If that's his claim, and not that of an ignorant 3rd party, then yes, irresponsible. Even criminal. Why hasn't the FDA paid him a visit? Or closed down his operation? There are strict laws against such claims, and the FDA are not generally known for slacking in their enforcement.

I'm still inclined to think that this is an oversight rather than deliberate deception, and an innocent explanation most likely exists. I might find it when I have more time to investigate it myself. Watch this space.