Category: Harm Reduction

GSTHR Report Finds Vapes Help Smokers Quit
The latest Briefing Paper from the Global State of Tobacco Harm Reduction (GSTHR), a project from public health agency Knowledge·Action·Change (KAC), focuses on Aotearoa New Zealand’s remarkable journey towards “smokefree” status.
“Pro-consumer laws and an endorsement for vaping: why smoking is disappearing in Aotearoa New Zealand” tells the story of the country’s rapid and growing embrace of vaping, which overtook smoking in 2022, and provides another vital case study showcasing the potential of tobacco harm reduction through the adoption of safer nicotine products (SNP), following recent GSTHR Briefing Papers on Japan and the United Kingdom. This country profile also features in The Global State of Tobacco Harm Reduction 2024: A Situation Report published last month.
While Aotearoa, New Zealand, had been experiencing falling smoking rates for the last 50 years, this decline gathered pace following the widespread adoption and, in 2018, the legalization of nicotine vaping products. Thanks to the Government’s step change in vaping policy, Aotearoa New Zealand now has a considerable chance of reaching its “Smokefree 2025” goal, a designation indicating that smoking prevalence has been reduced to below 5%.
David MacKintosh, a director for KAC, said the Briefing Paper explores the rapid trajectory of Aotearoa New Zealand’s progress in reducing smoking, the approaches that have underpinned this, and the lessons that can be learned.
“By embracing vaping as a tool for smoking cessation, policymakers are accelerating the transition away from cigarettes and their associated harms,” he said. “More needs to be done in addressing high smoking rates in some groups, notably among Māori communities, which contributes significantly to health disparities in the country. However, the experiences and success of Aotearoa New Zealand provide food for thought for many other countries seeking to tackle smoking.”
This would be a remarkable achievement given the smoking rate in 1976 was 40% for men and 32% for women. This has now fallen to the point where only 8.3% of adults smoked in 2023. In the same year 11.9% of adults vaped in the country, up from 1.4% in 2016. But while the overall smoking figures are low, they mask much higher rates within some communities. Daily smoking prevalence for Maori, who make up 16% of the country’s population, was 17.1% in 2022/2023, which is in stark contrast to the 6.1% rate for people of European descent.
Alongside regulatory oversight of vaping products to ensure quality and safety, a key factor has been the proactive encouragement of vaping as a tool for smoking cessation by the Government. The Ministry of Health has provided official resources for people looking to stop smoking with the help of vaping. Smokefree New Zealand, a smoking cessation resource run by the country’s publicly funded healthcare service Health New Zealand, has stated that “using vaping products is a legitimate option for those people who are trying to quit smoking”.
Through the Vaping Facts website, the Ministry of Health of New Zealand and Health New Zealand have also emphasized the Cochrane Review’s position that vaping is significantly safer than smoking.
Aotearoa New Zealand’s attitude to vaping is in direct contrast to its neighbor Australia, which has heavily restricted the availability of SNP by making nicotine available only in pharmacies. Australia has sought to reduce significantly the availability of safer nicotine products, which has led to the proliferation of a thriving black market in the absence of a legal market. Meanwhile, with its broadly supportive public health messaging, Aotearoa New Zealand has enabled consumers to make positive changes in their own volition, enabling them to switch from smoking to safer products.
These differences in approach have resulted in a marked difference in smoking rates between the two countries, with Australia’s smoking prevalence plateaued in recent years after many years of steady decline. Indeed, the current smoking prevalence for Australians aged 14 and over has only fallen slightly in the last five years, from 12.8% in 2018 to 11.8% in 2023.
It should be noted that Aotearoa New Zealand’s attitude towards vaping is not mirrored for all SNP. While heated tobacco products are also legal, the sale of both snus and nicotine pouches is banned. Still, as this Briefing Paper shows, Government and public health organizations in Aotearoa, New Zealand, working with consumers, have highlighted the crucial role that vaping can play in reducing smoking.
The country has demonstrated its ability to enact pro-consumer legislation effectively, and its consistent endorsement of some safer nicotine products has been a key component of its stop-smoking strategy. Central to this has been consumers, who have established a demand for safer products and proven to the Government that these products can and will exist despite initial legislative opposition.
December 20, 2024
CoEHAR: Vapes Most Effective Quitting Tool

Image: CoEHAR
A recent review conducted by the Center of Excellence for the Acceleration of Harm Reduction (CoEHAR) at the University of Catania found that e-cigarettes are more effective than other treatments for smoking cessation.
Published in Drug and Alcohol Dependence, the study represents one of the most comprehensive analyses to date, evaluating 16 systematic reviews and encompassing data from 24 randomized controlled trials (RCTs).
According to the authors, e-cigarettes outperformed other cessation treatments in eight out of 11 meta-analyses. No evidence was found to suggest that e-cigarettes are less effective than any alternative treatments. And while mixed results emerged when comparing ENDS to traditional nicotine replacement therapy, the overall trend favored ENDS for cessation efficacy.
“The data from our umbrella review can support the integration of harm reduction strategies into public health policies in many countries,” said Renée O’Leary, lead author of the review, in a statement. “However, the review highlights a critical gap in existing cessation strategies, with long-term success rates for e-cigarettes remaining modest at 10 percent-12 percent and the effect of relapse has not been sufficiently studied. New treatments and approaches are urgently needed”.
Despite these promising findings, the study also emphasizes the need for greater scientific rigor in the field. According to the authors, the analysis exposes significant reporting biases in many studies.
“This study provides robust evidence supporting the potential of ENDS as an effective cessation aid, but it also calls for enhanced clinical guidelines and further exploration of long-term outcomes,” stated Riccardo Polosa, co-author and founder of CoEHAR.
December 4, 2024
Study: No Major Respiratory Symptoms Among Vapers

A groundbreaking international study conducted as part of the Veritas cohort project has provided crucial insights into the respiratory health of exclusive e-cigarette users with no established history of smoking. Published in Scientific Reports, the study assessed respiratory symptoms among adults who had never been habitual smokers but used e-cigarettes, offering a rare glimpse into the health effects of vaping in this specific population.
