Nebraska Cultures Inc., Walnut Creek, CA, has obtained GRAS (Generally Recognized As Safe) status for its ProDURA strain of Bacillus coagulans. 

Nebraska Cultures is the exclusive supplier of ProDURA, a highly resilient probiotic that has been shown to aid in digestion, discourage bacterial, yeast and fungal infections, and may contribute to lowering cholesterol levels in the blood.

“Achieving GRAS status for ProDURA’s Bacillus coagulans assures our customers and public consumers that they can safely use this probiotic strain to provide significant digestive health benefits,” explained Michael Shahani, director of operations for Nebraska Cultures. “ProDURA has become more popular as it has demonstrated significantly higher levels of thermal-resistance than other strains of Bacillus coagulans, which seem to be more susceptible to the rigors of manufacturing, processing, shipping, storage, and importantly, the digestive tract. This provides our customers with even more confidence going forward.”

Following an independent, critical evaluation, the GRAS expert panel unanimously agreed to the decision. The expert panelists, consisting of Robert Martin, PhD, Douglas Archer, PhD, and Madhusudan G. Soni, PhD, FACN, FATS, used available qualitative and quantitative scientific evidence, including human and animal data, to determine the safety of ProDURA.

GRAS status was granted for Nebraska Cultures’ Bacillus coagulans by meeting the FDA’s criteria for “reasonable certainty of no harm” for the following food uses: baked goods and baking mixes; beverages and beverage bases; breakfast foods; chewing gum; condiments and relishes; confections and frostings; dairy product analogs; fruit juices; frozen dairy desserts and mixes; fruit and water ices; gelatins, puddings, and fillings; grain products and pastas; hard candy; herbs, seeds, spices, seasonings, blends, extracts, and flavorings; jams and jellies; milk; milk products; nuts and nut products; plant protein products; processed fruits; processed vegetables and vegetable juices; snack foods; soft candy; soups and soup mixes; sugar; and sweet sauces, toppings, and syrups.

ProDURA’s durable thermal-resistance comes from a spore forming bacterium with a naturally protective coating that stays dormant until it meets the perfect conditions of heat, pH, and moisture found in the large intestine. It survives at temperatures up to 110°C with almost no loss in potency, so it can be used in processed food, softgel, and gummy applications. With stability at very low pH conditions, ProDURA can deliver higher counts to the digestive tract.

“Our clients are enjoying the freedom that ProDURA provides over some of the more traditional, and fragile, probiotics in the market,” Shahani added. “We’ve even got people working in extrusion applications, such as pet treats, food bars, and snacks. We are excited to support them with this new level of recognition, and will continue to invest in more science to aid in their success.”