Addiction potential, flavoring content, and substitutability of concept flavored cigarillos - PROJECT SUMMARY/ABSTRACT This proposal is responsive to NIDA strategic plan initiatives focused on applying addiction science to improve public health and policy. In April 2022, the Food and Drug Administration (FDA) announced proposed rulemaking to ban all characterizing flavors other than tobacco (like Chery, Chocolate) from cigars.1 Cigarillos, the most widely sold cigar product, are predominantly used by young adults (YAs, defined here as ages 18-24), as well as Black and Hispanic individuals,2-5 and flavors are cited as a primary reason for their use.6-8 The emergence of “concept flavors” – vague ambiguous flavor descriptors with no explicit flavor name – is a product characteristic used by tobacco companies to evade local flavor bans9 and have been shown to appeal to YAs.10-12 Notably, of all other tobacco products, cigarillos show the greatest increase in concept flavor sales in recent years, compared to sales of tobacco and other characterizing flavors.6 Existing research, including our own, shows that explicit characterizing flavor descriptors on cigar products are associated with greater perceptions of product appeal (e.g., subjective effects like taste, smell, and enjoyment to smoke)13, 14 and use behavior14-16 relative to products labeled with tobacco flavor descriptors. Despite the rapid increase in sales of concept flavored cigarillos6 and early evidence of the appeal of e-cigarettes with concept descriptors17, the addiction potential of concept descriptors (e.g., subjective reinforcing effects, use behavior, motivation to consume/purchase), especially among younger cigarillo users, remains unknown. These indices are important indicators of the neurobiological systems that underlie addiction and motivate subsequent tobacco use.18, 19 Limited research exists, but this is all done in adults, or via online experiments or cross-sectional designs20-23, indicating the need for more studies. Only one laboratory study has investigated the impact of flavor on different indices of cigarillo use and appeal,20 but it did not include concept flavors and recruited only cigar-naïve cigarette smokers. There is a critical need to isolate the unique effects of concept descriptors on increased cigarillo use and appeal among experienced YA cigarillo users. Without this information, regulatory actions will only target characterizing, but not concept flavors, unintentionally shifting the cigar market to concept-flavored cigarillos. This would undermine the intended public health benefits of a cigar flavor ban. To address this need, this multi-method study will determine the addiction potential of concept flavored cigarillos in YA cigarillo users (N=300) by examining associations of cigarillo flavor type (concept, characterizing, tobacco) and their flavoring additives to complementary measures of product appeal: subjective effects (e.g., satisfaction, reward, taste), actual smoking behavior (e.g., number of puffs), and cigarillo purchasing, product substitution, or quitting under different flavor ban scenarios via an Experimental Tobacco Marketplace (ETM).15, 24, 25 This study will contribute to the evidence-base that informs the implementation of the cigar flavor ban, can fortify FDA’s claims in potential legal challenges to the ban, and inform the addiction potential of tobacco products with concept flavor descriptors.