F.D.A. has no objection to probiotic's GRAS status

by Jeff Gelski
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CLEVELAND — Ganeden Biotech has received notice from the Food and Drug Administration that the F.D.A. has no questions or objections to the Generally Recognized As Safe (GRAS) status of GanedenBC30 (Bacillus coagulans GBI-30, 6086) for use as an ingredient in a range of foods and beverages.

GanedenBC30, a spore-forming probiotic ingredient, is the first Bacillus strain to receive GRAS status, according to Cleveland-based Ganeden Biotech. The company spent six years developing and implementing trials before filing a GRAS notice with the F.D.A. on Aug. 11, 2011.

The GRAS notice states GanedenBC30 may be used in baked goods and baking mixes; alcoholic beverages; beverages and beverage bases; breakfast cereals; chewing gum; coffee and tea; condiments and relishes; confections and frostings; dairy product analogs; fats and oils; fruit juices; frozen dairy desserts and mixes; fruit and water ices; gelatins, puddings and fillings; grain products and pastas; hard candy and cough drops; herbs, seeds, spices, seasonings, blends, extracts and flavorings; jams and jellies; milk; milk products; nuts and nut products; plant protein products; processed fruit; processed vegetables and vegetable juices; snack foods; soft candy; soups and soup mixes; sugar; and sweet sauces, toppings and syrups.

Ganeden Biotech reached a self-affirmed GRAS determination for GanedenBC30 in 2007 and then began selling it as an ingredient for foods and beverages. GanedenBC30 now is found in more than 60 foods and numerous beverage categories, including baked foods, soup mixes, drink mixes, prepared foods, dairy, confectionery products and nutrition bars.

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