The methodology decided upon by the FDA when constructing the e-cig study was flawed from the beginning. When formulating an hypothesis, all variables should be considered that may impact the topic under study. All pieces of the puzzle are required to complete the task.
The FDA chose to pair the e-cig with the Nicotrol product designed to be a cessation device. The e-cig is a smoking alternative, not a cessation device. It is obvious that NRT, which produces no vapor/smoke, will have less additives and constituents than a smoking alternative. So what exactly was the point of the study? NRT marketing???
A more informative and valuable analysis would include the variable that is the alternative to the e-cig. One has to ask why wasn't tobacco smoking included? The benefits of the e-cig when compared to cigarettes would be readily obvious. After all, the data points and measures were all tobacco specific and adding cigarettes would be an easy task. Further, a continuum of harm could have been "proved" that would enable the populace to make informed choices of acceptable levels of risk.
I submit the question to ask the FDA is why time and money was wasted to measure apples to oranges rather than a straight-forward analysis of the types of apple and which was healthier.