Kristin, I fully rebutted Phi's argument centered on the combination product prohibiton, more than once, months back. I'm not going to do it again.
All I'm going to say at this point is that with this repeated argument, Phi demonstratres a singular failure to comprehend some fundamental concepts integral to and pervasive throughout the entire FDCA, and the FDA's historical and current carrying out of its regulatory powers under it. Those concepts are related to "active ingredients" versus "inactive ingredients", "intended use" "marketed", etc, etc.
Furthermore, he reads the combination product prohibition of the FSPTCA completely erroneously, counter to even the FDA's own understanding of it, as evidenced by their own draft guidance on this provision published soon after the law was passed.
So phooey!
All I'm going to say at this point is that with this repeated argument, Phi demonstratres a singular failure to comprehend some fundamental concepts integral to and pervasive throughout the entire FDCA, and the FDA's historical and current carrying out of its regulatory powers under it. Those concepts are related to "active ingredients" versus "inactive ingredients", "intended use" "marketed", etc, etc.
Furthermore, he reads the combination product prohibition of the FSPTCA completely erroneously, counter to even the FDA's own understanding of it, as evidenced by their own draft guidance on this provision published soon after the law was passed.
So phooey!