ABSTRACT – Project 3 Our overall goal, reflecting AppalTRuST’s Integrative Theme of investigating the effects of regulatory changes on tobacco product use in Appalachian KY, is to assess the impact of proposed tobacco product regulations using behavioral economic methods that we have developed and refined in past years to characterize the consumption of tobacco products within the complex nicotine marketplace of Appalachian KY, a diverse and underserved rural region that would greatly benefit from focused tobacco regulatory science research. This project primarily falls under the Regulatory Scientific Domain of Impact Analysis. In 2009, the Food and Drug Administration (FDA) was granted authority to regulate tobacco products to benefit public health. In the years since, the FDA has proposed potential regulatory actions that may benefit public health, including regulating the maximum nicotine content in combustible cigarettes and restricting flavors of combusted and non- combusted tobacco products. Estimating the impact of any proposed regulatory action is complicated by the existence of a complex tobacco marketplace containing multiple products that are economic substitutes for one another and the frequent introduction of new tobacco products by manufacturers. Furthermore, when compared to more urban, non-Appalachian communities, rural Appalachian communities often have 1) higher rates of tobacco product use overall, 2) different use patterns that include more combusted tobacco products, and 3) different product availability in tobacco stores. It is therefore important to estimate any differential impact of proposed tobacco-product regulations in Appalachia. Using an Experimental Tobacco Marketplace (ETM) model where product availability is manipulated across groups and demand elasticity and substitution is measured across tobacco products, we will estimate the impact of regulating 1) nicotine content of combusted cigarettes, 2) menthol flavor restrictions in combustible cigarettes, and 3) flavor additive restrictions in non- combusted nicotine/tobacco products including ENDS. Across two aims, we will assess the impact of these three regulations within Appalachia (Aim 1) and the effect of rurality on impact of these proposed regulations in Appalachia (Aim 2).