The fundamental principle underpinning FDA decision making following PMTA submission for a novel tobacco product is whether the marketing the product is Appropriate for the Protection of Public Health (APPH).
Although multiple lines of evidence are necessary to support an APPH determination, understanding how novel tobacco products are used, and characterizing users’ prior and current tobacco product use histories, can provide important information for evaluating individual- and population-level impacts.
Product-specific user survey data can inform exposure assumptions for health risk assessments, characterize patterns of switching or dual use, and help assess whether product use is likely to occur among the intended adult tobacco-user population.
Purpose: To assess demographics, tobacco use history, patterns of use, reasons for initiation, future tobacco and nicotine product use intentions, use of oral nicotine pouches (ONPs) in relation to cigarette reduction or discontinuation, and dependence/subjective effects.
