FDA

Divided Sixth Circuit Refuses to Stay FDA's Denial of Vaping Product Application

In rejecting Breeze Smoke's application for a stay of the FDA's rejection of their product applications, the Sixth Circuit disagrees with the Fifth Circuit.

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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 company's 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 indicated 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 contrast, the FDA ignored the marketing plan entirely because prior marketing plans had not satisfied the agency.

This failing, and the impact of a PMTA denial on Breeze Smoke's business were still not enough to convince a majority of the panel to enter a stay however.

Because Breeze Smoke bears the burden of showing a strong likelihood of success on the merits, and because the FDA likely properly concluded that Breeze Smoke failed to show that its products adequately protected the public health, described above, we still deny Breeze Smoke's motion for stay, even in light of the FDA's possibly insufficient consideration of Breeze Smoke's marketing plan. This oversight has not "permeated the entire [adjudication] process." See Pub. Citizen v. Fed. Motor Carrier Safety Admin., 374 F.3d 1209, 1217 (D.C. Cir. 2004).

The FDA reasonably concluded that Breeze Smoke's application did not meet the TCA's requirements that new tobacco products be appropriate for the protection of the public health. The FDA cited well-developed evidence showing that flavored ENDS products' special appeal to youths harms the public health to a degree not outweighed by the (far-less-supported) effects of adult cigarette smokers switches to e-cigarettes. Breeze Smoke argues that the FDA deployed separate standards of review, considering literature that supported the thesis that flavored ENDS products pose special health risks to children and requiring Breeze Smoke present more than literature reviews to justify its products' public health benefits. Pet'r Br. at 18. But the FDA relied on literature concerning flavored ENDS products' appeal to youths because those risks are understood as a matter of scientific consensus. See Breeze Smoke Lit. Review, A66 ("There is substantial evidence that e-cigarette use increases risk of ever using combustible tobacco cigarettes among youth and young adults."); FDA Comm'r Speech, A171 ( "we know" that "kid appealing flavors in products like . . . ENDS . . . are a leading driver of youth smoking"); Enforcement Priorities for ENDS without Premarket Authorization Guidance for Industry, A272–78 (collecting data showing "substantial and increasing initiation of ENDS products by youth, particularly certain flavored, cartridge-based products" (on A278)). This differs sharply from an agency's "raw assertion that [two concepts] are different." Cincinnati Bell Tel. Co. v. Fed. Commc'ns Comm'n, 69 F.3d 752, 768 (6th Cir. 1995).

There are several things worth noting in this court's analysis here, in particular its characterization of the evidence on flavored vaping products and youth. For starters, the relevant literature on flavored ENDS and youth do not show a "scientific consensus," nor do the materials cited in the Sixth Circuit order support the court's assertion. That there is "substantial evidence" for an agency conclusion does not mean that the agency is correct, let alone that all the evidence points in the same direction. Far from it, as anyone remotely familiar with standards of review in administrative law should know.

Further, limitations on e-cigarettes do not only affect the rate at which adult smokers switch to less-harmful products. There is ample (and growing) evidence that restrictions on vaping products can actually increase youth smoking. Indeed, consistent with other research, one recent JAMA Pediatrics study found a significant increase in youth smoking after San Francisco banned sales of flavored tobacco products. I do not know whether this information was before the Sixth Circuit, but it shows why courts should be careful with how they characterize the evidence before them and not cavalierly claim the relevant literature shows contested claims "as a matter of scientific consensus."

One other item of note, Breeze Smoke is far from the only ENDS manufacturer to have challenged the FDA's PMTA denial for vaping products. Indeed, it is not even the only ENDS manufacturer to have sought a stay of such a denial from the Sixth Circuit. And here is where it gets curious.

Turning Point Brands also sought a stay of the FDA's order denying approval of its flavored ENDS PMTAs from the Sixth Circuit, raising similar concerns to those raised by Breeze Smoke (and by Triton in the Fifth Circuit). Yet in Turning Point's case, the FDA folded, rescinding its PMTA denial because it "found relevant information that was not adequately assessed." Accordingly Turning Point withdrew its stay application, meaning the Sixth Circuit ruled on the Breeze Smoke's application instead. Whether this was a deliberate, strategic choice by the FDA to manipulate which orders were subject to judicial review is unclear, but it's a definite possibility. (Note that the rescission occurred before the Fifth Circuit's decision in the Triton case.)

In rejecting Breeze Smoke's stay request, the Sixth Circuit expressly disagreed with the Fifth Circuit's assessment of the FDA's action when challenged on similar grounds. This split would seem to create the possibility of Supreme Court review, either in an argued case or an emergency stay request on the "shadow docket." Review of these decisions would provide the Court with opportunity to clarify the extent to which agencies are bound by their own guidance documents, as well as to corral the FDA's over-zealous regulation of non-combustible tobacco products. Stay tuned.