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Regulatory Intelligence Insights for October 6
Deep Dive - Analysis of the 2024 IQOS PMTA Postmarket Annual Report

Week of September 29 Regulatory Intelligence Recap
USA: Market Update – Sept 2025 - Tobacco Insider
According to the Circana retail audit/scan data, in the 52 weeks ending September 7, 2025, total U.S. tobacco sales declined -0.7% to $73.9 billion – driven by the cigarette volume decline and ongoing shift of vaping product sales to untracked channels (e.g. independent/low-tier retailers, specialty retailers, online).
Vapes: Circana covers roughly half of the U.S. vape sales as a large portion of illegal/illicit vapes are sold in independent/low-tier retailers, speciality stores and online. Due to the ongoing shift of vape sales to the untracked channels, Circana data indicates -12.5% volume and -8.4% dollar sales decline for the vaping products. This is not an accurate representation of the overall vape market in the U.S. We estimate that overall U.S. vape sales volume is up +10% and dollar sales is up +15% in the last 52 weeks albeit a slowdown in growth compared to 2023/24. In the tracked channels, BAT’s VUSE continues to gain share following the intensifying enforcement actions against illegal/illicit vapes (e.g. supply shortage in key illicit brands like GeekBar) and market exclusion orders for Altria’s NJOY ACE due to patent infringement.
A Statement From FDA Commissioner Marty Makary, M.D., M.P.H.: Encouraging Retailers to Stop Selling Illegal Vapes - FDA
We have received questions from retailers about which tobacco products are legal to sell, so we’re mailing materials to more than 300,000 retailers nationwide containing:
-A list of the 39 vapes and 20 nicotine pouch products that can be legally marketed in the United States, which features QR codes linked to the FDA real-time digital versions of these lists (www.fda.gov/authorizedecigs and www.fda.gov/authorizednicotinepouches);
-Information on accessing FDA’s new Searchable Tobacco Product Database, a database of over 17,000 tobacco products—covering all categories, such as cigarettes, cigars, hookah, and e-cigarettes—that may be legally marketed in the United States; and
-New tobacco retailer education materials, including a wall calendar of reminders focused on retailer requirements such as only selling tobacco products to those 21 and older and requiring a photo ID check of anyone under 30.