TIPS
Ⅰ.Dietary Supplement Regulation in Japan
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Regulation by ‘PMD Act’ (the former Pharmaceutical Affairs Act) on ad expression of product efficacies
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Evidence itself do not automatically permit claiming the product efficacies
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The only exception was ‘FOSHU’ (Food for Specified Health Use) known as ‘Tokuho’.
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It requires the government approval.
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The high approval standard was obstacle to popularization among the market.
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New functional food system was started in April, 2015.
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It’s not an ‘approval’ system, but a ‘notification’ system.
II.Design of Functional Food
What is ‘Function Claims’? ~ “Opportunity or Threat???”
Consumer Affairs Agency (CAA) has enforced the new FC rules for general food categories including dietary supplements and nutrition foods since Apr.1st, 2015, learned from the precedent case of ’Structure/Function Claims’ for DSHEA in the United States.
Although there had been conventional ‘FOSHU’ (as known as ‘Tokuho’) and ‘FNFC’ (basically foods and supplements containing a certain amount of listed vitamins or minerals) controlled by the Ministry of Health, Labour and Welfare (MHLW) in Japan, the new ‘FC’ system which application and authorization procedures were much simplified than those two existing systems, has certainly brought an great opportunity even to small-scale proprietors and entrepreneurs who conventionally couldn’t afford enormous time, labor and expenses to get a warrant from the government…
Comparison chart FC vs FOSHU, FNFC
| FC | FOSHU [Tokuho] | FNFC | |
|---|---|---|---|
| Government Approval | Non | Required | Non |
| Claim Scope | Broad | Limited (Almost 13 categories) | Limited (Almost 20 categories) |
However, FC doesn’t promise you a free hand to describe your product whatever you want at all. If you failed to conform your way to the relevant rules and regulations in the market, you could have been subject to the administrative disposition immediately, spread the bad news widely, and sent a tons of returned articles along with hysteric requests for refunding unexpectedly… We know you can’t bear that risk by all means.
About Required FC Elements
◆Subject Category: General foods except one that contains…
- 1. Alcohol
- 2. Excessive sodium and sugar
- 3. Ingredients exceptionally indicated by consumption criteria
◆Function Claims (FC): Need to be matched to regulation.
About FC Regulation ~ What FC cannot say…
It prohibits…
◆‘Disease Claim’ that indicates to diagnose, treat, cure or prevent any disease, as only drugs are allowed.
◆’Remodeling Body Claim’ that indicates to ensure any remodeling of body beyond a level of promoting general well-being or supporting a daily health care. ie) breast enlargement.
… and any other claims that are not explained with known scientific basis yet.
| ◆Efficacy Evaluation: | At least need either… |
|---|---|
| -Randomized Controlled Trial (RCT) / Clinical | |
| Trial (CT) or Systematic Review (SR) | |
| - Systematic Review (SR) |
| ◆Safety Evaluation(SE): | Also check as a part of RCT… |
|---|---|
| - Over Ingestion | |
| - Long Term Ingestion | |
| - Reciprocal side effects with other medicines |
◆Efficacy Mechanism Evidence
| ◆Ingredient analyses: | - Identifying effective ingredient |
|---|---|
| - Establishing method for quantifying the effective ingredient |
Remember, FC is NOT a magic cane… but it’s totally up to you, if you make it a ‘hard sell’ or ‘hard time’…
III.Operation
- 1. A ‘notification’ system, but to be screened for approval in reality.
- 2. It has accepted over 1,100 products by the end of 2017.
- 3. There are only 23 efficacies approved for FF health claim so far.(See below)
Approved Efficacies for FF Health Claim
| 1 | Body & visceral fat, neutral lipid |
|---|---|
| 2 | Obesity |
| 3 | BMI |
| 4 | Waist circumference |
| 5 | Skin moisture |
| 6 | Eyestrain, accommodative power |
| 7 | Knee joint flexibility |
| 8 | Walking ability |
| 9 | Muscle, muscle force |
| 10 | Intestinal regulation |
| 11 | Constipation tendency |
| 12 | Strain, tension |
| 13 | Sleep |
|---|---|
| 14 | Fatigue |
| 15 | Allergenic nasal & conjunctiva inflammation |
| 16 | Bone composition conservation |
| 17 | Body temperature maintenance |
| 18 | Blood pressure |
| 19 | Cognition, memory, judgement |
| 20 | Blood glucose (interdigestive & postprandial) |
| 21 | Cholesterol (TC, LDL) |
| 22 | Gum |
| 23 | Legs swelling |