Foods with Function Claims — Notification and Imported Food Practice
Interlink編集部What Are Functional Labeling Foods?
Functional labeling foods are a food category under a system where businesses, at their own responsibility, present scientific evidence on safety and functionality, and notify the Consumer Affairs Agency before sales, allowing them to display certain functionalities.
Unlike foods with specific health claims (FOSHU), this is not a system where the government individually reviews and approves safety or functionality of each product. Therefore, the responsibilities for labeling content, scientific evidence, quality control, and collection/reporting of health damage information rest heavily on the business entity.
Functional labeling foods include processed foods, supplement-shaped foods, fresh foods, etc., meeting specific conditions. Conversely, products aimed at people with diseases, minors, pregnant or lactating women, or those claiming to prevent or treat diseases may not be eligible under this system.
This article organizes the scope of functional labeling foods, non-applicable cases, notification and labeling requirements, import food practices, health damage information management from 2024 onward, GMP, and the relationship with advertising, from the perspective of food labeling and import logistics practice.
Scope Covered in This Article
| Subject | Organized in This Article | Topics to Confirm Separately |
|---|---|---|
| Basics of Functional Labeling Foods | Organized as a system where businesses present scientific evidence on safety and functionality and notify prior to sales. | Details of notification forms and latest operations should be confirmed via Consumer Affairs Agency information. |
| Eligible and Non-Eligible Foods | Organizes processed foods, supplement-shaped foods, fresh foods, and commonly excluded foods. | Individual product applicability should be checked by product category, target consumer, ingredients, and labeling content. |
| Notification and Labeling | Organizes notification labeling, functional active ingredients, scientific evidence, safety, quality management, and health damage information. | Input to notification database, attached documents, and notification changes should be verified individually. |
| Practical Import Food Handling | Organizes checks when treating overseas supplements and health foods as functional labeling foods in Japan. | Food Sanitation Act, import notification, food labeling standards, and customs documents should be confirmed under separate systems. |
| System Revisions from 2024 Onward | Organizes health damage information management, GMP for supplement-shaped foods, and labeling review. | Transitional measures, notices, Q&A, and latest notification operations should be confirmed through official information. |
| Advertising and Sales Labeling | Organizes advertising expressions beyond notified labeling, pharmaceutical-like claims, and risks of misleading consumers. | Advertising regulations under the Act against Unjustifiable Premiums and Misleading Representations, Health Promotion Act, and Pharmaceuticals and Medical Devices Act should be confirmed separately. |
| Forwarder and Importer Practices | Organizes documents to obtain before import, systems to check, and post-sales management. | Final notification responsibility, labeling responsibility, and handling of health damage information should be confirmed by the notifier/seller. |
Purpose and Background of the System
The functional labeling food system aims to clearly communicate to consumers the functionality of foods based on a certain level of scientific evidence. Consumers can check what kinds of functionality they can expect when selecting products.
However, this system does not involve government review and approval for individual products. The notifier business must establish systems to ensure safety, functionality, quality control, labeling content, and health damage information collection, assuming responsibility for selling the products.
Therefore, publication of notification does not equal government guarantee of efficacy or safety. For imported foods and supplement-shaped foods, it is important to clarify the roles of overseas manufacturers, domestic importers, sellers, notifiers, advertising personnel, and inquiry contact points.
