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Cargill developed rebiana as a natural, zero-calorie sweetening ingredient for use in food and beverages. Cargill commissioned a rigorous safety evaluation program for rebiana in consultation with regulatory authorities, leading scientists and respected research institutions. The results of the rebiana research program have addressed previously unresolved questions and established the safety of rebiana for use as a general purpose sweetener. This overview describes the rationale, design and results of the program.
To understand the context and purpose of the rebiana safety program, it is important to understand the relationship between rebiana, stevia and various components of the stevia plant: Stevia typically refers to a crude preparation (powder or liquid) made from the leaves of the stevia plant. Such preparations contain a mixture of many components, not just those that give a sweet taste to the leaf. Because the exact composition of the mixture is unknown, studies that have used "stevia" are often difficult to interpret.
Steviol glycosides are the sweet components of the stevia leaf. There are various kinds of steviol glycosides, but the two most abundant types are stevioside and rebaudioside A.
Stevioside is the most abundant steviol glycoside in the stevia leaf. It has been studied extensively.
Rebaudioside A is the best-tasting steviol glycoside. It is metabolized in the same way as stevioside.
Rebiana is purified rebaudioside A. Truvia™ rebiana was the first high-purity, well-characterized form of rebaudioside A that is purified from the leaf consistently to a food grade specification.
Stevia and its components have been evaluated in a range of studies over the past five decades. The studies have varied widely in purpose, design and quality, and have thus yielded sometimes inconsistent results.
Some smaller studies used crude preparations from or extracts of stevia - an undefined mixture of many components - making it difficult to attribute the results to any one substance within the leaf.
In addition to past use of uncharacterized or crude materials, some investigations used non-oral (non-dietary) routes of administration. Based on what is known about metabolism, this route of exposure is not relevant for the safety evaluation of a sweetener, which is consumed in food in beverages. Several attempts have been made in the past to petition the FDA for approval of stevia as a food additive. However, the petitioners could not provide sufficient data to the FDA to address key questions about the composition, quality and safety of stevia.
Cargill enlisted leading scientists to design and conduct a rigorous safety evaluation program for rebiana - the first such program to test a well-characterized, high-purity form of rebaudioside A.
Prior to this program, safety data on rebaudioside A was limited to several smaller metabolism and safety studies. However, stevioside had been evaluated extensively. Since rebaudioside A is broken down into the same basic parts in the body as stevioside, data from studies of purified stevioside are directly applicable in the safety assessment of rebiana.
The objectives of the rebiana safety program were to:
The outcomes of the rebiana scientific evaluation program confirmed the safety findings of earlier studies (of purified rebaudioside A and stevioside) while addressing unresolved questions and gaps in the data. The results help to fulfill regulatory requirements and to bring rebiana to consumers around the world.
ATLANTA, Ga., WAYZATA, Minn., [May 15, 2008] — Research published electronically today in the peer-reviewed scientific journal Food and Chemical Toxicology clearly establishes the safety of rebiana (common or usual name for high-purity Rebaudioside A from stevia) for general use to sweeten foods and beverages, according to experts at Cargill and The Coca-Cola Company.
Rebiana is the first consistent, high-purity sweetener composed of rebaudioside A, the best-tasting part of the stevia leaf. Beginning in 2004, Cargill commissioned a rigorous safety evaluation program for rebiana in consultation with leading scientists.
Cargill, in partnership with The Coca-Cola Company, has developed rebiana as a natural, zero-calorie ingredient which will be marketed by Cargill under the brand name TRUVIA™.
"These newly published data complement the body of existing scientific research on steviol glycosides, the sweet components of the stevia leaf," said Leslie Curry, regulatory and scientific affairs director, Cargill Food and Ingredient Systems. "The rebiana research program affirmed positive safety data from earlier studies on purified steviol glycosides and addressed unresolved questions resulting from studies with crude stevia extracts."
“TRUVIA™ natural sweetener was developed to meet the strong consumer demand for a natural, zero calorie way to sweeten foods and beverages. Rebiana provides a new great tasting alternative that meets that demand,” said Zanna McFerson, business director for Cargill Health and Nutrition. “The results of this research program pave the way to bring this long sought after sweetener to U.S. consumers.”
Although stevia today is sold in the U.S. as a dietary supplement, rebiana will be the first available sweetener for foods and beverages that has been purified from the stevia plant. Unlike many existing stevia products, which generally contain crude extracts of the plant, rebiana is a fully-characterized product that is consistent in quality and contains only the best-tasting components of the stevia leaf.
“We are pleased that these studies have proved definitively that rebiana is safe,” said Dr. Rhona Applebaum, vice president and chief scientific and regulatory officer of The Coca-Cola Company.
Rebaudioside A, the best-tasting component (steviol glycoside) of the stevia leaf. Rebiana is at least 97% rebaudioside A; other steviol glycosides make up the remaining 3 %. Rebiana was the first high-purity, well-characterized form of rebaudioside A.
The best-tasting of the steviol glycosides found in the stevia leaf.
The sweet components of the stevia leaf. There are various kinds of steviol glycosides, but the two most abundant types are stevioside and rebaudioside A.
The most plentiful of the steviol glycosides found in the stevia leaf. Stevioside has been extensively studied over the past several decades.
In the context of sweeteners or dietary supplements, "stevia" typically refers to a crude preparation (powder or liquid) made from the leaves of the stevia plant. Such preparations contain a mixture of many components, not just those that give a sweet taste to the leaf. Because the exact composition of "stevia" is unknown, scientific studies that have used crude preparations are difficult to interpret.
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