All eight companies market over-the-counter (OTC) chelation products online, which are not approved the FDA and involve the use of chemicals to remove heavy metals from the body in a process fraught with potential danger. Chelation products can alter the levels of certain substances in the blood, and even when used under medical supervision can cause dehydration, kidney failure and death.
The companies in question claim that their products treat a range of diseases by flushing toxic metals from the body. These diseases include autism spectrum disorder, cardiovascular diseases, Parkinson's disease, Alzheimer's disease, macular degeneration and other serious conditions.
The FDA says these chelation products haven't been evaluated by the FDA for treatment of these diseases, and violate the Federal Food, Drug, and Cosmetic Act (FFDCA). Seriously ill patients, the FDA added, may delay seeking effective medical care by relying on these unproven OTC products.
"These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options," Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said in a statement. "The FDA must take a firm stand against companies who prey on the vulnerability of patients seeking hope and relief."
The FDA says there's been an uptick in "chelation therapy" products marketed on the Internet that claim to cleanse the body of toxic chemicals and heavy metals. Although some of the products are marketed as dietary supplements, they're classified as unapproved drugs because they claim to treat, allay, prevent or diagnose disease. 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.
The agency advises consumers to avoid non-prescription products offered for chelation or detoxification. The only FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as lead poisoning and iron overload. Procedures involving these agents carry significant risks, and should be performed only under medical supervision.
"FDA will seek enforcement action against companies that promote therapeutic benefits of products not yet evaluated by the agency for safety and effectiveness," Dara A. Corrigan, associate commissioner for Regulatory Affairs, said in a statement.
Under the FFDCA, companies that market products that claim to prevent, diagnose, treat or cure diseases must file an application with the FDA and submit data to demonstrate their products' safety and effectiveness. Unless the eight companies take prompt action to correct the legal violations cited in the warnings letters, they face possible legal action, including seizure and injunction.
The FDA sent warning letters to the following companies (which contain links to all of their websites):
- 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)