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New Scientific Studies Establish the Safety of Rebiana, a Sweetener from the Stevia Plant

Source: Cargill, The Coca-Cola Company
15/05/2008

Atlanta and Wayzata, Minnesota, May 15 - 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.

Study Results

The rebiana safety evaluation program included metabolism and pharmacokinetic studies, general and multi-generational safety studies, intake studies and human studies. Cargill sponsored the studies to affirm earlier safety findings for purified steviol glycosides, and to confirm that rebiana is broken down by the body in the same way as stevioside, which has been studied extensively. Rebaudioside A – the main component of rebiana – is nearly identical in chemical structure to stevioside.

Study   Top-line Findings   Implications
Metabolism and pharmacokinetic studies
  • Metabolism of rebaudioside A is similar to that of stevioside
  • Safety data from stevioside studies can be applied to rebiana
  • The safety of rebiana is supported by a large database of scientific research
General safety

  • No negative effects on general health associated with doses equivalent to a 150-lb person drinking more than 2,000 8-ounce servings of a rebiana-sweetened beverage
  • No treatment-related effects on any organ, including kidneys and male reproductive organs
  • Supports safety of high-purity steviol glycoside ingredients, including rebiana
  • Refutes outdated studies suggesting adverse effects of stevia or stevioside on male reproductive organs (1985, 1999) or on kidney function (1988, 1994, 1997)
  • Rebiana does not affect general health or organ function
Multi-generational/ reproductive toxicology

  • Daily consumption equivalent to a 150-lb person drinking nearly 1,000 8-ounce servings of a rebiana-sweetened beverage had no negative effects on general health, reproduction, growth or development of adults or their offspring
  • Refutes studies (1968, 1985, 1998, 1999) suggesting potential adverse effects on male or female fertility, or health of offspring
  • Rebiana does not affect reproductive health or health of offspring
Chronic blood pressure study
  • Daily consumption of 1,000 mg rebiana – equivalent to drinking more than eight 8-ounce servings of a rebiana-sweetened beverage every day – for 4 weeks had no significant blood pressure effects in healthy subjects with normal or low-normal blood pressure
  • Addresses questions raised by two Taiwanese studies (2000 and 2003) suggesting that stevioside (purity unknown) lowered blood pressure in people with essential hypertension
  • Rebiana does not affect blood pressure
Chronic blood sugar study
  • Daily consumption of 1,000 mg of rebiana – equivalent to drinking more than eight 8-ounce servings of a rebiana-sweetened beverage every day – for 16 weeks did not affect blood sugar control and was well-tolerated in people with type 2 diabetes
  • Addresses questions raised by a single-dose study (2004) suggesting that stevioside reduced levels of blood sugar after meals in people with type 2 diabetes
  • Rebiana does not affect blood sugar control in people with type 2 diabetes
  • In safety studies, daily consumption of rebiana equivalent to a 150-lb person drinking between 1,000 and 2,000 8-ounce servings of rebiana-sweetened beverage had no negative effects on the general health, reproduction, growth or development of adults or their offspring.
  • In clinical studies, daily consumption of 1,000 mg rebiana – equivalent to consuming 29 packets of sweetener or drinking approximately eight 8-ounce servings of a rebiana-sweetened beverage every day for 4 or 16 weeks – had no effect on blood pressure in healthy subjects with normal or low-normal blood pressure; or on blood sugar control in subjects with type 2 diabetes.

About The Coca-Cola Company

The Coca-Cola Company is the world’s largest beverage company, refreshing consumers with more than 450 sparkling and still brands. Along with Coca-Cola, recognized as the world’s most valuable brand, the Company’s portfolio includes 12 other billion dollar brands, including Diet Coke, Fanta, Sprite, Coca-Cola Zero, vitaminwater, Powerade, Minute Maid and Georgia Coffee. Globally, we are the No. 1 provider of sparkling beverages, juices and juice drinks and ready-to-drink teas and coffees. Through the world’s largest beverage distribution system, consumers in more than 200 countries enjoy the Company’s beverages at a rate of 1.5 billion servings a day. With an enduring commitment to building sustainable communities, our Company is focused on initiatives that protect the environment, conserve resources and enhance the economic development of the communities where we operate.

About Cargill

Headquartered in Minneapolis, Minn., Cargill is a privately held international provider of food, agricultural and risk management products and services. With 158,000 employees in 66 countries, the company is committed to using its knowledge and experience to collaborate with customers to help them succeed.



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