Kaneka Americas Holding, Inc., has successfully obtained self-affirmed Generally Recognized as Safe (GRAS) status for its Baby Colic product, in accordance with FDA safety guidelines. The formulation’s safety was demonstrated to an expert panel through a combination of published clinical trials, phenotypic data, and genotypic analysis, the company said. Published clinical trials for the strains and species were evaluated for evidence of safety and the absence of adverse effects.
 
“GRAS determinations are based on rigorous scientific procedures,” said Mike Kolifrath, vice president, sales and marketing of the Probiotics Division at Kaneka. “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. The company’s 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.