P.S.  I am seeking suggestions on my reply to the FDA.

It is ludicrous for the FDA to not confirm or deny something like this.

If this is their hard stance then I see no reason to believe that we have in fact received this designation.  Maybe it was offered to us by the FDA and Don " " neglected " " (cough) to apply for it.

I don't know for sure but the designation is one thing I thought Don wasn't lying about, and now, I am not so sure. 

JMHO