Situations Where the Functional Labeling Food System Applies
| Situation | Subject for Confirmation | Common Issues | Practical Cautions |
|---|---|---|---|
| Displaying functionality on processed foods | General processed foods, beverages, confectionery, seasoning foods, etc. | Functional active ingredients, intake guideline amounts, basis of labeling content | Confirm that the notified labeling matches the actual product. |
| Selling supplement-shaped foods | Tablets, capsules, powders, granulate foods, etc. | GMP, quality control, lot control, ingredient content | Verify manufacturing management and quality control systems. |
| Displaying functionality on fresh foods | Vegetables, fruits, seafood, etc. | Functional active ingredient content, individual variability, basis of labeling | Fresh foods may also be subject to notification. |
| Selling imported health foods in Japan | Overseas supplements, dietary supplements, health foods | Differences between overseas and Japanese systems, insufficient notification documents | Do not simply use overseas labeling; verify under the Japanese system. |
| Selling via e-commerce sites | Product pages, landing pages, advertising images, reviews, SNS posts | Claims beyond notified labeling, pharmaceutical-like expressions | Check container/packaging labeling and advertising expressions together. |
| Continuing sales after notification | Quality control, ingredient standards, health damage information, advertising corrections | Insufficient post-sale management, failures in collecting health damage information | Notification is not the end; ongoing management is necessary. |
| When renewing or changing ingredients | Raw materials, formulation amounts, manufacturing site, labeling, advertising, sales format | Discrepancies between notified content and actual product | Check if change notification or labeling corrections are required. |
Application Requirements and Commonly Excluded Items
| Category | Content | Points to Check | Notes |
|---|---|---|---|
| Foods That May Be Subject | Processed foods, supplement-form foods, fresh foods, etc. | Check the food category, sales form, functional active ingredients, and labeling details. | Confirm not only the product category but also the labeling content. |
| Required Basis | Scientific evidence regarding safety and functionality. | Review research reviews, test data, safety data, consumption records, and ingredient specifications. | The labeling content must correspond to the supporting documentation. |
| Required Management System | Production, manufacturing, quality control, health damage information collection, and response system. | Check manufacturing location, GMP, lot management, specification sheets, and health damage response. | For imported foods, coordination with overseas manufacturers is important. |
| Frequently Excluded Target Groups | Those with diseases, minors, pregnant women, breastfeeding women, etc. | Verify advertising expressions, product design, target consumers, and cautionary labels. | Misidentifying the target group could exceed the system’s scope. |
| Foods Often Excluded | Specified Health Foods, Nutritional Functional Foods, alcoholic beverages, etc. | Check relationships with existing systems, product category, and labeling content. | If covered by other systems, verify the choice of system accordingly. |
| Prohibited Expressions | Expressions suggesting treatment, prevention, or diagnosis of diseases. | Confirm claims of curing, prevention, improvement, or pharmaceutical effects. | Could also raise issues under the Pharmaceutical and Medical Device Act or Health Promotion Act. |
| Items Not Easily Deemed Excluded | Overseas health foods, personal import-style sales, samples, commercial use, crowdfunding products, etc. | Check sales entity, sales method, advertising, target consumers, and actual domestic distribution. | Exercise caution especially if actually selling or advertising within Japan. |
Comparison Table with Other Systems
| System | Main Purpose | Main Items to Verify | Difference from Functional Labeling Foods | Practical Points |
|---|---|---|---|---|
| Functional Labeling Foods | System where businesses display scientifically based functional claims under their responsibility. | Functional active ingredients, safety, functionality, notification contents, quality control, health damage info | Notification system, not an individual government approval system. | Ongoing management of labeling, advertising, quality, and health damage info after notification. |
| Specified Health Foods | System where health claims require individual government review and approval. | Individual products, safety, efficacy, approval labeling | Government approval system, unlike functional labeling foods. | Check consistency between approved labeling and advertising expressions. |
| Nutritional Functional Foods | System allowing standardized function claims for nutritional components that meet defined criteria. | Vitamin, mineral, fatty acid levels | Focus on component labeling that meets criteria, not individual notification. | Confirm fixed expressions and upper/lower limits. |
| Nutritional Labeling | System for indicating caloric and nutrient content to consumers. | Calories, protein, fat, carbohydrates, salt equivalent, etc. | Displays nutrient amounts, not functional claims. | Functional labeling foods still require normal food and nutritional labeling. |
| Premiums and Representations Act | System to prevent false or misleading representations that could mislead consumers. | Advertising, sales pages, quality claims, efficacy claims, pricing. | Even with notification claims, excessive advertising claims can be problematic. | Watch for representations exceeding notification claims causing consumer deception. |
| Health Promotion Act | System preventing false or exaggerated claims about health maintenance and promotion effects. | Health foods, supplements, advertisements claiming health benefits. | Claims exceeding the permitted scope of functional labeling are problematic. | Avoid expressions like "improves," "prevents," or "makes you healthy." |
| Pharmaceutical and Medical Device Act | Regulates pharmaceutical efficacy and drug classification. | Disease treatment/prevention, strong effects on bodily functions, pharmaceutical-type expressions. | Food claiming pharmaceutical effects is problematic. | Avoid expressions such as "cures," "prevents," and "diagnoses." |
Eligible Foods
Functional Labeling Foods cover processed foods, supplement-shaped foods, fresh foods, and others meeting certain conditions. Fresh foods like vegetables, fruits, and seafood may also be subject to notification.
