Risk Assessment for Tobacco Regulation.

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.