Foods for Specified Health Uses (FOSHU) — Import Sales and Labeling Practice
Interlink編集部What Are Specified Health Foods (Tokutei Hokenyo Shokuhin)?
Specified Health Foods are foods that contain ingredients affecting physiological functions of the body, and whose consumption may be expected to have specific health benefits. These products are commonly referred to as "Tokuhō."
To sell a food product as a Specified Health Food, it must undergo government review for efficacy and safety on a case-by-case basis, and obtain approval for its labeling.
This system is significantly different from Functional Health Foods, which businesses can label based on their own scientific evidence, or Nutritional Functional Foods, which can display certain claims if they meet nationally established nutrient standards.
Specified Health Foods represent one of the higher-level regulatory systems within the food labeling framework, specifically for health and functionality claims. It is easier to understand if seen as a system that builds upon the basic labeling requirements under general food labeling standards, adding individually approved health-related claims.
Scope Covered in This Article
| Content Covered | How It’s Organized Here | Topics to Confirm Separately |
|---|---|---|
| Basics of Specified Health Foods | Reviewed as a system where each food is subject to national review for efficacy and safety, and approved for health-related labeling. | Details on application documents, review procedures, and approvals should be checked from official or specialized sources. |
| Positioning Within Health Functional Foods | Comparison and organization of Specified Health Foods, Functional Health Foods, and Nutritional Functional Foods. | Functional Health Foods, Nutritional Functional Foods, and nutrient labeling should be confirmed in their respective articles. |
| Scope of Approved Labeling | Clarifies allowed health claims in labeling and advertising expressions. | Specific product approvals, advertisement reviews, and related laws (Pharmaceutical Affairs Act, Health Promotion Act, Act against Unjustifiable Premiums and Misleading Representations) require separate confirmation. |
| Foods Typically Eligible and Those Often Excluded | Clarifies foods that can be handled as Tokuhō, where system selection is necessary, and expressions often excluded from eligibility. | Issues like drug classification, Food Sanitation Act, food additives, and import notifications fall under separate systems. |
| Practices for Imported and Overseas Health Foods | Outlines system selection, labeling, advertising, and document verification when selling overseas health foods in Japan. | Customs clearance, food notifications, ingredient labeling, nutrition labeling, and label affixing practices should be confirmed in other articles. |
| Advertising and Sales Labeling | Points out issues with expressions exceeding approved claims, medicinal effect claims, and comparative or ranking claims. | Advertising regulations under the Act against Unjustifiable Premiums and Misleading Representations, Health Promotion Act, and Pharmaceutical Affairs Act should be checked individually. |
| Cautions for Freight Forwarders and Importers | Clarifies areas where logistics companies should not bear judgment responsibility and highlights points for raising awareness. | Final decisions on labeling eligibility and approval acquisition should be confirmed with importers, sellers, experts, or regulatory authorities. |
Purpose and Background of the System
The Specified Health Food system was established to allow certain foods to carry specific health claims, despite being classified as foods. While regular foods can display ingredients and nutrition information, claims suggesting particular health benefits require system-based verification.
The key characteristic of Specified Health Foods is that each product undergoes government review regarding efficacy and safety, and is granted permission for its claims. Therefore, simply being perceived as “healthy” or being sold as a health food overseas does not qualify a product to be marketed as a Specified Health Food in Japan.
In practice, it is necessary first to comply with the basic food labeling standards, then determine whether to obtain approval as a Specified Health Food for health claims, submit notification as a Functional Health Food, treat as a Nutritional Functional Food, or sell as a general food product.
