Week of November 10 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

🏛️ U.S. Federal Government & Regulation

• Congress Bans Hemp-Derived THC: In a broad spending package (H.R. 5371) Congress approved language that effectively bans nearly all hemp-derived THC products. This move closes the "hemp loophole" from the 2018 Farm Bill, impacting an industry valued at $28.3 billion.

• FDA Appeals Graphic Health Warning Ruling: The FDA has appealed a U.S. District Court decision that vacated the agency's 2020 graphic health warning (GHW) rule for cigarettes. The appeal has been taken to the U.S. Court of Appeals for the Eleventh Circuit.

• Former FDA Commissioner Califf Discusses Nicotine Regulation: In a recent talk, former FDA commissioner Robert Califf stated that the FDA does not have the authority to outlaw nicotine itself but can set standards. He noted the political difficulties in regulating flavors, stating, "frankly, we just lost."

🌍 International Regulation & WHO (COP11)

The upcoming 11th Conference of the Parties (COP11) to the WHO Framework Convention on Tobacco Control (FCTC) has triggered significant global debate:

• WHO Stance on Harm Reduction: WHO Director-General Dr. Tedros Adhanom Ghebreyesus stated that the "aggressive marketing" of e-cigarettes and nicotine pouches is "fueling a new wave of addiction among young people" and is not harm reduction. The WHO also released a formal position paper warning that tobacco companies are misappropriating the public health concept of harm reduction.

• COP11 Agenda: Delegates are expected to discuss proposals targeting youth addiction and environmental harms, including a potential ban on cigarette filters.

Country-Specific International Updates:

• Australia: South Australia authorities have issued 100 28-day closure orders to stores selling illicit tobacco and vapes, seizing products valued at A$50 million.

• Ireland: The Department of Health is reportedly considering a ban on nicotine pouches to protect youth.

• United Kingdom: Experts expressed concern over high-dose nicotine pouches as sales soar. The pending Tobacco and Vapes Bill will introduce new restrictions, including bans on advertising and sales of nicotine pouches to minors.

• Mexico: The country faces a crossroads as lawmakers debate a constitutional reform that would ban the production and sale of all e-cigarettes.

• Vietnam: The Ministry of Health is moving to ban e-cigarettes and heated tobacco products.

• South Korea: A bill to regulate synthetic nicotine has once again been delayed by the National Assembly.

🇺🇸 U.S. State & Local Regulation

• California:

  • Tiburon: The Tiburon Town Council unanimously passed an ordinance to ban the sale of all tobacco and nicotine products, including cigarettes, vapes, and pouches.

  • Unflavored Tobacco List (UTL): State officials clarified that initial UTL enforcement, beginning next year, will focus on "obviously flavored" products and educating companies, rather than immediate fines for non-compliant products that are not obviously flavored.

  • National City: The city council approved a new tobacco retail license program that caps the number of retailers and prohibits new shops within 1,000 feet of youth-populated areas.

• Texas: The city of Dallas has banned vaping in all public spaces where smoking is already prohibited, effective December 10.

• South Carolina: Charleston County officials reported a decrease in student vaping incidents, attributing the success to vape detectors installed in school bathrooms. The detectors were funded by money from the 2023 Juul settlement.

• Florida: Vaping continues to be a major issue in Treasure Coast schools. A new bill (HB 389) has been proposed to expand smoking and vaping bans statewide.

🔬 Science, Industry & Market Analysis

• Juul Mention in Lobbying Investigation: An investigation by The Examination, Le Monde, and Reporters United alleges that prominent nicotine researcher Dr. Konstantinos Farsalinos was paid €7,000 by Juul to lobby Israel's health ministry regarding a ban on high-strength e-cigarettes.

• Market Trends:

  • Nicotine Pouches: A 2Firsts report highlights that the nicotine pouch category is a key growth driver for multiple companies, including PMI (ZYN sales up 39% YoY), Altria (on! shipments up 14.8%), KT&G, Turning Point Brands, and Haypp Group. Murphy USA reported its on! pouch volumes grew 45% (120% in October).

  • U.S. Vape Market: A 2Firsts special report details how the U.S. vape market is rebuilding and consolidating after intensified enforcement in mid-2024. Compliance (PMTA) and innovation (e.g., non-nicotine compounds) are now the key dividing lines.

• Youth Data (New York): New data from the New York State Department of Health shows youth cigarette smoking has fallen to 2.4%, the lowest level in recorded history. E-cigarette use among high school students also continued its sharp decline, dropping to 13.1% in 2024.

• Patent Dispute: The European Patent Office (EPO) Board of Appeal upheld a vape patent held by British American Tobacco (BAT) unit Nicoventures, rejecting objections from Philip Morris International (PMI).