Tokuho

Tokuho (特定保健用食品 — Tokutei Hoken-yō Shokuhin, internationally referred to as FOSHU — Foods for Specified Health Use) is Japan's pre-market reviewed functional food category, administered by the Consumer Affairs Agency (CAA) with scientific evaluation by the Food Safety Commission (FSC) under the Food Labeling Act and the Health Promotion Act. Established in 1991, Tokuho was the world's first formal functional food category and remains the most rigorous of Japan's three functional tracks.

Unlike FFC (Foods with Function Claims, established 2015) which is self-substantiated by notification, and Foods with Nutrient Function Claims which run on a CAA-published claim list, Tokuho requires full clinical evidence on the finished product itself — not a surrogate, not the active ingredient alone, not extrapolation from related studies. The review covers safety (toxicology, intake history, sub-chronic and chronic studies as warranted), efficacy (placebo-controlled clinical trial on the finished product in the intended consumer at the intended dose), stability of the active component, manufacturing quality, and the proposed claim wording. Approval takes 24-36 months and significant cost, and the approved product carries the distinctive Tokuho mark (a smiling figure raising its arms) on the front of pack alongside the specific approved claim.

Since FFC opened in 2015 the Tokuho approval volume has declined as most new functional supplements take the faster, lighter FFC notification route — but Tokuho remains the gold-standard track for category-defining products where the brand wants the explicit Japanese government efficacy mark. Sub-categories include Standardised Tokuho (claims from a CAA-published menu using pre-validated ingredients), Tokuho with Disease Risk Reduction Claims (a narrowly permitted category for specific calcium and folate claims), and Conditional Tokuho (reduced evidence bar for traditional functional foods). In V5 the Tokuho approval reference, the clinical study set, the manufacturing GMP attestation and the approved Japanese label live on one SKU spine, so a CAA post-market query or a label revision tracks back to one master record.