Foreign supplement brands arriving in Japan tend to carry one assumption from their home market: that a "supplement" or "nutraceutical" is a distinct regulatory category with its own approval track, separate from ordinary food and separate from drugs. Japan does not work that way. There is no standalone legal category called "supplement." A tablet, capsule, powder, or gummy sold as a health product is regulated as food under the Food Sanitation Act (食品衛生法), full stop, unless an ingredient or a claim pushes it toward the Pharmaceutical and Medical Device Act (薬機法) definition of a drug, in which case the product stops being a food matter entirely. This single fact drives almost every practical decision a brand has to make before its first shipment clears Japan customs, and it is the reason a supplement import cannot be handled with the same checklist used for packaged food or for cosmetics.
This post covers how Importer of Record (IOR) structuring interacts with that regulatory layer, and where the actual points of failure sit: ingredient permissibility, health-claim category, and labeling, layered on top of the customs and consumption tax mechanics common to any IOR shipment.
No Separate "Supplement" Category: Everything Is Food Unless It Is a Drug
Under the Food Sanitation Act (食品衛生法), any product ingested for nutritional or health purposes, packaged as a tablet or capsule or otherwise, is treated as food unless it makes a claim or contains an ingredient that crosses into the Pharmaceutical and Medical Device Act (薬機法) definition of a drug. That crossing point is narrower than most US or EU brands expect. A claim as mild as "supports liver function" or "improves blood circulation" can be read as an efficacy claim reserved for approved pharmaceuticals, and using it on an ordinary food product is a labeling violation, not a marketing nuance.
Within the food framework, Japan recognizes two specific regulatory sub-categories for products that want to make a health-related statement on the label, and brands should not treat either as optional formality:
Foods with Function Claims (機能性表示食品). A notification-based system, not pre-approval, where the business itself takes responsibility for the scientific substantiation and submits a notification to the Consumer Affairs Agency (消費者庁) before sale. This is the route most function-claim supplement products use because it does not require the multi-year review of the next category.
Foods for Specified Health Uses (特定保健用食品, commonly known as Tokuho), トクホ. An individual product approval system requiring government review of clinical evidence for each specific health claim. This is the most rigorous and slowest route, and it is generally not a realistic first-market-entry path for a foreign brand testing Japan demand.
A product with no health claim at all, sold as ordinary food, a plain multivitamin marketed only as "contains vitamin C," for example, without an efficacy statement, can bypass both categories and clear as a standard food import. The decision of which lane to use is a labeling and claims decision made before the first shipment is packed, not something to resolve after customs holds a container.
Ingredient and Additive Permissibility: The Step Brands Skip
The most common failure point for supplement importers is not the claims framework above. It is the ingredient list itself. Japan maintains its own positive-list logic for food additives and its own restrictions on certain botanical and herbal ingredients under the Food Sanitation Act (食品衛生法), and this list does not track the US or EU positive lists one-to-one. Ingredients that are unremarkable in a US-market or EU-market supplement, certain herbal extracts, specific vitamin forms, and some amino acid derivatives among them, can be restricted, subject to quantity caps, or simply absent from Japan's permitted list, which functionally means not permitted at all until a substance is added through formal review.
This is a pre-shipment check, not a post-arrival one. A formulation should be screened against Japan's food additive and ingredient rules before the first purchase order is placed with the manufacturer, because reformulating after a shipment is held at the border is materially more expensive than reformulating before manufacturing. Aplash's regulatory scoping for this category verifies the ingredient list against current Food Sanitation Act (食品衛生法) positive-list status before an IOR engagement proceeds, distinct from the customs classification exercise.
Labeling Requirements
Once the claims category and ingredient status are settled, Japanese-language labeling still has to satisfy the Food Sanitation Act (食品衛生法) disclosure requirements: ingredient list, allergen disclosure where applicable, net content, expiration or best-before date, storage instructions, and a Japan-based responsible party. This is where a Japan buyer, or Aplash's re-sale role in the IOR structure, typically appears on the label rather than the foreign brand's own overseas entity. For a product carrying a Foods with Function Claims (機能性表示食品) notification, the label must also carry the specific approved wording of the claim exactly as filed; the brand's original English marketing copy cannot simply be translated and pasted onto the Japanese package.
How This Sits on Top of the IOR Structure
None of the regulatory work above changes the underlying IOR mechanics. Under IOR, Aplash is the legal importer of record: Aplash purchases the goods from the overseas seller, files the import declaration in its own name under the Customs Act (関税法), pays the applicable customs duties and import consumption tax, and re-sells to the Japan-side buyer at cost plus the pass-through duty and tax. Aplash issues a qualified invoice (適格請求書) on that re-sale, which allows the Japan buyer to claim Japanese Consumption Tax (JCT) input credit. This structure lets a foreign supplement or vitamin brand ship into Japan without establishing a Japan entity of its own.
What the food regulatory layer adds is a precondition that sits before the customs declaration, not a substitute for it. Aplash's IOR customs work assumes the product has already cleared the Food Sanitation Act (食品衛生法) notification and labeling gate. A shipment that has not cleared that gate is not a customs delay; it is a stopped shipment, because Japan Customs coordinates with the health authority on food-category imports and will not release an uncleared food product regardless of how clean the customs paperwork is. The practical sequence for a first shipment is: confirm claims category and ingredient permissibility, prepare compliant Japanese labeling, then structure the IOR purchase-and-resale contracts and file the import declaration.
This is also why supplement IOR work is distinct in kind from the cosmetics IOR structure and from ordinary packaged-food IOR work covered elsewhere on this blog: the ingredient-permissibility check and the two-tier health-claim system, Foods with Function Claims and Tokuho, do not exist in the same form for either cosmetics or plain food and beverage products, even though all three ultimately route through the same Food Sanitation Act (食品衛生法) framework and the same IOR customs and JCT mechanics.
Conclusion
A foreign supplement, vitamin, or nutraceutical brand entering Japan is not filling out a "supplement approval" form, because that form does not exist. It is making three sequenced decisions: whether its ingredients are permitted as food in Japan, whether and how it wants to make a health claim under the Foods with Function Claims (機能性表示食品) or Tokuho (特定保健用食品) frameworks, and how its Japanese label will state that claim. Only once those are settled does the IOR customs and consumption tax structure apply in the ordinary way. Brands that treat the ingredient and claims review as a formality alongside the shipping paperwork are the ones who find their first container held at the border.
This article is informational only and does not constitute legal, tax, or regulatory advice. Consult a qualified advisor before acting on the content. Last updated: 2026-07.