Understanding Health Claims and Required Evidence under Thai and ASEAN Harmonization Guidelines
Health claims on food and herbal products play a critical role in ensuring consumer trust and product compliance. Both Thailand’s regulations and the ASEAN Harmonization Guidelines establish the framework for making valid health claims, requiring companies to provide sufficient scientific evidence to support them. This post explores the types of health claims allowed and the evidence required to substantiate them.
1. Overview of Health Claim Categories
According to both Thai FDA regulations and ASEAN harmonization guidelines, health claims are divided into three categories, each with specific requirements for scientific evidence.
| Claim Type | Description | Example |
|---|---|---|
| Nutrient Function Claims | Describes the role of a nutrient in normal bodily functions, development, or growth. | "Calcium supports bone development." |
| Other Function Claims | Highlights additional physiological benefits beyond basic nutrition. | "Ginseng boosts energy levels." |
| Reduction of Disease Risk Claims | Refers to the ability of a product to reduce risk factors for specific diseases. | "Omega-3 reduces the risk of cardiovascular disease." |
Sources: [19†ASEAN Guidelines], [20†Thai FDA Health Claims Guidelines]
2. Required Evidence for Health Claims
To ensure health claims are scientifically sound and not misleading, both Thai and ASEAN regulations specify the level and type of evidence required.
2.1 Nutrient Function Claims
- Definition: These claims focus on the impact of nutrients on the body's physiological functions.
- Required Evidence:
- Literature reviews or studies from peer-reviewed scientific journals.
- Historical evidence of safe and accepted use.
Example Evidence:
- Published research confirming calcium’s effect on improving bone mineral density.
2.2 Other Function Claims
- Definition: These claims describe functional benefits related to the product but do not mention disease prevention or cure.
- Required Evidence:
- Preclinical or clinical studies demonstrating physiological benefits.
- Systematic reviews or meta-analyses with evidence of efficacy.
Example Evidence:
- A clinical trial showing that ginseng increases physical performance and reduces fatigue.
2.3 Reduction of Disease Risk Claims
- Definition: These claims refer to reducing the likelihood of developing a specific disease.
- Required Evidence:
- Human intervention studies (clinical trials) conducted according to rigorous scientific standards.
- Meta-analyses of existing studies to strengthen the claim.
- Mechanistic evidence explaining how the product reduces disease risk.
Example Evidence:
- A randomized clinical trial confirming the impact of Omega-3 in lowering blood triglyceride levels, reducing heart disease risk.
3. ASEAN and Thai Compliance Requirements for Health Claims
Both Thailand’s Ministry of Public Health (MOPH) and ASEAN guidelines emphasize that:
- Claims must be truthful, not misleading, and backed by robust scientific evidence.
- Prohibited Claims:
- Claims to cure, treat, or prevent diseases (unless specifically authorized).
- False or exaggerated health benefits.
- Language and Wording:
The language must be precise and easy for consumers to understand, avoiding terms that imply certainty (e.g., “guaranteed to cure”).
Sources: [19†ASEAN Guidelines], [20†Thai FDA Guidelines]
4. Regulatory Processes for Claim Approval
4.1 Thailand’s FDA Approval Process
- Pre-Submission Phase: Gather scientific evidence, including clinical trial data and literature reviews.
- Submission: Submit the product dossier and claim substantiation to the Thai FDA.
- Review Period: Evaluation typically takes 60-90 days, with an option for resubmission if additional data is required.
4.2 ASEAN Harmonization Process
- For products marketed across multiple ASEAN countries, companies can submit a harmonized dossier following the ASEAN guidelines.
- ASEAN’s approach emphasizes alignment with international standards, such as those of the WHO and CODEX Alimentarius.
5. Conclusion
Health claims are an essential part of marketing food, herbal products, and health supplements, but they must be backed by credible evidence. Following the Thai and ASEAN guidelines ensures that companies meet regulatory standards while providing consumers with accurate and trustworthy information.
In summary:
- Nutrient Function Claims require peer-reviewed evidence.
- Other Function Claims demand clinical studies and preclinical evidence.
- Disease Risk Reduction Claims require human trials and mechanistic data.
By adhering to these guidelines, businesses can build consumer trust and open doors to regional markets under the ASEAN harmonization framework.
