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Article History

Received: 13 October 2025

Accepted: 11 August 2026

First Online: 25 August 2026

Declarations

Ethics approval and consent to participate: Not Applicable.

Consent for publication: Not Applicable.

Competing interest: AS is an employee of Pinney Associates, Inc. Since October 2019, Pinney Associates has been and continues to consult to Juul Labs on nicotine vapor products to advance tobacco harm reduction. JLI partly funded AS’s effort in the preparation of this manuscript and provided comments on a near-final draft. AS also consults to the Global Forum on Nicotine (GFN). In addition, in the past 3 years, Pinney Associates has consulted to Philip Morris International (PMI) solely on US regulatory pathways for non-combustible, non-tobacco, nicotine products. PA does not consult on combustible tobacco products. Also in the past 3 years, AS individually provided consulting services on behavioral science to the Center of Excellence for the Acceleration of Harm Reduction (CoEHAR) through ECLAT Srl., which received funding from the Foundation for a Smokefree World (FSFW; now the Global Action to End Smoking (GA). Neither FSFW/GA, GFN, nor PMI had any role in, or oversight, of this study. GL is employed by Juul Labs, Inc. (JLI). JLI provided comments on a near-final version of this manuscript. RP is full tenured professor of Internal Medicine at the University of Catania (Italy) and Medical Director of the Institute for Internal Medicine and Clinical Immunology at the same University. He has received grants from U-BIOPRED and AIR-PROM, Integral Rheumatology & Immunology Specialists Network (IRIS), Global Action to End Smoking, Pfizer, GlaxoSmithKline, CV Therapeutics, NeuroSearch A/S, Sandoz, Merk Sharp & Dohme, Boehringer Ingelheim, Novartis, Arbi Group Srl. (Independent nicotine company), JUUL Labs (Independent nicotine company), Duska Therapeutics, Forest Laboratories, Ministero dell'Universita’ e della Ricerca (MUR) PNRR 3277/2021 (CUP E63C22000900006), PNRR 341/2022 (CUP E63C22002080006), and PNRR TNE23-00019 (CUP H71I24000300002), funded by NextGenerationEU of the European Union (EU), and the ministerial grant PON REACT-EU 2021 GREEN- Bando 3411/2021 by Ministero dell Universita' and (MUR) – PNRR EU Community. He is founder of the Center for Tobacco Prevention and Treatment (CPCT) at the University of Catania and of the Center of Excellence for the Acceleration of Harm Reduction at the same university. He receives consultancy fees from Pfizer, Boehringer Ingelheim, Duska Therapeutics, Forest Laboratories, CV Therapeutics, Sermo Inc., GRG Health, Clarivate Analytics, Guidepoint Expert Network, and GLG Group. He receives textbooks royalties from Elsevier. He is also involved in a patent application for ECLAT Srl. He is a pro bono scientific advisor for Lega Italiana Anti Fumo (LIAF) and the International Network of Nicotine Consumers Organizations (INNCO); and he is Chair of the European Technical Committee for Standardization on “Requirements and test methods for emissions of electronic cigarettes” (CEN/TC 437; WG4); and scientific advisor of the non-profit Foundation RIDE2Med. VT is associate professor of Social Statistics at the University of Catania (Italy). She declares no conflict of interest.