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Category: Global Regulation

  • 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 However, critics say the standards are outdated, based on a 1997 U.S. framework by Dr.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.

  • Geneva Bans Disposable E-Cigarettes

    Geneva Bans Disposable E-Cigarettes

    Geneva’s cantonal parliament voted almost unanimously to ban disposable e-cigarettes, citing health risks for youth and environmental harm. The measure, passed with an emergency clause, takes effect immediately.

    Several Swiss cantons, including Valais, Bern, and Jura, have already adopted similar bans, while a nationwide ban is underway after both houses of parliament backed legislation to outlaw single-use “puff bars.” Rechargeable e-cigarettes remain exempt.

  • Singapore Vape Ban is Tourism Opportunity for Indonesia

    Singapore Vape Ban is Tourism Opportunity for Indonesia

    Officials in Batam, Indonesia say Singapore’s strict ban on vaping could boost cross-border tourism, as Singaporeans seek looser regulations just a 45-minute ferry ride away.

    Batam Tourism Agency head Ardiwinata told The Jakarta Post that restrictions in Singapore historically drive residents to neighboring Batam, citing past examples where tight rules created new tourism opportunities. “As long as it does not violate our regulations, they can choose Batam,” he said.

  • PM South Africa Pushes Harm Reduction in Tobacco Bill Debate

    PM South Africa Pushes Harm Reduction in Tobacco Bill Debate

    Philip Morris South Africa (PMSA) urged lawmakers on Tuesday (August 26) to adopt a science-driven, harm reduction approach in the pending Tobacco Products and Electronic Delivery Systems Control Bill. PMSA argued that the same harm reduction principles that helped South Africa curb HIV/AIDS could accelerate declines in smoking rates if applied to tobacco. Executives told Parliament’s Health Committee that smoke-free alternatives like heated tobacco, e-cigarettes, and oral nicotine are far less harmful than combustible cigarettes, citing global studies and international precedents.

    “The quit or die approach has not been proven to be effective, and we know it will not work,” said Themba Mathebula, PMSA’s director of external affairs. “Without a doubt, smoke-free products can give smokers a fighting chance, not just to survive, but to quit smoking for good.”

    The company called for a risk-proportionate framework that regulates traditional cigarettes more strictly than reduced-risk products, while tightening youth access and banning marketing that could appeal to minors. PMSA said it has submitted extensive scientific data and is committed to making cigarettes obsolete.

    “It is about 19 books’ worth of research that undeniably shows that smoke-free products are less harmful alternatives for adult smokers who make the choice to continue smoking,” said Buhle Binta, PMSA head of Scientific Engagement. “Scientific evidence needs to be the North Star that informs our health policies.