Ganeden gets GRAS no objection from FDA for BC30

02-Aug-2012 - Last updated on 03-Aug-2012 at 11:52 GMT

The US Food and Drug Administration (FDA) has said it has no objections to the Generally Recognized As Safe (GRAS) status of Ganeden’s BC30 strain (Bacillus coagulans GBI-30, 6086) for use in food and beverage.

The ingredient was self-affirmed in 2007 and re-affirmed in 2010. The submission to FDA was made in 2011 with the guidance of the AIBMR Life Sciences, Inc.

“What separates GanedenBC30 from other spore forming probiotics is not just the FDA’s stamp of approval, which very few probiotics have, but the fact that it is safe to ingest at such high levels,” said Mike Bush, Vice President of Business Development, Ganeden Biotech.

“We expect many companies both within and outside of the U.S. market to fast track their product development based on the FDA GRAS approval.”

Dr David Keller, VP of scientific operations of Ganeden Biotech, added: “The FDA’s No Objection letter affirms all of the time, the quality work and the extensive research put into demonstrating the safety of GanedenBC30.”

The strain

BC30 has significant advantages over rival probiotic strains in food and beverage applications owing to its unique ability to withstand extremes of temperature and harsh processing techniques.

BC30 is a spore-forming bacterium, which means that inside the bacterial cell is a hardened structure, or spore, a bit like a seed. This safeguards the cell’s genetic material from the heat and pressure of manufacturing processes, stomach acid and bile.

The ingredient is already used in more than 60 foods and numerous beverage categories including: baked goods, soup mixes, drink mixes, prepared foods, dairy, confectionary products and nutrition bars, said the company.

Model for the industry?

John Endres, ND, Chief Scientific Officer, AIBMR Life Sciences, and full member of the Society of Toxicology and lead panel expert for the GanedenBC30 GRAS self determination and FDA notification said: “Through their tremendous commitment to science and safety, Ganeden Biotech is a model for the probiotic and functional foods industries.”