With which of the following do you disagree?
1) The statute still allows for (completely) new products
outside of the SE pathway (pp.6-8, esp. p.8):
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM273425.pdf
2) In the case of vaping, new products submitted prior to the 2-year window could be sumitted
either under the SE pathway, or as entirely new products.
3) The SE pathway is easier. The "belief 3" that you quoted from my 'misconceptions' thread's OP refers only to that.
4) While you and others made a valiant attempt to get the Ruyan evidence, I think that's (at best) still in limbo, and no one ever assumed that the approval of cigAlikes was exclusively conditioned on the success of such efforts to find a predicate. (Otherwise the consensus would probably be that
no vaping products would be approved.
5) My understanding is that people believed that cigAlikes would make it as completely new products, i.e. with no predicates,
only because BT/BV had the deep pockets to fight (including the ability to sustain a number of years without sales), and/or that FDA didn't want to be in the embarassing position of rejecting all vaping products. (My own little 'conspiracy' theory' is that FDA likes cigAlikes because they know most users are dual users - see next para.)
Therefore it would either explicitly approve some of these cigAlikes, or simply leave them alone, since
pre-market approval is not required for any vaping product introduced and applied-for prior to the closing of the 2-year window.
(My theory on that was that the FDA would ignore the cigAlikes for some years, and then reject them after the evidence about dual users was incontrovertible. But that's not important - what matters is that the product stays on the market until the appl is reviewed, so long as the appl was submitted before the window closed.)
6) [Just as background] The reason that most people view the tobacco act as effectively
freezing the Feb 2007 state of tobacco cigarettes, is that
pre-market approval was required for any products introduced after March '11 (and even prior to March 11, they still had to be under the SE rubric). The consensus was that FDA would simply do nothing with the new product applications, thus effectively keeping any product off the market, so long as it required pre-market approval. Which is apparently what's occured in all-but-one case. (And since the applicant firms can't sue until the product is rejected, it's effectively denied-by-permanent-delay.)
***
My point in this thread is that NJOY has the deep pockets needed to drop tens of millions on the needed public health studies for new products, to sustain 5 years or so of no revenune, and to drop more tens of mllions on litigation. Eventually, a new vaping product that has a great track record in helping people quit
should be approved under the statute, even under the 100% new product (i.e. no SE) pathway. But of course, it will probably take a court to force FDA to do this, which is why the I'm assuming that any firm which tries this needs to be able to make no money on the product for 5 years or so until a DC ct. of appeals can hear the case, and maybe even until The Supremes either hear it or deny cert.
Sigh.... it's been assumed that the only possible predicate products will be cigalikes. The 'VTM' is a second/third gen type device. For new product applications to be accepted, they have to have substantial equivalence to a predicate product. Roger, this is why no one thinks, given the Feb 2007 date, that no existing products other than possibly cigalikes will pass muster. Surely you're familiar with that scenario.
"Belief 3: There are products available prior to Feb '07 which are "substantially equivalent" to products available now, such as unflavored nicotine base.
Almost certainly false
Anything available prior to Feb '07 would have to be tested and proven to be chemically identical to whatever is sold now. Furthermore it would need to be offered in identical quantity and packaging. No hardware solution available at that time (if one could be found) is in any way comparable to something that could likely be offered today."
