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Registering a dietary supplement in Thailand: steps, documents and common sticking points
What it means to register a dietary supplement in Thailand
To register a dietary supplement in Thailand, the legal step is filing a food registration form (Sor Bor 5) for the product with the Thai Food and Drug Administration (Thai FDA) to obtain a 13-digit food serial number before producing or importing it for sale. The Thai FDA guide to dietary supplement permits (2026 revision) explains that filing is done through e-Submission and the record issued is a food registration certificate, form Sor Bor 5/1.
Ministry of Public Health Notification No. 293 B.E. 2548 (2005) on dietary supplements defines a supplement as a product eaten in addition to normal food, containing nutrients or other substances, in the form of tablets, capsules, powder, flakes, liquid or another form that is not a normal food. A Thai FDA explanatory notice on Notifications Nos. 405 and 411 says every supplement is a food with prescribed quality or standards, whether or not its ingredients are on a named list, and is filed with the same evidence: formula, raw-material quality specifications and a product analysis report.
Understand one point from the start: the serial number permits the product to be made or imported as a food. It is not evidence that the product works. That is why every supplement label must carry the statement that it has no effect in preventing or curing disease, under Notification No. 293 as amended.
This guide follows the order of the real work: confirm the product is a supplement, who can file, the steps, the documents, quality limits, common sticking points and duties afterwards.
Is your product really a dietary supplement?
Before preparing documents, check that the product falls within food and uses ingredients that can be filed.
Purpose and claims
The food division’s guidance on classifying food for permits (August 2026) says a product presented as relieving or curing disease is not a food under the Food Act. Drug-like claims are not allowed, so the product name and planned wording must avoid them from the formulation stage.
Key ingredients
The Thai FDA advice on key ingredients in dietary supplements (8 July 2024) lists 444 entries. Entries 1–330 are plants, mushrooms, algae and animal materials, with scientific name, part used, key substance, process or extraction solvent and conditions; entries 331–444 are other substances such as GABA, inulin and L-theanine. Most conditions are daily maximums, for example garlic extract up to 2 g per day and L-theanine up to 200 mg per day. If the source, part used or process falls into a category that needs a safety assessment, that assessment comes first.
The food-type diagnosis manual for the Sor Bor 7 group says a substance with under 15 years of food use, or made by a new process that significantly changes its composition, is a novel food and must complete a safety assessment before a serial number can be requested.
Vitamins and minerals
Notification No. 448 (2023) sets permitted types and daily maximums in 26 entries, for example vitamin C 1,000 mg, vitamin D 15 µg and zinc 15 mg, and requires products positioned as a vitamin or mineral source to provide at least 15% of the Thai RDI.
Screen a formula with the formula checker and the product classification tool.
Who can file: a licensed manufacturer or importer
A supplement registration is filed under a licensed manufacturing or import premises. Brand owners without their own premises go through one of those.
Domestic manufacture
The 2026 guide splits premises licensing into two stages: first pass a premises audit against GMP, then apply for the licence. Premises with machinery totalling 50 horsepower or more, or 50 or more workers, file form Or 1 for a food manufacturing licence (Or 2); smaller premises file Sor Bor 1 for a non-factory premises certificate (Sor Bor 1/1).
Premises must meet Ministry of Public Health Notification No. 420 (2020). The Thai FDA notice on auditing food premises classes a supplement maker without production, distribution or recall records as a major defect, which fails the audit outright.
Import
Importers need a food import licence. The e-Submission manual on foreign plant certificates for supplements says a REF CER reference number must be obtained before filing, stating the plant’s certified system, such as GMP, HACCP, ISO 9001, ISO 22000, or a private standard with its equivalent system named, and selecting every dosage form the plant makes, such as tablet, capsule, powder or liquid, from the first request.
Brand owners
Brands outsourcing production should read hiring a supplement OEM factory; brands importing should read importing dietary supplements into Thailand.
Sor Bor 5 supplement application: the steps
The sequence below combines the Thai FDA supplement permit guide, the e-Submission manual on searching and adding substances, and the serial-number regulations.
- Set up access. Create an Open ID account and request access to the food system: Bangkok premises at the Thai FDA service centre, provincial premises at the provincial health office.
- Find the FDA Number of every ingredient. Supplement applications must list all ingredients so the system can calculate the formula. Extracts are searched on two tabs: general extracts, where every search field must match the extract actually used, and extracts on the list of plants permitted in supplements.
