Week of February 16 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

Federal Regulatory Developments

• FDA Leadership Changes: Dr. Jay Bhattacharya, the current Director of the NIH, has been confirmed as the temporary leader of the CDC. He replaces Jim O’Neill, who previously held the dual roles of acting CDC director and HHS deputy secretary.

• Modernization Efforts: Senator Bill Cassidy, Chairman of the Senate HELP Committee, released a report on February 18 aimed at modernizing the FDA. The report details legislative and regulatory reforms intended to accelerate patient access to treatments and maintain biomedical dominance.

• Legal Challenges: A nicotine oral pouch manufacturer is suing the FDA in D.C. federal court. The company alleges that the agency's requirement for health studies similar to those for traditional tobacco products is arbitrary, particularly since the FDA has acknowledged that pouches carry fewer health risks than combustible cigarettes.

State and Local Regulatory Updates

• South Dakota: On February 17, the House Health and Human Services Committee advanced House Bill 1220, which would require wholesalers and distributors of nicotine products to be licensed. A competing bill, House Bill 1240, which sought to restrict fruit and candy-flavored vapes specifically to smoke shops, was sent to the House without a recommendation.

• Delaware: Governor Matt Meyer’s FY2027 budget proposal includes significant tax increases for cigarettes (rising from $2.10 to $3.60 per pack) and adds new nicotine products, such as moist snuff and e-liquids, to the tax list to help close a $500 million budget gap.

• West Virginia: Lawmakers are advancing the "Vape Safety Act" (House Bill 5437). This legislation proposes a mandatory product registry for all vape products, requiring them to be FDA-approved or pending approval, alongside a new fee-based operational licensing system for shops.

• New York: Governor Kathy Hochul’s proposal to tax nicotine pouches at the same rate as traditional tobacco products is facing opposition from groups arguing it disincentivizes smokers from switching to safer alternatives.

• South Carolina: The General Assembly passed registry bill S 287, which would ban the sale of most vaping products not manufactured by tobacco companies. The bill is now awaiting a signature or veto from Governor Henry McMaster.

• Chicago: A city council committee advanced an ordinance on February 13 that would require businesses applying for retail tobacco licenses to undergo a public review process similar to that required for liquor licenses.

Trade Press

• Market Trends: A fourth-quarter 2025 Goldman Sachs "Nicotine Nuggets" survey of roughly 76,000 retail locations reported a moderation in cigarette volume declines and robust growth in the nicotine pouch category. Retailers expressed optimism for new products like on! PLUS and ZYN Ultra.

• Industry Sentiment: The Vapor Technology Association (VTA) expressed disappointment following an FDA roundtable on Premarket Tobacco Product Applications (PMTAs). The VTA criticized a lack of progress and continued "scientific ambiguity" regarding performance benchmarks for vapor products.

• Altria Market Analysis: Altria recently stated that over half of the 55 million U.S. nicotine consumers now use smoke-free products, with one-third using them exclusively.