The Intensive G.I. probiotic formulation by Kaneka has received self-affirmed Generally Recognized as Safe (GRAS) status in accordance with stringent FDA safety guidelines. Intensive G.I. is an IP-protected and patented probiotic formula developed for promoting gut health.
Intensive G.I. is part of the Floradapt Probiotic Portfolio, which are products based on a mechanistic approach to identify optimal strains for specific health applications. Kaneka launched the range at SupplySide West last year.
Mike Kolifrath, Vice President, Sales and Marketing of the Probiotics Division at Kaneka, commented: “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.”
Kaneka said the patented, Non-GMO Floradapt formulations have found much success internationally, with distribution in over 60 countries.
Kaneka's strain library collection has over 1,000+ strains strategically sourced from populations around the world with conserved microbiomes that have not lost their healthy functionality.
Commenting on the GRAS milestone, Dr Fumiki Aoki, Business Development Director, Probiotics Division, explained: 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.”