Supporting “Foods with Function Claims” Submission for Foreign Clients.
WysiWyg has started the document writing services for systematic literature review regarding functional food.
We can support those clients who are willing to seek the market potential of its targeted functional food in Japan.
“Foods with Function Claims”
System of “Foods with Function Claims” ……… Questions??
Who established this system and when ?
This health food labeling system was established by the Consumer Affairs Agency and came into effect on April 1st, 2015.
What is the system of Foods with Function Claims ? (FFC)
This is a new system of labeling the function claims of food in addition to the current Foods for Specified Health Uses (FOSHU, or Tokuho) and Foods with Nutrient Function Claims (FNFC).
FFC have the following characteristics:
- Allows labeling of the function of a food ingredient e.g. “helps maintain good GI condition,”, ” slows fat absorption.”. However, it is not allowed to use wording or expressions that reflect any subjective image of a drug treatment.
- Indicated for all types of health foods including supplements, drinks, and fresh foods.
- It is necessary to submit the following information package according to the guideline released by the Consumer Affairs Agency. It basically includes safety, manufacturing, and scientific information regarding the function (see the FFC guideline for further details).
- Scientific information must include either 1) Reports of clinical trials of the final product (follow FOSHU guideline) or 2) Systematic review of the targeted food ingredient(s).
- This is not an approval system like FOSHU. It is just required to submit (via e-submission) the above-mentioned information package.
- Once the information package is submitted to the Consumer Affairs Agency and the Agency confirms that there are no errors, then the submitter is allowed to launch the product after 60 days.
- The Consumer Affairs Agency does not evaluate the information package and submitter is responsible for all product/label information, the safety, product quality and health outcome.
What is the difference between FOSHU ?
Table – Comparison of two main food labeling system in Japan
| Foods with Function Claims | Foods for Specified Health Uses (FOSHU) | |
|---|---|---|
| Regulatory | Submit the required information package (no review and no approval by the Agency) | Approval by the Agency |
| Scientific Evidence | Clinical Trial or Systematic Review | Clinical Trial |
| Timeline | 60 days after submission | Review period: >6 months* |
| Cost | Low (few million JPY*) | High (>20 million JPY*) |
| Responsibility | Submitter (Company) | Agency |
| Transparency | Information package disclosed to the public via an URL | Details not disclosed |
*estimate
How has the FFC been doing so far ?
Since the launch of this system, more than 400 products including supplements, drinks, fruit and vegetables have already been listed (as of Aug 2016), and many more are expected.
The sales of FFC products last year was estimated as 30.3 billion JPY (approx. 297 million USD) and is expected to exceed 70 billion JPY (approx. 690 million USD) in 2016. A number of companies are already showing considerable sales growth and expansion of their manufacturing capacity
For more details or information regarding this system, please access the following URL:
Consumer Affairs Agency, Government of Japan
- （For Consumers) What are “Foods with Function Claims”? (December, 2015) (PDF:977KB)
- （Guidance for Industry) The system of “Foods with Function Claims” has been launched! (December, 2015) (PDF:793KB)
Supporting the document submission for “Foods with Function Claims” for Foreign Clients.
WysiWyg has started document writing services for systematic literature review regarding functional food. We can support clients who wish to explore the market potential of their targeted functional food in Japan.
Our Services
- Preliminary literature search of a targeted functional food ingredient.
- Primary and secondary screening and selection of appropriate literature.
- Writing of the required documents based on the guideline for Foods with Function Claims.
- Support the qualitative and overall evaluation of the targeted ingredient.
- Support translation of foreign literature (if needed).
Why WysiWyg ?
- WysiWyg has core expertise in the medical and life sciences area.
- We have an excellent track record and have built a full range of skills in the writing of technical documents e.g. scientific literature, pharmaceutical regulatory dossiers, and safety information.
- We have extensive experience in database construction by extracting and writing summaries of local and foreign literature.
- It is our primary commitment to provide our clients with high quality deliverables in a timely manner.
- We have no language barriers as we routinely handle different languages.
Standard Price*
Systematic review for one project: from 1.0 million JPY.
Timeline*
Preliminary search up to completion of the full document: 3 months.
*: may vary depending on the handled volume and complexity of the project
For further information, please contact…
Isato Ohmine (Mr.)
Director Business Development
Phone: 03-5566-1669 or +81-3-5566-1669
Email: 