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Category: Global Regulation

  • FDA Names Koplow as Tobacco Center Director

    FDA Names Koplow as Tobacco Center Director

    The U.S. Food and Drug Administration has selected Bret Koplow, Ph.D., J.D., as director of the Center for Tobacco Products, giving the center a permanent leader with more than a decade of legal, policy, and regulatory experience at the agency. Koplow has served at FDA since 2011, including as senior counselor to the FDA commissioner, where he focused on regulatory, policy, and operational matters involving tobacco products. He had been serving as CTP’s acting director before the appointment.

    According to the Department of Health and Human Services, Koplow will lead CTP around two priorities: promoting innovation and access to less harmful alternatives for adults who smoke while taking action to protect youth and minors from tobacco and nicotine. His appointment was part of four senior FDA leadership selections announced by HHS, including Jared Seehafer as the agency’s first deputy commissioner for technology and artificial intelligence, Michael Davis as director of the Center for Drug Evaluation and Research and Karim Mikhail as director of the Center for Biologics Evaluation and Research.

    HHS Secretary Robert F. Kennedy Jr. said the appointments are intended to advance reforms and strengthen FDA’s leadership in medical innovation. Acting FDA Commissioner Kyle Diamantas said the selections “signal the direction we are heading” as the agency seeks to build its workforce and infrastructure and accelerate innovation across its centers.

  • Report Finds EU Lagging in Fight Against Illicit Tobacco

    Report Finds EU Lagging in Fight Against Illicit Tobacco

    The European Court of Auditors (ECA) says the European Union lacks reliable data on the size and impact of the illicit tobacco market and that fragmented national rules and weak coordination are leaving gaps that criminal groups can exploit. Euractiv reported that the auditors estimate the illicit tobacco trade costs the EU and its member states about €13 billion in lost revenue annually, although the ECA cautioned that the estimate should be treated carefully. Euractiv also highlighted the ECA’s criticism of limited transparency around bilateral agreements between EU governments and tobacco companies to combat illicit trade.

    EUobserver reported that the ECA found one in 10 cigarettes made in the EU is either illegally produced or smuggled, while vapes and heated tobacco products account for 13% of the illicit market by value. EUobserver also said the European Anti-Fraud Office helped prevent €178 million in lost tax revenue in 2025 and that the European Commission has accepted most of the ECA’s recommendations but rejected some proposals, including a coordinated EU monitoring system and a framework for assessing member states’ effectiveness in fighting illicit tobacco.

  • UKVIA Launches Campaign to Preserve Vaping 

    UKVIA Launches Campaign to Preserve Vaping 

    The UK Vaping Industry Association (UKVIA) launched its “Enough is Enough” campaign alongside its 10-point “Fair Deal for Vaping,” calling for a more proportionate approach to vaping regulation. The campaign urges the UK government to crack down on youth access and illicit traders while preserving vaping as an alternative for adult smokers. UKVIA is particularly challenging upcoming measures including plain packaging, tighter flavor and display restrictions, a planned advertising and sponsorship ban, and the Vaping Products Duty taking effect Oct. 1 at 22p ($0.30) per milliliter, which it says could significantly increase prices. 

    The campaign calls for measures including accelerated retail licensing, tougher penalties for rogue traders, continued access to adult flavors, factual communication with adult consumers, and a review of the new vaping duty. UKVIA is encouraging adult vapers, former smokers, and their families to contact MPs and share their experiences, arguing that increasingly restrictive policies could discourage smokers from switching and fuel illicit trade. 

  • Swedish Election Threatens EU Tobacco Tax Talks 

    Swedish Election Threatens EU Tobacco Tax Talks 

    According to a Euractiv article today (Aug. 31), EU diplomats expect limited progress on the Tobacco Excise Directive (TED) at the September 14 meeting, as Sweden’s national election the day before could leave Stockholm without a firm position while coalition negotiations take place. The proposed TED would raise tobacco taxes across the EU and is linked to plans to generate €11.2 billion annually for the bloc’s next long-term budget. The file stalled after Sweden objected to proposed taxation of nicotine pouches, with Stockholm seeking to protect its traditional snus market. 

    Prolonged talks could also complicate Ireland’s efforts to secure a Council agreement in October and potentially lead Sweden to abstain from a key vote expected at the October 9 ECOFIN meeting. According to Euractiv, Ireland expects September discussions to focus mainly on technical issues rather than resolving political differences. The next Swedish government is likely to face continued pressure over snus and nicotine taxation, while EU officials remain focused on the bloc’s longer-term ambition to become both smoke-free and nicotine-free. 

  • FDA Authorizes Three Juul2 Products

    FDA Authorizes Three Juul2 Products

    The U.S. Food and Drug Administration announced it has authorized three products in the Juul2 e-cigarette system made by Juul Labs through the premarket tobacco product application pathway. The authorization covers the Juul2 device and 18 mg/mL tobacco- and menthol-flavored pods, equivalent to roughly 1.5% to 1.6% nicotine concentration. The FDA previously authorized several Juul products in tobacco and menthol flavors at 3% and 5% nicotine concentrations in July 2025.

