Week of November 24 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

US Regulation (Federal)

• FDA Leadership Friction: Tensions continue at the FDA following reports that the White House denied a promotion for Sanjula Jain-Nagpal, an aide to Commissioner Marty Makary. This follows recent reports of White House concerns regarding Makary’s management style and infighting among appointees.

• RFK Jr. on Nicotine Pouches: A profile on Robert F. Kennedy Jr. highlights his regular use of Zyn nicotine pouches. He has reportedly pushed for initiatives to stop the sale of illegal flavored vapes while personally using pouches, which he views as distinct from other health advisories he promotes.

• USA Vape Lab Lawsuit: USA Vape Lab, the manufacturer of Naked100 e-liquids, filed a lawsuit against the FDA on November 21, alleging the agency unlawfully delayed action on its Premarket Tobacco Product Applications (PMTAs) for over five years. (See analysis below)

• Fraudulent FDA Documents: The U.S. Attorney’s Office for the District of New Jersey charged a man with using counterfeit FDA documents to defraud investors. The individual allegedly misrepresented that he had obtained FDA authorization to market vaping products.

US Regulation (State & Local)

• Virginia (Flavor Ban Defense): The state of Virginia is defending its ban on unauthorized flavored e-cigarettes in federal court. The state argues the law is legally sound and necessary to protect youth from nicotine addiction, effectively barring most flavored products currently on the market.

• New York (Settlements): New York City reached settlements with two e-cigarette wholesalers accused of illegally selling flavored vapes. The distributors agreed to halt such sales within the city and face fines for future violations.

• Mississippi (Ban Approaching): A statewide ban on disposable vapes and e-liquids not authorized by the FDA is set to take effect on December 1. A registry system will be implemented, and non-compliant products must be removed.

• Kentucky (Licensing): The Kentucky Public Protection Cabinet reminded retailers that starting January 1, 2026, all businesses selling tobacco, nicotine, and vapor products must hold a state license.

• California (Shopify Crackdown): Attorney General Rob Bonta co-led a coalition of 25 attorneys general calling on e-commerce platform Shopify to take stronger action against merchants selling illegal e-cigarettes.

International Regulation

• WHO FCTC / COP11 Conclusion: The 11th Conference of the Parties (COP11) concluded with decisions to mandate a complete ban on the use and sale of tobacco and novel nicotine products across all UN premises worldwide. The conference also focused on liability, environmental protection, and sustainable financing for tobacco control.

• WHO Director-General Comments: Tedros Adhanom Ghebreyesus suggested that funding cuts (following President Trump's decision to withdraw from the agency) offer countries a chance for "self-reliance," recommending taxes on "health-damaging goods" like tobacco, alcohol, and sugary drinks as alternative funding sources.

• United Kingdom:

  • Vape Tax: The UK government confirmed plans to implement a vape product tax and a tax stamp scheme starting October 1, 2026.

  • Budget: Chancellor Rachel Reeves announced tobacco duty increases in the budget, with a one-off increase on cigarettes and an annual escalator.

  • Nicotine Pouches: A poll by We Vape suggests the UK public opposes an Ireland-style ban on pouches, favoring regulation and age restrictions instead.

• Vietnam: The WHO has urged Vietnam to explicitly classify the trade of e-cigarettes and heated tobacco products as prohibited sectors in its amended Investment Law.

• Russia: A group of State Duma deputies has proposed a complete ban on the sale of vapes and e-liquids.

• Mexico: Lawmakers are clashing over a bill approved by the Health Commission that would establish a total ban on vapes and e-cigarettes, with strict prison sentences and fines.

• Poland: The Ministry of Health has proposed legislation to ban all disposable e-cigarettes, including zero-nicotine variants.

• Mongolia: Parliament is reviewing amendments to bring e-cigarettes under the same legal framework as traditional tobacco, including tax increases and marketing restrictions.

Industry News

• Imperial Brands: Launched a video series aimed at debunking public misconceptions about next-generation products (NGPs) like vapes and pouches.

• KT&G / Altria: KT&G confirmed its global expansion plans for nicotine pouches are on track, including the acquisition of Another Snus Factory and a subsequent partial sale to Altria.

• Boutique Cigar Association: The association filed for dissolution on November 19, with board members returning focus to their own businesses.

Science & Health

• Public Misconceptions: Reports highlight persistent confusion among the public regarding the relative harm of vaping vs. smoking. An Imperial Brands survey noted 63% of young people believe vaping is as harmful or more harmful than smoking.

• Vaping vs. Smoking: NPR reported on the sharp divide among anti-smoking advocates, with some arguing e-cigarettes are a necessary "lesser of two evils" for cessation, while others focus on youth addiction risks.

• Pouch Health Risks: A Daily Mail article highlighted expert concerns over nicotine pouches, citing risks of dependence and potential cardiovascular or gastrointestinal effects.