5. The majority of dual users (e-cigarettes and cigarettes) are using e-cigarettes every day, and half are using at least two cartridges/disposables per day.

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.

In order to introduce a new electronic cigarette product to the market, the manufacturer will have to demonstrate that the product is beneficial to the public's health. This does not simply mean that one must demonstrate that the product is safer than cigarettes. The applicant also needs to show that the introduction of the product into the market will not deter smokers from quitting or encourage youth to start using the product. At the present time, there is a substantial body of opinion among tobacco control experts that electronic cigarettes do not reduce population risk. Therefore, how can we expect that a manufacturer could demonstrate, at the level of proof required, something which most tobacco control experts do not even agree with?

So the key argument against electronic cigarettes is that for every person who they help by getting them off of cigarettes, there is another person who they prevent from getting off cigarettes.

But that isn't the end of the story. If this were simply a bogus conclusion, then we could simply evaluate the article as being junk science, dismiss it as bogus, and leave it there. But unfortunately, it doesn't end there.

(2) A description of any reasonably foreseeable risks or discomforts to the subject; …

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