Regulations

GLG Receives Letter of No Objection for Reb C Blends

The United States Food and Drug Administration (FDA) has issued a Letter of No Objection for GLG Life Tech Corporation’s high-purity Rebaudioside C (“Reb C”) stevia extract where used as a general purpose sweetener in blends containing Rebaudioside A (“Reb A”) and from 10% to 50% Reb C (Filing No. GRN 536). GLG submitted its application pursuant to the FDA’s GRAS program, and is the first company to receive a Letter of No Objection from FDA for a high-purity Reb C product certified under the GRAS process. This letter confirms that FDA has no questions regarding GLG’s GRAS notice submitted earlier this year, in which the Vancouver, BC-based company, through in-depth consultation with GRAS Associates, LLC, reported the results of its extensive studies and its conclusion that Rebaudioside C is Generally Recognized as Safe (“GRAS”).
 
This accomplishment is significant because in December of 2014, GLG announced its major breakthrough in a new seedling rich in Reb C (its “Reb C Gold” seedling), which was developed through GLG’s patented non-GMO breeding methodology. Historically, conventional stevia leaf contained Reb C concentrations of around 1%. GLG’s Reb C Gold seedling contains Reb C concentrations verging on 7%. Lab tests show that Reb C comprises 53% of the glycosides in the Reb C Gold leaf, compared to values of 6% to 8% (relative to total glycosides) in other strains of stevia leaf – a remarkable 600% increase.
 
With this new GRAS announcement, GLG will soon commence providing product samples to customers as it begins developing its supply chain for Reb C Gold extracts.
 
The company has also submitted for review one more GRAS notice, for high-purity Rebaudioside D.  
 
Dr. Luke Zhang, Chairman and CEO of GLG, commenting on GLG’s Reb C accomplishments stated, “GLG is the first to market with a GRAS Reb C blend that will provide our customers with a superior flavor profile than existing Reb A stevia sweeteners. Our patented Non-GMO agriculture-breeding program once again enables GLG to provide our superior Reb C Gold blends on a commercial scale. Customers can expect to receive samples shortly of our Reb C Gold products and commence their formulation work. We are very excited to be able to offer our customers a natural non-GMO stevia product offering based on one of the best steviol glycosides known for its superior flavor profile compared to Reb A.”

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