Medicines and Food
Medicines (pharmaceutical products) are mainly used for diagnosis, treatment and prevention of diseases, while food is used for taking nutrition and enjoying taste and flavor. However, some food is considered to have the effect of preventing and treating diseases. In the Food Sanitation Act, article 4 defines that ‘The term “food” as used in this Act shall mean all food and drink; provided, however, that this term shall not include pharmaceutical products or quasi-pharmaceutical products specified by the Pharmaceuticals and Medical Devices Law’. Thus, the distinction between pharmaceutical products and food is defined by whether or not efficacy of such a treatment or prevention for diseases can be displayed. To display efficacy leads to being exposed as an infringement of the Pharmaceuticals and Medical Devices Law, even if some food can prevent a disease.
However, health-promoting food which was institutionalized in 2001 is an exceptional case, is divided into 3 types: “food for specified health uses”, “nutritional functional food“, and “food with function claims.” These are allowed to display efficacy about special health on particular expression. Only “food for specified health uses” was scientifically proved efficacy of special health in the national examination and was approved by the Minister of Consumer Affairs, and showed that it “maintains good digestion” or “prevents the absorption of fat.” “Food with function claims,” which was established in 2015, tends to be confused with “food for specified health uses,” however, the functionality based on scientific evidence is displayed under the responsibility of the owner. Thus, “food with function claims” is different from “food for specified health uses” in which the safety and functionality are not examined scientifically by the nation, and are approved only by papers without clinical studies.
Moreover, supplements are commonly called health foods so as to supply nutrition such as vitamins and amino acids which are deficient in persons. The position of supplements is not clarified although they are legally categorized as a food, not pharmaceutical products. Recently, the health hazards which are caused by taking excessive supplements have been reported, and it is high time that supplements should be legally regulated.