- Add missing ingredients. If an ingredient is not found, a request to add it must be completed before the product application can be filed.
- Complete form Sor Bor 5 with attachments. Check the food type, kind and process carefully; the guide says these cannot be changed after filing.
- Pay to confirm filing.
- Answer clarification requests completely, once. The guide says late replies lead to automatic return, and incomplete corrections lead to refusal and return.
- Receive the food registration certificate (Sor Bor 5/1) with the serial number.
- Submit the original analysis report on first manufacture or import for sale, under the serial-number regulation amendment No. 2 (2026).
Thai FDA guidance on post-number analysis says any lot may be used if product, formula and manufacturer are the same, and a report already attached to the application need not be sent again.
- 1Open ID and system accessBangkok at the Thai FDA service centre, provinces at the provincial health office
- 2Find every ingredient’s FDA NumberIf missing, request to add it first
- 3Complete Sor Bor 5 with attachmentsType, kind and process cannot be changed after filing
- 4Pay and answer clarificationsFix everything in one round, on time
- 5Receive Sor Bor 5/1 and the numberSubmit the original analysis on first manufacture or import
Source: Thai FDA guide to dietary supplement permits (2026) · substance search manual · serial-number regulation amendment No. 2 (2026)
Supplement registration documents
The Thai FDA notice on evidence for supplement label permission sets out the document set officers use. Prepare it in full, even if the system asks for some items only in a clarification request.
Raw materials and formula
- Raw material specifications: scientific name, part used, identification method, solvent and extraction ratio for extracts, and the assay method if a content is claimed. The 2024 serial-number regulation also requires the ratio of raw material to 1 gram of extract.
- Formula per unit or in percent, separating key and non-key ingredients.
- Manufacturing process as actually run.
- Product specification.
Analysis
A product analysis from a government body or accredited laboratory covering, for example, E. coli, arsenic, lead and any vitamins, minerals, amino acids or fatty acids claimed as key ingredients.
Safety evidence
- Raw materials with a traditional history of food use: evidence of that history.
- Materials developed into a new form: history plus acute toxicity data.
- Materials with no history of food use: chronic toxicity studies in animals.
- Products sold abroad: a certificate that the product has been sold in that country for at least 15 years.
Imported products
A manufacturing-site certificate and a Certificate of Free Sale. See Certificate of Free Sale for Thai FDA.
- ✓Raw material specificationsScientific name, part used, solvent, extraction ratio
- ✓FormulaPer unit or in percent, key and non-key ingredients separated
- ✓Manufacturing process and product specification
- ✓Product analysisFrom a government or accredited laboratory
- ✓Raw material safety evidenceHistory of use, or toxicity studies as applicable
- ✓Imported productsManufacturing-site certificate and Certificate of Free Sale
Source: Thai FDA notification on evidence for supplement label permission · Thai FDA Regulation on food serial numbers B.E. 2567
Quality limits the formula and analysis must meet
Supplement quality limits come from several notifications. Set them as release criteria before you file.
| Item | Limit | Source |
|---|---|---|
| E. coli | Less than 3 per gram (MPN) | Notification No. 293 and the Thai FDA evidence notice |
| Staphylococcus aureus | Not detected in 0.1 g | Thai FDA evidence notice |
| Clostridium spp. | Not detected in 0.1 g | Thai FDA evidence notice |
| Salmonella spp. | Not detected in 25 g | Thai FDA evidence notice |
| Lead | No more than 1 mg/kg | Notification No. 293 |
| Arsenic | No more than 2 mg/kg | Notification No. 293 |
| Cadmium, mercury | No more than 0.3 and 0.5 mg/kg | Notification No. 293 (citing No. 414) |
| Vitamins and minerals | Types and amounts within the 26-entry schedule | Notification No. 448 |
Food additives, manufacturing methods and containers must also meet their own notifications. Laboratories must be a government body, a government-recognised body or a laboratory accredited to international standards, under the serial-number regulation amendment No. 2 (2026).
Supplement registration problems: where applications get stuck
Based on the rules and manuals cited here, applications usually stall in these areas:
- Ingredient not in the database. No FDA Number means an add-ingredient request first, which pushes back everything else.
- Extract data does not match. Scientific name, part used, solvent or extraction ratio in the application differs from the supplier’s specification.
