Thailand is a member state of the ASEAN Economic Community, and next year, it is expected that the ASEAN Harmonization of Traditional Medicines and Health Supplements will be signed by the economic minister of each ASEAN country. Following ratification, the ASEAN Guidelines on Claims and Claims Substantiation for Traditional Medicines and Health Supplements will become the standard guidelines in the region, and various implementation efforts and instruments will follow. These guidelines cover a wide range of medicines and supplements; however, it is not possible to cover all herbal products.
There are three types of health supplement claims: nutritional claims, functional claims, and disease risk reduction claims. Examples of the three types of claims include the following:
- Nutritional claims: supplements nutrition, nourishes the body, supports healthy growth and development, etc.
- Functional claims: maintains healthy joints, supports immunity, maintains liver function, etc.
- Disease risk reduction claims: helps to reduce risk of dyslipidemia, helps to reduce risk of osteoporosis, etc.
The degree of evidence required for substantiating disease risk reduction claims is higher than for functional claims and nutritional claims. Functional claims and disease risk reduction claims must be substantiated by efficacy studies and the relevant toxicity data. It is the responsibility of the health supplement company to provide the required evidence in order to comply with the criteria for making such claims.
Tips on Health Claims for Health Supplements
1. Nutritional Claims
For essential nutrients such as vitamins and minerals, as listed by the Thai Food and Drug Administration (FDA), the amount included in a supplement must be between 15% and 100% of the Thai Recommended Daily Intake (RDI) values. Rules for specific kinds of nutritional claims are provided in the Notification of the Thai FDA RE: Nutrient Function Claims. For example, the nutrients that can be claimed as boosting the immune system include vitamin A, B6, B12, folic acid or folate, vitamin C, vitamin D, iron, zinc, copper, and selenium.
2. Functional and Disease Risk Reduction Claims
Phytochemicals, fish oil or animal extracts, and probiotics are substances not listed as nutrients by the Thai FDA. These substances are frequently used in health supplements, with claims as to their function and disease risk reduction properties. Some of these substances have specific laws and regulations regarding conditions of use and product claims.
For example, the Notification of the Ministry of Public Health RE: Use of Probiotics in Food prescribes the requirements of well-designed human intervention studies. Although the notification does not mention the number of studies required for submission to the Thai FDA, at least two reports of human interventional studies from two independent study centers are required by the Thai FDA.
For other products or food substances to be used in food products, the Thai FDA published the Manual for the Public RE: Applications for Health Claim Assessment. The manual follows the requirements in the ASEAN Guidelines. To substantiate claims, companies must submit:
- Well-designed human interventional studies;
- Meta-analysis/systematic review of said the substance or food product; or
- Scientific opinions from benchmark authorities, such as the EFSA Scientific Committee.
The selection of food substances and the design of a product formula are bases for claiming that a product is a health supplement. Science alone is not always enough—legal compliance and regulatory strategies are required for the acceptance of health claims by the authorities, which is paramount to determining the health supplement producer’s success. Companies seeking regulatory advice for submission of health claims to the Thai FDA can learn more by contacting Dr. Atthachai Homhuan at [email protected].