Comprehensive Guide to Herbal Product Regulations and Documentation: Key Requirements, Claims, and Innovations
In Thailand, herbal products are regulated under the Herbal Product Act, B.E. 2562 (2019). These products are categorized based on their purpose and risk level. Here is an overview of the allowed herbal products:
1. Traditional Herbal Medicines
These are developed based on traditional knowledge, including:
Thai traditional medicines: Derived from local herbal formulations used in Thai traditional medicine systems.
Chinese traditional medicines: Prepared using practices from traditional Chinese medicine.
These medicines generally do not require pre-clinical or clinical studies if their efficacy and safety are sufficiently supported by existing traditional knowledge.
2. Herbal Health Products
These products are intended for health maintenance, improvement, or reducing the risk of disease. They include:
Supplements and products aimed at general health enhancement: Such as vitamins and plant extracts, including cannabis-derived substances that comply with specific legal exemptions.
Non-high-risk herbal products: These focus on functions like enhancing body structure, regulating body systems, or preventive care (e.g., herbal teas or functional foods).
3. Herbal Drugs and Health Supplements with Specific Claims
Some herbal products require scientific substantiation for any health claims they make. This category includes health supplements marketed for specific purposes like improving body functions or reducing disease risks.
The Thai FDA requires these products to submit efficacy data, ensuring their safety and quality before registration.
4. High-Risk Herbal Products
These are tightly regulated, especially if used for treating serious diseases (e.g., asthma, diabetes, cancer). They include:
Sterile injections derived from herbs.
Products with a higher potential for misuse or with complex administration requirements.
These high-risk products must be evaluated for both pre-clinical and clinical efficacy before approval.
The regulatory framework aims to ensure the safety, efficacy, and quality of herbal products, with specific guidelines for different product types. Products must follow labeling requirements to specify their ingredients and health claims accurately. This ensures compliance with national and ASEAN guidelines for health supplements and herbal products.
1. Overview of Product Documentation Requirements
Herbal Products Classification
| Type of Product | Definition | Examples |
|---|---|---|
| Traditional Herbal Medicine | Medicines prepared according to ancient practices, such as Thai or Chinese medicine. No pre-clinical studies required. | Thai Herbal Pills, Chinese Herbal Tea |
| Developed Herbal Medicine | Products developed by refining or enhancing traditional knowledge. | Modern Herbal Capsules |
| Health Supplements | Products intended to improve health or reduce disease risks, often in capsule or powder form. | Vitamin C tablets, Herbal Health Drinks |
Source: [22†Herbal Product Categorization]
2. Required Information for Product Registration
| Category | Documentation Requirements | Examples |
|---|---|---|
| General Information | Product name, ingredients list, and description. | Supplement facts, herbal content description |
| Safety and Efficacy Documentation | Toxicology reports, literature reviews, and safety assessments. | Preclinical data, clinical trials summary |
| Quality Control Evidence | GMP certificates, lab test results for purity and potency. | Heavy metal screening results |
| Claims and Substantiation | Scientific proof for health claims (ASEAN guidelines). | Immunity-boosting claims for ginger extract |
Sources: [19†ASEAN Guidelines], [22†Thai Herbal Product Requirements]
3. Health Claim Guidelines
| Claim Type | Description | Required Evidence | Examples |
|---|---|---|---|
| Nutrient Function Claims | Describes roles of nutrients in maintaining body functions. | Published scientific literature. | “Calcium supports bone health.” |
| Other Function Claims | Highlights specific physiological benefits. | Clinical trials or equivalent studies. | “Ginseng enhances stamina.” |
| Reduction of Disease Risk Claims | Claims to reduce risk factors of diseases. | Human studies, significant peer-reviewed research. | “Omega-3 reduces the risk of heart disease.” |
Source: [20†FDA Health Claims Guidelines]
4. Legal and Compliance Framework for Herbal Products in Thailand
| Law/Guideline | Description | Reference Document |
|---|---|---|
| Herbal Product Act (B.E. 2562) | Governs herbal product production, import, and marketing. | [18†Thai Herbal Act 2562] |
| Registration Guidelines for Non-Risk Products | Simplifies the process for low-risk products to enter the market. | [22†Low-Risk Herbal Product Documentation] |
5. Quality and Labeling Requirements
| Requirement | Details | Regulation Reference |
|---|---|---|
| Ingredient Disclosure | Must specify all active ingredients in metric units on labels. | [21†Labeling Guidelines] |
| Minimum Number of Listed Ingredients | If more than five active ingredients, list at least 50%. | [21†Labeling Guidelines] |
| Safety Instructions | Mandatory warnings on potential interactions with medications. | [21†Thai Product Safety Guidelines] |
