Mike Montemarano, Associate Editor 04.14.21
BIO-CAT Microbioals, LLC announced that it has received a “Letter of No Objection” from the U.S. Food and Drug Administration (FDA) regarding the GRAS (generally recognized as safe) status of its probiotic product OPTI-BIOME, sourced from the Bacillus subtilis MB40 strain, for use in dietary supplements and food products.
AS a regulatory designation set by the FDA, GRAS applies to any substance intentionally added to a food, which is not a food additive, color additive, or prior sanctioned ingredient. GRAS status becomes more valuable as the food industry continues to grow and new ingredients are being investigated.
“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,” Elaine Cooling, compliance director, BIO-CAT Microbials, said. “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 to achieve safety compliance for U.S. market access.
“Supporting and assisting our customers to success is paramount,” William Rowe, Nutrasource president and CEO, said. “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.”
“This letter of no objection opens the door to more formulation options, including functional foods and beverages,” BIO-CAT CEO and co-founder Chris Schuler said in a company release.
Mike Montemarano has been the Associate Editor of Nutraceuticals World since February 2020. He can be reached at mmontemarano@rodmanmedia.com.
AS a regulatory designation set by the FDA, GRAS applies to any substance intentionally added to a food, which is not a food additive, color additive, or prior sanctioned ingredient. GRAS status becomes more valuable as the food industry continues to grow and new ingredients are being investigated.
“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,” Elaine Cooling, compliance director, BIO-CAT Microbials, said. “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 to achieve safety compliance for U.S. market access.
“Supporting and assisting our customers to success is paramount,” William Rowe, Nutrasource president and CEO, said. “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.”
“This letter of no objection opens the door to more formulation options, including functional foods and beverages,” BIO-CAT CEO and co-founder Chris Schuler said in a company release.
Mike Montemarano has been the Associate Editor of Nutraceuticals World since February 2020. He can be reached at mmontemarano@rodmanmedia.com.
