PROJECT SUMMARY/ABSTRACT
A novel class of oral nicotine pouches that contain a nicotine powder instead of tobacco leaves have recently
emerged and fall under FDA’s purview, but there is virtually no research to inform the regulation of these
products. These novel pouches are rapidly growing in popularity. For example, in 2020, dollar sales in U.S.
convenience stores grew by 470% for ‘Zyn’, a leading brand of these pouches. Our preliminary research indicates
that these products are being marketed heavily to consumers, often with advertising tactics that may convey
modified risk (i.e., descriptors of “tobacco-free”). These pouches contain non-tobacco flavors (e.g., fruit) with
known appeal to youth. Tobacco industry research shows that these pouches deliver similar, or greater, levels
of nicotine to users than traditional smokeless oral tobacco products, suggesting that they can produce
dependence. Because FDA applies a public health standard when regulating tobacco products, the risks and
benefits of novel oral nicotine pouches must be considered for current smokers (a population that may benefit
from switching to novel nicotine pouches) and non-nicotine users, especially youth (a population for whom
nicotine pouch use would have negative public health consequences). Using human lab studies, marketing
surveillance, and web-based experiments, this innovative project will elucidate product features and marketing
tactics that may drive initiation and continued use of novel oral nicotine pouches for smokers and non-nicotine
users, including youth, addressing FDA CTP’s areas of scientific interest in Addiction/Abuse Liability, Behavior,
and Marketing Influences. In Aim 1, smokers will use pouches of different flavors (tobacco; mint; fruit) and
nicotine doses (low; high), and their own brand of cigarettes, over 7 lab sessions and pharmacokinetic (PK) and
pharmacodynamic (PD) effects (e.g., subjective abuse liability and tobacco withdrawal) will be assessed. In Aim
2, we will surveil advertisements for novel nicotine pouches over 5 years to identify/monitor marketing tactics
and examine, via web-based experiments, how common tactics influence product perceptions (i.e., perceived
harm, addictiveness, and appeal) and use intentions among cigarette smokers and youth non-nicotine users. In
Aim 3, we will conduct a second lab study with smokers and adult non-nicotine users to determine how a common
marketing tactic (e.g., “tobacco-free” descriptors) impacts use behaviors and PK/PD effects of these pouches.
This project will provide vital new data on product features and marketing tactics that may influence whether
smokers and non-nicotine users (including youth) initiate, continue using, and possibly become addicted to novel
oral nicotine pouches. This information will allow FDA to make informed decisions about what features should
be allowable in novel nicotine pouches, how accessible they should be, and what marketing tactics should be
permissible. Ultimately, this research can protect public health by informing polices to mitigate use of these
pouches by nicotine-naïve youth as well as policies that may facilitate product switching for smokers.
