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Similarly, it is clear that a ban on all but tobacco-flavored e-cigarettes would constitute a tobacco product standard. Bates explains that the court justifies its assertion that the FDA is imposing a de facto standard with reference to the so-called fatal flaw memo. This was an expedited decision-making regime that stipulated that applications for nontobacco-flavored products must be supported with controlled trials or longitudinal studies showing a quitting or switching advantage over a tobacco flavor

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