U54 Pilot: The Impact of Rurality Level and Product Characteristics on Nicotine Pouch Sales Patterns in the U.S.

ABSTRACT Nicotine pouches have emerged as a noteworthy development in the landscape of tobacco and nicotine products in the U.S. Unlike traditional tobacco products, these pouches deliver nicotine through salts and flavorings without containing any tobacco leaf. Introduced in 2016, nicotine pouches have quickly become a major product category, reaching $217 million in sales by 2020. However, their increasing popularity raises public health concerns. Nicotine pouches, often marketed as a harm-reduction alternative for smokers, may promote nicotine dependence and dual use, especially in smoke-free environments. Moreover, these products may exhibit disparities in use between rural and urban populations. This study aims to examine how sales patterns and product characteristics of nicotine pouches (e.g., flavor, brand, nicotine concentration) vary across levels of rurality in the U.S. Using NielsenIQ retail scanner data, which provides weekly sales at the county and zip code levels, we will analyze the availability and demand for these products across different geographic regions. Additionally, the Index of Relative Rurality (IRR), a continuous measure of rurality, will be applied to assess sales variations by geography. The study''s two main aims are: (1) to determine nicotine pouch availability and sales trends across rural and urban areas, and (2) to describe sales patterns in relation to product characteristics, such as flavor and nicotine concentration, with a focus on rural- urban differences. The findings will offer critical insights into nicotine pouch demand, particularly among rural populations, providing the FDA with valuable data to inform regulatory actions and public health policies. This research has the potential to shape targeted pre- and post-market evaluations of nicotine pouches, ensuring that they meet public health protection standards, especially in rural communities.