Category: Harm Reduction

  • Ministers Oppose Vaping Ban

    Ministers Oppose Vaping Ban

    Image: wolcan | Adobe Stock

    Health Minister Orazio Schillaci has been labeled a “communist” for his proposal to extend Italy’s public smoking ban, reports Reuters.

    Schillaci’s plan, which also covers vaping, would cover the outside areas of bars and public transport stops, along with parks if pregnant women and children are present.

    Junior Culture Minister Vittorio Sgarbi called Schillaci’s view “intimidating” and said such bans would instead encourage people to smoke.

    “This is something typical of an authoritarian and dictatorial communist regime,” Sgarbi told AdnKronos news agency.

    Italy’s minister of infrastructure and transport, Matteo Salvini, too, was outraged by the proposed law, saying that it was thanks to electronic cigarettes that he quit smoking, according to The Blitz.

    “Electronic cigarettes are helping a lot of people to abandon regular cigarettes,” Salvini wrote on Twitter.

    Some 24 percent of adult Italians were smokers last year—roughly 12.4 million people and the highest percentage recorded since 2009, according to Italy’s ISS health institute.

    The government passed a ban on smoking indoors in 2003, which came into force two years later.

    Health association Fondazione Umberto Veronesi estimates that at least 43,000 people die in Italy every year from smoking-related diseases.

  • High-Tech Quitting

    High-Tech Quitting

    Photos: Qnovia

    Qnovia wants to increase smoking cessation rates with a disruptive inhaler technology.

    By Stefanie Rossel

    For smokers eager to quit, there’s a plethora of nicotine-replacement therapy (NRT) products on the market. However, whether they come in the form of lozenges, patches, gums, nasal sprays or prescription inhalers, the effectiveness of these cessation aids is disappointingly low. A study conducted by the Swiss Institute of Social and Preventive Medicine in 2006 found that the chance of a smoker quitting cigarettes long-term with the help of NRTs was a mere 7 percent. There’s no sign that this rate has improved in recent years. The poor performance is due in part to the fact that NRTs fail to provide instant relief of the physical sensations that contribute to cravings.

    Qnovia, a Richmond, Virginia, USA-based medical technology and pharmaceutical company established in 2018, has set out to address this shortcoming with a new drug delivery technology. The firm has developed RespiRx, a handheld, pocket-size device capable of producing a medically safe aerosol without heat. The device consists of a vibrating mesh nebulizer, which is a combination of a vibrating piezoelectric actuator and a piece of mesh that diffuses a drop of liquid into a fine mist on contact.

    Piezoelectric materials can produce electric energy upon application of mechanical stress. A commonly known piezoelectric is quartz. The technology, which usually involves clunky equipment and requires regular cleaning, has been used for many years for applications unrelated to smoking cessation.

    Qnovia has made it more user-friendly, according to Qnovia CEO Brian Quigley, who spent 16 years with Altria Group, including seven as president and chief executive of the company’s smokeless and innovative products/vapor businesses.

    “Vibrating mesh nebulization is a proven and safe method for delivering inhaled therapies; however, our proprietary device is designed to be orientation-agnostic and requires no cleaning or maintenance,“ he says. “Not only are there proprietary elements to achieve this, but the entire nebulizing engine is also miniaturized and part of the drug product containing carriage that continuously feeds the drug to the mesh, maintaining a controlled flow rate and thereby delivering a precise dose when activated with the user’s breath.”

    The device works with a 12-week step-down dosage regimen consistent with other Qnovia NRTs. Every three seconds of inhalation registers as an individual dose, with a running count displayed on a panel of the battery unit. Working with a general practitioner or tobacco treatment specialist, patients are given a tapering dosage schedule according to their own consumption level. The concentration of pharmaceutical-grade nicotine in the cartridges remains constant over the duration of the program, with the device limiting the dispensation of doses in a single day and adjusting the limit per the regimen.

