This week, the Attorney General’s Office filed a petition for certiorari FDA v. Salari and White Lion Investments LLC, asking the Supreme Court to review the United States Court of Appeals for the Fifth Circuit’s en banc decision, concluding that the FDA’s denial of certain premarket tobacco vaping product (PMTA) applications was arbitrary and capricious. According to the SG, the Supreme Court’s review of the Fifth Circuit’s decision is justified because the court relied on “legal theories that have been rejected by other appellate courts that have reviewed substantially similar FDA denial orders.”
On the one hand, the federal government’s decision to seek Supreme Court review is what one might expect. There is a circuit split over whether the FDA acted arbitrarily and capriciously when it refused to consider certain materials submitted with the PMTAs and departed from previous guidance provided to industry. Most circuits that heard such claims rejected them. The Fifth Circuit (along with the Eleventh Circuit) did not. Certiorari would then be empowered to resolve the circuit split and remove any uncertainty about the FDA’s continued ability to review (and deny) PMTAs for vaping products. Without Supreme Court review, vaping product manufacturers would have every incentive to seek review of any PMTA denials in the Fifth and Eleventh Circuits, and this could undermine the FDA’s regulatory authority.
On another level, I suspect there has been some discussion within the Departments of Justice and Health and Human Services about whether this case provides the best vehicle for Supreme Court review of FDA regulation of vaping products. The vaping companies in this case may seem like attractive targets, but the record here includes multiple opinions criticizing the FDA’s failure to comply with administrative law rules. For this reason, one might have thought that the FDA would prefer to see the Supreme Court grant certiorari in a case in which the FDA prevailed successively and without a dissenting opinion.
Up to this point, I have been under the impression that the FDA has been somewhat strategic in deciding which cases to discuss where. Notably, the agency has been more than happy to defend PMTA denials against relatively small (often regional) vaping product manufacturers, while strategically avoiding going to court against larger plaintiffs, particularly those with d DC appeal of the highest order. So the FDA voluntarily agreed to reconsider its decision to reject Turning Point and Juul’s PMTAs, but went to court against smaller startup fluid makers. The FDA has thus far also been more willing to approve tobacco-flavored vaping products made by larger companies (often companies with a long history in the tobacco industry) while rejecting PMTAs from almost everyone else. To date, the agency has yet to approve a vaping product with a flavor profile other than tobacco.
Triton Distribution (the name of the vaping company owned by W&WL) is a mid-sized vaping fluid manufacturer, but the case is sure to attract the attention of other companies struggling to keep their products on the market. Some of the larger players (including companies that also make cigarettes) may be happy to sit on the sidelines, or even take the FDA’s side, particularly if their products have made it through the FDA’s regulatory challenge. Government banning competing products is a surefire way to maintain market share.
Although the Supreme Court does not grant certiorari all that often, this would seem to be a strong candidate. The circuit split and its continuing effects on the FDA’s ability to administer the PMTA approval process make eventual Supreme Court review inevitable, and if that is the case as the Justice Department pushes to resolve the matter, it is likely that this is the case that the Court will accept.