Situations Where the Specified Health Food System Applies
| Situation | Points to Check | Common Issues | Practical Notes |
|---|---|---|---|
| When wanting to label health claims on foods | Product, active ingredient(s), specific health claims intended | Claims may exceed the scope allowed under general food labeling. | Organize whether to treat as Tokuhō, Functional Health Food, Nutritional Functional Food, or general food. |
| When wanting to use the Tokuhō Mark | Whether approval has been obtained, approved claims, product specifications | Products without approval cannot use the mark. | Verify approval details for each product. |
| When importing and selling overseas health foods | Overseas label, advertisements, ingredient(s), active substances, sales claims | Overseas health claims may not be directly usable in Japan. | Rebuild labeling and advertising according to Japanese system requirements. |
| When uncertain about Functional Health Food classification | Scientific evidence, sales strategy, lead time, scope of claims | Confusion can occur between approval and notification systems. | Compare system reliability, costs, duration, and advertising management. |
| When uncertain about Nutritional Functional Food classification | Vitamin, mineral quantities, claim wording | Nutritional Functional Food is not a flexible health claim system. | Verify allowable claim wording within standard phrases. |
| When advertising on EC sites or SNS | Product pages, ads, videos, reviews, in-store POP | Claims often exceed approved expressions. | Check all media expressions, not just labels. |
| When renewing a product | Ingredients, formulation amounts, manufacturing site, labeling, ads, sales method | Differences may arise between approval details and actual product specs. | Check impacts on approvals, need for label corrections, and re-verification. |
Application Requirements and Items Often Excluded
| Category | Details | Points to Confirm | Precautions |
|---|---|---|---|
| Foods That May Be Subject | Foods labeled with claims of specific health benefits. | Check active ingredients, efficacy, safety, recommended intake, and labeling content. | Each food requires individual review and labeling approval. |
| Required Approval | Each product must undergo national review and obtain approval for labeling. | Verify application documents, test data, safety data, and draft labeling. | Foods without approval cannot display the “Tokuhō” (specified health use) label. |
| Scope of Approved Labeling | The approved range of health use claims for labeling. | Confirm approved wording, target audience, recommended intake, active ingredients, and cautions. | Be careful not to strengthen wording or add different effects in advertising. |
| Labels Likely to Be Excluded | Claims intended for treatment, prevention, or diagnosis of diseases. | Check expressions such as “cures,” “prevents,” “improves,” or “can replace medicine.” | These may involve issues under the Pharmaceutical Affairs Law, Health Promotion Act, and Act against Unjustifiable Premiums and Misleading Representations. |
| Foods Requiring System Selection | Health foods, supplements, nutrition-claim foods, overseas health foods, etc. | Confirm whether to sell as Tokuhō, functional labeling food, nutritional function food, or general food. | The allowed labeling differs for each system. |
| Health Foods Approved Overseas | Foods with overseas certification, sales track record, or health claims. | Verify consistency with Japanese approval, notification, and labeling systems. | Avoid directly translating overseas claims into Japanese for use. |
| When Sold as General Food | When sold as regular food without health benefit or functional claims. | Check that health effects are not effectively promoted in ads or e-commerce pages. | Advertising regulations still apply even to general foods. |
Positioning Within Health Functional Foods
Specified Health Use Foods (Tokuhō) are part of the health functional foods system. The main types of health functional foods are Specified Health Use Foods, Functional Labeling Foods, and Nutritional Function Foods.
All these systems allow certain health or nutrition-related claims on foods, but they differ in whether approval or notification is required, the range of allowable claims, business operator responsibility, and whether there is official review.
| Category | System Characteristics | Approval / Notification | Allowed Claim Content | Practical Considerations |
|---|---|---|---|---|
| Specified Health Use Foods (Tokuhō) | A system where each food must undergo national review and obtain approval. | Individual approval is required. | Approved health use claims. | Expressions beyond the approved claim range are not permitted. Lead time and document preparation for approval can be significant. |
| Functional Labeling Foods | A system where business operators submit scientific evidence under their responsibility. | Notification prior to sales is required. | Claims related to contributing to health maintenance and promotion. | This is not a system where the government conducts individual efficacy review or grants approval. Consistency between notification content and advertising claims is important. |
