CLEVELAND, Ohio (December 10, 2007) – An independent panel of scientists has awarded Ganeden Biotech, Inc. self-affirmed GRAS (Generally Recognized as Safe) status for its patented probiotic, GanedenBC30 (Bacillus coagulans GBI-30, 6086). After an extensive evaluation of research studies and toxicology data, the panel concluded that GanedenBC30 is safe for use as an ingredient in food products. According to the FDA, self-affirmed GRAS status is awarded to any substance that is generally recognized among qualified experts as having been adequately shown to be safe under the conditions of its intended use.
“With so many health benefits and potential applications available for GanedenBC30, licensing partners now have one more level of confidence in the safety of GanedenBC30 as an ingredient,” commented Ganeden’s Founder and Chief Scientist, Sean Farmer. “Achieving GRAS status further supports our commitment to provide superior probiotic bacteria in widely available premium products,” Farmer said.
GanedenBC30 (Bacillus coagulans GBI-30, 6086) is a high-survivability strain of the probiotic, Bacillus coagulans. In addition to food products, GanedenBC30 is currently used in a broad range of applications including dietary supplements, animal health products, feminine hygiene and topical applications. The probiotic cells in GanedenBC30 are able to survive very harsh manufacturing processes, do not require refrigeration and survive gastric acidity. Overall, GanedenBC30 has shown to be heartier than other probiotic strains and exhibits excellent stability, offering more flexibility in manufacturing and delivery systems.
“GanedenBC30 is different from other traditional bacteria because it is surrounded by a natural organic layer that serves as a protective shield against the manufacturing process, shelf life and stomach acids and intestinal bile,” explains Farmer. “Because of this unique make-up, GanedenBC30 survives the hostile environment of the stomach, colonizes the intestines, and produces lactic acid, which are all critical factors to the success of a probiotic. That’s why we initially chose a strain of Bacillus coagulans over other conventional probiotic strains,” explained Farmer.
About Ganeden Labs
Established in 2006, Ganeden Labs is the licensing and development division of Ganeden Biotech, making proprietary, patented probiotic technology available for use in innovative products in a wide range of industries. Ganeden maintains an extensive intellectual property portfolio with patent and trademark protection for an array of technologies all over the world. GanedenBC30 and its related patents are available for license in a wide variety of applications. For more information, visit www.ganedenlabs.com.
About Ganeden Biotech
Founded in 1997, Ganeden Biotech Inc. is a consumer healthcare company based in Cleveland, Ohio that features a popular line of over-the-counter, products under the brand names Sustenex, Digestive Advantage, and Clearly Confident. Ganeden’s oral products including Sustenex and Digestive Advantage contain GanedenBC30, a patented strain of Bacillus coagulans.