The Food and Drug Administration (FDA) of the USA has recognized KANEKA PROBIOTICS’ and AB-BIOTICS conclusion that the patented probiotic strain Lactobacillus plantarum DR7® is Generally Recognized as Safe (GRAS). KANEKA PROBIOTICS’ receipt of a “No Questions Letter” from the FDA supports the use of the patented L. plantarum DR7® strain as an ingredient in conventional foods, allowing formulators to harness its notable benefits on the gut-brain axis with confidence, and without additional safety approvals.
“This regulatory win comes at a time when FDA recognition of GRAS status is more important than ever,” comments Jordi Riera, Chief Business Officer at KANEKA PROBIOTICS “As policymakers are moving to potentially eliminate the self-affirmation process, this FDA “No Questions Letter” brings peace of mind to customers and consumers alike that our probiotic strains meet the highest quality and safety standards, and are well researched for their intended application.”
L. plantarum DR7®: A safe and effective strain for the gut-brain axis
L. plantarum DR7® has been validated by three clinical trials, demonstrating benefits for digestive, respiratory and cognitive health.12 3 In particular, the strain showed strong potential in working along the gut-brain axis in applications for memory, cognitive function and emotional wellbeing. For example, in one randomized, double-blind, placebo controlled clinical study, adults receiving the strain for 12 weeks experienced reduced stress and improved stress response compared to the placebo group.1 A subsequent clinical trial reported that levels of key enzymes involved in the production of neurotransmitters were modulated by L. plantarum DR7®, in ways that may indicate support of beneficial serotonin and dopamine levels.2
“With this robust scientific backing, our L. plantarum DR7® strain offers a valuable tool for formulators of supplements and functional food and beverage,” Riera adds. “The market for cognitive support in these categories is projected to grow annually by more than 10% over the next 5 years, with products that offer benefits regarding stress support receiving particular interest from consumers.4,5The official FDA recognition of the GRAS status for L. plantarum DR7® means that our customers can quickly tap into this demand, without concern regarding the upcoming changes to GRAS legislation.”
To learn more about AB-BIOTICS and KANEKA PROBIOTICS’ probiotic strains and blends for brain health, visit: https://kanekaprobiotics.com/wellness-areas/cognitive-health/
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