Week of February 9 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

Federal Regulatory Updates

• FDA PMTA Roundtable for Small Manufacturers: On February 10, the FDA convened a roundtable session specifically for small electronic nicotine delivery systems (ENDS) manufacturers to solicit input on the Premarket Tobacco Product Application (PMTA) process. Manufacturers highlighted that the process remains prohibitively expensive and unpredictable without clear performance benchmarks. They urged for greater use of modeling and data-bridging, though the FDA maintained that clinical pharmacokinetic (PK) data remains the most reliable evidence for public health standards. (See analysis below)

• Nicotine Pouch Review Pilot: A CTP representative spoke about the nicotine pouch PMTA review pilot program as though it were concluding. While the FDA aimed to finish reviewing applications from five manufacturers by the end of 2025, public decisions have only been issued for products from one manufacturer to date.

State Regulatory & Legislative Actions

• South Carolina Registry Bill: The South Carolina General Assembly passed registry bill S 287, which now moves to the Governor for signature. If enacted, it would ban the sale of most vaping products not manufactured by major tobacco companies, potentially closing many dedicated vape shops in the state.

• Michigan Medicaid Funding Taxes: Governor Gretchen Whitmer proposed several new taxes to sustain Medicaid, including a 57% wholesale tax on vapes and other nicotine-delivery products like Zyn, and a $1 increase in cigarette wholesale taxes (from $2 to $3 per pack).

• Illinois Licensing measure: The Chicago City Council Committee on License and Consumer Protection approved a measure requiring businesses applying for retail tobacco licenses to undergo a public review process similar to liquor license applications.

• Iowa Tax Proposal: Governor Kim Reynolds proposed new taxes on smoking products, including raising the cigarette tax to the national average of $2.01 per pack and introducing a 15% tax on vapes and consumable hemp.

• Aurora, Colorado Licensing: The Aurora City Council advanced an ordinance requiring a $500 annual license for businesses selling tobacco, vapes, and age-restricted hemp products, with a requirement that products comply with federal regulations.

Trade Press & Industry Updates

• BAT Preliminary Results: British American Tobacco reported strong 2025 growth in its U.S. business, driven by momentum in combustibles and triple-digit revenue growth for Velo Plus nicotine pouches. The company also announced an AI-driven productivity program expected to impact staffing levels.

• China Export Compliance: China has begun requiring exporters of e-cigarettes to submit proof of compliance with destination-market laws, such as Marketing Granted Orders (MGO) or FDA Acceptance Letters, to curb illicit trade.