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Category: Global Regulation

  • CAPHRA Urges COP11 Attendees to Shift View on Harm Reduction 

    CAPHRA Urges COP11 Attendees to Shift View on Harm Reduction 

    The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) today (March 31) urged global tobacco control policymakers to abandon outdated prohibitionist approaches and embrace harm reduction strategies grounded in science.  

    Ahead of the Framework Convention on Tobacco Control’s (FCTC) COP11 meeting later this year, CAPHRA emphasized that meaningful progress requires inclusion, transparency, and a commitment to evidence-based policymaking. 

    Despite decades of tobacco control efforts, global smoking rates have stagnated at 1.1 billion smokers since 2000. CAPHRA attributes this failure to the FCTC’s refusal to engage with harm reduction strategies or include consumer organizations in its decision-making processes. 

    “The FCTC’s ‘quit or die’ approach has failed. It’s time for a mindset shift that prioritizes science over ideology and inclusion over exclusion,” Nancy Loucas, CAPHRA Executive Coordinator, said. “Consumer organizations like CAPHRA represent millions who have successfully transitioned to safer alternatives—our lived experiences must inform policy. 

    “COP11 presents an opportunity for the WHO FCTC to finally grant observer status to consumer advocacy groups. Without the voices of those directly impacted by tobacco harm reduction strategies, policymaking remains disconnected from reality. The secrecy surrounding COP meetings undermines trust and progress. Hosting open consultations with civil society during proceedings would ensure accountability and bring much-needed balance to global tobacco control discussions.” 

  • Senate Confirms New FDA Commissioner

    Senate Confirms New FDA Commissioner

    Last week the U.S. Senate confirmed former Johns Hopkins surgeon and professor Dr. Marty Makary to lead the U.S. Food and Drug Administration by a 56-44 vote. During his confirmation hearing, Makary said his goals for the agency were “more cures and meaningful treatments for Americans,” and offered several insights as to how he would achieve those goals throughout the hearing.  

    In the past, Makary has been critical of the FDA, in 2021 calling for “fresh leadership at the FDA to change the culture at the agency and promote scientific advancement, not hinder it.” Reporting to Health and Human Services Secretary Robert F. Kennedy Jr., Makary’s leadership of the FDA also includes its Center for Tobacco Products (CTP). However, it’s not yet clear how he will approach CTP’s looming issues of reviewing premarket tobacco product applications (PMTAs), the illicit vape market, and other tobacco-related issues.

    Much of the confirmation hearing centered around past problems, including those with Covid-19 vaccines, the pharmaceutical industry, and various other issues that have often gained headlines of late, but he did not commit to specifics in that venue.

    “I have no preconceived plans on mifepristone policy except to take a hard look at the data and to meet with the professional career scientists at the FDA who have reviewed the data,” he said at his hearing. “We now have a generational opportunity in American healthcare. President Trump and Secretary Kennedy’s focus on healthy foods has galvanized a grassroots movement in America. Childhood obesity is not a willpower problem, and the rise of early-onset Alzheimer’s is not a genetic cause. We should be, and we will, be addressing food as it impacts our health.”

    When asked about the backlog of cases the FDA has across all departments, Makary did not rule out leveraging artificial intelligence and making other regulatory changes to streamline the drug review process. He suggested FDA reviewers could use AI “to help reviewers in the review process—not to replace human reviews, but to improve efficiency.”

    National Association of Tobacco Outlets (NATO) Executive Director David Spross told CSP on Friday that “NATO looks forward to working with Dr. Makary and the team at FDA on tobacco and nicotine product regulatory issues, including for the FDA is to support tobacco harm reduction policies by authorizing more PMTA vapor and nicotine pouch product applications that provide adult smokers with more choices.”

    Spross added that there is a “need for more transparency from the agency by providing retailers more information on illicit products, specifically in the vapor and nicotine pouch categories.”

    Makary is a surgical oncologist and health policy researcher who has spent more than 20 years at Johns Hopkins.

