FDA v. R.J. Reynolds Vapor Co.

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Supreme Court of the United States
FDA v. R.J. Reynolds Vapor Co.
Term: 2024
Important Dates
Argued: January 21, 2025
Decided: June 20, 2025
Outcome
affirmed and remanded
Vote
7-2
Majority
Chief Justice John Roberts • Clarence Thomas • Samuel Alito • Elena Kagan • Neil Gorsuch • Brett Kavanaugh • Amy Coney Barrett
Dissenting
Sonia Sotomayor • Ketanji Brown Jackson

FDA v. R.J. Reynolds Vapor Co. is a case that was decided by the Supreme Court of the United States on June 20, 2025, during the court's October 2024-2025 term. The case was argued before the Supreme Court of the United States on January 21, 2025.

In a 7-2 opinion, the court affirmed and remanded the judgment of the United States Court of Appeals for the Fifth Circuit, holding that retailers who would sell a new tobacco product if it weren't for the FDA’s denial order can seek judicial review of that order under §387l(a)(1). Justice Amy Coney Barrett delivered the opinion of the court.[1]

HIGHLIGHTS
  • The issue: The case concerned whether a company may petition to a court in a circuit outside of the company's primary market, if another company located within that court's jurisdiction signs onto said petition. Click here to learn more about the case's background.
  • The questions presented: "Whether a manufacturer may file a petition for review in a circuit (other than the D.C. Circuit) where it neither resides nor has its principal place of business, if the petition is joined by a seller of the manufacturer's products that is located within that circuit."[2]
  • The outcome: In a 7-2 opinion, the court affirmed and remanded the judgment of the United States Court of Appeals for the Fifth Circuit.[1]


    • The case came on a writ of certiorari to the United States Court of Appeals for the Fifth Circuit. To review the lower court's opinion, click here.

    Background

    Case summary

    The following are the parties to this case:[3]

    • Petitioner: Food and Drug Administration, et al.
    • Respondent: R.J. Reynolds Vapor Co., et al.
      • Legal counsel: Noel John Francisco (Jones Day)

    The following summary of the case was published by Oyez, a free law project from Cornell’s Legal Information Institute, Justia, and the Chicago-Kent College of Law:[4]

    “

    These cases arise from the Food and Drug Administration’s (FDA) denial of R.J. Reynolds Vapor Co.’s applications to market various e-cigarettes, including menthol- and berry-flavored “Alto” e-cigarettes. R.J. Reynolds, along with retail entities like Avail Vapor Texas and the Mississippi Petroleum Marketers and Convenience Stores Association, challenged this denial in the U.S. Court of Appeals for the Fifth Circuit.

    The FDA filed a Motion to Dismiss or Transfer, arguing that the petitioners do not meet the venue requirements set forth in the Family Smoking Prevention and Tobacco Control Act for filing their petition in the Fifth Circuit. The case was consolidated with previous related cases, and the court had previously ruled that venue was proper in the Fifth Circuit in a related matter. In the present matter, the Fifth Circuit stood by its prior decision that venue was proper.[5]

    		”

    To learn more about this case, see the following:

    Timeline

    The following timeline details key events in this case:

    Questions presented

    The petitioner presented the following questions to the court:[2]

    Questions presented:
    “ Whether a manufacturer may file a petition for review in a circuit (other than the D.C. Circuit) where it neither resides nor has its principal place of business, if the petition is joined by a seller of the manufacturer's products that is located within that circuit.[5] ”

    Oral argument

    Audio

    Audio of oral argument:[7]




    Transcript

    Transcript of oral argument:[8]

    Outcome

    In a 7-2 opinion, the court affirmed and remanded the judgment of the United States Court of Appeals for the Fifth Circuit, holding that retailers who would sell a new tobacco product if it weren't for the FDA’s denial order can seek judicial review of that order under §387l(a)(1). Justice Amy Coney Barrett delivered the opinion of the court.[1]

    Opinion

    In the court's majority opinion, Justice Amy Coney Barrett wrote:[1]

