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

A divided U.S. Court of Appeals panel for the Sixth Circuit voted against Breeze Smoke LLC’s request for a stay of the Food and Drug Administration’s Order denying its Premarket Tobacco Products Application (PMTA). This order denied the company’s vaping products, also known as “ENDS” or electronic nicotine delivery system (ENDS). You can read the entire article here Breeze Smoke LLC, v. FDASixth Circuit rebuffed the Fifth Circuit’s assertion that FDA had orchestrated an “surprise switcheroo” in the PMTA Review process. This split creates an intriguing circuit that could attract Supreme Court attention.

On behalf of Judges Moore & Gilman, the Sixth Circuit found that FDA has never accepted PMTA applications to vape products with short-term studies. The FDA had only stated that they were aware of the fact. mayAccept evidence that is not long-term, provided it has sufficient scientific backing to support the conclusion. [Tobacco Control Act’s]a statutory obligation to demonstrate that flavored ENDS device are suitable for the protection and preservation of public health.” (emphasis added). 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 voted against, noting that he had agreed with the Fifth Circuit decision. Wages and White Lion Investments LLC v USFDA.

Although the FDA denied Breeze Smoke its stay request, the Sixth Circuit Panel expressed concern about the FDA handling the application of Breeze Smoke, especially the FDA’s “formulaic consideration” of Breeze Smoke’s plan to stop youth marketing.

Breeze Smoke’s marketing strategy should have been more carefully considered by the FDA.
plan. agency action should consider the relevant factors when making a decision. It may not be “entirely unsuccessful”.[]”An important aspect” is to be considered in the regulatory task. Manufacturers of Motor Vehicles. Ass’n of U.S., Inc. against State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983). FDA asserts that Breeze Smoke’s marketing strategy was properly rejected by the FDA because it “would not change its analysis” if they considered specific marketing methods proposed in petitioner’s application. FDA Br. FDA Br. at 18. This is unclear. FDA refers 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). This is in contrast to the FDA’s complete disregard for the marketing plan because the FDA had previously ignored them.
The agency was satisfied.

The threat of Breeze Smoke being denied the PMTA, as well as the failure to pass the test were not sufficient to persuade the majority of the panel to grant a stay.

Breeze Smoke must show a high likelihood of success and the FDA has likely concluded that Breeze Smoke did not adequately protect the public’s health. We deny Breeze Smoke’s request for stay. This is despite the FDA’s possible insufficient attention to Breeze Smoke’s marketing plan. This oversight “has not permeated the whole”. [adjudication] process.” Pub. Citizen v. Fed. Motor Carrier Safety Admin., 374 F.3d 1209, 1217 (D.C. Cir. 2004).

Breeze Smoke was not able to meet TCA requirements for new tobacco products being appropriate for public health. The FDA deemed Breeze Smoke’s application reasonable. FDA cited strong evidence to show that flavored ENDS products have a special appeal for youths and harm the public health in a way not outweighed (far less-supported) by adult cigarette smokers who switch to e cigarettes. Breeze Smoke argues FDA applied separate standards for review. Breeze Smoke had to present more literature reviews than the FDA to prove its product’s public health benefits. Pet’r Br. at 18. The FDA did not rely on the literature about flavored ENDS products appeal to young people because of their potential risks.
It is a matter for scientific consensus. Breeze Smoke Lithium. Review, A66. (“There is significant evidence that ecigarette use raises risk of ever smoking combustible tobacco cigarettes with youth and young adults.”FDA Comm’r Speech A171 (“We know that kids love products such as. . . 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 contrasts starkly with an agency’s claim that [two concepts] are different.” Cincinnati Bell Tel. Co. v. Fed. Commc’ns Comm’n, 69 F.3d 752, 768 (6th Cir. 1995).

It is important to note several points in the court’s analysis, particularly its description of the evidence on youth and flavored vaping. First, there is no “scientific consensus” in relevant literature regarding flavored ENDS or youth. Neither do the Sixth Circuit orders cite the material supporting the court’s claim. The mere existence of “substantial evidence,” or any evidence supporting a conclusion by an agency, does not necessarily mean it is right. It is far from the truth, and anyone who has ever been exposed to administrative law standards of review should be able to see this.

Limitations on vaping products do more than just limit the number of adult smokers who switch to safer alternatives. It is becoming increasingly clear that restricting vaping products may actually be beneficial. Increasing youth smoking. In fact, this research is consistent with the other. JAMA PediatricsA study showed that there was a marked increase in the use of tobacco-flavored products by youths after San Francisco’s ban. Although I don’t know if this information was available to the Sixth Circuit at the time, it is a reminder that courts must be cautious about how they describe the evidence and not simply claim that the literature supports the contested claims as a matter scientific consensus.

Breeze Smoke, another ENDS manufacturer that has challenged FDA’s PMTA rejection for vaping product products is also worth noting. It isn’t the only ENDS company to request a stop at the Sixth Circuit. Here’s the interesting part.

Turning Point Brands sought to stay the FDA order that denied approval of its flavor ENDS PMTAs in the Sixth Circuit. This raised similar concerns as those of Breeze Smoke and Triton in Fifth Circuit. Turning Point was denied approval by the FDA for its PMTA refusal. However, FDA filed and reversed it because they “found relevant information which had not been adequately evaluated.” Turning Point therefore withdrew the stay application and instead the Sixth Circuit ruled in favor of the Breeze smoke’s application. It is not clear if this was an intentional, strategic decision by FDA to alter which orders are subject to judicial scrutiny, but it is a strong possibility. The rescission took place before the Fifth Circuit’s Triton decision.

The Sixth Circuit rejected Breeze Smoke’s request for a stay and expressed disagreement with the Fifth Circuit’s evaluation of FDA’s actions when similar arguments were raised. The split could open the door to Supreme Court review in an unargued case or emergency request on the “shadow Docket”. The Court could review these cases to determine if agencies are legally bound to follow their guidelines. It also would be able to deflect the FDA from its overzealous regulation non-combustible tobacco items. Keep watching.