1 1 Health claim and evidence in health food in Japan: vocabulary and law International Conference and Exhibition on Nutraceuticals and Functional Foods (ISNFF) 2011 16 November 2011, Sapporo, Japan Kiichiro TSUTANI MD, PhD 津谷喜一郎 Dept. of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo 2 Health Technology Assessment Report of Glucosamine National Evidence-based Healthcare Collaborating Agency (NECA), Seoul, 2010 By systematic review, that there was lack of data to reach conclusions that glucosamine is effective for treatment and prevention of osteoarthritis. Bae SC. Glucosamine and chondroitin products: Are they being used appropriately?: NECA News letter EVIDENCE & VALUE 29. Sep. 2010; 20-1 http://neca.re.kr/ebook/vol4/eng/vol4_eng_all/EBook.htm
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Health claim and evidence in health food in Japan: vocabulary and law
International Conference and Exhibition on Nutraceuticals and Functional Foods (ISNFF) 2011
16 November 2011, Sapporo, Japan
Kiichiro TSUTANI MD, PhD津谷喜一郎
Dept. of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo
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Health Technology Assessment Report of GlucosamineNational Evidence-based Healthcare Collaborating Agency (NECA), Seoul, 2010
By systematic review, that there was lack of data to reach conclusions that glucosamine is effective for treatment and prevention of osteoarthritis.
Bae SC. Glucosamine and chondroitin products: Are they being used appropriately?: NECA News letter EVIDENCE & VALUE 29. Sep. 2010; 20-1 http://neca.re.kr/ebook/vol4/eng/vol4_eng_all/EBook.htm
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Dr. Dae Seog HEO, SNU
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Glucosamine not as “active ingredient”(有効成分)in OTC drug in Japan, but as “additive” (添加剤)
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Same brand name “Flexpower” in both as OTC drug and “so-called” health food
OTC drug(No information of glucos-
amine in the label)
健康補助⾷品(“health supplementary food”)
A kind of “so-called” health food
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“栄養補助食品”(Nutritional supplementary food) as “so-called” health food
Words: Sitting, standing and walking Image: knee pain
Questions: - What is people’s perception of this product ?- How people recognize this product ?
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Ethical glucosamine in ROK
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Package insert of Ethical glucosamine in ROK
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亜州薬品工業株式会社
OTC Reimbursed by nationalhealth insurance in ROK
Glucosamine
Binex 株式会社
OTC Not reimbursed by national health insurance in ROK
Malaysia (health supplement)Singapore (health supplement)
Korea (health supplement)
Yes KoreaTaiwan
Thailand
Korea
Dr. Dae Seog HEO, SNU and revised by TSUTANI K
My findings
• Different regulatory categories on same evidence exists even in one country
• Different words and/or graphic image appeals “health claim”
• Rich vocabulary and image !• Need people’s perception study• “How people distinguish “true” health
claim from fake/quasi health claim ?”
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Requirements for physiological conditions of subjects for human clinical study for FOSHU
(1)CholesterolTotal cholesterol in serum is essentially be between 200~240mg/dL、and LDL cholesterol must be between 120~160mg/dL ; duration of study must be longer than 12 weeks
(2)TriglycerideTriglyceride in serum is better to be somewhat higher those of rule and between 120~200mg/dL of fasting subjects and the study is continued for at least 12 weeks
(3)Blood pressureEssentially, subjects with normal higher blood pressure, low risk and middle risk high blood pressures are objects and the study is continued longer than 12 weeks
(4)Blood sugarAccording to the criteria, the fasting blood sugar levels are judged as bordering type diabetes or bordering by sugar loading. Study should be continued for longer than 12 weeks
(5) Body FatThe study must be carried out separately between male and female and classified depended on ages, and obesity criteria is 1 according to the Japan Obesity Society (BMI 25≦~<30). The study must be carried out for longer than 12 weeks
Requirements for clinical studies for FOSHU
• Randomized placebo controlled study• Subject number must be meet to statistically significance
(probably n = 100 – 200)• Enough duration of study to obtain the statistically
significant difference (≥ three months)• Clear endpoints• Exclude children, pregnant• Sample must be identical to the product which will be on
market• P-value for statistical analysis must be less than 5%• All clinical studies must be carried out according to
Helsinki Declaration• Approval by the Ethical Committee
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15Regulatory Systems of Health Claims in Japan. Food Labeling Division, Consumer Affairs Agency (CAA), June 2011 http://www.caa.go.jp/en/pdf/syokuhin338.pdf
“Daily exercise and healthy diet containing adequate dose of calcium maintain bone health and may reduce risk of osteoporosis in the elderly age.”
