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kidney cop calcium oxalate protector
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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. 

supplements to reduce oxalates

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:

  • Citric Acid | 21 CFR 184.1033

  • Magnesium Citrate | Magnesium Dietary Supplement DV

  • Inositol (IP6) (Phytin) Phytic Acid | 21 CFR 184.1370

  • Pyridoxine Hydrochloride | 21 CFR 184.1676

  • Ingredient Five (Common Food Item) | Musa paradisiaca, banana stems

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.

 

Calcium Oxalate Crystal Quick Links:

  • What Are Calcium Oxalate Crystals?
  • Calcium Oxalate Crystals and the Urinary Tract
  • Types of Calcium Oxalate Crystals
  • What Do Calcium Oxalate Crystals Look Like?
  • What Causes Calcium Oxalate Crystals?
  • Prevalence and Recurrence of Calcium Oxalate Crystals
  • Calcium Oxalate Crystal Risk Factors
  • Low Oxalate Reduction Diet
  • Importance of Hydration
  • Questions and Answers

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Also Available for Purchase at Amazon.com and Walmart.com

Paid link above. As an Amazon Associate, Calcium Oxalate Labs earns from qualifying purchases.

*In vitro tests show that patented formula inhibits the rate of calcium oxalate crystal growth by 99%. Kidney C.O.P.® Patent: Compositions and methods to inhibit kidney stone growth.

**These statements have not been evaluated by the Food & Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

***Kidney C.O.P.® patented formulation contains clinically researched ingredients. Each active ingredient in Kidney C.O.P. (or a combination of the ingredients) have been clinically tested and shown, to varying degrees of potential, to inhibit the rate of calcium oxalate crystal growth.

****Many of Kidney C.O.P.’s active ingredients (or combination of) have been tested in clinical studies & have shown to have an effect inhibiting calcium oxalate crystal growth. Many of these clinical studies are found in the five patents: 9,233,135; 9,492,491; 9,623,006; 9,789,152; 10,471,115 – pgs 1 – 3 of each patent.

Caution: If you are pregnant, nursing, taking any medications or planning any medical procedure, consult your doctor before use. Discontinue use and consult your doctor if any adverse reactions occur.

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