Kaneka’s Intensive G.I. probiotic formulation now self-affirmed GRAS

January 8, 2020

Safety was demonstrated through a combination of genotypic analysis, phenotypic data, and published clinical trials.

Kaneka Americas Holding Inc. announced that its Intensive G.I. probiotic formulation is now self-affirmed GRAS (generally recognized as safe). According to Fumiki Aoki, PhD, business development director for Kaneka’s probiotics division, safety was demonstrated 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,” explained Aoki, in a press release. “Published clinical trials for the strains and species were evaluated for evidence of safety and the absence of adverse effects.”

“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,” said Mike Kolifrath, vice president, sales and marketing of Kaneka’s probiotics division, in a press release. “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.”