Pasadena, TX—Kaneka Probiotics has completed the self-affirmation process to qualify its Floradapt BrainLactobacillus plantarum DR7 as Generally Recognized as Safe (GRAS) in accordance with FDA guidance regarding independent GRAS conclusions, according to a press release.

DR7 is intended to work along the gut-brain axis, promoting healthy brain metabolism by upregulating the Tryptophan-Serotonin pathway, which it does by driving the tryptophan metabolic pathway towards serotonin, instead of towards the kyneurine degradation pathway. The Tryptophan-Kyneurine pathway is associated with weaker immunity, as well, meaning that shifting tryptophan away from this pathway may help prevent the weakening of the immune system.

The GRAS Panel concluded that DR7 is not harmful under the conditions of its intended use after reviewing a combination of published clinical trials, phenotypic data, and genotypic analysis, the press release states. Published clinical trials for the strain and species were evaluated for safety evidence.

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Mike Kolifrath, Vice President, Sales and Marketing of the Probiotics Division at Kaneka, commented in the press release: “The neurochemistry of the brain is one of the most exciting new playgrounds of probiotics. We have the most competent strain in the gut-brain axis field with L. plantarum DR7, based on its unique ability to impact the biosynthesis of serotonin. The conclusion of the GRAS panel that Lactobacillus plantarum DR7 is GRAS under the conditions of its intended use is confirmation of the quality, safety and scientific rigor behind our proprietary DR7 strain.

L. plantarumis gluten-free, and is not genetically engineered.