| Nutritional Function Foods | A system allowing labeling if the product meets specified national standards for nutrients. | No individual approval or notification required. | Labeling of the function of specified nutrients. | The wording allowed is fixed. Free-form health claims are not permitted. |
| General Foods | Regular foods without health functional food claims. | No approval or notification for health functional claims required. | Limited to general food labeling scope. | Strong health effect promotion in advertising may cause issues under other regulations. |
Comparison with Other Systems
| System | Main Purpose | Main Inspection Items | Difference from Specific Health-Use Foods | Practical Considerations |
|---|---|---|---|---|
| Specific Health-Use Foods | A system where individual national examination and approval are obtained to make health-use claims. | Efficacy, safety, active ingredients, approved claims, intake guidelines, labeling content | National approval is required for each product’s labeling. | It is important not to exceed the scope of approved claims. |
| Functional Labeling Foods | A system where businesses take responsibility to display scientifically based functionality claims. | Notification display, functional active ingredients, safety, functionality, quality control, health damage information | This is a pre-market notification system, not individual national approval. | Check consistency between notification content and advertising expressions. |
| Nutritional Function Foods | A system that allows standardized functional labeling for nutritional components that meet criteria. | Nutrient amounts, upper/lower limits, standardized wording, caution labeling | Not individually approved; labeling is allowed if it meets regulatory standards. | Free-form health-use claims are not permitted. |
| Nutritional Labeling | A system to show consumers the calorie and nutrient contents of foods. | Calories, protein, fat, carbohydrates, equivalent salt content, etc. | This is nutrient amount labeling, not health-use approved claims. | Even for Tokuhō, normal food labeling and nutritional labeling are required. |
| Act against Unjustifiable Premiums and Misleading Representations | A system to prevent misleading representations that cause consumer misunderstanding. | Advertising, sales pages, quality claims, comparative displays, price displays | Even with approved claims, excessive advertising can cause issues. | Watch for exaggerated claims like "effective" or "definitely improves." |
| Health Promotion Act | A system to prevent false or exaggerated claims regarding health maintenance and promotion effects. | Health foods, supplements, advertising health effect claims | Claims exceeding Tokuhō approved claims for health effects may be problematic. | Check the overall impression of advertising. |
| Pharmaceutical and Medical Device Act | A system regulating medicinal efficacy, effects, and pharmaceutical classification. | Treatment or prevention of disease, strong actions on body functions, pharmaceutical expressions | Even for foods, making pharmaceutical efficacy claims can cause issues. | Avoid expressions like "cures," "prevents," or "substitute for medicine." |
What Can Be Displayed on Specific Health-Use Foods
For Specific Health-Use Foods, within the approved scope, claims of certain expected health benefits can be displayed.
For example, health-use claims such as "regulates stomach condition," "suitable for those concerned about blood sugar," "suitable for those with elevated blood pressure," "suitable for those concerned about cholesterol," or "moderates the rise of blood triglycerides after meals" may be approved.
However, these are health-use claims only within the approved scope. They are not claims intended for disease treatment, prevention, or diagnosis.
The Boundary Between Health-Use Claims and Pharmaceutical Efficacy Expressions
| Direction of Expression | Example | Practical Viewpoint | Notes |
|---|---|---|---|
| Approved Health-Use Claims | Regulates stomach condition, suitable for persons with elevated blood pressure | Claims are allowed if they align with the approved content. | Avoid strengthening wording arbitrarily or adding different effects. |
| Expressions Limited to Health Maintenance and Promotion | Supports a healthy diet, helps daily health management | Even general expressions require checking the overall impression. | Confirm whether the product’s overall labeling and advertising context avoid excessive claims. |
| Expressions Likely Considered Pharmaceutical Efficacy | Cures diabetes, improves hypertension, prevents fatty liver, substitutes for medicine | These may exceed the range allowed for food labeling. | These cause issues under the Pharmaceutical and Medical Device Act, Health Promotion Act, and Act against Unjustifiable Premiums and Misleading Representations. |
| Expressions Overemphasizing Approved Claims | Always lowers it, cures if taken, shows effect in a short period, recognized by doctors | Such expressions exceed approved claims and can create excessive consumer expectations. | Compare approved wording with advertising expressions. |
Scope of Approved Claims
For Specific Health-Use Foods, the approved labeling content is extremely important. Approved claims are health-use claims recognized by the government after review of the product.
