The FDA confirmed notification to the Vancouver-based functional protein developer for its Puratein and Supertein canola protein isolates in a letter confirming it had ‘no further questions’ – indicating it has no objections to the classification of the ingredients as generally recognized as safe (GRAS).
Burcon has been developing the patented protein ingredients since 1999, but commercial applications for the functional ingredients have hinged on their GRAS status. The company announced self-affirmed GRAS for Puratein and Supertein in October 2007, but FDA GRAS notification is often demanded by potential customers.
Earlier this year, Burcon said that the filing for FDA GRAS approval would advance negotiations with firms that demand more than self-affirmed GRAS.
"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,” said Johann Tergesen, Burcon president and chief operating officer.
“This marks a significant milestone in the development of Puratein and Supertein canola protein isolates for use in food and beverage applications," he added.
The GRAS notification covers the ingredients' use in eight food categories: meal replacement/nutrition bars; protein supplement powders; salad dressings; fruits and vegetable juices; beverages; grain products; processed meats; dairy products; and powdered egg/egg substitutes.
The patented process for the production of Puratein and Supertein canola protein isolates separates the two naturally occurring proteins found in canola - cruciferin and napin.
Burcon said the proteins have “distinct functional and nutritional characteristics, similar to the way that the two proteins in egg, egg-yolk and egg-white, have distinct characteristics.”
According to Burcon, the production process for Puratein and Supertein “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.”
To date Burcon NutraScience Corporation holds 135 issued patents in various countries, including 20 issued U.S. patents, and over 200 patent pending applications.
Disclaimer: This story has been updated from the previous publication version after the FDA confirmed Burcon's GRAS status.