FDA’s cynical attempt to shut the courthouse doors — and the threat it poses to our rights against all federal agencies

A pending Supreme Court case threatens the right of many citizens’ to challenge agency actions that unlawfully harm them. In Food and Drug Administration v. RJ Reynolds Vapor Co, the Supreme Court will either confirm that right or permit the FDA to shut the courthouse door on many people and businesses harmed by unlawful agency actions. NCLA filed an amicus curiae brief in this case, urging the Supreme Court to keep the doors open.

Congress has spoken clearly in favor of access to the courthouse, passing many laws that authorize court challenges by people and companies “aggrieved” or “adversely affected” by agency actions. These laws—called judicial review provisions—provide an important check on agencies’ compliance with the law. They also codify the principle that citizens injured by unlawful agency actions are entitled to their day in court. The Administrative Conference of the United States’ Statutory Analysis Spreadsheet lists more than 650 judicial review provisions, in which the particular language varies but all of which grant rights to take an agency to court. Provisions granting rights to “adversely affected” persons involve too many areas to note here—agriculture programs, immigration rights, veterans benefits, and many more.

In FDA v. RJ Reynolds Vapor Co., the FDA is trying to block many injured parties from asserting their rights under one of these provisions. The case involves the Family Smoking Prevention and Tobacco Control Act, commonly called the Tobacco Control Act, which prohibits the sale of new tobacco products without FDA approval. RJR Reynolds Vapor Co., a manufacturer and marketer, asked the FDA for permission to market some new vaping products. The FDA denied the requests. Under the Tobacco Control Act’s statutory review provision, “any person adversely affected” by an FDA denial can challenge it in court. Challengers can file in their home circuit or in the DC Circuit. 21 U.S.C. § 387l(a)(1)(B).

RJR Reynolds Vapor is based in North Carolina, which is in the Fourth Circuit. But it wanted to file a challenge in the Fifth Circuit, which covers Mississippi, Louisiana, and Texas. So it filed joint petitions there, along with a small Texas-based vape retailer and an association of Mississippi convenience stores and gas stations. The petitioners stated that FDA’s denial order had “adversely affected” them by prohibiting them from selling the vaping products covered by the decision, costing them lost revenue. The Texas retailer swore in an affidavit that that its business depended on sales of these and similar products.

FDA moved to dismiss the petitions (and for other relief). It attacked the retailers’ right to sue under the Tobacco Control Act by arguing that they were not “adversely affected” by the denial order. But FDA did not dispute that Tobacco Control Act directly regulates the retailers, or that the denial order prohibits them from selling the covered products and costs them lost sales revenue. FDA did not dispute that the retailers faced severe sanctions if they did sell the products. The FDA also argued that the North Carolina based RJ Reynolds Vapor could not sue in the Fifth Circuit by joining in a petition with parties who are based there. It accused Reynolds of “blatant forum shopping.”

A Fifth Circuit panel, with one dissenter, rejected the FDA’s arguments. It ruled that the retailers were adversely affected by the FDA order and that RJ Reynolds Vapor could file in the Fifth Circuit. Undaunted, the FDA petitioned for certiorari, which the Supreme Court granted.

Last month the Supreme Court held oral argument. Most of the justices seemed to meet FDA’s arguments with skepticism. The FDA’s main argument—that the denial order did not “adversely affect” the vape retailers—appeared to fall flat. When FDA’s counsel tried to brush the retailers aside as mere “bystanders” to the denial order, Chief Justice Roberts scoffed at that effort as “a bit much.” He pointed out that the “whole point” of the Tobacco Control Act approval process was to determine whether the products will be sold to the public—which is exactly what the retailers want to do.

At least two justices, Barrett and Alito, highlighted the case’s broader implications for injured parties’ rights under many other statutes that provide rights to parties harmed by agency actions. If the Supreme Court were to agree with the FDA and narrow the meaning of “adversely affected” in the Tobacco Control Act, its ruling could narrow the scope of other judicial review provisions that grant rights to “adversely affected” or “aggrieved” parties. That outcome would block many individuals and businesses from challenging unlawful agency actions that injure them.

This threat prompted NCLA’s amicus brief urging the Justices to reject FDA’s arguments. Our brief explains why it is important for the Supreme Court to respect Congress’s decision to make judicial review available to all those who are “adversely affected” by FDA’s denial decision.

The oral arguments give reason for some optimism.  The Supreme Court appears inclined to respect Congress’s chosen language by giving the term “adversely affected” its natural meaning and ruling for the retailers. That ruling also would defeat the danger the FDA’s argument poses to many other judicial review provisions, ensuring that parties “adversely affected” or “aggrieved” under the many other statutes can have their days in court.

February 7, 2025