Foods with Function Claims

Overview

Foods with Function Claims are foods for which a business operator submits information to the Consumer Affairs Agency before sale, based on scientific evidence regarding safety and functionality, and may display certain health-related functions under the operator’s own responsibility.

This system is different from Food for Specified Health Uses. Under the Foods with Function Claims system, the Japanese government does not individually review or approve the safety and effectiveness of each product before sale.

For this reason, the business operator bears significant responsibility for the claim wording, scientific evidence, quality control, product management, advertising control, and collection and reporting of health-related adverse information.

Foods Covered by the System

Foods with Function Claims may include processed foods, supplement-type foods and fresh foods, provided that the product meets the requirements of the system.

Fresh foods such as vegetables, fruits and seafood may also be eligible in certain cases. However, the product must have a clear functional component and the claimed function must be supported by appropriate evidence.

Some products are not suitable for this system. For example, products intended for persons suffering from diseases, minors, pregnant women or lactating women may not be eligible. Food for Specified Health Uses, Foods with Nutrient Function Claims and alcoholic beverages also need to be distinguished from this system.

Scope of Permitted Claims

The permitted function claim must relate to the maintenance or promotion of health for a specific health purpose.

Claims that suggest treatment, prevention or diagnosis of disease are outside the ordinary scope of food labeling and may create issues under the PMD Act.

For example, wording such as “cures,” “prevents disease,” “treats symptoms,” or “has a medical effect” should not be used for ordinary food products.

The practical point is that the claim must stay within the filed function and should not be expanded by package wording, online sales pages, advertisements, videos, social media posts or sales talk.

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 with Function Claims.

To sell the product under this system in Japan, the responsible Japanese-side business operator must prepare and submit the required notification under the Japanese system before sale.

For imported foods, practical review is needed for ingredients, active component amount, product specifications, manufacturing process, quality control, safety data, scientific evidence for the function, overseas sales history and post-market response arrangements.

Overseas labels and advertisements should not be translated directly for Japan. Claims that are acceptable in another country may create issues under the Food Labeling Act, Premiums and Representations Act, Health Promotion Act or PMD Act when used in Japan.

Supplement-Type Imported Products

Supplement-type imported foods require particular care.

The importer and responsible business operator should confirm the functional component, amount per daily intake, manufacturing control, lot control, product specifications, test data and stability of supply.

They should also check whether the overseas manufacturer can provide sufficient documents for Japanese notification and whether the Japanese-side operator can respond to consumer inquiries and health-related complaints after sale.

For supplement-type products, post-market quality management and health information collection are not optional administrative matters. They are central to maintaining compliance after the product is placed on the Japanese market.

Notification and Labeling

Before selling a product as a Food with Function Claims, the responsible food-related business operator submits the required information to the Consumer Affairs Agency.

The notification includes information on the intended claim, safety evidence, functional evidence, production and manufacturing control, quality control, and the system for collecting health-related adverse information.

Even after the notification is made public, this does not mean that the Japanese government has approved the product’s effectiveness. The responsibility remains with the business operator.

In practice, businesses must continue to check whether the package label, product page, advertisement and sales materials stay within the filed claim and scientific evidence.

Scientific Evidence and Claim Wording

The function claim must be supported by scientific evidence. The evidence may be based on clinical trials, systematic reviews or other accepted methods depending on the product and claim.

However, the existence of scientific data alone is not enough. The claim wording must correspond to the scope of the evidence.

If the evidence supports only a limited function, the advertisement should not suggest a broader benefit. For example, a claim related to one specific function should not be expanded into a general statement that the product improves overall health or prevents disease.

This point is particularly important for imported products, where overseas marketing copy may be broader and more aggressive than the claim allowed under the Japanese notification.

2024 Revisions and Health Information Management

Following the 2024 system review, health-related adverse information management, manufacturing control for supplement-type foods and review of labeling matters became especially important practical issues.

The notifier must maintain a system to collect information suspected to relate to health damage after sale and, where necessary, coordinate with administrative authorities and related parties.

