JAPAN — FOODS WITH FUNCTION CLAIMS & FOSHU
Foods with Function Claims let you carry a specific functional claim without pre-market approval, provided the substantiation dossier is filed with the Consumer Affairs Agency and published for anyone to read. That transparency is the discipline: the evidence has to hold up in the open.
THREE CLAIM CATEGORIES
FFC, FOSHU, or nothing at all.
Japan separates functional foods into Foods with Function Claims, which are notified with a published substantiation package; Foods for Specified Health Uses, which are individually approved after government review and carry a recognised seal; and ordinary foods, which may say almost nothing about function. Most imported supplements belong in the first category, but only if the active, the dose, and the wording match the evidence being cited. Kompete builds the notification around a claim you can actually defend.
THE FFC NOTIFICATION
Sixty days before launch, not after.
A notification is submitted well ahead of sale and includes the functional ingredient, the claim wording, the evidence — a systematic review or a qualifying clinical trial on the finished product — plus safety justification, quality control, and post-market monitoring arrangements. Incomplete files are returned rather than negotiated, so the review clock restarts. We assemble the package once, completely.
WHAT THE FILE MUST CONTAIN
Four pillars of a Japanese notification.
Published evidence
A systematic review or finished-product trial, filed in full and visible to competitors, regulators, and consumers alike.
Functional ingredient
One characterised active at a defined daily dose, with an analytical method proving it is present at end of shelf life.
Safety and interactions
History of intake, dose justification, and documented assessment of interactions with medicines and other actives.
Post-market monitoring
A named domestic contact, a complaint and adverse-event process, and quality control evidence held for inspection.
LABELLING & IMPORT
The importer carries the legal weight.
Japanese labels are prescriptive: name, ingredients in descending order, allergens, net content, best-before date, storage, importer details, nutrition panel, the notified claim, and the required cautionary statements sit in defined positions. Food sanitation import notification runs in parallel, and additives outside the permitted list will hold product at the border regardless of how the claim was handled.
Write the claim you can publish.
We assess whether your existing evidence supports a Japanese notification, and where it does not, what the shortest credible path to one looks like.