However, products intended for people with diseases, minors, pregnant women, or breastfeeding women may not be covered by the system. Caution is also necessary for specified health foods, nutritional functional foods, alcoholic beverages, and other foods excluded under the system.
The permitted labeling content is limited to claims that may contribute to maintaining or promoting health. Expressions suggesting treatment, prevention, or diagnosis of diseases go beyond food labeling scope and could potentially lead to issues under the Pharmaceutical and Medical Device Act.
Concept of Notification and Labeling
When selling as Functional Labeling Foods, food-related businesses must notify the Consumer Affairs Agency with required information before sales. Notification information includes labeling content, safety and functionality evidence, production, manufacturing and quality control, and the system for collecting health damage information.
Even after the notification has been published, it does not mean that the government guarantees the product's effectiveness. In actual logistics practice, it is necessary to continuously verify whether the displayed content corresponds with scientific evidence and that advertising expressions do not exceed the notified claims.
For imported foods, there may be discrepancies between the documentation held by the overseas manufacturer and the notification documents required in Japan. Before sales start, it is important to confirm the functional active ingredients, content amount, standards, safety, manufacturing control, quality control, and the system for collecting health damage information.
2024 Revision and Management of Health Damage Information
Under the Functional Food Labeling System, key practical points include the mandatory provision of health damage information, manufacturing control based on GMP for supplement-shaped foods, and review of labeling items, following the 2024 system revision.
Notifiers must maintain a system to collect health damage suspected information even after sales begin and be able to report to authorities or coordinate with relevant parties as needed. This is especially important for imported foods, where the roles of overseas manufacturers, domestic importers, sellers, and inquiry contact points should be clearly defined.
The functional food labeling system requires continuous management that includes not only the initial notification but also post-sale quality control, labeling management, advertising control, and the collection and reporting of health damage information.
Points to Note in Imported Food Operations
Even products sold overseas as "health foods," "supplements," or "dietary supplements" require notification based on the Japanese system to be marketed as functional labeled foods in Japan.
At the time of import, it is necessary to verify ingredients, content amounts, raw materials, manufacturing processes, quality control, safety data, scientific evidence of functionality, and overseas sales records. Simply translating the overseas manufacturer’s advertising expressions or label claims into Japanese may result in issues with the Food Labeling Act, the Act against Unjustifiable Premiums and Misleading Representations, the Health Promotion Act, or the Pharmaceutical Affairs Act.
Particularly for supplement-shaped imported foods, it is essential to confirm the content of functional active ingredients, manufacturing control, lot control, system for collecting health damage information, and post-domestic sales inquiry handling.
Relation to Advertising and Sales Claims
For functional labeled foods, not only the container and packaging labels but also advertising expressions on e-commerce sites, brochures, SNS, video advertisements, and in-store POP are critical.
Avoid expressions that imply pharmaceutical efficacy such as "cures," "prevents," "approved by doctors," or "guaranteed improvement." Moreover, advertising that exceeds the functional range reported or that misleads consumers into believing the product is significantly superior than it actually is could lead to issues under the Act against Unjustifiable Premiums and Misleading Representations.
