University of Arkansas for Medical Sciences, Little Rock, USA.
Cancer Epidemiol Biomarkers Prev. 2009 Dec;18(12):3241-62. doi: 10.1158/1055-9965.EPI-09-0948.
The harm produced by tobacco products is a result of frequent use of a highly toxic product. Reducing the adverse public health impact of tobacco products might be most effectively achieved by reducing the likelihood of their use and the toxicity of the products. Products that retain some characteristics of cigarettes but have been altered with the intention of reducing toxicity have been referred to as modified risk tobacco products or potential reduced exposure products (MRTP/PREP). Evaluation of their content, emission, and toxicity is discussed in other articles in this special issue. Here, we discuss the methodology that has been used to examine the likelihood of abuse or addiction. Abuse liability assessment (ALA) methodology has been used by the Food and Drug Administration (FDA) and other drug regulatory agencies world-wide for decades to assess the risks posed by a wide variety of pharmacologically active substances. ALA is routinely required among other evaluations of safety during the pre-market assessment of new drugs, and is continually adapted to meet the challenges posed by new drug classes and drug formulations. In the 2009 law giving FDA regulation over tobacco products, FDA is now required to evaluate new tobacco products including MRTP/PREPs to determine their risk for abuse and toxicity at the population level. This article describes the traditional tools and methods of ALA that can be used to evaluate new tobacco and nicotine products including MRTP/PREPs. Such ALA data could contribute to the scientific foundation on which future public policy decisions are based.
烟草产品造成的危害是由于频繁使用高度有毒产品所致。减少烟草产品对公众健康的不良影响，最有效的方法可能是降低其使用可能性和产品毒性。保留香烟某些特征但意图降低毒性的产品被称为改良风险烟草产品或潜在减害产品（MRTP/PREP）。本特刊的其他文章讨论了对其含量、排放和毒性的评估。在这里，我们讨论了用于检查滥用或成瘾可能性的方法。数十年来，滥用倾向评估（ALA）方法已被美国食品和药物管理局（FDA）和其他全球药物监管机构用于评估各种具有药理活性物质带来的风险。在新药上市前评估的安全性评估中，除其他评估外，通常需要进行 ALA，并且不断适应新的药物类别和药物配方带来的挑战。在赋予 FDA 对烟草产品监管权的 2009 年法律中，FDA 现在被要求评估包括 MRTP/PREP 在内的新型烟草产品，以确定其在人群层面上的滥用和毒性风险。本文描述了可用于评估新型烟草和尼古丁产品（包括 MRTP/PREP）的传统 ALA 工具和方法。此类 ALA 数据可以为未来的公共政策决策提供科学依据。
