This educational guide is based on the linked primary sources. It is not a Court publication, is not affiliated with the Court, and is not legal advice.
In brief
Overview
In 2016, the FDA decided that e‑cigarettes and related products were new tobacco products subject to the Tobacco Control Act.
The Supreme Court held that retailers are “adversely affected” by a denial order and are proper petitioners under § 387l(a)(1) of the Tobacco Control Act.
The Court noted that no court had ever held that an agency is “adversely affected” or “aggrieved” under the APA.
Justice Jackson (dissent) defined the “zone‑of‑interest test” as a guide for deciding whether a plaintiff can challenge an agency decision.
Background and question before the Court
The case arose after the FDA’s 2016 determination that e‑cigarettes are tobacco products, prompting retailers to seek review of an FDA denial order.
What each side argues
FDA Position
The FDA argues that the Tobacco Control Act is concerned exclusively with manufacturers, placing retailers outside the statute’s zone of interest.
The FDA contends that § 387l(a)(1) applies not only to denial orders under § 387j(c) but also to regulations promulgated under § 387g.
The FDA maintains that each petitioner in a joint petition for review must independently establish venue.
What happened at oral argument
What the Court decided
No court has ever held that an agency is “adversely affected” or “aggrieved” under the APA.
Retailers are “adversely affected” by a denial order and are proper petitioners under § 387l(a)(1).
Justice Jackson (dissent) defined the “zone‑of‑interest test” as a guide for deciding whether a plaintiff can challenge an agency decision.
According to Justice Jackson (dissent), retailers have no procedural rights after a manufacturer submits its marketing application, and the FDA may deny an application without regard to retailer impact.
According to Justice Jackson (dissent), congress may have intended to protect manufacturers’ reliance interests without extending similar protection to retailers.
According to Justice Jackson (dissent), in the APA context, the zone‑of‑interest test is “not especially demanding.”
According to Justice Jackson (dissent), the majority fails to show how retailers are protected by § 387j; they are not protected at all.
According to Justice Jackson (dissent), retailers’ participation was strategically important to circumvent venue restrictions, even though Congress did not intend to protect them.
- [1] f62f8853ef78b233e379-r1-45eca458b4c9706c.pdf, p. 11
- [2] f62f8853ef78b233e379-r1-45eca458b4c9706c.pdf, p. 12
- [3] f62f8853ef78b233e379-r1-45eca458b4c9706c.pdf, p. 20
- [4] f62f8853ef78b233e379-r1-45eca458b4c9706c.pdf, p. 23
- [5] f62f8853ef78b233e379-r1-45eca458b4c9706c.pdf, p. 25
- [6] f62f8853ef78b233e379-r1-45eca458b4c9706c.pdf, p. 28
- [7] f62f8853ef78b233e379-r1-45eca458b4c9706c.pdf, p. 31
- [8] f62f8853ef78b233e379-r1-45eca458b4c9706c.pdf, p. 33
Why it matters
Terms to know
No glossary terms are available for this guide.
Primary sources
Read the source materials on the official site or open the immutable repository copy used for this guide.
- 03b18a58a0265bccff9d-r1-d1ece530b6fe384e.pdforal argument transcript
- f62f8853ef78b233e379-r1-45eca458b4c9706c.pdfopinion
Guide generated September 27, 2026. Automated validation accepted this version.