The Japanese market for health foods and functional foods is substantial, driven by a health-conscious population and an increasing interest in foods that offer specific wellness benefits beyond basic nutrition. Navigating this market, however, requires a clear understanding of Japan's distinct regulatory categories for foods that make health-related claims. While these products are foods, not pharmaceuticals, their labeling and advertising are subject to specific rules designed to protect consumers and ensure claims are appropriately substantiated. Key categories include the well-established "Foods for Specified Health Uses" (FOSHU/TOKUHO), "Foods with Nutrient Function Claims" (FNFC), and the newer, rapidly growing category of "Foods with Function Claims" (FFC). This article will explore these classifications, with a particular focus on the FFC system, its notification process, claim substantiation requirements, and how it differs from other frameworks.

General Principles: Health Claims on Foods in Japan

Before examining specific categories, it's important to understand the overarching principles governing health claims for foods in Japan:

1. Distinction from Ordinary Foods (一般食品 - ippan shokuhin): Ordinary foods can make general nutritional claims (e.g., "rich in calcium") but cannot make specific health benefit claims related to bodily functions or disease risk reduction unless they fall into one of the regulated categories.
2. Prohibition of Drug-like Claims (PMD Act - Yakkiho): Foods, regardless of their category, are strictly prohibited from making claims that would classify them as unapproved pharmaceuticals. This means they cannot claim to diagnose, treat, cure, or prevent diseases in a manner similar to drugs (as per Article 66 of the PMD Act regarding false or exaggerated advertising that could cause a product to be mistaken for a pharmaceutical).
3. Health Promotion Act (健康増進法 - Kenkō Zōshin Hō): This Act (e.g., Article 65) prohibits false or exaggerated representations concerning the effects of foods on health maintenance or promotion, aiming to protect consumers from misleading health-related advertising.
4. Food Labeling Act (食品表示法 - Shokuhin Hyōji Hō): This Act mandates comprehensive and accurate labeling for all food products, including any health or functional claims, ensuring consistency and preventing consumer deception.

Within this context, Japan has established specific systems for foods that can legitimately make certain types of health-related claims.

1. Foods for Specified Health Uses (FOSHU / TOKUHO) (特定保健用食品 - Tokutei Hoken-yō Shokuhin)

FOSHU, often recognized by its "TOKUHO" mark, has long been the "gold standard" for foods with scientifically substantiated health benefits in Japan.

• Definition: FOSHU are foods that have received individual approval from the Secretary-General of the Consumer Affairs Agency (CAA) (prior to 2009, the Minister of Health, Labour and Welfare). This approval is granted based on a rigorous scientific review demonstrating that the food, when consumed as part of a regular diet, can be expected to have a specific beneficial effect on human health (e.g., "helps moderate blood glucose levels," "helps maintain healthy blood pressure in individuals with higher blood pressure," "helps reduce the absorption of dietary fat").
• Approval Process: This is an extensive, time-consuming, and costly process. Businesses must submit a detailed application dossier to the CAA, including:
  • Data on the food's safety and the characterization of its functional ingredients.
  • Robust scientific evidence, typically including human intervention studies (clinical trials), demonstrating the claimed health effect and its mechanism of action.
  • The CAA conducts a thorough review, often involving expert panels from the Food Safety Commission and the Consumer Commission.
• Types of FOSHU:
  • Standard FOSHU: Claims a specific health benefit.
  • FOSHU with Qualified Claims: Allowed when scientific evidence is supportive but not yet conclusive enough for a standard FOSHU claim. The claim must be worded with appropriate qualifications.
  • FOSHU with Disease Risk Reduction Claims: A subcategory allowing claims related to reducing the risk of developing certain diseases (e.g., osteoporosis by increasing calcium absorption), provided the evidence is exceptionally strong.
• Labeling: Approved FOSHU products can display the official "TOKUHO mark," a symbol of government endorsement that carries significant consumer trust.
• Significance: Due to the stringent approval process, FOSHU products are generally perceived by consumers as highly reliable in their claimed health benefits.

2. Foods with Nutrient Function Claims (FNFC) (栄養機能食品 - Eiyō Kinō Shokuhin)

FNFC is a category that allows for standardized claims related to the functions of specific vitamins and minerals.