Imported foods may include strong health claims in overseas sales pages or advertising materials. For sales in Japan, it is necessary to check that the notified claims, container/packaging labels, advertising expressions, and sales page wording are consistent.
System Application Flow
- Confirm whether the product is sold as a food.
- Confirm whether it falls under processed foods, supplement-shaped foods, or fresh foods.
- Check if the food is excluded, such as specified health foods, nutritional function foods, or alcoholic beverages.
- Check whether the target consumers fall under groups often excluded by the system, such as people with diseases, minors, pregnant women, or breastfeeding women.
- Confirm that the functional active ingredients, content amount, recommended intake, and mechanism of action are clear.
- Confirm whether there is scientific evidence regarding safety and functionality.
- Confirm production, manufacturing, quality control, standards, lot control, and whether GMP compliance is required.
- Confirm the system for collecting and reporting health damage information, inquiry contact points, and coordination with overseas manufacturers.
- Confirm that the notified claims, container/packaging labels, EC pages, SNS, and advertising expressions are consistent.
- If issues are found, conduct checks on the feasibility of notification, label corrections, additional documentation, or expert review before the start of sales.
Common Practical Problem Cases
| Case | Issues | Points to Confirm | Practical Response |
|---|---|---|---|
| Trying to sell overseas supplements as functional foods in Japan as is | Even if sold under overseas regulations, it does not necessarily meet Japan's notification system requirements. | Ingredients, content amount, scientific evidence, safety, quality control, notification documents | Confirm whether notification is possible under the Japanese system. |
| Emphasizing effects in advertising beyond the notified claims | Exceeding the scope of notified functionality can cause issues under the Act against Unjustifiable Premiums and Misleading Representations and the Health Promotion Act. | Notified claims, advertising text, e-commerce pages, SNS, video ads | Revise advertising expressions to stay within the scope of notified claims. |
| Using pharmaceutical-like expressions | Claims about disease treatment, prevention, or diagnosis lead to problems under the Pharmaceutical and Medical Device Act. | Expressions such as “cures,” “prevents,” “improves,” “doctor recommended” | Revise the wording to what is permissible for foods. |
| Stability issues with the amount of functional ingredients present | Lot variations or manufacturing control issues could cause discrepancies between the notified content and the actual product. | Specifications, analysis values, lot management, manufacturing processes, quality control | Confirm quality control system and specification management. |
| Inadequate setup for health damage information inquiries | Possibility of inadequate collection and reporting of post-sale health damage information. | Inquiry contact points, reporting standards, in-house procedures, coordination with overseas manufacturers | Establish a system for collecting and reporting health damage information before sales start. |
| Insufficient GMP verification for supplement-form foods | Risks arise from insufficient confirmation of manufacturing and quality control regarding regulatory compliance. | Manufacturing site, GMP, manufacturing records, specifications, quality control documents | Obtain necessary management documents including those from overseas manufacturers. |
| Large variability in content amounts in fresh foods | Due to individual or seasonal differences, amounts of functional ingredients may not be stable. | Ingredient amounts, analysis methods, seasonal differences, regional differences, units of expression | Confirm basis of labeling and quality control methods. |
| Label discrepancies after product renewal post-notification | Changes in raw materials, blend ratios, manufacturing sites, or labeling wording may not match notified information. | Change details, notification information, proposed labels, advertisements, quality documents | Check whether filing changes or label revisions are needed. |
Practical Scenario 1: Selling Overseas Supplements as Functional Foods in Japan
For example, there may be cases where capsule-shaped dietary supplements sold overseas are intended to be marketed as functional foods in Japan.
In this case, having sales performance overseas alone is not sufficient. It is necessary to confirm the functional ingredients, content amount, recommended intake, safety, scientific evidence for functionality, manufacturing management, quality control, and health damage information collection systems based on the Japanese regulatory framework.