    RespiRx has a higher pharmacokinetic curve than existing NRTs but a lower one than combustible cigarettes so that patients require progressively fewer doses as cravings subside. According to Quigley, one of the largest problems with existing buccal and transdermal solutions is that they don’t deliver the nicotine to the bloodstream quickly enough to alleviate withdrawal symptoms.

    Vibrating mesh nebulization is a proven and safe method for delivering inhaled therapies; however, our proprietary device is designed to be orientation-agnostic and requires no cleaning or maintenance.

    Brian Quigley, CEO, Qnovia

    Unique Features

    While RespiRx, with its high-tech design and elaborate features, may resemble an electronic cigarette, it is in fact a very different product, according to Quigley. “At its core, our device is a medical technology designed to achieve the FDA’s [U.S. Food and Drug Administration] Center for Drug Evaluation and Research’s [CDER] standards for safety,” he says. “So our device has multiple design features that make it wholly different than an e-cigarette. First, we use no heat to create the aerosol, which ensures there is no risk of exposing the user to thermal byproducts or degradants. Second, our drug product is also designed only using excipients that are safe for inhalation in a drug context, and third, the design of the device is meant to achieve CDER safety standards for airpath and safety, which are not requirements achieved by e-cigarettes.”

    RespiRx’s technology also differs from Kind Consumer’s Voke, a breath-activated device that worked like an asthma inhaler. The product was designed to deliver rapid nicotine craving relief without heat, combustion or vapor. It looked like a cigarette, and its consumption ritual mimicked smoking.

    The U.K. Medicine and Healthcare products Regulatory Agency granted Voke a medical license in 2015, and Public Health England endorsed the product as a safer alternative to smoking. However, after raising £140 million ($171.42 million) and attracting investments from major companies, including BAT, the venture ended in late 2020.

    According to Quigley, Voke delivered the user a cold shot of compressed polybutylene—in essence, a pressurized nicotine liquid, which appears to have impacted the user experience.

    By contrast, Qnovia’s device delivers a laminar, nonturbulent aerosol. “Not only does our aerosol appear to look vapor-like, but it’s also designed to be inhaled easily under normal inspiratory conditions, unlike the Voke,” says Quigley.

    Quigley is confident that RespiRx won’t suffer the same fate as Voke. “Firstly, the RespiRx’s on-device LCD screen prompts and future mobile app connectivity will play important roles in advancing patient adherence and compliance rates,” he says. “These tech-enabled features simply didn’t exist with Voke’s low-tech, data-absent approach. Secondly, from a broader drug-delivery platform perspective, the RespiRx is actually able to deliver complex, pressure-sensitive molecules like biologics. Voke was tied to one indication area, where the underlying technology for broader API adoption would have been a challenge. The RespiRx, on the other hand, is already engaging in activities to expand Qnovia’s active pharmaceutical ingredient portfolio beyond nicotine.”

    According to the company, the RespiRx technology could be used to deliver a variety of drugs for various future indications, including asthma, chronic obstructive pulmonary disease or chronic pain.

    Into the Clinical Trial Phase

    In the NRT category, RespiRx will compete with FDA-approved nicotine inhalers such as Nicorette, which is available without a prescription. Quigley believes RespiRx will prove to be a more effective solution.

    “The Nicorette inhaler delivers large droplets containing nicotine into the patient’s mouth,” he says. “This results in buccal absorption, so it’s not an inhaled delivery mechanism despite its name, which limits the ability of the drug to rapidly and effectively alleviate withdrawal symptoms, where our device delivers an aerosol with particle dynamics that deliver the drug to the lung, which will result in more immediate drug delivery and improved ability to alleviate withdrawals. Also, the inhaler has a very harsh and bitter taste, which limits adoption, whereas our formulation does not have these unpleasant effects.”

    Making smoking cessation medication—or novel nicotine-delivery products for that matter—permanently acceptable for smokers continues to be a challenge. Quigley says RespiRx’s formulation has no flavor. Since the product’s target audience is looking to ultimately stop consuming tobacco products altogether, they want an experience that is different from that offered by existing alternatives and one that helps them move away from smoking over the 12-week user regimen.