    The FDA said its review found that a substantial proportion of adults who smoke completely switched from cigarettes to the authorized Juul2 products. At six weeks, 19.9% to 34.6% of users of the tobacco-flavored pod and 28.4% to 49.3% of users of the menthol pod had stopped smoking completely, with the menthol product showing the higher switching rate. Adults who switched completely were exposed to lower levels of harmful chemicals than if they had continued smoking.

    The FDA determined that the population-health benefits for adults who smoke outweighed the risks of the menthol product, including its potential appeal to youth. The agency stressed that complete switching provides greater health benefits than dual use of cigarettes and e-cigarettes. The three authorizations bring the total number of e-cigarette products authorized by the FDA to 48.

  • Calif. Bans Disposable Nicotine Vapes

    Calif. Bans Disposable Nicotine Vapes

    California lawmakers passed legislation that would ban disposable nicotine vapes, with Assembly Bill 762 now awaiting Gov. Gavin Newsom’s signature. The bill, which passed the Senate Aug. 25 and Assembly Aug. 26, would prohibit the manufacture and import of single-use, battery-embedded e-cigarettes containing tobacco products beginning Jan. 1, 2027, and the sale or distribution of such devices on January 1, 2028; cannabis devices are exempt. To remain legal, vape devices would need to be refillable or use replaceable pods and have rechargeable batteries.

    Supporters, including bill sponsor Assemblymember Jacqui Irwin and environmental groups, cited litter, toxic waste, and lithium-battery fire risks, while vaping industry representatives have argued that the products help adults quit smoking and warned that restrictions could push some consumers back to combustible cigarettes. California already prohibits most flavored tobacco products, including flavored vapes.

  • FDA Releases New Smoking Cessation Posters

    FDA Releases New Smoking Cessation Posters

    The U.S. Food and Drug Administration’s Center for Tobacco Products has released new posters encouraging adults who smoke cigarettes to keep trying to quit. The free materials feature positive, motivational messages and direct smokers to EveryTryCounts.gov, a cessation website developed with the National Cancer Institute that offers online counseling and quitting resources. The posters are available to healthcare professionals, community organizations, and other stakeholders to order, download, and print through FDA’s Tobacco Education Resource Library.

  • Value of Seized Tobacco in Philippines Quadruples

    Value of Seized Tobacco in Philippines Quadruples

    The Philippines’ Bureau of Customs (BOC) said it seized nearly P11.68 billion ($186.9 million) worth of illegal cigarettes and vape products from January through July 2026, up 464% from the P2.52 billion ($40 million) seized during all of 2025, according to Enforcement and Security Services data presented to the House Ways and Means Committee. Cigarette and tobacco seizures accounted for most of the total, with major confiscations at the ports of Surigao, Manila, Zamboanga, and Cebu, while vape seizures were valued at about P1.65 billion ($26.4 million), primarily at the Manila International Container Port. BOC said confiscated products are destroyed and do not enter the market.

  • Tobacco Import Allowances Expanded for Returning Maldivians

    Tobacco Import Allowances Expanded for Returning Maldivians

    Maldivians aged 21 and older returning from overseas can now bring limited quantities of tobacco products for personal use without paying import duties. An amendment issued Aug. 24 allows up to 200 cigarettes, 20 cigars, or 100 grams of tobacco, along with limited quantities of cigarette-rolling materials.

    The exemption does not apply to anyone born in 2007 or later. Sheesha, e-cigarettes, e-liquids, and flavored cigarettes also remain ineligible for duty-free importation.

    The change comes despite the Maldives’ broader restrictions on tobacco use, including a ban on smoking for people born after a specified year and restrictions on vaping products.

  • FDA authorizes 11 additional ZYN nicotine pouches

    FDA authorizes 11 additional ZYN nicotine pouches

    Today (Aug. 21), the U.S. Food and Drug Administration authorized 11 new nicotine pouch products from Swedish Match USA under the Zyn Ultra brand through the premarket tobacco product application pathway. The products include 10 9-milligram varieties and one 11-milligram variety, covering flavors such as Chill, Citrus, Cool Mint, Deep Freeze, Menthol, Peppermint, Smooth, Spearmint, and Wintergreen.

    The FDA said its review found the products contain lower levels of most harmful and potentially harmful constituents than other oral and smokeless tobacco products. The agency also said product-specific data indicated the pouches appeal primarily to adults who currently smoke cigarettes or use smokeless tobacco and could provide sufficient nicotine to reduce cravings and withdrawal symptoms, potentially supporting switching among adult tobacco users.

    “We are delighted with the FDA’s decision to authorize a range of ZYN ULTRA products, which will build on ZYN’s position as America’s leading smoke-free product brand,” said Stacey Kennedy, PMI U.S. CEO. “We look forward to expanding our portfolio of better choices for the 45 million Americans who consume nicotine products.” 

    The authorizations bring the number of FDA-authorized nicotine pouch products to 43, including 23 approved through the agency’s nicotine pouch pilot program. The FDA said the pilot has streamlined PMTA reviews and reduced the time needed to resolve deficiencies, with efficiencies now being applied to other tobacco-product applications.