    “I am pleased to congratulate Dr. Makary on his new role as FDA commissioner,” said Johns Hopkins University President Ron Daniels. “We are fortunate to have one of our senior faculty members at the School of Medicine undertake this critical service to the nation.

    “An accomplished clinician and widely published health policy researcher, Dr. Makary has had a storied career at Johns Hopkins that reflects the research and clinical acumen and openness to different ideas and approaches undergirded by academic freedom that are the hallmark of our great institution,” said Daniels.

    Makary founded the Johns Hopkins Center for Surgical Trials and Outcomes Research and co-developed a surgical safety checklist used in operating rooms worldwide. He is a member of the National Academy of Medicine and has published more than 300 peer-reviewed articles and three New York Times bestselling books on healthcare.

    Senate also confirmed Jay Bhattacharya as the new director of the National Institutes on Health.

  • Bulgarian Cigarette Prices Set to Rise for Second Time in 2025 

    Bulgarian Cigarette Prices Set to Rise for Second Time in 2025 

    Starting on May 1, the price of cigarettes in Bulgaria will rise by 40 to 50 stotinki (22 to 28 cents) per pack. This increase follows the latest adjustments to excise duties on tobacco products, which were approved as part of the 2025 budget.

    The new excise duty rates mark the second price hike this year, following a similar increase earlier when excise rates were raised by nearly 6%. This earlier rise was part of a planned, gradual increase that had been set in place since late 2022, when a four-year schedule was introduced. However, the government accelerated the schedule, deciding that the 2026 rates would be applied a year earlier.

    The Bulgarian Tobacco Industry Association clarified that there was no truth to recent rumors about a price surge of 2.50 leva ($1.38) per pack starting in April as several groups warned that the new excise duty directive would lead to a significant price hike. The Bulgarian Tobacco Industry Association refuted these claims, stating that the proposed changes to the excise duty directive, which would have raised the minimum rate to 180 euros per 1,000 cigarettes, had not been implemented. They noted, however, that the European Commission is expected to increase the minimum tobacco product excise duties more substantially in the coming years.

    According to the Ministry of Finance, the current excise structure will see a phased increase. As of January 1, 2025, the minimum excise duty for every 1,000 cigarettes was raised to 202 leva ($111). This will rise to 210 leva ($115.50) per 1,000 cigarettes starting in May, with a further increase of 12 leva each year until 2029. Similar increases are expected for other tobacco products and those containing tobacco substitutes.

  • Lebanon to Adopt WHO FCTC Policies 

    Lebanon to Adopt WHO FCTC Policies 

    Lebanon’s Ministry of Public Health joined with leaders from the World Health Organization to announce the “Tobacco Control Investment Case Study in Lebanon,” which says the country could avert more than $400 million in economic losses and save up to 40,000 lives over the next 15 years by implementing several key tobacco control policies recommended by the WHO Framework Convention on Tobacco Control (WHO FCTC).

    “Today, we are presented with strong evidence showing that tobacco control is not only a health priority but also a sound economic investment,” Minister of Public Health of Lebanon, Dr. Rakan Nassereldine, said. “This study quantifies what we have long known: tobacco use is devastating to individual health, increasing the burden of non-communicable diseases such as cancer, heart disease, and respiratory illnesses. But beyond the human suffering, tobacco also imposes an enormous cost on our healthcare system, weakens productivity, and drains resources that Lebanon can no longer afford to lose.”

    Dr. Abdinasir Abubakar, a WHO Representative in Lebanon, emphasized that the national tobacco control law targeting to implement the various aspects of the WHO FCTC is an important public health measure that aims at improving people’s health, preventing harm to non-smokers’ health, and reducing the economic burden of smoking at the national level. He indicated that Lebanon stands as one of the top countries in the region for high smoking prevalence, highlighting an urgent need for decisive action in tobacco control.  “Integrating tobacco control into national economic recovery and growth plans and policies, will be critical in helping Lebanon achieve its economic goal” he said.

