Opinion ID: 6500930
Heading Depth: 2
Heading Rank: 1

Heading: FDA Authority

Text: We begin with the simpler matter. Petitioners argue that FDA “lacks authority . . . to impose a requirement that Triton demonstrate its flavored ENDS products are more effective at promoting smoking cessation than its tobacco flavored ENDS products.” Petitioners are blatantly wrong—the TCA authorizes FDA to consider comparative cessation evidence, if not expressly then impliedly. Beginning with the express authority. 21 U.S.C. § 387j is the relevant provision: subsection (b) sets out the requirements for a premarket tobacco application, and subsection (c) outlines the actions FDA may take with regards to the application. Id. § 387j(b), (c). Under subsection (b), applicants are required to include in their applications “full reports . . . concerning investigations which have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco products.” Id. § 387j(b)(1)(A) (emphasis added). Under subsection (c), FDA is then required to consider “the information 5 Upon success on the first argument (that FDA acted arbitrarily and capriciously) but failure on the second (that FDA lacks statutory authority), Petitioners request that the court grant them an eighteen-month-long injunction against the agency so that they could conduct randomized controlled trials and longitudinal studies. FDA rejects this request as incongruent with the APA, arguing that remand is the only appropriate remedy. Because we deny the petitions for review, we need not address the propriety of the requested relief. 9 Case: 21-60766 Document: 00516397516 Page: 10 Date Filed: 07/18/2022 No. 21-60766 c/w No. 21-60800 submitted to the Secretary as part of the application,” which necessarily includes the comparative efficacy reports that applicants must provide. Id. § 387j(c)(2). Petitioners ask us to ignore these provisions, arguing that the word “risk” in § 387j(b)(1)(A) “refers to physiological health risks, not some broader concept of risk that encompasses initiation and cessation behaviors.” This argument is unpersuasive. Initiation and cessation behaviors are physiological health risks. In fact, as Petitioners themselves note, cessation is one of the reasons Congress enacted the TCA in the first place. TCA § 3(9), 123 Stat. at 1782; see also TCA § 2(34), 123 Stat. at 1779 (“Because the only known safe alternative to smoking is cessation, interventions should target all smokers to help them quit completely.”). Moreover, subsection (c) provides further express authority for FDA to consider comparative efficacy. The statute provides that to determine compliance with the APPH standard, FDA must consider “the increased or decreased likelihood that existing users of tobacco products will stop using such products.” 21 U.S.C. § 387j(c)(4)(A). The phrase “increased or decreased likelihood” necessarily implies a comparative analysis. Nothing can “increase” or “decrease” in a vacuum. 6 Petitioners surely understood as much because, as FDA points out, Petitioners actually included evidence of comparative cessation in their PMTAs. But even if Petitioners are right that FDA lacks the express authority to consider such evidence, FDA certainly has implied authority to do so. In addition to the provisions cited above, FDA may consider “any other 6 If someone smoked 10 cigarettes today, you could not say that she “increased” or “decreased” her smoking ritual without having evidence of her prior smoking habits— that is, evidence that would allow you to compare her smoking today to her smoking yesterday and before. 10 Case: 21-60766 Document: 00516397516 Page: 11 Date Filed: 07/18/2022 No. 21-60766 c/w No. 21-60800 information before the Secretary with respect to [the] tobacco product,” 21 U.S.C. § 387j(c)(2), may commission an investigation to determine whether a product meets the APPH standard, id. § 387j(c)(5)(A), and may consider other “valid scientific evidence,” id. § 387j(c)(5)(B). Therefore, FDA’s consideration of the lack of cessation as a risk and comparing that risk between new tobacco products and old tobacco products “fall[s] squarely within the ambit of the FDA’s expertise and merit[s] deference.” Cf. Schering Corp. v. FDA, 51 F.3d 390, 399 (3d Cir. 1995).