In practice, it is necessary to manage so that the approved claims do not differ from the actual product packaging, e-commerce pages, brochures, video advertising, and sales materials.
| Situations Prone to Discrepancies | Examples of Common Issues | Points to Check | Practical Measures |
|---|---|---|---|
| Rephrasing of Authorized Claims | Changing "Suitable for people with slightly high blood pressure" to "Improves hypertension." | Confirm that the wording does not exceed the intent of the authorized claim. | Revert to expressions consistent with the authorized claims. |
| Overemphasis on Effectiveness | Using expressions such as "Works definitely," "Effects appear immediately," or "Improves just by taking it." | Check whether the expressions give consumers excessive expectations. | Avoid definitive or immediate-effect claims. |
| Adding Different Effects | Adding beauty effects, diet benefits, or disease prevention effects not included in the authorized claims. | Verify that advertising does not add efficacy beyond the approved scope. | Remove any claims outside the authorized range. |
| Expanding the Target Audience | Changing "People concerned about blood sugar levels" to "People with diabetes." | Confirm that expressions are not directed at patients with specific diseases. | Adjust target audience expressions to match the authorized claims. |
| Comparative and Ranking Expressions | Using claims such as "Japan's best," "Most effective," or "Most recommended by doctors." | Check for supporting evidence and the potential for misrepresenting quality. | Avoid usage if there is no credible basis. |
Options When Importing Overseas Health Foods
Even if products are sold overseas as health foods, supplements, or dietary supplements, they cannot be sold as Tokutei Hokenyo Shokuhin (Specified Health Foods) in Japan as-is.
Health claims or functional indications accepted overseas are based on different systems than Japan's Food Labeling System. When making health-use claims within Japan, it is necessary to choose display methods according to Japanese regulations.
| Option | Details | Suitable Cases | Considerations |
|---|---|---|---|
| Obtain approval as a Specified Health Food | Each food undergoes review for efficacy and safety, and permission is granted for health-use claims. | When long-term sales are intended and trust and promotional power as Tokutei Hokenyo Shokuhin are important. | Preparation of materials, testing, review process, lead time, and costs are significant. |
| Submit as a Functional Food with Notification | The business operator organizes scientific evidence and submits notification before sales. | When Tokutei Hokenyo Shokuhin approval is not sought but certain functional claims are desired. | Consistency between notification contents and advertising claims, as well as management of supporting materials, is crucial. |
| Sell as a Nutritional Functional Food | If target nutrients are within specified ranges, designated nutritional function claims can be made. | When promoting supply of vitamins, minerals, and other nutrients. | The allowed wording is standardized; free-form functional claims are not permitted. |
| Sell as General Food | Sell without health-use or functional claims, as ordinary food. | When no approval or notification is submitted, and no health benefits are promoted. | It is necessary to check that health effects are not effectively promoted in advertising or e-commerce pages. |
Key Points for Import Food Practicalities
When selling overseas health foods in Japan, it is necessary to organize the product classification, basic labeling, desired health/functional claims, system selection, supporting evidence, advertising drafts, and post-sale management before import.
Even if overseas manufacturers emphasize "FDA approved," "Sold overseas extensively," or "Recommended by doctors," this does not necessarily mean such claims can be used as-is for food labeling or advertising in Japan.
In practice, confirm sequentially whether the product can be sold as food, does not contain pharmaceutical ingredients or effects, meets basic labeling standards based on food labeling regulations, and which health functional food system is applicable.
Relationship with Advertising and Sales Claims
For Specified Health Foods, it is necessary to pay attention not only to container and packaging labels but also to expressions used on e-commerce sites, brochures, in-store POP, social media, video advertisements, and sales materials.
If expressions that go beyond the scope of the approved claims are used—such as overly strong effect portrayals or wording that suggests disease treatment or prevention—it could lead to issues under the Health Promotion Act, the Act against Unjustifiable Premiums and Misleading Representations, the Pharmaceutical and Medical Device Act, and others.
| Media | Checkpoints | Expressions Likely to Cause Issues | Practical Precautions |
|---|---|---|---|
| Product Label | Authorized claims, active ingredients, recommended intake amount, intake precautions | Displays inconsistent with authorized claims, excessive rewording | Confirm alignment with authorized claims. |
| E-commerce Sites | Product descriptions, review citations, ranking displays, comparative claims | Claims exceeding authorized claims, No.1 rankings, overemphasized testimonials | Review overall impression of product pages. |
| Brochures and Sales Materials | Sales explanations, promotional materials, documents for business partners | Explanations beyond authorized claims in materials for sales representatives | Maintain consistent expressions even for internal and business partner materials. |
| SNS and Video Advertisements | Short posts, subtitles in videos, influencer posts | Short or catchy phrasing that exaggerates efficacy | Be cautious not to overstate claims in shorter formats. |
| In-store POP | Point of sale displays, shelf tags, promotional materials, campaign displays | Additional expressions like "effective," "cures," "recommended by doctors" | Manage carefully to prevent unauthorized additions on site. |
System Application Flow
- Confirm whether the product can be sold as food and does not contain pharmaceutical-like ingredients or efficacy claims.
