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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 725

Inactivated Bacillus coagulans GBI-30, 6086

Intended Use: For use as an ingredient in non-exempt term infant formula at levels up to 2 x 108 CFU inactivated cells per 100 mL of infant formula as consumed.
Basis: Scientific procedures
Notifier: Ganeden Biotech, Inc.
Notifier Address: 5800 Landerbrook Drive, Suite 300 Mayfield Heights, OH, 44124
GRAS Notice (releasable information): GRN 725 (in PDF) (5.2 MB)
Date of closure: Feb 12, 2018
FDA's Letter: FDA has no questions (in PDF) (52 kB)