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

2. 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

3. 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

4. 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

5. 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

6. 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.

7. 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.

8. Thank you for your attention