Led by researchers from CoEHAR and their global collaborators, the study compared respiratory symptoms between a cohort of e-cigarette users and a control group who had never smoked conventional cigarettes. The results indicate that individuals who have never smoked but exclusively used e-cigarette devices do not exhibit clinically relevant respiratory symptoms. Moreover, the study highlights the importance of distinguishing between statistically and clinically significant results when evaluating the health impacts of e-cigarettes.
“Veritas lays the groundwork for longitudinal research to further assess the long-term effects of e-cigarettes on respiratory health. These findings are essential for shaping public health policies based on scientific evidence, especially as we work to differentiate the effects of vaping from those of traditional smoking,” said Riccardo Polosa, founder of CoEHAR.
“What makes the Veritas project unique is not only its reach across six geographically diverse areas,” said Jeffrey Zamora, the study’s lead author, “but also its ability to provide data on the real-world use of e-cigarettes, including the most commonly used device types (refillable, disposable, pod-based) flavor preferences, and variations across different socio-cultural groups.”
November 21, 2024
Derailing Harm Reduction?
Image: ArieStudio
The unhelpful contribution of illicit vaping products
By Pieter Vorster and Sudhanshu Patwardhan
The rise of vaping as an alternative to smoking has brought the promise of significant net public health benefits but equally meaningful regulatory challenges. While legitimate vaping products can serve as a powerful harm reduction tool for adult smokers, the proliferation of illicit vaping products has introduced a plethora of problems that require careful consideration.
This article will address the various impacts of illicit vaping products—ranging from health risks and tax revenue loss to underage use, environmental concerns and the potential for increased criminal activity. In countries where vaping products are banned, the illicit vape market has not only taken over but is also leading to a vicious cycle of vilifying an entire category of products that potentially offer a much less risky alternative to combustible tobacco users. The accompanying stigmatization and criminalization of smokers who seek safer alternatives is an affront to human rights. We will also explore the key drivers of the illicit market and potential solutions to mitigate these.
Health Risks Associated With Illicit Vaping Products
A key concern with illicit vaping products is the absence of regulatory oversight. Legitimate manufacturers must adhere to safety standards that ensure their products do not pose unnecessary risks to consumers. These regulations cover product composition, labeling and the disclosure of ingredients. In contrast, illicit products bypass these standards, introducing the potential for harmful substances in e-liquids, unsafe nicotine levels or faulty hardware, such as poorly constructed batteries.
Potential health risks include:
Contaminated ingredients: Illicit vaping liquids may contain dangerous additives such as harmful chemicals or poorly sourced nicotine, increasing the risk of respiratory issues and other health problems.
Unregulated nicotine levels: Illicit products can contain nicotine concentrations far beyond legal limits, exacerbating addiction or leading to nicotine poisoning.
Defective devices: Poorly made or counterfeit devices may lead to malfunctions, such as battery explosions or inadequate heating mechanisms, posing physical dangers to users.
Loss of Tax Revenue and Market Disruption
Illicit vaping products not only pose health risks but have economic consequences as well. In jurisdictions where vaping products are subject to excise taxes or sales tax, such as in many European countries and parts of the United States, the sale of untaxed products represents a significant revenue loss for governments. These funds are often intended to support public health programs, anti-smoking initiatives or infrastructure investments. The absence of taxes on illicit products undermines these efforts and contributes to a broader sense of inequity within the market.
Moreover, the price difference between legal and illicit products distorts the market. Legitimate operators who comply with taxation and regulatory requirements face unfair competition from cheaper illicit products. The lower price points of these illegal products not only make them more accessible but also undermine the efforts of legal businesses to compete, leading to the potential loss of jobs and investment in the legitimate sector.
Underage Use and Accessibility
One of the most troubling aspects of illicit vaping products is their role in enabling underage access and use. In most countries, the sale of vaping products to minors is strictly prohibited, and legitimate sellers are typically required to adhere to age verification processes. However, illicit products bypass these restrictions. Without regulated sales channels, these products can be more easily acquired by underage consumers, contributing to a rise in youth vaping.
Factors contributing to underage use include:
Lower prices: The affordability of illicit products makes them more accessible to those who are underage and often more price-sensitive.
Unregulated sales channels: Without the oversight that governs legitimate sales, underage individuals can purchase these products through informal networks or online marketplaces with little to no age verification.
The availability of illicit products for underage users creates a broader public health challenge. While the long-term effects of nicotine on developing brains remain debated, concerns about early nicotine exposure, potential addiction and its impact on cognitive function continue to drive public health discourse and have been key to the Food and Drug Administration’s highly restrictive premarket tobacco product application process in the United States.
Elsewhere, the rise in underage vaping, fueled by the availability of illicit products, has prompted calls for stricter regulation of the legitimate market. In the U.K., for example, concerns about underage use have led to proposals for more stringent controls on all vaping products, which could inadvertently restrict access for adult smokers who use vaping as a tool for tobacco harm reduction.
Environmental Concerns
The environmental impact of illicit vaping products is another significant issue. Many of these products, particularly disposable vapes, are not designed with recyclability in mind. Since illicit manufacturers often prioritize cost savings over environmental considerations, their products are less likely to comply with proper waste disposal or recycling guidelines.
Environmental risks include:
Disposable vapes: Many illicit, disposable vapes are discarded improperly, contributing to plastic waste and electronic waste.
Recycling challenges: Legal products are often part of recycling schemes or are designed with recoverable materials, but illicit products do not follow these environmental protocols.
A lack of proper disposal mechanisms for illicit products not only exacerbates broader environmental challenges such as electronic waste and plastic pollution but also fuels calls for stricter regulation, or bans, of legal products.
Criminal Violence and the Illicit Market
In addition to the public health and economic consequences, the illicit vaping market has the potential to fuel criminal activity, particularly organized crime. The sale of untaxed and unregulated products can provide a significant revenue stream for criminal organizations, which, in turn, may lead to increased violence. Australia, which has imposed a de facto ban on vapes through its prescription model, has seen rising concerns about criminal violence linked to the illegal trade in vaping products. As the illicit market grows, so does the likelihood of violence between rival groups vying for control of the black market.
