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Regarding Foods for special dietary uses (Japan)

The mark of Foods for special dietary uses"Regarding permission for labeling of Foods for special dietary uses (hereinafter referred to as "FOSDU")" was partially revised on November 17, 2020. With this revision, procedures of written-document submission can now be carried out online (via e-mail) for what is possible instead of in writing. FOSDU are foods with the mark on the right. Currently, 68 labeling cases for FOSDU have been permitted. Considering 18 permitted in the past two years (2019-2020), it seems that FOSDU have become more familiar.
Even if you don’t handle the food category, it may be useful to know what kind of permitted labeling is available for future reference, so I would like to revisit the basics of FOSDU.

What is "Foods for special dietary uses" (from the leaflet on FOSDU by the Consumer Affairs Agency)

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)?

  • Labels for special purposes such as the growth of infants and the maintenance and recovery of the health of pregnant or lactating women, people with dysphagia, and patients (labeling of special dietary uses).
  • In order to sell foods as FOSDU, the permission for the labeling must be obtained from the Commissioner of Consumer Affairs Agency (Article 43, Paragraph 1 of Health Promotion Act).
  • In order to obtain permission for labeling, it is necessary to be evaluated by the government regarding conformance with criteria or requirements.

Also, let's take a look at the breakdown of the number of permitted FOSDU and what kind of food groups there are from the materials posted on the CAA website.

"Breakdown of the number of permitted FOSDU"*1 as of December 18, 2020

Food group

Number of permitted labeling

Food for the patients Those with permission criteria Low-protein food products

12

Allergen-free food products

5*2

Lactose-free food products

4*3

Comprehensive nutrition food products

4

Combination foods for patients with diabetes

0

Combination foods for patients with kidney diseases

0

Those with individual Evaluation

12

 Powdered formulas for pregnant or lactating women

0

Infant formulas Infant powdered formulas

13

Infant formulas in liquid form

3

Foods for people with dysphagia Foods for people with dysphagia

17

Thickness-adjusted foods

1

Total

71*4

*1Excluding Foods for Specified Health Uses.
*2 Including three foods that are also permitted as Lactose-free food products.
*3 Including three foods that are also permitted as allergen-free food products.
*4 The number of permitted products is 68, because three allergen-free food products and three lactose-free food products are included in their respective food groups.

FOSDU can be labeled only after having permission by the Commissioner of the Consumer Affairs Agency. Therefore, it is a misleading display to label foods that don’t meet the requirement for FOSDU in the same way. For example, in "Regarding permission for labeling of FOSDU", the following are listed as items that need attention.

3 With regard to foods for patients, a label indicating suitability for a special use should correspond to any one of the following items.
Care should be taken to ensure that foods carrying these types of labels are not put on sale without permission.
  1. Labels simply stating that the food is suitable for patients
    e.g. Statements meaning "for patients," "diet for patients," etc.
  2. Labels stating that the food is suitable for a specific disease
    e.g. Statements meaning "for patients with diabetes," "for patients with kidney diseases," "suitable for hypertensive patients," etc.
    However, this type is not limited only to phrases indicating the name of a specific disease, but it also includes phrases which are considered to have the same effect on consumers as indicating the name of a specific disease
    e.g. phrases meaning "Does not affect blood sugar level," "Suitable for patients with edema," etc.
  3. Labels indicating a name similar to that of a food in a food group eligible for permission, which may give an impression that the food is for patients
    e.g. names meaning "food products with low protein," "hypoallergenic food," etc. However, in the case of foods with a claim of low protein content, this does not apply to products with a claim meaning "low protein content (x% of the general value of [name of the food])" or "low protein content, (x% lower than that of the general value of [name of the food])," so long as they are labeled with the nutrient declaration and accompanied by a statement meaning that "This product is not FOSDU (foods for patients) permitted by the Consumer Affairs Agency," because products labeled in this manner would not be mistaken by patients as FOSDU.

As mentioned above, even if a label such as "This product is not FOSDU permitted by the Consumer Affairs Agency,", etc. is used for "foods that are not permitted as FOSDU", it will possibly fall under exaggerated labeling, if the consumer is misled as a result. To prevent such inappropriate circumstances, appropriate measures should be taken not to mislead consumers. We recommend you to take a look at another material, "About labeling that may possibly be mistaken for FOSDU (notice)" included as the related information.

Reference:
About Foods for special dietary uses (CAA)

March 2021