Questions and Answers on Unapproved Chelation Products
The U.S. Food and Drug Administration (FDA) advises consumers to be wary of so-called “chelation” products that are marketed over-the-counter (OTC) to prevent or treat diseases. Companies are marketing unapproved OTC chelation therapy products to patients with serious and incurable diseases, including autism spectrum disorders and heart (cardiovascular) conditions.
1. What is chelation?
Chelation involves the use of certain chemicals to remove heavy metals from the body. In medicine, chelation has been used for the treatment of metal poisoning, among other conditions. All FDA-approved chelation therapy products require a prescription because they can only be used safely under the supervision of a healthcare practitioner.
2. What products are affected by this warning?
The products affected by this warning include so-called “chelation” products that are marketed for home use to prevent or treat diseases. Some of these products are marketed as dietary supplements. The products come in various dosage forms, including nasal sprays, suppositories, liquid drops, and clay baths. In addition, some of the companies that make chelation products also market screening tests that claim to detect the presence of heavy metals in urine to falsely justify the need for the treatment. FDA has not cleared these tests, either.
3. Are there any OTC chelation products approved by the FDA?
No. FDA has never approved any chelation product for OTC use for any health condition. All FDA-approved chelation products require a prescription because they can only be used safely under the supervision of healthcare practitioner.
4. Why did FDA take this action?
Companies marketing unapproved OTC chelation products with unsubstantiated treatment claims violate the Federal Food, Drug, and Cosmetic Act. Although some of these products are marketed as dietary supplements, they are, in fact, unapproved new drugs.
These companies marketing unapproved OTC chelation products commonly target patients with serious and incurable diseases who may have limited treatment options. Two common conditions that these products claim to treat are autism spectrum disorders and heart (cardiovascular) conditions, including treatment of high blood pressure, high cholesterol, clogged arteries, angina, prevention of heart attack or stroke, and even as an alternative to coronary bypass surgery. Some companies also claim their products can prevent or treat Alzheimer’s disease, Parkinson’s disease, complications of diabetes, and many more diseases and health conditions that may be unrelated to one another.
FDA is concerned that patients will delay seeking proven, sometimes essential medical care, when relying on unproven OTC chelation products to treat serious conditions such as heart and blood vessel disease. FDA is also concerned that chelation can result in serious side effects such as dehydration, kidney failure, and death.
5. Should consumers be concerned about OTC chelation products that claim to have FDA-approved ingredients?
Yes. Illegal OTC chelation products are frequently marketed to deceive consumers into thinking they are taking a product that has been evaluated by FDA. Companies that make unapproved products often highlight that their product contains the same ingredient as an FDA-approved drug, suggesting that it is OK for them to market their drug without FDA approval. However, this is not permitted. Under FDA law and regulations, the company first must show that its product (whether or not it includes a previously-approved drug) is safe and effective before it may be marketed. The OTC chelation products have not been subject to the rigorous approval process and manufacturing scrutiny required for FDA-approved products, and are therefore not being legally marketed.
6. Is chelation harmful even if consumers only use it to “detoxify” their bodies?
Consumers who use OTC chelation products for detoxification are exposed to all the risks associated with chelation. These risks are not acceptable, given that there is no proof that “detoxification” using these products is effective to prevent or treat any condition or disease.
Furthermore, many of the companies that were issued warning letters for marketing these unapproved OTC chelation products also promote home test kits. These test kits are promoted to “diagnose” metal and other environmental toxicities as part of the marketing scheme to convince consumers to purchase unapproved OTC chelation products. These test kits are not cleared by FDA and may offer false or misleading results to consumers.