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KANEKA’S Baby Colic Probiotic Formulation

By on May 24, 2020

Self-Affirmation GRAS Confirms Its Safety for Use in Dietary Supplement for Infants

Newark, CA — Kaneka Americas Holding, Inc., has successfully achieved the self-affirmed Generally Recognized as Safe (GRAS) status for its Baby Colic product, in accordance with stringent U.S. Food and Drug Administration (FDA) safety guidelines. The Baby Colic formulation safety was demonstrated to the expert panel through a combination of published clinical trials, phenotypic data, and genotypic analysis. Published clinical trials for the strains and species were evaluated for evidence of safety and the absence of adverse effects.

Screen Shot 2020 05 24 at 7.42.00 PM 645x1024 - KANEKA’S Baby Colic Probiotic Formulation

Mike Kolifrath, Vice President, Sales and Marketing of the Probiotics Division at Kaneka, commented, “GRAS determinations are based on rigorous scientific procedures. We are proud to inform the industry that the safety of the Baby Colic product has been reviewed by experts, qualified by both scientific training and experience to evaluate the safety of these clinical strains”. 

Baby Colic is a clinically studied probiotic combination of two strains that specifically helps to reduce the duration of crying episodes and promote infant gut health.  Tested in both breast-fed and formula-fed infants, the strains used in the Baby Colic formula were initially isolated via a screening process specifically designed to identify strains that have a beneficial effect on infant intestinal health while also showing the ability to adhere to the gut and provide microflora balance. Unlike some other strains, Baby Colic probiotics are not gas-producing in the intestine, based on in vitro studies.

Baby Colic is part of the Floradapt™ Probiotic Portfolio, which are products based on a mechanistic approach to identify optimal strains for specific health applications. Our strain library collection has over 1,000+ strains strategically sourced from populations around the world with conserved microbiomes.  Floradapt™ includes strains for Cardio, Digestive, Intensive G.I., Gum Health, Mature Immune Defense, Vaginal Health, and Urinary Tract. Floradapt’s efficacy is rooted in its clinical strains and accomplished through a unique mechanism of action (MoA) not seen in other probiotic products.

Kaneka has once again created a probiotic product that speaks directly to the dietary supplement consumer.  Kaneka is committed to promoting business development to provide solutions that support healthy and energetic lives.

About Kaneka

Kaneka is a leader in the development of scientifically based ingredients for the global nutrition industry, committed to promoting business development to provide solutions that support healthy and energetic lives. For more information, visit us at http://www.floradapt.com.