Illicit Vaping—A Bipolar Problem?
Growth in the illicit vaping market is being driven by a combination of factors. Peculiarly, the two bookends of the regulatory spectrum pose the highest risk: overly restrictive or prohibitive at one end and notification with poor enforcement at the other. It is easy to understand why prohibition or overly restrictive frameworks can be conducive for illicit products in the market—decades of prohibition experiments on alcohol, drugs and even chewing gums have shown how that can skew market economics in favor of bad actors.
Regulations that are perceived as overly restrictive can push consumers and sellers toward the black market. In countries like Australia and the United States, where vaping regulations are particularly stringent, the high cost of compliance, limited access to legal products and high taxes can drive demand for illicit alternatives. These overly restrictive policies, while intended to protect public health, may inadvertently encourage consumers to seek out cheaper, unregulated options that bypass legal requirements.
In the U.S., where only a limited number of products have been granted marketing authorization by the FDA (none of which are disposable), disposable vapes are estimated to account for close to 60 percent of national unit sales in tracked sales channels.
Australia is another widely reported example of rampant sales of illicit vapes in response to a draconian regulatory framework, and the list does not end there. India and Thailand, among others where sales of vaping products are banned, have seen significant black markets emerge.
At the other end are countries where there is no requirement for authorization per se and a basic notification process is considered adequate. Indeed, it may seem counterintuitive that harm reduction goals could be helped by the introduction of barriers to product launches and rapid innovation. However, an overly simplified notification process has the potential to put excessive responsibility on enforcement agencies in the marketplace. For example, in jurisdictions where a vaping product/SKU can be launched following a simple notification process of contents and related risk assessments, the potential exists for unscrupulous manufacturers and distributors to introduce products containing illegal additives or higher-than-allowed nicotine levels in a seemingly legal way. The EU Tobacco Products Directive and its transposition into local regulations in EU and ex-EU countries such as the U.K. creates such a situation. In the U.K., the U.K. Vaping Industry Association (UKVIA) believes that 40 percent to 60 percent of disposable vapes sold in the U.K. are likely illicit.
A lack of adequate resources for law enforcement agencies also contributes to the persistence of the illicit market. Without sufficient funding and personnel to investigate and crack down on illegal operators, the illicit trade in vaping products continues to thrive. The combination of an unregulated supply chain and weak enforcement allows illicit products to enter the market relatively unchecked.
Potential Solutions
Addressing the issue of illicit vaping products requires a multifaceted approach involving both regulatory reform and enhanced enforcement mechanisms. Some potential solutions include regulatory reform, strengthened law enforcement and public awareness campaigns.
Regulatory Reform
Governments must strike a balance between protecting public health and ensuring that regulations do not drive consumers to the black market. By adopting a regulatory framework that allows adult consumers to access legal vaping products while maintaining appropriate safety and quality standards, policymakers can reduce the demand for illicit alternatives. This could involve:
Harmonizing regulations: standardizing regulations across jurisdictions to prevent regulatory discrepancies that fuel the illicit trade.
Moderate taxation: implementing reasonable excise taxes that do not create a significant price disparity between legal and illicit products.
Allowing legal access to adult smokers: Providing adult smokers with accessible, affordable and satisfactory regulated alternatives will discourage the use of unregulated products.
Strengthening Law Enforcement
To effectively combat the illicit market, governments must provide law enforcement agencies with the necessary resources to investigate and shut down illegal operators. This could include:
Increased funding for investigations: allocating more resources to law enforcement agencies to crack down on illicit vaping supply chains.
International cooperation: As the illicit trade often involves cross-border networks, international cooperation between customs and law enforcement agencies can play a vital role in curbing the flow of illegal products.
Licensing and tougher penalties: In the U.K., the UKVIA has proposed a mandatory licensing framework for vape retailers and distributors, with fines of up to £10,000 ($13,038) for retailers and £100,000 for distributors. The scheme aims to generate additional funding for enforcement, estimated at £50 million annually.
Public Awareness Campaigns
Educating the public about the risks associated with illicit vaping products can help reduce demand. Public awareness campaigns can inform consumers about the health risks, potential legal consequences and environmental harms linked to using unregulated products.
By addressing the root causes of the illicit vaping market and implementing effective solutions, governments can safeguard public health, protect revenue streams and ensure that vaping products remain accessible to adult consumers seeking harm reduction.
Pieter Vorster is a harm reduction expert with a long career as a financial analyst reporting on tobacco industry stocks.

Sudhanshu Patwardhan is a medical doctor, nicotine expert and health tech entrepreneur from India, based in the U.K. He works on projects around the world to reduce harm from tobacco, especially among the most disadvantaged tobacco user populations.
November 20, 2024
Transition to Safer Products Underway: Report

Image: Rain
A new report from Knowledge Action Change (KAC) describes the extent to which safer nicotine products (SNP) are replacing and substituting for combustible and risky oral tobacco products.
Co-authored by experts in harm reduction, data science and economics, The Global State of Tobacco Harm Reduction 2024: A Situation Report (GSTHR 2024) considers what is driving these changes, how different regulatory environments have developed, and the complex interplay between products, consumers, and policy and regulation.
The latest market data shows that while sales of combustible tobacco remain significantly higher than sales of SNP, two key shifts are occurring in the tobacco and nicotine market: first, the total market share of SNP is increasing, and second, inflation-adjusted combustible tobacco sales are declining, while SNP sales are experiencing rapid growth.
Although the nominal value of combustible tobacco sales increased from $752 billion in 2015 to over $1 trillion in 2024, when adjusted for inflation (and assuming a constant currency value), combustible tobacco sales actually decreased to $685 billion in 2024—an 8.9 percent decline. Meanwhile, inflation-adjusted SNP sales grew nearly sixfold from 2015, reaching, in non-adjusted terms, $96 billion in 2024.
