Ganeden BC30 Granted GRAS for Infant Formulas

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Ganeden BC30 (Bacillus coagulans GBI-30, 6086) led the pack when it became the first Bacillus strain to receive Generally Recognized As Safe (GRAS) recognition from FDA for use in adult foods and beverages, and now the probiotic strain is making another first. Ganeden (Cleveland) announced last month that its probiotic strain has now become the first and only spore-forming probiotic to be recognized as GRAS for use specifically in infant formulas.

Ganeden explains that a panel of safety experts, including the chair of the Massachusetts General Hospital Department of Pediatrics, and overseen by AIBMR (Seattle), performed the evaluation of the probiotic strain’s enhanced GRAS status. Based on the research on Ganeden BC30, the panel unanimously determined the probiotic should be granted self-affirmed GRAS status. A notification of the GRAS status was then submitted to FDA, which has now issued a “no objections” letter in response to the GRAS notification.

“The safety and efficacy of the Ganeden BC30 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.”

Ganeden adds that while Ganeden BC30 already appears in more than 550 probiotics foods and beverages worldwide, including many children’s products, the new GRAS notification allows it to be used in infant formulas specifically. As probiotics have become increasing popular in infant products, the firm believes this regulatory approval will open up further formulation opportunities for Ganeden BC30.

“Whether a baby is bottle fed, delivered via C-section, or has to be put on antibiotics, all adversely affect their GI system,” said David Keller, vice president of scientific operations for Ganeden. “It is important to build up the good bacteria, and using a proven probiotic strain like Ganeden BC30 can aid infants in this process.”

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Michael Crane
Associate Editor
Nutritional Outlook Magazine
michael.crane@ubm.com