Stevia First, an early-stage agribusiness based in California's Central Valley growing region, today announced that the company has entered into a non-disclosure agreement with GRAS Associates, LLC. The agreement will apply mainly to discussions intended to expedite the regulatory approval of the company's stevia extracts, particularly those manufactured through fermentation-based processes.
GRAS is an acronym which stands for "Generally Recognized As Safe". Originally used in the 1958 Food Additives Amendment to the Federal Food Drug and Cosmetic Act (FD&C Act), the phrased made exempt certain food ingredients from the definition of food additive. Having already successfully prepared and submitted 17 separate stevia GRAS applications, which represents more than half of all public GRAS notifications for stevia extracts, GRAS Associates has received a "No Questions" letter from the U.S. FDA each time.
Current regulations demand general recognition of safety through scientific procedures and requires the same quantity and quality of scientific evidence as is required to obtain approval of a substance as a food additive and ordinarily is based upon published studies, which may be corroborated by unpublished studies and other data and information. GRAS Associates employs and offers a team of highly skilled toxicologists and regulatory scientists delivering the expertise that the law requires in order to make GRAS determinations.
GRAS Associates CEO & CO-Founder Robert McQuate, Ph.D. said, "We are pleased to have this interaction with Stevia First as they advance plans to obtain GRAS status. We are very familiar with the stevia industry and related technologies, and so the path to compliance is clearly delineated. We look forward to the process and a positive outcome."
Company CEO Robert Brooke added, "By introducing GRAS Associates into the process, we can gain significant access to knowledgeable scientific expertise that is directly familiar with the regulatory approval process. For us, the goal is all about moving rapidly ahead towards commercialization, and such GRAS approvals are a key component for widespread market adoption."
For more information on Stevia First, please visit steviafirst.com
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