Further analysis shows, however, that Chinese data skews these figures. China’s tobacco market accounts for an astonishing $344 billion of the $1 trillion global combustible tobacco market. Despite being the global center of production for nicotine vapes, the Chinese market for all SNP is extremely small, at less than 1.2 percent of its market for combustibles. GSTHR analysis removing China from the calculations reveals the true scale of the acceleration in the global SNP market: it has reached 12.3 percent of the total tobacco and nicotine market in 2024, up from virtually zero in 2004.

The evidence from this report shows that when safer products are appropriate, acceptable, accessible and affordable—people will switch.
Gerry Stimson, founder, KAC
According to KAC, legal access to a range of SNP will be essential for the billion people who smoke worldwide to benefit from tobacco harm reduction (THR). Research undertaken for GSTHR 2024 shows that more than two-thirds of the world’s adult population can now legally access at least one form of SNP. Access to combustible tobacco products, by contrast, remains legal for 100 percent of the world’s adult population. The report also reveals that the global number of vapers has increased from 58 million in 2018, to reach an estimated 114 million in 2023. With 30 million people using other safer nicotine products, this means the GSTHR estimates there are now around 144 million users of SNP worldwide.
“Harm reduction is often thought about as policies and strategies, driven by public health. But it isn’t only this. It’s also what people do themselves to reduce risks and improve their own health,” said KAC Founder Gerry Stimson in a statement. “Governments and both international and national health organizations, need to help create an environment in which people can be informed and empowered to make those safer choices. And the evidence from this report shows that—when safer products are appropriate, acceptable, accessible and affordable—people will switch, in fact they are already switching, in their millions.”
November 18, 2024
Sweden Achieves ‘Smoke Free’ Status

Image: Summit Art Creations
Sweden officially became “smoke free” on Nov. 13
Health data released by Sweden’s public health agency show that just 4.5 percent of the nation’s Swedish-born adults smoke—below the globally recognized benchmark of 5 percent for smoke free status.
At 24 percent, average smoking rates in Europe are five times higher than Sweden’s.
According to tobacco harm reduction activists, the Swedes’ success is the result of their pioneering policy approach to safer alternatives to cigarettes.
“This outstanding achievement marks a significant moment in global public health and stands as a testament to the progressive policies that have guided Sweden’s approach to tobacco control,” said Delon Human, leader of Smoke Free Sweden, in a statement.
“In the early 1960s, nearly half of Swedish men smoked. By embracing and encouraging the use of alternative nicotine products such as snus, oral nicotine pouches and vapes, Sweden has paved a clear path to a smoke-free society while safeguarding public health.
“They should serve as a beacon of hope for the rest of the world and as inspirational proof that a pragmatic, enlightened approach can deliver sensational public health gains and save lives.”

By embracing and encouraging the use of alternative nicotine products such as snus, oral nicotine pouches and vapes, Sweden has paved a clear path to a smoke-free society while safeguarding public health.
Delon Human, Smoke Free Sweden
The new statistics show that 5.3 percent of all adults in Sweden, including immigrants, currently smoke. Remarkably, the data also reveals that people born elsewhere in Europe would be three times more likely to smoke if they had not moved to Sweden.
“Key to Sweden’s success is its pragmatic focus on harm reduction rather than prohibition,” said Anders Milton, a physician and former president and CEO of the Swedish Medical Association.
“A wide range of safer nicotine products, with a variety of strengths and flavors, is legally available both online and in stores, supported by advertising, which raises awareness and encourages uptake.
“The Swedish government also applies a proportional excise tax, keeping smoke-free products more affordable than cigarettes. This tax policy, coupled with public education campaigns, has empowered Swedish consumers to make healthier choices and contributed to the country’s leading role in tobacco harm reduction.”
As a result of its strategy, Sweden has the lowest percentage of tobacco-related diseases in the EU and a 41 percent lower incidence of cancer than other European countries.
“While Sweden celebrates this historic achievement, most other nations remain far from reaching their smoke-free goals,” said Human. “Their rigid, prohibitionist policies limit access to safer nicotine alternatives, including oral nicotine products and e-cigarettes. These regressive measures are pushing smokers away from potentially life-saving tools and stalling progress toward reducing tobacco harm.
November 14, 2024
Increasing Stakeholder Engagement

Image: ngstock
Accelerating actions to clear the smoke: finding common ground in a polarized world
By Scott D. Ballin
During September and October 2024, there were a number of tobacco-related and nicotine-related conferences, including the Global Tobacco and Nicotine Forum in Athens; the Nicotine and Tobacco Science Conference in Charleston, South Carolina, USA; the Tobacco Science Research Conference in Atlanta; CORESTA in Edinburg; and the Food and Drug Law Institute annual tobacco and nicotine conference in Washington, D.C. The E-Cigarette Summit will convene in London in December.
All of these conferences have a number of things in common, including looking at how to move forward in advancing public health and harm reduction and advocating for more stakeholder engagement. While these objectives are to be applauded and enjoy support, the tobacco and nicotine space remains more divided, polarized and tribal than ever.
This division and the animosity that often goes with it mirrors what we see happening in societies around the world. This is tragic in terms of public health when more time is being spent fighting perceived enemies than looking for common-ground solutions to save lives.
The divide is not merely between Big Tobacco and mainstream public health organizations but now also seems to include anyone associated with tobacco and nicotine. It is troubling to me that significant divisions continue to occur within the public health community to the extent that some take the position that anyone engaging with the tobacco and nicotine sector needs to be “called out,” blacklisted and even banned from attending some meetings or conferences.
For some years now, I have taken the position that “safe-haven” dialogues between stakeholders are essential to advancing our public health objectives of reducing disease and death from the use of tobacco and especially the combustible cigarette, which is by far the riskiest tool for nicotine consumption. Today’s rapidly changing tobacco and nicotine environment is very different from the days of the “tobacco wars” of the late 20th century.
We should be constantly reminding ourselves that globally, there are approximately 1 billion smokers who are subject to dying prematurely from cigarette smoking. In the U.S. alone, the number of smokers remains close to 30 million, making cigarette smoking the single most preventable cause of death.
Many battles must be fought, but new approaches, ideas and opportunities need to be discussed and considered as well.
