantly contributed to formulating progressive vaping regulations in Chile. Sharing his vision of the situation in Brazil, Leiva considers that Thronicke’s project represents a notable advance for Brazilian legislation, which currently faces unfavorable conditions due to the total ban.

    According to him, this situation has fostered the rise of a black market that not only puts consumers’ health at risk due to the lack of control over product quality but also deprives the state of significant tax revenues in addition to benefiting marginal groups that trade in these products.

    Leiva expresses concern about the BRL100,000 required for product registration, which he sees as a particularly onerous barrier for small-sized and medium-sized enterprises, possibly favoring large corporations and potentially resulting in a monopoly in the sector.

    While he supports advertising restrictions for conventional tobacco, Leiva advocates for greater freedom in promoting harm reduction products. He highlights the need to inform society about less harmful alternatives. He argues that regulation facilitating access to safe and regulated options can motivate a positive change in consumption habits, reducing tobacco use and benefiting public health. Moreover, he defends adopting fair regulatory measures that do not unjustly favor large corporations to the detriment of smaller market players.

    Leiva emphasizes the importance of achieving a balance between offering less harmful alternatives to smokers and protecting minors. He positively values the measures included in Thronicke’s proposal to prevent minors from using electronic cigarettes. He applauds the initiative to restrict the sale of these products alongside items aimed at the child and youth audience. This approach reflects, in his opinion, a solid commitment to the protection of young people, ensuring that efforts to minimize the harms associated with tobacco do not increase the use of electronic devices among the most vulnerable population.

    Protecting Public Health and Promoting Equity

    The voices of politicians, civil society members and scientists urgently highlight the need for a more coherent and safer regulatory framework for managing nicotine products in Brazil. There is widespread agreement on the need to focus policies on protecting public health and combating illegal trade as well as addressing smoking-related complications.

    It is also recognized that adopting appropriate regulations in the country would benefit public health and boost the economy through job creation, increased revenues and significant fiscal contributions to the state. This perspective underscores the importance of a balanced approach that combines health objectives with economic incentives to positively impact the population’s well-being and the country’s economic development.

    Although Brazil records lower smoking rates compared to other nations, there remains a significant fraction of the adult population, approximately one in eight adults, who continue to smoke. This represents about 22 million people. This data, derived from national statistics on tobacco consumption, highlights the pressing need to implement effective public health policies.

    The prohibition of products recognized as harm reduction options in Brazil poses a severe challenge in terms of social justice. A higher incidence of smoking is observed in the lower socioeconomic classes compared to the ability of middle and high classes to access less harmful alternatives, which evidences an apparent disparity in access to healthier options.

    This inequality suggests that strategies to promote a healthier lifestyle are predominantly available to those with greater economic capacity, leaving people with fewer resources and limited options to quit or reduce tobacco use. This scenario underscores the need to adopt inclusive measures that allow all layers of society to benefit from safer and more effective alternatives for smoking cessation.

    The current prohibition becomes a significant obstacle to implementing public policies aimed at improving access to harm reduction methods in communities most impacted by smoking. In this context, adopting effective regulation emerges as a crucial element, with the potential to make harm reduction strategies accessible to all levels of society, thus helping to mitigate health inequality.

    The discussion on regulating less harmful alternatives, such as electronic cigarettes, becomes especially relevant, offering solutions to the adverse consequences of prohibition in Brazil’s social fabric. Furthermore, this debate opens a new avenue in the fight against smoking. Considering social justice issues, it is imperative to promote policies that foster equity and ensure fair access to safer options for all citizens.

    Claudio Teixeira is a journalist, director of C3PRESS Agency and editor of The Vaping Today. He lives in Brazil.
  • Doubling Down

    Doubling Down

    Australia’s proposed crackdown on vaping is unlikely to achieve its objectives.

