EpiCor Receives No Objection Letter for GRAS Notification

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Ankeny, IA—FDA has responded with a letter of no objection to Cargill’s GRAS notification for EpiCor when used as a postbiotic in certain foods and beverages, according to a press release.

EpiCor is a dried yeast fermentate shown in clinical trials to beneficially modulate the gut microbiota and provide immune system support, the press release states. It is backed by 15 published studies, including eight human clinical trials. The product is heat stable and can handle a range of pH levels. EpiCor is also Non-GMO Project Verified.

“Increasingly, consumers are seeking food and beverages that offer better ways to support their health,” said Chuck Warta, president, Cargill Health Technologies. “Through our work in understanding and influencing the microbiome, Cargill is creating solutions like EpiCor postbiotic that support digestive and immune health at all stages of life and help both people and pets live more healthy days.”

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Postbiotics are an emerging category in this space; the International Scientific Association for Probiotics and Prebiotics (ISAPP) published a consensus statement earlier this month on the definition and scope of postbiotics. The definition—“a preparation of inanimate microorganisms and/or their components that confer health benefits on the host”—includes EpiCor.

“This definition validates EpiCor as a postbiotic,” said Liz Spence, General Manager for EpiCor, in the press release. “Having an internationally recognized definition is an important step in broadly bringing the benefits of postbiotics to consumers. As a leader in postbiotic technology, we are continually investing in research and innovation and EpiCor postbiotic’s GRAS status helps to further demonstrate the safety of this platform.”