Additionally, advertisements by overseas manufacturers may use strong efficacy claims. However, when selling as food in Japan, expressions claiming disease treatment or prevention, or efficacy claims beyond the notified range, must be avoided.
Importers need to check not only the import procedures but also the notification documents, labeling proposals, advertising plans, inquiry contacts, and health damage reporting systems as an integrated process before moving forward with sales preparations.
Practical Scenario 2: Using Stronger Claims on EC Pages Beyond Notified Claims
For products notified as functional foods, although labeling on containers and packaging may follow the notified claims, stronger expressions such as “definitely improves,” “recognized by doctors,” or “changes in a short period” may be used on e-commerce pages.
In such cases, even if container and packaging labeling is appropriate, advertising expressions may still cause issues under the Act against Unjustifiable Premiums and Misleading Representations, the Health Promotion Act, or the Pharmaceutical and Medical Device Act. Being a functional food product does not mean freedom to use advertising claims beyond those notified.
In practice, labels, notified claims, e-commerce pages, ad banners, SNS posts, video advertisements, and in-store POP should be reviewed side-by-side to confirm that only the allowed functional effects are expressed consistently.
If sales or advertising agencies do not fully understand the regulatory scope, advertisements may be more exaggerated than labels. Having a system to review advertising expressions before sales launch is important.
Practical Scenario 3: When a Health Damage Inquiry is Received
After sales, consumers may contact the company reporting “feeling unwell after taking the product.” This should not simply be treated as a complaint but checked to see if it qualifies as health damage information.
Notifiers and sellers should document the inquiry details, intake amount, intake period, symptoms, medical visits, concomitant use of other foods or pharmaceuticals, lot numbers, purchase timing, etc. Reporting to authorities or coordination with relevant parties may be necessary depending on circumstances.
For imported foods, it may be necessary to confirm manufacturing lot, raw materials, quality inspections, and shipment information with overseas manufacturers. For this reason, it is important to have a communication system with overseas manufacturers, obtain quality documents, and establish internal reporting routes before sales.
The functional food notification system does not end with the submitted documents alone. Continuous management including collection and reporting of health damage information post-sale is required.
4-column Judgment Checklist
| Check Point | Person to Check With | Items to Confirm | Actions if Issues Arise |
|---|---|---|---|
| At Product Planning Stage | Importer, Seller, Overseas Manufacturer, Labeling Responsible | Food category, target foods, excluded foods, target consumers, feasibility of functional labeling | If there is a possibility of exclusion, reconsider the choice of system. |
| When Confirming Functional Ingredients | Overseas Manufacturer, Quality Control, Experts | Ingredient names, content amount, recommended intake, specifications, analysis data | If the ingredients or content amounts are unclear, do not proceed with preparing the notification. |
| When Confirming Scientific Evidence | Notifier, Experts, Research Institutions, Overseas Manufacturer | Safety data, functional data, research reviews, test data, target consumers | Confirm that the labeling content corresponds with the supporting evidence. |
| When Handling Imported Foods | Overseas Manufacturer, Importer, Customs Broker, Labeling Responsible | Ingredients, raw materials, manufacturing process, quality control, overseas labels, draft Japan labeling | Do not use overseas advertisements or labels as is; verify and adjust for the Japanese system. |
| When Handling Supplement-Form Foods | Overseas Manufacture Site, Quality Control, Notifier | GMP, manufacturing control, quality control, lot control, specification sheets, inspection data | Obtain necessary manufacturing control documents and verify the system. |
| When Creating Advertising or Sales Pages | Advertising Staff, Sales Staff, Importer, Experts | Notification labeling, advertising text, SNS, videos, in-store POP, relation to the Act against Unjustifiable Premiums and Misleading Representations and the Pharmaceutical and Medical Device Act | Correct expressions that exceed the notification labeling or imply pharmaceutical effects. |
| When Responding to Health Damage Information | Seller, Notifier, Inquiry Desk, Overseas Manufacturer | Symptoms, intake status, lot, purchase date, medical institution visits, report requirements | Follow internal procedures and, when necessary, report to authorities or check with related parties. |
