Differences on the Regulation between Foods with Health Claims and Ethical Pharmaceuticals from the Viewpoint of Regulatory Science

Abstract

Currently, self-medication, including the use of foods with health claims (FHCs), is promoted as means of increasing our health span. However, the functional substance(s) in FHCs and its actions are diverse, and therefore it is difficult to evaluate their safety and efficacy in clinical trials. In this review article, we describe the definition and the history of regulations regarding FHCs. After discussing their types and features, we explain the differences on regulations between FHCs and ethical pharmaceuticals regarding their safety and efficacy in clinical trials, which are required to provide them with scientific evidence. Finally, we believe that transparent standards regarding the evaluation of FHCs would help increase the use of FHCs and their market value in the future.