    By Stefanie Rossel

    As a vaper in Australia, you basically have two choices. The first option is to behave like a good citizen, go to your doctor, get a prescription and convince a pharmacist to sell it to you. The alternative is to be not so good and do what 92 percent of Australian vapers do—source your e-cigarettes on the black market. Vapes have been regulated Down Under since October 2021 but so poorly that Australian health professionals speaking at the Warsaw Global Forum on Nicotine in June apologized for the legislation.

    Getting a prescription is more difficult than one might think, according to Carolyn Beaumont, an Australian general practitioner (GP) who advocates for the right of adult smokers to access vaping products. As Beaumont explained during her presentation, among the many barriers is the challenge to find a doctor who is not only familiar with vaping products but also believes in their potential as smoking cessation tools. But Australia is a huge country, where most of the population—and doctors—live along the Eastern Seaboard. In other regions, there are fewer physicians. Additionally, clinics may not be open daily, wait times are getting worse, and more GPs are charging privately. An estimated 20 percent of Australians have no regular GP; Beaumont said it could be even 35 percent.

    Doctors often lack product knowledge and have an inadequate understanding of smoking, vaping and nicotine dependence. Tobacco harm reduction is not taught in Australia, according to Beaumont, and the medical guidelines are not supportive of vaping. Doctors also face an administrative barrier: They need to be registered as an authorized nicotine prescriber. However, the prevailing negative media narrative in Australia makes many GPs reluctant to register. In April 2023, the Australian Department of Health and Aged Care listed 1,963 authorized prescribers nationwide, which equals one in 20 practitioners.

    Once vapers have secured a prescription, they need to find a pharmacy that sells vapes. But few establishments do so, and often, they have only limited stock. Vapes can also be ordered online and imported for personal use under the Therapeutic Goods Administration’s (TGA) personal importation scheme. With a valid prescription, Australians may legally import a three-month supply per order. “It remains illegal for other Australian retailers, such as tobacconists, vape shops and convenience stores, to sell you nicotine vaping products, even if you have a prescription,” the TGA stresses on its website.

    At present, merely 8 percent of vapers have a prescription, and only 2 percent purchase from pharmacies, according to a Roy Morgain survey in February 2023.

    Additional Restrictions

    Colin Mendelsohn

    Things are unlikely to get easier for smokers seeking less hazardous alternatives to combustible cigarettes. In May 2023, Health Minister Mark Butler announced a further crackdown on recreational vaping. He claimed that vaping had been advertised to the public as a therapeutic product meant to help smokers quit but instead spawned a new generation of nicotine users, particularly young people. At press time, details on the new rules were unavailable, but tobacco harm reduction advocates were bracing for restrictions on disposable vapes, flavor options and nicotine concentrations, along with a requirement to package vaping products in pharmaceutical-style packaging and an end to the personal importation scheme, with sales permitted only through authorized pharmacies.

    Writing on his blog, professor Simon Chapman, a determined opponent of vaping, suggested that Butler might ban refillable vaporizers as well. The planned legislation will require federal authorities to seize products at the border and states to police retail sales, but so far, it has not allocated any funding to enforcement.

    The proposed plan is de facto prohibition, according to Colin Mendelsohn, a former GP who has been helping smokers quit for more than 30 years. “It is a doubling down on a failed highly restrictive model that has been rejected by vapers and prescribing doctors and has created a thriving black market, which sells freely to underage users,” he says. “The history of prohibition and the war on drugs shows consistently that it does not reduce long-term illicit drug supply, and there is no reason to believe that this will be different. Bans are effective short-term political strategies but are bad public health policy. The Australian Border Force (ABF) does not have the resources or interest in intercepting vapes and is correctly more focused on dangerous illicit drugs, such as heroin, cocaine, ice, etc., or weapons.”

    In an interview in May, ABF Chief Michael Outram warned that banning vapes at the border wouldn’t be enough to stamp out a rampant black market, as his organization managed to intercept barely 75 percent to 80 percent of illicit drugs making their way into Australia “on a good day.” Of the 8 million containers coming into the country each year, only 1 percent to 1.5 percent are scanned.

