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TSRC, Tob. Sci. Res. Conf., 2021, 74, abstr. 69

Human abuse liability assessment of tobacco and nicotine products: considerations to meet current regulatory recommendations

VANSICKEL A.(1); BAXTER-WRIGHT S.(2); CAMPBELL L.(2); SHERWOOD N.(3); KONG M.C.(4)
(1) Altria Client Services, Richmond, VA, USA; (2) RAI Services Company, Winston-Salem, NC, USA; (3) Neil Sherwood Consulting, Nyon, Vaud, Switzerland; (4) Altasciences, Overland Park, KS, USA

The U.S. Food and Drug Administration (FDA) recommends that tobacco product manufacturers provide information regarding the abuse liability of tobacco and nicotine-containing products to support pre-market tobacco, modified risk tobacco product and substantial equivalence applications. While many methods exist, no standard tobacco product abuse liability assessment methodology has been established and no formal guidance document for such testing has been issued. A CORESTA Product Use behavior subgroup reviewed the FDA’s recommendations, published literature and studies related to the abuse liability of tobacco, and information from other authoritative bodies to identify the most promising approaches for abuse liability assessment of tobacco products. The current regulatory recommendations around abuse liability assessments as well as strategies to apply traditional abuse liability testing approaches for pharmaceutical products to tobacco and nicotine-containing products will be discussed. Considerations include the key study endpoints, subject population, study design, relevant comparator products, and product use approaches. Additionally, insights drawn from regulatory reviews of abuse liability information for a variety of tobacco product applications will be summarized. Recommendations for abuse liability testing of tobacco products and for synthesis and interpretation of findings from these assessments will be shared. Finally, global considerations for abuse liability assessments of tobacco and nicotine products for pre-marketing applications/regulatory review will be presented.