    Among the policies being recommended are increasing tax rates on tobacco, creating smoke-free public places and workplaces, requiring graphic health warnings on tobacco product packaging, strengthening public awareness of tobacco control issues, and promoting the cessation of tobacco use.

  • CAPHRA Continues Criticism of WHO’s Funding, Procedures

    CAPHRA Continues Criticism of WHO’s Funding, Procedures

    The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) today (March 24) condemned the World Health Organization (WHO) for dismissing its recent scrutiny of the WHO’s funding as “misinformation,” when it said it allows billionaire philanthropies to disproportionately influence global tobacco policy.

    “The WHO’s hypocrisy is staggering, it attacks critics as purveyors of ‘misinformation’ while allowing private donors like the Gates Foundation and Bloomberg Philanthropies to steer its agenda,” said Nancy Loucas, CAPHRA Executive Coordinator.  

    CAPHRA said Euronews confirmed that the Bill & Melinda Gates Foundation is WHO’s second-largest donor, contributing 12% of its total budget, and that Bloomberg Philanthropies has funded anti-harm reduction campaigns in Asia-Pacific nations, including the Philippines and India. 

    CAPHRA accuses the Framework Convention on Tobacco Control (FCTC) COP meetings of operating “under unprecedented secrecy compared to other UN conventions. No consumer group representing smokers or ex-smokers has ever been granted observer status, violating the WHO’s own guidelines for civil society engagement.” A 2023 WHO Western Pacific Office report emphasized that “meaningful engagement of civil society” is critical to tobacco control—a principle CAPHRA says is ignored by the FCTC. 

    CAPHRA also says internal documents reveal the FCTC Secretariat controls all COP agendas and materials, with Bloomberg-funded NGOs often drafting policy recommendations for low-income countries, creating an echo chamber that excludes scientific evidence supporting safer nicotine alternatives. 

    “When billionaires dictate policy while the WHO silences consumer voices, public health becomes secondary to ideology,” Loucas stated. “The FCTC’s failure is undeniable—global smoking rates remain unchanged since 2000, with 1.1 billion smokers worldwide. We demand the WHO FCTC grant observer status to consumer groups at COP11, host open consultations with civil society during proceedings, and implement UN human rights oversight for tobacco control policies. Accountability and inclusion are non-negotiable. The WHO must prioritize science over dogma to save lives.”   

  • Fiji Assessing Needs to Implement FCTC’s Illicit Tobacco Protocol  

    Fiji Assessing Needs to Implement FCTC’s Illicit Tobacco Protocol  

    An international team is working with officials in Fiji this week to assess the nation’s needs for effectively implementing the Protocol to Eliminate Illicit Trade in Tobacco Products, the first protocol adopted under the World Health Organization Framework Convention on Tobacco Control (WHO FCTC). Illicit trade, officials say, threatens public health by increasing access to cheaper tobacco products, fueling the tobacco epidemic, and undermining tobacco control policies. It also leads to significant government revenue losses and contributes to the funding of international criminal activities.

    This international treaty aims to eliminate all forms of illicit trade in tobacco products through a package of measures implemented by countries cooperating. The assessment is being conducted by the Ministry of Health and Medical Services, WHO FCTC Secretariat, and WHO.

    Fiji loses FJD 319 million ($140 million) to tobacco-related costs annually, which represents 2.7% of its GDP and significantly exceeds revenues from cigarette taxes. A key finding from “Operation EXIT,” a collaboration between the Oceania Customs Organization and the WHO, revealed that illicit tobacco trade is on the rise in the Pacific region.

    “Every year, tobacco use claims more than 1,200 Fijian lives, with 71% of these deaths occurring in individuals under the age of 70,” Permanent Secretary for Fiji Health and Medical Services Dr. Jemesa Tudravu said. “The prevalence of smoking in Fiji remains notably high, particularly among adults and young people, posing a severe threat to our public health. The impact of tobacco-related diseases results in increased morbidity and mortality, affecting families, communities, and our entire nation.” 

