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Regulatory Intelligence Insights for November 23

Deep Dive - PMTA Marketing Denial Order Analysis

Week of November 17 Regulatory Intelligence Recap

United States Federal

  • A virtual Tobacco Products Scientific Advisory Committee (TPSAC) meeting will be held on January 22, 2026, to discuss the modified risk tobacco product (MRTP) applications from ZYN nicotine pouches made by Swedish Match USA, Inc. The company is proposing to use the following claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

  • FDA Funding for Illicit Vape Crackdown: The Senate passed legislation steering $200 million in tobacco user fees to the FDA for enforcement against unauthorized e-cigarettes and vapes. At least $2 million is earmarked for a multi-agency task force (FDA, DOJ, DHS) targeting illicit products, primarily from China. The law also grants the FDA new authority to destroy illicit tobacco products at the border.

  • Leadership Changes:

    • ATF Director Nomination: President Trump nominated Robert Cekada, a career ATF veteran and current Deputy Director, to lead the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF).

    • FDA Commissioner Priorities: FDA Commissioner Dr. Marty Makary is pushing for an "America-first" user fee structure to incentivize domestic clinical trials and manufacturing.

    • UnitedHealth Board: Former FDA Commissioner Dr. Scott Gottlieb joined the Board of Directors for UnitedHealth Group.

Global & International

  • WHO COP11 Conference (Geneva):

    • Prohibition Push: Internal documents and reports reveal a push by WHO leadership and some member states for stricter prohibitions on alternative nicotine products (vapes, pouches), despite opposition from other members.

    • Harm Reduction Conflict: WHO Director-General Tedros Adhanom Ghebreyesus opened the session warning that e-cigarettes and nicotine pouches are targeting youth and are not effective harm reduction tools. Critics and industry advocates are protesting the exclusion of consumer voices and the "secretive" nature of the proceedings.

  • Ireland: The Cabinet approved the Public Health (Single-Use Vapes) Bill 2025, which will ban the retail sale of disposable vapes six months after enactment. The bill also includes provisions to regulate nicotine pouches.

  • Belgium: Health Minister Frank Vandenbroucke announced plans to ban all e-cigarette flavors except tobacco, following new advice from the Superior Health Council. Retailers have threatened legal challenges.

  • United Kingdom:

    • Enforcement: A nationwide police operation (led by the National Crime Agency) raided nearly 3,000 shops, seizing over 100,000 illegal vapes and £10.7 million in illicit proceeds.

    • Disposable Ban: Discussions continue regarding the effectiveness of the disposable vape ban, with industry data suggesting a rise in "lookalike" reusable products that are still discarded.

  • Australia: Seizures of illicit tobacco and vapes continue to rise, with authorities shutting down stores selling black market products under new state laws.

  • Other International:

    • Russia: The Ministry of Finance drafted amendments allowing regional authorities to ban vape sales from September 2026.

    • Czech Republic: New rules tightening e-cigarette sales and banning candy flavors/cannabinoids will take effect in December.

    • Thailand: The government is establishing an inter-agency committee to strengthen enforcement against e-cigarettes.

United States State & Local

  • Kentucky: New legislation will require all tobacco and vape retailers to be licensed by January 1, 2026.

  • Texas: Litigation challenging the state's ban on Chinese vaping products has narrowed to a single defendant after a federal judge dismissed others.

  • New York:

    • Westchester County: Proposed legislation would ban vaping products designed to look like school supplies or toys to prevent youth access.

    • Enforcement: The state concluded a major criminal enforcement action against illegal online vape shipments, resulting in arrests and seizures.

  • Florida: St. Johns County is considering a ban on smoking and vaping in public parks and beaches.

  • California: Tiburon passed a ban on the sale of all tobacco and nicotine products, one of the strictest in the nation.

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