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As currently proposed, the deeming regulations will require virtually every e-cigarette product on the market to submit a pre-market review application, in which the company must demonstrate that the introduction of the product into the market is beneficial for the public's health. The data required to demonstrate this is complex, as it requires a consideration of not only the benefits of the product to intended users (adult smokers), but also the consequences of the product's availability in the market to others, such as nonsmokers and youth. The complexity and burden of this requirement makes it unfeasible for most e-cigarette companies, which are small and do not have adequate resources for such an undertaking. The result would be to pull tens of thousands of products from the market and constrict the market severely. In addition, it would create an absolute bureaucratic, nightmarish mess.


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