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Selling supplements in Japan

In Japan, supplements are food under the Food Sanitation Act and the Food Labelling Act. A function may be stated only as a Food for Specified Health Uses, a Food with Nutrient Function Claims, or a Food with Function Claims notified to the Consumer Affairs Agency 60 days before sale. Medicinal claims fall under pharmaceutical law.

Updated · Each section links to the official source it comes from

Legal status
Food, under the Food Sanitation Act and Food Labelling Act
Claims allowed
FOSHU, nutrient function claims, or function claims
Function claims
Notified to the CAA 60 days before sale
FOSHU
Permission from the CAA for each product
Tablets and capsules
Manufacturing standard for function-claim products from natural extracts
Label language
Japanese

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Does anything in the product, its label or its adverts make it a medicine or quasi-drug? Read more
  2. 2Which claim route, if any, does the product use? Read more
  3. 3For function claims, is the notification filed 60 days before sale, with safety and efficacy evidence? Read more
  4. 4Is a tablet or capsule made from natural extracts manufactured to the CAA's standard? Read more
  5. 5What must the Japanese label show? Read more
  6. 6Who files the import notification? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

The health-claim routes

The only ways a food may state a function in Japan.

  • Foods with Health Claims (保健機能食品) are of three kinds: Foods with Nutrient Function Claims (栄養機能食品), Foods for Specified Health Uses (特定保健用食品, FOSHU) and Foods with Function Claims (機能性表示食品).
  • Other foods may not show effects or functions (Food Labelling Standards, Article 9, as cited by the CAA).
  • Foods with Nutrient Function Claims are self-certified: the daily intake must fall within set upper and lower limits, and the label shows the nutrient's set function and precautions for intake.
  • FOSHU must be reviewed by the State for effectiveness and safety and permitted product by product (Health Promotion Act, Article 43(1)).
  • Any food labelled as a nutritional supplement or health supplement without one of these statuses is a food in general, in the CAA's outline.

How we help: Compliant Always records which route each product uses and keeps the permission, notification or nutrient evidence behind its claims with the product. Ask about this

Foods with Function Claims

The notification route, run on the business's own responsibility.

  • A business may state a function if, before sale, it notifies the CAA Commissioner of the scientific evidence for safety and function and other required matters. The State does not review it.
  • The notification is filed in the CAA's database at least 60 days before the planned start of sale, not counting administrative holidays.
  • It covers the label, the business, the evidence for safety and function, production and quality control, and how health damage information is collected and passed to authorities.
  • Tablets, capsules and similar products made from natural extracts follow a manufacturing standard set by Cabinet Office Notice No. 108 of 2024; other products state their GMP, HACCP or ISO 22000 status.
  • Notifiers report a self-check to the CAA within a year of the notification number, and yearly after that.
  • What was notified is published on the CAA's website for anyone to check.

How we help: Compliant Always keeps the notification, the evidence behind it and the factory's manufacturing records together, and shows when the yearly self-check report is due. Ask about this

The boundary with medicines

When a product stops being food.

  • Food under the Food Sanitation Act excludes pharmaceuticals and quasi-pharmaceutical products under the Pharmaceuticals and Medical Devices Act (Article 4).
  • Before notifying a Food with Function Claims, the business confirms the product is not a pharmaceutical or quasi-drug.
  • Foods with Health Claims are not medicines and are not taken to treat or prevent disease, the CAA states.

How we help: Compliant Always sets your label and adverts beside the claims your route allows, so wording that reads as a medicine shows up before it is printed. Ask about this

Labelling and advertising

What the label shows, and what an advert may not say.

  • Supplements are labelled under the Food Labelling Standards, in Japanese, with allergens, dates, ingredients, additives and the nutrition label.
  • Foods with Nutrient Function Claims show the function set for the nutrient and the precautions for intake (Food Labelling Standards, Articles 7 and 21).
  • Representations about health effects that are significantly contrary to fact or misleading are prohibited in advertising food (Health Promotion Act, Article 65).
  • The CAA has warned against adverts for Foods with Function Claims that implied the State had recognised their effect, and against adverts that go beyond what was notified.

How we help: Compliant Always reads your label and marketing copy against the notified wording, and keeps the version of each with the product. Ask about this

Import and safety standards

How a supplement comes into Japan.

  • Each import of food for sale is notified to an MHLW quarantine station (Food Sanitation Act, Article 27).
  • Additives, including vitamins, minerals and amino acids, must be designated or otherwise permitted, and used within their standards.
  • A business that handles food containing ingredients designated as needing special attention notifies the prefecture without delay when it learns of possible harm to health (Article 8).

How we help: Compliant Always keeps the ingredient specifications and certificates the import notification relies on with the product and lot. Ask about this

Who answers for what

WhoWhat they answer forHow we help
Notifier or permit holderThe function-claim notification or FOSHU permission, the evidence behind it and the yearly self-check.The notification and its evidence kept together, with the next report date.
ImporterThe import notification and a product that meets Japan's standards.Suppliers' documents read and dated before the goods arrive.
ManufacturerProduction and quality control, including the standard for tablets and capsules from natural extracts.Batch and GMP records kept with each product.
Brand or sellerThe label and adverts, and that claims stay within what was notified or permitted.Claims set beside the notified wording before they go out.

National law, prefectural enforcement

Product law in Japan is national. Ministries and the Consumer Affairs Agency set the standards; prefectural governors and cities with public health centres license food businesses, receive food recall notifications and carry out inspections.

Imports are checked at the border: food and food contact articles at MHLW quarantine stations, and liquor licences are granted by the tax office for each place of sale.

Questions businesses ask

Is there a supplement law in Japan?
No separate one. Supplements are food under the Food Sanitation Act and the Food Labelling Act. A product that reads as a medicine falls under the Pharmaceuticals and Medical Devices Act instead.
Can a supplement make a health claim in Japan?
Only as a Food for Specified Health Uses (FOSHU), a Food with Nutrient Function Claims or a Food with Function Claims. Other foods may not show effects or functions.
What is a Food with Function Claims?
A food whose business notifies the CAA Commissioner, before sale, of the scientific evidence for its safety and function. The State does not review it; the business is responsible for the claim.
How far ahead must a function claim be notified?
At least 60 days before the planned start of sale, not counting administrative holidays, through the CAA's notification database.
Does FOSHU need approval?
FOSHU needs the State's review of effectiveness and safety and permission for each product under Article 43(1) of the Health Promotion Act.
Do Foods with Nutrient Function Claims need a licence?
No. They are self-certified, but the daily intake must sit within set upper and lower limits and the label must show the set function and precautions.
Is GMP required for supplements in Japan?
For Foods with Function Claims in tablet, capsule and similar forms made from natural extracts, a manufacturing standard set by Cabinet Office Notice No. 108 of 2024 applies.
Are function-claim notifications public?
Yes. What a business notifies, including the evidence for safety and function and the production and quality control information, is published on the CAA's website.
Do supplements need an import notification?
Yes. They are food, so each import for sale is notified to an MHLW quarantine station under Article 27 of the Food Sanitation Act.
Can a supplement advert promise health effects?
Not where the representation is significantly contrary to fact or misleading (Health Promotion Act, Article 65), and the CAA has warned against adverts that go beyond what was notified.
How does Compliant Always help with selling in Japan?
Our team reads the rules for the markets you sell in, including the Japanese-language sources. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in Japan and what your paperwork needs to show.

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