Safe for babies: FDA has no objections to GRAS status of Ganeden's BC30 probiotic strain for use in infant formula

By Adi Menayang

- Last updated on GMT

Photo: iStock/Dangubic
Photo: iStock/Dangubic

Related tags Probiotic Infant

The FDA has no objections to Ganeden BC30s GRAS status for use in infant formulas, the company announced this week.

This allows GanedenBC30 to expand its formulation opportunities into 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 the first and only spore-former to be used specifically in infant formulas,”​ the company said.

According to Ganeden, the evaluation was conducted by a panel of safety experts, including the Chair of the Department of Pediatrics at Massachusetts General Hospital, and overseen by AIBMR. Scientific research on Ganeden’s strain was evaluated and the panel unanimously determined that GanedenBC30 is GRAS for use in infant formula.

“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.”

Probiotics have become increasingly popular in infant products as awareness continues to rise around the importance of boosting beneficial bacteria from the start of life.

“Whether a baby is bottle fed, delivered via C-section or has to be put on antibiotics all adversely affect their GI system,” ​said Dr. David Keller, VP of scientific operations. “It is important to build up the good bacteria, and using a proven probiotic strain like GanedenBC30 can aid infants in this process.”

GanedenBC30 has been formulated into more than 550 probiotic foods and beverages worldwide, including a variety of children’s products. The ingredient supplier is now in discussions with leading companies in the infant category to discuss new probiotic developments.