R01DA055962

Novel "Tobacco-Free" Oral Nicotine Pouches: The Impact of Product Features and Marketing Influences on Abuse Liability, Perceptions, and Use Behavior in Smokers and Non-Nicotine Users - 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 policies to mitigate use of these pouches by nicotine-naïve youth as well as policies that may facilitate product switching for smokers.

The Johns Hopkins University

THE FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT (TCA) PROVIDES THE AUTHORITY TO REGULATE TOBACCO PRODUCT MANUFACTURING, DISTRIBUTION AND MARKETING. REGULATORY RESEARCH WILL PROVIDE THE SCIENTIFIC EVIDENCE TO GUIDE THE IMPLEMENTATION OF THIS AUTHORITY. RESEARCH AREAS INCLUDE: 1) TOBACCO PRODUCT COMPOSITION AND DESIGN 2), THE TOXICITY OF TOBACCO PRODUCTS, 3) ADDICTION AND ABUSE LIABILITY OF TOBACCO PRODUCTS, 4) THE SHORT- AND LONG-TERM HEALTH EFFECTS OF TOBACCO PRODUCTS, 5) PEOPLE'S BEHAVIORS RELATED TO TOBACCO PRODUCT USE AND CHARACTERISTICS, 6) COMMUNICATING TO THE PUBLIC REGARDING NICOTINE AND THE HEALTH EFFECTS OF TOBACCO PRODUCTS, 7) THE INFLUENCES OF TOBACCO MARKETING ON SUSCEPTIBILITY AND TOBACCO PRODUCT USE, AND 8) THE POTENTIAL OR ACTUAL IMPACT OF FDA REGULATORY ACTIONS. THE STRATEGIC PRIORITIES FOR THESE RESEARCH AREAS CAN BE FOUND AT HTTPS://WWW.FDA.GOV/TOBACCOPRODUCTS/RESEARCH/RESEARCH-PRIORITIES

93.077 - Family Smoking Prevention and Tobacco Control Act Regulatory Research

National Institute on Drug Abuse (NIDA) [HHS - NIH]

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

Baltimore, Maryland 212051832 United States

Single Zip Code

Tobacco Regulatory Science (R01 Clinical Trial Optional) (RFA-OD-21-002)

Amendment Since initial award the total obligations have increased 285% from $813,127 to $3,131,112.