    In October 2022, Qnovia raised $17 million to help RespiRx through the FDA’s Investigational New Drug Application process. “Once we submit our IND, we will execute phase I, II and III studies with FDA guidance; however, the study design, powering and endpoints are all already very clearly defined,” says Quigley.

    The company plans to submit its final new drug application to the FDA in 2025. Approval is likely to come faster than for new tobacco products going through the FDA’s premarket tobacco product application process. “At the appropriate time, we expect to also request breakthrough and accelerated review status, which are established programs to facilitate the submission, review and final decisions for drugs,” says Quigley. “Largely, I believe CDER does a very good job hitting its timing performance requirements, and the burden of proof we have to demonstrate is clear and well defined. For all these reasons, I believe we have a significant advantage engaging with CDER despite the cost and time we invest in generating strong data for the agency.”

    Instead of marketing RespiRx as an over-the-counter product, Qnovia has chosen to pursue prescription-only status. “We believe that it is important to ensure that this therapy is only used as intended, and we want to be sure to not have abuse liability concerns. Given the design of the pharmacokinetic profile and the delivery of nicotine via inhalation, we strongly believe that a prescription path is important to ensure appropriate use under the care of a physician.”

    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.
  • Researchers Condemn Medical Body’s Position on E-cigarettes

    Researchers Condemn Medical Body’s Position on E-cigarettes

    Colin Mendelsohn

    Australia’s National Health and Medical Research Council’s (NHMRC) statement on e-cigarettes fails to meet the scientific standard expected of a leading national scientific body, according to 11 addiction scientists, reports Medical Express.

    Published in June 2022, the NHMRC statement aims to provide “public health advice on the safety and impacts of electronic cigarettes (e-cigarettes) based on review of the current evidence.”

    This critique of the NHMRC statement, published in Addiction, argues that the statement inaccurately summarizes the current evidence on e-cigarettes. The authors contend that the NHMRC exaggerates the risks of vaping and fails to compare them with smoking;  incorrectly claims that adolescent vaping causes subsequent smoking; and ignores evidence of the benefits of vaping in helping smokers quit.

    The NHMRC statement also ignores evidence that vaping is likely already having a positive effect on public health and misapplies the precautionary principle, which requires policymakers to compare the risks of introducing a product with the risks of delaying its introduction.

    “Many leading international scientists in the field hold more supportive views than the NHMRC on the potential of e-cigarettes as a strategy to improve public health,” said Colin Mendelsohn, lead author of the Addiction article. “In particular, invoking the precautionary principle to prevent the use of much less harmful smoke-free products is unjustified in the face of the massive public health burden of smoking.”

  • Warner: Evidence for Vapes as Cessation Tool

    Warner: Evidence for Vapes as Cessation Tool

    Kenneth Warner (Photo: University of Michigan News)

    There is enough evidence to support using e-cigarettes as a first-line aid for smoking cessation in adults, according to Kenneth Warner, dean emeritus and the Avedis Donabedian Distinguished University Professor Emeritus at the University of Michigan’s School of Public Health.

    “Far too many adults who want to quit smoking are unable to do so,” Warner said in a statement. “E-cigarettes constitute the first new tool to help them in decades. Yet relatively few smokers and indeed health care professionals appreciate their potential value.”

    In a study published in Nature Medicine, Warner and colleagues took a global view of vaping, examining countries that promote vaping as a smoking cessation and countries that don’t. 

    While agencies in the United States and Canada acknowledge the potential benefit of e-cigarette use, they deem the evidence to recommend e-cigarettes for smoking cessation as insufficient, according to the authors.  

    However, in the United Kingdom and New Zealand there is high-level support and promotion of e-cigarettes as a first-line smoking cessation treatment option.

    “We believe that governments, medical professional groups and individual health care professionals in countries such as the U.S., Canada and Australia should give greater consideration to the potential of e-cigarettes for increasing smoking cessation,” Warner said. “E-cigarettes are not the magic bullet that will end the devastation wrought by cigarette smoking, but they can contribute to that lofty public health goal.”

