Login/Register

Taiwan red yeast extract obtains qualification from the US FDA, the only one able to legally claim efficacy in the USMay 08, 2024

Recently, red yeast extract products have raised concerns among consumers regarding their safety due to the presence of citrinin, which may harm the kidneys. SunWay Biotech stated that their self-produced ANKASCIN 568-R red yeast extract undergoes rigorous control of citrinin content, with up to four inspections per batch from fermentation source white extract to processing, all of which comply with the regulations of the Taiwan Food and Drug Administration. It is also currently the only red yeast extract product to receive certification as a New Dietary Ingredient (NDI) from the US FDA, ensuring its quality and safety. 

Red yeast extract breakthrough! ANKASCIN 568-R solid-state fermentation for enhanced safety 

Red yeast extract is a traditional ingredient with a long history, not only enhancing culinary flavor but also possessing various health benefits. However, traditional red yeast extract may produce the risky component Monacolin K during fermentation. In response, SunWay Biotech's research and development team spent years developing the red yeast extract material ANKASCIN 568-R from their patented effective red yeast extract strain (Monascus purpureus NTU 568). Utilizing exclusive automated solid-state fermentation technology, they effectively remove Monacolin K, which may cause side effects, while retaining the new active ingredients Monascin and Ankaflavin, making it safer and more effective. 

ANKASCIN 568-R receives qualification from the US FDA, the only one Able to legally claim efficacy in the US 

SunWay Biotech's ANKASCIN 568-R obtained qualification from the US FDA in 2015, becoming the only red yeast extract material that can legally claim efficacy and clearly label the content of active ingredients in the US. This marks an important milestone for Taiwanese red yeast extract products entering the international market. 

ANKASCIN 568-R's efficacy and safety have been verified through multiple animal experiments and human clinical trials, making it especially suitable for dietary supplements and functional food products. 

Recipient of the Symbol of National Quality for health materials bronze award! 

SunWay Biotech's ANKASCIN 568-R is a domestically developed health food material with multiple patents and has published over 130 SCI journal research papers, demonstrating strong theoretical foundations. It was awarded the Bronze Award in the "Special Functional Health Material Group" of the 26th Symbol of National Quality Awards in 2023. 

Mr. Chia-Yueh Pan, General Manager of SunWay Biotech, stated that their self-produced ANKASCIN 568-R red yeast extract undergoes strict quality control throughout the entire process. The white rice used in fermentation sources is sourced from local rice merchants in Taiwan through local contracts. Additionally, citrinin content is rigorously controlled up to four times per batch throughout the entire process, with inspection results meeting the regulations of the Taiwan Food and Drug Administration, making it a reassuring choice for consumers! 

Resource (mandarin): 

台灣紅麴原料取得美國FDA資格,唯一能在美國合法宣稱功效