Current Regulatory Status of Health Foods

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
特別用途食品
一般食品
（医薬部外品
を含む）
Foods for Special Dietary Uses (FOSDU)
General Foods
Drugs
病者用食
品
乳児用調整
粉乳
妊産婦・授
乳婦用粉乳
えん下困難
者用食品
特定保健用
食品
（トクホ）
栄養機能食
品
いわゆる
健康食品
その他の
食品
 Prescribe
d drug ,
• Kampo
OTC
drug
Foods
for
Patients
Infants
Formula
Foods
for
expectin
g and
lactating
mothers
Foods
for
dysphagi
a
Food for
Specified
Health
Uses
(FOSHU)
Food
with
Nutrient
Function
Claims
(FNFC)
12 vitamins
So-called
health
foods
Conventi
o-nal
foods
medicine
• Direct OTC
(herbal drug),
etc.
Quasi
drug
Low sodium
 Lactose free
 Elemental
diet (Liquid
type), etc.
Oligosaccharides, soy
isoflavon, etc.
& 5 minerals
Prohibited to
indicate
Health Claims
or Functional
Claims.
保健機能食品
Foods with Health
Claims
健康食品
Health Foods
3
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 peerreviewed 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.
Thank you for your attention

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