    Warner’s previous research has found considerable evidence suggesting e-cigarettes are an effective smoking-cessation tool for adults in the U.S., where hundreds of thousands of people die of smoking-related illness each year. 

    In addition to evaluating differences in regulatory activities across countries, the researchers examined evidence that vaping increases smoking cessation, the health consequences of e-cigarettes and the implications for clinical care. 

    They also cite the Food and Drug Administration’s designating some e-cigarette brands as “appropriate for the protection of the public health”—the standard required to receive approval for marketing. This action, the researchers say, implies indirectly that the FDA believes e-cigarettes can help some individuals quit smoking who would not do so otherwise.

    Warner and colleagues conclude that “acceptance of the promotion of e-cigarettes as a tool for smoking cessation will likely depend on continuing efforts to reduce access to, and use of, the products by young people who have never smoked. The two objectives can and should co-exist.”

    Study co-authors include Neal Benowitz of the Department of Medicine at the University of California, San Francisco; Ann McNeill of the National Addiction Centre, King’s College London, U.K.; and Nancy Rigotti, Department of Medicine, Harvard Medical School. 

  • Olczak Outlines Harm Reduction

    Olczak Outlines Harm Reduction

    Jacek Olczak (Photo: PMI)

    In an address at the recent ET Global Business Summit 2023 in New Delhi, Philip Morris International CEO’s, Jacek Olczak, emphasized the need for leveraging science and technology for a better, more sustainable future, according to a PMI press release.

    Conceived in 2015, and now in its seventh edition, the Global Business Summit seeks to provide solutions to macroeconomic challenges by curating government-to-government interactions, business to government meetings, business-to-business engagements and to serve as a conduit for corporates and governments to secure investments in India from domestic and international allies.

    Held on Feb. 17-18, the New Delhi summit was attended by Indian Prime Minister Narendra Modi, along with several CEOs, policymakers and academics.

    Speaking on the theme “Sustainable economy for the greater good,” Olczak stressed how innovation has grown rapidly over the past decades with investments across a wide range of industries, including the energy and automotive sectors.

    “Science and technology integrated with a collaboration between private and public has proven to be key to identify solutions to overcome difficult challenges,” he said.

    Olczak then touched up PMI’s commitment to realizing a smoke-free future. Thanks to advances in science and technology, it is now possible to eliminate combustion and replace it with controlled heating, at much lower temperatures. At these lower temperatures, these products generate significantly lower levels of harmful compounds, according to Olczak, who also spoke about the clinical and non-clinical studies that have been conducted on PMI’s heated tobacco products.

    Drawing parallels with other industries, Olczak spoke about the need to address challenges at their source, while also working to identify safer alternatives. The harm-reduction principles underpinning the moves from wood-fuel stoves to gas-fueled stoves, and from combustion-engine vehicles to less-polluting alternatives, also apply to tobacco, according to Olczak.

    Taking the example of Japan, he noted how the introduction of heated tobacco products in that country has contributed to a decline in cigarette sales at an annual rate of 1.8 percent on average over the past few years.

    With the expanded availability of heated tobacco products, almost 35 percent of cigarettes in Japan have been replaced by heated tobacco products over the past seven years. Recent analysis has also shown a downward trend in hospitalizations for Chronic Obstructive Pulmonary Disease. Additionally, research funded by the country’s Ministry of Health and Welfare shows there is negligible adoption of these products by minors, according to PMI. “Similar dynamics are being observed in several European countries,” said Olczak.

    Olczak also spoke about how the estimated 200 million users of oral tobacco in India could be offered modern, safer oral tobacco products, like the ones available in Scandinavia.

    According to Olczak, PMI’s biggest contribution to society lies in addressing cigarette health effects. Throughout the company’s history, it has been a leading player in the cigarette market. Now, the company is intentionally leaving that behind, he said, embarking on a transformation to provide adults who would otherwise continue to smoke.

