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  • Structure/Function Claims of Nutritional Supplement in Japan

Structure/Function Claims of Nutritional Supplement in Japan

YAKUJIHOU.COM ~ “Our Mission”

YAKUJIHOU.COM (YDC) has contributed to firm, steady growth and results for more than 600 health and beauty-related companies here in Japan since its foundation in 1995.

However, after the 20 years of our business history, the market is now facing the quite revolutionary period brought by drastic change in legal environment for health and beauty industries, such as enactment of ‘Function Claims’ system led by Consumer Affairs Agency (CAA).

But you don’t need to be afraid of the change… we the YDC as your reliable partner turns your ‘risk’ into ‘opportunity’ even in the time of uncertainty and turmoil like we have today.

Don’t take a risk, but a full advantage of the brand-new ‘Function Claim’ to your business leap with YDC!

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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)
◆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’…

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YDC, who we are? ~ “A group of expertes, You can find in nowhere else in Japan!”

Our exceptional professionalism in ‘Legal Marketing’ domain guides your business to safe and proper direction even in the stormy sea. The quality of our human resource is definitely a premise for your success in the fastest way!

Our Human Resource / Your Partners

◆Ex-bureaucrats For legal and administrative strategy
◆Lawyers
◆Medical Doctors For evidence buildup
◆Food Science Professionals
◆Marketing Professionals For marketing strategy
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What we can do? ~ Yes, we can make it happen!

YDC’s unique ‘one-stop’ full-scale support is the only solution for total strangers who are not familiar with unknown habitat like Japanese market.

Just knocking our door… you’ll be soon aware that things are going to change!

Our specialties? ~ No need to knock around from door to door any more…

We provide a wide-range of legal marketing support as nobody else does in Japanese market, so that you’d be able to focus on your own, instead of diluting your time and efforts for dealing with several different counterparts outside your office.

【Our Service Coverage】
  • Consulting on product development, direct selling business strategy, product labeling and communication design in both online and offline.
  • Planning and execution of RCT and SE, representing application of FC to relevant governing authorities.
  • Providing proper legal assistance in times of trouble with government or media.
Our Service Menu ~ Everything you need is here in YDC.
  • Comprehensive legal marketing support (membership)
  • Legal proof check and counseling (on demand)
  • Planning and execution of CT(RCT) and SE
  • Writing thesis for medical journals
  • Deputizing relevant administrative procedures for FC

…Contact us for many more.

Sample time frame

Sample time frame
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Now tell us about your dreams and plans in Japan…

Don’t miss the big wave behind you!

Contact us NOW in English

  • Feel free to email or call us in English.
  • Our multilingual staffs will take care of your request.
email: ydc004@usjri.com
Phone: 81-3-6274-8781
Our office hours from 9:30-18:30 JST (Mon.-Fri.)