    “

    Even without the word ‘any,’ the phrase ‘person adversely affected’ suggests an intent to cover more than one party. If Congress intended to convey the FDA’s reading, it would more naturally have said ‘applicant.’ And there is ‘no basis in text or prior practice’ for limiting ‘person adversely affected’ to mean ‘the applicant.’ Cf. Thompson, 562 U. S. 170 (rejecting analogous argument that Title VII’s use of ‘person claiming to be aggrieved’ refers to a single person). Congress knows how to limit the scope of a cause of action—in fact, it did so elsewhere in the TCA. When the FDA withdraws an existing approval of an application to market a new tobacco product, only the ‘holder of [the] application’ may challenge the withdrawal order. §387j(d)(2). Congress’s use of materially different terms in the TCA—’holder of [the] application’ in §387j(d)(2) and ‘any person adversely affected’ in §387l(a)(1)—raises the presumption that the different terms mean different things. This principle is fatal to the FDA’s reading of §387l(a)(1). The FDA’s other structural and policy arguments likewise cannot be squared with Congress’s use of the phrase ‘any person adversely affected.’

    The retailers had the right to petition for review under the TCA, and the Fifth Circuit denied the FDA’s motion to dismiss or transfer because it correctly concluded that at least one proper petitioner had venue. [5]

    		”
    —Justice Amy Coney Barrett

    Dissenting opinion

    Justice Ketanji Brown Jackson filed a dissenting opinion, joined by Justice Sonia Sotomayor.

    In her dissent, Justice Jackson wrote:[1]

    “

    The majority correctly acknowledges that the disputed ‘any person adversely affected’ language in §387l(a)(1) of the Tobacco Control Act implicates our well-established zone-of-interest test. All agree, too, that, under the zone-of-interest test, the watchword is congressional intent. But I would proceed to determine Congress’s intent as normal, by applying the traditional tools of statutory interpretation to investigate the scope of §387j(c)—the provision that respondents argue the FDA violated. Every available indicator reveals that Congress intended to permit manufacturers—not retailers—to challenge the denial of a manufacturers’ marketing application (and to do so only in the designated courts). In concluding otherwise, the majority not only opens up an avenue for judicial review that Congress did not intend, it also allows manufacturers like RJR Vapor to evade the statute’s venue requirements.[5]

    		”
    —Justice Ketanji Brown Jackson

    Text of the opinion

    Read the full opinion here.

    October term 2024-2025

    See also: Supreme Court cases, October term 2024-2025

    The Supreme Court began hearing cases for the term on October 7, 2024. The court's yearly term begins on the first Monday in October and lasts until the first Monday in October the following year. The court generally releases the majority of its decisions in mid-June.[9]


    See also

    External links

    Footnotes

    1. ↑ 1.0 1.1 1.2 1.3 1.4 1.5 U.S. Supreme Court, "FDA v. R.J. Reynolds Vapor Co.," June 20, 2025
    2. ↑ 2.0 2.1 Supreme Court of the United States, "23-1187 FDA V. R.J. REYNOLDS VAPOR CO. QP", October 4, 2024
    3. ↑ Supreme Court of the United States, "No. 23-1187," accessed November 22, 2024
    4. ↑ Oyez, "Food and Drug Administration v. R.J. Reynolds Vapor Co.," accessed November 22, 2024
    5. ↑ 5.0 5.1 5.2 5.3 Note: This text is quoted verbatim from the original source. Any inconsistencies are attributable to the original source.
    6. ↑ [United States Court of Appeals for the Fifth Circuit, FDA v. R.J. Reynolds Vapor Co., decided February 2, 2024]
    7. ↑ Supreme Court of the United States, "Oral Argument - Audio," argued January 21, 2025
    8. ↑ Supreme Court of the United States, "Oral Argument - Transcript," argued January 21, 2025
    9. ↑ SupremeCourt.gov, "The Supreme Court at Work: The Term and Caseload," accessed January 24, 2022
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