• Definition: These are foods labeled with the recognized functions of certain nutrients (vitamins and minerals designated by the CAA, such as Vitamin C, Calcium, Iron, etc.) for which national standards regarding minimum and maximum content levels and permissible function claims have been established.
• No Pre-market Approval/Notification: If a product meets the established standards for nutrient content, businesses do not need to obtain pre-market approval or notify the authorities. It is a self-certification system where the business is responsible for ensuring compliance.
• Permitted Claims: Only standardized, pre-defined claims for the recognized physiological functions of the included vitamins or minerals can be made (e.g., "Vitamin D promotes calcium absorption in the intestinal tract and helps bone formation," "Iron is a necessary nutrient for making red blood cells").
• Labeling: The label must clearly state:
  • That it is a "Food with Nutrient Function Claims."
  • The name of the nutrient(s) providing the function.
  • The amount of the nutrient(s) per serving.
  • The standardized function claim(s).
  • Daily recommended intake.
  • Cautionary statements regarding intake (e.g., "Excessive intake does not cure diseases or improve health," "Consult the recommended daily intake").
• Scope: This system is limited to the specific vitamins and minerals designated by the CAA.

3. Foods with Function Claims (FFC) (機能性表示食品 - Kinōsei Hyōji Shokuhin)

Introduced in April 2015 by the Consumer Affairs Agency, the FFC system represents a significant development, offering a more accessible pathway for businesses to make functional claims for a wider range of food products and ingredients.

• Definition: FFCs are food products (including supplements) for which the business operator, under its own responsibility, can label specific health functions (e.g., related to maintaining or promoting health, or suitable for those with particular health concerns, but not for treating, curing, or preventing diseases) based on scientific evidence, by notifying the Secretary-General of the CAA before marketing the product.
• Key Distinguishing Feature from FOSHU: The most crucial difference is that FFCs are not individually reviewed and approved by the government for their efficacy or safety in the same way as FOSHU. The CAA reviews the submitted notification for administrative completeness and compliance with procedural rules, but the scientific substantiation of the functional claim and the safety of the product remain the sole responsibility of the business operator.
• Advantages over FOSHU (Potentially):
  • Broader Scope: Applicable to a wider array of food components and ingredients beyond those typically seen in FOSHU (e.g., various phytochemicals, probiotics, specific fatty acids, processed foods with functional ingredients).
  • Faster Time-to-Market: The notification process, while detailed, is generally less lengthy and less costly than the FOSHU approval process.

Notification Process for FFC (届出制度 - Todokede Seido)

Businesses must submit a comprehensive notification dossier to the CAA at least 60 days prior to the planned start of marketing. The dossier must include:

1. General Information: Details about the product, the business operator, etc.
2. Safety Information: Data and assessment demonstrating the safety of the food product as consumed according to the recommended intake. This may involve history of safe use, toxicity studies for novel ingredients, etc.
3. Manufacturing and Quality Control: Information on the manufacturing process, quality control measures, and specifications for the functional substance(s). Adherence to Good Manufacturing Practices (GMP) is strongly recommended and often a practical necessity to ensure quality and safety, and to support the scientific evidence.
4. Information on Functional Substance(s): Characterization and quantification of the active component(s) responsible for the claimed function.
5. Scientific Evidence for the Claimed Function (科学的根拠 - Kagaku-teki Konkyo): This is the cornerstone of the FFC system. The business must provide robust scientific evidence to support the specific functional claim being made. This evidence can take one of two forms:
   • Systematic Literature Review (SR - システマティックレビュー): A comprehensive systematic review of relevant published human clinical trials concerning the effects of the finished product or the specific functional ingredient(s) on the claimed health outcome. The SR must be conducted according to established methodologies.
   • Human Clinical Trial on the Finished Product: The business can conduct its own human clinical trial on the final product formulation to directly demonstrate the claimed function. Such trials should be conducted adhering to principles similar to Good Clinical Practice (GCP), ensuring ethical conduct and robust methodology.
6. Proposed Labeling: A draft of the product label, clearly showing the intended functional claim and all other required information.
7. Consumer Affairs System: Information on the system the business has in place to collect and respond to consumer inquiries and complaints.

Public Disclosure: A key feature of the FFC system is transparency. Upon acceptance of the notification, the CAA makes the submitted information (including the product details, claimed function, and the summary of the scientific evidence) publicly available on its website. This allows consumers, healthcare professionals, and competitors to review the basis for the claims.

