Week of January 5 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

Federal & National Updates

• Judicial Scrutiny of FDA: A panel for the U.S. Court of Appeals for the Fifth Circuit questioned the FDA's denial of flavored refillable e-cigarette applications (VDX Distro, Inc. v. FDA), with Judge Cory T. Wilson suggesting the agency's near-100% denial rate for the category could amount to a "de facto ban." (See Analysis Below)

• FDA Engagement: The FDA’s Center for Tobacco Products (CTP) announced a roundtable scheduled for February 10, 2026, specifically for small e-cigarette manufacturers to discuss the Premarket Tobacco Product Application (PMTA) process.

• Political Activity: Filings revealed that Juul Labs donated $1 million to the Trump-aligned Super PAC, MAGA Inc., in early November 2025, following the FDA's authorization of its products earlier that year.

• Youth Usage Data: The National Institute on Drug Abuse (NIDA) released Monitoring the Future Survey data indicating that youth use of nicotine vapes, alcohol, and cannabis has remained at record lows following declines during the pandemic.

State-Level Activity

• Pennsylvania: Governor Shapiro signed House Bill 1425 into law, establishing a directory of FDA-compliant e-cigarettes and granting the Attorney General inspection authority to curb illicit sales.

• California: * San Francisco: The City Attorney secured a nearly $4 million settlement from online retailers, including Lucy Goods Inc., for violating the city’s ban on flavored nicotine pouches like Zyn.

  • Statewide: The Department of Justice published its first "Unflavored Tobacco List" (UTL); products not on this list are deemed flavored and ineligible for sale.

• Arizona: The Attorney General ordered Pro Source vape shops to pay $460,000 in restitution for selling tobacco and nicotine products to minors.

• Colorado: Enforcement of Denver's voter-approved ban on flavored tobacco sales began January 1, with reports of retailers feeling the economic impact.

• Washington: New laws took effect imposing a 95% excise tax on all nicotine products, including vapes and synthetic nicotine.

• Alabama: Legislation (Senate Bill 9) was introduced to include vaping in the state's Clean Indoor Air Act, effectively banning it in public spaces where smoking is prohibited.

• Kentucky: New licensing requirements for tobacco and vape retailers took effect, mandating state licenses to operate.

International Updates

• China: In a major regulatory shift, China issued a framework bringing nicotine pouches and oral nicotine products under the State Tobacco Monopoly Administration. These products will now be regulated similarly to cigarettes, barring private manufacturers from the domestic market.

• Vietnam: The government issued Decree 371, establishing fines of up to $190 (5 million VND) for e-cigarette use and mandating the destruction of confiscated devices. This follows a ban on investment and trade in these products.

• United Kingdom: * The government confirmed that while nicotine pouches are safer than smoking, concerns remain regarding high nicotine levels.

  • Retailers are being urged by Action on Smoking and Health (ASH) to prepare for the "smokefree generation" law taking effect in 2027.

  • Schools reported feeling isolated in their battle against youth vaping, with many installing vape detectors.

• Malaysia: The Ministry of Health announced aims to implement a vape ban in 2026, starting with open pod systems.

• Bangladesh: An ordinance was approved banning the production, sale, and use of vapes and nicotine pouches.

• Croatia: Excise duties on e-liquids and heated tobacco products were increased effective January 1.