In my reading of this document, it has (like many documents) 2 parts to it. The "why" are we doing this and once that is established the "what" with various scenarios. I've reviewed posts in this thread and most, if not all, are dealing with the "what." I see no way to look at the "what" and not be, at least a little bit, nervous going forward if you are one who is immersed in vape culture, and/or politically aware vaper.
Yet, the why is not something to ignore and is taking whatever was ambiguous in the main proposal and making it less ambiguous (apart from the science stuff, which is arguably most important data of them all).
This document is written because FDA had to submit it as a matter of federal policy. As stated on p.6 of the document:
The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. FDA has determined that this proposed rule would have a significant economic impact on a substantial number of small entities.
It is written because FDA knows the policy will impact small businesses, and thus has to do a huge CYA which is what this report is addressing.
IMO, everything that is of relevance for the comment period, and how consumers and (mostly) small eCig vendors ought to be responding to the main proposal, is found on p.6 and 7 of this document. If not quite seeing why that matters, than the "what" section from p.8 and onward could possibly serve as motivation as to why.
I don't currently see any quick, easy peasy way to overcome the economics of the main proposal, but do think it will be challenged based on how FDA has worded its version of why on pages 6 and 7. Plus main proposal will be addressed scientifically based on how it chose to word language and invite comments, in that document.
I do think, as a layperson / consumer, that the economics must change. And I think they will change, but it will depend on how consumers and advocates stand up and respond to this proposal. If not able to get what we want right now, then I do see things going very dark for awhile, a black market being open for business (and doing very well) and that signaling to next political generation that, hmmm, maybe we should've changed the economics for small businesses way back in 2014. As they didn't we can, and thus regulation of the reasonable kind that kills the black market, but meets demand, will be in place.
In reviewing info on the "Regulatory Flexibility Act," which, like most things government, has umpteen subchapters and tangents, I found this
link on SBA site that I do think is helpful going forward in addressing what FDA can and can't do with it's main proposal. Perhaps that or information just like it, could help on this issue. And perhaps that is just technical enough to not be of use to average vaper during this open period of response to the main proposal. I intend on reviewing that SBA document a few times, as I think it is 'part of' the answer.
The economics of FDA proposed regulations as that will impact small businesses absolutely must change. If it does not, demand will not disappear. Business for innovative products, beyond what the big guys produce, will not disappear. For sure they might take a huge setback, based on how this generation chose to address things, but I don't see it disappearing anytime in next 30 years, at least.
I truly believe, now is the time to step up our game, and to adopt an attitude of "we can do this" or "we will win." If you have doubts, then welcome to the club, call yourself normal, but then get back in the game where you realize you do matter, and your purchasing power will be exercised regardless of how short-sighted fools (i.e ANTZ or tobacco prohibitionist) wish to spin this.
We've been mentally and emotionally preparing for this for years. We do not fight alone. We have science on our side, and resources that are available to help. We can, and inevitably will, win this.
