Burcon NutraScience Corporation (TSX – BU) (“Burcon”) has announced that the U.S. Food and Drug Administration (FDA or the Agency) has issued a no objection letter with respect to Puratein® and Supertein™ canola protein isolates.
This response indicates the FDA has no objection to the conclusion that Puratein® and Supertein™ are Generally Recognized as Safe (GRAS) among qualified experts for use alone or together as an ingredient in dairy products, grain products, fruit and vegetable juices and beverages, salad dressings, meal replacements, and nutritional bars.
Based on the information provided, as well as other information available to the FDA, the Agency has no questions at this time regarding the conclusion that Puratein® and Supertein™ are GRAS under the intended conditions of use. As such, Puratein® and Supertein™ are now considered to be GRAS Notified.
Burcon’s patented process for the production of Puratein®and Supertein™canola protein isolates broadly separates the two naturally occurring proteins found in canola. The two naturally occurring proteins in canola, cruciferin and napin, have highly distinct functional and nutritional characteristics, similar to the way that the two proteins in egg, egg-yolk and egg-white, have distinct characteristics. Burcon’s patented process for the production of Puratein®and Supertein™canola protein isolates thereby creates two distinct protein ingredients with separate and distinct nutritional and functional profiles allowing for their use in a broader variety of food and beverage applications.
“Receipt of the official response from the U.S. Food & Drug Administration paves the way for the advancement of our canola protein isolates Puratein® and Supertein™. Producers of branded food and beverage products demand quality safe ingredients,” said Johann F. Tergesen, President and Chief Operating Officer, adding, “To our knowledge, no other canola protein has achieved this level of regulatory recognition. This marks a significant milestone in the development of Puratein® and Supertein™ canola protein isolates for use in food and beverage applications.”
About Burcon NutraScience
Burcon is a leader in nutrition, health and wellness in the field of functional, renewable plant proteins. Since 1999, Burcon has developed a portfolio of composition, application, and process patents originating from our core protein extraction and purification technology. We are developing Puratein® and Supertein™ canola protein isolates with unique functional and nutritional attributes, and CLARISOY®, a revolutionary soy protein isolate which is 100% soluble and completely transparent in acidic solutions. Our team of highly specialized scientists and engineers work from our own research facility to develop and optimize environmentally sound technologies. To-date, our patent portfolio consists of 135 issued patents in various countries, including 20 issued U.S. patents, and in excess of 200 additional pending patent applications, 66 of which are U.S. patent applications.