Supreme Court Rules Against FDA in "Venue Shopping" Case

The Supreme Court today ruled against the FDA, finding that appeals of FDA marketing denial orders (MDOs) are not limited only to the products’ manufacturers, and that vape manufacturers may appeal denials in any federal circuit court, as long as they are joined by an affected party located in the judicial circuit being petitioned.

The ruling clears the way for R.J. Reynolds Vapor Co. to pursue its challenge of MDOs for menthol versions of its Vuse vape devices in the Fifth Circuit Court of Appeals, far from its home state of North Carolina. The MDO petition for review has been stayed for over a year.

Liberal Justices Ketanji Brown Jackson and Sonia Sotomayor dissented from today’s ruling, but fellow liberal Elena Kagan joined the six conservative justices in a 7-2 majority. The court’s decision was written by Justice Amy Coney Barrett.

Menthol MDOs, the Fifth Circuit, and venue shopping

In January 2023 the FDA denied marketing applications for menthol refills of the Vuse Vibe and Ciro devices (the Ciro was later discontinued and removed from the legal challenge). Less than two months later, the agency issued an MDO for Reynolds’ Vuse Solo menthol refill, and in October 2023 issued a denial for Vuse Alto menthol pods. 

Reynolds appealed all three denial orders to the Fifth Circuit  Court of Appeals, with businesses residing in the Fifth Circuit listed as co-petitioners in the lawsuits. Reynolds quickly received temporary stays from the court in all three cases, allowing Vuse menthol products to remain on the market while the appeals proceeded. On Oct. 19, 2023, the three appeals were consolidated by the court into one case.

The FDA asked the court to dismiss the consolidated petition, or to transfer it to an appropriate venue, since its understanding of the law was that Reynolds was limited to appealing the MDOs in the District of Columbia Circuit or the Fourth Circuit, where its business was headquartered.

On Feb. 1, 2024, soon after the Fifth Circuit had ruled against the FDA in the Triton Distribution case, Reynolds moved to stay the consolidated appeal until final resolution of the Triton case (which Reynolds correctly assumed the FDA would take to the Supreme Court), and two weeks later the Fifth Circuit granted Reynolds’ motion. 

Meanwhile, on Feb. 2, the Fifth Circuit granted Reynolds a stay pending review for the consolidated Vuse appeal, and denied the FDA’s motion to transfer or dismiss the case based on inappropriate venue. 

In March 2024, the FDA petitioned the Supreme Court to review the Fifth Circuit’s Triton decision (which the court granted). Then in May 2024, the FDA petitioned the Supreme Court to rule on what it called “venue shopping” by R.J. Reynolds. 

“Any person adversely affected” 

The 2009 Family Smoking Prevention and Tobacco Control Act (TCA) is the basis of tobacco regulation in the United States, providing foundational rules and creating the FDA Center for Tobacco Products (CTP), which was given regulatory control over tobacco products. 

The TCA spelled out a process by which “any person adversely affected” by the denial of a tobacco marketing application (premarket tobacco applications, or PMTAs) could appeal the decision—either in the D.C. Circuit Court or the federal circuit “in which such person resides.” 

The FDA argued that the TCA granted the right to appeal a marketing denial only to the manufacturer who had filed the application, and not to other affected parties like retailers and trade associations. 

The two dissenting justices agreed with that position, but the majority didn’t. The plain language of the statute, they said—”any person adversely affected”—made clear that MDO challenges are not limited to the manufacturer.

The Vuse MDO appeals will now proceed in the Fifth Circuit—unless the Trump FDA decides to rescind the denials.

In either case, the result of the Supreme Court decision is likely to be even more MDO appeals filed in the Fifth Circuit, with retailers from the region covered by the Fifth (Louisiana, Mississippi and Texas) signing onto the actions as co-petitioners.

In its January 2025 oral argument before the court, the FDA said 75 percent of all 2024 MDO challenges were filed in the Fifth Circuit—all of them by companies outside that court’s purview, and all with local partners from the Fifth Circuit. 

Last year, the Fifth Circuit used its own Triton Distribution decision as precedent to find in favor of several vaping manufacturers challenging MDOs outside the federal judicial circuits nearest to their business locations. In each case, the manufacturer had filed its appeal with a local retail seller as a co-petitioner.

Future challenges—including the Vuse appeals—will have to be made without using the Triton arguments rejected by the Supreme Court earlier this year. But there are other grounds that can be employed by aggrieved vaping businesses.

Today's Supreme Court decision, along with all related documents and court filings, is available to read on the Supreme Court case docket.