The product is a combination of two proprietary strains of Pediococcus pentosaceus and Bifidobacterium longum that the company says have been shown to reduce the duration of crying episodes and promote infant gut health.
The self affirmed GRAS process allows companies to form their own scientific review panels. While the evidence of safety is supposed to meet the same standard as those of submission evaluated by the US Food and Drug Administration itself, the self affirmation process does not require a submission to FDA.
According to Kaneka Americas Holding, Inc. (the Japanese company’s American entity), the Baby Colic formulation, which is part of the company’s Floradapt line of probiotics, was demonstrated to the expert panel to be safe 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.
“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,” said Mike Kolifrath, vice president of sales and marketing for Kaneka’s Probiotics Division.