Cargill Receives Official Notification from FDA Supporting the Safety of Truvia Rebiana

Cargill is the only petitioner to the FDA that has made the safety dossier for rebiana publicly available as part of its GRAS notification.

17/12/08 Cargill received official notification from the U.S. Food and Drug Administration (FDA) stating that the agency has no objection to the conclusion of an independent expert panel which reviewed research that rebaudioside A (rebiana), the identity in Truvia rebiana, is generally recognized as safe (GRAS) for use as a general purpose sweetener. The FDA letter affirms and supports rebiana’s safety and the data used to make that determination.

“Given the extensive research conducted to assure the safety of Truvia rebiana, Cargill has tremendous confidence in the product. The FDA letter further validates what the science has concluded – that Truvia rebiana is safe for use for all consumers,” said Marcelo Montero, president, Cargill Health & Nutrition. “The FDA brought the appropriate rigor to the process and we are extremely pleased with the news.”

Truvia rebiana is a well-characterized, high-purity ingredient derived from the best tasting part of the stevia leaf. Cargill has spent the past five years developing the product to its specifications and working to produce the ingredient on a commercial scale. The high-purity ingredient - Truvia rebiana - is consistent in quality and composition. The FDA letter and the safety studies for Truvia rebiana pertain to only the high-purity products that meet the established criteria and not to all stevia.

In June 2008, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) conducted a multi-year review of all the available scientific and clinical data on high purity steviol glycosides, including rebiana. In July 2008, the Committee determined that high purity, food-grade rebiana is safe for its intended use as a general-purpose sweetener, and established a permanent Acceptable Daily Intake (ADI).

Cargill submitted a GRAS notification to the FDA on May 15, 2008. Prior to this, an independent expert panel convened in March 2008 to review the comprehensive safety dossier for rebiana that also included safety assurance of composition and quality of rebiana. The panel unanimously affirmed that rebiana is safe for its intended use as a general-purpose sweetener. Cargill published all the safety studies for scientific and public comment.

Cargill enlisted leading scientists to design and conduct a rigorous safety evaluation program for Truvia rebiana – the first such program to test a well-characterized, high- purity form of rebaudioside A. The comprehensive design of the studies and the peer-review process were the foundation of the research program for rebiana. These peer-reviewed, scientific studies, published in the scientific journal Food and Chemical Toxicology establish the safety of Truvia rebiana.

Cargill is the only petitioner to the FDA that has made the safety dossier for rebiana publicly available as part of its GRAS notification.

Stevia is a shrub in the chrysanthemum family that is native to northeastern Paraguay. First discovered by natives of Paraguay, the plant has been grown, harvested and used in South America to sweeten foods and beverages for more than 200 years. The stevia leaf is a good source of natural, zero-calorie sweetness. Due to the fact that there are more than 200 varieties of the stevia plant, all stevia is not the same and stevia products currently on the market vary in their production, composition, purity level and sensory or taste characteristics. Cargill has applied its global expertise and knowledge in agriculture and agronomy to identify the varieties of stevia that will produce the best plants for each geography. Truvia rebiana comes from only from the best-tasting components of the stevia leaf and is a high-purity sweetener that is consistent in quality and taste.

“The search for a great tasting natural, zero calorie sweetener has been underway for more than three decades,” added Zanna McFerson, business director for Cargill Health and Nutrition. “Consumer demand for non-caloric, natural sweeteners has increased over the years. Truvia natural sweetener is the first great tasting natural zero calorie sweetener available in the U.S. to meet that growing consumer demand.”