The U.S. Supreme Court appeared skeptical on Jan. 21 of federal government arguments advocating for restrictions on where the e-cigarette industry can sue to limit a practice known as forum shopping.
The federal government argues that the manufacturer has been unfairly gaming the judicial system by engaging in forum shopping—a frowned-upon practice in legal circles—to obtain the most favorable result in court.
The oral argument in Food and Drug Administration (FDA) v. R.J. Reynolds Vapor Co. focused on procedural issues rather than on whether the FDA was correct in its 2023 ruling denying approval of certain flavored vaping products from the company.
R.J. Reynolds Vapor Co. manufactures e-cigarette products marketed under the name Vuse. The company is incorporated and headquartered in North Carolina, which falls within the geographical boundaries of the U.S. Court of Appeals for the Fourth Circuit.
In 2016, the FDA introduced a rule to regulate electronic nicotine delivery systems.
Reynolds sought FDA approval for its products in three applications, which the FDA denied in 2023.
The company appealed the FDA’s denial of its application to market its products to the Fifth Circuit instead of the Fourth Circuit. The Fifth Circuit covers Texas, Louisiana, and Mississippi.
The Fifth Circuit issued an order allowing the products to continue to be marketed while the case remains pending. The court allows challenges to FDA product denials to be filed within it even if the manufacturer isn’t headquartered within the geographical boundaries of the circuit.
U.S. Department of Justice attorney Vivek Suri said on Jan. 21 that the Fifth Circuit “has effectively nullified” the federal Family Smoking Prevention and Tobacco Control Act’s “restrictions on venue.”
The statute provides that “an adversely affected person may challenge the denial of an application only in its home circuit or the D.C. Circuit.”
The Fifth Circuit allows applicants to challenge denials as long as they can convince a retailer to join the legal action, he said.
Suri said retailers are mere “bystanders” in FDA applications.
“They don’t submit information to the agency, don’t participate in the agency’s review process, don’t receive the order issued by the agency at the end of that process, and don’t even get to see the full contents of the application or administrative record. Their interests lie outside the zone that Congress sought to protect,” he said.
Chief Justice John Roberts told Suri: “It’s a bit much to call them bystanders. ... I don’t know why the retailers aren’t the most likely people to bring an action.”
Justice Brett Kavanaugh said retailers that are losing money because they aren’t being allowed to sell vaping products are being “adversely affected.”
Suri said his side was “not aware of a single case where a retailer has brought a freestanding challenge unaccompanied by the applicant.”
The manufacturer is using the retailer as “a prop” to gain access to a preferred circuit, he said.
“They’re not adding any value to the case itself,” the attorney said.
The tactic of outside applicants suing in the Fifth Circuit is being abused, Suri said.
“In 2024, by our count ... about 75 percent of e-cigarette cases were filed ... in the Fifth Circuit, all of them by out-of-circuit applicants trying to use the tactic,” he said.
Justice Amy Coney Barrett seemed concerned that reining in available judicial forums could have a ripple effect beyond the tobacco control statute.
“The government gets sued in a lot of places,” she told Suri. “And this would matter beyond just the [Tobacco Control Act], correct?”
Reynolds attorney Ryan Watson said: “The Tobacco Control Act allows any person adversely affected to challenge a marketing denial order. And retailers easily qualify. ... By allowing any person adversely affected to challenge denials, Congress plainly intended to extend review beyond the applicant. And the retailers are the next in line.”
Justice Ketanji Brown Jackson told Watson that retailers lack an interest in selling vaping products until the FDA grants them regulatory approval.
“Now their skin is really in the game,” she said.
The Supreme Court is expected to rule on FDA v. R.J. Reynolds Vapor Co. by the end of June.