A Role for CTP
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has an important role to play in providing stakeholders a safe haven where civil dialogue can take place. For me, obtaining FDA regulatory oversight of the tobacco industry and its products was a major priority and a gamechanger in reigning in the bad behavior of the tobacco industry. All three CTP directors—Lawrence Deyton, Mitchell Zeller and Brian King—recognized and acknowledged the critical need for stakeholder engagement. Stakeholder input and engagement has and will continue to assist the agency in its efforts to not only prevent future generations from using tobacco and nicotine products but also to provide significantly lower risk, science-based regulated products to the millions of addicted adult smokers worldwide. It can ensure that bad actors distributing, marketing and selling illegal, unauthorized products are punished and expeditiously removed from the marketplace.
Many will recall that in July of 2017, the FDA announced a visionary, comprehensive tobacco and nicotine plan. In its press release, then FDA Commissioner Scott Gottlieb and the Center for Tobacco Products Director Zeller wrote: “Envisioning a world where cigarettes would no longer create or sustain addiction and where adults who need or want nicotine could get it from less harmful alternative sources need to be the cornerstone of our efforts, and we believe it is vital that we pursue common ground …. To succeed, participants from all sectors [emphasis added] need to take a step back and work together to reach greater common ground.”
This visionary plan was generally well received by a broad spectrum of stakeholders as a way to discuss and address important issues in a rapidly changing environment. Unfortunately, and for many reasons, the CTP has put much of the plan on the back burner.
The time has come for the FDA/CTP to move the comprehensive plan back to the “front burner” and to begin a series of important discussions on how many of these ideas, challenges and opportunities can be addressed and implemented.
The Morven Dialogue
In July, the University of Virgnia’s Institute for Engagement and Negotiation (IEN) released its latest report, titled Accelerating Action to Clear the Smoke: Finding Common Ground in a Polarized World. Referred to as the Morven VII dialogue, the report builds on past dialogues and reports and lays out a set of 10 interrelated and overlapping core principles designed to “provide stakeholders guidance and encouragement to commit to engage and work together in a more transparent and cooperative way.”
The report addresses topics such as updating definitions and terminologies; recognizing the differences between the risks and relative risks of a spectrum of products along the continuum of risk; the need to “modernize” and develop a more flexible and consumer-friendly regulatory framework; ensuring that scientific research is of the highest integrity; encouraging innovation and technology; ensuring comprehensive regulatory oversight while providing flexibility for “fast-tracking” of approved lower risk products for use by adults; ensuring that adolescents do not have access to any tobacco and nicotine products; providing consumers, the general public, medical professionals and other stakeholders with truthful, accurate and consistent information about the risks and relative risks of all tobacco and nicotine products; and encouraging all stakeholders in both the public and private sectors to engage civilly and honestly.
The Morven VII dialogue report serves as a means for having a more in-depth civil discussion on issues confronting the tobacco and nicotine space. As the IEN director has stated: “It is owned by no one but can be used by everyone.” There are no copywrite restrictions on the report, and all entities are encouraged not only to use it but also to make it available to others, including policymakers, medical professionals, nongovernmental organizations and the media.
The Morven VII report can be accessed at http://www.tobaccoreform.org.
Scott D. Ballin worked in the public health policy arena for more than four decades, with much of his time spent on issues pertaining to tobacco and nicotine. He is a former vice president and legislative counsel for the American Heart Association and two-time chairman of the Coalition on Smoking OR Health, which later became the Campaign for Tobacco-Free Kids. In recent years, he has focused on the importance of bringing stakeholders together in both the public and private sectors. He also served as an advisor to the Institute for Engagement and Negotiation at the University of Virginia and as an advisor to the Food and Drug Law Institute.

November 1, 2024
Spread the Word

BAT’s Danielle Tower shares her views on the tremendous opportunity presented by tobacco harm reduction.
By George Gay
Ahead of the 2024 CORESTA Congress that was held in Scotland Oct.13-17 under the theme “Advancing Tobacco Harm Reduction through Scientific Collaboration,” Tobacco Reporter took the opportunity to interview Danielle Tower, group head of scientific and regulatory affairs at BAT, the host of the Congress.
Tobacco Reporter: In March, BAT went public with the opening of its new U.K. Innovation Centre in Southampton, U.K. (see “Driving Transformation,” Tobacco Reporter, May 2024). More recently, with your Omni initiative, you have presented a summary of BAT’s progress toward making “A Better Tomorrow by Building a Smokeless World.” And last month, you hosted the CORESTA conference under the banner “Advancing Tobacco Harm Reduction Through Scientific Collaboration.” This is all very praiseworthy, but do you have evidence that your tobacco harm reduction (THR) messages are getting through to those people making regulatory decisions about tobacco and nicotine?
Tower: Governments, the public health community as well as manufacturers like BAT and their business partners have a key role to play in maximizing the potential of smokeless products to contribute to tobacco harm reduction.
In July 2023, the FDA [U.S. Food and Drug Administration] has authorized the marketing and sale of our vapor product Vuse Alto with Golden Tobacco and Rich Tobacco flavors in the United States. This is good news for adult smokers, who would otherwise continue to smoke, and for public health.
Evidence-based regulation requires a comprehensive scientific assessment, from data that assesses the health impact of new products, to the impact on the population, including users of new products and nonusers of nicotine products.
At BAT, we are focused on driving awareness and understanding of our science across multiple scientific and other nonconsumer audiences. We believe that by being open and transparent with our data, we can meaningfully contribute to the discussion on tobacco harm reduction.
Even in the U.K., where regulations have tended toward the pro-THR, the signs are that things are going to get more difficult for those offering smokeless alternatives to combustible tobacco products. How can you navigate this potentially more hostile regulatory landscape in such a way as to take THR forward?
We believe that tobacco harm reduction—the switching of smokers, who would otherwise continue to smoke, to alternatives with a reduced-risk profile—is the best way to reduce the harm associated with smoking cigarettes.
We have a vast body of scientific evidence to substantiate the reduced-risk profile of our smokeless products. And, when required, we conduct new science to support our regulatory submissions.
BAT is in favor of progressive regulation—based on the best available scientific evidence—allowing adult smokers to have access to smokeless alternative products while providing consumers with high product standards and preventing underage access.
