Most supplements sold on Japanese shelves with a health-function statement on the front of pack carry one label: Foods with Function Claims (機能性表示食品, kinousei hyouji shokuhin). Brands abroad hear the term and assume it works like an approval system elsewhere. It does not, and the difference changes what a factory can and cannot put on a Japan-made label.
This guide sets out what a Foods with Function Claims (FFC) notification actually is, how the notification-before-sale process works, what evidence it needs, the reforms tightened since 2024, and why the system applies only to products sold in Japan.
Health supplements are foods, not medicines, and are not a substitute for medical treatment.
💬 Planning a function-claim product made in Japan? We map the notification and manufacturing requirements together before you commit to a formula. See Japan-made supplement OEM.
What a Foods with Function Claims notification is
FFC is one of three Japanese systems that let a food state a health function, and it is the only one based on the selling business’s own responsibility rather than a government review of that specific product.
Japan groups these under “foods with health claims” (保健機能食品). The Consumer Affairs Agency (CAA) distinguishes them by how the claim gets on the label:
| System | Who reviews it | What backs the claim |
|---|---|---|
| Foods with Function Claims | No individual government review; the notifying business takes responsibility | Scientific evidence the business itself compiles and submits |
| Foods for Specified Health Uses (Tokuho) | CAA Commissioner reviews and approves each product individually | Product-specific safety and efficacy data judged by the government |
| Foods with Nutrient Function Claims | No review or notification at all | A fixed nutrient already established as safe and effective by law |
An FFC label states a function in everyday language — for example, that an ingredient is associated with a particular bodily function — based on evidence the notifying company selected and is legally responsible for. The CAA does not judge whether that evidence is convincing before the product reaches shelves.
How notification works before a product goes on sale
A business notifies the Consumer Affairs Agency before it starts selling an FFC product, but notification is not the same as approval.
The notifying business submits safety and scientific-basis information to the CAA Commissioner ahead of sale, using the agency’s prescribed notification format. Once accepted, the notification and its supporting documents become publicly searchable in the CAA’s own database, so any competitor, retailer or customer can look up exactly what evidence a given product relies on. This transparency is the trade-off for the lack of individual review: the evidence is public, but nobody at the CAA has pre-cleared it as sound before sale.
Because there is no individual government approval step, the CAA can and does spot-check notifications after the fact, request corrections, or ask a business to withdraw a notification it finds inadequate — which is a different mechanism from Tokuho’s pre-sale product-by-product approval.
💬 Want a plain-language walkthrough of what a notification requires before you brief your regulatory adviser? Tell us the ingredient and claim you have in mind.
The evidence a notification needs
A notification’s scientific basis comes from one of two routes: a clinical trial run on the actual final product, or a systematic review of the existing published research.
| Evidence route | What it involves | How commonly it is used |
|---|---|---|
| Clinical trial on the final product | A trial run specifically on the product being notified, testing the claimed function in humans | The minority route; most notifications rely on the review route instead |
| Systematic review (research review) | A structured search and evaluation of published studies on the ingredient, following a defined methodology, rather than a new trial on the product itself | The majority route for current notifications |
Either way, the responsibility for judging whether the evidence supports the claim sits with the notifying business, not with the CAA. From April 2025, new systematic-review notifications must follow the PRISMA 2020 reporting standard, part of the CAA’s push for more consistent, checkable reviews after concerns were raised about reviews built on a single, sometimes conflicted, published study.
The 2024 reforms tightening the system
Since 2024, Japan has added a mandatory health-damage reporting duty and, on a longer timeline, mandatory GMP manufacturing for supplement-shaped Foods with Function Claims.
The reforms followed a widely reported 2024 health-damage incident involving a red yeast rice ingredient in supplement form, which exposed gaps in how quickly health-damage signals reached the authorities and how manufacturing quality was assured.
- Health-damage reporting obligation. From 1 September 2024, a notifying business must collect information on suspected health damage and, once it becomes aware of a case diagnosed by a doctor, report it promptly to the CAA Commissioner and the relevant prefectural governor — even if a causal link to the product has not been established. This is now a compliance requirement under the Food Labelling Standards.
- Mandatory GMP for supplement-shaped products. From 1 September 2026, after a two-year transition, an FFC product in tablet, capsule, powder or liquid form must be manufactured under GMP, with the manufacturer subject to CAA on-site inspection. Whether gummy, jelly and other confectionery-style FFC products fall within this mandate is not spelled out, and a new supplement regulation still under discussion proposes leaving such forms out of mandatory GMP at first.
