FDA Attacks Oral “Chelation Therapy” Products

Stephen Barrett, M.D.
October 21, 2010

The U.S. Food and Drug Administration has warned eight companies that their over-the-counter (OTC) chelation products are unapproved drugs and that making unproven claims about them is illegal [1]. The companies have been claiming that their products 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. Four of the companies also sell unapproved screening test kits that they claim will detect the presence of heavy metals in urine and thus justify the need for chelation therapy. The warning letters were sent to:

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

The FDA has noted an increase in “chelation therapy” products marketed on the Internet that claim to cleanse the body of toxic chemicals and heavy metals. The products come in various dosage forms, including transmucosal sprays, suppositories, capsules, liquid drops, and clay baths. Although some are marketed as “dietary supplements,” they are unapproved drugs because they are claimed to treat, mitigate, prevent, or diagnose disease.mThe FDA advises consumers to avoid all nonprescription products offered for chelation or detoxification. The only FDA-approved chelating agents are available by prescription only and have limited use.

The warning letters state that failure to promptly correct the violations could subject the companies to legal action that includes seizure and injunction. Whether this is true remains to be seen. In 2005, the FDA warned Ionetics that therapeutic claims the company made for Angioprim on three Web sites were illegal [2]. One of the sites is no longer posted, but the other two still contain violative claims.

  1. FDA issues warnings to marketers of unapproved ‘chelation’ products. FDA press release, Oct 14, 2010.
  2. Baca J. Warning letter to Thomas Snee. Jan 4, 2005.

This article was posted on October 21, 2010.