04.28.22
Ingredient supplier NutriLeads received a letter from the U.S. Food and Drug Administration (FDA) after submitting a Generally Recognized as Safe application to the agency for its immune health ingredient marketed as BeniCaros.
The FDA letter stated that the agency has no questions regarding the safety of the immune health ingredient for use in dietary supplements, beverages, and functional foods. GRAS is a designation created under the Federal Food, Drug, and Cosmetic Act which determines that a new food or ingredient already has adequate evidence of safety to be consumed under the conditions and dosage of intended use.
BeniCaros is a fiber unique to carrot pomace, known as cRG-1, which has been studied for its role in supporting healthy immune function. A study published in Nutrients in January concluded that BeniCaros improved immune response and resilience to rhinovirus (the common cold) in a group of 177 individuals.
BeniCaros was launched in 2021, and prior to the human clinical trial, was also the subject of pre-clinical and in vitro research which provided supporting evidence for the ingredient’s immune function claims. It is believed to exert beneficial effects by inducing helpful changes to the gut microbiota, with one change being an increase in the production of short-chain fatty acids.
The FDA letter stated that the agency has no questions regarding the safety of the immune health ingredient for use in dietary supplements, beverages, and functional foods. GRAS is a designation created under the Federal Food, Drug, and Cosmetic Act which determines that a new food or ingredient already has adequate evidence of safety to be consumed under the conditions and dosage of intended use.
BeniCaros is a fiber unique to carrot pomace, known as cRG-1, which has been studied for its role in supporting healthy immune function. A study published in Nutrients in January concluded that BeniCaros improved immune response and resilience to rhinovirus (the common cold) in a group of 177 individuals.
BeniCaros was launched in 2021, and prior to the human clinical trial, was also the subject of pre-clinical and in vitro research which provided supporting evidence for the ingredient’s immune function claims. It is believed to exert beneficial effects by inducing helpful changes to the gut microbiota, with one change being an increase in the production of short-chain fatty acids.
