The FDA has spoken, you are a drug!
It's difficult to fathom the FDA letter. All those many-numbered regulations and licenses are simply mind boggling. I wonder what the FDA would have to say about the cellular goings-on in the common act of human procreation? Would that pass the minimal manipulation sniff test? What about all those hormones and other chemicals that facilitate the deed? Perhaps we are all children of criminals who had the audacity to practice cellular medicine without a license?