FDA warns against chelation products

The US Food and Drug Administration on Oct 14 announced that it has sent a warning letter to a number of companies that manufacture and sell over-the-counter chelation products for making unproven claims about their products. 

The FDA said the companies received the warning letters because they claim that their chelation products treat a variety of health conditions including autism, cardiovascular diseases, Parkinson's disease, Alzheimer's disease, macular degeneration and other serious diseases by removing toxic metal from the body. 

The FDA said it is illegal to claim that any product is indicated to treat, mitigate, diagnose and prevent any disease without prior approval by the agency. 

The effectiveness of these chelation products in treating claimed diseases is unsubstantiated. Even worse, these products were associated with serious safety issues like dehydration, kidney failure and death. 

“These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options,” said Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA must take a firm stand against companies who prey on the vulnerability of patients seeking hope and relief.” 

The FDA advised that consumers should avoid non-prescription products offered for chelation or detoxification. 

The companies that received the warning letter and products of concern are listed below.  

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) 

The FDA offers the following to help consumers understand unapproved chelation products. 

1. What is chelation? 

Chelation is removal of heavy metal from the body via certain chemicals. Prescription drugs that can be used for chelation are available to treat metal poisoning.

 2. What products are affected by this warning? 

Chelation products sold for home use to prevent or treat diseases are affected by this warning.  Some chelation products marketed as screening tests to detect the presence of heavy metals in urine in order to falsely justify the need for the treatment are also affected.  The FDA says these products are unapproved. 

3. Are there any OTC chelation products approved by the FDA? 

The FDA says it has not approved any chelation product for over-the-counter use for any health condition. 

4. Why did FDA take this action? 

The FDA says marketing unapproved OTC chelation products with unsubstantiated treatment claims violate the Federal Food, Drug, and Cosmetic Act. The FDA says it is concerned that consumers may use these products and delay seeking medical attention for their condition – additionally,  these products per se may cause harm to the users. 

5. Should consumers be concerned about OTC chelation products that claim to have FDA-approved ingredients? 

The FDA says it is not okay to market unapproved products even if they contain FDA-approved ingredients. 

6. Is chelation harmful even if consumers only use it to detoxify their bodies? 

The FDA says "consumers who use OTC chelation products for detoxification are exposed to all the risks associated with chelation." 

Also some companies sell home test kits, which are promoted to diagnose metal and other environmental toxicities.  The agency says this is not allowed. 

It is interesting to note that at least some companies like World Health Products, LLC - if not all companies marketing chelation products - include a disclaimer that states "These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease." 

Hormonal Health, LLC. also has its disclaimer in place stating "The statements featured in this website and any related packaging, brochures, or other marketing materials, have not been evaluated by the U.S. Food and Drug Administration. This information and products are not intended to diagnose, treat, cure or prevent any disease." 

Other companies also have similar disclaimers in place.

By Jimmy Downs and editing by Rachel Stockton