Current Regulatory Status of Health Foods in Japan 11 March 2011 JIHFS Hirobumi Ohama, Ph.D.

Contents Current Regulatory Status of Health Foods Agencies for regulation of health foods Reexamination and reevaluation of FOSHU Ensuring safety of Health Foods and its ingredients

Current Regulatory Status of Health Foods Substances taken orally 経口摂取されるもの 医薬品 （医薬部外品を含む） Drugs Prescribed drug , OTC drug Quasi drug 特別用途食品 Foods for Special Dietary Uses (FOSDU) 一般食品 General Foods 病者用食品 Foods for Patients 乳児用調整粉乳 Infants Formula 妊産婦・授乳婦用粉乳 Foods for expecting and lactating mothers えん下困難者用食品 Foods for dysphagia 特定保健用食品 （トクホ） Food for Specified Health Uses (FOSHU) 栄養機能食品 Food with Nutrient Function Claims (FNFC) いわゆる 健康食品 So-called health foods その他の 食品 Conventio-nal foods 保健機能食品 Foods with Health Claims Health Foods Kampo medicine Direct OTC (herbal drug), etc. Low sodium Lactose free Elemental diet (Liquid type), etc. Prohibited to indicate 　Health Claims or Functional Claims. Oligosaccha-rides, soy isoflavon, etc. 12 vitamins & 5 minerals

Agencies for regulation of health foods (From Sep. 1st, 2009) MHLW： Food Drug Classification, Food Hygiene, Food Safety CAA（Consumer Affairs Agency） : Approval of FOSHU and FNFC Food Claiming and Labeling Consumer Protection CC（Consumer Commission） : Assessment, Evaluation and Revision of 　　　　Regulatory Systems Food Safety Agency： Evaluation of Safety of Foods and Ingredients

Reexamination and reevaluation of FOSHU No new category of claim has been permitted recently CＣ and ＣＡＡ are now discussing the reexamination and reevaluation systems of FOSHU products Update of the safety and efficacy data, periodially Development of reexamination and reevaluation systems Reason: The possibility of carcinogenicity was found in one of FOSHU ingredients which has been approved since 13 years ago

Ensuring safety of Health Foods and its ingredients The MHLW’s most important concern is the protection of people from hazard of food and food ingredients especially used for health foods. In 2005, MHLW required introduction of GMP and certification of the safety of ingredients by the third party, because of lack of comprehensive law for health foods in Japan.

GMP and Safety Certification About 90 manufacturing facilities obtained GMP approval by two GMP approval organizations. For the safety certification, comprehensive and systematic review of the articles published in the peer-reviewed journals is required. Further, some toxicity studies are requires according to the results on the above systematic review. About 70 ingredients and one finished product have already been approved for safety and special mark was given.

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