Xin Tianhe Biotechnology has successfully completed the US FDA Self-GRAS scientific evaluation for AKG and Ca-AKG, meeting official GRAS standards.
With this approval, the company becomes the first domestic fermentation-based AKG producer to receive authoritative GRAS recognition, unlocking access to the US nutrition and health market and accelerating its global expansion strategy.
This milestone marks the first domestic certification of a fermentation-derived AKG product under US FDA GRAS standards.
Unlike traditional chemically synthesized AKG, Xin Tianhe’s products are approved as food raw materials, not just flavoring agents. This distinction significantly broadens their application in dietary supplements and functional nutrition.
Alpha-ketoglutaric acid (AKG) plays a central role in human metabolism. It is a key intermediate in the tricarboxylic acid (TCA) cycle, supporting:
AKG is already listed as an “old dietary ingredient” in the US, enabling lawful use in nutritional formulations.
Xin Tianhe’s CynbioX™ AKG is produced using a full-cell catalytic fermentation process.
Key technical strengths include:
This approach delivers safety and quality control from the molecular level upward.
As a pioneer in AKG innovation, Xin Tianhe combines synthetic biology with international quality systems. The company holds multiple global certifications, including:
Its R&D team has also conducted multi-dimensional animal studies, validating AKG’s role in:
Several findings have been published in international SCI journals, strengthening the scientific foundation behind its products.
Securing US Self-GRAS status reinforces Xin Tianhe’s international credibility in R&D and quality management.
It also provides a launchpad for deeper penetration into global markets, where AKG demand is rapidly growing across:
With regulatory clearance and fermentation-based technology advantages, Xin Tianhe is positioned to compete aggressively in the global AKG market and drive innovation across the nutrition and health sector.