Health supplements are divided into three categories: health food, food with nutrient function claims (FNFC), and food for specified health uses (FOSHU)
Most dietary supplements fall under so-called health food and health claims or functional claims are prohibited to be made on this type of products. No registration is needed but required documents must be submitted to Quarantine Office under the Minister of Health, Labour and Welfare (MHLW) for prior consultation and to apply for import authorization. Evaluation of ingredient safety happens at this stage.
FNFC covers 12 vitamins and 5 minerals, where nutrient function claims can be made, as specified by the MHLW. These foods may be freely manufactured and distributed without pre-market approval provided they meet the standards and specification. Import authorization is required.
FOSHU refers to products officially approved to claim physiological effects on the human body. Product in this category requires registration concerning efficacy, safety, health claims, etc. FOSHU applications are accepted every 3 months and the evaluation process takes a minimum of 1 year. FOSHU approval can cost up to US$1,500,000.
Cosmetics are regulated by the MHLW. When importing cosmetics into Japan, products samples are to be tested and inspected in MHLW designated facilities to verify ingredients and components, to ensure compliance with Pharmaceutical Affairs Law (PAL). Once tests have been done and the Cosmetic Manufacturing and Sales License has been obtained the importer is required to apply for several notifications before the products can be marketed. Costs can vary between JPY 30,000-7000 and cover the formula check and component analysis, as well as JPY 20,000 for the various notification applications.
NHP Consulting will provide all regulatory documentation to achieve market compliance for the Japan marketplace.