The fight over whether this is a drug delivery device or not is extremely important. Cigarettes are commodities. They don't require huge clinical trials and expensive Pre-Market Approvals to be sold. If e-cigs lose this battle and get categorized as Class III combination devices by either the CDRH or CDER (the two FDA divisions that govern devices and drugs respectively), EVERY model of e-cig from EVERY company will require a clinical trial before sale.... not to mention the requirement to follow a whole slew of regulations under 21 CFR for manufacturing, labeling, etc. We're talking millions of dollars to make a damned e-cig. Eventually they might be downgraded to Class II, maybe, but a 510(k) submission is more often not so simple either lately.