Oct. 14, 2010 -- The U.S. Food and Drug Administration has warned eight companies to stop marketing over-the-counter chelation products they claim will treat everything from autism and Alzheimer's to macular degeneration.
The products are sold as dietary supplements -- a market not regulated by the FDA -- in the form of nasal sprays, suppositories, capsules, liquid drops and clay baths.
"This is dangerously misleading, targeting patients and caregivers of patients who have serious conditions with limited treatment options," Michael Levy, director of new drugs and labeling compliance at the FDA's Center for Drug Evaluation and Research (CDER), said during a press briefing.
The products claim to cure a range of diseases by removing heavy metals from the body. These conditions including autism and cardiovascular conditions, as well as Parkinson's, Alzheimer's, and macular degeneration.
Some of the companies also make urine tests to detect the presence of heavy metals and advise whether their products would make for helpful treatment.
The agency said the products contain ethylenediaminetetraacetic acid (EDTA), a main ingredient (as disodium EDTA or calcium disodium EDTA) in intravenous chelation therapies that are FDA-approved to treat heavy metal intoxication, including lead, arsenic, iron, and copper overexposure.
Though no adverse events have yet been reported, Dr. Charles Lee, medical officer at CDER, said the products can cause side effects including dehydration, kidney failure, liver damage and death.
"Just because we don't have evidence of lots of adverse events doesn't mean there's no risk from them," Lee said, adding that such events are likely underreported.
Many parents have turned to intravenous chelation to treat their autistic children -- an indication that is not FDA-approved. The agency said it is aware of one death in an autistic child given intravenous chelation therapy.
The agency said it does not have data as to how widespread is the use of the over-the-counter agents.
The companies and their products include:
World Health Products LLC: Detoxamin Oral, Detoxamin Suppositories, and the Metal Detector test kit
Hormonal Health LLC: Kelatox Suppositories
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)