The formulation safety of Baby Colics has been demonstrated to be GRAS an expert panel through a combination of published clinical trials, phenotypic data, and genotypic analysis
Photo as seen on company website
Kaneka Americas Holding has successfully achieved the self-affirmed Generally Recognized as Safe (GRAS) status for its Baby Colic product. The status is in accordance with stringent US 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.
Mike Kolifrath, VP of Sales and Marketing for the Probiotics Division at Kaneka, said: “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.”
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 breastfed 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. Floradapt includes strains for Cardio, Digestive, Intensive GI, 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.