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®.

Alexander Belderok is a Senior Partner at Roland Berger. He focuses on strengthening the competitive position of companies in the Food, Agri, Food Ingredients, Biotech and the fine Chemicals Industry. He has specific functional expertise in the area of business and corporate strategy development, operations, organizational restructuring, innovation, and complexity management.

Alexander has five years of industry experience in flavors, fragrances and food ingredients and over twenty years of consulting experience. He began his career at Unilever and has worked at Roland Berger since 2006.

He studied both Mechanical Engineering and Business Administration at the University of Twente, Business-to-Business Marketing at IMD and in the Advanced Management Program at Harvard. Next to that he participated in the European Comenius Course.

Florentine is an investment partner at SHIFT Invest, a Dutch Venture Capital Fund backed by (amongst others) Rabobank, Menzis and Wageningen University & Research, and EIF.

She started her career at Rabobank where she worked in various positions before joining SHIFT in 2014. In the first years of her career, Florentine gained valuable experience including debt restructuring and private equity. At SHIFT, Florentine is dedicated to backing companies that are on a mission to create positive change, both environmental and health related. Besides Nutrileads, she is responsible for the investment in GreenA and serves on the boards of Changing Health Ltd. and The Renewal Workshop Inc.

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

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