- Check if the product can meet the basic labeling requirements based on the Food Labeling Standards.
- Verify whether there is a desire to display health-related uses, functional claims, or nutritional functions within Japan.
- Compare which category the product will be sold under: specific health food (Tokuhō), functional food with labeling, nutritional functional food, or general food.
- If choosing specific health food, confirm efficacy, safety, active ingredients, recommended intake, and proposed labeling.
- Check the materials, testing, lead times, and costs required for review and label approval for each food type.
- Confirm consistency between approved labeling and the expressions used in labels, EC pages, advertisements, sales materials, and in-store POP.
- For imported foods, review overseas manufacturer documents, ingredient lists, specifications, manufacturing processes, and quality control materials.
- Verify that labeling and advertising do not include disease treatment or prevention claims, pharmaceutical-like efficacy claims, or excessive efficacy appeals.
- If there are issues, take actions such as selecting the appropriate system, revising labeling or advertising, seeking expert confirmation, or obtaining pre-import documents.
Common Practical Issues
| Case | Problem | Items to Check | Practical Response |
|---|---|---|---|
| Trying to sell an overseas health food as Tokuhō just as is | Even if it is sold as a health food overseas, it does not mean it has Tokuhō approval in Japan. | Approval status in Japan, label content, ingredients, supporting documents, sales method | Confirm the sales classification under the Japanese system. |
| Strengthening Tokuhō labeling in advertisements | Expressions that exceed the approved labeling may violate the Health Promotion Act, Act against Unjustifiable Premiums and Misleading Representations, and Pharmaceutical Affairs Act. | Approved labeling, advertising text, EC page, SNS, video ads | Revise expressions to remain within the approved scope. |
| Using expressions like "cures disease" | Such expressions exceed food labeling scope and tend to be considered pharmaceutical efficacy claims. | Words related to treatment, prevention, improvement, diagnosis, or replacement of medicine | Revert to the scope of health-related functional claims. |
| Emphasizing only the Tokuhō mark | Consumers may perceive it as if the government guarantees overall effectiveness. | Use of the mark, approved labeling, overall impression of advertisements | Accurately indicate the approved health function uses. |
| Advertising health benefits while selling as general food | Even if categorized as general food, advertisements could effectively become functional or efficacy claims. | Advertising, EC page, reviews, SNS, in-store POP | Revise to expressions permissible for general foods. |
| Confusing functional food with Tokuhō | Mixing the notification system and approval system may cause misunderstandings among consumers and business partners. | System names, labeling wording, advertisements, sales materials | Clearly explain the differences between the systems. |
| Requesting only label application work from logistics company | The responsibility for judging label content and the actual label application work tend to be confused. | Label content, work instructions, scope of responsibility, importer confirmation | Separate labeling judgment to importer side and application work to logistics side. |
| Using old advertisements after product renewal | If ingredients or approved content changes, advertisements may not match the actual product. | Change details, approved labeling, ingredients, advertisements, sales materials | Conduct a comprehensive review of advertisements and labeling when changing products. |
Practical Scenario 1: When wanting to sell an overseas health food as Tokuhō
For example, there may be inquiries about selling a product that is marketed overseas as a supplement or dietary supplement as "Tokuhō" in Japan.
In this case, having sales history or health claims approval overseas does not constitute grounds to sell as specific health food (Tokuhō) in Japan. In Japan, each food product must undergo examination on efficacy and safety, and obtain approval for labeling.
Importers should review ingredients, active ingredients, quantities, test data, safety data, manufacturing processes, quality control documents, overseas labels, and advertising expressions, and then determine whether to obtain Tokuhō approval, file notification as functional food with labeling, sell as nutritional functional food, or sell as general food.
