Category: Harm Reduction

  • Consumer Group Says No to PMTA Registries

    Consumer Group Says No to PMTA Registries

    U.S. states must recognize the unintended consequences of passing laws requiring premarket tobacco product application (PMTA) registries for alternative nicotine products such as vaping devices, heaters, and nicotine pouches, according to the Consumer Choice Center, an organization claiming to represent consumers in more than 100 countries.

    In the first months of 2024, more than a dozen bills have been introduced in U.S. states calling for a state-based registry for alternative nicotine products. Such legislation has already been passed in Oklahoma, Louisiana and Alabama.

    “While the intention behind these bills is to manage consumer access to unregulated nicotine products on the illicit market, the reality is that the FDA is not approving enough new devices and products to create a competitive, regulated marketplace that meets consumer demand,” said Elizabeth Hicks, U.S. affairs analyst at the Consumer Choice Center.

    While 26 million nicotine alternative products submitted PMTAs to the Food and Drug Administration, only 23 have been approved. Of those 23 approved products, 12 are tobacco-flavored e-liquid refills.

    “The FDA is hiding the ball here on product approvals and how few new products are actually coming to market. If the goal is to improve public health across the country, then consumers deserve to choose from a variety of different nicotine alternatives,” said Hicks.

    The Consumer Choice Centers urges state legislatures to refrain from adding to counterproductive federal policies and instead advance tobacco harm reduction through a competitive marketplace.

  • FDA Urged to Follow the Science

    FDA Urged to Follow the Science

    Photo: Pixel-Shot

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) should open the marketplace for electronic nicotine delivery systems to products with varied characteristics so that those interested in alternative nicotine products can access them, according to R Street resident senior fellow Jeffrey Smith.

    In a recently published analysis, Smith critiques the FDA’s disregard for the current research on ENDS, diving into new data that he says represents a “tectonic-shift in the academic medicine community” regarding the safety of ENDS for smoking cessation. 

    ”As evidence grows for the utility of ENDS and other potentially life-saving alternative products, the CTP continues to limit Americans’ access to these products,” writes Smith.

    “Though the CTP has received millions of applications for ENDS products, it has only allowed a few to be marketed legally in the United States. Of those that have received marketing clearance, only older closed systems have been approved—with tobacco as the only permitted flavor.”

    Arguing that a diverse range of ENDS products available to those who smoke and want to quit is critical to reducing the health burdens associated with smoking, Smith urges the CTP to revise its processes and procedures, and allow more cigarette alternatives on the market. Continued delay by the CTP, he says, will only lead to more unnecessary deaths and disease in the United States.

  • Tax Would Restrict Harm Reduction to the Rich

    Tax Would Restrict Harm Reduction to the Rich

    Photo: Anastasia Kargapolov

    The U.K. risks becoming a harm reduction country for the wealthy only, according to the World Vapers Alliance (WVA).

    The government, led by Prime Minister Rishi Sunak, is reportedly planning to impose increased taxation on vaping products alongside traditional cigarettes. The proposal has sparked significant concern among U.K. vaping advocates, who argue it threatens to undermine the nation’s progress in harm reduction and smoking cessation efforts.

    “It appears that in a bid to generate additional tax revenue, the U.K. government is willing to compromise the health of thousands of smokers,” said WVA Director Michael Landl. “This is yet another step in the wrong direction. By making less harmful alternatives to smoking more expensive, the government is effectively deterring smokers from making the switch. This measure will disproportionately affect the less affluent and exacerbate health inequalities, especially during a cost of living crisis.”

    The WVA cites statistical evidence revealing the disproportionate impact of smoking on lower socioeconomic groups. In 2021, the Office for National Statistics highlighted a stark disparity in smoking prevalence related to economic status in the U.K. Unemployed individuals reported a significantly higher smoking rate (25.7 percent) compared to those in paid employment (13.3 percent). Furthermore, in England, a pronounced smoking prevalence was observed in the most deprived neighborhoods (23.8 percent) in contrast to the least deprived (6.8 percent).

