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The US Food and Drug Administration (FDA) 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.[i],[ii],[iii] 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.[iv],[v] The 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/
[i] Chong, H. X., et al. (2019). Lactobacillus plantarum DR7 alleviates stress and anxiety in adults: a randomised, double-blind, placebo-controlled study. Beneficial microbes, 10(4), 355-374.
[ii] Liu, G., et al. (2020). Lactobacillus plantarum DR7 modulated bowel movement and gut microbiota associated with dopamine and serotonin pathways in stressed adults. International journal of molecular sciences, 21(13), 4608.
[iii] Chong, H. X., et al. (2019). Lactobacillus plantarum DR7 improved upper respiratory tract infections via enhancing immune and inflammatory parameters: A randomized, double-blind, placebo-controlled study. Journal of dairy science, 102(6), 4783-4797.
[iv] Grand View Research (2023). Brain Health Functional Food And Beverage Market Size, Share & Trends Analysis Report By Ingredient (Choline, Curcumin), By Product (Dairy, Bakery), By Distribution Channel (Specialty Stores, Online), And Segment Forecasts, 2023 - 2030. Available at: Brain Health Functional Food And Beverage Market Report 2030
[v] Grand View Research (2023). Brain Health Supplements Market Size, Share & Trends Analysis Report by Product (Natural Molecules, Vitamins & Minerals), by Application (Memory Enhancement, Attention & Focus), by Region, and Segment Forecasts, 2023 – 2030. Available at: Brain Health Supplements Market Size & Growth Report, 2030
About Kaneka Probiotics
The Kaneka Probiotics portfolio includes formulations for Immune, Upper Respiratory Tract, Digestion, GI Health, Oral-Gum Health, Baby Colic, Women’s, Gut-Brain Axis, Cardiovascular, and Stress/Mood/Anxiety. Kaneka Probiotics is committed to quality, innovation & science and have 20+ studies that are ongoing for areas in Sports Nutrition, Gut Health [or Permeability], Nutrition Absorption, Halitosis, and many other disciplines.
About AB-BIOTICS
Barcelona based AB-BIOTICS is a leading manufacturer of forward-looking biotic solutions. A company of the KANEKA Group, AB-BIOTICS focuses on research, development and distribution of clinically documented, natural probiotic strains targeting specific therapeutic areas. The company leverages its global footprint to provide a unique view of the ever-changing probiotic landscape, regulatory support in supplements, functional foods, OTC and medical application.