Justices Side With E-Cigarette Makers in FDA Venue Dispute (1)

The US Supreme Court declined to cut back on what the government said was “remarkable” forum shopping concerning where e-cigarette manufacturers can sue to challenge FDA decisions.

In a 7-2 ruling on Friday by Justice Amy Coney Barrett, the court broadly read the Family Smoking Prevention and Tobacco Control Act to allow retailers to sue alongside manufacturers. That allows industry to bring their cases outside of the US Court of Appeals for the D.C. Circuit, which is considered a national forum for determining the legality of federal administrative actions.

Justice Ketanji Brown Jackson said in a dissent joined by Sonia Sotomayor that the ruling allows manufacturers to do an “end run” around the TCA’s restrictions, permitting business to search for a friendly court.

The case comes from the Fifth Circuit, which has become the go-to venue for industry groups and conservatives seeking to challenge federal policies and social issues. It’s the only appellate court to side with e-cigarette manufacturers challenging FDA denial of applications to sell their products.

In a separate case decided by the court in April, the justices unanimously vacated the Fifth Circuit’s decision siding with different e-cigarette manufacturers in another challenge to FDA denials. In FDA v. Wages and White Lion Investments, LLC, the Supreme Court undid the ruling, which accused the agency of unfairly moving the goal line for approval.

Adversely Affected

The case decided Friday concerns the FDA denial of R.J. Reynolds’ application to market e-cigarettes, including its Vuse Alto products.

In siding with e-cigarette makers and retailers, the court said the TCA allows “any person adversely affected” by an FDA denial to sue in either the D.C. Circuit or the circuit in which the company is incorporate or has its principal place of business.

For RJ Reynolds, that would be the Richmond-based Fourth Circuit, which has rejected similar challenges to the FDA’s denials.

The question for the justices was whether the retailers, based in the New Orleans-based Fifth Circuit, could also sue, making venue proper in that circuit.

The majority said the retailers are adversely affected, meaning they too can challenge the denial.

“If the FDA denies an application, the retailers, like the manufacturer, lose the opportunity to profit from the sale of the new tobacco product—or, if they sell the product anyway, risk imprisonment and other sanctions,” the court said.

Jackson’s dissent accused R.J. Reynolds of an obvious ploy to team up with retailers to get around the adverse rulings in both the D.C. and Fourth Circuits. “It is not hard to see where this is going,” Jackson wrote.

By siding with R.J. Reynolds, the majority “opens up an avenue for judicial review that Congress did not intend,” she said.

The case is Food and Drug Administration v. R.J. Reynolds Vapor Co., U.S., No. 23-1187, 6/20/25.