July 21/Medical Letter on the CDC & FDA -- Ajinomoto AminoScience LLC (AAS) announced that it has confirmed GRAS (Generally Recognized As Safe) status of its AjiGRAS-Leucine, meeting the safety standards demanded by the U.S. Food and Drug Administration (FDA). The company notes in a press release, "As the only formulation of Leucine currently with FDA acknowledged GRAS status, Ajinomoto's AjiGRAS-Leucine is the first amino acid to be allowed as an ingredient for use in conventional foods like non-milk and milk based meal replacements, sports and isotonic beverages, vitamin enhanced waters, and meal replacement bars, at levels of 0.5 to 3 grams per serving."

"This GRAS designation creates new opportunities for food and beverage manufacturers looking to offer the benefits of Leucine to consumers. Leucine is an essential amino acid the human body needs for key metabolic functions such as building body protein. Researchers have now established that Leucine can act to stimulate protein synthesis, helping to maintain or build muscle and also to help reduce the loss of body protein associated with strenuous exercise, weight loss and even aging."

Amino acids, including Leucine, have long been available to dietary and nutritional supplement manufacturers, but due to regulatory constraints, food and beverage manufacturers have been limited to using amino acids only to enhance the quality of protein in foods. This GRAS status marks the first time Leucine can be added as an ingredient into conventional foods and beverages to support and enhance normal metabolic function, giving manufacturers the opportunity to add value and consumer appeal with nutritional labeling, while potentially enhancing consumers' overall health.

"Food and beverage manufacturers are looking for ways to gain a competitive edge and differentiate themselves in the minds of consumers," explained Jack Heaton, president of Ajinomoto AminoScience LLC."This GRAS status is a significant milestone for the food and beverage manufacturing industry as a whole, to create value-added products for health-conscious consumers."

AjiGRAS-Leucine from Ajinomoto is produced via fermentation using vegetables as the raw material source. Ajinomoto does not use animal ingredients.

From the August 2, 2010, Prepared Foods E-dition