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The Supreme Court has granted certiorari in FDA v. R.J. Reynolds Vapor Co., No. 23-1187, to decide whether a federally regulated product’s manufacturer and retailers can join together, in a single federal court of appeals, to challenge a final agency action that impairs their shared commercial interests.
ALF has filed a merits-stage amicus brief explaining that this case affords the Supreme Court an important opportunity to reaffirm, or at least clarify, the breadth of a statute-specific right to judicial review that encompasses “any person adversely affected” by a final agency action.
Case Background
The product at issue, e-cigarettes, heat a nicotine-containing liquid into an inhalable aerosol. Although e-cigarettes contain no tobacco, the Food and Drug Administration (FDA) in 2016 deemed them “new tobacco products” subject to regulation, including premarket approval, under the Family Smoking Prevention and Tobacco Control Act (“TCA”). FDA has denied marketing authorization applications submitted by R.J. Reynolds Vapor Co. (“RJRV”) for Vuse e-cigarettes, which in accordance with an FDA compliance/enforcement policy, remained on the market while the marketing applications were being considered.
The TCA states that “any person adversely affected by such . . . denial may file a petition for judicial review of such . . . denial with the United States Court of Appeals for the District of Columbia or for the circuit in which such person resides or has their principal place of business.” 21 U.S.C. § 387l(a)(1). RJRV, along with a Texas retailer of Vuse e-cigarettes and a Mississippi-based gasoline station/convenience store assocation, jointly filed a judicial review petition in the U.S. Court of Appeals for the Fifth Circuit challenging FDA’s marketing denial for Vuse “Alto” e-cigarettes. FDA sought to block the Fifth Circuit from hearing the appeal, arguing that RJRV does not reside in the Fifth Circuit and that the retailers are not “adversely affected” by, and thus lack statutory standing (as distinct from Article III constitutional standing) to challenge, the denial of RJRV’s marketing authorization applications.
A divided Fifth Circuit panel held that the appeal can proceed because the TCA “grants the Petitioners statutory standing to challenge FDA decisions that affect them. . . . All the Petitioners are ‘person[s] adversely affected’ under the Act, and two of the Petitioners [the retailers] have their principal places of business here in the Fifth Circuit.” FDA then filed a petition for a writ of certiorari, which the Supreme Court has granted.
ALF's Amicus Brief
ALF’s amicus brief focuses on why e-cigarette retailers, like manufacturers, have statutory standing (as well as Article III standing) under the TCA to seek judicial review of FDA marketing denials.
The brief argues that the TCA judicial review provision at issue, 21 U.S.C. § 387l(a)(1), should be broadly construed because it entitles “any person adversely affected” by an FDA marketing denial to seek judicial review. The Court should reject FDA’s form-over-substance contention that the TCA “zone of interests” circumscribing the meaning of “any person” under § 387l(a)(1) is limited to e-cigarette manufacturers because it is they that submit marketing applications and receive denial letters. Instead, the Court should take the same lenient approach to interpreting the scope of “any person adversely affected” in § 387l(a)(1) as it does for the nearly identical phrase in the federal Administrative Procedure Act’s omnibus judicial review provision, 5 U.S.C. § 702. This is particularly important because the Court’s ruling may affect the availability of judicial review under numerous additional federal statutes that use the same, or essentially the same, phrase.
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