The U.K. is a tobacco harm reduction success story. The number of smokers is at an all-time low—6 million—and nearly 3 million people have switched to vaping in the last five years. We are calling for smart regulation that allows smokers to have access to smokeless alternatives while providing consumers with high product standards and guarding against underage access. One of our proposals is a retail licensing system—similar to alcohol. Most importantly, good regulation must be accompanied by robust enforcement—otherwise, it is unlikely to be effective.
And how do you navigate your way in jurisdictions where regulations are not as supportive of THR as they have been to date in the U.K.?
Harm reduction approaches have produced diverse opinions from numerous stakeholders. We encourage anyone interested in learning more about tobacco harm reduction to read more and consider the broadest range of available viewpoints.
Regulation should be based on the best available scientific evidence. And lessons can be learned from countries like Sweden, the U.K., New Zealand and Canada that have embraced tobacco harm reduction and have experienced an associated acceleration in the decline of smoking rates.
One of the problems with nicotine product regulations seems to be that they are not always fully enforced, something that can unfairly put legitimate companies in a bad light in the general media. Again in the U.K., rogue manufacturers seem able to market noncompliant products because imports, compliance and retail sales, including to those underage, are not properly policed. Is there anything that you can do to turn this around?
Yes, I think there are three main challenges: Firstly, the lack of awareness or acceptance of tobacco harm reduction. Many prestigious public health organizations are in favor of THR as the way to reduce the harm associated with smoking cigarettes for those consumers who would otherwise continue to smoke.
Secondly, the lack of enforcement. Regulation must be well enforced with strong sanctions for those who don’t comply. Otherwise, situations as seen in the United States arise where the majority of the vapor market consists of illegal, illicit disposable vapes.
And thirdly, the lack of flexibility to keep pace with innovation. Regulatory frameworks often struggle to keep pace with a fast-evolving, consumer-led market. It’s important to cater for innovation so that adult smokers have access to the best available smokeless alternatives, which has the potential to accelerate tobacco harm reduction.
Your new Innovation Centre involved a considerable investment, but, in fact, it is only a part of the total investment needed to bring forward efficacious alternative smokeless products. How do you ensure that these investments are used to the best advantage in producing good products while keeping investors happy? Do you mainly seek to improve the categories of alternative smokeless products already established, or are you involved in blue-sky projects that might come up with revolutionary products?
Consumer choice is driving the transformation of the tobacco industry. Adult smokers are more likely to switch to a product that delivers comparable satisfaction. That is why we are obsessed with innovation and invest £300 million [$392.27 million] a year in the development of our smokeless products. The Innovation Centre in Southampton will collaborate with BAT’s Innovation Centres in Shenzhen and Trieste [see “Shaping Tomorrow,” Tobacco Reporter, April 2023] to anticipate and meet the needs of consumers through science, technology and innovation.
I can’t disclose our innovation pipeline, but we are constantly innovating and utilizing new technology to improve our portfolio of smokeless products.
You compete in most if not all the smokeless product categories and, at the opening of your new Innovation Centre, presentations were given concerning the seemingly impressive levels by which the health risks associated with the consumption of these products is potentially lower than that of smoking combustible cigarettes. But this sort of information does not seem to see the light of day too often. Can this situation be turned around?
Already today, several public health organizations and regulators are supporting the use of smokeless products. However, to ensure that the full potential of the tobacco harm reduction opportunity is realized, much more focus is required by regulators to ensure that adult smokers in all markets across the world have access to smokeless products and accurate information about their relative risk—so they can make informed decisions about switching.
We publish the findings of science in peer-reviewed publications and present the results at conferences. This helps to informs other scientists working in the field and those undertaking evidence reviews.
Governments have an important role to play as a trusted source of information. The U.K. is a good example. The government has undertaken reviews of the scientific evidence on vaping—publishing its key findings (OHID evidence review). And the National Health Service has a page dedicated to vaping as a means of promoting THR—covering the myths and facts (Vaping myths and the facts—Better Health—NHS [www.nhs.uk]).
Questions have been asked in the recent and not-so-recent past about the relevance of CORESTA in the current tobacco/nicotine environment. Do I take it that, in hosting this year’s congress, you are giving a stamp of approval to this organization and the idea of scientific co-operation even within a highly competitive industry?
It is a great honor for BAT to host the 2024 CORESTA Congress concentrating on the theme of “Advancing Tobacco Harm Reduction Through Scientific Collaboration.” We are proud to welcome around 500 attendees to the congress, bringing together member and nonmember organizations from over 30 countries, including companies, research institutes, laboratories, associations and regulatory bodies. Our focus is to promote discussion and the sharing of knowledge and understanding in the science related to tobacco harm reduction across a variety of disciplines, from agricultural raw material production to product characterization, nonclinical and clinical assessment and product use behavior. With increasing regulatory requirements, the scientific work and outputs of CORESTA have become a worldwide reference point for tobacco policymaking and support the development of testing standards—such as ISO standards.
How do you see the future for THR?
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 tobacco harm reduction and the well-being of millions of people worldwide.
Countries that have recognized the opportunity tobacco harm reduction 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 itself smoke-free this year—defined as having [less] than 5 percent of daily smokers in the population—16 years ahead of the 2040 EU target.
Sweden’s experience with snus is a useful case study for tobacco harm reduction. Snus is a traditional smokeless tobacco product that is placed between the lip and gums and held in the mouth for around 30 minutes, during which time it slowly releases nicotine without inhalation. It has been available in Sweden for 200 years, and, while the composition has changed, manufacturing methods have improved dramatically over that time.
Although Sweden has the highest consumption of smokeless tobacco per capita in the world, Swedish men have the lowest death rate attributable to tobacco and the lowest incidence of lung cancer and other tobacco-related diseases of nearly every country in the world.
More recently, other smokeless products—vapor, heated products and tobacco-free oral nicotine pouches—have been introduced in Sweden, helping to further reduce the prevalence of smoking.
