Thailand, known for its rich cultural heritage and breathtaking landscapes, is also a significant player in the global nutraceutical industry. Nutraceuticals, which combine the benefits of nutrition and pharmaceuticals, have gained popularity worldwide for their potential health benefits. However, entering the Thai market with nutraceutical products requires a thorough understanding of the country's regulatory framework. The Thai food supplement market was worth around ฿87 billion ($2.6 billion) in 2021, and it tends to grow by 10% annually.
The steady rise in demand for beauty supplements, weight loss, and sports nutrition products continues to drive market expansion. Thailand boasts 6,300 registered companies under the Ministry of Commerce, dedicated to producing dietary supplements. In 2023, the vitamins and minerals market records a revenue of US$0.37 billion, with an anticipated annual growth rate of 5.34% (CAGR 2023-2028).
Regulatory framework for nutraceutical regulation in Thailand.
Nutraceuticals in Thailand fall under the jurisdiction of the Thai Food and Drug Administration (FDA), a branch of the Ministry of Public Health. In Thailand, the Thai Food and Drug Administration (Thai FDA) of the Thailand Ministry of Public Health (MOPH) is responsible for regulating food products under the Food Act B.E. 2522 (1979). The primary regulatory framework governing all food-related matters in Thailand is the Thailand Food Act. This legislation empowers government authorities to oversee domestic production, imports, exports, and the sale of food products. It also establishes the standards and consequences applicable to food businesses operating within Thailand's borders.
Nutraceutical Classification -Thai FDA.
Notification 293 B.E.2548 (2005) defines food supplements as “products taken for consume other than conventional foods which contain nutrients or other substances as ingredients, are in forms of tablets, capsules, powders, flakes, liquids or others; which are not conventional foods for consumers who expect for benefit of health promotion” Accordingly, “other substances” include:
(i) Vitamins, amino acids, fatty acids, minerals and produces obtained from plants or animals.
(ii) Concentrates, metabolites composition or extracts of substances of (i).
(iii) Artificial substances imitated like substances of (i)
(iv) Mixtures of one or more of substances of (i) (ii) or (iii).
Nutraceutical Registration process in Thailand
Step 1: Preparing Documentation
Before beginning the registration process, manufacturers and importers of nutraceuticals must gather the necessary documentation, including:
Product Composition: Detailed information about the product's ingredients, including their sources and specifications
Manufacturing Process: A comprehensive description of the manufacturing process, including adherence to Good Manufacturing Practices (GMP)
Safety Data: Scientific evidence demonstrating the safety of the product's ingredients and formulation
Efficacy Data: Scientific studies supporting any health claims made about the product
Step 2: Submitting the Application
Once the required documentation is ready, it can be submitted to the Thai FDA. The application should include:
A completed application form
A product sample for evaluation
A copy of the product label and packaging
Proof of GMP compliance
Safety and efficacy studies (if applicable)
Step 3: Evaluation and Approval.
The Thai FDA will review the submitted documents and conduct a thorough evaluation. This evaluation may include laboratory testing of the product sample. If the product meets safety and efficacy standards, it will be approved for sale in Thailand.
Nutraceutical Labeling Requirements.
Thailand imposes strict labeling requirements to ensure that consumers have accurate and comprehensive information about nutraceutical products. Key labeling requirements include:
Product Name: A clear and concise product name
Ingredients List: An accurate list of all ingredients, including their concentrations
Net Content: The quantity or volume of the product
Directions for Use: Instructions for proper consumption
Storage Conditions: Recommended storage conditions
Batch Number and Expiry Date: Information to trace the product's manufacturing and expiry dates
Health Claims: Any health claims must be supported by scientific evidence
Importer's Details: Contact information of the local importer or distributor
Timeline and fees associated in nutraceutical product registration:
Typically, the process of nutraceutical regulation in Thailand can take between 6 to 12 months.
Registration fees can range from approximately 30,000 to 100,000 Thai Baht (THB),