HD,
IMO: You are far to kind in your treatment of the FDA. You make them sound like the lady's knitting circle down at the local church. Clearly you need to read the NCE transcripts.
The transcript paint a far uglier picture. FDA comes across as high on its own authority. The transcripts reveal a pattern of the FDA ignoring or changing congressional statutes, changing definitions and decisions in a arbitrary an inconsistent manner and making interpretation where the statute does not grant FDA the authority to interpret.
And this does not even get into the possibility that corruption might play a major role in some of the decision making. Hard to come up with other plausible explanations. As a graduate of MIT and Harvard Med School, I do not for a minute believe the FDA's argument in rescinding the SPA holds water and that it would persuade a fourth grader..Just pure unadulterated BS put out by people who think they answer to nobody.
":>) JL