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Category: Global Regulation

  • Sources: Big Changes for Hong Kong Tobacco Laws in 2026  

    Sources: Big Changes for Hong Kong Tobacco Laws in 2026  

    Last year, Hong Kong’s Special Administrative Region government proposed 10 tobacco control measures that prompted backlash from businesses and smokers alike. Now, sources say the Health Bureau plans to submit an amendment bill to the Legislative Council by the end of this month based on those measures, which would include items such as increased penalties for illegal tobacco sales, a ban on flavored cigarettes, and expanded smoke-free areas.

    The sources said the regulations would be implemented in 2026, typically in two phases.

    E-cigarettes would be banned in public spaces starting as early as the second quarter of next year, with potential extensions to private areas and other devices depending on favorable outcomes. The ban on flavored cigarettes would begin with non-menthol flavors first, and then menthol later, with no specific timeline set.

    The new proposal would also focus on combating illegal tobacco, with a trial starting mid-year to add identification labels on duty-paid cigarettes. Authorities would also increase penalties for smuggling; the maximum fine for buying, selling, or possessing illegal cigarettes will rise from HK$1 million ($130,000) and two years in prison to HK$2 million ($260,000) and seven years in prison. Travelers bringing more than 19 packs of duty-free cigarettes to Hong Kong would see fines increased from HK$5,000 ($650) to over HK$8,000 ($1,040).

  • Supreme Court Favors FDA in Flavor Battle

    Supreme Court Favors FDA in Flavor Battle

    Today (April 2), the Supreme Court unanimously overturned a lower court’s decision that the U.S. Food and Drug Administration incorrectly blocked flavored nicotine e-liquids, rejecting e-cigarette makers that were challenging regulatory hurdles on tobacco products.

    E-liquid companies Triton Distribution and Vapetasia LLC claimed the FDA unlawfully denied the marketing authorization for flavored vape products and disputed that the products appealed to children, arguing that the government was harming nicotine-addicted adults by keeping a cigarette alternative off the market.

    The vape companies argued the FDA failed to review the company’s own scientific evidence, which demonstrates its flavored products were crucial to getting smokers to switch from combustible cigarettes to e-cigarettes. The Fifth Circuit Court agreed with the e-cigarette maker, ruling that “the agency’s rejection was arbitrary and capricious because the FDA relied on conflicting evidence requirements.” The court also faulted the FDA for dismissing “out-of-hand companies’ strategies to keep their products away from minors.” The agency said such efforts haven’t proven to be effective.

    Public health groups had already sued the FDA for not moving fast enough to review the products after the agency, in 2016, finalized rules for regulating them under the 2009 Family Smoking Prevention and Tobacco Control Act. Under the Act, vape companies were forced to submit applications to the FDA in order to bring new vape flavors to market, and the FDA was to assess the public health effects of those products. A rift, however, emerged over the agency’s criteria for approving or denying those applications, which culminated in the Fifth Circuit.

    The fight was brought to the Supreme Court in November with the FDA contending it correctly applied the Tobacco Control Act, saying it considered both the “likelihood that existing users of tobacco products will stop using such products” and the “likelihood that those who do not use tobacco products will start using such products.”

    Oral arguments in front of the Supreme Court centered on whether the FDA standards are a policy position or a substantive rule imposed without notice and comment. The Biden administration argued the standards fell into the policy bucket, pushing the court to give the agency deference to interpret its role under the Tobacco Control Act. 

    Under the Biden administration, the FDA rejected more than a million flavored products, saying companies failed to show that flavored vapes will do more to benefit public health by helping smokers quit tobacco products than the harm they cause by appealing to young people.

    Vaping companies hope they’ll find a friendlier regulatory environment under the Trump administration, as the President previously promised to “save” flavored vaping.

  • Australia’s New Packaging Warnings Take Effect

    Australia’s New Packaging Warnings Take Effect

    Beginning today (April 1), Australia’s new cigarette packaging laws have gone into effect, including that each individual cigarette has a health warning printed on it. Warning phrases include “causes 16 cancers,” “damages your lungs,” and “poisons in every puff.” Canada is the only other country in the world to have such requirements.

    The new laws that went into effect also introduced 10 new graphic health warnings that will be printed on tobacco packaging as well as 10 new inserts that will be placed inside packaging, providing information on the benefits of quitting smoking.

    Sarah Durkin from the Cancer Council said that the graphic health warnings on tobacco packaging have proven effective in educating Australians about the harms of smoking but that the effectiveness of the warnings has decreased over time. 

    “We also have new scientific information that extends our knowledge of the health effects of tobacco use,” she said. “The new graphic health warnings feature some of these harms of smoking that people may not be aware of, such as diabetes, erectile dysfunction, cervical cancer, DNA damage, and the impact of second-hand smoke on children’s lung capacity.”