- Stricter review of new notifications. The CAA has tightened its intake checks on new and revised notifications and introduced the PRISMA 2020 requirement above, part of a broader push for more careful review before a notification is accepted.
Failing these duties can lead to a suspension of sale or a demand to withdraw the notification.
What this means for a brand outside Japan
Foods with Function Claims is a Japanese notification mechanism for products notified and sold in Japan; it does not apply to, or transfer to, a product sold only in another market.
A brand that makes its product in Japan for sale elsewhere follows its own market’s health-claim framework instead, not Japan’s. Those frameworks work on different logic from FFC and from each other:
| Market | Claim framework | How a claim reaches the label |
|---|---|---|
| Japan (FFC) | Foods with Function Claims | Business self-notifies to CAA before sale; no individual product approval |
| European Union | Nutrition and Health Claims Regulation (EC) No 1924/2006 | Claim must already be on the EU register of authorised health claims, evaluated by EFSA |
| United States | Structure/function claims under DSHEA | No pre-approval; manufacturer notifies FDA within 30 days of first marketing and carries a mandatory disclaimer |
The practical point for a Japan-made product: a Japanese FFC notification is not evidence your home market will accept, and your home market’s health-claim wording will not automatically satisfy Japan’s if you also sell there. Each market’s claim needs its own path.
Before you ask for a quotation
A factory can quote and plan production once the intended claim route and market are fixed.
- Whether the product will carry a notified function claim in Japan, or be sold there as an ordinary food without one
- If notifying in Japan: which evidence route you intend to rely on, and who will prepare it
- Whether the dosage form is tablet, capsule, powder or liquid, which brings the GMP mandate into scope from 1 September 2026
- Your process for monitoring and reporting suspected health-damage signals, if selling in Japan
- The health-claim framework of every other market you plan to sell in
💬 Ready to plan a Japan-made product against these requirements? Send us your ingredient, intended claim and target markets and we will map out what applies.
Frequently asked questions
1. Does Foods with Function Claims mean the Japanese government approved my product?
No. The CAA does not individually review or approve an FFC product before sale. The notifying business takes responsibility for the safety and scientific evidence, which becomes publicly searchable once the notification is accepted.
2. What evidence does an FFC notification need?
Either a clinical trial run on the final product itself, or a systematic review of published research on the ingredient. Most current notifications rely on the systematic-review route, which must follow the PRISMA 2020 standard for notifications from April 2025 onward.
3. What changed in the 2024 reforms?
A mandatory duty to report suspected health damage to the CAA and prefectural authorities, effective 1 September 2024, plus mandatory GMP manufacturing for tablet, capsule, powder and liquid FFC products from 1 September 2026, and stricter intake checks on new notifications.
4. Does my product need a Japanese FFC notification if I only sell outside Japan?
No. FFC is a notification mechanism for products sold in Japan. A product made in Japan for another market follows that market’s own health-claim rules instead.
5. Is FFC the same as Japan’s Tokuho mark?
No. Tokuho (Foods for Specified Health Uses) involves individual CAA approval of each product; FFC does not. They are two of three separate Japanese systems for stating a food’s health function.
Sources: Consumer Affairs Agency, “機能性表示食品について” (caa.go.jp/policies/policy/food_labeling/foods_with_function_claims); Consumer Affairs Agency, “保健機能食品について” (caa.go.jp/policies/policy/food_labeling/foods_with_health_claims); Consumer Affairs Agency, “機能性表示食品等に係る健康被害の情報提供義務化について”, August 2024 (caa.go.jp/notice/assets/food_labelling.cms201_240821_2.pdf), effective 1 September 2024; Consumer Affairs Agency, “「錠剤、カプセル剤等食品の製造管理及び品質管理(GMP)に関する指針(ガイドライン)」に係る項目解説及び自己点検表について” (caa.go.jp/notice/entry/042170/); Consumer Affairs Agency, “機能性表示食品の今後について”, August 2024 (caa.go.jp/notice/assets/food_labeling_cms201_240823_01.pdf); Regulation (EC) No 1924/2006 on nutrition and health claims made on foods; US FDA, “Structure/Function Claims” and “Notifications for Structure/Function and Related Claims in Dietary Supplement Labeling” (fda.gov). Checked on 25 September 2026.