sleven, where do you think that FDA fraud guideline I referenced came from? FDA's creative imagination? Somewhere out in the boondocks? How about 18 U.S.C. 1001 and its predecessors? From questionable, fraudulent conduct of earlier generic companies? Better yet, how about Hazel-Atlas, its predecessors and followers as authority, even binding authority? As an extreme, what about that salad found (from an investigation) to contain deadly mushrooms that a woman is asserted to have served her in-laws this past week?