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Category: Global Regulation

  • Germany Plans to Ban Disposable E-Cigs

    Germany Plans to Ban Disposable E-Cigs

    Germany is preparing legislation to ban disposable e-cigarettes, with Environment Minister Carsten Schneider last week citing safety and environmental concerns as the primary drivers. The government plans to introduce a draft bill in the coming months that would effectively end sales of single-use vapes, following reports of increased fires at waste facilities linked to improperly discarded devices.

    Officials said the lithium-ion batteries in disposable e-cigarettes pose a risk when crushed during waste processing, endangering workers and infrastructure. The proposed ban also aligns with broader environmental goals, as authorities seek to address the growing impact of electronic waste and improve recycling outcomes.

  • Finland’s Kokoomus Plans Generational Tobacco Ban

    Finland’s Kokoomus Plans Generational Tobacco Ban

    Finland’s National Coalition Party (Kokoomus) proposed a generational tobacco ban as part of its long-term policy platform, aiming to prohibit tobacco sales from 2030 to individuals born in 2015 or later. The proposal, included in a broader program outlining policy goals through 2040, will be voted on at the party’s congress in June.

  • Philippines’ Health Renews Total Vape Ban Push

    Philippines’ Health Renews Total Vape Ban Push

    The Philippine Department of Health renewed its call for a total ban on vaping products, citing public health risks and positioning prohibition as the most straightforward and cost-effective solution. While a full ban is not yet in place, the agency is urging stricter enforcement of existing regulations under the Vape Regulation Act, particularly provisions restricting flavored products that may appeal to minors.

    The DOH pointed to regional precedents, noting that several neighboring Asian countries have already implemented comprehensive vape bans. In the interim, officials are prioritizing the removal of flavored vape products from the market, emphasizing that flavor descriptors linked to fruits, candy, desserts, or cartoon imagery are considered to disproportionately attract youth.

  • 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.