Thai FDA Dietary Supplement Registration for Foreign Manufacturers
In Thailand a dietary supplement is not treated as a supplement at all. It is regulated as food, under the Food Act B.E. 2522 (1979), and both the product and its label require Thai FDA approval before the first unit is sold. A single health claim or one ingredient above a permitted limit can also reclassify the product as a drug. DeeMED helps foreign manufacturers structure the classification, importer, and label decisions correctly before submission, not after a rejection.
Last reviewed: July 2026
The cost of getting it wrong
A dietary supplement in Thailand sits in a controlled category of food, not a low-risk product that can simply be notified and sold. It is classified as standardized food, which means the product and its label both require Thai FDA approval before market entry. There is no shortcut tier for a genuine supplement.
A foreign manufacturer cannot register or import a supplement on its own account. Nothing moves until a qualified Thai importer holds a food import license under the Food Act. Manufacturers who begin their commercial timeline before that structure exists find that the paperwork they assumed was a formality is in fact the gate, and the gate is closed until an appointed, licensed Thai importer is in place.
The most expensive errors are structural rather than technical. A claim the product cannot legally make, an ingredient above its permitted ceiling, or an importer without the correct license are not fixed by improving the dossier. They are fixed by rebuilding the structure, which costs the one resource a market-entry plan cannot spare: time.
How Are Supplements Classified in Thailand?
Under the Food Act B.E. 2522, food sold in Thailand is sorted into four risk-based groups, and where a product lands decides whether it must be registered at all. A supplement does not land in the low-risk tier.
Standardized food, where supplements sit
Medium-risk and tightly controlled. Requires product approval and a food serial number before sale. Food supplements are named directly in this tier under Thai FDA's formal classification.
Food supplement under MOPH Notification No. 293
A product taken other than as a conventional food, containing nutrients or other substances, in tablet, capsule, powder, flake, or liquid form, intended for health promotion. The Thai term ผลิตภัณฑ์เสริมอาหาร (food supplement) must appear as part of the product name on the label.
General food
Low-risk and not subject to product registration. Manufacturers sometimes assume their product qualifies here by analogy to their home market. A supplement does not.
Food supplement vs. drug boundary
A disease or therapeutic claim, or an ingredient at a drug-level dose, removes a product from the food regime and moves it into the Drug Act. The historic Vitamin C ceiling illustrates the point: until July 2, 2024, more than 60 mg pushed a product toward drug registration. That ceiling is now 1,000 mg, but the underlying principle stands. The line between food and drug is drawn by both dose and claim.
What foreign manufacturers must establish before filing
Thai law requires structures a foreign manufacturer cannot hold directly from outside Thailand. Each must be in place before the stage of registration that depends on it.
Local importer of record
Must be a Thai person or juristic person with a commercial registration certificate and a place of business in Thailand. This entity holds the import license and carries legal responsibility for the product on the Thai market.
Form Orr.7 import license (Section 15)
The License for Importation or Ordering of Food into the Kingdom, issued under Section 15 of the Food Act. No food may be imported for sale without it. It is valid until December 31 of the third year from the year of issue.
GMP evidence from the manufacturing site
The foreign factory must show a food manufacturing system equivalent to or not inferior to GMP 420, the general Thai food-manufacturing GMP standard (GMP 386 is a separate, narrower standard scoped to fresh fruit and vegetable packing houses, not relevant here). Codex GMP, HACCP, and ISO 9000 or 22000 are accepted equivalents, subject to Thai FDA's November 27, 2024 rules on how certificates are submitted.
Thai-language label and food serial number
Mandatory under MOPH No. 293. The label cannot be finalized until the product clears its approval pathway, so artwork should not be locked before classification and claims are settled.
The registration pathway, stage by stage
Thai FDA registration for a food supplement follows a defined sequence, and a deficiency at one stage delays every stage that follows. Timelines vary with application complexity, from the completeness of the GMP documentation package to how quickly Thai FDA's queries during review are answered.
1. Classification
Determine whether the product is general food, a food supplement under MOPH No. 293 B.E. 2548 (2005), or whether an ingredient or claim pushes it into the drug regime. This decision governs the pathway, the data package, and the label rules that follow.
2. Local importer appointment
A Thai person or juristic person with a commercial registration certificate and a place of business in Thailand is appointed to hold the import license and bear legal responsibility for the product.
