2014 SOT FDA Colloquium: Complexities in Evaluating Human Clinical and Observational Data for Ingredient Safety Assessment

The Society of Toxicology in conjunction with the US FDA Center for Food Safety and Applied Nutrition (CFSAN) have partnered to provide this colloquia series. The series presents scientific information that is high-quality, cutting-edge, future-oriented toxicological science to provide a well-grounded foundation to inform the work of US FDA employees.

On November 7, 2014, SOT and US FDA co-hosted a colloquium that provided a state-of-the art review of methodological approaches used in toxicology studies, using research related to Partially Hydrogenated Oils as a case study.

Traditional controlled studies are difficult to conduct in humans although evidence can be brought together from epidemiological and other clinical studies. In addition, application of data obtained in animal studies has to be carefully evaluated for applicability for humans.