    Landl also criticized the government’s proposed bans on disposable vapes and generational restrictions on heat-not-burn products.

    “Along with the proposed tax increases, these bans will only serve to transform the U.K. from a leader in tobacco harm reduction into a haven for black market activities,” he said.

  • E-cig Harm Perceptions Worsening: Study

    E-cig Harm Perceptions Worsening: Study

    Photo: Asier

    Harm perceptions of e-cigarettes have worsened substantially over the last decade among adult smokers in England, according to a study published by Jama Network Open.

    In 2023, most adults who smoked believed e-cigarettes to be at least as harmful as cigarettes. The timing of the changes in harm perceptions coincided with the e-cigarette, or vaping product, use-associated lung injury outbreak in 2019 and the recent increase in youth vaping in England since 2021.

    Researchers collected data from 28 393 adult smokers. In November 2014, 44.4 percent thought e-cigarettes were less harmful than cigarettes, 30.3 percent  thought e-cigarettes were equally harmful, 10.8 percent thought they were more harmful, and 14.5 percent said they did not know.

    However, by June 2023, the proportion who thought e-cigarettes were less harmful had decreased by 40 percent, and the proportion who thought e-cigarettes were more harmful had more than doubled.

    Changes over time were nonlinear: late 2019 saw a sharp decline in the proportion who thought e-cigarettes were less harmful and increases in the proportions who thought they were equally or more harmful. These changes were short-lived, returning to pre-2019 levels by the end of 2020.

    However, perceptions worsened again from 2021 up to the end of the study period: the proportion who thought e-cigarettes were more harmful increased to a new high, and the proportion who thought e-cigarettes were less harmful decreased to levels comparable to those in late 2019.

    As a result, in June 2023, the perception that e-cigarettes were equally as harmful as cigarettes was the most commonly held view among adults who smoke, with roughly similar proportions perceiving e-cigarettes to be less and more harmful.

  • Experts Urge Greater Urgency on Smoking

    Experts Urge Greater Urgency on Smoking

    Cliff Douglas (left) and Nataliya Toropova

    The nongovernmental organization Healthy Initiatives convened an international forum Feb. 14-15 in Prague, bringing together a diverse array of healthcare professionals, public health experts, economists and scientists from seven countries to address the challenges to making greater progress in smoking cessation.

    Despite initial strides in implementing tobacco control measures outlined by the WHO’s Framework Convention on Tobacco Control, data shows smoking remains a critical public health concern across Eastern Europe and Central Asia.

    The forum shed light on the ongoing challenges and opportunities in combatting the smoking epidemic, with a particular focus on countries such as Ukraine, Moldova, Georgia, Kazakhstan and Turkey. High rates of smoking persist, especially among men, with up to 50 percent identified as daily smokers in some of those countries.

    Cliff Douglas, President and CEO of the Foundation for a Smoke-Free World, emphasized in his keynote speech the urgent need for intervention, highlighting smoking as the leading cause of preventable deaths globally. He underscored the transformative impact of providing support for smoking cessation, promoting healthier choices and ultimately saving lives.

    “It’s quite clear there needs to be a much greater focus on providing smokers with support and alternatives, and clinicians in the region need and deserve additional educational resources. That can be done, and I congratulate Healthy Initiatives on playing a critical and enabling role in that endeavour,” said Douglas.

    A major concern raised during the discussions was the lack of adequate smoking cessation programs and wider support for adult smokers attempting to quit.

    The ongoing instability in the region, exacerbated by Russia’s invasion of Ukraine, has further contributed to the stubbornly high smoking rates. The link between war and tobacco use is well documented, and there are concerns rates in Ukraine are climbing due to a rise in mental health conditions and poverty levels.

