Regulations on Dietary Supplements
Essential Supplement Registration Regulations Every Business Owner Should Know
Relevant FDA regulations and notifications for dietary supplement manufacturing.
Pre-Production: Verification of the formula, raw materials, and accuracy before entering the production line.
- The primary laws governing the manufacture, importation, distribution, standards, labeling, and advertising of food products, including penalties for non-compliance.
- Definition of Dietary Supplements
- Requirements for Product Registration
- Basic Labeling Requirements
- Vitamin and mineral fortification must be declared on the label and must be within the permitted levels as specified by the Thai FDA.
- Meal replacement products must meet the legally required levels of protein, fiber, and other essential nutrients.
During Production: Control the manufacturing process to comply with standards and legal requirements.
- Manufacturing standards that factories must comply with to ensure food safety and quality.
Post-Production: Ensuring products enter the market legally and communicating marketing messages in full compliance with regulations.
- Food packaging label requirements, including mandatory information, warning statements, label presentation format, and the full enforcement deadline on 1 July 2027.
- The label must follow the standard formats and abbreviations prescribed by the FDA, such as using the date format “day-month-year” or “year-month-day”, depending on the product category.
- Do not use any images or statements that may mislead consumers into believing that the product is a drug or has disease-treating properties.
- If you wish to make any health-related claims, such as “helps support the immune system,” scientific evidence is required and prior approval from the FDA must be obtained.
- Imposed on certain categories of dietary supplements, especially those that make nutritional claims or contain high levels of key nutrients such as protein, vitamins, or minerals.
- It establishes the criteria for using statements such as “High Vitamin C” or “Low Sugar,” which must comply with the legally defined nutrient thresholds.
- Any advertisement that refers to benefits, quality, or therapeutic properties must be approved by the FDA and must display the approval number (Khor.).