According to Michael Wang, president of NuLiv Science USA, the AIBMR expert panel unanimously support the generally recognized as safe (GRAS) status of AstraGin as a food ingredient, produced in accordance with Good Manufacturing Practice (GMPs).
"Achieving independent GRAS status solidifies AstraGin as a superior quality compound to significantly enhance bioavailability of nutraceutical ingredients for a wide range of health and wellness support," said Wang.
Mr Wang told NutraIngredients-USA that the ingredient could be used in a number of products, including popular convenience foods such as powdered mixes, baked goods, nutraceutical-containing confections (chews, bars), and nutraceutical-infused beverages such as waters, teas, and carbonated protein drinks.
The ingredient
The ingredient is said to be a botanical extract of Panax notoginseng and Astragalus membranaceus roots standardized to contain a minimum of 1.5% total saponins, 0.01% astragaloside I, and 0.1% ginsenoside Rb1.
Wang added that the ingredient is light in color, tasteless and water soluble, and it will blend well in any foods and beverages.
“AstraGin is a proprietary food and dietary ingredient that significantly enhances the absorption of many essential human nutrients (such as amino acids and folate, among others) in human intestinal lumen, which are responsible for extraction and uptake of nutrients,” he explained.
“AstraGin has been shown to enhance specific nutrient absorption regulating DNA, mRNA, and transporter proteins in the human body.”
Data
The AIBMR scientists used information about the historical use of both ingredients in Traditional Chinese Medicine in combination with modern studies of safety, said NuLiv.
Included in this was a 28-day, repeated oral toxicity study of AstraGin in Wistar rats, at doses from 0 up to 1000 mg per kg of body weight, representing 100, 300 and 1000 times the suggested daily human dose of 1 mg per kg/body weight daily of the compound.
A spokesperson for AIBMR confirmed that no mortality was observed in any animal in the control or test groups during the study period. Also, there were no clinical signs or abnormalities in behavior, motor activity, or general state in control or test group animals in the daily general and weekly detailed clinical observations.
Wang said that the company intends to submit the GRAS documentation to FDA for a letter of no objection.