| When Changing Product After Notification | Notifier, Overseas Manufacturer, Quality Control, Labeling Responsible | Changes in raw materials, formulation, manufacturing site, labeling, advertising, sales format | Check whether change notifications, labeling revisions, or advertising corrections are required. |
Common Misconceptions
| Misconception | Correct Understanding | Practical Notes |
|---|---|---|
| Functional Labeling Foods are Government-Guaranteed Effective Foods | This is not a system where the government reviews and guarantees the efficacy of individual products but a notification system based on business operator responsibility. | Be careful not to make advertisements appear as if "the government recognizes the effect." |
| Once Notification is Published, Advertising is unrestricted | Advertising must stay within the range of the notified labeling. | Check EC pages, social media, and video advertisements as well. |
| If It’s Sold as a Health Food Overseas, Same Labeling Can Be Used in Japan | Selling as a functional labeling food in Japan requires notification and labeling confirmation based on Japanese regulations. | Avoid direct translation of overseas labels or advertisements. |
| Functional Labeling Foods Can Claim Disease Prevention | Expressions implying treatment, prevention or diagnosis of disease go beyond food labeling scope. | Also confirm relations with the Pharmaceutical and Medical Device Act and Health Promotion Act. |
| Once Notified, No Post-Sale Management is Necessary | Post-sale quality control, labeling management, advertisement management, and health damage information collection/reporting systems remain necessary. | Establish inquiry desks and internal reporting channels. |
| Importer Only Needs to Check Customs Clearance | When selling imported foods as functional labeling foods, notification materials, quality control, labeling, advertising, and health damage response are involved. | Obtain required materials from overseas manufacturers before sales. |
| Manufacturing Control Can Be Left to Manufacturer Even for Supplement-Form Foods | The notifier’s side must also confirm manufacturing and quality control status. | Confirm GMP, specifications, lot control, and quality data. |
Practical Notes
When handling functional labeling foods, start by confirming whether the product falls under the system, whether functional ingredients are clearly defined, if there is scientific evidence, and if there are no safety concerns.
A key practical point for imported foods is whether adequate documentation can be obtained from overseas manufacturers. It's important to have an integrated management system from notification, labeling, advertising, ingredient checking at import, through to health damage information collection and reporting after domestic sales before starting sales.
Especially for supplement-form foods, confirm functional ingredient content, manufacturing control, lot management, health damage information collection, and post-sale inquiry response systems.
The Importance of Record Keeping
For functional labeling foods, it is important to keep records not only of notification materials but also post-sale labeling management, advertisement checks, quality control, and health damage response.
Documents to be kept include notification materials, functional ingredient data, safety data, functional data, research reviews, manufacturing process documents, specification sheets, analysis certificates, GMP-related documents, health damage inquiry records, advertisement check records, labeling correction history, and correspondence records with overseas manufacturers.
Having these records makes explaining labeling content, advertising wording, quality control, and health damage response easier. Conversely, if records are insufficient, even if notification contents align with actual sales management, later explanations may become difficult.
Summary
Functional labeling foods are a food system allowing indication of certain functions by showing scientific evidence on safety and functionality based on business operator responsibility, with notification to the Consumer Affairs Agency before sales.
Unlike Foods for Specified Health Uses (FOSHU), this system does not involve government review and guarantee of the effectiveness of individual products. The notifier is responsible for the accuracy of the labeling, scientific basis, quality control, advertising management, and the collection and reporting system for health damage information.
For imported foods, overseas manufacturers' health foods and supplements cannot always be sold to the Japanese market as-is. It is necessary to verify ingredients, content, safety, functionality, production management, GMP, health damage information systems, and advertising expressions in accordance with Japanese regulations.
In the actual logistics practice of functional display foods, it is important to continuously manage not only the notification process but also pre-sale document review, post-sale quality control, label management, advertising management, and response to health damage information.