    The proposed crackdown, cautions Mendelsohn, will likely have many unintended consequences. “Criminal networks will continue to find ways to import vapes,” he says. “This is a high-profit and low-risk crime, and it is accompanied by stand-over tactics, such as firebombing of retail outlets, gang wars and violence, and corruption of officials. The proceeds fund other, more serious criminal activities. There will be continuing sales to youth and more difficult legal access for adult smokers. Some vapers will relapse to smoking. It will be harder for current smokers to switch to vaping.”

    According to Mendelsohn, the planned law will criminalize otherwise law-abiding citizens who simply want to improve their health, and cause the government to lose revenue from taxes, licensing and vape shops while shouldering increased cost of policing, enforcement, the justice system and prisons. “We will continue to see dodgy, mislabeled, unregulated products with high nicotine levels,” he says. “The harm from unregulated black market products was demonstrated during the EVALI [e-cigarette or vaping product use-associated lung injury] outbreak. There will also be higher prices, increased drug potency [and] stockpiling of nicotine e-liquids prior to the change. All legal, legitimate vape businesses will be closed. It’s a violation of the human right to access a safer alternative to smoking.”

    Unsuccessful Measures

    Low-income and otherwise disadvantaged people, among whom rates of smoking and smoking-related death and disease are significantly higher than in the rest of the population, will be disproportionately affected, according to Mendelsohn. “Australian research has shown that vaping may help to reduce health inequalities,” he says. “Smoking is a leading cause of financial stress in disadvantaged populations, especially at a time of sluggish wage growth, high interest rates and a high cost of living. Spending is diverted from food, clothing, etc., to smoking.”

    Australia has the highest cigarette prices in the world, with a pack of 20 retailing at AUD40 ($25.60). Based on a consumption of 13 cigarettes a day, the average cost of smoking is AUD11,850 per year. Vaping, by comparison, costs AUD500 to AUD1,500 per year, depending on the device used.

    “At the current high levels, further tax rises are no longer effective due to the law of diminishing returns,” says Mendelsohn. “Many addicted smokers are simply unable to quit no matter how high the price. Smoking rates in Australia have not declined over the last four years in spite of high prices, plain packaging and other tobacco control strategies.”

    So where’s the consumer in all of this? Mendelsohn says that the lack of a consumer voice is a big problem. “We had a New Nicotine Alliance AU, which disbanded about five years ago. Recently, the Australian Smokefree Alternatives Consumer Association was formed but is still very quiet. Legalise Vaping is a part of the Australian Taxpayers Association and is the most active advocacy group. I believe they have had some indirect tobacco company funding in the past, but they are focused on legalizing and regulating vaping and the rights of adults to make their own choices. Overall, they do an excellent job with limited resources. All anti-vaping groups are subject to great scrutiny and are smeared and undermined by anti-vaping advocates if there is any potential opportunity.”

    Ideology Instead of Science

    Butler’s plan has attracted criticism from several institutions. On July 8, internal confidential e-mails sent by members of the Australian National Advisory Council on Alcohol and Other Drugs (ANACAD) expressed concerns about further restrictions, saying it would exacerbate the black market problem, criminalize more people and make smoking more attractive. On July 18, Mendelsohn and a group of more than 40 experts from Australia and New Zealand urged lawmakers to listen to the ANACAD ahead of Butler’s proposed vaping crackdown. At the time of this interview, they had not received a response to their letter.

    Mendelsohn is not optimistic that Butler will change course. “Butler has committed himself to this crackdown, and there is no indication that he will soften his approach,” he says. “He is taking advice from a small group of ideologically driven tobacco control academics and health bureaucrats with extreme anti-vaping views.” According to Mendelsohn, Butler operates in a bubble and is ignoring the pro-vaping arguments. “He has refused to meet with Dr. Wodak [a fellow tobacco harm reduction proponent] and me, although we met with his adviser, who was clearly committed to a predetermined position,” says Mendelsohn. “He is under considerable pressure from Australian health charities, medical associations, public health organizations and state governments that are almost universally opposed to vaping. The media is also hostile to vaping. Any turnaround will be very difficult politically.”

