8 companies of over-the-counter (OTC) chelation products were told that they are selling unapproved drugs and devices and are violating federal law with respect to unproven claims about these products.

These products purport to treat a range of diseases by removing toxic metals from the body. Some also claim to treat autism spectrum disorder, cardiovascular diseases, Parkinson’s disease, Alzheimer’s disease, macular degeneration, and other serious conditions.

Here are the companies and products involved in the FDA warning.

  • World Health Products, LLC:
    • Detoxamin Oral, Detoxamin Suppositories, and the Metal Detector test kit
  • Hormonal Health, LLC and World Health Products, LLC:
    • Kelatox Suppositories, and the METALDETECTOR Instant Toxic Metals Test
  • 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
  • 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
  • Cardio Renew, Inc:
    • CardioRenew and CardioRestore
  • Artery Health Institute, LLC:
    • Advanced Formula EDTA Oral Chelation
  • Longevity Plus:
    • Beyond Chelation Improved, EndoKinase, Viral Defense, Wobenzym-N
  • Dr. Rhonda Henry:
    • Cardio Chelate (H-870)

Some companies that received the warning letters also claim their products detect the presence of heavy metals to justify the need for chelation therapy.

The bottom line?

There are no FDA-approved OTC chelation products.

The key point is “OTC.”  Chelation is serious treatment that must be carefully monitored. It’s not something you do on your own.

For example, chelation is used as part of a comprehensive approach to lead poisoning in children, which also includes a thorough environmental investigation and laboratory testing as needed,

10/15/10 16:10 JR

Hi, I’m JR

John Russo, Jr., PharmD, is president of The MedCom Resource, Inc. Previously, he was senior vice president of medical communications at www.Vicus.com, a complementary and alternative medicine website.