FDA Warns Against Over the Counter Chelation

The FDA warned eight companies that market over-the-counter (OTC) chelation therapies that their products are unapproved drugs and it is a violation to make unsubstantiated claims about these products.  Recently there has been an upsurge of chelation products in the internet.  Chelation is a process to bind toxic chemicals such as heavy metals like lead and excrete them from the body.  There have been claims that chelation can help a variety of diseases including autism, Alzheimer’s disease, Parkinson’s disease, and heart diseases.  There are no studies to show that chelation can help these diseases.  Unfortunately these diseases have limited medical treatment and preys on the desperation of patients seeking a cure.  The only approved chelation therapies are by prescription only and need to be closely monitored by a physician.  The prescription chelation treatments also have adverse side effects and must be monitored.  Chelation therapies can cause severe dehydration and kidney failure if not used properly.  In addition to causing serious medical problems, OTC chelation treatments may prevent patients from obtaing effective medical therapy.  Some of these are marketed as dietary supplements but they fall under the FDA’s regulation because they claim to treat, mitigate, prevent, or diagnose disease.

The FDA issued warnings to the following products:

  • 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
  • If you have concerns about possible heavy metal toxicity, contact your physician for testing.  The OTC testing kits are unreliable and may lead to unnecessary and dangerous treatments.