Food and Drug Administration  |  May 30, 2018

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In its discussions and analyses of whether or not a significant illicit trade might develop in non-complying tobacco products after the implementation of an FDA tobacco product standard, FDA should make it very clear that all it must consider, pursuant to the Tobacco Control Act, are the impacts of any such illicit trade on the health of the population as a whole. Non-health impacts are irrelevant to whether a tobacco product standard (or other FDA tobacco control rule) is “appropriate for the protection of the public health.”

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