No-observed-adverse-effect level

Okay.

That 1,000 milligrams is your NOAEL.

But you don't just tell the consumer they can take 1,000 milligrams per kilogram.

I mean, a 70-kilogram human taking 70,000 milligrams of an extract would be absurd and potentially lethal because humans aren't rodents.

Okay.

How does that math work?

Well, the standard practice is to divide the NOAEL by 10 to account for interspecies differences, meaning the biological difference between a rat and a human.

Got it.

That's the cliff being measured in real time on real people.

NOAEL, the therapeutic index, directly into how doses get approved.

Goodman and Gilman codifies all of it as canonical standard.

The regulatory goal was never maximum dose.

It's not one data set, but a prospective mechanistic study, not retrospective curve fitting, showing precisely why a low dose carcinogen, say, stimulates repair while a high dose overwhelms it.

We don't have that cleanly yet.

What? The FDA's NOAEL framework assumes the curve only moves one direction.

Yes, built entirely on monotonic assumptions, which means if a meaningful subset of dose response curves actually reverses direction, the safety standards derived from that framework could be systematically wrong for that subset, not slightly off, wrong in the wrong direction.