The company was assisted by Nutrasource subsidiary, GRAS Associates, in the regulatory process
BIO-CAT Microbials has received a "Letter of No Objection" from the FDA regarding the GRAS (generally regarded as safe) status of its Opti-Biome Bacillus subtilis MB40 probiotic, an ingredient for dietary supplements and food products.
GRAS is a regulatory designation set by the FDA which applies to any substance intentionally added to a food, that is not a food additive, colour additive, or prior sanctioned ingredient.
“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. “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.”
GRAS Associates, a Nutrasource subsidiary, assists supplement and food ingredient companies with full service regulatory, claims substantiation, technical label review and testing specifications in delivering customised food and dietary supplement safety solutions for US market access.
“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.”