The ninth-circuit denied Drip More’s petition for review and left in place the FDA’s marketing denial order for its candy- and fruit-flavored e-cigarette products. The court held that the FDA lawfully denied the premarket tobacco applications because Drip More did not provide the comparative scientific evidence the agency required to show that its flavored products were “appropriate for the protection of the public health” under 21 U.S.C. § 387j(c)(2)(A). The court said the Tobacco Control Act makes the FDA’s review inherently comparative: the agency must weigh whether a new product is likely to help existing smokers switch or quit against the likelihood that nonusers, especially youth, will start using it, and the statute also calls for information on whether a product presents less risk than other tobacco products. Applying that standard, the FDA reasonably required robust and reliable evidence—such as randomized controlled trials, longitudinal cohort studies, or similarly strong evidence—showing that Drip More’s flavored products offered a greater benefit to adult smokers than tobacco-flavored ENDS, enough to outweigh the known youth-appeal risks of flavored ENDS. The court found the denial was not arbitrary or capricious because Drip More did not submit that comparative-efficacy evidence and did not meaningfully distinguish its products from the general youth risks associated with flavored vapes. The court also rejected Drip More’s arguments that the FDA improperly ignored its marketing plan and sales restrictions, explaining that the agency gave reasons for not reaching those materials once the applications failed the comparative-efficacy requirement, and any error was harmless because Drip More did not show its proposed restrictions materially differed from measures the FDA had already found ineffective at preventing youth access. The court further rejected Drip More’s challenge to the inclusion of its “zero nicotine” products because Drip More’s own applications represented those products were covered by the Tobacco Control Act. Finally, the court held the FDA did not need to adopt the comparative-efficacy requirement through notice-and-comment rulemaking under either the Tobacco Control Act or the APA; absent a statutory command to proceed by rule, the agency could develop and apply that standard through case-by-case adjudication. As a practical result, Drip More’s applications remain denied, and the company cannot market the covered products unless it obtains FDA authorization through new or revised applications that satisfy the statutory public-health standard.