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Category: Global Regulation

  • Indonesia Stepping Up Vape Surveillance

    Indonesia Stepping Up Vape Surveillance

    Indonesia’s National Food and Drug Monitoring Agency (BPOM) is set to gain oversight of vape distribution nationwide, working alongside the National Narcotics Agency (BNN) following reports of drug-laced e-liquids in the market. BPOM said it will develop technical regulations under the country’s recent health laws to determine which vape products are permitted and which will face sanctions, with decisions guided by scientific assessment.

    While BNN has proposed a total ban on e-cigarettes to combat narcotics risks, BPOM signaled a more targeted approach, focusing on stricter control of illegal products lacking excise stamps rather than blanket prohibition. Authorities noted that illicit vapes are the primary source of drug contamination.

  • FDA Changes PMTA Structure

    FDA Changes PMTA Structure

    On May 8, the FDA issued updated guidance outlining its current enforcement approach for electronic nicotine delivery systems (ENDS) and nicotine pouch products without premarket authorization, emphasizing that its policies are nonbinding and reflect the agency’s current priorities. The guidance indicates that while unauthorized products remain illegal, the FDA does not intend to prioritize enforcement against products with pending and sufficiently complete applications under scientific review, allowing the agency to better allocate resources.

    The document also clarifies that enforcement will focus on products with higher public health risks, including those appealing to youth or lacking required safety features, while encouraging manufacturers to provide transparency around application status. The FDA said it will maintain a public-facing list of products under review, as part of efforts to improve visibility for stakeholders and streamline regulatory oversight.

    “For four years, nicotine pouch manufacturers, suppliers, and retailers like Nicokick.com have been patiently waiting for authorization decisions, and this guidance finally gives them the ability to stop operating in a grey area of regulation,” said Laura Leigh Oyler, Vice President of Regulatory Affairs for Nicokick.com. “For an agency that typically operates without much clarity, this is mind-blowingly clear — file a PMTA for your product that includes everything the FDA has explicitly listed they expect to see, wait 180 days, and then you can launch your product in the market. This is a ground-breaking announcement for American consumers who deserve a wealth of options as they try to leave cigarettes behind.”

  • WSJ: Trump Ready to Fire Makary

    WSJ: Trump Ready to Fire Makary

    According to The Wall Street Journal, President Donald Trump signed off on a plan to remove FDA Commissioner Marty Makary, though the decision has not yet been finalized and could still change. The report, citing people familiar with the matter, said Makary has faced mounting criticism within the administration over his management of the agency, including clashes with officials at the Department of Health and Human Services and the White House. His handling of key policy areas—including drug approvals, vaccines, and vaping regulation—has drawn particular scrutiny.

    The reported move follows a turbulent period at the FDA marked by leadership turnover and internal disruptions, including recent high-profile departures and ongoing restructuring efforts. Earlier in the week, Trump reportedly criticized Makary for not moving quickly enough on authorizing flavored vaping and nicotine products, an issue that has become a point of tension within the administration.

    Makary, a former Johns Hopkins surgeon nominated in late 2024 and confirmed in 2025, has been a visible figure in the administration’s health agenda, including its “Make America Healthy Again” initiative. While no official confirmation has been issued by the White House or HHS, sources cited in the report indicated growing consensus among senior officials that a leadership change at the FDA may be imminent.

  • NSW Ups Penalties for Landlords With Tenants Selling Illicit Products

    NSW Ups Penalties for Landlords With Tenants Selling Illicit Products

    New South Wales, Australia, passed legislation introducing criminal penalties for landlords who knowingly allow tenants to sell illicit tobacco or illegal vapes, as part of a broader crackdown on the black market. Under the new law, offenders face up to 12 months’ imprisonment and fines of up to A$165,000 ($118,800). The measure builds on recent reforms, including tougher penalties for possession and sale, expanded closure powers for non-compliant premises, and new enforcement tools targeting false licensing and interference with seizures.

    The government also increased enforcement capacity, adding 30 inspectors to support statewide operations alongside police, with more than 220 closure orders issued since late 2025. Officials say the reforms are designed to address evolving tactics, including online and QR code-based sales, and to strengthen accountability across the supply chain to curb illicit tobacco and vape distribution.

  • Vapes Thriving in Hong Kong Despite Ban

    Vapes Thriving in Hong Kong Despite Ban

    An investigation by Sing Tao Daily found that illicit online sales of e-cigarettes and heated tobacco products continue in Hong Kong despite a strengthened public-use ban that took effect last week. Reporters were able to purchase disposable vapes through social media channels, with sellers offering home delivery or convenience store pickup and showing little concern about enforcement. Prices for disposable devices were quoted at around HK$120 ($15.60), with digital payment options and delivery within days.