    “All that’s needed is for today’s innovative, science-based products to be matched by equally innovative policies that encourage people that smoke to switch to less harmful alternatives. This is where India can help drive positive change for the rest of the world. And as chair of the G20, it can be a prime example for emerging economies,” he opined.

    “Innovation in the tobacco industry is finally a reality,” said Olczak. “The question we must ask ourselves is this: How do we ensure that innovations are used in the service of people? In other words, how do we leverage technology, science, and innovation to accelerate public health progress and get millions of Indian smokers away from cigarettes? Given India’s history in leveraging innovative solutions to solve issues of society, I am confident that India will be a global leader in progressive tobacco policies going forward,” he concluded.

  • THR Summit to Take Place in Spain

    THR Summit to Take Place in Spain

    Image: somartin | Adobe Stock

    The Tobacco Harm Reduction Summit Spain 2023 is scheduled to take place Feb. 23, 2023, in Madrid at the Universidad Rey Juan Carlos.

    The Tobacco Harm Reduction Summit Spain 2023 aims to provide a space for evaluation and debate on the impact that harm reduction strategies can have in the field of smoking, offering a range of international perspectives ranging from scientific analysis of the issue to its political and regulatory implications, according to the website. It provides a forum to contribute to the generation of new proposals for tackling the problem of smoking, providing new points of reflection for scientists, professionals, technical and political decision-makers.

  • Survey Details Advocacy for Safer Nicotine

    Survey Details Advocacy for Safer Nicotine

    Image: Andrii Yalanskyi | Adobe Stock

    Knowledge-Action-Change (KAC) has released a global survey investigating the role and activities of consumer organizations advocating for access to safer nicotine products (SNPs) and tobacco harm reduction.

    Carried out by KAC’s Global State of Tobacco Harm Reduction project, the research was published in Public Health Challenges.

    It reveals that there are 54 active consumer advocacy groups working around the world to raise awareness about, and promote the availability of and access to, SNPs, which include nicotine vaping products (e-cigarettes), Swedish-style snus, nicotine pouches and heated-tobacco products.

    The authors of the survey found that the vast majority of organizations (42) were operated entirely by volunteers, most of whom had successfully quit smoking with the help of SNPs.

    Only seven of the groups had any contracted or paid staff (13 people globally), and for the last full year, the total funding for all organizations surveyed amounted to $309,810. This is in stark contrast to the millions of dollars spent on campaigns by actors, such as Bloomberg Philanthropies, seeking to limit access to SNPs, such as nicotine vaping products. The paper also notes that none of the consumer advocacy organizations reported receiving funding from tobacco or pharmaceutical companies.

    This paper starkly demonstrates the major imbalance in resources available to consumer organizations advocating for access to safer nicotine products and those opposed to tobacco harm reduction, unfairly skewing the debate.

    Gerry Stimson, director, KAC

    Many of these organizations are members of four regional umbrella organizations covering Latin America (ARDT Iberoamerica), Africa (CASA), Europe (ETHRA) and Asia-Pacific (CAPHRA).

    “This survey offered a unique opportunity to map these advocacy organizations for the first time and provide valuable insight into how they are operating all over the world,” said Tomasz Jerzynski, lead author and data scientist for the Global State of Tobacco Harm Reduction project. “The sustainability of these organizations is one of the main concerns that has come out of the data. All of these groups face challenges due to their small numbers of core workers and their dependence on volunteers.”

    “This paper starkly demonstrates the major imbalance in resources available to consumer organizations advocating for access to safer nicotine products and those opposed to tobacco harm reduction, unfairly skewing the debate,” said Gerry Stimson, report author, director of KAC and emeritus professor at Imperial College London. “It also highlights why consumer groups must be recognized as legitimate stakeholders in the policy sphere.”

  • A Good News Story

    A Good News Story

    Photo: Teo

    Tobacco harm reduction has made more progress than is often assumed.

    By Patrick Basham

    The good news about tobacco harm reduction is the bad news is wrong. The tobacco harm reduction experience is actually a positive story.