Although freight forwarders and customs brokers are not responsible for deciding Tokuhō approval, in practice, if overseas manufacturer documents or label proposals contain strong health effect claims, it is helpful to encourage importers to verify the applicable system.
Practical Scenario 2: Strengthening approved labeling on EC pages
For products approved as specific health food, while product labels present expressions aligned with approved labeling, there are cases where the EC page or advertising banners use strong expressions such as "definitely works," "lowers immediately," or "replaces medicine."
In this situation, even if the product itself is Tokuhō, if the advertising expressions exceed the scope of approved labeling, there is a problem. Being Tokuhō does not mean advertising can freely exaggerate efficacy.
In practice, check approved labeling, product labels, EC pages, SNS, video ads, brochures, and in-store POP side-by-side to confirm there are no expressions exceeding the approved health function uses.
Especially with short advertising texts or video ads, expressions may be overly strong. Before sales launch, it is important to share the approved labeling scope with advertising staff and external production companies.
Practical Scenario 3: Selling as general food while appealing health benefits
Some overseas health foods are sold as general food without applying for Tokuhō approval or functional food labeling notification. In this case, if showing no health usage or functional claims is the premise, selling as general food is an option.
However, even if the product label treats it as a general food item, if the online shop page, social media, advertisements, or quoted reviews strongly claim health benefits such as "lowering blood pressure," "reducing fat," or "preventing disease," it effectively amounts to making claims not permitted under the regulations.
In such cases, issues may arise not only under the Food Labeling Act but also the Health Promotion Act, the Act against Unjustifiable Premiums and Misleading Representations, and the Pharmaceutical and Medical Device Act. Advertising expressions are not unrestricted even when selling as a general food item.
Importers need to verify not only the sales format but also the online pages, advertisements, social media, videos, and in-store POP materials to ensure that no health function claims or medicinal efficacy expressions are being made.
Points Freight Forwarders and Importers Should Be Aware Of
Freight forwarders and customs brokers typically are not responsible for obtaining specific health food approvals or making display decisions. However, when arranging imports of health foods or supplements, they may handle documents such as ingredient lists, specification sheets, manufacturing process records, label drafts, food notifications, temperature control records, and expiration dates.
It is important not to treat overseas manufacturers’ product descriptions as-is for Japan-specific sales displays, to confirm with importers the distinction between Foods for Specified Health Uses (FOSHU), Foods with Functional Claims, Nutrient Function Foods, and general foods, and to be cautious about whether customs documents, label drafts, or advertising materials include any health benefit or disease prevention claims.
If undertaking label affixing, clearly separate the responsibility for display content judgment from the responsibility for the affixing work. It is important that logistics companies do not too readily assume responsibility for judging the legality of displays or advertisements.
4-Column Decision Checklist
| Stage of Confirmation | Parties to Confirm With | Items to Confirm | Actions If Issues Are Found |
|---|---|---|---|
| Product Planning | Importer, Seller, Overseas Manufacturer, Display Supervisor | Whether it can be sold as food and does not contain medicinal ingredients or effects | If there is a possibility of medicinal properties, reconsider the choice of regulatory scheme. |
| If intending to display health claims | Importer, Seller, Expert | Whether to handle as FOSHU, Food with Functional Claims, Nutrient Function Food, or general food | Select the system according to the desired content to be displayed. |
| When considering FOSHU approval | Importer, Expert, Testing Organization, Manufacturer | Active ingredients, efficacy, safety, test data, draft display, application materials | If data is insufficient, recheck feasibility and lead time for obtaining approval. |
| When handling imported health foods | Overseas Manufacturer, Importer, Customs Broker, Display Supervisor | Overseas labeling, advertising, ingredients, specification sheets, food notifications, Japan-specific label drafts | Verify that overseas expressions are not used as-is for Japanese labeling. |
| When creating advertisements or sales pages | Advertising Staff, Sales Staff, Importer, Expert | Permitted labeling, e-commerce page, social media, videos, in-store POP, comparative claims | Correct expressions that exceed permitted claims or include medicinal-like statements. |
| When affixing labels | Importer, Warehouse, Logistics Company, Display Supervisor | Label content, affixing targets, work instructions, responsibility scope, final approver | Separate responsibilities for display judgment and affixing work to confirm. |
