Foods for Specified Health Uses in Japan

Overview

Foods for Specified Health Uses in Japan are foods that contain ingredients affecting physiological functions of the body and are permitted to display that they may be useful for a specific health purpose. They are commonly known as FOSHU.

To sell a product as a Food for Specified Health Uses, the product must be reviewed by the Japanese government for effectiveness and safety, and permission must be obtained for the health claim. This is a major difference from Foods with Function Claims, where the system is based on notification by the business operator rather than individual government permission for each product.

Difference from Foods with Function Claims

Foods with Function Claims are based on a notification system under which the food business operator submits scientific evidence and related information under its own responsibility. In contrast, Foods for Specified Health Uses require government review and permission for each product before the permitted health use can be displayed.

For FOSHU products, it is important that the permitted claim, functional ingredient, recommended intake, precautions for use and other labeling items are shown accurately within the scope of the permission.

Foods Covered by the System

Foods for Specified Health Uses are foods that may display a permitted health use, such as helping maintain or improve certain physiological functions. Examples may include claims related to intestinal condition, blood glucose, blood pressure or other specific health purposes, within the scope of the permission granted.

There are also related categories within the FOSHU system, such as conditional FOSHU and standards-based FOSHU. However, for overseas suppliers and freight forwarders, the key point is that FOSHU is a permission-based Japanese system and cannot be used merely by translating overseas health claims.

FOSHU products are not intended to treat, prevent or diagnose diseases. Expressions suggesting drug-like efficacy go beyond the scope of food labeling and may create issues under the PMD Act.

Practical Points for Imported Foods

Even if a product is sold overseas as a health food, supplement or dietary supplement, it cannot automatically be sold in Japan as a Food for Specified Health Uses. To use FOSHU labeling in Japan, permission must be obtained under the Japanese system.

Health claims or function claims accepted overseas cannot simply be translated into Japanese and used for the Japanese market. For imported foods, ingredients, content levels, manufacturing process, safety data, functionality data, proposed label wording and advertising expressions must be reviewed under Japanese rules.

For overseas manufacturers and Japanese importers, the key practical issue is whether sufficient documents can be prepared for the Japanese review and whether the product, claim and evidence can be aligned with the Japanese FOSHU system.

Labeling and Permission Concept

For a FOSHU product, the permitted health claim must be used within the approved scope. The business operator should not expand the meaning of the permitted claim through additional advertising copy, images, testimonials or comparison claims.

The label and sales materials should also reflect the permitted functional ingredient, recommended intake, precautions for use and other required information. If the advertising message gives consumers a stronger impression than the permitted claim, it may create regulatory risk even where the package label itself follows the permission.

Relationship with Advertising and Sales Descriptions

For Foods for Specified Health Uses, not only the package label but also e-commerce pages, brochures, in-store displays, social media posts and video advertisements require careful control.

Expressions suggesting treatment, prevention or guaranteed improvement, such as “cures,” “prevents disease,” “endorsed by doctors,” “clinically proven,” or “guaranteed to improve your health,” should be avoided unless they are clearly within the permitted scope and supported by appropriate evidence. In many cases, such expressions may raise issues under the Health Promotion Act, Premiums and Representations Act or PMD Act.

For imported products, overseas sales pages and marketing materials may contain health-related claims that are stronger than what can be used in Japan. Japanese sales materials should be checked against the permitted claim and the actual evidence.

Practical Checklist

When handling Foods for Specified Health Uses, the first step is to confirm whether the product has actually obtained permission as a FOSHU product in Japan. The permitted claim, functional ingredient, labeling items and advertising expressions should then be checked together.

For imported foods, it is not enough to rely on overseas manufacturer materials alone. The product must be reviewed from the viewpoint of whether it can legally be sold in Japan as a Food for Specified Health Uses.

In practice, the following points should be checked:

• whether the product has obtained official permission as a Food for Specified Health Uses in Japan;
• whether the permitted claim and actual label wording are consistent;
• whether the functional ingredient and content level match the permission;
• whether recommended intake and precautions for use are properly shown;
• whether advertising expressions stay within the scope of the permitted claim;
• whether the wording suggests treatment, prevention or diagnosis of disease;
• whether overseas health claims have been reviewed before use in Japan;
• whether e-commerce pages, social media posts, video advertisements and in-store displays are consistent with the permitted claim.

Why This Matters for Overseas Suppliers and Export-Side Freight Forwarders

For overseas suppliers, exporters, customs brokers and export-side freight forwarders, FOSHU can easily be misunderstood as a general health food or supplement category. In Japan, however, FOSHU is a specific permission-based system. A product accepted overseas as a supplement or functional food cannot be treated as FOSHU in Japan unless it meets the Japanese requirements.

The practical issue is not only whether the product has a beneficial ingredient. The Japanese importer must align the permitted claim, functional ingredient, safety and effectiveness data, package label and advertising materials. Early confirmation helps prevent incorrect claims, sales delays, retailer objections and repeated document requests from Japanese business partners.