    Vaping policy in Australia, says Mendelsohn, is driven by ideology rather than science. “Australia’s peak health and medical research organization, the National Health and Medical Research Council (NHMRC), prepared an anti-vaping position paper on vaping. The NHMRC is very influential in guiding national health policy. The NHMRC document was critiqued in a peer-reviewed article in Addiction by leading Australian and international experts and found to be riddled with serious scientific flaws and misinformation. However, it remains unchanged.”

    For sensible regulation of vaping, says Mendelsohn, Australia should look to its neighbor, New Zealand, which in August 2020 legalized and regulated vaping. “Over the next two years, there was an unprecedented 33 percent decline in the adult smoking rate among those aged 15 and over—from 13.7 percent to 9.2 percent. In Australia during the same period, the smoking rate increased by 4.5 percent. In that time, there have been no major smoke-free policy interventions, almost no mass media spend on quit campaigns and no tobacco tax increases in NZ.”

    Lessons From Drug Policy

    Alex Wodak

    Alex Wodak, Mendelsohn’s ally in the battle for harm reduction-based legislation, is more confident that Australia will eventually change its stance on vaping. Wodak has dedicated his career to drug harm reduction and was instrumental in reforming drug law in Australia. Together with colleagues, he created the country’s first needle exchange program in 1986 and its first medically supervised injecting center in 1999. At this time, both were pre-legal.

    He observes parallels with his country’s current crackdown on vaping. “The World Health Organization opposed drug harm reduction, including needle and syringe programs for a few years in the 1990s, apparently relenting to intense U.S. pressure,” says Wodak. “The default policy for communities, governments and the WHO for new drugs, new forms of drug administration and new forms of drug harm reduction is generally negative. It seems sensible to be initially cautious about changing situations regarding drugs, but we have a problem when the opposition to a new form of drug harm reduction is maintained long after the evidence of effectiveness and safety has become compelling, especially when the costs of delay are so substantial as they are with needle and syringe programs and tobacco harm reduction.

    “The case in favor of vaping and other forms of tobacco harm reduction is now overwhelming. Smokers increasingly prefer to continue to use nicotine but prefer to consume it in safer ways. Many traded tobacco companies are transforming from combustible cigarettes to safer products, some faster than others, but they are changing. Investors pay higher prices for tobacco companies transforming more rapidly. Unfortunately, tobacco control, governments and the WHO are still resisting change, which now seems inevitable. This change is an enormous opportunity for public health, similar to the scale of the benefits from vaccination.”

    Wodak remembers the time when harm reduction was refused in favor of an abstinence-only approach in drug policy circles. “The political debate lags behind the scientific debate,” he says. “There are many lessons from this experience. It is important to continue improving the quantity and quality of evidence. It eventually does make a difference. Being polite and respectful to harm reduction opponents matters. So does persistence. There are no shortcuts. Harm reduction involves consequentialism—that is, making an assessment of both the benefits and costs of a policy or intervention. Opposition to harm reduction often involves deontology—that is, following a set principle, such as aiming for a tobacco-free—or nicotine-free—outcome rather than a smoke-free outcome. The net effect of the policy or intervention is not a concern.”

    Staying Power Needed

    The current approach of the Australian government to vaping is unsustainable, Wodak emphasizes. “It is destined to collapse sooner or later,” he says. “Opponents of harm reduction are unable to justify why a far safer option is severely restricted while a deadly option remains readily available. Despite dominating politics, mainstream media and medical and health publications, 73 percent of Australians support vaping being regulated like cigarettes and alcohol while only 20 percent support prescription-only regulation of vaping.”

