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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
FDA's Letter: Pending