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    Breaking News

    EpiCor Postbiotic Receives ‘No Objection’ from FDA for GRAS Notification

    The letter of no objection verifies the safety and tolerability of EpiCor as an ingredient in certain foods and beverages.

    EpiCor Postbiotic Receives ‘No Objection’ from FDA for GRAS Notification
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    Mike Montemarano, Associate Editor 05.20.21
    Ingredients supplier Cargill recently announced that the U.S. Food and Drugs Administration has responded to its GRAS notification for the postbiotic ingredient EpiCor with a letter of no objection, providing verification of the ingredient’s safety and tolerability when incorporated into certain foods and beverages.
     
    EpiCor postbiotic is a dried yeast fermentate which has been shown in human clinical trials to beneficially modulate the gut microbiota in ways that support healthy immune function. As a first-of-its-kind ingredient, the letter of no objection enables food and beverage manufacturers to incorporate EpiCor into their products.
     
    “Increasingly, consumers are seeking food and beverages that offer better ways to support their health,” Chuck Warta, president of Cargill Health Technologies, said. “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.”
     
    Postbiotics are an emerging category in the immune and gut health space, and, earlier this month, the International Scientific Association for Probiotics and Prebiotics (ISAPP) published a consensus statement on the definition and scope of postbiotics in the Nature Reviews Gastroenterology and Hepatology journal. They define postbiotics as “a preparation of inanimate microorganisms and/or their components that confer health benefits on the host.”
     
    “This definition validates EpiCor as a postbiotic. Having an internationally recognized definition is an important step in broadly bringing the benefits of postbiotics to consumers,” Liz Spence, general manager for EpiCor, said. “As a leader in postbiotic technology, we are continually investing in research and innovation and EpiCor postbiotics’s GRAS status helps to further demonstrate the safety of this platform.”
     
    EpiCor has been the subject of 15 published studies, including eight human clinical trials, which support EpiCors’ ability to confer digestive and immune health benefits.
     
    Some advantages that come with the use of postbiotics such as EpiCor include formulation stability – because a postbiotic is not a live organism, it is highly heat-stable and can handle a wider range of pH levels.
     
    Cargill also received Non-GMO Project Verification for EpiCor postbiotic. “For brands looking to position their offerings in today’s health-conscious environment, EpiCor postbiotic has much to offer,” Spence said. “Its Non-GMO Project Verification adds another layer of credibility to a trusted product, with clinically-shown immune and digestive health benefits in dietary supplements.”



    Mike Montemarano has been the Associate Editor of Nutraceuticals World since February 2020. He can be reached at mmontemarano@rodmanmedia.com.
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