    The new approach announced by Butler on May 1 requires legislation to be passed by the House of Representatives and the Senate. “This legislation will most likely be passed by the House of Representatives but is unlikely to be passed by the Senate,” says Wodak. “The black market currently meets 92 percent of the demand from a rapidly growing number of adult Australian vapers, now estimated to number 1.3 million. Although the government asserts it will strengthen law enforcement border efforts to reduce the number of illegal vapes entering Australia, now estimated at about 10 million per month, no additional funds have been provided for this purpose. Heroin was prohibited 70 years ago in Australia. However, in 2022, a survey of people who use drugs found that 87 percent said that obtaining heroin was ‘easy’ or ‘very easy.’ When demand for a good or service is strong and controls are easy to subvert, as is the case with vaping, other sources of supply almost invariably emerge.”

    Wodak views the battle for vaping reform in Australia through the lens of drug harm reduction rather than from a perspective of tobacco control. “I have been involved in battles for drug law reform in Australia over about 40 years. We have won almost all of these battles, although it has often taken more time and effort than we would have preferred. I am very confident that tobacco harm reduction will prevail in Australia. Taking a bet against drug harm reduction is very brave as harm reduction almost always wins.”

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • McKeganey on the Mystery of the PMTA Process

    McKeganey on the Mystery of the PMTA Process

    Photo: Olivier Le Moal

    How effective must a product be in helping adult smokers quit to overcome the theorized level of harm to youth?

    By Neil McKeganey

    If there is one thing that you can say about the U.S. Food and Drug Administration’s premarket tobacco product application (PMTA) process, it is that it is exceedingly data heavy. E-cigarette manufacturers’ submissions under the PMTA process can run to the thousands of pages, reporting the results of research costing millions of dollars. To receive a marketing authorization, e-cigarette manufacturers have to be able to show that their product is “appropriate for the protection of the public health” (APPH).

    The APPH standard has become something of a modern-day mantra in the world of tobacco regulation, but what exactly does it mean? While nobody would accuse the FDA of excessive clarity in its communications with industry, this much is clear—in the simplest of terms, manufacturers need to be able to show that their product is helping adult smokers to quit, or at least to substantially reduce their smoking, and that their products are not being used by nonsmokers. This, in a nutshell, is what the FDA means when it talks about the importance of assessing the net public health impact of new tobacco products—the capacity to assess the likely overall impact of a new tobacco product on the nation’s health.

    The kind of evidence that manufacturers are required to present under the PMTA process ranges from longitudinal customer studies collecting data from consumers of their products over weeks or months to assess how those products are impacting on the individual’s smoking behavior. Alongside such customer studies are the randomized control trials that monitor changes in smokers’ behavior when they are using the new tobacco product under control conditions. The randomized trials are probably the sort of things most manufacturers have heard of before even if they have not carried them out. These studies are often presented as the gold standard in research evaluating the impact of a new drug. The shortcoming with the control trial design, though, is that it tells you about the impact of your product under controlled conditions; it does not tell you how people will use your product in their real life.

    The results of these studies can be presented to the FDA along with studies showing which population groups are currently using the new tobacco product and which ones are likely to start using the new tobacco product if it were approved. This is where the PMTA process starts to get more mysterious. One of the key groups that the FDA wants to know about is young people. With recent studies showing that more than one in 10 young people in the U.S. are using e-cigarettes, the FDA has repeatedly stressed that in deciding whether a manufacturer’s product is going to be judged as APPH, it needs to balance the impact of the product on adult smokers and young people. When the former FDA commissioner stated in 2018 that the “offramp” to adult smoking must not be achieved at the cost of the on-ramp to youth vaping, he was making it clear that the FDA would be prepared to deny approval to a new tobacco product that might be helping adult smokers to quit if at the same time it was being used by youth or likely to be used by youth.

