Category: Harm Reduction

  • Sweden First Country to ‘Officially’ be Smoke Free

    Sweden First Country to ‘Officially’ be Smoke Free

    Credit: Summit Art Creations

    Today, the Swedish government released data showing that Swedes have made history by officially becoming the first country to be ‘smoke-free’.

    Swedes have hit the remarkable milestone 16 years ahead of the European Union target – while most of the EU’s fellow member states are set to miss it by some distance.

    Official health data released by Sweden’s public health agency show that just 4.5% of Swedish-born adults smoke – significantly below the globally recognized benchmark of 5% for smoke-free status.

    Average smoking rates in Europe (24%) are five times higher than Sweden’s.

    The Swedes’ extraordinary success results from their pioneering policy approach to safer cigarette alternatives, according to press releases.

    Dr. Delon Human, leader of Smoke-Free Sweden, said the 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.

    “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,” he said. “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.”

    The new statistics show that 5.3% 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.

    Dr. Anders Milton, a physician, former president, and CEO of the Swedish Medical Association, said that the key to Sweden’s success is its pragmatic focus on harm reduction rather than prohibition.

    “A wide range of safer nicotine products, with a variety of strengths and flavours, is legally available both online and in stores, supported by advertising, which raises awareness and encourages uptake,” he said. “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.”

    The benefits of Sweden’s strategy are enormous, with the country having the lowest percentage of tobacco-related diseases in the EU and a 41% 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.

    “Rather than follow Sweden’s lead, these nations are heading in the opposite direction, with smoking prevalence stagnating or even rising. Sweden’s success is living proof that alternative nicotine products are a powerful force for positive change when supported by evidence-based policies.

    “Smoke-Free Sweden calls on all countries to re-evaluate their tobacco control strategies and adopt harm reduction as a central pillar in their fight against smoking. Sweden’s smoke-free status should be a wake-up call to policymakers across the globe: progressive, science-backed policies on nicotine alternatives can make smoking history without sacrificing public health goals.”

  • Consumer Groups Demand Seats at COP11

    Consumer Groups Demand Seats at COP11

    Photo: v-a-butenkov

    The Coalition of Asia Pacific Harm Reduction Advocates (CAPHRA) is calling on the World Health Organization to open the upcoming Framework Convention on Tobacco Control (FCTC) Conference of the Parties (COP11) to consumer advocacy groups, in line with human rights principles and evidence-based policymaking.

    “The WHO FCTC process must adopt a human rights approach that considers the implications across the entire life cycle of tobacco products, from growing to consumption,” said Nancy Loucas, executive coordinator of the CAPHRA. “This requires meaningful engagement of all stakeholders, including consumers, to strengthen policy formulation and implementation.”

    The CAPHRA points to a WHO Western Pacific Regional Office’s report highlighting that “a key element to creating a successful tobacco control social movement is the meaningful engagement and involvement of civil society.” The report notes civil society’s crucial role in “initiating, leading and sustaining tobacco control efforts to improve public health.”

    “Consumer groups are not constrained by bureaucracy and can hold both industry and government accountable,” Loucas added. “Our exclusion from COP11 flies in the face of the WHO’s stated principles on civil society engagement.”

    The CAPHRA is urging the FCTC Secretariat to formally invite consumer advocacy groups as observers to COP11, to create dedicated sessions for civil society input during COP11 proceedings and to establish an ongoing mechanism for consumer group consultation between COPs.

    The organization emphasizes that evidence clearly shows tobacco harm reduction strategies like vaping have helped millions quit smoking. Consumer voices are critical to ensure policies reflect real-world impacts.

    “The WHO cannot claim to take a human rights approach while silencing the very people their policies affect,” said Loucas. “It’s time to practice what they preach on civil society engagement and let consumers into COP11.”

  • Tools to Quit

    Tools to Quit

    Credit: Qnovia

    The RespiRx, the first inhalable nicotine-replacement therapy, gains IND clearance.

    By VV staff

    A Virginia-based pharmaceutical company is developing inhaled therapeutics across a variety of indication areas leveraging its proprietary inhaled drug delivery platform. Qnovia announced that its RespiRxNicotine Inhaler (QN-01) received clearance for its Investigational New Drug (IND) application by the U.S. Food and Drug Administration.

