Category: Global Regulation

  • WHO Report Links Tobacco Use to Child Stunting

    WHO Report Links Tobacco Use to Child Stunting

    The World Health Organization (WHO) published a new report warning that tobacco use plays a significant role in child stunting, a condition that affects nearly 150 million children worldwide, particularly in Africa and Asia. Stunting increases the risk of disease, delayed development, and early death. The document, the 11th in WHO’s tobacco knowledge summary series, is aimed at health professionals, policymakers, and public health advocates.

    WHO said that maternal smoking during pregnancy is strongly linked to preterm birth, low birth weight, and restricted fetal growth, all major predictors of stunting by age 2. Children exposed to second-hand smoke are also at higher risk, it said, with evidence showing that the harm intensifies with the level of exposure. By contrast, quitting smoking during pregnancy improves growth outcomes, reducing the risk of stunting.

    The organization is urging governments to strengthen tobacco control policies in line with the WHO Framework Convention on Tobacco Control (FCTC) and MPOWER measures. WHO stressed that reducing tobacco exposure is critical to improving survival, growth, and development, and to achieving global health goals.

  • Spain Proposes Outdoor Smoking and Vape Ban

    Spain Proposes Outdoor Smoking and Vape Ban

    Today (September 9), Spain’s minority leftist government unveiled a bill that would ban smoking and vaping in outdoor spaces, including beaches, bar and restaurant terraces, bus stops, and stadiums, according to Reuters. Health Minister Monica García said the move puts “public health ahead of private interests,” stressing that everyone has the right to breathe clean air.

    The proposal, which mirrors recent restrictions in France but goes further by including e-cigarettes, still needs parliamentary approval. The hospitality sector has criticized the plan, noting that Spain’s outdoor terraces are central to its dining culture and widely used by smokers. Smoking indoors has been banned since 2011.

  • Employers, Union Push Back Against Indonesian Tobacco Tax Hike

    Employers, Union Push Back Against Indonesian Tobacco Tax Hike

    The Indonesian Employers Association (Apindo) and industry representatives warned the government against raising tobacco excise duties next year, citing risks to competitiveness, jobs, and supply chains in the country’s labor-intensive cigarette sector. Apindo chairwoman Shinta Kamdani said further hikes would add pressure on producers already hit by higher excise this year. “If a higher excise is implemented without considering the real conditions of the [tobacco] industry, risks of weakening competitiveness and eroding job opportunities will only grow,” she said.

    Tobacco manufacturers and unions echoed the concerns, noting that higher duties would further squeeze margins, reduce farmer tobacco purchases, and accelerate the shift toward untaxed illegal cigarettes, which already make up nearly half of consumption. With the sector employing millions and contributing heavily to state revenue, they urged the government to balance fiscal goals with economic stability.

    The warning comes as the government targets a 10% increase in state revenue in 2025 to Rp 2.86 quadrillion ($174.9 billion). Finance Minister Sri Mulyani Indrawati has set a 13.5% rise in tax collection as the benchmark, though she admitted the goal was “ambitious” amid weak revenue performance this year.

  • South Korea Updates Tobacco Disclosure Rules Amid Criticism

    South Korea Updates Tobacco Disclosure Rules Amid Criticism

    South Korea will begin enforcing its Tobacco Harm Management Act on November 1, requiring manufacturers and importers to disclose harmful components in tobacco products for the first time. The law mandates inspections every two years for existing products and within one month for new launches. Public disclosure of results is expected to begin late next year.

    The Ministry of Food and Drug Safety (MFDS) has identified 44 harmful substances in combustible cigarettes and 20 in liquid e-cigarettes for mandatory disclosure. However, critics say the standards are outdated, based on a 1997 U.S. framework by Dr. Dietrich Hoffmann, and have obvious “gaps” as products containing synthetic nicotine or marketed as “nicotine-free” are excluded. South Korean law defines tobacco only as products made from tobacco leaves.

    In defense, MFDS noted that South Korea’s list already exceeds WHO and ISO requirements and matches Canada in scope. Officials said they will expand the list in the future and are considering whether disclosures will be published by product type, brand, or in aggregate, along with explanations of toxicity and carcinogenicity.

  • FDA Launches Pilot to Fast-Track Nicotine Pouch Reviews

    FDA Launches Pilot to Fast-Track Nicotine Pouch Reviews

    The U.S. Food and Drug Administration is set to fast-track reviews of nicotine pouches from Philip Morris International, Altria, Reynolds American, and Turning Point Brands in a pilot program launching Monday, according to Reuters. According to transcripts of an agency meeting last Friday, the agency aims to complete assessments by December, providing a quicker path to market for products like Zyn, on!, Velo, Fre, and Alp. The initiative comes amid pressure from the Trump administration to accelerate approvals and streamline the review process for the fastest-growing category of U.S. tobacco alternatives.

    The pilot program will reportedly feature reduced and expedited reviews, more frequent communication between FDA staff and companies, and a focus on essential scientific and safety data, including product characterization, manufacturing consistency, and abuse-liability information. For products already on the market without full authorization, the process could remove uncertainty over legality and potential enforcement actions. Tobacco firms have long lobbied for a faster FDA authorization route, noting that lengthy reviews have allowed competitors to capture market share in the meantime.

    “Adult nicotine and tobacco consumers are increasingly seeking nicotine pouches as a smoke-free alternative, and the industry is rapidly growing in response,” said Laura Leigh Oyler, vice president of U.S. Regulatory Affairs at Haypp Group, who will be speaking at GTNF 2025 in Brussels on the U.S. regulatory landscape. “These consumers deserve a marketplace of FDA-reviewed product choices to support their journey away from more harmful products. 