    Authorities said enforcement efforts have been stepped up through intelligence-led operations and increased patrols, but the report highlights the persistence of a well-established black market that has adapted to restrictions introduced in 2022. Analysts and policy observers noted that the latest ban may push usage further underground, complicating monitoring and enforcement as illegal supply channels remain widely accessible online.

  • Argentina Lifts Alternative Product Ban, Imposes New Regs

    Argentina Lifts Alternative Product Ban, Imposes New Regs

    Argentina introduced a comprehensive regulatory framework for nicotine products under Resolution 549/2026, establishing legal pathways for vapes, heated tobacco, and nicotine pouches while imposing strict requirements on registration, traceability, and product standards. The new rules replace a previously prohibitive regime and aim to bring a largely informal market under formal oversight, with mandatory ingredient disclosure, limits on nicotine content, and enforcement mechanisms targeting unregistered products.

    The framework also includes a ban on vape flavorings and is intended to strengthen inspection and taxation while addressing youth use and unregulated sales. Officials said the move seeks to formalize a market currently dominated by illicit trade, improve regulatory control, and integrate nicotine products into the legal and tax system, while maintaining public health safeguards.

  • FDA Authorizes Four New ENDS Products

    FDA Authorizes Four New ENDS Products

    The U.S. Food and Drug Administration has authorized four Glas electronic nicotine delivery system products through the PMTA pathway, including Classic Menthol, Fresh Menthol, Gold, and Sapphire pods containing 5% nicotine. The decision marks the first FDA authorization of ENDS products beyond traditional tobacco and menthol flavors, expanding the range of legally marketed vaping products in the U.S. to 45.

    The agency said the authorization was based on evidence that the products’ device access restriction technology—requiring age verification via government ID, smartphone pairing, and biometric checks—can effectively limit youth access.

    “By helping to prevent youth use, device access restrictions are a potential game changer,” said Dr. Bret Koplow, acting director of the FDA’s Center for Tobacco Products. “This technology is also an indication of the role innovation may serve in the effort to protect young people from threats posed by nicotine use and addiction while helping to enable [the] availability of an expanded array of flavored options for adults who smoke who may use these products to completely switch away from regular cigarettes.”

    The FDA emphasized that marketing must be targeted to adults and that the company must monitor and report on youth prevention measures, while noting that authorization could be withdrawn if compliance requirements are not met or if youth usage increases.

  • Tennessee Amends Penalties for Underage Tobacco Use

    Tennessee Amends Penalties for Underage Tobacco Use

    Tennessee enacted new penalties for minors purchasing or possessing tobacco products under legislation signed by Governor Bill Lee on April 27 and approved as a Public Chapter yesterday (May 4). The law allows courts to impose a range of measures, including up to 50 hours of community service, completion of a court-approved education program, and/or civil fines between $10 and $50. Fines for minors younger than 18 may be levied on a parent or guardian.

    The legislation also introduces escalating consequences for repeat violations, including a 90-day informal adjustment period for first offenses and up to six months of probation for subsequent violations, alongside mandatory community service and participation in programs focused on the risks of tobacco and vapor products. The law will take effect July 1.

  • Dutch Flavor Ban Backfires: Report  

    Dutch Flavor Ban Backfires: Report  

    A report by advocacy group Prohibition Does Not Work (PDNW) claims the Netherlands’ 2024 ban on flavored vaping “backfired,” with over half of consumers reportedly shifting to illicit or cross-border sources. The report states that youth vaping rates increased from 3.7% in 2023 to 7.6% in 2024, while adult vaping declined from 3.86% to 2.3% by 2026. It also cites data indicating that 27% of users purchased products abroad, 31% used illicit online sellers, and 33% continued to access products through local retail channels despite the ban.

    According to the report, cigarette consumption rose by approximately 1% in 2024, equivalent to around 60 million additional cigarettes, while 27% of former vapers reported increased smoking or initiation after the policy change. The findings also note that 42% of inspected retailers were non-compliant and that most consumers reported ease of access to flavored products. PDNW said the data reflects a shift toward unregulated channels following the restriction, with implications for enforcement and market oversight.

  • Survey Says Pakistan’s Tobacco Control Not Working

    Survey Says Pakistan’s Tobacco Control Not Working

    A nationwide survey in Pakistan found widespread non-compliance in the cigarette market nearly four years after the introduction of the Track and Trace System. Conducted across 1,520 retail outlets in 19 districts, the study found that only 22 of the 477 identified brands in circulation were consistently compliant, with 455 failing to meet at least one regulatory requirement, including missing tax stamps, health warnings, or printed retail prices.

    The survey also found that 392 brands were being sold below the government’s minimum price of PKR 162.25 ($0.58) per pack, with some as low as PKR 50 ($0.18), indicating a significant presence of untaxed and non-compliant products. Both smuggled and locally produced duty-unpaid cigarettes were widely available, with higher non-compliance rates in rural areas. The findings point to ongoing challenges in enforcement, monitoring, and market control, despite the formal rollout of digital tracking systems.