Thailand is one of the biggest health supplement markets in Southeast Asia. Therefore, it is a key market of interest among many health supplements companies although the ease of launching products depends on the category in which the Thai Authority classifies the product. To develop effective business and marketing strategies in Thailand, therefore, it is important to understand the country’s regulatory framework for health supplements.

Classification

The Thai Food and Drug Administration (FDA) of the Ministry of Public Health (MOPH) is responsible for regulating health supplement products. The classification of these products depends on the types of ingredients used, daily dosages and claims.

Table 1: Classification of health supplement in Thailand

A health supplement is classified as a ‘food supplement’ if it contains common herbal ingredients and other bioactive ingredients at a daily dosage level recognised by the Thai FDA as safe for food. An example is crude ginseng powder at the maximum daily dosage of 2g. For common vitamin and mineral supplements, the levels of the nutrients must be kept between 15 – 100 percent of the Thai Recommended Daily Intake (RDI) in order to be classified as a food supplements.

In terms of bearing nutritional claims, such as nutrient content or comparative nutrient claims, health supplements regulated as food supplements are permitted to bear claims that are in line with the Codex Alimentarius nutrition labelling guidelines. For claims pertaining to functions of nutrients (e.g. vitamin A for night vision, Calcium for healthy bones), food supplement products are permitted to bear claims that are in the Thai FDA’s permitted list of nutrient function claims for conventional food.

It is important to note that as a member of the Association of South East Asian Nations (ASEAN) working group on the harmonisation of health supplements and traditional medicine, the Thai FDA is in the process of reviewing its regulatory framework for evaluating the substantiation of health claims. Food supplements are not permitted to bear medicinal claims, unless the product is registered as a traditional medicine or drug.

Health supplements containing ingredients not approved as food ingredients and/or containing vitamins and minerals that exceed the Thai RDI value, must be registered as traditional medicines, drugs or any other related sub-categories, such as modern herbal drugs, generic drugs or new drugs. Glucosamine, for example, is considered a generic drug, whereas as echinacea is considered a traditional medicine.

Product approval

Products classified as traditional medicines and drugs must be evaluated and approved by the Thai FDA’s product evaluation committee prior to marketing. Registration dossiers are required, which include information such as quality controls reports, manufacturing processes, safety evidence, and efficacy data.

Products classified as food supplements, on the other hand, require a notification process.

It is important, therefore, for companies to take to continually review their product formulas, marketing strategies and their ability to comply with the regulatory requirements before deciding on the category in which they wish to register their product. Such due diligence will help to minimise the risk for companies keen to enter Thailand’s market.

EAS has released a unique and easy-to-follow guide to help companies build successful regulatory strategies to enter Asian region’s nutritional product market. The guide, titled ‘Marketing Health Supplements, Fortified & Functional Foods in Asia: Legislation & Practice’, covers national and regional rules for health supplements, including rules for ingredients (vitamins and minerals, herbs and other functional ingredients), claims and regulatory procedures for product marketing. Visit www.eas.asia for more information.