GanedenBC30 receives GRAS status for use in infant formulas
Ganeden has announced that GanedenBC30 (Bacillus coagulans GBI-30, 6086) has been granted GRAS status for infant formulas from the U.S. Food and Drug Administration (FDA).
Ganeden has announced that GanedenBC30 (Bacillus coagulans GBI-30, 6086) has been granted GRAS status for infant formulas from the U.S. Food and Drug Administration (FDA). Already used as a probiotic ingredient for functional foods and beverages, GanedenBC30 is now expanding its formulation opportunities into the new space. While the probiotic supplier’s previous FDA GRAS certification covered products that could be fed to infants and children, the newest approval allows the strain to be used specifically in infant formulas.
An independent and critical evaluation was performed reviewing the safety of GanedenBC30 relating to usage in infant formulas. Scientific research on Ganeden’s strain was evaluated and an expert panel unanimously determined that GanedenBC30 is GRAS for use in infant formula. After receiving self-affirmed GRAS in late 2016, the ingredient supplier submitted a notification to the FDA for use in infant formula, which has now received a no objection letter.
“The safety and efficacy of the GanedenBC30 strain continues to be undoubtedly proven through solid science, leading to the receipt of numerous domestic and international certifications and approvals,” said Mike Bush, president of Ganeden. “There are few approvals more stringent than those pertaining to infants, and our certification in infant formula speaks highly to the quality and safety of our strain, and the solid foundation of research behind it.”