Check out HR1256 9.11(g)(4). These are the criteria that need to be reviewed.
I think that we would fall under 9.11(g)(4)(E). Paragraph (2) shows how a product could be marketed and sold without scientific data, contingent on scientific data being provided at a point in the future. I guess they just go by anecdotal evidence on that accord?
I don't know, SM, it seems like we should be able to at least make a decent case for the overall idea, and then just have specific manufacturers submit their own apps and data. It's awfully ambiguous as to whether the law applies to new technology or new products (to me, anyway). I still say that we band together and get some testing done. At the very least we'll be better informed about what is going into our bodies, and that's NEVER a bad thing.
This refers, in numerous places, to "the tobacco product that is the subject of the application". Are our e-cigs a "tobacco product" as SE has contended in their lawsuit, or, like the FDA has said, are they medical delivery devices. I think someone somewhere needs to decide this before any thing else. IMO, if the FDA comes out on the winning end, i.e., medical delivery devices, the row is gonna be a really long one to hoe.