August 6, 2012
CLEVELANDFDA did not object to the GRAS (generally recognized as safe) status for Ganeden Biotech's GanedenBC30® (Bacillus coagulans GBI-30, 6086), a spore-forming probiotic ingredient. Ganeden Biotech spent the last six years developing and implementing trials to prepare for the full GRAS filing. The Department of Health and Human Services contacted Ganeden Biotech regarding GRAS Notice No. 000399 to inform the company that, based on the information provided by Ganeden Biotech, as well as other information available to the FDA, the agency has no questions or objections at this time regarding the expert panel conclusion that GanedenBC30 is GRAS under the intended conditions of use.
GanedenBC30 is a probiotic intended for use in a wide variety of foods including baked goods and baking mixes, beverages, cereals, gum, coffees and teas, condiments and relishes. In 2007, Ganeden Biotech reached a self-affirmed GRAS determination for GanedenBC30 which allowed it to sell to the food market. In 2010, the company reaffirmed this status and later submitted its claim to the FDA in 2011 with the guidance of the AIBMR Life Sciences Inc. A recent study showed supplementation of GanedenBC30 also increases amino acid absorption.
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