The beauty of a randomized study is that it can equalize the levels of smoking addiction, reasons for wanting to quit, and motivation to quit across groups. In addition, it equalizes other confounders, including unknown confounders which could affect the study results. There is no way for a survey study to accomplish this. Thus, to simply throw out the RCT is quite unscientific, in my opinion. It throws out one of the most valid pieces of evidence that is necessary to make an informed judgment about the effect of these products: the differences in effectiveness of the products under conditions in which confounding cannot throw off the results.

The deeming regulations subject electronic cigarettes to section 911 of the Family Smoking Prevention and Tobacco Control Act, which prohibit the marketing of tobacco products as modified risk products without the approval of the FDA. Specifically, what this means is that electronic cigarette companies cannot tell consumers the simple truth: that their products are safer than tobacco cigarettes. They cannot even tell consumers that the intended purpose of these products is to provide a safer alternative to smoking.

If the FDA doesn't have the evidence needs at the current time to conclude that smoking is more dangerous than vaping, then what kind of evidence will it take?

"There is no evidence, no convincing evidence that using e-cigarettes leads to people quitting, there's not even convincing evidence it leads to people smoking less, although that might be possible," he said.

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