,
3 min read
Japan is globally recognized for its stringent and science-driven food and supplement regulation approach. At the heart of its Regulatory framework lies a strong emphasis on claims substantiation, ensuring that health-related claims are accurate, scientifically credible, and transparent.
For manufacturers, understanding and complying with Japan’s unique three-tier system—FOSHU, FNFC, and FFC—is essential for lawful market entry, consumer trust, and long-term success.
1. Foods for Specified Health Uses (FOSHU)
FOSHU, often considered the benchmark for health claims in Japan, involves a rigorous evaluation process by the Consumer Affairs Agency (CAA), previously overseen by the Ministry of Health, Labor, and Welfare (MHLW). Beyond “regular” FOSHU, the framework also includes Standardized FOSHU, Qualified FOSHU, and Reduction of Disease Risk FOSHU, each designed to address specific claim categories.
Key Requirements:
- Scientific Evidence: Mandatory human clinical trials demonstrating product safety and efficacy for the claimed function.
- Supporting Data: Additional in vitro or animal studies may support the core clinical evidence.
- Application Process: Can take (6–12 months or longer depending on Data Quality.
- Approval & Labeling: Only upon approval can the product carry the prestigious FOSHU seal, signifying its verified health benefit.
Examples of Claims:
Foods related to blood cholesterol level, Foods affecting blood sugar levels.
Impact:
FOSHU status enhances consumer trust and market credibility but requires heavy investment in research, Regulatory documentation, and time.
2. Foods with Nutrient Function Claims (FNFC)
FNFCs are general foods that include specific vitamins or minerals (17 nutrients) at levels established by MHLW.
Key Requirements:
- No Pre-market Approval Needed: Products can be marketed if they meet CAA's nutrient standards.
- Standardized Claims: Limited to claims pre-defined by the government (e.g., “Vitamin C contributes to the maintenance of normal immune function”).
- Scientific Basis: Relies on global consensus and existing nutritional science—no new clinical trials needed.
Impact:
FNFC enables rapid market entry and is widely used by supplement manufacturers targeting basic nutritional support.
3. Foods with Function Claims (FFC) Japan
Launched in 2015, the FFC system provides a more flexible pathway by allowing companies to submit their scientific evidence to support function claims without formal product-by-product approval. Before marketing, businesses must notify the Consumer Affairs Agency (CAA) with supporting scientific data and labeling details.
Key Requirements:
- Scientific Substantiation: Requires either:
- Clinical trials on the finished product, or
- Systematic literature review on the ingredient or product.
- Notification-based system (NO government review before marketing), must notify CAA 60 days before with scientific evidence
- Transparency: All dossiers are made public, reinforcing accountability.
- Labeling: Must clearly state the claim without exaggeration or ambiguity.
- Safety & Quality: Requires proof of safe use, interaction risks, and detailed manufacturing controls.
Examples of Claims:
“Helps maintain healthy blood pressure,” “Improves sleep quality.”
Impact:
FFC democratizes health claims access but demands high scientific integrity and Regulatory diligence.
Consequences of Non-Compliance with the claims-
Failing to adhere to Japan’s claims substantiation rules can lead to severe consequences, including:
- Product Delisting or Ban: Regulatory authorities may suspend sales of products with non-compliant or misleading claims.
- Public Disclosure of Non-compliance: The CAA may list non-compliant companies or products, damaging brand credibility.
- Fines and Legal Action: Violating the Health Promotion Act or the Act against Unjustifiable Premiums and Misleading Representations can lead to legal sanctions and fines.
- Loss of Consumer Trust: Japanese consumers trust Regulatory marks like FOSHU. Any breach of trust can result in long-term reputational damage.
- Mandatory Product Recalls: Companies may be required to recall products at their own expense for false or harmful claims.
Summary Table: Claim Substantiation by Category
| Category | Claim Type | Substantiation | Approval/Registration | Reviewed By | Example Claim |
|---|---|---|---|---|---|
| FOSHU | Specific health use | Human clinical trials + supporting studies | Full approval | CAA/MHLW | “Supports gut health” |
| FNFC | Standardized claims | Based on pre-approved science | No prior approval or notification required | CAA (standards) | “Calcium is necessary for bone and teeth formation.” |
| FFC | Function claim | Clinical trial or literature review | Registration (no approval) | CAA (public DB) | “Helps maintain normal blood pressure.” |
How Freyr Can Help
Navigating Japan’s claims substantiation landscape requires local insight, scientific rigor, and Regulatory precision. Freyr, a global Regulatory partner, brings unmatched expertise to help you successfully launch compliant food and supplement products in Japan.
Freyr’s Comprehensive Support Includes:
- Regulatory Pathway Evaluation: Determine whether FOSHU, FNFC, or FFC is right for your product.
- Scientific Dossier Preparation: Assist with clinical trial design, literature reviews, safety assessments, and analytical data compilation.
- FFC Registration Support: Guide you through Japan’s FFC registration system and ensure public dossier readiness.
- Label and Claim Review: Ensure claims comply with CAA standards and are not misleading.
- Translation & Documentation: Provide accurate Japanese translations and adapt claims to cultural and legal expectations.
- Post-Market Surveillance: Monitor Regulatory changes and competitor activity and assist with compliance maintenance.
With Freyr, food and food supplement manufacturers can accelerate the time spent on the market, minimize Regulatory risk, and establish a trusted presence in the Japanese health product space.
Conclusion
Japan’s claim substantiation system reflects the country’s commitment to consumer safety, scientific credibility, and Regulatory transparency. Whether you’re seeking the prestige of FOSHU, the simplicity of FNFC, or the flexibility of FFC, compliance is non-negotiable.
Non-compliance can lead to reputational damage, legal consequences, and commercial failure.
By partnering with Freyr, you can confidently navigate Japan’s complex Regulatory terrain and ensure that your food or supplement product is safe, trusted, and compliant—every step of the way.
