Michael Wang, President, NuLiv Science USA, has announced that the company's signature ingredient, AstraGin, has received GRAS status.
An expert panel from AIBMR Life Sciences, Puyallup, WA, a research and regulatory compliance consulting firm, performed a critical evaluation of the safety profile of AstraGin. The panel unanimously concluded that the intended use of AstraGin as a food ingredient, produced in accordance with Good Manufacturing Practice, and meeting the specifications presented in the document that is the basis for the GRAS determination, is generally recognized as safe.
AstraGin is 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. Both botanicals have long histories of safe human consumption. Both roots have been reported to have been used as tonics, suggesting long–term daily use is appropriate.
AIBMR performed an exhaustive and thorough safety assessment, beginning with historical use of both ingredients in Traditional Chinese Medicine as well as more modern studies of safety.
According to the AIBMR report, the totality of evidence of AstraGin's safety is comprised of both pivotal and corroborative data. Pivotal data included 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. 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. The conclusion is that testing showed that there are no safety concerns with respect to consumption of AstraGin.
In addition, the report points out that pivotal information also relates to NuLiv Science's high quality control standards for this ingredient. This data was corroborated by safety studies (including a bacterial reverse mutation test, mouse micronucleus tests, sperm morphology tests, a reproductive and developmental toxicity study, and acute and subchronic animal toxicology studies) performed on the individual botanicals—Panax notoginseng and Astragalus membranaceus—contained in the AstraGin blend, as well as a long history of safe consumption of these herbs.
Further, potential allergenicity was explored. AIBMR's report asserts that AstraGindoes not contain or have added, and is manufactured in a facility free of, gluten containing cereals, oats, crustaceans, eggs, fish, peanuts, soybeans, milk, nuts, celery, mustard, sesame seeds, or sulphur dioxide and sulphites or any derivatives or products thereof the aforementioned. AstraGinalso doesnot contain melamine or silica gel. Itis non–GMO and not–irradiated and conforms to EU regulations EC 1829/2003 and 1830/2003.
"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," Wang asserts. "As more and more consumers become educated about quality and safety of dietary supplements, the now-GRAS AstraGin may engender their trust, which bodes well for the brands that utilize it."
About NuLiv Science USA
NuLiv Science USA, headquartered in Walnut, CA, is a wholly owned subsidiary of NuLiv Holding Inc., a multi-national holding company with operations on three continents. Its vision is to evolve traditional holistic medicine into effective evidence-based mind and body medicine. Its mission is to become the recognized leader for the development of evidence-based health therapy interventions as well as a commercial platform that facilitates nutraceutical business between the East and West. For more information, visit nulivusa.com.