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TSRC, Tob. Sci. Res. Conf., 2023, 76, abstr. 58

Standardizing the evaluation of appropriateness for the protection of public health in premarket tobacco product applications

SELTZER R.(1); CHEN Ding-Geng(2); FEARON I.M.(3)
(1) Safety in Numbers, Tucson, AZ, USA; (2) Arizona State University, Phoenix, AZ, USA; (3) whatIF? Consulting Ltd, Harwell, UK

Behavioral surveys for Premarket Tobacco Product Applications (PMTAs) for novel non-combustible tobacco products are intended to show that the benefits to smoking cessation outweigh the risks of youth initiation and use among nicotine non-users. We developed a statistical approach to quantify this risk-benefit balance. This optimization algorithm is created by calculating a composite score based on multiple survey responses and then using this score to predict the likelihood of using or intending to use a product. We accessed behavioral survey data from the 2017 IQOS PMTA. A principal components analysis was run on 26 questions that indicate perceptions of health and addiction risk. A two-factor model was revealed based on the derived scree plot and Eigen values of 21.71 and 1.06. Factor scores were calculated and summed for each respondent to create a composite risk score. This risk score was then used to predict likelihood of IQOS use and intention to use IQOS. We demonstrate models varying in survey response patterns in which IQOS use for adult cessation benefit is more likely than the risk of youth initiation and in which youth initiation risk is more likely than adult cessation benefit. This method is intended to objectively assess a product’s Appropriateness for the Protection of Public Health (APPH) and offer explicit criterion on which the FDA can evaluate APPH of a product in a PMTA. Knowledge of these factors can provide direction on what areas of youth use and smoking cessation need to be addressed to improve the risk-benefit balance. This approach can help clarify what information should be collected in PMTAs and guide efforts to standardize the regulation and review process.