22nd Century Group Inc (XXII)

[rightcoast1]

I agree. I think that was the FDA’s original intention - promote ENDs products as an off-ramp to combustible cigarettes, after inducing smokers to smoke less by mandating VLN. However, the FDA somewhat blew it by not regulating ENDs products strictly enough (very few studies of short/long-term health impacts; failure to regulate sales to kids), but rather assumed that the Big T/vaping/ENDs suppliers would “do the right thing” and not focus on addicting high-schoolers. So now the FDA is in a tough spot. ENDs products certainly seem to be “better” than combustible cigarettes on the spectrum of risk; however the FDA is playing catch-up now trying to ensure that those products are kept away from kids etc. I still think that the FDA knows that their initial 2-prong smoking cessation initiative is the right path to go down; they just hit a self-inflicted speed bump.

Regardless, I still think FDA wants to (and will) approve XXII’s MRTP soon, and that there’s a better than 60% chance that the VLN mandate will be placed back on the Unified Regulatory Agenda within the next 6 months.