Week of November 3 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

Top Headlines

• The U.S. Senate advanced a compromise funding package on November 10, 2025, to end the ongoing government shutdown: This package includes three appropriations bills authorizing spending through fiscal year 2026, one of which is the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act. That act authorizes $200 million specifically for enforcement activities related to electronic nicotine delivery systems (ENDS, or e-cigarettes) within the FDA's Tobacco Center, which has a total of $712 million. This funding aims to boost investigations and removal of illegally sold products. The Senate's version of the bill, advanced earlier, included this provision, and the compromise maintains it to align with public health priorities. The package now heads to the House for a vote, with retroactive pay for federal workers and no further layoffs through January.

• Rep. Van Duyne and Senator Cornyn Introduce the END Act to Crack Down on Illegal Vape Imports: The Ensuring the Necessary Destruction of Illicit Chinese Tobacco (END) Act authorizes the Secretary of Health and Human Services to destroy adulterated, misbranded, or counterfeit tobacco products that are offered for import into the United States.

  This legislation will update the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) to explicitly include tobacco products, ensuring they are treated the same as counterfeit drugs or medical devices when intercepted by federal authorities.

• FDA CTP Director Signals Support for Harm Reduction: At a recent policy conference, FDA CTP Acting Director Bret Koplow acknowledged the "continuum of risk" for tobacco products and recognized the potential beneficial use of e-cigarettes, nicotine pouches, and heated tobacco products for adult smokers willing to switch from combustibles.

• Denver Upholds Flavor Ban: Voters in Denver, Colorado, upheld the city's ordinance banning the sale of flavored tobacco products, including menthol cigarettes and e-cigarettes. Enforcement is set to begin in January.

• Illicit Vape Seizures Continue: U.S. Customs and Border Protection (CBP) officers in Chicago seized a shipment from China containing 43,200 units of illicit Kangvape disposable vapes, valued at over $358,000.

U.S. Federal & Regulatory Developments

• Congressional Action: Senator Tom Cotton (R-AR) sent a letter to the FDA Commissioner urging the agency to authorize more legal, American-made nicotine products to combat the influx of "illicit Chinese nicotine products." The letter noted that the FDA has only authorized 39 e-cigarette products from over 26 million applications.

• FDA Regulatory Actions: The FDA has set a December 8, 2025 deadline for public comments on the MRTP (Modified Risk Tobacco Product) renewal applications for Philip Morris's IQOS heated tobacco products.

• Corporate Compliance: Altria announced it is pausing new orders for its on! PLUS nicotine pouches. This product had been launched without explicit FDA marketing authorization.

State & Local Regulatory Updates

• Colorado: In addition to Denver voters upholding the city's flavor ban, critics of the ban, such as Smoker Friendly, warned that similar policies in other towns have resulted in volume losses of up to 50%.

• Kentucky: The state will implement Senate Bill 100, effective January 1, 2026, which requires all retailers of tobacco, nicotine, or vapor products to be licensed by the Kentucky Department of Alcoholic Beverage Control.

Industry & Market Insights

• New Products:

  • PMI: Philip Morris is reportedly launching a limited edition "Zyn After Dark" collection in the U.S., with flavors including Spiced Cider, Mojito, and Espresso Martini.

  • SKE: The company launched its V-BOT disposable vape, claiming it is "Made in the USA" with domestic blending and filling.

  • Nicotine Alternatives: New "non-nicotine blend" products, such as Nixodine and Metatine, are reportedly appearing in the U.S. market.

• Corporate Performance:

  • Turning Point Brands (TPB): The company reported a 628% year-over-year increase in Q3 sales for its nicotine pouches and announced plans for a U.S.-based production line by 2026.

  • BAT: The VELO Shift nicotine pouch, launched in September, is gaining attention for its novel design, though some social media feedback indicates a desire for higher nicotine strengths.

  • Murphy USA: The convenience store chain reported strong Q3 results, driven by performance in the smokeless nicotine space.

• Strategic Partnerships: KT&G and Altria are moving forward with a "Partnership + Acquisition" strategy to compete in the global nicotine pouch market, notably acquiring the "LOOP" brand.

Public Health & Research

• JAMA Study on Teen Vaping: A significant study published in JAMA Network Open found that while overall nicotine vaping among youth declined from 2020 to 2024, the proportion of users who vape daily nearly doubled (from 15.4% to 28.8%). The study also found that the percentage of daily vapers who tried to quit but were unable rose sharply from 28.2% to 53%.

• Harm Reduction Analysis: An article from "Our World in Data" analyzing the scientific literature concluded that the evidence clearly shows vaping is "much less harmful than smoking" and serves as an effective tool for quitting.

• Anti-Tobacco Campaigns: An APHA 2025 session discussed the evolution of public health campaigns to counter tobacco and nicotine marketing on social media and through influencers.

International Developments

• United Kingdom: For the first time, the number of vapers in Great Britain (5.4 million) has officially surpassed the number of smokers (4.9 million), according to the Office for National Statistics.

• Australia: The illicit tobacco market is reportedly costing the nation $4 billion. Reports also indicate a local tobacco cartel is working with a crime syndicate to dominate the illicit vape trade.

• Maldives: The country has passed a law banning smoking for anyone born on or after January 1, 2007.

• Europe:

  • Scotland: The Scottish government is considering a minimum price for tobacco products.

  • Luxembourg: The country passed new legislation to regulate heated tobacco, e-cigarettes, and nicotine pouches. The law bans flavorings and caps nicotine content.

Juul Labs Specifics

• Juul2 Platform: Juul's "strategic reset" and "second life" were the subject of multiple reports. These articles focused on the Juul2 device, which is awaiting FDA authorization and reportedly features advanced age-verification technology, including Bluetooth app connectivity and biometric safeguards like Face ID, to prevent underage access.

• FDA Authorization: An industry overview article highlighted the FDA's Marketing Granted Orders (MGOs) for Juul's Virginia Tobacco and Menthol pods (3.0% and 5.0%) and the Juul device, noting the agency's determination that the products are "appropriate for the protection of public health."

• PMTA Research: The research group CSUR, noted for its role in Juul’s successful PMTA, was mentioned as now outlining a new, expedited pathway for nicotine pouch applications.