The FDA appears to be moving against compounded EDTA,
a crucial medicine used to remove heavy metals from the body.
FDA Attacks Heart Health Modality
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.