Claims Substantiation For Food And Food Supplements In Japan: A Regulatory Deep Dive

Japan is globally recognized for its stringent and science-driven regulatory approach to foods and supplements. At the heart of this framework is claims substantiation, ensuring that all health-related claims are accurate, scientifically validated, and transparent.

For manufacturers, complying with Japan’s unique three-tier claims system—FOSHU, FNFC, and FFC—is essential for successful market entry, consumer trust, and long-term business growth.

1. Foods for Specified Health Uses (FOSHU)

Often regarded as the gold standard, FOSHU involves a rigorous evaluation process by the Consumer Affairs Agency (CAA), previously overseen by the Ministry of Health, Labor, and Welfare (MHLW).

Key Requirements:

• Scientific Evidence: Human clinical trials proving safety and efficacy.
• Supporting Data: In vitro or animal studies to strengthen findings.
• Application Process: Can take 6–12 months depending on data quality.
• Approval & Labeling: Only approved products may carry the FOSHU seal, a mark of credibility and consumer trust.

Examples: Claims related to cholesterol and blood sugar regulation.
 Impact: High trust and credibility, but significant investment in research and regulatory documentation.

2. Foods with Nutrient Function Claims (FNFC)

FNFC covers general foods containing vitamins or minerals (17 nutrients) at levels set by MHLW.

Key Requirements:

• No Pre-Market Approval: Products can be marketed if they meet nutrient standards.
• Standardized Claims: Restricted to government-approved statements (e.g., “Vitamin C supports immune function”).
• Scientific Basis: Relies on existing global nutritional clinical trials required.

Impact: Fast market entry and widely adopted by supplement companies.

3. Foods with Function Claims (FFC)

Introduced in 2015, the FFC system provides a more flexible pathway by allowing companies to submit their scientific evidence directly to the CAA without formal product-by-product approval.

Key Requirements:

• Scientific Substantiation: Either clinical trials on the product OR systematic literature review.
• Notification-based: Must notify the CAA 60 days prior to launch.
• Transparency: All dossiers are made public for accountability.
• Safety & Quality: Requires proof of safe use, ingredient safety, and quality control.

Examples: “Helps maintain blood pressure,” “Improves sleep quality.”

Impact: More accessible for manufacturers but demands strict scientific integrity and robust regulatory submissions.

Risks of Non-Compliance

Failure to comply with Japan’s claims substantiation rules can lead to:

• Product Delisting or Bans
• Public Disclosure of Non-compliance by CAA
• Fines and Legal Action
• Loss of Consumer Trust
• Mandatory Recalls

Claims Substantiation: Comparison Table

How Maven Regulatory Solutions Supports Compliance

Navigating Japan’s complex regulatory framework requires local insight, scientific validation, and robust documentation. Maven Regulatory Solutions offers end-to-end support:

• Regulatory Pathway Evaluation – Guidance on FOSHU, FNFC, or FFC.
• Scientific Dossier Preparation – Clinical trials, literature reviews, safety assessments, data compilation.
• FFC Registration Support – Seamless CAA notification and dossier submission.
• Label and Claim Review – Ensuring claims are compliant, accurate, and non-misleading.
• Translation & Documentation – Accurate Japanese translations with cultural adaptation.
• Post-Market Surveillance – Monitoring regulatory changes and competitor activity.

Conclusion

Japan’s claims substantiation framework reflects its commitment to consumer safety, scientific credibility, and regulatory transparency. Whether pursuing the prestige of FOSHU, the simplicity of FNFC, or the flexibility of FFC, compliance is non-negotiable.

By partnering with Maven Regulatory Solutions, manufacturers can successfully navigate Japan’s strict regulatory system, minimize risks, and ensure consumer trust in food and supplement products.