NuLiv's AstraGin Affirmed GRAS

WALNUT, Calif.NuLiv Science USA announced its signature ingredient, AstraGin, was affirmed GRAS (generally recognized as safe) by an expert panel convened by AIBMR Life Sciences, Puyallup, Wash. AstraGin is a botanical extract of Panax notoginseng and Astragalus membranaceus roots standardized to contain a minimum of 1.5-percent total saponins, 0.01-percent astragaloside I and 0.1-percent ginsenoside Rb1.

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.

In addition, the report cited pivotal information relating to NuLiv Science's high quality control standards. 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 contained in the AstraGin blend, as well as a long history of safe consumption of these herbs. AstraGin is also non-allergenic and non-GMO, 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," said Michael Wang, president of NuLiv Science USA. "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."

More information on GRAS determinations and possible operational changes from FDA is available from the SupplySide Store in an on-demand video, Finalizing FDAs Operating Procedures for GRAS Determinations , featuring Robert McQuate, GRAS Associates.