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Discussion on the system for Foods for Specified Health Uses (Claims of disease risk reduction) started in Japan

This month, I would like to take up the news about the review of the system for Foods for Specified Health Uses (Hereinafter, "FOSHU"). The first and second "Discussion on the system for FOSHU (Claims of disease risk reduction)" (Hereinafter, "the Discussion") were held at the Consumer Affairs Agency (CAA) on December 25, 2020 and January 22, 2021 respectively.

Background of the Discussion

Claims of disease risk reduction for "FOSHU" has been operated since 2005, when its standards were set for calcium and folic acid. On the other hand, its operation has not been reviewed since the system started.
For this reason, CAA has decided to hold the Discussion to listen to a wide range of opinions from experts and consider the future operation of claims of disease risk reduction, taking into account the situation in other countries.

What is FOSHU (Claims of disease risk reduction)?

First of all, the classification of FOSHU is organized as follows.

"FOSHU": Food that is labeled to indicate that FOSHU are expected to enable those who have specific health purposes to achieve such purposes by consuming them in their dietary habits
"FOSHU (Claims of disease risk reduction)" : FOSHU approved for claims of disease risk reduction when the risk-reducing effects of the involved component have been established medically and nutritionally. Currently, calcium and folic acid are among the components involved
"Standardized FOSHU": FOSHU approved when it meets the standards and specifications for the involved ingredients of which scientific evidence has been accumulated, such as those that have been long approved in other FOSHU cases, and therefore, it allows CAA to review and permit its compliance with the standards without individual examination by the Consumer Commission
"FOSHU(re-approval, etc.)": FOSHU with minor changes such as one in the product name, flavour, etc. for foods that have already been approved
"Qualified FOSHU": FOSHU approved when a certain level of efficacy of foods is confirmed on the condition that the food is labeled with limited scientific evidence, although it does not reach the level of scientific evidence of efficacy required for FOSHU

"FOSHU (Claims of disease risk reduction)", the second from the top in the above list, was the subject of the Discussion this time. The labeling standards for the "Claims of disease risk reduction" are as follows.

Involved components Labeled claims related to functions of specific health uses Precautions for intake Lower limit of recommended daily intake Upper limit of recommended daily intake
Calcium
(which is stipulated in Japan's Specifications and Standards for Food Additives or the one which derives from foods that have sufficient experience of being consumed by humans)
This food is rich in calcium. Daily exercise and a healthy diet with the right amount of calcium may help young women maintain healthy bone and reduce their risk of osteoporosis after they get old. In general, diseases are caused by a variety of factors, and excessive intake of calcium does not eliminate the risk of osteoporosis. 300mg 700mg
Folic acid
(pteroylmonoglutamic acid)
This food is rich in folic acid. A healthy diet with adequate amounts of folic acid may reduce a woman's risk of having a child with a neural tube defect, such as spina bifida. In general, diseases are caused by a variety of factors, and excessive intake of folic acid does not eliminate the risk of having a child with neural tube defects. 400µg 1,000µg

Thirty products have been approved for labeling as "Claims of disease risk reduction" (excluding items that have already expired). The breakdown is 30 cases for calcium and 0 for folic acid. According to the materials of the Discussion, the total number of approved foods for FOSHU is 1,075, and the number of notifications for Foods with Function Claims is 3,168.

Main issues

The main points (draft) of the Discussion are as follows.

  1. Consideration based on claims of disease risk reduction permitted in the USA, Canada, and EU
  2. Permitted wording flexibility
  3. Application for claims of disease risk reduction of which standards such as the contents of the labeling are not established
  4. Others (protection of rights of prior applicants)

Currently, there are only two components allowed in the "Claims of disease risk reduction": calcium (potential for reducing the risk of osteoporosis) and folic acid (potential for reducing the risk of neural tube defects). The Discussion is expected to deliberate the expansion of the scope and flexibility of the permitted wording, referring to claims of disease risk reduction allowed in other countries.

Examples of claims of disease risk reduction approved in USA, Canada, and EU

Content of expression

Countries / regions where claims are permitted
(△ indicates when similar labeling is permitted)

USA Canada EU
1.Labeling for reducing the amount of intake
Sodium and hypertension

 
Saturated fat, cholesterol and coronary heart disease

Dietary fat and cancer

   
2.Labeling in line with the current system of FOSHU (Claims of disease risk reduction)
Calcium, Vitamin D and Osteoporosis

 

Vitamin D and falls    

3-1. Labeling similar to the already approved FOSHU (direct indication that it reduces the risk of disease)
Noncariogenic sugar sweeteners and cavities

Fluorine-added water and cavities

   
3-2.Labeling similar to the already approved FOSHU (Handling of alternative indicators of disease)
Water-soluble dietary fiber from certain foods and coronary heart disease

 

Soy protein and coronary heart disease

   
Vegetable sterol ester, stanol ester and coronary heart disease

 

4.Labeling that the target ingredients are not limited
Grain products containing dietary fiber, fruits, vegetables and cancer

   
Fruits, vegetables and cancer

 
Fruits, vegetables and coronary heart disease

 

Future schedules

The third Discussion is scheduled to take place in March, where the direction of future operations is expected to be compiled. At that time, if it is judged necessary to take measures, for example, "to set standards for new ingredients involved," etc., specific consideration will be conducted after April. In particular, we recommend that those who handle food products with health-related labels read through the Discussion materials.

Reference:
Discussion on the system for Foods for Specified Health Uses (Claims of disease risk reduction) (CAA)

March 2021