GanedenBC30 Becomes the First Probiotic to Receive a FCC Monograph

The U.S. Pharmacopeial Convention (USP), announced the first probiotic monograph for testing the identity, concentration and purity of Bacillus coagulans GBI-30, 6086 (GanedenBC30 by Ganeden). Bacillus coagulans GBI-30, 6086 is a gram-positive, spore-forming bacterium, classified as a probiotic for its purported support to good digestive and immune health. It was the first bacillus to receive a generally recognized as safe (GRAS) notification in 2012 from the FDA. The monograph will assist companies in complying with the new Food Safety Modernization Act, which requires that companies be able to identify and test incoming raw materials. The proposed monograph is to be included in USP's Food Chemicals Codex (FCC), First Supplement. The proposed monographs are available for review on the FCC Forum.

Bacillus coagulans GBI-30, 6086 can be used in a variety of foods, including baked goods, baking mixes, breakfast cereals, coffee and tea, dairy products, grain products and pastas. Because of the unique characteristics of food ingredients comprised of live microorganisms, the proposed monograph is specific to the strain level and represents only food ingredients that are labeled as this specific strain of Bacillus coagulans.