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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 660

Bacillus coagulans GBI-30, 6086 spores

Intended Use: Ingredient in non-exempt powdered and liquid infant formulas for term infants (infant formula) at levels up to 2 x 10^8 colony forming units (CFU) per 100 milliliters (mL) infant formula as consumed.
Basis: Scientific procedures
Notifier: Ganeden Biotech, Inc.
Notifier Address: 5800 Landerbrook Drive, Suite 300; Mayfield Heights, Ohio 44124
Date of filing: Aug 16, 2016
GRAS Notice (releasable information): GRN 660 (in PDF) (3.6 MB)
Date of closure: Jan 13, 2017
FDA's Letter: FDA has no questions (in PDF) (81 kB)
Notes: Infant formula uses. Same strain at GRN 399, though not a spore, and for use in infant formula (not covered in GRN 399)