FDA Thailand Hiring a supplement OEM factory in Thailand: what to check before you sign
What to know before choosing a supplement OEM in Thailand
Using a supplement OEM in Thailand means having a licensed factory produce dietary supplements under your brand. You avoid building a plant, but much of your legal position is tied to the factory you pick. If the factory is not ready, your brand stalls with it, from failing to obtain a serial number to having to change factories midway.
Dietary supplements fall under the Food Act B.E. 2522 (1979) and MOPH Notification No. 293 B.E. 2548 (2005), which defines them as products taken in addition to normal food, in tablet, capsule, powder, flake, liquid or other non-conventional forms, and treats them as food with prescribed quality or standards. This guide collects what to check before signing, citing Thai FDA notifications and guides.
Licences a supplement factory must hold
The Thai FDA's revised 2026 supplement licensing guide classifies manufacturing sites by size.
| Size | Authorisation |
|---|---|
| Machinery of 50 hp or more, or 50 or more workers | Food production licence (Or.2), renewed every three years |
| Under 50 hp and under 50 workers | Non-factory site certificate (Sor.Bor.1/1) |
Ask for a copy of every page and check the licensee name, site address and validity. The Food Act prohibits producing or storing food outside licensed premises, so if the factory has several sites, make sure your product will be made at the licensed one.
The guide also explains that site licensing has two steps: passing a GMP audit first, then applying for the licence. A licensed factory has therefore passed at least one audit, but still ask for the latest results.
GMP 420 and the supplement-specific major defect
Supplement plants must meet MOPH Notification No. 420 B.E. 2563 (2020). To pass, every basic category must score at least 60% with no major defect. Ask the factory for:
- The latest audit report, or a manufacturing-system certificate from a certification body listed with the Thai FDA, with a scope covering your dosage form, such as capsules, tablets or powder.
- Production, distribution and recall records, because the Thai FDA audit notification classifies a supplement plant without production, distribution or recall records as a major defect.
- Final-product results from an accredited lab at least once a year.
- Evidence of yearly internal audits and staff health checks.
The Thai FDA guide is explicit that hand mixing is not allowed and that accurate scales are needed, since many ingredients have daily intake limits. Walking the line before signing is the easiest way to confirm this. See GMP 420 explained for audit criteria.
The serial number is tied to the factory
A supplement's food serial number is obtained by filing a food registration through e-Submission under the licensed manufacturing site, and the 13-digit number encodes that site. In practice, if your brand later moves production to another factory, the product needs a new serial number under the new site. See reading the 13-digit Thai FDA number.
Agree this in the contract from day one: who files for the serial number, who holds the supporting documents such as formula, raw material specifications and lab results, and whether you receive those documents back to file with a new factory if the relationship ends.
Labels must show the manufacturer's name and address under MOPH Notification No. 450 B.E. 2567 (2024) on prepackaged food labelling, so your brand and distributor details appear alongside the factory, not instead of it. Agree the label layout with the factory so it matches the authorisation.
Formula and raw materials: documents to have ready
The 2006 Thai FDA notification on evidence for supplement label approval lists the document set officers use, which the 2026 guide recommends preparing in case it is requested:
- Raw material specifications (physical, chemical, microbiological); botanicals need the scientific name and part used; extracts need the solvent, marker compounds and extract ratio.
- The formula per unit or by percentage, separating key and non-key ingredients.
- The actual manufacturing process, step by step.
- The finished product specification.
- Results from a government or accredited laboratory.
- Safety evidence for ingredients, depending on whether they have a history of food use.
Before fixing the formula, confirm every ingredient is permitted in supplements at the intended amounts. Our formula checker compares a formula with the Thai FDA lists.
Quality standards the product must meet
Notification No. 293 and the 2006 Thai FDA notification set quality limits for supplements. Write them into the contract as release criteria.
| Parameter | Limit |
|---|---|
| E. coli | Fewer than 3 per gram (MPN) |
| Staphylococcus aureus | Not detected in 0.1 g |
| Clostridium spp. | Not detected in 0.1 g |
| Salmonella spp. | Not detected in 25 g |
| Arsenic | Not more than 2 mg/kg |
| Lead | Not more than 1 mg/kg |
Notification No. 293 also refers to other contaminant limits, such as cadmium and mercury, in related notifications, and requires vitamins and minerals to follow the published list. Agreeing which tests are run, on every batch or periodically, and at which lab avoids disputes when a result fails. For lab support see our testing service.
Questions to ask a supplement OEM
| Topic | Question | Evidence to see |
|---|---|---|
| Licence | Which site makes our product and when does the licence expire? | Every page of the Or.2 or Sor.Bor.1/1 |
| GMP | What did the last audit find, and does the scope cover our dosage form? | Audit report or certification-body certificate |
| Records and recall | How would you recall one batch? | Written production, distribution and recall procedures |
| Serial number | Who files and who holds the documents? | An agreement on documents and handover |
| Quality | Which tests, at which lab? | Past lab reports |
| Label | Who checks labels before printing? | Label artwork reviewed against the notifications |
Factories that answer clearly and show documents straight away usually have working internal systems. If a factory says it handles everything but shows nothing, ask for more before deciding.
Labels: a joint responsibility
Notification No. 293 sets mandatory supplement label content: the name must include the words dietary supplement product in Thai, key ingredients with amounts in descending order, and boxed warnings in the prescribed format, plus ingredient-specific warnings for certain ingredients. Full details are in Thai dietary supplement labels.
A label error can mean reworking a whole batch. Specify in the contract that artwork must be reviewed before printing and who pays if a label does not comply. Our label checker helps check mandatory text and prohibited words.
Supplement OEM contract terms to include
- Ownership of the formula and rights to the authorisation documents.
- Who files for the serial number and how documents are handed over at the end.
- Release criteria, test lists, laboratories and delivery of results to the brand.
- Retained reference samples for each batch.
- Complaint handling and a joint recall procedure.
- Advance notice of changes in raw material sources or process.
- Pre-print label review and responsibility for label errors.
If you would like our consultants to review the factory, formula and documents before you sign, see our product development service or registration service, or reach us via the contact page.
Frequently asked questions
What licence must a supplement OEM factory hold?
Sites with 50 hp or 50 workers or more hold a food production licence (Or.2); smaller ones hold a non-factory site certificate (Sor.Bor.1/1). Both must meet GMP 420.
Can I keep my serial number if I change factories?
The serial number is tied to the manufacturing site, so moving to another factory means a new number under the new site. Cover documents in the contract.
Which defect fails a supplement plant outright?
One example: no production, distribution or recall records for dietary supplements, which the audit notification classifies as a major defect.
Can my brand name replace the factory name on the label?
No. Labels must show the manufacturer's name and address under Notification No. 450; brand and distributor details can appear alongside, not instead.
What microbiological tests must supplements pass?
E. coli fewer than 3 per gram, and no Staphylococcus aureus or Clostridium spp. in 0.1 g and no Salmonella spp. in 25 g.
Sources
- MOPH Notification No. 293 B.E. 2548 (2005) on dietary supplements · Open source · Search our archive
- Thai FDA dietary supplement licensing guide (revised 2026) · Open source · Search our archive
- MOPH Notification No. 420 B.E. 2563 (2020) on production methods, equipment and food storage · Open source · Search our archive
- Thai FDA notification on auditing food premises against No. 420 · Open source · Search our archive
- Thai FDA notification on evidence for supplement label approval (2006) · Open source · Search our archive
- MOPH Notification No. 450 B.E. 2567 (2024) on prepackaged food labelling · Open source · Search our archive
- Food Act B.E. 2522 (1979) · 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.