Stevia First Corp. Achieves Milestone Towards GRAS Assessment for Reb A From Enzyme Enhancement
Jun 25, 2014
SACRAMENTO, CA--Stevia First Corp. (OTCQB: STVF) ("Stevia First" or the "Company"), an agricultural biotechnology company based in California's Central Valley growing region and focused on the industrial scale production of stevia, the all-natural zero-calorie sweetener that is rapidly transforming the food and beverage industry, is pleased to announce that it has completed a preliminary GRAS assessment overseen by GRAS Associates, LLC, for the production of Rebaudioside A ("Reb A"), by using an innovative enzymatic enhancement process.
GRAS is an acronym for the phrase "Generally Recognized As Safe." The phrase was used in the 1958 Food Additives Amendment to the Federal Food Drug and Cosmetic Act ("FD&C Act") to exempt certain food ingredients from the definition of food additive. GRAS Associates, LLC (www.gras-associates.com) has already successfully prepared and submitted 22 separate stevia GRAS applications, which represents more than half of all public GRAS notifications for stevia extracts. Of these, 21 have already received a "No Questions" letter from the U.S. FDA, and their latest GRAS notification was recently filed and is presently under review.
Under the current regulations, general recognition of safety through scientific procedures 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approval of a substance as a food additive and ordinarily is based upon published studies, which may be corroborated by unpublished studies and other data and information.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 provides a team of highly skilled toxicologists and regulatory scientists delivering the expertise that the law requires in order to make GRAS determinations.
Stevia First completed a preliminary GRAS assessment in April 2014 for Reb A produced using an enzyme enhancement process, where a Stevia enzyme is used to convert low-grade stevia extract into high purity Reb A. Additional data is required from Stevia First in order to obtain a formal GRAS approval, but the overall report concluded that a favorable GRAS determination could likely be achieved provided that Stevia First is able to provide additional data related to shelf life stability, final product specifications, certificates of analysis for multiple production lots, and other customary analytical reports, and pending final review of the application and FDA guidelines by its panel of experts.
Stevia First recently agreed to form an alliance with Qualipride International in order to substantially take over their stevia sales and distribution business, and to obtain access to an annual supply of 1,500 or more tons of stevia extract capacity. This stevia extract could be used as starting material within an enzyme enhancement process and converted into highly purified Reb A, which may command market prices estimated at approximately $100,000 per ton. Stevia First is now scaling up its process for industrial production with plans to first commercialize a purified Reb A product derived from fermentation and enzyme enhancement.
Stevia First's CEO Robert Brooke adds, "We have more data to provide to support formal GRAS approval and this type of oversight will be an ongoing process as we further develop our proprietary process and products. We are very encouraged by completion of this preliminary GRAS assessment and happy to gain significant access to experts that are directly familiar with the regulatory approval process."
GRAS Associates, LLC CEO & Co-Founder Robert McQuate, Ph.D. comments that, "Stevia First's team has provided a strong package of data to support production methods for a high purity Reb A product. The path to formal approval is clearly delineated and we look forward to next steps and a positive outcome."
About Stevia First Corp. (OTCQB: STVF)
Stevia First Corp. is an agricultural biotechnology company that has developed expertise for the production of stevia using fermentation and for improvement of traditional stevia farming and processing methods. The Company is also applying breakthrough technologies in software and the life sciences to develop product applications far beyond stevia and the food and beverage industry. For more information visit: www.steviafirst.com.
About the Stevia Industry
The market for all-natural, zero-calorie stevia sweeteners is expanding rapidly. The World Health Organization (WHO) estimates stevia intake could eventually replace 20-30% of all dietary sweeteners. The total global sweetener market was estimated at $58.3 billion in 2010. For more information visit: www.steviafirst.com.
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