Permitted Functional Claims and Labeling for FFC

• Nature of Claims: Functional claims must relate to the maintenance or promotion of health or be suitable for individuals with particular health concerns. They must not suggest diagnosis, treatment, cure, or prevention of diseases. Claims are typically phrased with qualifiers like "helps maintain X," "supports Y function," "may contribute to Z in individuals with [specific characteristic]."
  • Examples: "This product contains [functional substance X], which has been reported to help maintain memory function that declines with age." "This product contains [functional substance Y], which has been reported to help reduce moderately high levels of visceral fat."
• Labeling Requirements:
  • Clear identification as a "Food with Function Claims" (「機能性表示食品」).
  • The specific notified functional claim.
  • The name of the functional substance(s) responsible for the claim.
  • The unique notification number (届出番号 - todokede bangō) assigned by the CAA.
  • A mandatory disclaimer stating: "This product has been notified to the Secretary-General of the Consumer Affairs Agency as a food for which specific health purposes can be expected based on the responsibility of the business operator. However, unlike Foods for Specified Health Uses, it has not undergone individual review and approval by the Secretary-General of the Consumer Affairs Agency." (この製品は、事業者の責任において特定の保健の目的が期待できる旨を表示するものとして、消費者庁長官に届出されたものです。ただし、特定保健用食品と異なり、消費者庁長官による個別審査を受けたものではありません。)
  • A statement clarifying that the product is not intended for the diagnosis, treatment, or prevention of disease, nor for consumption by individuals suffering from disease, minors, pregnant or lactating women (unless specifically developed and substantiated for these groups).
  • Recommended daily intake, precautions for consumption, allergen information, etc.
  • Contact information for the business operator.

Advertising Health Foods, Including FFCs

The advertising of all health foods, including FFCs, FOSHU, and FNFCs, is subject to multiple laws:

• PMD Act (Yakkiho): If any food product is advertised with claims that make it resemble an unapproved pharmaceutical (e.g., claiming to treat, cure, or prevent specific diseases), it will violate Article 66 of the PMD Act.
• Health Promotion Act: Prohibits false or exaggerated advertising concerning effects related to health maintenance or promotion.
• Food Labeling Act: Ensures that advertised claims are consistent with the information provided on the product label.
• Act against Unjustifiable Premiums and Misleading Representations (景品表示法 - Keihyōhō): This law also polices misleading representations about products, including health foods.

Specifics for FFC Advertising:

• Claims must be identical to, or fully consistent with, the functional claim that was notified to and published by the CAA. No expansion or exaggeration is permitted.
• The disclaimer that the product is not individually approved by the government and is not for treating diseases should be clearly communicated or readily accessible in advertising materials, where appropriate, to avoid misleading consumers.
• Scientific-sounding language, data, or imagery must be truthful, accurately reflect the supporting evidence, and not create a misleading impression of higher certainty or broader applicability than is justified.
• Care must be taken when linking general information about an ingredient's health benefits (e.g., in an article or on a general information website) to a specific FFC product containing that ingredient, to ensure that unnotified claims are not implicitly made for the product itself.

Foods for Special Dietary Uses (特別用途食品 - Tokubetsu Yōto Shokuhin)

This is another distinct category of foods that requires pre-market approval from the MHLW/CAA. It includes:

• Foods for infants and young children (e.g., infant formula).
• Foods for pregnant or lactating women.
• Foods for the elderly with difficulties in swallowing.
• Medical foods (病者用食品 - byōsha-yō shokuhin) intended for individuals with specific diseases, to be used under a physician's guidance (e.g., foods for diabetics, low-protein foods for kidney disease patients).
  These are generally intended for specific vulnerable populations or medical conditions and have different approval criteria and intended uses than FFCs or FOSHU.

Practical Considerations for Businesses

For companies considering entering Japan's functional food market:

1. Choose the Right Regulatory Pathway: The decision between FOSHU, FFC, or FNFC (or developing a standard food with no specific health claims) is strategic and depends on the nature of the product, the strength of scientific evidence, the desired claims, available resources (time and budget), and marketing objectives.
2. Robust Scientific Substantiation for FFC: The success of an FFC notification and the credibility of the product hinge on the quality, relevance, and methodological rigor of the scientific evidence (Systematic Review or human clinical trial) supporting the functional claim.
3. Navigating FFC Notification: While designed to be less burdensome than FOSHU approval, the FFC notification dossier is complex and requires meticulous preparation. Expertise in CAA requirements and scientific evidence evaluation is often beneficial.
4. Post-Marketing Responsibilities (FFC): Businesses remain responsible for the ongoing safety of their FFC products, monitoring consumer feedback, maintaining quality control in manufacturing, and staying abreast of scientific developments that might affect their product's claims or safety profile. They must also be prepared to respond to inquiries from the CAA.
5. Advertising Compliance: All marketing and advertising materials must be carefully vetted for compliance with all applicable laws and guidelines to avoid regulatory scrutiny and potential sanctions.

Conclusion

Japan offers a structured yet nuanced regulatory environment for foods making health-related claims. The FOSHU system provides a pathway for products with strong, government-vetted scientific backing, while the FNFC system allows for standardized nutrient function claims. The newer Foods with Function Claims (FFC) system has opened up significant opportunities for a broader range of products and ingredients by placing the primary responsibility for claim substantiation and product safety on the business operator, with government oversight focused on procedural compliance and transparency. For businesses, success in this dynamic sector requires not only innovative products but also a deep understanding of these regulatory categories, a commitment to robust scientific evidence, accurate and compliant labeling, and truthful, non-misleading advertising.