Safety Alerts & Recalls

What does this mean?

Consumers should avoid non-prescription products offered for chelation or detoxification. Relying on unproven OTC chelation products to treat serious conditions such as heart and blood vessel disease may delay or interfere with proven, sometimes essential medical care. There are concerns that use of unapproved chelation products may result in serious side effects such as dehydration, kidney failure, and death.

Please speak to your healthcare professional to discuss any concerns you have about your medical condition or if you think you have suffered side effects from a chelating agent.

FDA Provides Answers to Common Questions About Unapproved Chelation Products

The U.S. Food and Drug Administration (FDA) warns consumers to be wary of so-called "chelation" products that are marketed over-the-counter (OTC) to prevent or treat diseases. Companies are marketing unapproved OTC chelation therapy products to patients with serious and incurable diseases. The FDA says the companies have not proven their products are safe and effective in treating autism spectrum disorder, cardiovascular disease, macular degeneration, Parkinson's disease or any other serious illness. Some of the companies also claim their products can detect the presence of heavy metals in the body in an attempt to justify the need for chelation therapy.

The FDA has sent letters to warn the following companies that they are facing possible legal action if they continue to make unsupported claims about the listed chelation products they market: 1) World Health Products, LLC: Detoxamin Oral, Detoxamin Suppositories, and the Metal Detector test kit

2) Hormonal Health, LLC and World Health Products, LLC: Kelatox Suppositories, and the METALDETECTOR Instant Toxic Metals Test

3) Evenbetternow, LLC: Kids Chelat Heavy Metal Chelator, Bio-Chelat Heavy Metal Chelator, Behavior Balance DMG Liquid, AlkaLife Alkaline Drops, NutriBiotic Grapefruit Seed Extract, Natur-Leaf, Kids Clear Detoxifying Clay Baths, EBN Detoxifying Bentonite Clay, and the Heavy Metal Screen Test

4) Maxam Nutraceutics/Maxam Laboratories: PCA-Rx, PC3x, AFX, AD-Rx, AN-Rx, Anavone, AV-Rx, BioGuard, BSAID, CF-Rx, CreOcell, Dermatotropin, Endotropin, GTF-Rx, IM-Rx, Keto-Plex, Natural Passion, NG-Rx, NX-Rx, OR-Rx, Oxy-Charge, PN-Rx, Ultra-AV, Ultra Pure Yohimbe, and the Heavy Metal Screening Test

5) Cardio Renew, Inc: CardioRenew and CardioRestore

6) Artery Health Institute, LLC: Advanced Formula EDTA Oral Chelation

7) Longevity Plus: Beyond Chelation Improved, EndoKinase, Viral Defense, Wobenzym-N

8) Dr. Rhonda Henry: Cardio Chelate (H-870)

To view the FDA's Questions and Answers web page, please visit: more information here

For more information, please visit: more information here

Source: FDA
Publication Date: 2010-10-15
Last Updated: 2010-10-23

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