    “It makes sense that our government should also work to meet the demands of citizens, supporting a regulatory regime that quickly reviews well-designed and well-tested products from responsible and compliant manufacturers. This is a positive step not just for the regulator and the regulated industry, but for the millions of American adults looking for products they can trust.”

  • Texas Ban on Disposable Vapes Takes Effect

    Texas Ban on Disposable Vapes Takes Effect

    Texas outlawed nearly all disposable e-cigarettes under Senate Bill 2024, which took effect on September 1. The law bans the sale, marketing and advertising of vape products that could appeal to minors, including those without nicotine, and specifically targets devices manufactured in China. Refillable vape devices made in the U.S. remain legal.

    Retailer Edgar Ramirez, owner of Smokeex in Killeen, told KWTX reporters the move is devastating. Ramirez said disposable vapes accounted for the majority of his sales, but now his shelves and cabinets sit empty, with more than $4,000 of unsellable inventory in storage. “None of them are made in America at all,” he noted, adding that distributors cannot source compliant products.

    Violators of the new law face a Class A misdemeanor, punishable by up to a year in jail and a $4,000 fine. Retailers say the ban leaves them few options as consumers shift away from cigarettes and traditional tobacco.

  • Bhutan Raises Taxes on Tobacco, Alcohol to “Fight Health Crisis”

    Bhutan Raises Taxes on Tobacco, Alcohol to “Fight Health Crisis”

    Bhutan’s government announced it will roll out a revised tax framework on alcohol, tobacco, and related products early next year as part of efforts to curb non-communicable diseases. The changes include steep excise duties to nicotine products, including Nu 10 ($0.11) per cigarette stick, Nu 40 ($0.44) per cigar, and Nu 1,500 ($16.50) per kg of chewing tobacco. E-cigarettes and vapes will face a 100% excise tax along with customs and GST charges. The government will also tighten regulations by revising the Tobacco Control Rules to explicitly cover newer products like heated tobacco and vapes.

    Health Minister Lyonpo Tandin Wangchuk said the move is part of a multisectoral strategy involving education, trade, law enforcement, and civil society. Alongside taxation, the ministry is planning stricter advertising controls and public campaigns to discourage harmful consumption.

  • Macau Considers Full Ban on E-Cigarette Possession

    Macau Considers Full Ban on E-Cigarette Possession

    The Macau Health Bureau is considering a full ban on e-cigarette possession, expanding current rules that already prohibit their sale, manufacture, and import/export. Lam Chong, head of the bureau’s Office for the Prevention and Control of Smoking and Alcohol, said authorities are also reviewing regulations on shisha and herbal cigarettes.

    The bureau plans a one-year trial of designated smoking areas in busy locations, including the Ruins of St. Paul’s and Border Gate Square, focusing first on public education before penalties are enforced. Rising youth usage is a concern, with reports showing e-cigarette use among students overtaking traditional smoking.

  • Malaysian Ministry Slammed for Lack of Transparency on Vape Policy

    Malaysian Ministry Slammed for Lack of Transparency on Vape Policy

    Today (September 3), the Consumer Choice Center (CCC) Malaysia criticized the Ministry of Health for withholding details of a July 21 closed-door briefing on e-cigarettes and vaping from both the public and most Members of Parliament. It said, “to date, the details of this briefing have not been made available to the public or Members of Parliament beyond the [Parliamentary Special Select Committee (JKPK)]. Requests from other MPs for more information were reportedly dismissed on the grounds that the session was strictly an internal JKPK matter.”

    According to CCC Malaysia Country Associate Tarmizi Anuwar, the ministry’s lack of transparency and its plan to propose a nationwide vape ban undermine democratic accountability and risk driving consumers to illicit markets. The CCC warned that the proposed prohibition would be premature given the recent enactment of the Control of Smoking Products for Public Health Act 2024 (Act 852), inconsistent across jurisdictions, and contradicted by international evidence showing bans fail to curb use.

    The group urged the government to instead form an Implementation Committee on Vape Policy with federal, state, consumer, and industry representation to ensure coherent enforcement and evidence-based regulation.

  • Georgia Judge Vacates FDA Graphic Cigarette Warning Rule

    Georgia Judge Vacates FDA Graphic Cigarette Warning Rule

    A federal judge in South Georgia struck down the U.S. Food and Drug Administration’s (FDA) rule requiring graphic health warnings on cigarette packs and ads, siding with Philip Morris USA and Georgia retailers, according to The Atlanta Journal-Constitution. U.S. District Judge Lisa Wood ruled that the FDA failed to disclose all raw data used in developing the 2020 rule, preventing stakeholders from offering meaningful feedback. While Wood rejected most of the plaintiffs’ arguments, she vacated the rule, citing a violation of the Administrative Procedures Act.

    The Georgia plaintiffs, including the Georgia Association of Convenience Stores, argued the rule would cost millions, force retailers to “speak against their own products,” and deter customers by making convenience stores unwelcoming. It said the FDA arbitrarily focused on certain smoking-related risks over others without explanation, and claimed it ignored countless red flags in its studies. The FDA defended its process, noting the warnings aimed to better inform consumers of smoking risks.

    The decision marks another setback in the FDA’s long-running effort to implement graphic warnings under the 2009 Family Smoking Prevention and Tobacco Control Act. A similar case is pending in Texas, where a judge has already blocked enforcement until appeals are resolved.

    The case is likely to head to the 11th Circuit Court of Appeals.