Divided Sixth Circuit Refuses to Stay FDA’s Denial of Vaping Product Application
Last Friday, a divided panel of the U.S. Court of Appeals for the Sixth Circuit rejected Breeze Smoke LLC’s application of a stay of the Food and Drug Administration’s order denying the companies Premarket Tobacco Product Application (PMTA) for some of its vaping products (also referred to as electronic nicotine delivery systems or “ENDS”). In Breeze Smoke LLC v. FDA, the Sixth Circuit rejected the Fifth Circuit’s conclusion that the FDA had orchestrated a “surprise switcheroo” in the PMTA review process. This creates an interesting circuit split that might attract Supreme Court interest.
The Sixth Circuit’s order, on behalf of Judges Moore and Gilman, concluded that the FDA had never committed itself to accepting PMTA applications for flavored vaping products that lacked long-term studies. Rather, the FDA had merely implicated that “it might accept evidence other than long-term studies, if that evidence had sufficient scientific underpinnings to meet the [Tobacco Control Act’s] statutory mandate of demonstrating that flavored ENDS devices are appropriate for the protection of public health” (emphasis in original). Thus the court concluded that Breeze Smoke had failed to demonstrate the strong likelihood of success on the merits necessary to support a stay. Judge Kethledge dissented, noting his agreement with the Fifth Circuit’s decision in Wages and White Lion Investments LLC v USFDA.
While rejecting Breeze Smoke’s stay request, the Sixth Circuit panel did note some concern with the FDA’s handling of the company’s application, particularly its “formulaic consideration” of Breeze Smoke’s plans to prevent marketing to youth.
The FDA likely should have more thoroughly considered Breeze Smoke’s marketing
plan. Agency action must consider “the relevant factors” when reaching a decision, and may not “entirely fail to consider an important aspect” of the relevant regulatory task. Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983). The FDA argues that it properly declined to consider Breeze Smoke’s marketing strategy because “consideration of the specific marketing measures proposed in petitioner’s application would not alter its analysis.” FDA Br. at 18. It is not clear how the FDA could have known this. The FDA cites Butte County v. Chaudhuri for the proposition that an agency need not explicitly mention each piece of evidence, but there the agency’s analysis cited countervailing evidence showing why it had rejected the allegedly ignored evidence. 887 F.3d 501, 509 (D.C. Cir. 2018). Here, by con
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