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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 399

Preparation of Bacillus coagulans strain GBI-30, 6086 spores

Intended Use: As an ingredient in baked goods and baking mixes; beverages and beverage bases; breakfast cereals; chewing gum; coffee and tea; condiments and relishes; confections and frostings; dairy product analogs; fruit juices; frozen dairy desserts and mixes; fruit and water ices; gelatins, puddings, and fillings; grain products and pastas; hard candy; herbs, seeds, spices, seasonings, blends, extracts, and flavorings; jams and jellies; milk; milk products; nuts and nut products; plant protein products; processed fruits; processed vegetables and vegetable juices; snack foods; soft candy; soups and soup mixes; sugar; and sweet sauces, toppings, and syrups at a maximum level of approximately 2 x 109 colony forming units per serving
Basis: Scientific procedures
Notifier: Ganeden Biotech, Inc.
Notifier Address: 5915 Landerbrook Drive, Suite 304
Mayfield Heights, OH 44124
Date of filing: Aug 23, 2011
GRAS Notice (releasable information): GRN 399 (in PDF)
  Part 2: GRN 399 amendments (1.2 MB)
Date of closure: Jul 31, 2012
FDA's Letter: FDA has no questions