This week, the Office of the Solicitor General filed a petition for certiorari in FDA v. Wages & White Lion Investments LLC, asking the Supreme Court to review the U.S. Court of Appeals for the Fifth Circuit's en banc decision concluding that the FDA's denial of some vaping product pre-market tobacco applications (PMTAs) was arbitrary and capricious. According to the SG, Supreme Court review of the Fifth Circuit's decision is warranted because the court relied upon "legal theories that have been rejected by other courts of appeals that have reviewed materially similar FDA denial orders."
At one level, the federal government's decision to seek Supreme Court review is what one might expect. There is a circuit split on whether the FDA acted in an arbitrary and capricious fashion when it refused to consider certain materials submitted with PMTAs and departed from previous guidance it had given the industry. Most circuits to hear such claims turned them away. The Fifth Circuit (along with the Eleventh Circuit) did not. Certiorari would thus be warranted to resolve the circuit split and remove any cloud over the FDA's continuing 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.
At another level, I suspect there was some discussion within the Departments of Justice and Health & Human Services as to whether this case provides the best vehicle for Supreme Court review of the FDA's regulation of vaping products. The vaping companies in this case may seem like appealing targets, but the record here includes multiple opinions excoriating the FDA's failure to comply with administrative law norms. For this reason, one might have thought the FDA would have preferred to see the Supreme Court accept certiorari in a case in which the FDA prevailed below, and without a dissenting opinion.
Up until this point, it has been my impression that the FDA has been somewhat strategic in deciding which cases to litigate and where. In particular, the agency has been more than happy to defend PMTA denials against relatively small (often regional) vaping product manufacturers, while it has strategically avoided going to court against larger players, particularly those with top-notch DC appellate representation. Thus the FDA voluntarily agreed to reconsider its decision to reject PMTAs from Turning Point and Juul, but went to court against smaller fluid manufacturers of startups. The FDA, thus far, has also been more willing to approve tobacco-flavored vaping products produced by larger companies (often companies with a long history in the tobacco industry) while rejecting PMTAs from just about everyone else. To date, the agency has yet to approve a vaping product with any 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 attention from other companies fighting 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, however, or even take the FDA's side, particularly if their own products have made it through the FDA's regulatory gauntlet. Government prohibition of competing products is a sure-fire way to maintain market share.
While the Supreme Court does not grant certiorari all that often, this would seem like a strong candidate. The circuit split, and its ongoing effects on the FDA's ability to administer the PMTA approval process makes eventual Supreme Court review inevitable, and if this is the case the DOJ pushes to tee up this issue, this is likely the case the Court will accept.
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