There is plenty of time to get products currently on the market OK'd, and that appears to be an easy process. Products that are essentially the same as other products do not have to go through a separate process.
3mg, I'm not meaning to be argumentative. Please don't take my comments as such.
The predicate date currently is 2/15/07. Per cursory analyses by Smokey Joe (Oliver Kershaw), Cynthia Cabrera and Michael Siegal, it is highly unlikely that products currently on the market (except for cigalikes) will meet the substantial equivalence test. The time per PMTA, according to revised estimates by FDA, is 1500 hours, at a cost north of $1mm per product. Further, the window is two years, but FDA can pull products off the market if they (FDA) fail to timely review an application - e.g., within 12 months following the two years. BT, on the other hand, may be able to use -- get this-- cigarettes in their SE applications! The jury is out on "accessories," which appear to be defined ambiguously.
IMO, and only mine, it is critical that HR2058 or the Appropriations Bill is passed. Without a change to the predicate date, the industry will be decimated.