Regulations for health foods are related to the Food Sanitation Act and the Pharmaceutical and Medical Devices Act. As a starting point, raw materials such as ingredients present in health foods that humans ingest orally need to be assessed as pharmaceuticals or nonpharmaceuticals. After the assessment, they are listed as raw materials exclusively used as pharmaceuticals or non-pharmaceuticals. In April 2015, a Foods with Functional Claims (FFCs) system, based on advance notifications from manufacturers, was launched as a new category of health food. Before the submission of FFCs, it is necessary to confirm that they are not exclusively used as pharmaceuticals. Recently, the Ministry of Health, Labour and Welfare (MHLW) amended the Enforcement Regulation of the Food Sanitation Act for obligatory reporting of health damage incidents caused by the intake of food containing designated ingredients that call for special attention (designated ingredients, etc.). In June 2020, Forskohlii (Coleus forskohlii (Willd.) Briq.), Greater celandine (Chelidonium majus L. var. asiaticum (H.Hara) Ohwi), White Kwao Keur (Pueraria candollei Wall. ex Benth var. mirifica (Airy Shawand Suvat.) Niyomdham) and Black cohosh (Actaea racemose L.) were stipulated as designated ingredients by MHLW. Additionally, controlled ingredients were set to be verified that their designated ingredients, contained in raw materials, products, and partly finished products, conformed to standards appropriate for manufacturing and quality control. The current status of regulations that relate to health food, that is, the borderline of pharmaceuticals to non-pharmaceuticals, FFCs, and designated ingredients are described in this report using actual cases.
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