Bio-Cat Microbials announced GRAS status of its Opti-Biome probiotic strain

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Bio-Cat Microbials LLC has received a “Letter of No Objection” from the U.S. Food and Drug Administration (FDA) regarding the company’s GRAS (generally recognized as safe) notice for its Opti-Biome Bacillus subtilisMB40 probiotic. The ingredient is highly concentrated and shelf-stable for dietary supplements and food applications.

“Regulatory compliance and safety are non-negotiable values at Bio-Cat Microbials. To ensure we were able to efficiently navigate the GRAS submission and approval process, we knew it would be beneficial to augment our efforts with incremental expertise,” said Elaine Cooling, Compliance Director, Bio-Cat Microbials, in a press release. “It was the Nutrasource GRAS Associates that helped guide us through the process and proved to be the right partner as evidenced by our recent non-objection letter from the FDA for our Opti-Biome Bacillus subtilis MB40.”

“Supporting and assisting our customers to success is paramount,” said William Rowe, Nutrasource President and CEO. “That is why at Nutrasource/GRAS Associates LLC, we focus on providing strong capabilities, and a very talented team to ensure our customers achieve their goals of compliance, authorization or approvals through quality FDA dossier development and submissions.”