Kaneka Probiotic Formula Self-Affirmed GRAS

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Newark, CA—Kaneka Americas Holding, Inc., announced in a press release that the company’s Intensive G.I. probiotic formulation has received self-affirmed Generally Recognized as Safe status in accordance with FDA safety guidelines.

Intensive G.I. is part of the Floradapt Probiotic Portfolio, products based on a mechanistic approach to identify optimal strains for specific health applications, according to the release.

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Dr. Fumiki Aoki, Business Development Director of the Probiotics Division, said in the release: “Safety was demonstrated to the expert panel through a combination of genotypic analysis, phenotypic data, and published clinical trials. Whole Genome Sequencing was performed to establish the identity of the strains and allow the use of bioinformatics for genomic analysis, which demonstrated the absence of a genetic basis for any safety concerns. Published clinical trials for the strains and species were evaluated for evidence of safety and the absence of adverse effects.”

Mike Kolifrath, VP Sales & Marketing of the Probiotics Division at Kaneka, added: “We are committed to establishing Kaneka’s Floradapt probiotic portfolio as one of the most innovative and efficacious products for a variety of health targets, as supported by scientific evidence. This milestone significantly advances our leadership in the probiotic space and will offer our Intensive G.I. formula access to consumer brands searching for G.I. probiotics with unique mechanisms of action, while removing any doubts on the safety and benefits of the strains.”

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