Thailand treats a dietary supplement as a category of “standardised food” that still needs its own Thai FDA registration and a Thai-language label before a foreign brand can sell it — a combination that trips up brand owners who expect either a simple food notification or a full drug-style approval, but not both elements at once.
This guide covers who regulates a Japan-made supplement in Thailand, what the local importer’s licence involves, what the Thai FDA registration requires, and how labelling works.
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Who regulates a dietary supplement in Thailand
The Thai Food and Drug Administration (Thai FDA), under the Ministry of Public Health, is the single regulator for food supplements in Thailand, which it treats as a category of standardised food rather than as a medicine.
Thai FDA is responsible for product evaluation and registration, licensing, quality control and post-market surveillance of food supplements. A food supplement is classified as a standardised food under Thai food law, which is why it needs Thai FDA registration for a food serial number even though it is not treated as a pharmaceutical product. The principal reference notification for the category is the Ministry of Public Health’s Notification on Food Supplement.
The local importer must hold the import licence
A Japanese factory cannot import or register its own product into Thailand; a Thai-registered importer must hold the import licence and act as the party responsible to Thai FDA.
Bringing a food product, including a food supplement, into Thailand for sale requires the importing party to hold a food import licence from Thai FDA. This licence, along with the food supplement registration itself, must be held by a company registered in Thailand — a foreign manufacturer, including a Japan-based factory, cannot hold it directly. In practice this means your Thai importer or distributor is the party of record with Thai FDA, and your role as the brand owner is to supply that importer with a complete, accurate specification and supporting documents so it can complete the registration.
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Registration and label review
A food supplement needs a Thai FDA product registration before sale, and the approved product’s Thai FDA serial number — the “Or.Yor.” (อย.) mark — must appear on the label.
| Step | Who is responsible | What it establishes |
|---|---|---|
| Food import licence | Thai-registered importer | Legal authority to import food products, including supplements, into Thailand |
| Food supplement registration | Thai-registered importer/registrant, using the factory’s specification and supporting documents | The product’s Thai FDA serial number, shown on the label as the Or.Yor. mark |
| Label review | Thai-registered importer | Confirms the label meets Thai FDA’s format and language requirements before sale |
Thai FDA maintains an online database where the registered serial number can be checked against the product to confirm the registration is current — useful for a distributor or retailer verifying a supplier’s claim of registration.
Thai-language labelling
A food supplement label sold in Thailand must be presented in Thai; a foreign language may also appear alongside it, but Thai is the required primary language.
Health supplements are foods, not medicines, and are not a substitute for medical treatment. Any health claim on a Thai label must be substantiated and must comply with Thai FDA’s own rules on food supplement claims — a claim carried over unchanged from a Japanese domestic label, such as wording used under Japan’s Foods with Function Claims system, has no standing in Thailand and needs to be reassessed against Thai requirements by the Thai registrant.
Before you ask for a quotation
- Confirm your Thai-registered importer, since the import licence and product registration must be held locally, not from Japan
- Prepare a full specification sheet: every ingredient, its amount per serving, dosage form and packaging
- Decide what health claim, if any, you want on the Thai label, and confirm it independently against Thai FDA’s rules
- Plan for a Thai-language label as the primary label language
- List supporting documents your importer will likely need: specification sheet, Certificate of Analysis, Certificate of Free Sale
💬 Ready to prepare documents for your Thai importer’s FDA registration? Send us your product details.
Frequently asked questions
1. Is a Japan-made dietary supplement treated as a food or a drug in Thailand?
As a food. Thai FDA classifies food supplements as a category of standardised food, but this still requires its own Thai FDA registration before sale — it is not a simple, unregulated food notification.
2. Can our company import the product directly from Japan without a Thai partner?
No. Thailand requires a Thai-registered importer to hold the food import licence and the food supplement registration; a foreign factory or brand owner cannot hold these directly.
3. What is the “Or.Yor.” mark on a Thai supplement label?
It is the visible form of the Thai FDA registration/serial number assigned once a food supplement is registered. Consumers and retailers can check it against Thai FDA’s product database.
4. Can we keep our Japanese label’s health claim wording for the Thai market?
Not automatically. Thai FDA requires any health claim to be substantiated and to comply with Thai rules; a claim from a Japanese domestic label needs to be reassessed by your Thai registrant, not carried over as-is.
5. What language does the Thai label need to be in?
Thai is required as the primary label language. A foreign language may be shown alongside it, but Thai text cannot be omitted.
Sources: Thai Food and Drug Administration (FDA Thai), Ministry of Public Health, “FDA THAI: Food and Drug Administration, Thailand,” FAQ on food licensing, en.fda.moph.go.th/entrepreneurs-food/category/food-faqs/; Ministry of Public Health Notification (No. 293) B.E. 2548 (2005) Re: Food Supplement, en.fda.moph.go.th/cat2-health-products/nmp-80. Checked on 25 September 2026.