Is it correct that the FDA refused to allow someone to put their product forward for trials etc? I thought i'd read that somewhere on the Forum.
I heard something like that, too. I recall hearing that one company approached the FDA about being approved as a modified risk
tobacco product and were told that the FDA doesn't have the process set up yet.
I do know at one point, there was a study set up to test the air in a room full of people
vaping at a Vaper's Club meeting. It had approval of the Institutional Review Board.
IRB approval is required for any study that will use human subjects. Since the only people being exposed would be people who are regularly exposed to vapor, the study seemed safe enough.
All of a sudden, the IRB withdrew its approval, with no explanation. The study was dead in the water.
In both these cases, what I have just reported above is "hear-say". I have no first-hand knowledge.
BTW, an IRB is usually a committee set up at a university or research facility to approve and review any studies that will be done by their employees, a subcontractor, or a client. The person who was organizing the study suspects that the IRB had some type of political pressure applied to them to quash the approval for the study.