    In a scenario where youth use of a new tobacco product can become a deal breaker for a company seeking regulatory approval for their new tobacco product, it is clear that the FDA is placing greater weight on youth vaping prevention than on adult smoking cessation. For many people, the greater value placed on youth vaping prevention may seem entirely fair—but the question at the heart of all this is by how much is the FDA valuing youth vaping prevention over adult smoking cessation? The answer to that question, or more accurately, the failure of the FDA to answer that question, is the mystery at the heart of the PMTA process. An e-cigarette manufacturer may be able to present stellar data to the FDA showing the benefit of their product in helping adult smokers to quit and still receive a marketing denial order on the basis that in the view of the FDA, the product poses too great a risk to youth.

    In interpreting the results of the empirical studies that manufacturers may have carried out, the FDA is trying to model the likely impact of the product on the total population—adults and youth. Modeling, though, is a mysterious process in which you try to anticipate what you think might happen in the future under various assumed conditions in the present. Some years ago, the National Academies of Science Engineering and Medicine carried out a modeling exercise to try to quantify the impact of e-cigarettes on population health in the U.S. This was a limited exercise carried out under precisely stated assumptions about how effective e-cigarettes might be in helping smokers to quit and how harmful they may be compared to combustible cigarettes. In contrast to such transparency, the FDA has never specified how it is weighing youth harm prevention against adult smoking cessation. As a result, e-cigarette manufacturers will never know how effective their product needs to be in helping adult smokers quit to overcome the theorized level of harm to youth to be judged APPH.

    Neil McKeganey is the director of the Center for Substance Use Research in Glasgow, Scotland.

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  • A Tale of Two COPs

    A Tale of Two COPs

    Image: Tobacco Reporter archive

    This year, the first two weeks of November will witness two COPs (Conference of Parties), large policy gatherings aimed at moving the needle on ratified global U.N.-related conventions. Both have to do with health—individual, population and the planet’s health. Yet, one COP is attracting the leaders of the developed world as well as developing worlds in Glasgow, United Kingdom, along with another 20,000-odd stakeholders. The other COP will be held virtually and quietly from its secretariat in Geneva, Switzerland.

    The United Nations Framework Convention on Climate Change (UNFCCC) secretariat is tasked with supporting the global response to the threat from climate change. With 197 members, the UNFCCC has a near universal coverage. The 26th Conference of the Parties (COP26) Glasgow was kicked off on Oct. 31 with great fanfare, high expectations and drama befitting a Hollywood premiere—e.g., Greta Thunberg arrived on a “climate train,” a test in patience and endurance for Greta, her 150 fellow passengers, the media and the climate activists’ mob at Glasgow Central.

    Throughout the course of these two weeks of negotiations, haggling and posturing, the best possible outcome from COP26 could be that all countries commit to keeping global warming limited to 1.5 degrees Celsius. That calls for some serious re-engineering of human behavior and entire societies. Millions of conventional jobs and livelihoods will be lost, millions more potentially created in the new green economy. Some would argue (and justify): Desperate times call for desperate action. Green economy advocates and solution providers, including transforming oil companies and automobile manufacturers, are in full attendance at the summit and are missing no photo-op to burnish their green credentials.

    The UN climate change conference will consider the input of the manufacturers it seeks to regulate, many of which are eager to show how they can be part of the solution. (Photo: adrian_ilie825)

    The other COP, of the Framework Convention on Tobacco Control (FCTC), created by the U.N.’s World Health Organization and run by the FCTC secretariat, follows a completely different tack. It is notionally intended for addressing the harms to society and the world due to risky forms of smoked (cigarettes, bidis, cigars) and smokeless (khaini, gutkha, zarda, etc.) tobacco products that over a billion people consume today. The FCTC is ratified by most of the countries in the world (the USA and Indonesia being notable exceptions), and the ninth Conference of Parties from Nov. 8–13 will see yet another biannual get together making decisions that affect 1.3 billion tobacco users, their families and millions from the tobacco supply chain globally. However, it is held behind closed doors, driven by health activists that simply see the tobacco industry as the problem and tobacco users as AstroTurf for the tobacco industry. Neither are allowed anywhere near the meeting nor are the lay media.