    The company will initiate a Phase 1, randomized, crossover, open-label trial in the U.S. to determine the pharmacokinetics, safety and tolerability following self-administration of nicotine-containing products in up to 24 healthy adult subjects who currently smoke combustible cigarettes, according to Brian Quigley, CEO of Qnovia.

    “The FDA clearance of our IND application for QN-01 marks a significant achievement for Qnovia as we transition to a clinical-stage therapeutics company. Our U.S. clinical development plan is derisked by the positive first-in-human data we generated last year in support of advancing QN-01 in the United Kingdom where we demonstrated pulmonary delivery and a superior pharmacokinetic profile for the RespiRx when compared to existing nicotine-replacement therapies [NRTs],” said Quigley. “The next step for our U.S. program is to initiate a randomized Phase 1 trial that evaluates QN-01 compared to the Nicotrol Inhaler and combustible cigarettes in a head-to-head comparison.

    “We remain on track to dose our first patient in the fourth quarter of 2024 and in parallel will be advancing to a pivotal clinical trial in the U.K. to support an MAA submission to the MHRA [Medicines and Healthcare products Regulatory Agency] in 2026.”

    Qnovia’s proprietary drug/device combination already demonstrated dose-dependent pharmacokinetics, pulmonary delivery and was well tolerated in a first-in-human study conducted to support advancing QN-01 in the U.K., according to Mitch Zeller, the former director of the FDA’s Center for Tobacco Products, who is now serving as Qnovia’s policy and regulatory strategy advisor.

    “There have been no treatment options for smoking cessation approved in the U.S. in over 20 years. As a result, attempting to quit ‘cold turkey’ remains the most popular method of quitting smoking,” said Zeller. “There is an extraordinary public health need for truly innovative products to help health-concerned smokers stop using cigarettes. Any effort to reduce the death and disease caused by tobacco use must include new and better tools in the treatment toolkit.”

    Qnovia’s goal is for RespiRx to be the first inhaled prescription smoking cessation therapy product, Quigley told Vapor Voice last year (“Licensed to Thrive,” Issue 1, 2023, page ?). Instead of using heat to create vapor, the RespiRx device uses an orientation-agnostic vibrating mesh nebulizer. The aerosolizing engine is nothing like a traditional e-cigarette that heats a coil to atomize nicotine based in PG and/or VG.

    RespiRx is activated when a user inhales on the device. To aerosolize the nicotine, it sends an electrical current that causes the perforated piezo mesh to vibrate more than 100,000 times a second. “It’s that vibrating action of the mesh that then forces the liquid to the holes, creating an aerosol that appears vapor-like, allowing it to be inhaled,” says Quigley. That, he says, is fundamentally different from a traditional e-cigarette product, where the heating process can create undesired thermal by-products.

    RespiRx uses proprietary software to deliver a precise dose of nicotine. Every time it’s activated, the device fires for three seconds and delivers a targeted dose of the drug. The base is reusable and serves as the housing for the battery and software. The RespiRx nebulizer sits within the pod that houses the nicotine drug product.

    Credit: Qnovia

    “The nebulizing unit (cartridge) gets replaced by the patient every one [day] to two days. That interface means that the patient doesn’t have to clean the nebulizer,” explains Quigley. “The biggest challenge with other vibrating mesh products is that they require cleaning if used over an extended period. We’re mitigating that through the design of the interface. There is no cleaning required. We do believe that this will result in RespiRx having a very long use life.”

    Mario Danek, Qnovia’s founder and chief technical officer, agrees that eliminating the cleaning requirement was a priority. “The idea was to create a technology that emulates the form factor of a successful high-adoption consumer product but that is imbued with technologies that would pass CDER’s [Center for Drug Evaluation and Research] stringent standard for safety—combined with Qnovia’s purposeful design features, it should bring patient adherence and quit rates to new highs, which historically have been found lacking in NRT,” he said. “Additionally, from a drug delivery platform perspective, those CDER-aligned device safety requirements are just as imperative to Qnovia’s API expansion strategy into other indication areas.”

    RespiRx is a “step-down” therapy, like many NRT products. However, instead of buying different pods with varying levels of nicotine, Qnovia’s device has a dosage-monitoring system programmed into the device. Uniquely, the use regimen is determined based on how much a smoker is smoking, said Quigley. For example, a one-pack-a-day smoker would start with 20 doses per day. The two-pack-a-day smoker would start with 40 doses per day.

