Evaluating the impact of nicotine pouch characteristics in the context of a combustible cigarette standard on overall tobacco product use

Bans on menthol as a characterizing flavor in combustible cigarettes have been implemented in multiple US jurisdictions with additional bans proposed. Naturalistic and experimental studies suggest that such bans are associated with decreased smoking in those who smoke menthol cigarettes but that a large proportion continue to smoke combustible products by switching to non-menthol cigarettes. A potentially less harmful pattern of tobacco use would be to switch to non-combustible products if such use decreased combustible cigarette smoking and did not undermine complete tobacco cessation. Among the available non-combustible tobacco products, nicotine pouches are a relatively new, rapidly growing and largely understudied product category that do not contain tobacco leaf and are neither aerosolized nor inhaled. On a continuum of risk, nicotine pouches are therefore likely among the least harmful tobacco products. Considering that people who smoke menthol cigarettes prefer menthol/mint flavored non-combustible products when switched to non- menthol cigarettes, it is important to assess how flavors in pouches affect the extent to which they are acceptable substitutes for menthol cigarettes. Using an experimental marketplace, this application aims to 1) Evaluate the acceptability of nicotine pouches relative to medicinal nicotine in people who smoke menthol cigarettes; 2) Evaluate how flavors influence the substitutability of nicotine pouches for non-menthol cigarettes; and 3) Evaluate the effects of a menthol cigarette ban on pouch use. The central hypotheses are that nicotine pouch uptake is greater than that of medicinal nicotine; that flavored pouches will lead to more substitution for cigarettes than unflavored pouches; and that a menthol cigarette ban will further increase the extent of pouch substitution. We propose a randomized study in which 252 people who smoke menthol cigarettes will for 6 weeks receive all tobacco products from experimental marketplaces designed for the study that will simulate either: 1) a ban on all pouch flavors; 2) a flavor ban that exempts menthol flavors in pouches; 3) no flavor ban (i.e., all flavors available) or 4) a control condition in which menthol cigarettes continue to be available along with all pouch flavors. In all conditions, non-menthol cigarettes and medicinal nicotine are available but menthol cigarettes are only available in the control condition. The study will provide data, under simulated real-world conditions, on the amount of each product used (including cigarette use), biomarkers of exposure, motivation to quit smoking, and subjective ratings of the products used. This work is innovative as there is little data regarding the impact of nicotine pouches and their flavors in the context of menthol removal in cigarettes. It is significant in that it assesses how these products are likely to be perceived and used by people who smoke thereby building a scientific basis for determining the public health impact of their availability, acknowledging that studies are also needed to assess the impact on youth. It is also significant in that it would contribute to the evidence that a menthol ban would accelerate reducing harm from smoking. Project Number: 1R01CA299669-01A1 | Fiscal Year: 2026 | NIH Institute/Center: National Cancer Institute (NCI) | Principal Investigator: MICHAEL KOTLYAR (+1 co-PI) | Institution: UNIVERSITY OF MINNESOTA, MINNEAPOLIS, MN | Award Amount: $621,549 | Activity Code: R01 | Study Section: Addiction Risks and Mechanisms Study Section[ARM] View on NIH RePORTER: https://reporter.nih.gov/project-details/11319360