- Amounts over the limit. Vitamins or minerals above Notification No. 448, or ingredients above the daily maximum in the key-ingredient advice. Overseas formulas often hit this.
- Novel ingredient. A safety assessment is needed before filing.
- Drug-like name or claims. Such claims are not allowed: the product is not a food, and the serial-number regulation lists them as grounds for cancellation.
- Premises not covering the product. The manufacturing licence does not cover supplements, or the foreign plant’s REF CER does not include the dosage form filed.
- Incomplete clarification replies. The guide requires everything to be fixed in one round; otherwise the application is refused and returned.
- Laboratory not eligible. Reports must come from a government, government-recognised or internationally accredited laboratory.
To have an expert check the category, formula and label before filing, or to have our team file for you, see our registration service or contact our team. Costs and lead times are given in our quotation.
After the serial number: label, advertising and records
Records and number display
The 2024 serial-number regulation requires the 100% formula, manufacturing process, container type and, where a key substance is added, the raw material specification to be kept at the premises for inspection, and the number shown inside the prescribed frame with digits at least 2 mm high. Having no 100% formula available for inspection is one of the grounds for cancellation.
Label
Notification No. 293 as amended requires the name to include the Thai words for “dietary supplement”, key ingredients with amounts, and four boxed warnings, plus ingredient-specific warnings. See Thai dietary supplement labels.
Advertising
A serial number does not permit benefit advertising. Advertising benefits, quality or properties needs an advertising permit under the 2026 food advertising criteria, and models in supplement ads must be 15 or older and not pregnant. Read Thai food advertising permits.
Premises licence
The number is tied to the premises licence. If the manufacturing licence, import licence or non-factory premises certificate is cancelled, every number under it lapses. Consumers checking a number can read reading the 13-digit Thai FDA number.
Frequently asked questions
Do I need my own factory to register a supplement?
No, but the application must be filed under a licensed manufacturing premises that meets GMP 420, or under a licensed importer. Brand owners usually file through a contract manufacturer or importer.
Which form is used for dietary supplements?
The food registration form Sor Bor 5 through e-Submission. When permitted, you receive a Sor Bor 5/1 certificate and a 13-digit food serial number.
What if an ingredient is not in the system database?
File a request to add the ingredient and obtain an FDA Number first, then file the product. If the ingredient is a novel food, a safety assessment comes first.
When must the analysis report be submitted?
The original report is submitted on first manufacture or import for sale. If it was attached to the application, it need not be sent again.
Can I advertise benefits once I have the number?
No. Advertising benefits, quality or properties needs an advertising permit first, and claims about relieving, curing or preventing disease are never allowed.
Sources
- MOPH Notification No. 293 B.E. 2548 (2005) on dietary supplements · Open source · Search our archive
- Explanatory note on supplement Notifications Nos. 405 and 411 · Open source · Search our archive
- Thai FDA notification on evidence for supplement label permission and pathogenic microorganism standards · Open source · Search our archive
- Thai FDA advice on key ingredients in dietary supplements · Open source · Search our archive
- MOPH Notification No. 448 B.E. 2566 (2023), dietary supplements (No. 5) · Open source · Search our archive
- Thai FDA guide to dietary supplement permits (2026 revision) · Open source · Search our archive
- Thai FDA Regulation on food serial numbers B.E. 2567 (2024) · Open source · Search our archive
- Thai FDA Regulation on food serial numbers (No. 2) B.E. 2569 (2026) · Open source · Search our archive
- Thai FDA guidance on submitting analysis reports after a food serial number is issued · Open source · Search our archive
- Thai FDA e-Submission manual: searching and adding substances for food applications · Open source · Search our archive
- Thai FDA e-Submission manual: foreign plant certificates for dietary supplements · Open source · Search our archive
- Thai FDA guidance on classifying food for permits (August 2026 update) · Open source · Search our archive
- Thai FDA food-type diagnosis manual for the Sor Bor 7 group (revised 20 August 2026) · Open source · Search our archive
- Thai FDA notification on auditing food premises under Notification No. 420 · Open source · Search our archive
- Thai FDA Notification on food advertising criteria B.E. 2569 (2026) · Open source · Search our archive
This article is for general information. It is not a Thai FDA ruling or legal advice, and rules change — check the latest notification or ask an expert before filing or producing.
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