2. Product Categories

Ingredients Regulation Overview for Ingredient Manufacturers
Thailand

This section provides the regulatory definition of the ingredients' categories in scope.

2.1 Pharmaceutical Product

Drugs are defined in the Drug Act, B.E. 2510 (1967) and Amendment No.2 (1975), No.3 (1979), No.4 (1985) No.5 (1987), and No.6 (2019), and as presented below:

1. Substances recognized by pharmacopeias notified by the Minister of Public Health;
2. Substances intended for use in the diagnosis, treatment, relief, cure, or prevention of human or animal diseases or illnesses;
3. Substances that are pharmaceutical chemicals, semi-processed pharmaceutical chemicals; or
4. Substances intended to affect the health, structure, or function of the human or animal body.

2.2 Health Supplement

The classification of food supplements is defined in the Notification of Ministry of Public Health (No. 293) B.E.2548 (2005) Re. Food Supplement. A food supplement is a product consumed other than conventional foods, containing nutrients or other substances as ingredients. It must be in the form of tablets, capsules, powders, flakes, liquids, or others, which are not conventional foods, for consumers who expect the benefit of health promotion. 

Nutrients or other substances mean:

1. Vitamins, amino acids, fatty acids, minerals, and products obtained from plants or animals. 
2. Concentrates, metabolites, or extracts of substances of (1). 
3. Synthetic substances of (1) or (2). 
4. Mixtures of one or more substances of (1), (2), or (3).

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.

Health supplements are classified as food, which is categorized based on risks into four categories:

• Category 1: Specifically controlled food (e.g. food additives, infant formula)
• Category 2: Food with quality or standard requirements (e.g. food supplements)
• Category 3: Food with labeling requirements (e.g. ready to eat food, food derived from GMOs)
• Category 4: General food, not in categories 1–3, and mostly used as raw materials in food production and cooking
  • 4.1: Animals and animal products, flour and flour products
  • 4.2: Extracts, synthetic substances derived from plants and nutrients

2.3 Veterinary Drugs

Veterinary drugs are regulated by the Drug Act of 1967 and its six revised versions, with the same definition as for human drugs (Section 2.1).

2.4 References

1. Drug definition

https://en.fda.moph.go.th/entrepreneurs-medicines/category/what-is-drugs/

2. Categorization of Food

https://en.fda.moph.go.th/entrepreneurs-food/category/food-what-is-food-and-how-to-categorize-food