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

Heading: Marketing Plans

Text: The majority holds that the FDA’s decision to ignore and not review the petitioners’ plans was not arbitrary and capricious. To do this, the majority must themselves ignore the MDOs’ only stated reason for ignoring 32 Case: 21-60766 Document: 00516397516 Page: 33 Date Filed: 07/18/2022 No. 21-60766 c/w No. 21-60800 the plans: “for the sake of efficiency.” The majority does not deny that “‘efficiency’ is no substitute for ‘reasoned decisionmaking.’” Wages & White Lion Invs., L.L.C. v. FDA, 16 F.4th 1130, 1137 (5th Cir. 2021) (quoting Michigan v. EPA, 576 U.S. 743, 750, 135 S. Ct. at 2706). Instead, the majority relies on FDA’s post hoc justifications for ignoring the marketing plans. First, the majority accepts FDA’s assertion that it had not in the past evaluated a marketing plan that discouraged youth from using ENDS products. This is not a “reason” for refusing to even look at these petitioners’ MDOs. As the stay panel noted, this excuse is akin to a judge’s saying, “she stopped reading briefs because she previously found them unhelpful.” Wages & White Lion, 16 F.4th at 1137. It is obviously illogical and unreasonable to infer from the general to the particular, especially when FDA acknowledged its duty to consider each PMTA individually and holistically. Nor is the mere invocation of agency “expertise” a non-arbitrary substitute for an explanation how such expertise was brought to bear on the particular PMTA. “The requirement of explanation presumes the expertise and experience of the agency and still demands an adequate explanation in the particular matter.” CS Wind Viet. Co., Ltd. v. United States, 832 F.3d 1367, 1377 (Fed. Cir. 2016)(citations omitted). The agency’s failure to meaningfully consider an aspect of the petitioners’ PMTAs that it had previously deemed essential is quintessentially arbitrary and capricious. Univ. of Texas M.D. Anderson Cancer Ctr. v HHS, 985 F.3d 472, 475 (5th Cir. 2021). Second, the majority makes much of an FDA 2020 Guidance that decried increasing adolescent use of tobacco products starting in 2018 even after the agency cracked down on vape companies that marketed and sold ENDS products in packaging that looked like juice boxes and candy cartons. The 2020 Guidance, however, has nothing to do with this case because (a) it 33 Case: 21-60766 Document: 00516397516 Page: 34 Date Filed: 07/18/2022 No. 21-60766 c/w No. 21-60800 discussed enforcement priorities, and it did not purport in any way to amend the definitive PMTA Guidance documents that emphasized the importance of marketing plans; (b) there is no evidence at all that these petitioners marketed or sold to youth directly or indirectly, knowingly or objectionably; (c) the 2020 Guidance was not referenced at all in the MDOs and is therefore an inadmissible post hoc explanation; and (d) the high level of youth vaping that spawned the 2020 Guidance had been underway since 2018, yet FDA did not adjust its PMTA Guidance materials significantly during this period. 6 Moreover, recourse to the 2020 Guidance as a basis for FDA’s having disregarded the marketing plans is flatly contradicted by the Final PMTA Rule, which continued to stress the importance of such plans as a “critical factor” in FDA’s approval decisions. Third, the majority admits that since FDA never reviewed the marketing plans, “one could argue” it had no basis to find them neither “novel or materially different” from others. But wait—the majority relies on FDA’s statement—in oral argument to this court—that its review actually included a summary of the marketing plan. This is judicial post hoc reasoning about a post hoc justification. Fourth, and most objectionably, the majority blames petitioners for not knowing that “marketing plans on their own are not particularly useful.” 6 The 2020 Guidance also focuses almost exclusively on the continuing attractiveness to youth of closed-system ENDS products, and very little if at all on bottled e-liquids for use in open systems. These petitioners produce bottled e-liquids. To the extent FDA means to say that youth will migrate to any flavored ENDS products if other avenues are closed off, it provided no evidence of that migration toward petitioners’ products during the periods in question. In fact, the 2020 Guidance stated that it “should have minimal impact on those vape shops that primarily sell non-cartridge ENDS products and ensure that purchasers are of the requisite age and are not purchasing for resale[.]” Triton FDA-2-000321-000322. 34 Case: 21-60766 Document: 00516397516 Page: 35 Date Filed: 07/18/2022 No. 21-60766 c/w No. 21-60800 That statement stands the requirement of reasoned agency decisionmaking on its head. Every single statement by the agency, until it issued its MDOs to these petitioners, reasonably led petitioners to believe that if they devised marketing arrangements that would prevent underage persons from purchasing their flavored e-liquids for open systems, they would have surmounted a significant requirement for marketing approval. Finally, to assert that the agency’s deliberate lapse amounted to “harmless error” is simply incorrect. Prejudice in the administrative law context does not involve a “complex system of ‘burden shifting’ rules or a particularly onerous requirement.” Shinseki v. Sanders, 556 U.S. 396, 410, 129 S. Ct. 1696, 1706 (2009). An “APA deficiency is not prejudicial only when it is one that clearly had no bearing on the procedure used or the substance of decision reached.” United States v. Johnson, 632 F.3d 912, 930 (5th Cir. 2011). Taken in conjunction with the agency’s violation of other administrative norms through its failures of notice and ignoring petitioners’ reliance interests, the majority has no basis for claiming harmless error. For all these reasons, the agency cannot run away from individually reviewing petitioners’ marketing plans when, for two years, it assured the public that properly tailored marketing of flavored ENDS products could protect youth from exposure and abuse while the products also helped those who need to stop smoking. It is the epitome of agency hubris to pull the rug out from entities whose very existence depends on the agency’s careful balancing of all factors relevant to this public health issue.