The Supreme Court decided on Oct. 4 to hear a case about flavored vaping products the government says the manufacturer improperly filed in the wrong court to seek a favorable result.
The nation’s highest court is expected to deal with procedural issues instead of the question of whether the U.S. Food and Drug Administration (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 is incorporated and headquartered in North Carolina, which is within the geographical boundaries of the U.S. Court of Appeals for the Fourth Circuit.
But the company brought its appeal of the FDA’s denial of its products in 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. That court allows challenges to FDA product denials to be filed there even if the manufacturer isn’t headquartered within the geographical boundaries of the circuit.
The government argues that the manufacturer engaged in what is known as forum shopping—a frowned-upon practice in legal circles—in order to obtain the most favorable result in court.
The Supreme Court should agree to hear the case “to put a stop to that practice,” U.S. Solicitor General Elizabeth Prelogar argued in court papers.
“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,” she wrote.
If the agency denies authorization, any person “adversely affected” by the denial 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.”
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 filed includes sellers of its products. 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 allows 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 determined that the company had not complied with that requirement, the petition states.
Reynolds appealed in the Fifth Circuit, as opposed to the Fourth and D.C. Circuits, because its products are sold in the Fifth Circuit. The company said there is no split in rulings by the various circuit courts of appeal 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 Fifth Circuit “correctly held” that both manufacturers and retailers have a right under the law to appeal a product denial order, the company said.
Because the retailers are based in the Fifth Circuit, the “venue is proper,” it said.
The Supreme Court is expected to hear the case in December or January.