    It is true that the preponderance of influential and well-funded public health institutions and stakeholders are rabidly anti-tobacco harm reduction (THR). The World Health Organization is the most clear-cut example, with billionaire philanthropists funding global campaigns that, in concert with the WHO, incentivize national governments and their public health agencies either to ignore or to disparage THR’s demonstrated ability to improve public health.

    It is also true that most politicians who talk about THR-related reduced-risk products (RRPs) are critical of the technology and its marketing and are subsequently prohibitionist with regard to e-cigarettes, heated-tobacco products (HTPs), oral smokeless tobacco, etc. It is also true that the tone and substance of the vast majority of media coverage is highly negative.

    Such a choreographed chorus of naysaying has most everyone with even a passing interest in THR assuming that the political, institutional and media criticism is, first, representative of a global consensus among stakeholders that THR is a bad idea and second, that THR policies fail whenever and wherever they are introduced. Consequently, when surveyed, the public is at best ambivalent about RRPs’ comparative benefits vis-a-vis combustible cigarettes.

    All of the above may be true, but it is not the entire truth about tobacco harm reduction and reduced-risk products.

    The Other Side of the Coin

    My recent THR report pushes back against the criticisms—and against the broader skepticism they engender. The report does not attempt to catalogue THR’s critics and their mostly ill-informed critiques. The case against THR is readily available, easily accessible and delivered ad nauseam. Instead, this report seeks only to inform the reader that there is actually another, distinctive and very positive side to the THR coin.

    To that end, my report addresses overlooked and underappreciated elements of this policy conundrum. The report discusses the public opinion hurdle that must be surmounted by THR proponents in order for their political representatives to adopt more progressive and enlightened positions on this crucial aspect of public health policymaking. A summary is also provided of RRPs’ successful, yet largely unknown and therefore unappreciated, track records since their adoption in many parts of the world.

    There is an accounting of the many pro-THR governments who have adopted sophisticated strategies and policy prescriptions; there is also recognition of influential public health stakeholder endorsements since THR products became a commercial reality more than a decade ago. The report concludes by drawing lessons from the THR story so far, so that open-minded political and regulatory decision-makers may be better guided on their policymaking journey.

    Consumers worldwide are, on average, either uninformed or ill-informed about the concept of tobacco harm reduction and the specific reduced-risk products central to its implementation. Such ignorance is understandable as the THR paradigm is a comparatively new concept beyond public health circles and RRPs are innovative new technologies that only recently delivered commercially viable options for consumers.

    Such ignorance is nonetheless frustrating because respective prohibitionist politicians, philanthropists, regulators, public health organizations, academics and consumer groups have consciously erected the central barriers to better consumer understanding of, and appreciation for, THR and RRPs.

    The aforementioned anti-THR actors are seemingly dedicated to the proposition that tobacco and nicotine products scientifically proven to be less harmful than combustible cigarettes should not be readily available for use either by current smokers seeking less (often far less) toxic sources of tobacco and nicotine or even by smokers seeking to quit smoking altogether.

    Layered upon the anti-THR and anti-RRP campaigns are unhidden, viscerally anti-industry agendas that reflexively oppose any innovative technology or business model that may preserve, let alone enhance, the profitability of the tobacco and nicotine industries.

    A great many countries, international institutions and public health organizations are employing, and advocating for, THR policies and strategies to reduce cigarette consumption. To date, nearly 70 countries have adopted regulatory frameworks on reduced-risk products.

    An enormous number and variety of electronic nicotine-delivery products are in the marketplace, with nearly 16,000 flavors available and global sales rising to $15 billion in 2019. HTPs were also available in over 50 markets worldwide in 2020. Only one Western democracy (Australia) still requires its citizens to acquire a nicotine prescription in order to vape.

    Snus can be legally bought in 81 countries. RRPs are already being used by 112 million people worldwide, with approximately 82 million using nicotine vaping devices, 20 million using heated-tobacco products and 10 million using smokeless tobacco.

