FFC

Foods with Function Claims (機能性表示食品, kinosei hyoji shokuhin — FFC) is the Japanese functional-food category introduced in April 2015 by the Consumer Affairs Agency (CAA) under the Food Labeling Act. Unlike Foods for Specified Health Use (FOSHU / Tokuho — 特定保健用食品), FFC requires no pre-market government review of efficacy. The operator (manufacturer or seller) self-substantiates the function claim with a published systematic review or its own clinical trial, files a pre-marketing notification with the CAA at least 60 days before sale, and the notification is published on the CAA database. The CAA can challenge the substantiation post-market.

FFC sits inside a three-track Japanese functional food framework. (1) FOSHU / Tokuho — pre-market government efficacy review, the most rigorous and now the slowest-growing track. (2) Foods with Nutrient Function Claims (栄養機能食品, eiyou kinosei shokuhin) — claims from a CAA-published list of 20 vitamins and 5 minerals, no notification needed but only allowed claims permitted. (3) FFC — self-substantiated claims with notification but no review, by far the fastest-growing track since 2015 and the route most international supplement brands take to enter the Japanese functional channel. FFC has been extended beyond processed foods to fresh foods and supplement-format products.

The 2024 red yeast rice (紅麹) incident prompted the CAA to tighten post-market surveillance and GMP expectations on FFC; the pre-market mechanics did not change, but the bar on adverse event reporting and on the quality system behind the notification rose, particularly for supplement-format FFC. In V5 the FFC notification ID, the systematic review or clinical trial substantiation, the GMP attestation, and the Japanese-language label with mandatory disclaimers all live on the SKU's Japan regulatory record, so a CAA post-market query or an adverse event report has its substantiation and batch context on one page.