    “The consequences of war in widening societal inequalities will inevitably result in higher smoking rates, illness and death. This is an issue I feel passionately about and will be continuing to explore what more I, and the Foundation, can do to help the incredible, dedicated health leaders in this region,” Douglas added.

    Experts presented a range of research findings at the conference, including forecasts of morbidity and mortality based on tobacco restrictions, strategies to combat illegal trade’s impact on smoking, analysis of smoking trends and harm-reduction products, and the correlation between mental health and tobacco control efforts.

    “The gathering in Prague should act as an urgent call to action for public health leaders in the region,” said Nataliya Toropova, founder of Health Initiatives. “Smoking rates are not falling fast enough. We need collaborative efforts to combat the smoking epidemic, and that can only be achieved by pooling our expertise and resources. There’s the expertise and evidence to develop effective strategies to support smokers and promote healthier lifestyles, but we need decision makers to move the issue higher up on the priority list.”

  • A Misguided Crusade

    A Misguided Crusade

    Photo: Swedish Match

    The campaigns against lower risk nicotine products serve political goals at the expense of public health.

    By Catharine Dockery

    Cigarette smoking remains the leading cause of preventable death in the United States and many other countries. Shouldn’t our leaders do everything they can to prevent deaths and reduce harm? 

    Unfortunately, U.S. Senator Chuck Schumer and the Food and Drug Administration have missed a profound public health opportunity by not encouraging reduced-harm nicotine products such as Zyn. Instead, they are targeting these lifesaving products and proposing wide-reaching bans.

    While youth usage of nicotine is a deeply concerning issue, product prohibitions are an ineffective distraction from the failure of the FDA to act proactively to protect Americans. Flavored recreational nicotine options are essential tools to present combustible cigarette smokers with less harmful options they enjoy. Public health officials need to stop scapegoating harm reduction products targeted to adult smokers and instead focus on addressing youth use.

    Other public health organizations, such as the U.K. National Health Service (NHS), have recognized the potential of harm reduction products in saving lives and promoted recreational nicotine options. For example, their “swap to stop” program has offered new noncombustible tobacco products to smokers in an effort to move them to lower risk alternatives. The NHS website offers that “[i]n recent years, e-cigarettes have become a very popular stop-smoking aid in the U.K. Also known as vapes or e-cigs, they’re far less harmful than cigarettes and can help you quit smoking for good.”

    In the United States, by contrast, government officials and public health agencies are spurning a significant opportunity in reduced-harm nicotine products. In 2023, nearly half a million adults died in the United States from the effects of cigarettes.

    Research demonstrates that flavored nicotine products provide a less harmful option for adult cigarette smokers who are trying to find a substitute for their habit.

    A 2021 study found that among U.S. adults who smoke, despite only 29 percent being aware of nicotine pouches, nearly 17 percent expressed interest in trying the products in the coming six months.

    To the extent adult smokers are able to substitute pouches for cigarettes, it’s absolutely appropriate to view these products as lower harm options on a continuum of risk.

    Some research indicates that e-cigarettes can be more effective than nicotine-replacement therapy products like gums and lozenges at helping smokers quit, showing the role of these products in the public health fight against tobacco-related harm.

    Policymakers’ efforts to restrict harm reduction products are often done under the guise of protecting children. But in no other industry do we consider product bans a reasonable control to address underage use. It would be unheard of to ban alcohol to prevent underage drinking. 

    Product bans have been largely unsuccessful in addressing youth vaping, a failure made clear by the fact that the top 2 youth e-cigarette brands of 2023 are illegal (Elf Bar and Esco Bar, used by 57 percent and 22 percent of youth surveyed, respectively). The FDA has completely failed to enforce bans on these illegal brands with flavors and designs designed specifically to appeal to underage users. The numbers are clear—10 percent of middle school and high school students use tobacco products, and the vast majority of those (7.7 percent) use e-cigarettes. 

