If a company were to make such a claim, it would constitute a reduced exposure claim, which is prohibited under section 911. To make matters worse, such a claim can only be approved by the FDA if the company shows that if consumers hear that the product is free of tobacco, they will not be led to believe that the product is safer. In other words, to simply make the truthful and uncontroversial claim that your electronic cigarettes are free of tobacco, you would have to first demonstrate that consumers will not interpret the absence of tobacco as indicating that the product is any safer. But we know for a fact that consumers will interpret (and should interpret) the absence of tobacco as an indication that vaping is safer than smoking. Therefore, the deeming regulations place a de facto, permanent ban on electronic cigarette companies making the simple claim that their products do not contain tobacco.

Although the survey approach described above would lead to "invalid" results, I would never argue that survey studies should be thrown out and that we should only be conducting RCTs. My point is that there are strengths and limitations of various study designs, and causal inference is enhanced by having research evidence from multiple study designs. On balance, the strengths and weaknesses balance each other out, leading to a much greater ability to draw valid conclusions.

Second, the results suggest that a ban on flavorings in e-cigarettes would have devastating consequences for the public's health. Specifically, it would likely cause a massive migration of vapers back to the severely toxic, real, tobacco cigarettes, and with that transition, all of the associated adverse health sequelae.

In other words, it is time to acknowledge that the law was flawed. It is not the cigarette companies that are to blame for the fact that consumers still understand which brand is which. The law is to blame. If the intent of Congress were to ban any brand that might mislead consumers, then the Congress should simply have banned these brands, requiring them to be pulled from the market.

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