Berman Micah L, El-Sabawi Taleed, Shields Peter G
The Ohio State University College of Public Health and Moritz College of Law, Columbus, OH.
The Ohio State University College of Public Health, Columbus Ohio.
Tob Regul Sci. 2019 Jan;5(1):36-49. doi: 10.18001/TRS.5.1.4.
Risk assessment is a process that uses a transparent, reproducible and pre-established methodology to evaluate alternatives for managing health-related risks. Although an array of federal agencies regularly use risk assessment to inform regulatory decisions, its application to tobacco regulation is new. By comparing examples of FDA risk assessments for food and tobacco, this paper highlights some of the challenges inherent in applying risk assessment methodologies to tobacco regulation. In doing so, it calls upon researchers to work with the FDA to develop a tobacco-specific approach to risk assessment that reflects the Tobacco Control Act's regulatory framework and the distinctive features of tobacco products and tobacco use.
风险评估是一个运用透明、可重复且预先确定的方法来评估管理健康相关风险的替代方案的过程。尽管一系列联邦机构经常使用风险评估来为监管决策提供依据，但其在烟草监管中的应用却是新的。通过比较美国食品药品监督管理局（FDA）对食品和烟草的风险评估实例，本文突出了将风险评估方法应用于烟草监管所固有的一些挑战。在此过程中，它呼吁研究人员与FDA合作，开发一种针对烟草的风险评估方法，该方法应反映《烟草控制法》的监管框架以及烟草制品和烟草使用的独特特征。