    We also need to engage with the facts of youth nicotine abuse. E-cigarettes are far and away the main method of consumption among underage users, used by 7.7 percent of students in 2023 relative to the 1.5 percent using nicotine pouches. Significantly more effort is needed to crack down on illegal sales, particularly online sales, of these products. If product bans can’t solve youth usage issues, can we really justify the public health costs of denying vital options to smokers?

    On this issue, we’re repeatedly offered a false choice between youth nicotine abuse and robust options for adult smokers. This is a purely political characterization of the problem. There are a multitude of actions that can be taken to protect youth from the dangers of nicotine. Significantly stronger enforcement is needed at retailers, both for age verification and to prevent the sale of illegal products.

    A strong FDA focused on hands-on enforcement is needed to ensure that nicotine companies operate responsibly and avoid appealing to underage consumers. We also need stronger import controls on these products, with illegal imports often coming from unfriendly nations. These common-sense actions can protect youth without dramatic costs to adult smokers.

    The public health conversation around nicotine has been unfortunately politicized, and we’ve lost sight of the most important goal: saving lives. Product bans and public policies targeting reduced-harm products would have material impacts on the options available to adult smokers while doing little to address the underlying factors enabling youth nicotine use in this country. Targeting some of the lowest risk tobacco products available is an unacceptable government overreach, serving political rather than public health goals.

     
     
  • Replica 2.0 Team to Meet in Catania

    Replica 2.0 Team to Meet in Catania

    Photo: CoEHAR

    The Center of Excellence for the Acceleration of Harm Reduction (CoEHAR) will hold the Annual International Meeting for its Replica 2.0 project in Catania, Italy, March 25–29.

    The Replica project is one of CoEHAR’s most successful projects, according to the organization. In the last couple of years, the research team replicated and validated the results from well-known international studies in the field of tobacco harm reduction.

    The project benefits from its collaboration with an international network of independent laboratories all around the world, which includes the Universitas Padjadjaran in Indonesia, the Institute of Research and Development Nosmoke in Greece, the Faculty of Medical Sciences, University of Kragujevac in Serbia, the Sultan Qaboos University in Oman, the Temple University-SHRO in the United States and Kazan Federal University, Russia.

    During the event, the Replica team will discuss lessons learned, harmonize standard operation procedures for the project and continue the laboratory training emphasizing critical steps for harmonization.

    On March 29, CoEHAR will host the ceremony for its Talent Research Award.

    Tobacco Reporter profiled CoEHAR in its January 2024 print edition and online (see, “Reviewing their Peers”).

  • Snus Documentary to Screen in Spain

    Snus Documentary to Screen in Spain

    Image: fergregory

    Somos Innovacion announced the avant-premiere of the documentary How Sweden Stopped Smoking by award-winning Polish director Tomasz Agencki. The screening will take place on Feb. 27 at Espacio Balboa in Madrid and will include a panel discussion with leading experts in health and activism.

    This documentary delves into the story of how Sweden became a smoke-free nation. Through interviews with scientists, doctors, innovators and artists, Agencki spins a tale that examines the complex interplay of science, politics, history and personal will behind this “Swedish miracle.”

    “We are excited to share this inspiring story about the courage and creativity that made a healthier future possible for Swedes,” says Federico N. Fernandez, CEO of Somos Innovacion, in a statement. “We believe the lessons from Sweden’s journey can guide other nations to achieve the same progress.”

    Following the screening, a panel of experts composed of Fernando Fernandez Bueno, oncologic surgeon and prominent anti-smoking opinion leader; Josep Maria Ramon Torrell, head of the Tobacco Treatment Unit at Bellvitge Hospital and professor of medicine; Julio Ruades, popular YouTuber and spokesperson for the Spanish Association of Personal Vaporizer Users; Federico N. Fernandez, CEO of Somos Innovacion; and moderated by Carmen Escrig, coordinator of the Spanish Medical Platform for Tobacco Harm Reduction will share unique perspectives and discuss key lessons that inspire other nations to follow Sweden’s example in the fight against smoking.

