Vansickel Andrea, Baxter Sarah, Sherwood Neil, Kong Michael, Campbell Leanne
Regulatory Affairs, Altria Client Services LLC, Richmond, VA, USA.
Clinical Studies, RAI Services Company, Winston-Salem, NC, USA.
Nicotine Tob Res. 2022 Feb 14;24(3):295-305. doi: 10.1093/ntr/ntab183.
Many regulatory bodies now recommend that tobacco product manufacturers provide information regarding new tobacco products' abuse liability to inform regulatory authorization of currently marketed tobacco products or new product applications (including premarket tobacco product applications in the United States). In addition, the US Food and Drug Administration (FDA) recommends including this information as part of modified risk tobacco product applications. Regulators, including FDA, and many public health officials and researchers consider abuse liability assessment a model which predicts the likelihood that the use of the tobacco product would result in addiction and be used repeatedly or even sporadically resulting in undesirable effects. Abuse liability of a new, potentially reduced harm product can also inform its ability to substitute completely for more harmful tobacco products. While many methods exist, no standard tobacco product abuse liability assessment has been established. The purpose of this review is to provide background information and practical recommendations for human abuse liability testing methods to meet tobacco regulatory needs. A combination of nicotine test product pharmacokinetic, subjective effect and/or behavioral response, and physiological response data relative to comparator products with known abuse liability satisfies some regulatory requirements. Implications: This review provides a practical inspection of the current, international regulatory recommendations for abuse liability assessment of tobacco and regulatory review of such information within the United States and also recommends study designs and methods for abuse liability testing of tobacco products based on scientific and regulatory knowledge. Given that tobacco product abuse liability testing is of increasing interest to regulatory bodies globally, especially with the emergence of novel tobacco products, this timely work provides background and functional recommendations for tobacco product abuse liability testing.
现在，许多监管机构建议烟草产品制造商提供有关新型烟草产品成瘾可能性的信息，以便为当前上市烟草产品的监管授权或新产品申请（包括美国的上市前烟草产品申请）提供依据。此外，美国食品药品监督管理局（FDA）建议将此信息纳入改良风险烟草产品申请的一部分。包括FDA在内的监管机构以及许多公共卫生官员和研究人员认为，成瘾可能性评估是一种模型，可预测使用烟草产品导致成瘾并被反复使用甚至偶尔使用而产生不良影响的可能性。新型潜在危害较小产品的成瘾可能性也可表明其完全替代危害更大烟草产品的能力。虽然存在多种方法，但尚未建立标准的烟草产品成瘾可能性评估方法。本综述的目的是提供背景信息和关于人体成瘾可能性测试方法的实用建议，以满足烟草监管需求。将尼古丁测试产品的药代动力学、主观效应和/或行为反应以及与已知成瘾可能性的对照产品相关的生理反应数据相结合，可满足一些监管要求。启示：本综述对当前国际上关于烟草成瘾可能性评估的监管建议以及美国对此类信息的监管审查进行了实际考察，并根据科学和监管知识推荐了烟草产品成瘾可能性测试的研究设计和方法。鉴于全球监管机构对烟草产品成瘾可能性测试的兴趣日益浓厚，尤其是随着新型烟草产品的出现，这项及时开展的工作为烟草产品成瘾可能性测试提供了背景和实用建议。