    The FCTC, in its simplest form, is a demand and supply reduction treaty, underpinned by tobacco harm reduction principles. Broadly, what this could mean in policy as well as practice is that those not currently using risky forms of tobacco products, especially children and young adults, should be disincentivized from initiation, and those currently using risky forms of tobacco should get the necessary help to quit. This may take the form of providing nicotine-replacement therapy, prescription medications and behavioral support. It could also mean that those involved in the supply chain, such as farmers and bidi worker women, should be given support to switch to alternative livelihoods.

    Sixteen years on from the ratification of the FCTC, great progress has been made in adopting parts of the treaty that relate to demand reduction by prevention of initiation into national regulations. Advertising campaigns, tax hikes, health warnings and packaging and sale restrictions have led to significant reductions in initiation, especially among youth. On the other hand, support to current users of risky forms of tobacco remains wanting, lacking innovation and largely under-funded.

    The nicotine in these products makes consumers dependent. The cancers, however, are caused by the toxic chemical mix in the smokeless products and from the smoke itself—but not the nicotine. Pharmaceutically licensed nicotine-replacement therapy products, in the form of gums and patches, are on the WHO’s model essential medicines list for tobacco dependence treatment. It is scientifically proven: Quitting risky forms of tobacco (cessation) is not easy; relapse is very common. The high retail price of the cessation products, poor availability and inadequate training of doctors in prescribing these cessation treatments means that current tobacco users miss out on any meaningful access and support.

    It is easy to point to the tobacco industry’s morally and ethically unacceptable behavior for most of the 20th century that led to the smoking epidemic globally, and even today, to the manufacturers of gutkha and pan masala in India who are fueling an oral cancer epidemic. Based on this historical context, the COP organizers exclude this industry from their deliberations. Sadly, that exclusion extends to consumers, effectively the current and future patients suffering from tobacco dependence.

    This raises a sticky question: Are the global public health community, led by the WHO’s FCTC signatories who meet every two years formally at the COP, simply giving up on the 1.3 billion current users of cigarettes, bidis, khaini and gutkha-like products, letting them die preventable premature deaths, for the want of adequate cessation products and support? Would public health not benefit from a wider range of innovative nicotine-replacement products, manufactured to high standards, regulated appropriately and specifically available as cessation aids for current adult users of risky tobacco products?

    In stark contrast to the climate change COP26, at this tobacco-related COP9, manufacturers of cleaner nicotine products (the “solution providers” to the problem) and consumers (the victims of the problem) will be glaringly absent. (Photo: lezinav)

    This COP season, it may be time to draw parallels between two very similar gatherings with diametrically opposite profiles and approaches. Climate change and tobacco-related harms—both are urgent issues facing humankind. Both are being addressed by global treaties and conventions. For both problems, a wide range of solutions are coming from old and new industries.

    In the case of climate change, the Teslas of the world lead the rally. Conventional fossil fuel giants such as BP (of the Gulf of Mexico spill fame) and Shell are not far behind either, showcasing their renewables’ commitment in every ESG communication. The Volkswagen emissions scandal (from less than five years ago) is distant memory, and the automobile industry is at the table, providing cleaner cars by “electrifying” their offerings.

    In tobacco cessation, underpinned by tobacco harm reduction principles, innovation came from a wide range of inventors and manufacturers globally: e-cigarettes from China, heated-tobacco products from Switzerland and the U.K., nicotine pouches from Sweden and cessation apps from the USA. Pharmaceutical manufacturers of conventional nicotine-replacement products and prescription medications are either withdrawing from the markets or not innovating any more. They have not made any visible effort to make their products available at affordable prices in the developing world—and there was never a huge hue and cry about that from public health.