    Space is limited. Reserve free tickets on Eventbrite: https://bit.ly/SueciaLibreDeHumo. This avant-premiere is in-person only; it will not be streamed.

  • Past WHO Officials Highlight THR Strategy

    Past WHO Officials Highlight THR Strategy

    Photo: Alexander Ovsyannikov

    Harm reduction should be a central strategy of the Framework Convention on Tobacco Control (FCTC) in addition to the measures for demand and supply reduction, according to Robert Beaglehole and Ruth Bonita.

    Writing in The Lancet, the two former World Health Organization directors argue that while the FCTC has been influential in encouraging a global response to tobacco control, it has been challenging to show a strong and consistent association between the implementation of FCTC measures and smoking prevalence and cigarette consumption outcomes.

    The FCTC does not prohibit harm reduction approaches but leaves it up to member states to decide how to regulate e-cigarettes and other novel nicotine products. The WHO’s lack of endorsement of tobacco harm reduction limits healthier choices for the 1.3 billion people globally who smoke and who are at an increased risk of early death, according to Beaglehole and Bonita.

    The authors note that there is no scientific justification for WHO’s position that e-cigarettes and other novel nicotine products should be treated in the same way as tobacco products. This position, they argue, overlooks a risk-proportionate approach.

    “We believe WHO needs to provide positive leadership and technical support to countries as they consider the use of e-cigarettes and other nicotine delivery devices,” the authors write. “WHO’s current approach to these lower-risk product is to reward countries, such as India, for banning e-cigarettes; thirty-four countries, primarily low-income and middle-income countries, now ban e-cigarettes.”

    Beaglehole and Bonita note that, in some countries, substantial reductions in smoking prevalence have coincided with the uptake of novel nicotine products. In New Zealand, for example, the prevalence of adult daily smoking plummeted from 13.3 percent in 2017–2018 to 6.8 percent in 2022–2023 after e-cigarettes became widely available, a 49 percent decline in five years.

    In the same period, and with the support of the government and regulation of vaping, the prevalence of adult daily vaping increased from 2.6 percent to 9.7 percent. New Zealand’s recent decline in smoking occurred in the absence of any other major tobacco control policy, apart from the annual cost-of-living price increases, according to the authors. “The decrease in smoking during this period in New Zealand shows what can be achieved, and exceeds the WHO smoking prevalence reduction goals of 30 percent over 15 years from 2010 to 2025,” they write.

    The New Zealand 2022 smoke-free legislation includes a “tobacco-free generation”, a 90 percent reduction in smoked tobacco retail outlets, and compulsory denicotinization of retail tobacco. The New Zealand government, elected in November 2023, is committed to reaching the Smokefree 2025 goal of 5 percent (or less) smoking prevalence for the adult population, but intends to repeal the 2022 smoke-free legislation.

    However, because of the implementation timelines, fears that this repeal would jeopardize the Smokefree 2025 goal can be allayed, according to Beaglehole and Bonita. This is because none of the three headline measures would be expected to have an impact before 2025 and might have had negative unintended consequences. “Based on recent progress, New Zealand’s Smokefree 2025 goal looks likely to be reached by consent rather than coercion and by further support for switching to smoke-free nicotine products,” the authors note.

    Beaglehole and Bonita also highlight the success of other high-income countries in reducing smoking prevalence in association with the use of a range of lower-risk nicotine delivery devices to complement FCTC demand and supply reduction measures.

    Sweden, with a long tradition of snus use, has the lowest prevalence of adult daily smoking in the world, down to 6 percent in 2022, accompanied by low mortality from tobacco-related diseases.

    Norway has had similar success with reducing smoking prevalence in the context of increased use of snus and e-cigarettes, and in England vaping is helping adults to quit smoking. The substantial decline in cigarette consumption in Japan is associated with the rapid uptake of products that heat, rather than burn, tobacco.

