The FDA appears to be moving against compounded EDTA, a crucial medicine used to remove heavy metals from the body. Action Alert!
Earlier this month, the FDA announced that edetate disodium (EDTA) made at compounding pharmacies poses “significant safety risks.” This kind of move is a prelude to a full ban on individualized EDTA medicines, which would be a disaster for patient health, particularly those looking to improve cardiovascular health. This is part of a longstanding war against EDTA and chelation from the medical establishment looking to protect drug industry profits. We must protect access to this crucial medicine.
Over the last few years, we’ve been reporting on the FDA’s activities to increase regulation over compounding pharmacies that make individualized medicines to meet patient needs. Most of our coverage has focused on “traditional” pharmacies, but the FDA created another category of pharmacies called “outsourcing” pharmacies. Outsourcing pharmacies are generally larger manufacturing facilities and can only make medicines that appear on a pre-approved list by the FDA, referred to as the Bulk Drugs List.
EDTA was nominated to be added to the Bulk Drug List for outsourcing pharmacies. The FDA has a process for reviewing nominations that includes adding nominated substances to one of three categories: those nominated with sufficient supporting information; nominated substances that pose “significant safety risks”; and those nominated without sufficient information. On October 12, the FDA added EDTA to the second category.
The FDA’s reasoning is telling: “[EDTA] poses significant safety risks due to medical providers inadvertently interchanging edetate disodium with edetate calcium disodium.” That is, EDTA should potentially be banned because some doctors have made mistakes. Really? The FDA also states, seemingly as an afterthought, that there are safety concerns when EDTA is used for indications other than those approved by the FDA, which is the treatment of lead poisoning.
Note that this action does not currently affect traditional pharmacy compounding of EDTA. Our concern is that the FDA will eventually move against all forms of compounded EDTA by adding it to the “Difficult to Compound” List for traditional pharmacies’, alongside bioidentical hormones, citing these bogus safety concerns as justification. And if that happens, access to EDTA will be lost, as the FDA-approved EDTA products are discontinued or withdrawn.
That EDTA is a safety risk is not supported by the facts. Research has demonstrated that chelation is both safe and beneficial. The federally funded TACT (Trial to Assess Chelation Therapy) study, which included 1,708 patients across the US and Canada, showed that EDTA-chelation therapy reduced cardiovascular events in patients who were over 50 and had previously experienced a heart attack. The results of this randomized, double-blind study were even more profound for diabetic patients, who experienced a 43% reduction in death from any cause over five years.
Research based on the TACT trial has showed that concerns over the safety of EDTA are unwarranted. One study concluded: “The experience with 55,222 infusions of edetate disodium or placebo in TACT shows that this therapy is extremely safe when used according to the TACT safe infusion protocol.”
Chelation is used by integrative physicians to remove heavy metals like lead, cadmium, and arsenic from the body. Doing so can clear up many, many health conditions and prevent worse ones from developing. The process involves injecting patients with organic chemicals—such as EDTA, which is typically compounded—that bind and remove the heavy metals present in the bloodstream. In IV chelation, mineral and nutrient IVs are typically added to support the body during the detoxification process. EDTA is also available in other forms, such as suppositories.
Think of your body as a bathtub, slowly being filled with environmental contaminants that we are constantly exposed to in the modern world—like the pesticides on your tomatoes, the arsenic in your rice, the BPA in your plastic food wrap, or mercury in the fish you eat, or the amalgam your dentist uses. If your “bathtub drain” is clear, these toxins will exit the body naturally. If the drain is clogged—because of an ill-functioning system caused by genetic mutations, stress, the accumulation of many exposures, a poor diet, or other lifestyle factors—your “tub” will overflow, making every fresh chemical exposure a new assault. This is why chelation is so helpful for some—it returns the body to homeostasis by removing many of these harmful toxins.
Chelation therapy has long been demonized by the medical establishment. Even after the TACT trial results were published, mainstream media outlets called the government-funded study “highly controversial” and “fringe medicine.” Some state medical boards have severely restricted the use of chelation therapy.
Why is mainstream medicine so threatened by chelation? Is it because that, if it is shown to improve cardiovascular health, the need for blood thinners and cholesterol-reducing pharmaceutical drugs (two of the primary methods conventional doctors use to manage cardiovascular health) is sharply reduced? Never mind that both blood thinners and cholesterol reducing drugs are themselves dangerous and often harmful to the patient.
We must push back against the FDA and make it known that consumers will not stand for further attacks against our ability to detoxify heavy metals.
Action Alert! Write to the FDA and Congress, telling them to retain consumer access to compounded EDTA. Please send your message immediately.