3. Form Orr.7 import license
The importer obtains the food import license under Section 15 of the Food Act. No lawful import for sale occurs without it.
4. GMP evidence submission
The manufacturing site's GMP, Codex, HACCP, or ISO certification is submitted in the format Thai FDA requires following its November 2024 revision to certificate documentation rules.
5. Registration or label approval
Under Clause 4 of MOPH No. 293, food registration applies to export products and products whose main ingredients are prescribed by Thai FDA; label approval applies to products with other active ingredients supported by evidence. Both are mandatory pre-market controls.
6. Label and health-claim review
The Thai-language label and any health claim clear Thai FDA review against MOPH No. 293 and the health-claims regime effective July 2, 2024, before the label can be used commercially.
7. Food serial number and novel-ingredient branch
On approval the product receives a food serial number for the label. If an ingredient has been used as human food for under 15 years, it routes through a separate novel food safety assessment under MOPH No. 376 B.E. 2559 (2016) before the product can proceed.
Ingredients, claims, and the limits of "health"
Two features decide whether a product is viable in Thailand before the dossier is even assessed: the claim intended for the label, and the ingredients used to formulate it. Both are governed by positive lists.
Health claims are a positive list
Governed by MOPH Notification No. 447 B.E. 2566 (2023), effective July 2, 2024. It permits three claim categories: nutrient function claims, other function claims, and risk-reduction claims. Listed claims need no pre-approval; unlisted claims go to Thai FDA-registered certifying bodies for case-by-case assessment.
Disease claims are prohibited
A supplement may not claim to prevent or treat disease. Crossing that line reclassifies the product as a drug and moves it out of the food regime entirely.
Vitamin and mineral ceilings
Thailand maintains a positive list with maximum levels for vitamins and minerals, set in the annex to MOPH No. 448 B.E. 2566 (2023), in force since July 2, 2024. A formula compliant in another market can still sit above a Thai ceiling.
Novel ingredients
A substance used as human food for under 15 years requires safety assessment by an FDA-recognized risk-assessment center under MOPH No. 376 B.E. 2559 (2016) before it can be included in a supplement sold in Thailand.
Why it goes wrong
Most delays in this process do not begin with a technical flaw in the dossier. They begin earlier, in a decision made before submission or in the gap between a foreign manufacturer and its Thai importer.
The classification miss comes first. A product built and sold as a supplement in its home market is not automatically a Thai food supplement, and a borderline claim or an ingredient above a Thai ceiling can place it outside the food regime entirely, a fact that often surfaces only after the structure is already built. The second common failure is a claim that cannot be made: marketing built around a strong function or disease claim the Thai positive list does not allow, discovered only after artwork and inventory are already committed. The third is an importer appointed too late, after the commercial timeline has already started against a license that does not yet exist.
How Much Does Thai FDA Supplement Registration Cost?
Fees below are set under the Ministry of Public Health Notification on Fees Collectable from Applicants in the Food Product Licensing Process, issued under the Food Act B.E. 2522 (1979). All fees are paid to Thai FDA and are non-refundable on rejection. For the full structure behind the Orr.7 line item below, including who can hold the license and how long it lasts, see our guide to the local importer and Form Orr.7 import license.
| Fee | Amount (THB) | Notes |
|---|---|---|
| Food import license — Form Orr.7 | 15,000 | Per license; held by the Thai importer; valid until December 31 of the third year from issue |
| Food advertising permit (Kho Or 2) | 7,000 | 2,000 application fee plus 5,000 license fee; per advertisement item; Thai FDA pre-approval required before dissemination; valid 5 years |
| Novel food safety assessment filing fee | 3,000 | Per application; applies only to products with novel ingredients under MOPH No. 376 B.E. 2559 (2016) |
Note on assessment center costs: the novel-ingredient filing fee above is paid to Thai FDA. The safety assessment itself is separately commissioned from a Thai FDA-recognized assessment center and is priced by that center, not by government regulation.
Note on product registration: the Food Act's separate 5,000 THB Product License fee under Section 31 applies to Specifically Controlled Food, not food supplements. A food supplement's product-level approval runs through Notification 293's own registration-or-label-approval mechanism under Clause 4, folded into the Orr.7 import license process above rather than carrying its own separate statutory fee.