    Less progress has been made in low-income and middle-income countries where tobacco control capacity and political will to advance tobacco control measures are weaker, and the potential of tobacco harm reduction is not being realized, according to the authors.

    Beaglehole and Bonita say two concerns suggest why tobacco harm reduction is not more actively embraced, despite its association with reduced smoking prevalence. The first is that, compared with cigarettes, where the damage has been known for more than half a century, the long-term effects of e-cigarettes are unknown.

    Although vaping may not be risk-free, especially for people who do not smoke, the risks of there being substantial long-term harm from the constituents of e-cigarettes are likely to be low, especially when compared with the damage caused by smoked tobacco, the authors point out.

    The second concern is that the widespread availability of e-cigarettes in the absence of adequate controls and regulations encourages youth nicotine dependence and enables the vaping industry to act unethically. Beaglehole and Bonita say there is little evidence to suggest that vaping leads to smoking among youth, and although the proportion of non-smoking youth who vape is increasing, it remains at a fairly low level.

    Stricter regulations, including enforcing sales restrictions, and appropriate health promoting campaigns are needed to prevent vaping by young people, according to the authors, but these measures must be balanced with the health needs of older adults who smoke and require support to quit.

    Beaglehole and Bonita acknowledge that there is understandable skepticism about the motives of the tobacco industry in selling smoke-free products while continuing to expand tobacco markets in low-income and middle-income countries. To remain profitable, they say, the tobacco industry will eventually need to migrate its global business to less harmful alternatives since cigarettes will no longer monopolize the delivery of nicotine.

    The authors express concern about the recommendations, found in COP10 background papers, to treat nicotine products as equivalent to cigarettes and regulating them in a similar way. This approach, they argue, is a retrograde step because they are not comparable products in terms of the damage they cause; after all, it is the burning of tobacco that causes harm, not nicotine. Worse, such a strategy would ultimately favor the global cigarette market and may discourage vaping, according to Beaglehole and Bonita.

    The focus, they insist, must remain on the central public health problem—the damaging health effects of tobacco consumption. “Reducing cigarette smoking is the most effective way to prevent tobacco-related deaths and tobacco harm reduction is the fastest and fairest way to lower smoking prevalence,” the authors write.

    “WHO needs to embrace these innovations in nicotine delivery. Countries that are reaping the benefit of tobacco harm reduction, such as New Zealand, Sweden, Norway, England and Japan, should encourage participating countries at COP10 to support proposals that will quickly reduce smoking rates. The world’s 1.3 billion people who smoke, half of whom will die early, deserve this leadership.”

     

  • Activists Criticize COP10 Tactics

    Activists Criticize COP10 Tactics

    Photo: Alexey Novikov

    The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) today issued a sharp critique of the World Health Organization’s Framework Convention on Tobacco Control (FCTC) for its exclusion of consumer groups and harm reduction advocates from the 10th Session of the Conference of the Parties (COP10).  

     “CAPHRA argues that this exclusionary practice is in stark contrast to the successful, pragmatic approaches of countries like New Zealand, the Philippines and Malaysia, which have embraced vaping as a harm reduction tool,” said Nancy Loucas, a public health policy expert and passionate advocate for tobacco harm reduction and executive coordinator of CAPHRA. 

    The press release condemns the COP10 meetings for silencing the voices of those who advocate for harm reduction strategies, such as vaping, which have been shown to significantly reduce smoking prevalence in countries where they are available and regulated. 

     CAPHRA points out that the prohibitionist approach of countries like Australia, which recently banned vaping products, is not in the best interest of public health. 

     “CAPHRA calls on FCTC officials to open their minds to harm reduction and to consider the evidence from countries like New Zealand, where smoking rates have decreased due to the availability of regulated vaping products,” said Loucas. 

    The organization stresses the importance of including consumer groups in the decisionmaking process, as they provide essential insights into the needs of smokers and how alternative products can be used effectively.