[sorcerer-mar]

So in summary, the FDA prevents you from marketing something as a medicine unless you have gone through the approval process and developed all the regulatory apparatus around a medicine (e.g. packaging, suppliers, prescription guidelines, etc)?

[hinterlands]

Yes. Look, I'm not arguing this is bad, I'm just trying to respond to the original question and capture the essence of the debate.

There are three pertinent points: (1) it's EDTA; (2) it's not that EDTA is safe or not safe, it's that no one applied to have it approved as an OTC medication; (3) you can still (probably) sell EDTA as a supplement in the US, but the FDA grumbled about it, which angered various chelation cranks.