Foods for Specified Health Uses

Overview

Foods for Specified Health Uses are foods that contain ingredients affecting physiological functions and are permitted to display that their intake may be useful for a specific health purpose.

In Japan, these products are commonly known as FOSHU. They are different from ordinary health foods or supplements because each product must undergo government review for effectiveness and safety and obtain permission for the specific health-use claim.

This is a major difference from Foods with Function Claims. Foods with Function Claims are based on notification by the business operator, while Foods for Specified Health Uses require product-by-product review and permission.

Difference From Foods with Function Claims

Foods with Function Claims are based on the business operator’s responsibility and pre-sale notification of scientific evidence and related information.

Foods for Specified Health Uses, by contrast, are products for which the business operator obtains government permission after review of the product’s safety, effectiveness and proposed claim.

For this reason, businesses handling Foods for Specified Health Uses must follow the permitted claim, functional ingredient, intake amount, caution statements and other approved conditions accurately.

A product should not be advertised beyond the scope of the permitted health-use claim.

Foods Covered by the System

Foods for Specified Health Uses are foods that may display a permitted health-use claim, such as helping maintain normal digestive condition, being suitable for people concerned about blood glucose, or being suitable for people with slightly high blood pressure.

The claim must stay within the permitted scope. The product is not intended to diagnose, treat or prevent disease.

Expressions that suggest medicinal efficacy, disease treatment, disease prevention or medical diagnosis may go beyond ordinary food labeling and may create issues under the PMD Act.

Importance of the Permitted Claim

The permitted claim is central to the FOSHU system.

Even if the product has obtained permission, the business operator should not freely expand the claim in package wording, sales pages, advertisements or customer-facing materials.

The functional ingredient, permitted health-use statement, intake guidance and caution statements should be consistent with the permission.

In practice, compliance requires checking not only the product label, but also all sales and advertising materials used for the product.

Important Points for Imported Foods

A product sold overseas as a health food, supplement, dietary supplement or functional food cannot automatically be sold in Japan as a Food for Specified Health Uses.

To sell an imported product as FOSHU in Japan, permission under the Japanese system is required.

Overseas health claims or function claims cannot simply be translated and used in Japan. The importer or responsible business operator must check the ingredients, active component amount, manufacturing process, safety data, functional evidence, proposed label and advertising expressions under the Japanese system.

For imported foods, cooperation from the overseas manufacturer is often essential because documents on specifications, manufacturing control, safety, functional ingredients and test data may be required.

Advertising and Sales Materials

For Foods for Specified Health Uses, the package label is not the only issue. Online stores, product pages, brochures, video advertisements, social media posts, influencer content and in-store POP displays must also be controlled.

Advertising should not exceed the permitted claim. Expressions that make the product look more effective than the permitted claim, or that suggest disease treatment or prevention, may create issues under the Health Promotion Act, Premiums and Representations Act or PMD Act.

For imported products, overseas marketing materials may contain strong health claims. These materials should be reviewed and adjusted before being used for Japan-bound sales.

Relationship With Other Health-Related Food Categories

Foods for Specified Health Uses should be distinguished from other health-related food categories in Japan.

Foods with Function Claims are based on notification by the business operator and are not individually approved by the government for effectiveness. Foods with Nutrient Function Claims are based on nutrient-related standards. Ordinary health foods and supplements without the relevant permission or notification cannot display FOSHU-type permitted health-use claims.

This distinction is especially important for overseas suppliers because foreign categories such as “dietary supplement,” “functional food” or “health supplement” do not automatically match Japanese legal categories.

Practical Points for Imported Food Businesses

When handling a product that may be sold as a Food for Specified Health Uses, the first step is to confirm whether the product has obtained the required permission in Japan.

The business should also confirm whether the actual label, product page, advertisement and sales materials match the permitted claim and approved conditions.

Imported food businesses should not rely only on overseas manufacturer materials. They should check whether the product is actually in a condition that can be sold in Japan as FOSHU.

This includes confirming the permission status, functional ingredient, permitted claim, intake guidance, caution statements, product specifications, manufacturing information and advertising wording.

Checklist Before Sale in Japan

Before selling or promoting a product as a Food for Specified Health Uses in Japan, check the following points:

• Has the product obtained FOSHU permission in Japan?
• Does the label match the permitted claim?
• Are the functional ingredient and amount consistent with the permission?
• Is the recommended intake amount properly shown?
• Are the required caution statements included?
• Do the online store, advertisement, video content, social media posts and in-store POP displays stay within the permitted claim?
• Does the wording avoid disease treatment, prevention or diagnosis claims?
• Are overseas marketing materials reviewed before use in Japan?
• Can the overseas manufacturer provide specifications, manufacturing information and safety-related documents?
• Is the product clearly distinguished from Foods with Function Claims, Foods with Nutrient Function Claims and ordinary health foods?

Practical Points for Overseas Suppliers

Overseas suppliers exporting health foods or supplements to Japan should understand that FOSHU is a permission-based Japanese system.

A product that is lawfully sold overseas with health-related wording may still need a different claim structure, different label wording or a different regulatory route in Japan.

The supplier may be asked to provide detailed information on ingredients, specifications, functional components, manufacturing process, safety data and functional evidence.

Before finalizing package design, product pages, advertisements or social media materials for Japan, the overseas supplier should coordinate with the Japanese importer or responsible business operator.

Common Mistakes

A common mistake is assuming that an overseas supplement or health food can be sold in Japan as FOSHU simply because it has strong scientific evidence or is popular overseas.

Another mistake is using advertising expressions that go beyond the permitted claim. Even where the product itself has permission, advertising can create risk if it suggests stronger effects than approved.

It is also risky to confuse FOSHU with Foods with Function Claims. The regulatory route, responsibility structure and claim control are different.

Key Takeaway

Foods for Specified Health Uses are health-related foods that require product-by-product government review and permission in Japan.

They are different from Foods with Function Claims, which are based on notification by the business operator.

For imported foods, overseas health claims cannot simply be translated and used in Japan. Importers and overseas suppliers should confirm the permission status, permitted claim, functional ingredient, label wording and advertising materials before sale.

The practical rule is simple: the product, label and advertisement must stay within the permitted FOSHU scope.