As we announced months ago (see the POST HERE) Starting July 2nd, 2024, significant updates to the submission process for dietary supplements to the Thai FDA will come into effect. The Food Division of the Food and Drug Administration is set to enhance its system in accordance with Ministry of Public Health’s Announcement No. 448, B.E. 2567, under the Food Act B.E. 2522. This update specifically addresses the registration of food supplements (No. 5) and aims to streamline the calculation and reporting of vitamin and mineral contents.
What Does This Mean for Importers and Manufacturers?
Importers and manufacturers of dietary supplements in Thailand will need to adhere to these revised guidelines to continue distributing their products in the market. The key implications include:
- Updated Maximum Limits: Under the new regulations, maximum limits for certain vitamins and minerals in dietary supplements will be adjusted to ensure safety and compliance. For instance, the maximum allowable daily dose of Vitamin C may increase significantly from the current 60 mg/day to 1,000 mg/day. This adjustment reflects updated scientific research and recommendations, providing consumers with broader access to essential nutrients within safe limits.
- Improved Calculation Standards: The Thai FDA’s Food Division will enhance its infrastructure to support more accurate calculation and reporting of vitamin and mineral amounts in dietary supplements. This improvement aims to standardize practices across the industry, ensuring consistency and reliability in product formulations and labeling.
- Compliance with Announcement No. 448, B.E. 2567: Manufacturers and importers must align their product formulations and submissions with the requirements outlined in Announcement No. 448, B.E. 2567. This includes detailed documentation and verification of ingredient quantities, as well as adherence to labeling guidelines to accurately reflect nutritional content.
Example Scenario: Vitamin C
Previously, Dietary Supplement Registration in Thailand were limited to a maximum of 60 mg/day of Vitamin C per serving. With the new regulations effective from July 2nd, 2024, manufacturers can now formulate products containing up to 1,000 mg/day of Vitamin C. This adjustment not only broadens consumer choice but also aligns with international standards, accommodating varying nutritional needs.
The full list of new limits is published here: https://www.siamdevelopment.com/new-limits-for-vitamin-and-mineral-in-thai-fda/
Preparing for the Transition
As the implementation date approaches, importers and manufacturers are encouraged to:
- Review Formulations: Audit existing product formulations to ensure compliance with new maximum limits and nutritional requirements.
- Update Labeling: Revise product labels to accurately reflect the revised vitamin and mineral content based on the updated calculations.
- Engage with Authorities: Seek guidance from the Thai FDA or relevant regulatory bodies to clarify any questions regarding the new regulations and ensure smooth transition.
Conclusion
These regulatory updates mark a significant step forward in enhancing the safety, transparency, and quality of dietary supplements available in Thailand. By aligning with international best practices and scientific research, the Thai FDA aims to foster consumer trust and support the sustainable growth of the dietary supplement industry.
For further details on how these changes will impact your business and the updated submission process, please refer to the official communication from the Thai FDA or contact their representatives directly.
Stay informed, stay compliant, and continue to contribute to the health and well-being of consumers in Thailand through safe and effective dietary supplements.
Read the official press release here: https://food.fda.moph.go.th/press-release/e-submission-2july/
