Evaluating Safety and Efficacy of Functional Foods

Abstract

The author reviews and comments on the present state of safety evaluation and efficacy of functional foods in Japan: Dietary experience has been of great importance in food safety; however, when doses/concentrations of functional foods or their components considerably exceed levels in ordinary foods, safety can no longer be guaranteed. In the author’s view, such products thus need to be treated like drugs. In addition, when researching the efficacy of functional foods, randomized controlled trials are key, and findings obtained from observational epidemiology should also be taken into account.