    “Then the device will, over the 12 weeks, gradually reduce the available number of doses to that patient. It is a much more manageable step-down over the 12 weeks, unlike currently available cessation methods. And the device itself will prevent the patient from using more than they’re supposed to use,” said Quigley. “Patients would also have the on-device LCD screen interface to help them understand how to use their doses. That, too, is another benefit of our product versus the existing smoking cessation therapies.”

    Danek said the company is proud to lead the charge in encouraging the innovation and development of safe and effective pharmacotherapies to help the millions of smokers who are trying to quit smoking.

    “We believe our proprietary drug delivery platform has the potential to be a highly differentiated treatment option not only for treatment of nicotine dependence but for a wide variety of treatments that would benefit from inhaled drug delivery,” said Danek.

  • Catania Set to Host Conference On Harm Reduction

    Catania Set 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.

  • University of Louisville to Host THR Course

    University of Louisville to Host THR Course

    Image: 4kclips

    The University of Louisville School of Medicine will host a continuing education course on tobacco harm reduction (THR).

    The program educates healthcare professionals about less-hazardous alternatives to cigarettes that still satisfy a smoker’s desire for nicotine/tobacco satisfaction. Rather than promoting medical intervention, the course equips health professionals to offer lifestyle options, especially to smokers who are unable or unwilling to quit nicotine/tobacco entirely.

    This program covers the following in five one-hour recorded PowerPoint presentations. Dozens of links to primary source materials demonstrating the critical public health value of THR are included.

    • Nicotine: Correcting misperceptions
    • Smoking and vaping in the U.S.
    • Risks of smokeless tobacco use and cigar smoking explained
    • Risks of e-cigarettes and heat-not-burn tobacco explained
    • Tobacco harm reduction can work: Evidence from around the world

     For more information, visit: https://louisville.edu/medicine/cme/credits/tobacco-harm-reduction.

  • U.S. States Fail to Harness Vaping’s Potential: Report

    U.S. States Fail to Harness Vaping’s Potential: Report

    Photo: pavelkant

    The Consumer Choice Center has released its second U.S. State Vaping Index, which looks at 50 states plus the District of Columbia. It reveals that only three states, including Alaska, North Dakota and Tennessee, received an A+ in the study for an evidence-based approach to vaping policy.  

    This rating means these states are in a position to harness the enormous potential of vaping as a harm-reduction tool while still letting consumers choose for themselves. Other states that perform well are Arizona, Michigan, Mississippi, Missouri, Montana, Texas, Alabama, Arkansas, Oklahoma and Wisconsin. 

    By contrast, 12 states have overwhelmingly embraced restrictive policies on vapers and vaping, including Utah (0 points), California (second to last at 5 points), Vermont (10 points), Oregon, New York, New Jersey, Nebraska, Massachusetts, Illinois, Hawaii, D.C. and Colorado (all at 15 points). The number of low scores has doubled since the 2020 edition of the Vaping Index. 

    “Vaping saves lives,” said Emil Panzaru, research director for the Consumer Choice Center. “If every smoker in the United States switched to vaping over 10 years, you’d have 6.6 million fewer premature deaths in the U.S.

    “Unfortunately, policymakers across America do not recognize that vaping is a valid harm-reduction substitute for traditional combustible tobacco products. Vapes are often mistakenly referred to as tobacco products, and in turn, targeted with draconian flavor bans, taxed higher than cigarettes, subject to registries meant to gatekeep the products, and faced with bans on online sales.

    “These policies deter consumers from switching away from the more dangerous habit of smoking and fuel black markets for vape products. The end result is a patchwork of state laws at odds with the most up-to-date public health practices from around the world.”

    The purpose of the U.S. Vaping Index is to inform consumers about vaping policies in their area and highlight the need for more informed and level-headed lawmaking. The Consumer Choice Center weighed five factors in the index:

    1) Whether the state considers vapes to be tobacco products;

    2) State-level vaping flavor restrictions;

    3) Requirements for state registries (which mirror the FDA-approved database);

    4) Additional excise taxes on vaping; and

    5) The presence or absence of online sales bans.

