FoSHU (food for specified health uses) are evidence-based functional foods regulated and approved by the Japanese government. Products to improve intestinal microflora were developed using probiotics/prebiotics and were approved as FoSHU to promote gut health. Food substances which suppress intestinal digestive enzymes were also used to develop FoSHU products to lower blood glucose or lipid levels. Recent studies have shown that dietary components, particularly probiotics/prebiotics, may play important roles in regulating the gut immune system. Although scientific evidence is still lacking, they may suppress intestinal inflammation and allergic reactions and therefore may hold promise as ingredients in functional foods.