    Contributing to Cessation

    The evidence in favor of THR as a complementary intervention to help drive down death and disease from smoking is robust. For example, we now have evidence of the impact vaping has had on smoking. Vaping is today widely considered to be the world’s most effective smoking cessation tool.

    Extensive international evidence supports the conclusion that vaping plays a major role in smoking cessation. All of the nearly 70 countries that have adopted regulatory frameworks on safer nicotine products subsequently report a decline, often a dramatic one, in smoking prevalence. Countries that embrace vaping have witnessed a decrease in smoking rates that is twice as fast as the global average.

    Snus’ extensive contribution to improvements in Swedish public health is well documented. When Norway allowed snus products to be more widely available, cigarette smoking fell by half in just 10 years.

    Japanese tobacco harm reduction is the story of HTP-driven success.

    Japan’s policies have led to a remarkable drop in cigarette smoking. In October 2020, in the world’s largest heated-tobacco market, the smoking rate dropped to a record low of 16.7 percent, down 1.1 percent on the previous year. Between 2016 and 2021, domestic combustible cigarette sales declined 43 percent.

    This decline is directly attributable to the availability of noncombustible RRPs, mainly HTPs. HTP popularity caused cigarette sales to plummet five times faster than before HTPs were available.

    Tobacco harm reduction is a refreshingly good news story, as detailed in the preceding sections. That is the reason governments around the world are increasingly placing THR at the heart of their tobacco control strategies.

    Pro-THR policymakers are legalizing RRPs for widespread consumer use as regulators in these countries construct regulatory frameworks that harness the products’ potential to reduce tobacco-related harm while restricting their availability to adult consumers exclusively.

    That said, certain governments and regulatory agencies have disproportionate influence on the global stage. The governments of many smaller and medium-sized nations, in particular, look to the likes of the U.S. Food and Drug Administration, the European Union and the Chinese government for case studies, regulatory models, bureaucratic signals and political cover regarding THR’s innate veracity, as well as the applicability and suitability of specific RRPs to public health in general and the consumer marketplace specifically.

    Some of the steps taken by governments and public health bodies with outsized influence have empowered THR while other steps have retarded its progress. My report’s accounting and cataloging of THR successes and adoptions provides these institutional actors, and those influenced by them, with numerous lessons concerning the best way forward should public health be the overriding concern.

    Ten policymaking lessons stand out:

    • Tobacco harm reduction should be the principal driving force behind a nation’s tobacco control strategy.
    • Legalize the import, export, sale, possession and use of reduced-risk products. These products should be as widely available as tobacco products and available without a prescription.
    • The debate is not legalization versus prohibition. The latter approach is empirically unsound, unenforceable and counterproductive. Hence, it is crucial that specific regulations and tax policies are THR-friendly, too.
    • Employ the “weighting principle,” that is, employ concepts such as absolute risk, relative risk, and usage patterns in order to calculate the net public health effect of RRPs, and utilize that data to guide the adopted regulation.
    • RRPs are most suitably regulated as consumer products rather than as medicines or tobacco products.
    • Apply the “continuum of risk” approach across tobacco and nicotine products. Regulation should reflect the lower toxicity levels of RRPs and, therefore, regulations and taxes should correspond to the level of harm caused by a given product, hence the need for the differential taxation of RRPs.
    • Lower rates of taxation for RRPs than for cigarettes help to ensure the affordability of RRPs for low-income consumers, who smoke disproportionately, and incentivize smokers to switch from combustible products.
    • Smokers have the right to accurate information on RRPs; therefore, governments should underwrite health education messages about the comparative risks of RRPs. A pragmatic regulatory approach furthermore recognizes the utility in fewer restrictions on RRP advertising than on cigarettes, hence reduced-risk claims for RRPs should be permitted in advertising.
    • Providing a choice of flavors to adult consumers encourages them to switch from combustibles to less harmful products.
    • Traditional cessation approaches are not the only tools available to help people transition away from smoking cigarettes. Vaping is the world’s most effective smoking cessation tool.