  • Brian King, Dozens of Staffers Out at CTP

    Brian King, Dozens of Staffers Out at CTP

    The Associated Press is reporting that Brian King, the Food and Drug Administration’s chief tobacco regulator, was removed from his post this morning (April 1) amid sweeping cuts at the agency and across the federal health workforce. According to sources familiar with the situation, King sent an email to staff saying, “It is with a heavy heart and profound disappointment that I share I have been placed on administrative leave.”

    King was removed from his position and offered reassignment to the Indian Health Service, according to a person familiar with the matter who did not have permission to discuss the matter publicly and spoke on the condition of anonymity. Dozens of staffers in the FDA’s Center for Tobacco Products (CTP) also received notices of dismissal Tuesday morning, including the entire office responsible for enforcing tobacco regulations.

    In recent years, the CTP has been besieged by criticism from all sides, including politicians, anti-smoking advocates, and tobacco and vaping companies. Under King, the FDA rejected applications for millions of flavored e-cigarettes, citing insufficient data that the products would help adult smokers while not becoming popular with underage kids. Those rejections have resulted in multiple lawsuits against FDA from vape makers.

    “King, who joined the agency in 2022, has been vigorously criticized by vaping lobbyists for ordering thousands of companies to remove their fruit and candy-flavored e-cigarettes from the market,” the AP wrote. “During his time at FDA, teen vaping has fallen to a 10-year low.”

    The latest changes mean that nearly all of FDA’s top leaders overseeing drugs, food, vaccines, medical devices, and now tobacco products have resigned or retired in recent months. This comes after Robert F. Kennedy Jr.’s moves to fire 3,500 FDA staffers and push ahead with plans to scrutinize ultra-processed foods, childhood vaccines, antidepressants, and other long-established products.

  • Leaked EU Document Calls for “Substantial” Taxes on Nicotine Pouches

    Leaked EU Document Calls for “Substantial” Taxes on Nicotine Pouches

    According to The Vaping Post, a confidential European Commission (EC) document, leaked by Snusjournalen, has revealed a contentious plan to impose a substantial EU-wide tax increase on nicotine pouches (NPs). Spearheaded by the Directorate-General for Taxation and Customs Union (DG TAXUD), the proposed measure could trigger widespread economic, political, and criminal repercussions across the Union.

    Europe already finds itself in a tenuous economic situation, dealing with economic instability that includes inflation and escalating trade tensions with the United States. Worse on the nicotine front, a recent Europol report shared by Euroreporter, “The Changing DNA of Serious and Organised Crime,” highlights the direct link between excessive taxation and the rise of black markets—specifically citing tobacco and nicotine products. The report warns that strict tax policies create opportunities for criminal networks to expand operations, smuggle products across borders, and launder illicit funds. Experts fear that a steep price increase on NPs could drive a surge in illicit sales, with products being illegally imported from non-EU nations like China.

    Although the European Commission has yet to confirm the directive publicly, the leak has already sparked significant concerns among key stakeholders, including law enforcement, investors, and consumer advocacy groups. Given Europol’s warnings on illicit trade and the broader political and economic climate, this proposed tax increase is shaping up to be one of the most contentious regulatory battles in the coming months.

    “In light of these developments, the proposed tax hike on NPs adds yet another layer of uncertainty to an already volatile regulatory and economic landscape,” wrote The Vaping Post. “More importantly, with the vaping industry currently facing such a critical juncture, which could result in less availability of vaping products to smokers using them to quit, a harsh tax set on snus would be currently all the more detrimental to public health.”

  • Tennessee Bill Would Outlaw Most Vape Products

    Tennessee Bill Would Outlaw Most Vape Products

    A bill in Tennessee that would impose a state tax of up to 10% on vape products – a higher rate than tobacco – and effectively ban the sale of many vape products in the state by requiring application for FDA approval before products are sold is headed for a final Senate vote this week. Senate Bill 763 passed the Senate Finance Committee in a 9-2 vote, and a counterpart House panel with bipartisan support.

    Bill sponsor Ken Yager said the bill is aimed at stopping “the influx of Chinese vape products that are addicting our children and wreaking havoc on our schools” ― not an attack on Tennessee’s vape industry. However, critics say it is a “legislative weapon for big tobacco to crush competition.”

    “I don’t take my orders from big tobacco,” Yager told reporters.

    If signed into law, the bill would ban the sale of vapor products including hundreds of disposable and flavored products in Tennessee that are not approved or in the process of being approved by the U.S. Food and Drug Administration. Currently, just 34 vapor products have been approved by the FDA, and all are tied to big tobacco companies. Most vape products sold in the U.S. are imported from China. If passed, the bill would fine vape retailers $500 to $1,500 per product illegally sold.

    According to The Tennessean, Tennessee is one of about 20 states that does not currently levy a tax on vape products. If passed, the bill would impose a 10% tax on open system vape products and a 7% tax on closed system vape products. Tennessee taxes tobacco products at 6.6%. Yager told reporters his proposed tax on vape products “is really no different from the tax on other nicotine products.”

  • 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.