FDA GRAS Ingredients

Kidney C.O.P.® is Formulated with FDA GRAS Approved and Other Safe Ingredients

fda gras ingredients

Generally Recognized As Safe (GRAS) is an U.S. Food and Drug Administration (FDA) designation that a chemical or substance is considered safe by experts.

FDA GRAS ingredients: Three of Kidney C.O.P.®’s five active ingredients are FDA GRAS approved. The fourth, Magnesium, is listed within National Institutes of Health’s Office of Dietary Supplements Fact Sheet along with recommended Daily Values. The fifth ingredient is ground Musa Paradisiaca (banana stems), a natural food consumed throughout the world. 

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Government Documentation on Kidney C.O.P.®’s FDA Generally Recognized As Safe (GRAS) Ingredients can be found in CFR Government Federal Code of Regulations Title 21 – see links below.

Kidney C.O.P.’s® FDA Generally Recognized As Safe (GRAS) Designations and Other Safety Information:

What Are GRAS Ingredients?

Generally Recognized as Safe or GRAS ingredients refer to sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act; it states that all ingredients added to food must be evaluated and approved by the U.S. FDA.

A GRAS ingredient is one that has undergone safety evaluations and has proven not to cause harm when used properly. Once a panel of experts agree the ingredient does not cause harm when used properly, it is added to the list of GRAS ingredients meaning manufacturers can use the ingredient in their products and is safe for consumers.

In addition, a GRAS ingredient is one that has been used regularly before 1958 by a large population, over a sustained period of time, without causing any health issues or negative effects. Ingredients that meet these criteria are considered safe and do not require additional safety evaluations.

GRAS ingredients allow food and dietary supplement manufacturers to produce products that are safe for consumption. If the FDA required food and supplement manufactures to reevaluate an ingredient for for each product with the ingredient, it would be impossible. It would overburden the regulatory agency and stifle innovation.

By creating an approved list of GRAS ingredients, food and supplement manufacturers can provide innovative products (like Kidney C.O.P.®) by using approved GRAS ingredients.