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Nutrileads’ Novel Immune Ingredient, BeniCaros® Receives No Questions from FDA on GRAS Declaration

April 21, 2022 – Nutrileads has received a letter with no questions from the United States Food and Drug Administration (FDA) regarding their Generally Recognized As Safe (GRAS) application for their revolutionary immune health ingredient, BeniCaros®. The FDA letter states that the agency has no questions to Nutrileads’ application for GRAS status for BeniCaros® for inclusion in Dietary Supplements, Beverages and Functional Foods. 

GRAS is a designation created by the FDA under the Federal Food, Drug and Cosmetic Act. It determines that a new food ingredient or additive has adequate evidence of safety to be consumed under the conditions and dosage of intended use.

Launched in the US in October 2021, BeniCaros® is an award-winning, natural, clinically proven immune health ingredient that trains your immune system to be fit.  BeniCaros® is the commercial name for the unique polysaccharide (fiber), also known as cRG-I (rhamnogalacturonan-I  derived from carrot pomace). A recently published breakthrough clinical trial demonstrated that BeniCaros® improved immune response and resilience in a validated Rhinovirus respiratory infection model. 

Established in 2012, Nutrileads is an innovative health ingredients company that develops and commercializes crop-derived food ingredients with clinically proven health benefits.  NutriLeads’ proprietary ingredients undergo clinical trials to demonstrate their efficacy in improving human health and are taken through regulatory approval for market access before being licensed out to partner companies, that will incorporate the ingredients in their finished products to bring the benefits to consumers. 

What sets Nutrileads apart is their dedication to the scientific discovery of innovative techniques that unlock the health potential of natural foods, meaning that all ingredients developed by the company bring benefits that are science-based.  Living up to this standard means that Nutrileads submitted its GRAS self-affirmed dossier to the FDA for evaluation.  Opening their submission to FDA review and receiving a letter of no questions highlights the confidence that Nutrileads has in the quality of the ingredient and the scientific substantiation behind BeniCaros®.