This remarkable transformation in Sweden, and other countries, has been driven by acceptance of tobacco harm reduction from policymakers, regulators and health officials in these markets, encouraging smokers, who would otherwise continue to smoke, to migrate to smokeless alternatives.
And the $60,000 question: Is it, or will it ever be, acceptable for nonsmokers to take to using smokeless nicotine products?
We market our smokeless products to existing adult tobacco and nicotine consumers. For those who don’t smoke, my message is simple: Don’t start. For those who do smoke, my recommendation is to quit entirely. However, if they will not quit, then I encourage them to completely switch to smokeless nicotine products backed by scientific evidence that shows their reduced-risk potential compared to smoking cigarettes.
Is there anything you would like to add?
Tobacco harm reduction represents a significant public health opportunity that cannot be ignored. It is my hope that the Omni will spur dialogue with stakeholders—scientists, public health authorities, policymakers, and investors—and across the wider scientific and regulatory ecosystem related to tobacco and nicotine products. I appreciate that some people will be skeptical of our motivations and actions. The Omni is not intended to be a panacea. It is, however, designed to underscore our commitment to science and facilitate an important conversation about tobacco harm reduction. Omni can be accessed at www.asmokelessworld.com.
George Gay is Tobacco Reporter’s European editor, but his territory spans the globe. Based in London, George has covered the tobacco industry since 1982, initially for a U.K.-based publication and since 2004 for Tobacco Reporter. George’s understanding of industry issues, combined with his keen sense of observation and dry wit, have earned him a loyal following among Tobacco Reporter’s readers.

November 1, 2024
Derailing Harm Reduction?
Image: ArieStudio
The unhelpful contribution of illicit vaping products
By Pieter Vorster and Sudhanshu Patwardhan
The rise of vaping as an alternative to smoking has brought the promise of significant net public health benefits but equally meaningful regulatory challenges. While legitimate vaping products can serve as a powerful harm reduction tool for adult smokers, the proliferation of illicit vaping products has introduced a plethora of problems that require careful consideration.
This article will address the various impacts of illicit vaping products—ranging from health risks and tax revenue loss to underage use, environmental concerns and the potential for increased criminal activity. In countries where vaping products are banned, the illicit vape market has not only taken over but is also leading to a vicious cycle of vilifying an entire category of products that potentially offer a much less risky alternative to combustible tobacco users. The accompanying stigmatization and criminalization of smokers who seek safer alternatives is an affront to human rights. We will also explore the key drivers of the illicit market and potential solutions to mitigate these.
Health Risks Associated With Illicit Vaping Products
A key concern with illicit vaping products is the absence of regulatory oversight. Legitimate manufacturers must adhere to safety standards that ensure their products do not pose unnecessary risks to consumers. These regulations cover product composition, labeling and the disclosure of ingredients. In contrast, illicit products bypass these standards, introducing the potential for harmful substances in e-liquids, unsafe nicotine levels or faulty hardware, such as poorly constructed batteries.
Potential health risks include:
Contaminated ingredients: Illicit vaping liquids may contain dangerous additives such as harmful chemicals or poorly sourced nicotine, increasing the risk of respiratory issues and other health problems.
Unregulated nicotine levels: Illicit products can contain nicotine concentrations far beyond legal limits, exacerbating addiction or leading to nicotine poisoning.
Defective devices: Poorly made or counterfeit devices may lead to malfunctions, such as battery explosions or inadequate heating mechanisms, posing physical dangers to users.
Loss of Tax Revenue and Market Disruption
Illicit vaping products not only pose health risks but have economic consequences as well. In jurisdictions where vaping products are subject to excise taxes or sales tax, such as in many European countries and parts of the United States, the sale of untaxed products represents a significant revenue loss for governments. These funds are often intended to support public health programs, anti-smoking initiatives or infrastructure investments. The absence of taxes on illicit products undermines these efforts and contributes to a broader sense of inequity within the market.
Moreover, the price difference between legal and illicit products distorts the market. Legitimate operators who comply with taxation and regulatory requirements face unfair competition from cheaper illicit products. The lower price points of these illegal products not only make them more accessible but also undermine the efforts of legal businesses to compete, leading to the potential loss of jobs and investment in the legitimate sector.
Underage Use and Accessibility
One of the most troubling aspects of illicit vaping products is their role in enabling underage access and use. In most countries, the sale of vaping products to minors is strictly prohibited, and legitimate sellers are typically required to adhere to age verification processes. However, illicit products bypass these restrictions. Without regulated sales channels, these products can be more easily acquired by underage consumers, contributing to a rise in youth vaping.
Factors contributing to underage use include:
Lower prices: The affordability of illicit products makes them more accessible to those who are underage and often more price-sensitive.
Unregulated sales channels: Without the oversight that governs legitimate sales, underage individuals can purchase these products through informal networks or online marketplaces with little to no age verification.
The availability of illicit products for underage users creates a broader public health challenge. While the long-term effects of nicotine on developing brains remain debated, concerns about early nicotine exposure, potential addiction and its impact on cognitive function continue to drive public health discourse and have been key to the Food and Drug Administration’s highly restrictive premarket tobacco product application process in the United States.
Elsewhere, the rise in underage vaping, fueled by the availability of illicit products, has prompted calls for stricter regulation of the legitimate market. In the U.K., for example, concerns about underage use have led to proposals for more stringent controls on all vaping products, which could inadvertently restrict access for adult smokers who use vaping as a tool for tobacco harm reduction.
Environmental Concerns
The environmental impact of illicit vaping products is another significant issue. Many of these products, particularly disposable vapes, are not designed with recyclability in mind. Since illicit manufacturers often prioritize cost savings over environmental considerations, their products are less likely to comply with proper waste disposal or recycling guidelines.
Environmental risks include:
Disposable vapes: Many illicit, disposable vapes are discarded improperly, contributing to plastic waste and electronic waste.
Recycling challenges: Legal products are often part of recycling schemes or are designed with recoverable materials, but illicit products do not follow these environmental protocols.
A lack of proper disposal mechanisms for illicit products not only exacerbates broader environmental challenges such as electronic waste and plastic pollution but also fuels calls for stricter regulation, or bans, of legal products.
