Week of December 8 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

U.S. Federal Regulatory Updates

• FDA Leadership Stability Concerns

  • The FDA is facing internal upheaval following the sudden retirement of Richard Pazdur, director of the Center for Drug Evaluation and Research (CDER), shortly after his appointment by Commissioner Marty Makary.

• FDA Pilot Program Scrutiny

  • Senators Richard Blumenthal (D-CT) and Jeff Merkley (D-OR) led a coalition of lawmakers in sending a letter to FDA Commissioner Makary expressing concern over a new pilot program designed to expedite the review of nicotine pouches.

  • The lawmakers argue this accelerated process could undercut scientific standards and potentially lead to increased youth usage of flavored products.

• Legal Challenges to FDA Authority

  • Litigation challenging the FDA's authority to impose Civil Money Penalties (CMPs) for tobacco violations continues, with potential rulings that could dismantle key enforcement tools.

  • If courts rule these proceedings unlawful, it would significantly hinder the agency's ability to enforce compliance with the Food, Drug, and Cosmetic Act.

U.S. State-Level Enforcement & Regulation

• Wisconsin

  • Enforcement Crackdown: The Wisconsin Department of Revenue has issued millions of dollars in fines to vape shops for selling products not approved by the FDA.

  • Major Penalties: Exclusive Tobacco in Oshkosh faces nearly $13 million in fines for selling illegal vape products and operating with an expired license, while Davez Smoke and Tobacco in Green Bay was fined nearly $500,000.

• Texas

  • Dallas Ban Effective: A comprehensive ban on vaping in public spaces in Dallas took effect on December 11, 2025.

  • Scope: The ordinance prohibits vaping in all indoor public spaces, parks, and within 15 feet of building entrances, with fines of up to $500 per offense.

• Virginia

  • Litigation: The State Attorney General is urging a federal court to dismiss a lawsuit filed by vape wholesalers challenging the state's ban on unapproved e-cigarettes.

  • State Argument: Virginia argues that the plaintiffs lack legal standing because the products they intend to sell are federally illegal and therefore they cannot demonstrate irreparable harm.

• Alaska

  • Settlement: The state reached a $7.8 million settlement with Juul Labs and Altria regarding marketing practices accused of targeting teenagers.

  • Terms: Funds will be split between tobacco control programs and consumer protection enforcement.

International Regulatory Developments

• World Health Organization (WHO)

  • Rejection of Harm Reduction: The WHO has issued a statement explicitly rejecting harm reduction as a legitimate strategy for tobacco control, asserting that such concepts are promoted solely to advance industry commercial interests.

  • FCTC Updates: The Conference of the Parties (COP11) concluded with decisions to ban tobacco and novel nicotine products at all UN premises and emphasized strict regulation of nicotine products.

• Vietnam

  • Strict Prohibition: The WHO welcomed a decision by Vietnam's National Assembly to prohibit investment in or the commercial trade of e-cigarettes and heated tobacco products.

  • No Exceptions: The legislation removes any exceptions for these products in the Law on Investment, effectively banning the sector.

• Mexico

  • Constitutional Reform: Mexico's Chamber of Deputies approved a constitutional reform prohibiting the production, distribution, and marketing of vapes and e-cigarettes.

  • Penalties: The new law imposes prison sentences of one to eight years and significant fines for violations.

• United Kingdom

  • Wales Ban: The Senedd (Welsh Parliament) backed UK government plans to ban tobacco sales to anyone born after January 1, 2009, creating a "smoke-free generation".

  • Tax & Stamps: The UK announced a new tax on vaping products and a tax stamp scheme effective October 1, 2026.

Trade Press & Industry Updates

• Altria Leadership: Altria Group CEO Billy Gifford announced his retirement effective May 2026; he will be succeeded by current CFO Sal Mancuso.

• Juul Product Launch: Juul Labs UK announced the launch of a new Peach variant for its JUUL2 system, available starting January 1, following the release of four other fruit flavors in October.

• PMI Financials: Philip Morris International declared a quarterly dividend of $1.47 per share, payable in January 2026.

• Market Trends: British American Tobacco (BAT) reported that while it is seeing benefits from the U.S. crackdown on illicit vapes, a "massive inventory wall" and a record $590 million export spike from China in October threaten these gains.

FDA Center for Tobacco Products Released FY 2025 (Through September 2025) Application Metrics: