EAGAN, MN – December 5, 2006 – Biothera announced today that its dietary supplement and functional food ingredients are the first yeast beta glucans to be Generally Recognized As Safe (GRAS) under the provisions of U.S. Food and Drug Administration 21CFR170.35.
An independent panel of medical and toxicology experts recently determined that Biothera’s WGP 3-6 and BetaRight® 3-6 meet the requirements for self-affirmed GRAS status. The panel reviewed extensive scientific data, including safety, toxicology and manufacturing process data. Biothera will provide the U.S. FDA with notification of the GRAS Panel’s decision.
“Achieving GRAS status for our ingredients is an important milestone in the commercialization of our products in the functional food and nutrition marketplace,” said Richard Mueller, Biothera president and chief executive officer. “As the only yeast beta glucan with GRAS status, we have an opportunity to expand our leadership in immune health to new markets and products.”
GRAS status is a critical standard that food manufacturers require before considering an ingredient for their products.
“Our success is based on the purity of our ingredients, the integrity of our research and the quality of our manufacturing processes,” said Don Cox, Ph.D., Biothera vice president of research and development, healthcare group. “WGP 3-6 and BetaRight 3-6 are the only yeast beta glucans that can truthfully claim to be Generally Recognized As Safe.”
About Biothera, the Immune Health Company
Biothera is a biotechnology company dedicated to improving immune health. The company's primary focus is developing pharmaceuticals that engage the immune system to fight cancer and that produce white blood cells following chemotherapy or radiation. In addition, Biothera manufactures and markets food-grade ingredients that support healthy immune function to the nutritional supplement, functional food, cosmetic and animal nutrition markets.
Contact: David Walsh
Biothera, the Immune Health Company