Japan is the world's third-largest supplement market and one of the most sophisticated. Japanese consumers are discerning, quality-focused, and brand-loyal. The regulatory framework has two key pathways — Foods with Function Claims (FFC) and Foods for Specified Health Uses (FOSHU) — each with different requirements, timelines, and permitted claims.
Foods with Function Claims (FFC): Introduced in 2015. Notification-based — no pre-approval needed. You notify the Consumer Affairs Agency (CAA) and can begin sales 60 days later (if no objections). Claims must be supported by systematic reviews or RCTs. Most international brands use this pathway.
Foods for Specified Health Uses (FOSHU): Full government approval required. Stronger, more specific claims are permitted. Process takes 12–24 months and requires rigorous clinical evidence. Rare for new market entrants.
Products sold simply as dietary supplements with no function claims can be sold in Japan as standard food with minimal regulatory barriers. No registration, no notification. However, you cannot make any efficacy or health-related claims — not even implied ones in marketing materials.
Labels must be in Japanese. Required elements: product name, net weight, ingredient list, nutritional information, best before date, storage conditions, manufacturer or importer name and Japanese address, and country of origin. FFC-notified products must include the function claim exactly as notified and a disclaimer that the product has not been evaluated by the Consumer Affairs Agency.
Finding a trusted Japanese importer/distributor with regulatory expertise is essential. Japanese retail buyers expect: Japanese-language materials, local regulatory compliance documentation, product liability insurance, and a local point of contact. The sales cycle from first meeting to shelf placement is typically 6–12 months for major retail chains.
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