FDA v. R. J. Reynolds Vapor Co.
606 U. S. ____ (2025) (2025)
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Rule of Law:
The phrase 'any person adversely affected' in a statute creating a cause of action for judicial review is presumptively interpreted broadly to encompass any party with an interest arguably sought to be protected or regulated by the statute, consistent with the 'zone of interests' test under the Administrative Procedure Act.
Facts:
- In 2016, the Food and Drug Administration (FDA) deemed e-cigarettes to be 'new tobacco products' subject to regulation under the Family Smoking Prevention and Tobacco Control Act (TCA).
- The TCA requires manufacturers to obtain premarket authorization from the FDA before a new tobacco product can be marketed.
- R. J. Reynolds Vapor Co. (RJR Vapor) manufactured popular e-cigarette products, including the Vuse Alto line.
- RJR Vapor submitted premarket authorization applications to the FDA to continue marketing its Vuse Alto products.
- The FDA denied RJR Vapor's applications, finding the company had failed to demonstrate that marketing the products would be 'appropriate for the protection of the public health.'
- Avail Vapor Texas, L.L.C., was a Texas-based retailer, and the Mississippi Petroleum Marketers and Convenience Stores Association was a trade association for retailers, both of whom sold or would sell Vuse Alto products.
- As a direct result of the FDA's denial order, these retailers could no longer legally sell Vuse Alto products, causing them to lose the opportunity to profit from their sale.
Procedural Posture:
- RJR Vapor, along with Avail Vapor Texas (a retailer) and the Mississippi Petroleum Marketers and Convenience Stores Association (a trade group), filed a joint petition for judicial review of the FDA's denial order.
- The petition was filed in the U.S. Court of Appeals for the Fifth Circuit, where the retailer and trade group were located.
- The FDA moved to dismiss the petition for improper venue or, alternatively, to transfer the case to the D.C. or Fourth Circuit.
- The FDA argued that only the applicant, RJR Vapor, was 'adversely affected' and a proper petitioner, making venue in the Fifth Circuit improper.
- A divided panel of the Fifth Circuit denied the FDA's motion, concluding that venue was proper.
- The FDA petitioned the U.S. Supreme Court for a writ of certiorari, which was granted.
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Issue:
Does the phrase 'any person adversely affected' in the Family Smoking Prevention and Tobacco Control Act's judicial review provision, §387l(a)(1), encompass downstream retailers of a product whose manufacturer was denied premarket marketing authorization by the FDA?
Opinions:
Majority - Justice Barrett
Yes, the phrase 'any person adversely affected' in the TCA encompasses downstream retailers. The phrase is a legal term of art that presumptively carries the same broad meaning it has under the Administrative Procedure Act (APA), which covers anyone 'arguably within the zone of interests' a statute protects or regulates. Retailers fit this description, as the FDA's denial order directly impacts their ability to profit and exposes them to penalties. This broad interpretation is supported by the statute's text; if Congress had intended to limit the right to sue to the manufacturer, it would have used narrower language like 'applicant,' as it did in another section of the TCA dealing with withdrawal orders (§387j(d)(2)). The use of materially different terms ('any person adversely affected' versus 'holder of [the] application') implies Congress intended different meanings.
Dissenting - Justice Jackson
No, the phrase 'any person adversely affected' does not encompass retailers in this context. The majority's interpretation improperly isolates the phrase from the statutory scheme it governs. The zone-of-interests inquiry must focus on the specific provision being challenged—here, the premarket authorization process in §387j. That process is an exclusive, adjudicatory scheme between the manufacturer and the FDA; retailers have no rights or role. The statutory structure in Block v. Community Nutrition Institute is analogous, where parties excluded from the administrative process were also precluded from judicial review. Furthermore, it is illogical that Congress would allow retailers to challenge an initial denial, where they have no reliance interest, but explicitly bar them from challenging a withdrawal of approval, where they would. The majority's holding facilitates strategic forum shopping, allowing manufacturers to evade the TCA's venue restrictions.
Analysis:
This decision reinforces the Supreme Court's preference for a broad, APA-style interpretation of 'zone of interests' for any statute using the phrase 'any person adversely affected.' It establishes a strong presumption against narrow, statute-specific readings that would limit judicial review to only the direct subjects of agency action. The ruling empowers economically affected third parties, such as suppliers and retailers, to challenge agency decisions, which will likely increase administrative litigation. It also highlights the strategic interplay between broad standing rules and specific venue provisions, as the decision effectively allows a petitioner to gain access to a preferred judicial circuit by joining with a co-petitioner located there.
