US-based consumer healthcare company Ganeden Biotech has received US Food and Drug Administration (FDA) Generally Recognized As Safe (GRAS) status for GanedenBC30 (Bacillus coagulans GBI-30, 6086), a spore-forming probiotic ingredient.
GRAS is an FDA designation which indicates a chemical or substance added to food is considered safe by experts and is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements.
The company noted that GanedenBC30 is the first Bacillus strain to receive GRAS status. It can be used in a several food and beverage categories including baked goods, soup mixes, drink mixes, prepared foods, dairy, confectionary products and nutrition bars.
GanedenBC30 protects the cell's genetic material from the heat and pressure of the manufacturing process. It easily incorporates into products; overcomes shelf life challenges; and withstands the acid and bile to which it's exposed during digestive transit, the company said.
Ganeden Biotech business development president Mike Bush said that GanedenBC30 is safe to ingest at high levels.
"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," Bush added.