    The greater the number of governments that learn and apply these lessons, the greater will be the public health benefit that the world experiences from tobacco harm reduction’s focus upon the reduced-risk potential of innovative tobacco and nicotine products.

    Patrick Basham directs the Democracy Institute, a politically independent think tank. Basham was previously a Cato Institute senior fellow and taught tobacco regulation at Johns Hopkins University. Prior to Cato, he led tobacco policy research at Canada’s Fraser Institute. In 2016, he was the only pollster to predict both Brexit and Donald Trump’s Electoral College victory. A prolific author, Bahsam recently published “Covid-19: WHO is to blame?”
  • Advocates Clarify Science Controversies

    Advocates Clarify Science Controversies

    Photo: Alliance

    Tobacco harm reduction (THR) advocates are keen to clarify controversies surrounding the science on nicotine and vaping ahead of the Conference of the Parties (COP10) to the World Health Organization’s Framework Convention on Tobacco Control (FCTC), which will take place in November 2023.

    The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) has written FCTC delegation heads to help inform their respective countries’ positions.

    In its letter, CAPHRA notes that two high-profile studies, which have been quoted by tobacco controllers regarding the dangers of nicotine and vaping, have since been retracted and removed from significant medical journals.

    “The first retraction is an article published in February 2022 in The World Journal of Oncology, claiming that nicotine vapers face about the same cancer risk as cigarette smokers,” CAPHRA wrote.

    Another article, in the Journal of the American Heart Association, which reported an association between vaping and heart attacks was also retracted. Astoundingly, advocates noted, this article is still used as a reference in the FCTC guidelines around e-cigarettes.

    “Consumers’ rights to choose to use less harmful products to switch from smoking remain under tremendous threat from FCTC’s continuing failure to address scientific evidence, democratic processes and human rights.”

    Nancy Loucas, executive coordinator, CAPHRA

    In addition, the THR regional advocacy group sent delegates a bibliography of key and current studies that disprove some of the more outrageous claims around harm.

    On the supposed “youth vaping epidemic,” CAPHRA noted “a new survey from the Centers for Disease Control and Prevention and Food and Drug Administration suggests that youth vaping rates appear to be dropping compared to pre-pandemic levels … In fact, youth vaping in the U.S. has plummeted by 60 percent over the past two years.”  

    “Consumers’ rights to choose to use less harmful products to switch from smoking remain under tremendous threat from FCTC’s continuing failure to address scientific evidence, democratic processes and human rights,” says CAPHRA executive coordinator Nancy Loucas.

    The CAPHRA representatives reminded the health leaders that the FCTC has a mandate to pursue harm reduction as a core tobacco control policy—a position it has failed to acknowledge or implement since its inception, according to CAPHRA.

    “WHO and its FCTC continue to press for signatory states to adopt ever more restrictive policies, including outright bans, based on dubious science. Delegates to COP10 should be representing the rights and aspirations of the citizens,” wrote the CAPHRA member organizations.

    “Consumers have the right to make choices that help them avoid adverse health outcomes and smokers have the right to access less harmful nicotine products as alternatives to smoking. Please take account of these rights when making and presenting your submissions to COP10,” the letter concluded.

  • Italy to Ban Indoor Vaping

    Italy to Ban Indoor Vaping

    Image: metamorworks | Adobe Stock

    Italy’s health minister, Orazio Schillaci, announced new measures against tobacco to prevent smoking and achieve a “tobacco-free generation,” reports Euractiv.

    “Measures will have to be taken to guarantee all citizens maximum protection of their health, a fundamental right of the individual and an interest of the community,” said Schillaci.

    Smoking rooms indoors will be banned, and the ban on smoking in open-air places in the presence of minors and pregnant women will be extended.

    E-cigarettes and heated-tobacco products will also be included in the ban, taking into account “the constantly increasing diffusion of new products on the market and the growing evidence on their possible harmful effects on health.” Plans to extend the cigarette advertising ban to new nicotine-containing products are also in place.

    “This process aims to allow the different multiple interests related to tobacco products, involving economic ministries, not to override health protection,” Schillaci said.