FDA Issues Warnings to Marketers of Unapproved ‘Chelation’ Products
The Food and Drug Administration warned eight companies on October 14, 2010 that their over-the-counter (OTC) chelation products, some of which are marketed as dietary supplements, are unapproved drugs and devices, and that it is a violation of federal law to make unproven claims about these products.
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FDA Has Not Approved Any OTC Chelation Products
FDA states that it has not approved any OTC chelation products. The companies that received the warning letters claim that their products treat a range of diseases and health problems by removing toxic metals from the body. FDA states that procedures involving these agents carry significant risks and should be performed only under medical supervision.
Products Come in Various Forms, Screening Tests Also Sold
The products come in various dosage forms, including transmucosal sprays, suppositories, capsules, liquid drops, and clay baths. Some of the companies also sell unapproved screening tests that claim to detect the presence of heavy metals in urine to justify the need for chelation therapy. FDA listed the eight affected companies are:
- 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)