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In requesting an easier path, the court wrote, the Industry impermissibly assumes the very public health conclusion that premarket authorization requires be substantiated before a product may be sold: that e-cigarettes are no more risky to the population as a whole than preexisting tobacco products, balancing the prospect that they may lead existing users to less harmful products or usage patterns against the risks that existing tobacco users will postpone reductions or intensify their usage and that non-users will start. [4] Thus, the fact that few e-cigarettes have been authorized does not suggest that the premarket review process as conducted by FDA has been flawed with respect to e-cigarettes or other claimed reduced risk products

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