History and current status of functional food regulations in Japan

A large-scale research project on food functions started in Japan in the early 1980s brought about the world’s first policy on legally approving functional food as “food for specified health use” (FoSHU). About 10 categories of health claim are currently permitted, which include promotion of gut and bone health, hypotension, and reduction of blood glucose and lipid levels. More than 1000 FoSHU products have been listed since 2012. The approval of FoSHU is given to each functional food product after time-consuming strict inspection and verification of the submitted data regarding effectiveness and safety. Therefore a committee launched an investigation in 2011 for a more practical and convenient evaluation system, and the usefulness of systematic review in evaluating the effectiveness of functional food was confirmed. Based on this, a new health claim labeling system for functional food was established in 2015. This new system was termed “foods with function claims (FFC).” Unlike FoSHU, the manufactures can collect scientific evidence data to be submitted only by systematic review, and inspection and verification by governmental committees is not required in the FFC system. FFC products with new health-promoting functions are increasing, although there are several problems to be solved for better regulation.