Blue California Submits Stevia Reb-A GRAS Notification to FDA

Blue California, a manufacturer of highly purified botanical extracts, announced the submission of its GRAS petition to the FDA for Good&Sweet™ Rebaudioside-A 97%, a natural zero-calorie sweetener derived from the stevia leaf. Pure Reb-A (Rebaudioside-A) is sweeter and better-tasting than other stevia extracts and offers a natural and better choice for use in a variety of food products.

Blue California started commercial production of this natural sweetener derived from stevia in December 2007 and began the GRAS self-affirmation process in February 2008. After months of extensive review of scientific data and studies related to the stevia plant and Rebaudiosisde, in particular, the Expert Panel convened by GRAS Associates, LLC, concluded that Good&Sweet Reb-A 97% meets the safety criteria for use as a general purpose sweetener in a variety of food products for consumer use including, food, beverages, confectioneries and table-top products.

GRAS self-affirmation is a legal, FDA-allowed process that enables companies to conduct their own GRAS self-determinations by convening an independent panel of scientists to determine if an ingredient meets the FDA’s criteria for safety. Though Blue California has already completed GRAS status for Good&Sweet, the company decided to take its safety assessment one level further by submitting its GRAS portfolio to the FDA.

On December 17, 2008, the FDA issued no objection letters of GRAS status for two other stevia sweetener submissions, thereby paving the way for greater use of the product.

Cecilia McCollum, Blue California’s Executive Vice President, commented, “Submission of our GRAS dossier to the FDA was the obvious and logical step for Blue California. From the very beginning, we've had absolute confidence in the safety and the unmatched purity of our Reb-A”. Blue California’s Reb-A is offered at 97% and 99% purity and it is independently validated by Eurofins Scientific, of California.

Robert S. McQuate, PhD, and CEO of GRAS Associates, adds, “Our Expert Panel was impressed by the documented high purity of Blue California’s Rebaudioside A, and this had a substantial bearing on the GRAS conclusion that was reached. We have submitted the dossier to the FDA with the expectation that Good&Sweet’s high quality compositional profile should result in a favorable response from the FDA.”

Rebaudioside A is a non-caloric natural sweetener derived from the stevia leaf, is heat-stable and 400 times sweeter than sugar. Rebaudioside A and other stevia products are approved for general food use in Australia, New Zealand, Switzerland, Russia, Israel, Japan, South Korea, Brazil, Argentina, Paraguay and in a few other countries. It has been approved for use in dietary supplements in the U.S. since 1995.

Good&Sweet is manufactured by Blue California under strict GMP and ISO-9001:2000 quality certifications by NSF. Blue California is a manufacturer of Kosher-certified high purity botanical extracts and other unique ingredients for use in foods, beverages, cosmetics and dietary supplements.

For more information, contact Cecilia McCollum at Blue California, 30111 Tomas, Rancho Santa Margarita, CA 92688. (949) 635-1990, (949) 635-1988 Fax, [email protected],

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