For imported foods, the roles of the overseas manufacturer, Japanese importer, domestic seller and consumer inquiry contact should be clearly allocated.

Foods with Function Claims are not a “file once and forget” system. They require continuing management of quality, labeling, advertising and post-market health information.

Advertising and Sales Materials

For Foods with Function Claims, 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.

Expressions such as “cures,” “prevents,” “doctor-approved,” “guaranteed improvement,” or “works for everyone” should be avoided because they may suggest medicinal efficacy or exceed the filed function.

Advertising that goes beyond the notified claim may also create risk under the Premiums and Representations Act if it gives consumers the impression that the product is significantly better than it actually is.

For imported foods, overseas advertising materials may contain strong health claims. For Japan-bound sales, the notification, package label, product page and advertising expressions should be checked together.

Relationship With Other Food Categories

Foods with Function Claims should be distinguished from other health-related food categories in Japan.

Food for Specified Health Uses is a different system involving individual review and permission. Foods with Nutrient Function Claims are based on specified nutrient-related standards. Ordinary health foods or supplements without notification cannot display function claims as Foods with Function Claims.

This distinction is important for overseas suppliers because foreign categories such as “dietary supplement” or “functional food” do not automatically correspond to the Japanese legal categories.

Practical Points for Imported Food Businesses

When handling Foods with Function Claims, the first step is to confirm whether the product can fit within the system.

The business should check whether the functional component is clear, whether the daily intake amount is defined, whether scientific evidence exists, whether safety can be explained, and whether the overseas manufacturer can provide sufficient documentation.

For imported foods, the Japanese-side operator must also prepare a system for post-market management, including quality control, inquiry handling, complaint management and health-related information collection.

The product should not be sold as a Food with Function Claims until the notification, labeling, advertising review and internal management system are ready.

Checklist Before Sale in Japan

Before selling an imported food as a Food with Function Claims in Japan, check the following points:

• Is the product eligible for the Foods with Function Claims system?
• Is it a processed food, supplement-type food or fresh food?
• Is the functional component clearly identified?
• Are the component amount and daily intake amount clear?
• Is there scientific evidence supporting the claimed function?
• Is there sufficient safety information?
• Can the overseas manufacturer provide specifications, manufacturing process information, quality control documents and test data?
• Does the claim avoid disease treatment, prevention or diagnosis wording?
• Does the advertisement stay within the filed function claim?
• Is a system in place for collecting and reporting health-related adverse information?
• For supplement-type products, has the manufacturing control status, including GMP-related matters where applicable, been checked?
• Are the package label, online store, advertisement, video content, social media posts and in-store POP displays consistent?

Practical Points for Overseas Suppliers

Overseas suppliers exporting health foods or supplements to Japan should understand that the Japanese importer may require detailed technical documents.

These may include product specifications, ingredient composition, functional component data, manufacturing process information, quality control records, safety data, scientific evidence and adverse event information.

The supplier should also understand that marketing claims used overseas may need to be changed for Japan. Strong health claims, disease-related wording and broad wellness claims may not be acceptable.

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

Common mistakes include assuming that a product sold overseas as a supplement can automatically be sold in Japan as a Food with Function Claims.

Another mistake is preparing the notification but allowing advertisements to exceed the filed function claim. In practice, online advertising and social media content often create more risk than the package label itself.

It is also risky to rely on incomplete overseas data. If the functional component, manufacturing control, safety information or scientific evidence cannot be confirmed, the Japanese-side operator may not be able to maintain proper compliance.

Key Takeaway

Foods with Function Claims are based on the business operator’s responsibility. The system allows certain function claims when the required information is submitted before sale, but the Japanese government does not individually approve the product’s effectiveness.

For imported foods, the main practical issue is whether the overseas manufacturer can provide sufficient evidence, specifications, quality control information and post-market cooperation.

Importers and overseas suppliers should manage not only the notification and package label, but also advertising, online sales pages, social media posts, quality control and health-related adverse information after sale.