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TSRC, Tob. Sci. Res. Conf., 2023, 76, abstr. 57

The case for a revised abuse liability assessment framework for tobacco products

Altria Client Services, Richmond, VA, USA

For new or modified risk tobacco product applications, the U.S. Food and Drug Administration (FDA) recommends tobacco product manufacturers provide an abuse liability assessment (ALA) of their products to inform the likelihood that product use will lead to addiction and repeated or sporadic use that results in undesirable consequences. The typical approach to tobacco product ALA stemmed from the methods and framework used to evaluate pharmaceutical products, with primary outcomes derived from clinical laboratory studies that assess subjective effects (e.g., liking and satisfaction) and nicotine delivery. While this approach has been successful in meeting FDA recommendations, recent data reveal opportunities to reevaluate the tobacco ALA framework. Controlled, clinical conditions do not necessarily reflect nicotine delivery under real world conditions or likelihood of product use and existing subjective measures often do not differentiate products within the same category, even when products vary by nicotine level or flavor, making it difficult to infer the likelihood that product use would lead to addiction and undesirable consequences. This presentation will describe a potential revised ALA framework that would rely foremost on data from actual use and topography studies, including tobacco use patterns, subjective responses, and product use intentions. These data along with nicotine pharmacokinetic data can serve as inputs to models that predict resultant nicotine and toxicant exposure and infer the likelihood that the product would serve to displace more harmful tobacco use behaviors. This framework represents a more relevant and fulsome tobacco product ALA that prioritizes information inclusive of product preferences and real-world usage patterns, which better describes whether individuals would use the product in a way that would result in undesirable consequences relative to other tobacco products.