The U.S. Supreme Court will hear a case on Jan. 21, 2025, that pertains to flavored vaping products and alleged forum shopping by a manufacturer of those products.
The justices scheduled the case—known as Food and Drug Administration (FDA) v. Reynolds Vapor Co.—on Oct. 31 after agreeing on Oct. 4 to hear the dispute.
The nation’s highest court is expected to explore procedural issues instead of looking at whether the FDA was correct in its ruling denying approval of the products.
R.J. Reynolds Vapor Co. makes e-cigarette products marketed under the name Vuse. The company was incorporated and is headquartered in North Carolina, which is within the geographical boundaries of the U.S. Court of Appeals for the Fourth Circuit.
However, the company brought its appeal of the FDA’s denial of its application to market its wares to the Fifth Circuit instead of the Fourth Circuit.
The Fifth Circuit, which issued an order allowing the products to continue to be marketed while the case remains pending, is perceived to be sympathetic to the vaping industry. Moreover, that court allows challenges to FDA product denials to be filed with it even if the manufacturer isn’t headquartered within the geographical boundaries of the circuit.
The federal government argues that the manufacturer engaged in what is known as judicial forum shopping—a frowned-upon practice in legal circles—in order to obtain the most favorable result in court.
The Supreme Court should hear the case “to put a stop to that practice,” U.S. Solicitor General Elizabeth Prelogar argued months ago when urging the high court to grant its petition.
“The Fifth Circuit’s decision permits retail sellers of a tobacco product who have no right of judicial review under the Act to nevertheless gain review; effectively nullifies the Act’s limits on venue; facilitates blatant forum shopping; and undermines the precedents of other circuits,” Prelogar said.
When the agency withholds authorization, any person “adversely affected” by the decision may seek review from the U.S. Court of Appeals for the District of Columbia Circuit or “the circuit in which such person resides or has their principal place of business,” according to the act.
In this case, the Fifth Circuit has decided that a manufacturer is allowed to file an appeal in that circuit even if it doesn’t have its principal place of business there as long as the petition it files includes as litigants sellers of its products who do operate in a state covered by the Fifth Circuit. Often, vaping products are sold at gasoline stations and convenience stores.
In 2016, the FDA introduced a rule to regulate electronic nicotine delivery systems. These battery-powered devices heat up a liquid containing nicotine and transform it into an aerosol to be inhaled by the user, according to the petition.
Reynolds sought FDA approval for its products in three applications, which the FDA rejected in 2023.
The law permits the agency to approve marketing authorization only if the manufacturer demonstrates that marketing of the product is “appropriate for the protection of the public health.”
The FDA found the company had not complied with that requirement, the petition states.
Reynolds appealed to the Fifth Circuit because its products are sold there. The company said there is no split in rulings between the various circuit courts and that it was justified in filing the case in the Fifth Circuit.
The Fifth Circuit ruled against the FDA in February, finding that because sellers of the products within the boundaries of the circuit were added as parties to the lawsuit, the case could be heard in that court.
The company said the Fifth Circuit “correctly held” that both manufacturers and retailers have a right under the law to appeal a product denial order.
Because the retailers are based in the Fifth Circuit, the “venue is proper,” it stated.