| At product changes or renewal | Importer, Manufacturer, Display Supervisor, Advertising Staff | Ingredient changes, manufacturing location changes, display changes, advertising changes, impact on approval content | Confirm whether post-change display and advertising conform to approval content. |
| Final check before sales start | Importer, Seller, Advertising Staff, Quality Staff, Expert | Consistency among labels, e-commerce pages, brochures, social media, in-store POP | Make corrections before sales if expressions are inconsistent across materials. |
Common Misunderstandings
| Misunderstanding | Correct Understanding | Practical Notes |
|---|---|---|
| If a health food is sold overseas, it can also be sold in Japan as FOSHU | To sell as a Food for Specified Health Uses in Japan, approval under Japanese regulations is required. | Do not directly translate or reuse overseas certifications, approvals, or health claims as Japanese. |
| If a product has the FOSHU mark, anything can be written on it | Only claims approved within the permitted range can be displayed. | Ensure no advertising or sales pages add effects beyond the approved claims. |
| FOSHU can claim to treat or prevent diseases | FOSHU indicates health uses, and the system is not for claiming disease treatment or prevention. | Check the relationship with the Pharmaceutical and Medical Device Act, Health Promotion Act, and Act against Unjustifiable Premiums and Misleading Representations. |
| Foods with functional claims are simpler, so always choose them | The characteristics, consumer appeal, documentation requirements, advertising operations, and brand strategies differ between systems. | Do not select schemes solely based on procedural simplicity. |
| When selling as general food, health claim regulations do not apply | Even general foods can face issues if health benefits are strongly claimed in advertising. | Verify online pages, social media, video ads, and in-store POP as well. |
| If the logistics company affixes labels, it means they have verified the display content | Label affixing operations and the legality judgment of display content are separate matters. | Separate responsibilities in contracts and instructions between display judgment and affixing work. |
| Once approval is obtained, checking advertisements is no longer needed | Even after approval, continued confirmation is needed to ensure labels, online pages, advertisements, and sales materials remain within the permitted claims. | Reconfirm when product or advertisement changes occur. |
Practical Points
Specified Health Foods (特定保健用食品) are subject to an additional system of health use labeling on top of the standard food labeling requirements. Therefore, it is necessary to first confirm basic labeling based on the Food Labeling Standards and then verify the permitted content specific to the Specified Health Foods status.
For imported health foods, it is more important how they will be sold under Japanese regulations rather than the sales track record or labeling overseas. It should be clarified before import whether the products will be marketed as Specified Health Foods, submitted as Functional Claims Foods (機能性表示食品), sold as Nutritional Function Foods, or treated as general foods.
Also, for Specified Health Foods, it is essential not only to obtain permission but to manage advertising and sales displays within the scope of the approved labeling. Consistent control of the labeling content needs to cover everything from labels, e-commerce pages, advertisements, sales materials to in-store POP.
Importance of Record Keeping
For Specified Health Foods, it is important to keep records not only at the time of obtaining permission but also for post-approval label management, advertisement review, product changes, and revision histories of sales materials.
Documents to be retained include permission-related documents, ingredient data, safety data, efficacy data, testing materials, approved labeling, product labels, advertisement drafts, e-commerce page drafts, pamphlets, in-store POP, sales materials, revision histories, and records of confirmation with importers and overseas manufacturers.
Having these records makes it easier to explain the consistency between approved labeling and advertising expressions. Conversely, if records are insufficient, it may become difficult to justify the alignment between permission content and sales floor displays later on.
Summary
Specified Health Foods are foods that have undergone national review for each product and are allowed to display a health use indication. Commonly known as "Tokuhō," their regulatory framework is different from Functional Claims Foods and Nutritional Function Foods.
When selling imported health foods in Japan, health claims recognized overseas cannot be used as is. It is necessary to verify before import which system will be utilized in Japan or whether the products will be sold as general foods without functional claims.
For Specified Health Foods, expressions that exceed the permitted labeling, pharmaceutical-type efficacy claims, and excessive advertising are prone to cause issues. After meeting the basic labeling standards under the Food Labeling Standards, it is important to carefully check that the permitted content matches the actual labeling and advertisements.
