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The company "relied upon these representations when crafting its [applications] and supplemental filings." Yet when the FDA rejected the menthol application, it complained that "studies were not brand- or product-specific" and "thus did not demonstrate that [RJRV's] menthol-flavored new products are more likely to promote complete switching or significant cigarette reduction compared to tobacco-flavored products." The FDA said RJRV's studies failed to "assess the impact of menthol-flavored ENDS [electronic nicotine delivery systems] on cigarette smoking switching behavior" such as "complete switching or significant cigarette reduction over time." It added that the company "did not submit evidence from a [randomized controlled trial] or cohort study showing that its menthol-flavored ENDS provide an added benefit to adult smokers in terms of complete switching or significant cigarette reduction over tobacco-flavored ENDS." In other words, after indicating that manufacturers of menthol-flavored vapes did not need longitudinal or product-specific studies, the FDA suddenly decided that they did

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