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U.S. Department of Health and Human Services

GRAS Notices
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GRN No. 1177

Bacillus coagulans Unique IS-2 spore preparation

Intended Use: Intended for use as an ingredient in powder, liquid concentrate, and ready-to-feed, soy- and milk-based, non-exempt infant formula for term infants at a maximum use level of 2 x 108 colony forming units/100 mL infant formula as consumed.
Basis: Scientific procedures
Notifier: Unique Biotech Limited, India
Notifier Address: Plot No. 2, Phase-II, M.N. Park
Kolthur Village, Shameerpet Mandal
Medchal Malkajgiri District
Hyderabad, Telangana 500 101
India
GRAS Notice (releasable information): GRN 1177 with amendments (in PDF) (7.4 MB)
Date of closure: Jul 5, 2024
FDA's Letter: FDA has no questions (in PDF) (214 kB)
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