FDA Nixes Over-the-Counter Chelation

The FDA has ordered eight companies to stop marketing over-the-counter chelation products primarily intended to remove heavy metals such as lead and mercury from our bodies. The heavy metal chelation products included a range of substances, in particular calcium disodium EDTA, which the FDA still allows in prescription form. The Agency cited the companies for making inappropriate health claims. In some cases, this seems to have been happening. In at least one case, the only “inappropriate” health claim seems to have been factual statements about what heavy metals do to our bodies and links to peer-reviewed scientific articles. The Agency was not just concerned with inappropriate health claims. It also took the position that all non-prescription chelating products are unsafe. Charles Lee, the medical officer at the FDA’s Center for Drug Evaluation and Research (CDER), noted that no adverse events have yet been reported for the products pulled. He then claimed they can cause side effects including dehydration, kidney failure, liver damage, and death. In a remarkable bit of double-speak, Lee said, “Just because we don’t have evidence of lots of adverse events doesn’t mean there’s no risk from these products.” Let’s look closely at what Lee said. “No risk”? Is that a reasonable standard? Taking almost anything in excess or in the wrong way can be dangerous. And we are not talking about there not being “lots of adverse events.” We are talking about there not even being one. The risks of allowing calcium disodium EDTA outside a doctor’s office can be debated. It is important to remember, however, that few doctors are interested in either heavy metal testing or chelation, much less knowledgeable and skilled at it. At least we are left with other ways to chelate heavy metals—foods like garlic and cilantro, and supplements like alpha-lipoic acid, vitamin C, selenium, and the amino acid N-acetylcysteine (NAC). We can use the latter supplements so long as the manufacturers keep completely silent about their chelating benefits. And there is no doubt that in today’s world we need heavy metal removal. Let’s not forget: the same government which is now protecting us from non-prescription heavy metal chelating agents also puts mercury in our flu shots—even flu shots for infants—as a preservative, even though this preservative is banned in Europe. For an important action alert on doctor-supervised prescription chelation for heart disease, please see our next story.