Criminal Violence and the Illicit Market
In addition to the public health and economic consequences, the illicit vaping market has the potential to fuel criminal activity, particularly organized crime. The sale of untaxed and unregulated products can provide a significant revenue stream for criminal organizations, which, in turn, may lead to increased violence. Australia, which has imposed a de facto ban on vapes through its prescription model, has seen rising concerns about criminal violence linked to the illegal trade in vaping products. As the illicit market grows, so does the likelihood of violence between rival groups vying for control of the black market.
Illicit Vaping—A Bipolar Problem?
Growth in the illicit vaping market is being driven by a combination of factors. Peculiarly, the two bookends of the regulatory spectrum pose the highest risk: overly restrictive or prohibitive at one end and notification with poor enforcement at the other. It is easy to understand why prohibition or overly restrictive frameworks can be conducive for illicit products in the market—decades of prohibition experiments on alcohol, drugs and even chewing gums have shown how that can skew market economics in favor of bad actors.
Regulations that are perceived as overly restrictive can push consumers and sellers toward the black market. In countries like Australia and the United States, where vaping regulations are particularly stringent, the high cost of compliance, limited access to legal products and high taxes can drive demand for illicit alternatives. These overly restrictive policies, while intended to protect public health, may inadvertently encourage consumers to seek out cheaper, unregulated options that bypass legal requirements.
In the U.S., where only a limited number of products have been granted marketing authorization by the FDA (none of which are disposable), disposable vapes are estimated to account for close to 60 percent of national unit sales in tracked sales channels.
Australia is another widely reported example of rampant sales of illicit vapes in response to a draconian regulatory framework, and the list does not end there. India and Thailand, among others where sales of vaping products are banned, have seen significant black markets emerge.
At the other end are countries where there is no requirement for authorization per se and a basic notification process is considered adequate. Indeed, it may seem counterintuitive that harm reduction goals could be helped by the introduction of barriers to product launches and rapid innovation. However, an overly simplified notification process has the potential to put excessive responsibility on enforcement agencies in the marketplace. For example, in jurisdictions where a vaping product/SKU can be launched following a simple notification process of contents and related risk assessments, the potential exists for unscrupulous manufacturers and distributors to introduce products containing illegal additives or higher-than-allowed nicotine levels in a seemingly legal way. The EU Tobacco Products Directive and its transposition into local regulations in EU and ex-EU countries such as the U.K. creates such a situation. In the U.K., the U.K. Vaping Industry Association (UKVIA) believes that 40 percent to 60 percent of disposable vapes sold in the U.K. are likely illicit.
A lack of adequate resources for law enforcement agencies also contributes to the persistence of the illicit market. Without sufficient funding and personnel to investigate and crack down on illegal operators, the illicit trade in vaping products continues to thrive. The combination of an unregulated supply chain and weak enforcement allows illicit products to enter the market relatively unchecked.
Potential Solutions
Addressing the issue of illicit vaping products requires a multifaceted approach involving both regulatory reform and enhanced enforcement mechanisms. Some potential solutions include regulatory reform, strengthened law enforcement and public awareness campaigns.
Regulatory Reform
Governments must strike a balance between protecting public health and ensuring that regulations do not drive consumers to the black market. By adopting a regulatory framework that allows adult consumers to access legal vaping products while maintaining appropriate safety and quality standards, policymakers can reduce the demand for illicit alternatives. This could involve:
Harmonizing regulations: standardizing regulations across jurisdictions to prevent regulatory discrepancies that fuel the illicit trade.
Moderate taxation: implementing reasonable excise taxes that do not create a significant price disparity between legal and illicit products.
Allowing legal access to adult smokers: Providing adult smokers with accessible, affordable and satisfactory regulated alternatives will discourage the use of unregulated products.
Strengthening Law Enforcement
To effectively combat the illicit market, governments must provide law enforcement agencies with the necessary resources to investigate and shut down illegal operators. This could include:
Increased funding for investigations: allocating more resources to law enforcement agencies to crack down on illicit vaping supply chains.
International cooperation: As the illicit trade often involves cross-border networks, international cooperation between customs and law enforcement agencies can play a vital role in curbing the flow of illegal products.
Licensing and tougher penalties: In the U.K., the UKVIA has proposed a mandatory licensing framework for vape retailers and distributors, with fines of up to £10,000 ($13,038) for retailers and £100,000 for distributors. The scheme aims to generate additional funding for enforcement, estimated at £50 million annually.
Public Awareness Campaigns
Educating the public about the risks associated with illicit vaping products can help reduce demand. Public awareness campaigns can inform consumers about the health risks, potential legal consequences and environmental harms linked to using unregulated products.
By addressing the root causes of the illicit vaping market and implementing effective solutions, governments can safeguard public health, protect revenue streams and ensure that vaping products remain accessible to adult consumers seeking harm reduction.
Sudhanshu Patwardhan is a medical doctor, nicotine expert and health tech entrepreneur from India, based in the U.K. He works on projects around the world to reduce harm from tobacco, especially among the most disadvantaged tobacco user populations.

Pieter Vorster is a harm reduction expert with a long career as a financial analyst reporting on tobacco industry stocks.
October 28, 2024
Catania to Host Conference on Harm Reduction

Image: CoEHAR
The Center of Excellence for the acceleration of Harm Reduction (CoEHAR) will host its national conference on Oct. 30 at the University of Catania, Italy.
The 2024 edition will host 25 speakers from prestigious research centers and international universities, including the Moffitt Cancer Center, Dartmouth College, George Washington University and the Milken Institute School of Public Health.
“Scientific research on harm reduction strategies has reached a critical turning point, where information about new frontiers represented by modified-risk devices can no longer be ignored,” said CoEHAR founder Riccardo Polosa in a statement.
“This year’s gathering with our colleagues from the harm reduction scientific community will allow us to capture the current state of research, providing even more important answers on the health benefits that modified-risk devices can bring to dental health, vision and diabetes management. There will also be a focus on new technologies and the application of artificial intelligence systems in smoking cessation therapies.”
The full program can be downloaded here.
October 28, 2024