Now, if those 100 resistant smokers were then followed for six months, we would expect that very few of them would quit smoking because all of them had already tried e-cigarettes and failed.

The FDA's Center for Tobacco Products simply does not have the capacity to review 22,000 new product applications. After all, it has taken more than 4 years for the agency to even begin to process the more than 3,500 substantial equivalence applications submitted by tobacco companies, and as of this date, there are still thousands of those applications pending. It is easy to see that the proposed deeming regulations would create a bureaucratic nightmare.

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