FLER at APE

At the 2026 New Approaches Summit in New York, FDA Center for Tobacco Products Director Bret Koplow said the PMTA pathway is “predicated on tobacco harm reduction.” He outlined four CTP priorities: youth prevention, helping adults quit or switch to lower-risk products, improving relative-risk communication, and reducing unauthorized products. Koplow also addressed flavored e-cigarettes, public risk perceptions, industry credibility and efforts to make PMTA reviews more efficient and predictable.

At the 2026 New Approaches Summit in New York, former FDA Center for Tobacco Products Director Mitch Zeller called for the tobacco harm reduction debate to shift from the traditional “end game” toward defining a desired “end state.” He also highlighted unresolved concerns around dual use, argued that biomarkers of exposure may be more meaningful than cigarettes-per-day in assessing risk reduction, and said nicotine misperceptions remain a major barrier to public health progress.

FDA’s Center for Tobacco Products detailed new PMTA review data and process changes at the 2026 FDLI conference. Pending PMTAs fell from about 450,000 at the start of 2025 to 135,000 by September 2026. CTP also discussed its 180-day review goal, current sPMTA pilot, alternate-supplier planning, more than 50,300 pending SE reports, and lessons from the nicotine pouch pilot already being applied to ENDS review.

JNR released the Crown Shisha 100K on August 14, 2026, positioning the ultra-high-capacity disposable around a direct-to-lung (DTL) e-shisha experience. The device combines a 58ml e-liquid capacity, triple 1.0Ω mesh coils and a 1,300mAh rechargeable battery, with JNR claiming up to 100,000 puffs. Adjustable airflow, battery and e-liquid status displays, a leather-style exterior and a shisha-inspired sound effect further differentiate the product. JNR is currently promoting the device through international wholesale and distribution channels, while a specific first retail market has not been disclosed.

U.S. Rep. Raja Krishnamoorthi on Oct. 6 questioned the FDA over its plan to reassess and potentially replace the 2021 PMTA regulatory framework, asking the agency to identify provisions it may change or eliminate, state whether current scientific evidentiary standards will be maintained, and disclose communications with Altria, Reynolds and other parties challenging the rule. Krishnamoorthi led a congressional investigation into JUUL and youth vaping in 2019 and has since remained active on e-cigarette regulation and enforcement.

Dragos Constantinescu has officially taken up his role as Chief Financial Officer and Executive Director at British American Tobacco (BAT). He previously spent 16 years at BAT across finance and general management roles in Europe before joining Asahi in 2019 and becoming CEO of Asahi Europe & International in 2025. His return comes as BAT continues to advance its “A Better Tomorrow” transformation.