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.

I believe that such a modified, randomized clinical study is essential to add another line of evidence with which to evaluate the potential benefits of electronic cigarettes. Yes, there are limitations to RCTs, but it makes no sense to throw out the baby with the bath water.

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