    “Let’s set the empirical record straight,” said Panzaru. “The best available research by authorities such as Public Health England recognizes that vaping is 95 percent safer than combustible tobacco for users. Evidence in the New England Journal of Medicine finds that vaping is twice as effective at smoking cessation than any nicotine tablet, patch or spray at helping people quit smoking. 

    “What’s more, a review of 15 different studies found little evidence of a supposed gateway effect leading teens down the path from vaping to smoking or hard substances.”

    “Rather than embracing policies that ignore the evidence and do not work, state authorities should commit to studying and learning from the example of Sweden, the first country to become smoke-free in Europe thanks to the research-driven recognition of vapes as harm-reduction tools,” Panzaru concluded. 

  • CAPHRA Activists Celebrate Slowing Smoking Rates

    CAPHRA Activists Celebrate Slowing Smoking Rates

    Photo: sezerozger

    New Zealand has achieved its Smokefree 2025 goal ahead of schedule, with smoking rates plummeting to unprecedented lows, according to the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA).

    Data from the most recent New Zealand Health Survey reveals that smoking rates have fallen dramatically, particularly among youth. The decline has been so significant that statisticians now struggle to accurately measure the small proportion of young smokers due to sample size limitations, says CAPHRA, which attributes the success to New Zealand’s accommodation of new nicotine products as tools to helps nicotine users transition away from cigarettes.

    “New Zealand’s success in reducing smoking rates is a testament to the country’s progressive approach to tobacco harm reduction,” said Nancy Loucas, executive coordinator of CAPHRA. “By embracing vaping and other less harmful alternatives, we’ve seen smoking rates drop from 11.9 percent in 2020 to an astounding 6.8 percent in 2023. This is a clear indication that our strategy is working.”

    Our success story should be a wake-up call for countries like Australia who are still clinging to prohibitionist policies.

    Nancy Loucas, executive coordinator, CAPHRA

    The success is particularly notable among young people, with youth smoking rates reaching historic lows. “The fact that we’re having difficulty measuring youth smoking rates due to their minuscule prevalence is a cause for celebration,” Loucas added. “It’s a clear sign that we’re winning the battle against smoking-related harm.”

    Despite this undeniable success, some in the tobacco control and public health sectors seem reluctant to acknowledge the effectiveness of New Zealand’s approach, according to CAPHRA.

    “It’s perplexing that some individuals in tobacco control can’t seem to accept our successful strategy,” said Loucas. “We’ve achieved what many thought impossible, yet instead of celebrating, they’re focusing on potential issues with vaping. We need to recognize this victory and continue supporting policies that have proven effective in reducing smoking rates.”

     CAPHRA urges policymakers and health advocates worldwide to look to New Zealand as a model for successful tobacco harm reduction. The organization emphasizes the importance of embracing evidence-based approaches that include a range of less harmful alternatives to smoking.

    “Our success story should be a wake-up call for countries like Australia who are still clinging to prohibitionist policies,” said Loucas. “It’s time to put aside preconceived notions and focus on what works – a pragmatic, harm-reduction approach that prioritizes public health over ideology.”

  • French Vape Organization SOVAPE to Shutter Doors

    French Vape Organization SOVAPE to Shutter Doors

    Credit: Zoran Milic

    French consumer vaping organization SOVAPE announced this week it will dissolve. The group has been active since 2016.

    Best known for organizing three Vape Summits in France between 2016 and 2019, SOVAPE also co-founded the European Tobacco Harm Reduction Advocates (ETHRA) umbrella organization. Since 2019, the group has commissioned annual surveys of French public opinion on vaping and nicotine conducted by major market research firm BVA.

    However, this year BVA notified SOVAPE that it could no longer participate due to a health industry client’s contract prohibiting BVA from also working with nicotine-associated organizations, according to media reports.  

    The abrupt cancellation of the survey followed other recent blows, including news articles accusing SOVAPE and other consumer groups of connections to the tobacco industry, and attacks on scientists and health professionals who supported SOVAPE’s mission.

    In an Oct. 6 website post, SOVAPE explained it can no longer carry out its mission due to the current climate of “censorship, threats, lies, denigration and slander, to which can be added the dissemination of fake news and the denial of scientific data.”

