Traditional definitions of abuse and misuse do not apply to a consumer product such as tobacco that consumers essentially use ‘as intended’. In contrast to pharmaceutical products, a guidance for abuse liability testing of nicotine and tobacco products has not been issued in a U.S. regulatory context. As a result, no definitive industry guidance exists for abuse liability testing of such products to aid in obtaining a marketing order in the U.S. from the Food and Drug Administration. This presentation is intended to summarize current consensus on the best abuse liability assessment methodologies.

Some of the key issues that will be discussed include the importance of including a variety of abuse liability assessments including chemistry, toxicology, preclinical pharmacology, animal behavioral and dependence pharmacology, pharmacokinetics/pharmacodynamics, human abuse potential laboratory studies, clinical trial data relative to abuse dependence potential, integrated summaries of safety and efficacy, and any foreign experience with the drug. “Gold standard” human abuse potential laboratory studies will be examined in detail. In addition, subjective effects questionnaires measures that evaluate the perceived rewarding effects of the tobacco product, product acceptability, central nervous system (CNS) and peripheral effects of tobacco products will be discussed. All topics will be integrated to assess perceived regulatory requirements and challenges.