FDA has no objections to GRAS status of Ganeden’s new probiotic-derived ingredient Staimune

The new ingredient Staimune is based off Ganeden’s patented probiotic BC30 strain, utilizing the cells of the probiotic to support immune health. The no objections letter from FDA was received in March of this year​​, and the ingredient will be available later this summer.

Described as “Inactivated Bacillus coagulans GBI-30, 6086”,​ Staimune was developed to be easily included in functional foods and beverages, especially in shelf-stable beverages and high-water-activity products. “Staimune is FDA GRAS, non-GMO, organic compliant and kosher, making it extremely accessible for use in a vast amount of applications,”​ according to the company.

There have been multiple peer-reviewed and published studies showing the immune health benefits of GanedenBC30 cells, claims Ganeden. In vitro and human clinical studies on the Staimune ingredient itself are currently underway.

“After seeing the impressive immune supporting benefits of GanedenBC30, we decided to dive further into the mechanism of action,”​ said Michael Bush, president and CEO of Ganeden. “We discovered and ultimately patented this novel ingredient which provides the opportunity to share the immune benefits of the probiotic in product formats that do not support the use of the live organism.” ​

50mg of the ingredient is needed in a product to be effective, according to the company, and Staimune was designed to not alter the flavor or texture profiles of finished goods.

“Staimune provides the option for manufacturers that want to focus specifically on immune health, and for those with processes that cause formulation challenges for live probiotics,”​ the company added.