CHICAGO – PureCircle Ltd. has received a “no objection” letter from the Food and Drug Administration for the use of the company’s Rebaudioside D as a sweetener for foods and beverages in the United States.
The company made an F.D.A. Generally Recognized As Safe (GRAS) filing on Jan. 23. It sought the use of Reb D, which is purified from the leaves of stevia plants, as a general purpose sweetener in foods, excluding infant formula and meat and poultry products, at levels determined by good manufacturing practices, as well as use as a table top sweetener. With the F.D.A.’s GRAS affirmation, PureCircle is prepared for the immediate commercialization of Reb D.
“We have invested over $300 million in a supply chain infrastructure capable of delivering breakthrough ingredient innovation,” said Jason Hecker, vice-president of global marketing and innovation for PureCircle, which is based in Malaysia and has a U.S. office in Oak Brook, Ill. “We are proud to now work with our customers to turn this investment into breakthrough food and beverage solutions.”
PureCircle, which supplies stevia ingredients for the global food and beverage industry, gave potential commercialization plans for Reb D on March 4. According to the company, the clean sweetness of Reb D will further enable PureCircle’s customers to develop naturally sweetened formulations with low to no calories, particularly in foods and beverages with higher sweetness levels, such as carbonated soft drinks.
Investments are focused on scaling the new technology with plans for market introductions as early as the second half of this year. In addition to proprietary high Reb D content leaf varieties, PureCircle has secured process, method and application patents. The company has a suite of more than 25 patents and patent applications for Reb D.
Reb D should not be confused with Reb X. PureCircle is hoping for a “no objection” letter from the F.D.A. after a May 23 GRAS filing for the use of purified steviol glycosides, with Rebaudioside X as the principal component, as an ingredient in food. In conjunction with The Coca-Cola Co., Atlanta, PureCircle is seeking global intellectual property coverage for Reb X.