Week of December 1 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

Federal Agencies (FDA, HHS, CDC)

• Personnel Changes: Tracy Beth Høeg was named Acting Chief of the FDA’s Center for Drug Evaluation and Research (CDER), becoming the fifth person to hold the post this year. This follows the abrupt resignation of Rick Pazdur, the FDA’s top drug regulator, just weeks after accepting the role to stabilize the agency.

• Tobacco Control Funding Cuts: Messaging related to tobacco control has reportedly been pulled back under the new HHS leadership. The "Tips From Former Smokers" campaign is in jeopardy with no contractor signed for the coming year, leading experts to warn of an "apocalypse for national tobacco education campaigns". The elimination of the CDC's Office on Smoking and Health (OSH) has already resulted in significant funding losses for states, with West Virginia losing 73% of its prevention funding and North Carolina losing 23% of its cessation budget.

• New FDA Technology: The FDA launched a web-based Premarket Tobacco Product Application (PMTA) system to replace the legacy PDF/eSubmitter model, aiming to shorten screening times and accelerate acceptance timelines. Additionally, the agency deployed "Agentic AI" capabilities to assist staff with complex, multi-step regulatory tasks.

• Legislative Action: Senator Rick Scott introduced the Destruction of Hazardous Imports Act to expand HHS authority to destroy FDA-regulated products deemed public health risks, specifically targeting re-imported dangerous goods like illegal vapes.

  • U.S. Senators Richard Blumenthal (D-CT) and Jeff Merkley (D-OR) wrote to Food and Drug Administration (FDA) Commissioner Martin Makary, raising concerns about a recently announced pilot program at FDA that would accelerate the review of nicotine pouches like Zyn.

State Level Updates

• Virginia: The state's Vapor Product Directory is facing a challenge in federal court. Unlike other state registries, Virginia's statute may allow certification for products on the market as of August 8, 2016, or those with timely submitted PMTAs, regardless of final authorization status. Meanwhile, enforcement of anti-vape laws has reportedly forced the closure of retailers in Annandale.

• State Enforcement: In Virginia, uncertified products face fines of $1,000 per day per product, with retailers given 60 days to remove non-certified inventory.

International Regulatory Updates

• Canada (British Columbia): The province passed the Vaping Product Damages and Health Care Costs Recovery Act, allowing the government to sue vape manufacturers to recoup public health costs associated with vaping-related disease.

• United Kingdom: The government announced a new tax on e-cigarette products (VPD) and a tax stamp scheme (VDS) effective October 1, 2026, requiring manufacturers to apply for approval by April 2026.

• Russia: State Duma deputies proposed amendments to implement a complete national ban on the sale of vapes and e-liquids.

• Vietnam: The World Health Organization (WHO) urged Vietnam to explicitly classify e-cigarette and heated tobacco trade as prohibited sectors in its amended Investment Law.

• Maldives: The nation's move toward a generational tobacco ban is being watched by global policymakers, though harm reduction advocates warn it ignores evidence on safer nicotine alternatives.

Trade & Market Intelligence

• Nicotine Pouch Surge: U.S. convenience stores are restructuring backbar displays to accommodate a surge in nicotine pouch sales, which the New York Association of Convenience Stores reports are up over 40% this year.

• Partnerships: Philip Morris International (PMI) extended its partnership with Scuderia Ferrari HP through 2026, with ZYN branding set to appear on F1 cars for the first time.

• Market Forecast: The global Heat Not Burn (HNB) market was valued at $13.9 billion in 2023 and is projected to reach $98.9 billion by 2031.