Marketers of unapproved drugs and devices are not allowed to make unproven medical claims, the FDA (Food and Drug Administration) has warned eight marketers of unapproved chelation products. In fact, the FDA has never approved any OTC (over the counter, no prescription required) chelation products.
According to the FDA, these eight companies say that their products remove toxic metals from the human body and treat a selection of diseases, even autism spectrum disorder, Parkinson's disease, Alzheimer's, macular degeneration, and cardiovascular diseases. Some of the marketers say that their products can tell whether heavy metals are present in the body, thereby validating the usage of chelation therapy.
By making such medical claims, the marketers are violating the FFDCA (Federal Food, Drug, and Cosmetic Act). The FDA adds that it has not received any submissions for approval and has not evaluated any of these products.
FDA writes in a communiqué:
Despite the claims of the companies that received warning letters, the effectiveness in treating any of the diseases listed is unsubstantiated. Depending on the condition, when relying on unproven OTC chelation products to treat serious conditions, patients may delay seeking effective medical care.
Chelation products have the potential to alter some substance blood levels, raising serious safety concerns. Chelation products can cause serious harm, including kidney failure, dehydration and even death, and that is when they are used under medical supervision, the FDA adds.
Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said:
These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options. The FDA must take a firm stand against companies who prey on the vulnerability of patients seeking hope and relief.
Patients and other member of the general public are advised by the FDA to avoid these OTC products that are offer detoxification or chelation. There are some chelation products which the FDA has approved - all of them are prescription only, and even then, doctors can only use them for specific purposes, such as iron overload or lead poisoning. Because of the considerable risks these products pose, chelation products are only authorized if they are used under medical supervision.
The number of chelation therapy products being offered on the Internet has grown over the last few years, the FDA notes. Many of them claim to rid the body of heavy metals and toxic chemicals. They may claim to be promoted as merely dietary supplements, but if they make a medical claim to treat a disease, or mitigate and diagnose illnesses they are unapproved drugs if the FDA has not approved them. Chelation products may appear as transmucosal sprays, suppositories, clay baths, liquid drops or capsules.
Some of the companies say they have diagnostic kits that claim to detect whether heavy metals are present in urine, hence determining whether the purchaser is in need of chelation products.
Dara A. Corrigan, associate commissioner for Regulatory Affairs, said:
FDA will seek enforcement action against companies that promote therapeutic benefits of products not yet evaluated by the agency for safety and effectiveness.
A product must be submitted to the FDA with data that demonstrate its safety and efficacy if its marketer wishes to make a medical treatment claim. Only if and when the FDA approves the product, can it be marketed.
In its letter to the eight companies the FDA tells them to "take prompt action to correct the legal violations cited in the warning letters or face possible legal action, including seizures and injunction."
According to the FDA, the following companies received warning letters:
- 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)
Written by Christian Nordqvist