In Thailand a dietary supplement is not a supplement. It is regulated as food, under the Food Act B.E. 2522 (1979), and a single health claim or one ingredient above a permitted limit can reclassify the product as a drug. Manufacturers who treat Thai entry as a labeling exercise discover the structural problem after the product has shipped. The ones who clear first submission settle classification before anything else.
A dietary supplement in Thailand is a controlled category of food, not a low-risk product you can simply notify and sell. It is classified as standardized food, which means both the product and its label require Thai FDA approval before the first unit is sold. There is no shortcut tier for a true supplement.
A foreign manufacturer cannot register or import on its own. Nothing moves until a qualified Thai importer holds a food import license under the Food Act. Companies that begin the commercial timeline before that structure exists discover that the paperwork they assumed was a formality is in fact the gate, and the gate is closed.
The most expensive errors are structural, not technical. A claim the product cannot legally make, an ingredient above the permitted ceiling, an importer without the right license: these are not fixed by improving the dossier. They are fixed by rebuilding the structure, which costs the one thing a market-entry plan cannot spare, which is time.
Thai FDA registration for a food supplement follows a defined sequence. Each stage has its own requirements, and a deficiency at one point delays every stage that follows. Timelines are stated as ranges and should be confirmed with Thai FDA or a qualified local specialist before reliance.
Determine whether the product is general food, a food supplement (ผลิตภัณฑ์เสริมอาหาร) under MOPH Notification 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. An error here propagates through everything after it.
A Thai person or juristic person with a commercial registration certificate and a place of business in Thailand must be appointed. This entity holds the import license and bears legal responsibility for the product on the Thai market. A foreign manufacturer cannot hold it from outside Thailand.
The importer obtains the License for Importation or Ordering of Food into the Kingdom (Form Orr.7) under Section 15 of the Food Act. No import for sale is lawful without it. The license is valid until 31 December of the third year from issue.
The foreign factory must show a food manufacturing system equivalent to or not inferior to GMP 386 or GMP 420. Codex GMP, HACCP, and ISO 9000 or 22000 are accepted equivalents. A Thai FDA notification dated 27 November 2024 revised how these certificates are submitted.
Under Clause 4 of No. 293, two routes exist. 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. Neither is a notify-and-sell option.
The Thai-language label and any health claim must clear Thai FDA review before use, against No. 293 and the health-claims regime effective 2 July 2024.
On approval the product receives its food serial number, which must appear on the label. Submission is electronic, through the Thai FDA e-Submission System, using an OPEN ID account from the Digital Government Development Agency.
If any ingredient qualifies as novel food, used as human food for under 15 years, it routes through a separate safety assessment under MOPH No. 376 B.E. 2559 (2016) before the product can proceed. This is a parallel gate, not a step every product hits.
Under the Food Act B.E. 2522, food is sorted into 4 risk-based groups. Where a product lands decides whether it must be registered at all, and a supplement does not land in the low-risk tier.
Medium-risk and tightly controlled. Requires product approval and a food serial number. Food supplements and royal jelly products are named in this tier. Thai FDA's formal label is food with quality or standard requirements; industry calls it standardized food.
Under 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 must appear as part of the product name.
Low-risk and not subject to product registration. Manufacturers sometimes assume their product qualifies here. A supplement does not.
A disease or therapeutic claim, or an ingredient at a drug-level dose, removes a product from the food regime and into the Drug Act. The historic Vitamin C ceiling is the clearest example: until 2 July 2024, more than 60 mg pushed a product toward drug registration. That ceiling is now 1,000 mg, but the principle stands. The line between food and drug is drawn by dose and by claim.
Thai FDA requires structures a foreign manufacturer cannot hold directly from outside Thailand. Each must be in place before the stage that depends on it. Addressing any of them late is expensive.
Must be a Thai person or juristic person with a commercial registration certificate and a place of business in Thailand. It plays the role the LAR plays on the drug side, but it is an importer under the food regime, not a marketing authorization holder. The quality of this relationship predicts both approval and long-term stability.
Product- and entity-specific, valid until 31 December of the third year from issue. No lawful import for sale without it.
Equivalent to or not inferior to GMP 386 or 420. Codex GMP, HACCP, and ISO 9000 or 22000 accepted, subject to the 27 November 2024 certificate rules.
Mandatory under No. 293. Cannot be finalized until the product clears approval, which means artwork should not be locked before classification and claims are settled.
Applications are filed through the Thai FDA e-Submission System using an OPEN ID account from the Digital Government Development Agency. A foreign manufacturer relies on its Thai importer to operate this.
Two features decide whether a product is viable in Thailand before the dossier is even assessed: the claim you intend to make, and the ingredients you intend to use. Both are governed by positive lists.
