Effective communication strategies are urgently needed to convey the relative risks of tobacco products accurately among adults who currently use combustible tobacco while minimizing such appeal among youth populations. The long-term objective of this project is to optimize future public health communication on the continuum of risk for tobacco products to minimize tobacco use harms among adults who use tobacco products and prevent youth initiation and progression of tobacco product use. Our proposed project, will assess the effects of FDA tobacco product risk continuum messaging on adult users of combustible tobacco products (including those who have not yet been able to quit) and youth/young adults using an integrated study design that captures the full range of relevant outcomes, from immediate message response and receptivity to longer-term behavior. This NCI-funded 4 year project is guided by a theoretical framework integrating key constructs in health communication (Message Impact Framework), persuasion (McGuire's persuasion framework), behavioral economics, and behavioral change theories (Reasoned Action). 

Our specific aims are to: (1) Generate rankings of messages and identify effective message features based on perceived message effectiveness, and message comprehension; (2) Characterize effects of messages and message features on response and receptivity, and precursors to behavior, including behavioral intentions, and (3) Specify immediate and long-term behavioral effects of tobacco product risk continuum messages. 

Approach: We will deploy a nimble framework to: refine messaging and develop control messages (message rating survey, cognitive interviews); formally test message response, receptivity, and effects on behavioral precursors (online national experiments, eye-tracking and neuroimaging); and assess immediate and long-term effects on behavior (mobile device-based message delivery and laboratory smoking topography studies) among samples of adults who use combustible tobacco, youth/young adults who use non-combustible tobacco, and youth/young adults who do not use tobacco. Impact: The successful completion of this project will provide FDA with clear, rigorous, and comprehensive evidence regarding the effectiveness of the specific messages provided for this study, as well as theory-informed insights regarding broader message strategies to optimize future public health communication on the continuum of risk for tobacco products to diverse audiences.

Sale of cannabis for recreational use is rapidly becoming legal across states in the US. While cannabis use policies typically contain marketing restrictions, including prohibitions on misleading marketing claims, there is limited research to inform operationalization of these policies, and these policies are rarely enforced. Cannabis products are often labeled based on “species” or cultivar (Indica, Sativa, or Hybrid). Notably, there is limited evidence that different species consistently have different profiles of chemical constituents. Despite this, cannabis is marketed directly to consumers with product labels “Indica”, “Sativa”, and “Hybrid”, and with corresponding marketing claims that the product has sedative (e.g., relaxation, sleepiness) or energizing (e.g., focus, productivity, physical activity) effects. Consumers also report experiencing sedative effects from Indica- labeled cannabis and energizing effects from Sativa-labeled cannabis. This may translate into unsafe use: our prior work has found consumers are more likely to report using Sativa-labeled (vs. Indica-labeled) cannabis before driving or going to work. Despite the potential for public health harm, there is no data demonstrating whether product perceptions, use expectancies, and subjective and objective acute effects of use vary by label or marketing claim. Research from other consumer domains, including tobacco, indicates that labeling and marketing can have powerful effects on product perceptions, use behavior, and use experience. Marketing and labeling for cannabis could similarly foster inaccurate product perceptions (e.g., regarding harm), expectancy effects (e.g., anticipating a product to increase focus) and lead to unsafe use (e.g., while driving). This undermines initiatives to promote safe use of cannabis and risks public health. To date, controlled research has not systematically evaluated how product labeling (Indica, Sativa, Hybrid) or associated marketing claims (sedative vs. energizing) affect use behavior, risk perception, or acute drug effects. 

This five year NIDA-funded research uses a large-scale content analysis of cannabis labeling and marketing (Aim 1), a randomized online experiment (Aim 2), and a placebo-controlled randomized laboratory experiment (Aim 3) to document the scope and effects of cannabis labeling (Indica, Sativa, Hybrid) and marketing claims (sedative, energizing). Ultimately, this work will provide evidence to inform cannabis marketing and labeling policies, which are necessary to protect public health.

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 NIDA-funded project elucidates 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.

A nuanced understanding of physiological and neural response to FDA Center for Tobacco Product’s “The Real Cost” Cigarette and E-cigarette Youth Prevention campaign advertisements provides insight into communication strategies likely to effectively educate the public about tobacco product risks. This FDA-funded study assessed physiological and neural response to “The Real Cost” Cigarette and E-cigarette Youth Prevention campaign ads, and explored associations between these responses and self- reported indicators of message response and effects. Forty-eight youth ages 13-17 and 50 young adults ages 18-24 participated in a study in which they viewed either “The Real Cost” Cigarette or E-cigarette campaign messages while facial electromyography, electrodermal activity, heart rate, activity in the medial prefrontal cortex and right dorsolateral prefrontal cortex, and eye-tracking data were collected. Participants also self-reported message response and effects. Results indicate that physiological and neural responses to the ads were largely favorable. In particular, ads demonstrated notable indications of attentional response and of self-referential processing, which has been found to be an important indicator of persuasion. Assessment of associations between physiological and neural indicators of ad response with self-reported ad response indicated that while these measures may provide complementary data to self-reported measures, self-reported measures nonetheless can offer a level of specificity regarding