FFC-Notified Cognitive Supplements in Japan — 機能性表示食品 + FOSHU
Japan regulates functional foods through two main systems: FFC (Foods with Function Claims / 機能性表示食品) and FOSHU (Foods for Specified Health Uses / 特定保健用食品). Cognitive supplements sold in Japan typically use the FFC notification route. Imported brands without FFC status fall under "general foods" and cannot make function claims under the Pharmaceutical and Medical Device Act (薬機法). This page explains the categories, how to verify FFC status, and the ¥16,000 personal-import threshold for non-domestic brands.
Japan's functional-food categories
FOSHU (Foods for Specified Health Uses)
特定保健用食品 (トクホ)
Evidentiary burden: Highest evidentiary bar — pre-market approval by the Consumer Affairs Agency based on submitted clinical data.
Permitted scope: Health-function claims approved on a per-product basis. Display the FOSHU mark on packaging.
Examples: Specific approved cognitive products are limited; FOSHU is more commonly used for blood-glucose, cholesterol, and intestinal-health products.
FFC (Foods with Function Claims)
機能性表示食品
Evidentiary burden: Manufacturer notification system; manufacturer responsible for evidence; submitted to CAA database 60 days before sale.
Permitted scope: Function claims describing specific health-function effects (memory, attention, fatigue reduction, etc.). Most cognitive nootropic products in Japan use this route.
Examples: DHC ginkgo extract, Suntory Boltage, FANCL memory-support products, multiple Asahi cognitive products.
Foods for Special Dietary Uses
特別用途食品
Evidentiary burden: Approval by Consumer Affairs Agency based on suitability for a specific dietary purpose (e.g. for the elderly, infants, those with specific medical conditions).
Permitted scope: Distinct system from FOSHU/FFC; less commonly used for cognitive products.
Examples: Most relevant for elder-care and clinical-nutrition products
General foods (no notification)
いわゆる健康食品 (ノーマル食品)
Evidentiary burden: No regulatory notification required.
Permitted scope: Cannot make function claims of any kind. Can only describe ingredient content. Imported supplements via personal-import channels generally fall here.
Examples: Imported brands (Mind Lab Pro, Onnit, Qualia) shipping to Japan via cross-border channels
How to verify an FFC notification
- Locate the FFC notification number on the product packaging (typically marked 届出番号).
- Open the Consumer Affairs Agency FFC database.
- Search by notification number or product name; verify notifier matches the brand and the function claim matches the product label.
- If notification is "withdrawn" (撤回) or "rejected", do not purchase.
Personal-import threshold for non-domestic brands
For imported nootropic brands (Mind Lab Pro, Onnit, Qualia, Hunter Focus, etc.) shipped from overseas:
- Personal-use importation up to approximately ¥16,000 per shipment is permitted without an individual import licence.
- Shipments exceeding this value may require personal-use import documentation; customs may detain.
- One-month supplies of most premium nootropic stacks fall within the threshold; bulk orders may not.
- Repeated shipments to the same address may be aggregated by customs.
Audit of our Japanese catalog
We track 6 products in our Japanese catalog. The mix includes FFC-notified domestic brands (DHC, Suntory Wellness, FANCL, Asahi) and imported brands available via personal-import channels. Our reviews note FFC notification status where visible on packaging and frame imported-brand reviews as consumer experience rather than function claims, in line with PMD Act constraints. Per-product FFC field surfacing is on our 2026 roadmap.
Until per-product FFC surfacing ships, verify each FFC notification directly via the Consumer Affairs Agency database link above before purchasing.
Frequently asked questions
What is FFC (機能性表示食品) and how does it differ from FOSHU?
FFC (Foods with Function Claims) is a notification system introduced in 2015. The manufacturer is responsible for compiling and submitting scientific evidence supporting function claims to the Consumer Affairs Agency 60 days before sale. CAA does not approve products under FFC — it accepts notifications. FOSHU (特定保健用食品) is the older approval system requiring direct CAA approval based on submitted clinical trials. FFC is faster and used by the majority of newer cognitive supplements in Japan; FOSHU is more commonly used for blood-glucose, cholesterol, and intestinal-health products.
How do I verify a product's FFC notification?
Search the Consumer Affairs Agency FFC database (機能性表示食品の届出情報検索) using the product name or notification number. The database returns the notified function claim, recommended intake, scientific basis summary, and notification status. Notifications can be withdrawn or rejected — verify currency before purchase. The notification number typically appears on FFC product packaging.
Why does it matter for imported supplements?
Imported nootropic supplements (Mind Lab Pro, Onnit, Qualia, Hunter Focus) generally do not have FFC or FOSHU status because the FFC notification is per-product per-formulation and applies only to products marketed in Japan. They are sold through personal-import channels and fall under the "general foods" category. Marketing materials that assert cognitive benefits for these products in Japan can run afoul of the Pharmaceutical and Medical Device Act (PMD Act / 薬機法) — claim-language must be carefully framed as ingredient mechanism or consumer experience rather than disease treatment or function claim.
What is the ¥16,000 personal-import threshold?
Japan permits personal importation of supplements up to approximately ¥16,000 worth per shipment without an individual import licence. Beyond this threshold, the importer must obtain personal-use import documentation. In practice this means most one-month supplies of premium nootropic stacks are within the threshold, but multi-month bulk orders may not be. Customs may request import documentation for larger or repeated shipments.
Is the PMD Act the same as FDA regulation in the U.S.?
No. The PMD Act (Pharmaceutical and Medical Device Act, 薬機法, formerly the Pharmaceutical Affairs Law) regulates medicines, medical devices, cosmetics, and quasi-drugs. Foods (including supplements) are regulated under the Food Sanitation Act and the Health Promotion Act. The PMD Act becomes relevant to supplements when marketing claims describe disease treatment, prevention, or pharmacological effects — at that point the product is treated as an unapproved drug, which is a serious regulatory violation.
Regulatory sources (6)expand
- RegulatoryConsumer Affairs Agency (消費者庁) — Foods with Function Claims
- RegulatoryCAA — FFC notification database (届出情報検索)
- RegulatoryConsumer Affairs Agency — FOSHU (特定保健用食品)
- RegulatoryPharmaceutical and Medical Device Act (PMD Act / 薬機法)
- RegulatoryJapan Customs — Personal import of pharmaceuticals and supplements
- EditorialThe Nootropic Lab — Methodology