Governed by MOPH No. 447 B.E. 2566 (2023), the health-claims notification effective 2 July 2024. It permits three claim categories: nutrient function claims (28 items, 135 statements), other function claims (8 statements across six ingredients), and risk-reduction claims (4 statements across two ingredients). Listed claims need no pre-approval. Unlisted claims go to Thai FDA-registered certifying bodies for case-by-case assessment.
A supplement may not claim to prevent or treat disease. Crossing that line reclassifies the product as a drug.
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 2 July 2024. It raised several ceilings and sets a floor of not less than 15 percent of the Thai reference daily intake for products whose purpose is to deliver a given nutrient. A formula compliant abroad can sit above a Thai ceiling.
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).
Thailand's framework follows the ASEAN approach to traditional medicines and health supplements, including the principles for maximum vitamin and mineral levels. Alignment shapes both what is permitted and where the ceilings sit.
Most delays in this process do not begin with a technical flaw in the dossier. They begin earlier, in a decision made before submission and in the gap between a foreign manufacturer and its Thai importer.
The classification miss is first. A product built and sold as a supplement in its home market is not automatically a Thai food supplement. A borderline claim, or an ingredient above a Thai ceiling, can place it outside the food regime entirely, and that is discovered after the structure is already built.
The second is the claim that cannot be made. Marketing built around a strong function or disease claim that the Thai positive list does not allow, settled only after artwork and inventory are committed. The third is the importer appointed too late, after the commercial timeline has already started against a license that does not yet exist.
None of this reflects poorly on Thai FDA or on local practice. It reflects the difficulty of running a regulated process across 2 languages and 2 regulatory traditions, where silence can be read as progress and an acceptance at one stage can be mistaken for clearance at the next. An experienced local specialist who says clearly what is confirmed and what is not changes the outcome more than any single piece of dossier work.
Fees below are set under กฎกระทรวง ฉบับที่ 5 (พ.ศ. 2522) issued under the Food Act B.E. 2522 (1979 CE) and the Ministry of Public Health Notification on Fees Collectable from Applicants in the Food Product Licensing Process. All fees are paid to Thai FDA and are non-refundable on rejection.
| Fee | Amount (THB) | Notes |
|---|---|---|
| Food import license — Form Orr.7 (ใบอนุญาตนำเข้า) | 15,000 | Per license; held by the Thai importer; valid until 31 December of the third year from issue |
| Food advertising permit — ฆอ.2 (ใบอนุญาตโฆษณาอาหาร) | 7,000 | 2,000 application consideration fee + 5,000 licence fee; per advertisement item; Thai FDA pre-approval required before dissemination; valid 5 years |
| Novel food safety assessment filing fee (ค่าธรรมเนียมการยื่นขอประเมินความปลอดภัยอาหารใหม่) | 3,000 | Per application; paid to Thai FDA when submitting the safety assessment report from a recognized assessment center; applies only to products containing novel ingredients under MOPH No. 376 B.E. 2559 (2016) |
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.
| Factory Tier | Assessment Fee (THB) |
|---|---|
| Tier 1 — smallest | 3,000 |
| Tier 2 | 5,000 |
| Tier 3 | 10,000 |
| Tier 4 | 15,000 |
| Tier 5 — largest | 20,000 |
GMP assessment fee: This is a per-inspection charge for Thai FDA evaluation of the food manufacturing premises (ค่าใช้จ่ายในการตรวจประเมินสถานที่ผลิตอาหาร). The tier applied is calculated by the horsepower of the machinery in the facility and the number of workers, as defined in the MoPH Notification on Fees Collectable from Applicants. Source: Thai FDA GMP FAQ, confirmed B.E. 2566 (2023 CE).
Novel-ingredient assessment center cost: The 3,000 THB filing fee above is paid to Thai FDA. Separately, the applicant must commission and pay for the safety assessment itself from a Thai FDA-recognized assessment center (such as the Department of Medical Sciences or TRAC Thailand). That center cost is set by the center, not by government regulation, and typically runs 70,000–90,000 THB per ingredient based on published rates from recognized centers. It is not a government fee and is not included in the table above.
Our work is done by senior regulatory professionals, Thai and Western, not by coordinators passing files between offices. Every engagement is managed by people who have classified products, prepared food supplement submissions, and structured importer relationships in Thailand.
We tell a client early when a claim they have built a brand around cannot be made in Thailand, and when an ingredient sits above a permitted ceiling, while it still costs nothing to change course. When the answer on classification or claim feasibility is no, or not yet, we say so plainly.
Our clients are not new to supplements. They are new to Thailand. Our work is to make the Thai food regime legible to a team that already knows its product, without adding a layer of opacity in the process.