FDA regulates tobacco products based on a public health standard that considers the risks and benefits of the tobacco product on the population as a whole. A part of this consideration includes the evaluation of a tobacco product’s abuse liability, or the ability for a product to promote continued use and lead to addiction and dependence. Abuse liability also directly informs whether one product may be acceptable as a substitute for another product, whether using a product is likely to result in a pattern of continued use, and the likelihood of an individual being able to quit using a product successfully. Tobacco product abuse liability assessments are multifaceted and rely on many different measures, including behavioral and clinical pharmacology outcomes. Many product characteristics can influence abuse liability and an understanding of these product specific characteristics is important when designing studies to inform tobacco product abuse liability evaluations.

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