22nd Century Group Inc (XXII)

[Orion Nebula]

Call this an expression of skepticism about timely and forthright government action in dealing with an issue. I think the FDA is fine with, and likely secretly hoping for, a quality VLN product being in the marketplace right now and will not put any roadblock in the way of XXII moving forward and labeling a product as such. Production could start very soon with the MSA. I suspect the FDA actually is hoping for passive widespread adoption before they conclude their years of study that might drive them to actually have to decide to do something like mandate lower nicotine levels. Market driven acceptance makes their job easier by avoiding a backlash from tobacco companies and other parties that the FDA will likely confront with a ruling that is perceived as a radical departure from the status quo. Why not let XXII (and BAT through Reynolds) carry the ball and get things rolling for them as they are part of the industry and it is easier to let it evolve from within than be forced from outside the industry? With this in mind, I feel it will be quite awhile, if ever, before the FDA formally regulates nicotine content, but that will not be an impediment to the adoption of xxii technology, albeit in a more gradual fashion. In fact I could see at the conclusion of all the studies that the FDA might proclaim that their research program was a resounding success but no further action is necessary because the research supports what the marketplace has already decided and those wanting to try the VLN route have several options available to them that have been used by many people to quit smoking. Sound about right?