Example 3-3
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Disease Risk Reduction Claim
• Evidences must be based on the comprehensive and intensive researches of published scientific papers and results from published meta-analysisare also submitted.
• Disease risk reduction claims should be are strongly related to the domestic nutritional circumstances
• Applications of Disease risk reduction claims and FOSHU must be simultaneously done
Notification Shokuanhatsu 0201003, 2007 Feb.1 21
Recognized Disease Risk Reduction Claims of FOSHU
Disease risk reduction claims are permitted to FOSHU products with conditions shown below. Permission of claiming disease risk reduction are limited to calcium and folic acid.
Calcium:Daily intake of calcium from FOSHU products should be included between 300mg and 700 mg
Claim:This product contains calcium in abundance. Intake of appropriate amount of calcium contained in healthy meals with appropriate exercise supports health of bones of young women and may reduce the risk of osteoporosis when aged.
13/967 (as of 13 Oct 2011)
Folic Acid:
Daily intake of folic acid from FOSHU products should be included between 400㎍and 1,000㎍
Claim:This product contains folic acid abundance. Healthy meals containing appropriate amount of folic acid may supports women to bear healthy baby by reduction of risk of neural tube defect such as spondyloschisis.
0/967 (as of 13 Oct 2011)
Calcium
Folic acid
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Various categorical terms have no legal basis
Legal base
1) Food for Specified Health Uses (FOSHU, 特定保健用食品);
2) Food with Nutrient Functional Claims(FNFC, 栄養機能食品);
3) Food for Special Dietary Uses (FOSDU,特別用途食品)
No legal base
health food (健康食品), health supplementary food (健康補助食品), nutritional supplementary food(栄養補助食品), nutritional strengthened food(栄養強化食品), nutritional regulating food(栄養調整食品), health drink(健康飲料), “sapurimento”(サプリメント)
Rich vocabulary !But problem in Japan is that market of so-called “health food” isso large.
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PICO in EBM: defining problem
Patient : young female
Intervention: calcium rich food
Control : non-treatment
Outcome : bone density or fracture
“prevention of osteoporosis”
risk reduction of disease
In Japan• In risk reduction health claim, word is
simple and easy to understand. Poor vocabulary.
• But in “structure and function claim” in so-called health foods, there are lots of words, which is difficult to understand. Rich vocabulary.
• Why ?
• Problems in regulation in “structure andfunction claim”
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Japanese Pharmaceutical Affairs Law (1961)
(Definitions)Article 2 The term “drug” used in this law refers to the
articles specified in the following items.(1) the article recognized in the Japanese Pharmacopeia.(2) The article (excluding quasi-drugs) which is intended
for use in the diagnosis, treatment, or prevention of disease in humans or animals, and which is not equipment/instrument (including dental materials, medical or sanitary supplies; the same herein after)
(3) The article (excluding quasi-drugs and cosmetics) which is intended to affect the structure or functions of the human or animal body, and which is not equipment/instrument etc.
From website of National Institute of Health and Nutrition
Because that “health food” is not drug, it can not have health claim with aim of treatment, prevention and others; nor affect structure and function of the body. However, ... FOSHU and FNFC can do it.
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US Federal Food, Drug and Cosmetic Act (FD&C Act)
SEC. 201. [21. U.S.C. 321]
The term “drug” means
(A) Articles recognized in USP, others
(B) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease...
(C) Articles (other than food) intended to affect the structure or any function of the body...
(D) …
Japanese Pharmaceutical Affairs Law (1948)
(Definitions)Article 2 The term “drug” used in this law refers to the
articles specified in the following items. But excludes equipment.
(1)… (almost same as 1961 law) (2)… (almost same as 1961 law)(3) The article (excluding food) which is intended to
affect the structure or functions of the human or animal body
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Clinical trial on each “product”
or
Systematic review on food or ingredient
In the US, systematic review has been used for assessment of food and ingredient for SSA and QHC by FDA.
In EU, systematic review has been used for assessment of food supplement by EFSA.
In Japan, systematic review has been used for certain field of drugs, and is being used in certain field of food by regulatory agency.
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平成9 (1997)年度厚生科学研究オーファンドラッグ開発研究事業
「難治疾患・稀少疾患に対する医薬品の適応外使用のエビデンスに関する調査研究」
班長:津谷喜一郎
報告書 平成10(1998)年4月33
FY 1997 MHW funded project“Study on the evidence of off-label use of
drugs for intractable or rare diseases”Chair: Kiichiro Tsutani
Report published in April 1998
Application on the base of “publicly known evidence”
(公知申請)
• Not based on individual clinical trial• But based on systematic review of all