Many thanks for the kudos.
THR and e-cigarettes were highlighted (and heavily supported) by most folks at the FDLI conference's three tobacco sessions. While I and other presenters criticized the deeming regulation and the FDA's handling of SE applications, nobody spoke in support of the deeming regulation.
Heard that e-cigarettes were the highlight at the NATO conference (National Association of Tobacco Outlets) in Las Vegas earlier this week (where FDA's Mitch Zeller also spoke).
My goal remains to convince the FDA to NEVER PROPOSE the Deeming Regulation (nor Additional Regulations) for vapor products, cigars, pipe tobacco, hookah/shisha, dissolvables, or other currently unregulated tobacco products (because the regulations would threaten, instead of benefit, consumer and public health).
My second goal is to continue delaying and delaying the Deeming regulations (hopefully until Obama leaves office).
I strongly suspect FDA's Mitch Zeller will first take action on (i.e. approve and/or reject) at least some (perhaps many/most) of the 3,700 Substantial Equivalence applications that have already been submitted by tobacco companies before the agency officially proposes a Deeming Regulation and Additional Regulations for e-cigarettes.
Also suspect the FDA's forthcoming rulings on SE applications will create controversy, and potential litigation against FDA.
If FDA were to propose a Deeming Regulation and additional regulations before it rules on the huge backlog of existing SE applications, however, it will be much easier for us to convince Republicans in Congress to conduct hearings and to oppose the newly proposed FDA regulations.
So I think at least several more months will pass before FDA proposes a Deeming Regulation and Additional Regulations for e-cigarettes, cigars, pipe tobacco, hookah, dissolvables, etc.
If/when the FDA proposes a Deeming Regulation and Additional Regulations, there would be a public comment period of perhaps six months (when we'll need to generate hundreds of thousands of opposition comments to the FDA docket by vapers and e-cig companies, and the tobacco industry will generate many opposition comments as well, probably including some threatening legal action).
And it will take at least another six months before the FDA could take any final action on their proposed regs.
If e-cigarette sales continue to skyrocket every quarter (as has occurred since 2007, and as I expect and envision will continue for many years to come), pressure will continue mounting against unwarranted and excessive regulation by FDA. So time is on our side.
The FDA cannot put this rapidly growing Genie back into the bottle, and they should know they cannot because they already tried to do so from 2009-2011 when the agency banned and seized e-cigarette imports (and yet, e-cigarette sales still skyrocketed).