    None of the new innovative products are a silver bullet but promise to provide cleaner, safer nicotine to the billion-plus current consumers of risky forms of tobacco. In countries such as the U.K. and USA, where regulators are informed by scientific evidence and risk assessment, these products are regulated and allowed. Slowly but surely, this will transform the nicotine use profile in these countries, no doubt saving millions of lives and billions of dollars in future health costs from tobacco-related diseases. In Japan, previously known for its high smoking incidence among men, nearly 30 percent of the cigarette market has been replaced by heated-tobacco devices. These devices are increasingly acknowledged for their reduced toxicant exposure vis-a-vis cigarettes. The U.S. Food and Drug Administration has authorized the sale of a specific brand of heated device, an e-cigarette and a Swedish snus-style smokeless tobacco product for their reduced toxicant exposure and potential to reduce tobacco-related harms. In the U.K., e-cigarettes are one of the many options of quitting tools supported by national health bodies.

    In stark contrast to the climate change COP26, at this tobacco-related COP9, manufacturers of cleaner nicotine products (the “solution providers” to the problem) and consumers (the victims of the problem) will be glaringly absent. In countries where regulators do not need the WHO’s blessings to make their own policies (the U.S., U.K. and increasingly the EU), innovation and better regulation will lead to a reversal of harms from risky 20th century tobacco products. In the developing world, including South Asia, the harms from tobacco will remain unabated in the absence of strong regulatory leadership and industry transformation.

    Whether or not we can manage to curb the global temperature rises to a maximum of 1.5 degrees Celsius by 2050, today’s direction of tobacco control as symbolized by COP9 will hinder access to safer nicotine alternatives to over 1.3 billion current users, 80 percent of whom live in developing countries, accounting for millions of preventable deaths in the next three decades.

    Sudhanshu Patwardhan is a British-Indian, U.K.-licensed medical doctor who is passionate about helping people quit risky forms of tobacco. For the past two decades, he has lived and worked in three continents, doing senior roles in research, strategy and policy in the pharmaceutical and tobacco industries.

    In his early years in tobacco harm reduction, his team of clinical researchers and lab scientists set the foundations for the assessment of reduced-risk products, now accepted by regulators and the industry as the definitive approach for duty of care and regulatory compliance. At Nicoventures, a wholly owned subsidiary of British American Tobacco, he was instrumental in enabling the first e-cigarette company acquisition by a global tobacco business. In his policy role there, Patwardhan shaped the creation of a global key opinion leader network in consumer advocacy and public health champions. .

    With the British Standards Institution, Patwardhan led the creation of the world’s first vaping products’ standards for safety and quality in 2015 and the BSI Online Age Checking specifications in collaboration with the Westminster-based Digital Policy Alliance in 2018. .

    In 2018, he co-founded the Centre for Health Research and Education that now has a team of over 40 medical and public health experts globally working in cancer prevention. Patwardhan splits time between the U.K. and South Asia on tobacco harm reduction projects that address the needs of the most disadvantaged tobacco users. He is also a board director of Art Asia, a charity with a mission to communicate the rich and exciting experience of South Asian Arts to the widest possible audiences.
  • Menthol Sales up After U.S. Flavor Ban

    Menthol Sales up After U.S. Flavor Ban

    Photo: Photo: Miriam Doerr | Dreamstime.com

    Sales in menthol e-cigarettes have risen since the U.S. Food and Drug Administration (FDA) guidance banning flavors has gone into effect, according to an article in Tobacco Control.

    Since Juul Labs has taken mint flavors off the market and the FDA has banned flavors other than menthol and tobacco, market shares of menthol-flavored e-cigarettes increased.

    After Juul’s actions, there was a 59.4 percent increase in the market share of menthol products after four weeks, and after the FDA guidance, there was a 54.5 percent increase after four weeks and an 82.8 percent increase after eight weeks.