The first thing to know: Japan decides “food or medicine” by ingredient
Before dosage form, before price, the formula has to pass Japan’s food–medicine boundary — and that boundary is drawn by ingredient.
Japan’s Ministry of Health, Labour and Welfare publishes a list of substances treated exclusively as medicines. It is attached to the Ministry’s notice of 31 March 2020 (薬生監麻発0331第9号), which builds on the principles of Notice No. 476 of 1 June 1971. A product that contains one of those substances is treated as a medicine, whatever its label says — so a Japanese food factory cannot make it as a supplement, even for export.
This is the point where many overseas brands first get a short refusal from a Japanese factory: a formula that sells as a supplement at home contains an ingredient, or a part of a plant, that Japan classifies as medicinal. We run that check on your formula first, and suggest a compliant alternative where one exists.
Why it matters for your export documents too
Japan issues a Certificate of Free Sale only for foods made in Japan that are, or could be, sold in Japan — so a formula that fails Japanese food law cannot get one.
Many importing countries ask for a Certificate of Free Sale when a supplement is registered. Since 1 April 2020, certificates for food exported from Japan have been issued by the regional agricultural administration offices of the Ministry of Agriculture, Forestry and Fisheries, a role that previously sat with the Regional Bureaus of Health and Welfare. The certificate covers foods manufactured in Japan that are or could be sold in Japan, and Japan’s issuance guideline states that it does not certify the safety of an individual export shipment. See our Certificate of Free Sale guide.
| Document | What it shows | Who issues it |
|---|---|---|
| Certificate of analysis (CoA) | Test results for the production batch against its specification | The factory (or a testing laboratory) |
| Product specification | Ingredients, amounts, dosage form, shelf life and storage | The factory |
| Certificate of Free Sale | Made in Japan and freely saleable in Japan as a food | Regional agricultural administration office (MAFF) |
| Certificate of origin | Country of origin, for customs and any preferential tariff | The competent issuing body in Japan |
Checked against the published texts of the Ministry of Agriculture, Forestry and Fisheries and the Ministry of Health, Labour and Welfare on 25 September 2026.
Manufacturing quality in Japan
Japanese supplement makers work to good manufacturing practice, and for Foods with Function Claims in tablet and capsule form GMP has been a legal requirement since 1 September 2026.
Japan’s Consumer Affairs Agency made GMP-based manufacturing control a requirement for Foods with Function Claims in supplement form — tablets, capsules and similar products made with natural extracts — with the rule fully in force from 1 September 2026. Your product does not need to be a Japanese Food with Function Claims to be exported, but the requirement shows the standard Japanese supplement production now works to. Our production takes place at a GMP-certified partner factory in Japan.
From concept to shipment
Six steps, each agreed in writing before the next starts.