Foods with Function Claims in Japan

Overview

Foods with Function Claims in Japan are foods for which a food business operator submits information to the Consumer Affairs Agency before marketing and displays certain function claims based on scientific evidence under its own responsibility.

Unlike Foods for Specified Health Uses, commonly known as FOSHU, Foods with Function Claims are not individually reviewed and approved by the Japanese government for safety and effectiveness before sale. This means that the responsibility of the business operator is particularly important in relation to the claim, scientific evidence, quality control, labeling, advertising and post-market safety management.

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 applicable conditions. In some cases, vegetables, fruits, fishery products and other fresh foods may also be notified under the system.

However, not all foods can be handled as Foods with Function Claims. Products intended for people suffering from diseases, minors, pregnant women, women planning pregnancy or nursing mothers may fall outside the scope of the system. Foods for Specified Health Uses, Foods with Nutrient Function Claims, alcoholic beverages and certain other products also require separate review under the relevant rules.

The claim must be limited to a statement that the product can be expected to contribute to the maintenance or promotion of health for a specific health purpose. Claims suggesting treatment, prevention or diagnosis of disease 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 with Function Claims. To use the Foods with Function Claims system in Japan, the required notification must be submitted under the Japanese system before marketing.

For imported products, the importer or responsible food business operator must review ingredients, content levels, raw materials, manufacturing process, quality control, safety data, scientific evidence for the claimed function and overseas sales records. Overseas advertising copy or package wording should not be translated directly for the Japanese market without legal and regulatory review.

Particular care is required for imported supplement-type foods. The business operator should confirm the content of the functional ingredient, manufacturing control, batch management, lot traceability, post-market safety reporting and the domestic consumer response system after sale.

Notification and Labeling Concept

When a product is to be sold as a Food with Function Claims, the food business operator submits the required notification information to the Consumer Affairs Agency before sale. The notification information includes the claim, evidence for safety and functionality, production and manufacturing control, quality control and the system for collecting suspected health damage information.

Even after the notification information has been published, this does not mean that the Japanese government has approved or guaranteed the effectiveness of the product. In practice, the business operator must continue to check whether the label and advertising claims remain within the scope of the notified claim and the supporting evidence.

2024 Reform and Post-Market Safety Reporting

Following the 2024 review of the Foods with Function Claims system, post-market safety reporting, manufacturing control for supplement-type foods based on GMP, and revisions to required labeling items have become especially important practical issues.

The notifier must maintain a system to collect information on suspected adverse health effects after sale and, where necessary, report or coordinate with the relevant authorities and business partners. For imported foods, it is important to clarify the roles of the overseas manufacturer, Japanese importer, seller and consumer inquiry system.

Foods with Function Claims are not a system where the work ends once the notification is completed. Continuous management is required for quality control, label control, advertising control and post-market safety reporting after sale.

Relationship with Advertising and Sales Descriptions

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

Expressions such as “cures,” “prevents disease,” “doctor approved,” or “guaranteed improvement” should be avoided because they may suggest drug-like efficacy. Claims that go beyond the notified function, or claims that make the product appear significantly better than it actually is, may also create issues under the Premiums and Representations Act.

For imported products, overseas sales pages and marketing materials may contain strong health-related claims. For Japanese sales, the notified claim, package label, advertising copy and product page wording should be checked for consistency.

Practical Checklist

When handling Foods with Function Claims, the first step is to confirm whether the product can fall within the system, whether the functional ingredient is clear, whether there is scientific evidence, and whether there are any safety concerns.

For imported products, the ability to obtain sufficient documents from the overseas manufacturer is a major practical point. The notification, labeling, advertising, ingredient confirmation at importation, and post-market safety reporting system should be organized before the product is sold in Japan.

In practice, the following points should be checked:

• whether the product can be handled under the Foods with Function Claims system;
• whether the product is a processed food, supplement-type food or fresh food;
• whether the functional ingredient, content level and recommended daily intake are clear;
• whether there is scientific evidence for safety and functionality;
• whether the notified claim and advertising expressions are consistent;
• whether the wording suggests treatment, prevention or diagnosis of disease;
• whether manufacturing process information, quality control documents, specifications and test data can be obtained from the overseas manufacturer;
• whether a system exists for post-market safety reporting;
• whether GMP-based manufacturing control has been confirmed for supplement-type foods;
• whether e-commerce pages, social media posts, video advertisements and in-store displays stay within the notified claim.

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

In the case of health foods and supplements, overseas suppliers, exporters, customs brokers and export-side freight forwarders may not immediately see the difference between a general food, a supplement-type food and a Food with Function Claims in Japan. The product may be treated as food, but its label and advertising can still create issues under the PMD Act, Health Promotion Act, Food Labeling Act or Premiums and Representations Act.

The practical issue is not only whether the product contains a beneficial ingredient. The Japanese importer must align the functional claim, scientific evidence, quality control, package label, advertising copy and post-market safety system. Early document preparation reduces notification problems, label corrections, sales delays, retailer objections and repeated requests from Japanese business partners.