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FDA has no objections for GRAS status of BeniCaros carrot-derived immune ingredient

By Stephen Daniells

- Last updated on GMT

© Alvarez / Getty Images
© Alvarez / Getty Images

Related tags carrot immune support Gras status Immune health Upcycling

Netherlands-based NutriLeads has received a letter of no objection from the US Food and Drug Administration (FDA) regarding the Generally Recognized as Safe (GRAS) status of its upcycled immune health ingredient, BeniCaros.

The company filed its GRAS notification with the agency in 2020, according to the Agency’s GRAS Notice Inventory​. The ingredient was officially launched in the US in October 2021.

The GRAS notification covers the used of the carrot-derived ingredient in a range of food and beverage products, including: non-alcoholic beverages and beverage bases, breakfast cereals, dairy product analogs, grain products and pastas, baby food, milk products, processed fruit juices, processed vegetable juices, snack foods, and soup.

BeniCaros is composed of plant-based rhamnogalacturonan-I (RG-I) polysaccharides extracted from carrot pomace.

As reported previously by NutraIngredients-USA​, RG-I may modulate immunity measures and the microbiota in vitro​. Additional data from a proof-of-concept trial in humans showed that RG-I was well tolerated and enhanced innate immune responsiveness.

Subsequent data published in Microorganisms ​(2021, doi: 10.3390/microorganisms9102142​) indicated that the carrot-derived RG-1 may also possess prebiotic potential.

And earlier this year, results from a controlled, randomized, double-blind dose-response study of RG-1 on early innate immune and anti-viral responses following a standardized an attenuated rhinovirus (rhinovirus strain 16, RV16).

Data published in Nutrients​ revealed that daily consumption of BeniCaros prior to the rhinovirus infection significantly accelerated protective innate immune and antiviral responses, resulting in a 20% reduction in severity of symptoms, and a 25% reduction in symptom duration.

Stem & Root, a brand developed by Bayer, recently became the first commercial launch for BeniCaros​ when it announced its new Stem & Root Daily Immunity product.

                                                                                                                                       

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