    “Dialogue in this context is impossible,” SOVAPE wrote, “and clearly, it is now even ‘forbidden’ to provide information, such as a banal survey, on reducing the risks of smoking in France.”

    SOVAPE will donate the balance of its funds equally to the Pasteur Institute and fellow vaping groups AIDUCE and La Vape du Cœur. SOVAPE has paid to keep its website available for 10 years, and maintains videos of Vape Summit proceedings on its Youtube channel.

    “We regret that we are no longer able to cultivate a dialogue to promote the risk reduction approach against the main cause of preventable diseases and premature deaths in France,” SOVAPE said in its post. “We do not regret having tried, but must acknowledge that it is no longer possible for us to lead this fight that is dear to us, and which has nevertheless contributed to saving lives!”

  • Canadian Trade Group Supports Flavored Vapes

    Canadian Trade Group Supports Flavored Vapes

    Photo: DD Images

    The Canadian Vaping Association (CVA) has expressed concern over recent attempts by tobacco control lobbyists to convince the government to ban vape flavors nationwide. According to the trade group, such a ban would have negative public health consequences and undermine Canada’s goal of reducing smoking rates to less than 5 percent by 2035.   

    “We must acknowledge and not ignore that more than 1.5 million adult vapors in Canada use flavored vaping products to stop smoking,” the CVA wrote in a statement.

    “We agree underage youth should not vape; however, more needs to be done through education and providing the necessary tools for parents, teachers, coaches and community members, to understand the underlying issues as to why youth are vaping and providing solutions to solve their nicotine dependence.”

    According to the CVA, Canada already has some of the best vape regulations globally, covering labeling, packaging, marketing, promotions, reporting and nicotine concentration limits. The group also urged the tobacco control lobbyist to consider the risks of the illicit market.

    “The bullying tactics of anti-harm reduction lobbyists pressuring Minister Saks and Health Canada to act quickly, will only help grow the black market of vaping products,” the CVA wrote. “This will make vaping more accessible to youth, at much lower prices and greater risk to their health.”

  • Experts: Ignoring THR a ‘Death Sentence’ for Smokers

    Experts: Ignoring THR a ‘Death Sentence’ for Smokers

    VV Archives

    International health experts have warned that governments of the world are condemning millions to die if they continue to ignore the benefits of tobacco harm reduction (THR) policies.

    In an open letter to delegates at the United Nations General Assembly, Delon Human of Smoke Free Sweden, along with other leading THR specialists, call for THR to be incorporated into standard tobacco control measures worldwide.

    By doing so, millions of lives could be saved from smoking-related diseases, the letter states.

    The experts’ letter points to real-world evidence, particularly from Sweden, which proves the success of THR policies. Through the promotion of safer alternatives like snus, nicotine pouches and vapes, Sweden has reduced its smoking rates by 55 percent over the past decade, resulting in a staggering 44 percent fewer tobacco-related deaths compared to the rest of the European Union.

    “Sweden’s achievement underscores the effectiveness of harm reduction policies in not only saving lives but also reducing the strain on healthcare systems,” Human said. “Their success serves as a blueprint for other nations.”

    The letter also highlights New Zealand’s progress, where the Ministry of Health endorsed vaping as a cessation tool in 2019. Since then, New Zealand’s smoking rates have nearly halved, positioning the country as another example of how THR can drive down smoking-related deaths and diseases.

    While countries like Sweden and New Zealand lead the way, many other nations continue to struggle with high smoking rates while rejecting harm reduction. Countries in Eastern Europe, the Middle East, Asia and Africa could witness similarly dramatic reductions in smoking-related mortality by adopting THR policies.

    A recent study cited in the letter estimates that Czechia alone could save 280,000 lives over the next four decades if it adopts THR strategies. Further studies report similar potential benefits in other nations including Brazil, Bangladesh, South Africa and Saudi Arabia.

    “This is not about promoting nicotine use,” Human said. “It’s about offering safer choices to individuals who would otherwise continue smoking harmful cigarettes. We are on the cusp of a public health revolution, and THR has the potential to be a game-changer in saving millions of lives.”

    The letter, also signed by Derek Yach and Marewa Glover, calls on global leaders and the United Nations to prioritize THR as a crucial element of tobacco control, urging governments to act swiftly and decisively. “The evidence is clear,” the letter concludes. The time to act is now.”