Thai FDA Health Claims for Dietary Supplements: A Practical Guide to Notification No. 447
Health claims are one of the most sensitive regulatory elements for dietary supplements and functional foods in Thailand. While many companies focus primarily on ingredients, formulations, or foreign approvals, the Thai FDA places decisive weight on what is claimed, how it is worded, and how it is substantiated.
Notification of the Ministry of Public Health No. 447 B.E. 2566 (2023) represents a consolidated and structured framework governing health claims made on food labeling, including food supplements. Misunderstanding this notification is one of the most common reasons for regulatory delays, rejections, or post-market enforcement actions in Thailand.
This article provides a practical interpretation of Notification 447, with specific relevance to dietary supplements.
Health Claims Under Thai FDA Regulation
Under Notification 447, a health claim is broadly defined as any statement, image, symbol, or implication that suggests a relationship between a food (or its constituents) and health, whether directly or indirectly.
This definition is intentionally wide. Claims do not need to mention diseases explicitly to fall under regulatory scrutiny. Even seemingly mild expressions such as “supports”, “helps”, or “contributes to” can be considered health claims and must comply with strict criteria.
The Thai FDA evaluates claims based on consumer perception, not manufacturer intention.
Why Notification No. 447 Is Critical for Food Supplements
For dietary supplements, Notification 447 acts as a boundary-setting regulation. It determines:
- what claims are permitted,
- which claims require pre-approval,
- and which claims are strictly prohibited.
Unlike some jurisdictions where enforcement is more flexible or post-market driven, Thailand applies a preventive regulatory model. If a claim does not clearly fit within the allowed framework, the product may be blocked before entering the market.
Types of Health Claims Recognised by Thai FDA
Notification 447 formally recognizes three categories of health claims:
| Claim Type | Regulatory Status | Key Risk |
|---|---|---|
| Nutrient function claims | Generally allowed | Overstatement of effect |
| Other function claims | Restricted | Scientific substantiation |
| Reduction of disease risk claims | Very limited | Medical implication |
Each category carries different evidentiary and labeling requirements. Download the full list of permitted nutrient function claims under Thai FDA Notification No. 447 (ODF)
What Claims Are Allowed — and What Are Not
Thai FDA health claims for dietary supplements: Nutrient Function Claims
These describe the physiological role of nutrients in normal bodily functions. Examples include contributions to:
- normal immune function,
- energy metabolism,
- maintenance of bones or muscles.
They are allowed only if:
- the nutrient is listed in Thai RDIs,
- the claim wording follows approved statements,
- the nutrient quantity is nutritionally meaningful.
What Is Not Allowed
Thai FDA health claims for dietary supplements that imply:
- prevention,
- treatment,
- cure,
- or mitigation of disease
are not permitted for food supplements, regardless of scientific literature or foreign approvals.
Common Misinterpretations by Foreign Manufacturers
A frequent mistake is assuming that:
- EFSA-approved claims,
- FDA structure/function claims,
- or claims used legally in the EU or US
are automatically acceptable in Thailand.
They are not.
Thailand applies a claim-driven classification logic. A compliant ingredient paired with a non-compliant claim can reclassify a product, trigger rejection, or invite enforcement action.
Scientific Substantiation: What Thai FDA Really Expects
Notification 447 requires that health claims be supported by generally accepted scientific evidence, with a strong preference for:
- human intervention studies,
- relevant target populations,
- measurable biomarkers.
However, scientific evidence alone is not sufficient. The evidence must align with:
- the specific claim wording,
- the consumption pattern,
- and the realistic intake level of the product.
This is where many dossiers fail.
Labeling and Mandatory Disclaimers IN Thai FDA health claims for dietary supplements
Health claims trigger additional labeling obligations, including:
- disclosure of active ingredient quantities,
- consumption instructions,
- target population (if applicable),
- mandatory disclaimers.
For other function claims and risk reduction claims, labels must clearly state:
“Not intended to treat, relieve, cure or prevent any disease.”
Failure to include mandatory statements is treated as mislabeling, not a minor editorial issue.
Why Claim Strategy Determines Product Classification
In Thailand, claim strategy is not a marketing exercise — it is a regulatory decision.
The same formulation can be:
- a compliant food supplement,
- a rejected application,
- or a product at risk of reclassification,
based solely on claim wording and presentation.
This is why claim assessment should occur before submission, not after.
Practical Takeaways for Supplement Companies
- Ingredients do not define compliance — claims do.
- Foreign approvals have limited relevance.
- Over-promising is the fastest way to regulatory failure.
- Notification 447 should be treated as a design document, not a constraint.
For operational use, the complete list of permitted nutrient function claims under Thai FDA Notification No. 447 can be consulted as a working reference document.