  • $3.9M of Illegal Vapes Seized in Thailand 

    $3.9M of Illegal Vapes Seized in Thailand 

    The Metropolitan Police Bureau’s investigation team raided warehouses in Thailand’s Nonthaburi province yesterday (March 18) and seized more than 260,000 e-cigarettes with a street value of over 130 million baht. ($3.9 million). Investigators believe the vaping products had been smuggled in from China through the Laem Chabang port in Chonburi and distributed to more than 100 retail outlets nationwide.

    Dubbed “Operation Smoke Out,” police said they targeted six warehouses in the province that were linked to five individuals who were responsible for shipping and distributing the products. Two men were arrested, the police said, adding that the suspects were allegedly paid 20,000 baht ($600) each to look after one of the warehouses.

    “This is considered a major raid with high value,” Prime Minister Paetongtarn Shinawatra said while visiting the scene. “The officers will expand the investigation to the masterminds and bring them to justice.”

  • Bangladesh Officials Meet to Stop Tobacco Use, Tax Evasion 

    Bangladesh Officials Meet to Stop Tobacco Use, Tax Evasion 

    Yesterday (March 18), National Board of Revenue (NBR) chairman Md Abdur Rahman Khan said Bangladesh was considering the introduction of a QR code system band-roll for the tobacco sector to prevent tax evasion. Speaking at a pre-budget meeting with the Anti-Tobacco Media Alliance (ATMA), he said that high taxes on tobacco products have created a huge amount of illicit cigarettes entering the country, thus depriving the NBR of due revenue.

    The chairman said some bidi companies use counterfeit band-rolls to avoid paying taxes in the national exchequer.

    “Even they bring those band-rolls from abroad after printing in there,” he said. The NBR chairman put emphasis on establishing a cashless society to stop tax evasion.

    The ATMA argued cigarette prices in the country were too low, and that having a four-tier price system (low, medium, high, and premium) has rendered the tobacco price and tax measures less effective. It proposed merging the low and medium categories.

  • Report: Dutch Flavor Ban is Working

    Report: Dutch Flavor Ban is Working

    According to its first evaluation, the Dutch health institute RIVM says The Netherlands’ ban on flavored e-cigarettes and vapes has been successful with one out of five vapers quitting.

    The RIVM surveyed more than 500 adolescents and young adults and more than 450 adults about their vaping. About 40% said that they have reduced their use of e-cigarettes due to the ban that took effect last year. About 22% said they stopped vaping altogether. According to the report, daily use of vapes decreased from 29 to 18%, weekly use dropped from 30 to 14%, and monthly use from 42 to 16%.

    Most consumers, according to the RIVM, who stopped vaping did not look for substitutes, such as buying flavors via the illegal market or switching to more harmful products. Those who did opt for illegal flavors mainly sourced them from physical stores in Germany.

  • Last-Second Petition Filed to Stop Flavor Ban in Denver

    Last-Second Petition Filed to Stop Flavor Ban in Denver

    One day before a flavored tobacco ban is set to go into effect in Denver, vape and tobacco store owners have filed a petition with more than 17,000 signatures asking to delay the ban so voters can decide on it in November’s election. Less than 9,500 signatures are required to get a question on the ballot.

    “It asks if the ban should be upheld and we are saying no, it should not be,” Phil Guerin, Owner of Myxed Up Creations and president of the Smoke-Free Alliance Colorado said about the potential ballot question. “Let’s let the voters decide. I feel like city council has made a lot of bad decisions when it comes to the economy and just the future of our city. We’re here to stand up for our city and stand up for what we believe in.”

    Vape store owners and manufacturers argued that city council members rushed the ban on flavored tobacco purchases as last year ended, and that the city will miss out on $13 million in annual revenue if the ban is upheld.

    According to KDVR’s Gabrielle Franklin, those against the ban would face major opposition, though, as “the City Council’s near-unanimous decision and signature into law by Denver Mayor Mike Johnston to end the sale of flavored tobacco reflect the will of our community, with over 100 organizations endorsing the measure and nearly two-thirds of Denver voters indicating their support.”