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Food and Drug Administration v. Wages and White Lion Investments, LLC

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Supreme Court of the United States
Food and Drug Administration v. Wages and White Lion Investments, LLC
Term: 2024
Important Dates
Argued: December 2, 2024
Decided: April 2, 2025
Outcome
vacated and remanded
Vote
9-0
Majority
Chief Justice John Roberts • Clarence Thomas • Samuel Alito • Sonia Sotomayor • Elena Kagan • Neil Gorsuch • Brett Kavanaugh • Amy Coney Barrett • Ketanji Brown Jackson
Concurring
Sonia Sotomayor

Food and Drug Administration v. Wages and White Lion Investments, LLC is a case that was decided by the Supreme Court of the United States on April 2, 2025, during the court's October 2024-2025 term. The case was argued before the Supreme Court of the United States on December 2, 2024.

In a 9-0 opinion, the court vacated and remanded the judgment of the United States Court of Appeals for the Fifth Circuit. The court ruled against the Fifth Circuit’s conclusion that the FDA acted arbitrarily and capriciously in denying the manufacturers’ applications to market new e-cigarette products.[1]

HIGHLIGHTS
  • The issue: The case concerned a legal challenge to the Food and Drug Administration’s regulation of e-cigarettes. Click here to learn more about the case's background.
  • The questions presented: "Whether the court of appeals erred in setting aside FDA's denial orders as arbitrary and capricious."[2]
  • The outcome: In a 9-0 opinion, the court vacated 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]

    The following summary of the case was published by SCOTUSblog:[5]

    “ And in Food and Drug Administration v. Wages and White Lion Investments, the justices granted a petition filed by the Biden administration, seeking review of a ruling by the 5th Circuit in a challenge to the FDA’s denial of applications to market new e-cigarette products. The court of appeals set aside the FDA’s orders denying the applications, but now the Supreme Court will weigh in.[6] ”
    —Amy Howe

    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 the court of appeals erred in setting aside FDA's denial orders as arbitrary and capricious.[6] ”

    Oral argument

    Audio

    Audio of oral argument:[8]



    Transcript

    Transcript of oral argument:[9]

    Outcome

    In a 9-0 opinion, the court vacated and remanded the judgment of the United States Court of Appeals for the Fifth Circuit. The court ruled against the Fifth Circuit’s conclusion that the FDA acted arbitrarily and capriciously in denying the manufacturers’ applications to market new e-cigarette products.

    When making its decision, the court considered the respondent’s argument that “the FDA told them in guidance documents that it would do one thing and then turned around and did something different when it reviewed their applications.” Through the change-in-position doctrine,“[a]gencies are free to change their existing policies as long as they provide a reasoned explanation for the change.” SCOTUS determined that the FDA’s denial orders were consistent enough with its predecisional guidance and therefore did not violate the change in-position doctrine. Justice Samuel Alito delivered the opinion of the court.[1]

    Opinion

    In the court's majority opinion, Justice Samuel Alito wrote:[1]

    “

    Echoing the Fifth Circuit, respondents claim that the FDA violated the change-in-position doctrine with respect to the four principal themes discussed above. See supra, at 9–14. First, according to respondents, the FDA, after initially telling applicants that no specific kinds of scientific evidence were required, turned around and rejected all applications lacking evidence from a randomized controlled trial or longitudinal cohort study. See Brief for Respondents 37, 40–42. Second, respondents claim, the FDA told applicants they had discretion to choose appropriate comparator products, but it ultimately denied applications on the ground that they failed to make specific comparisons between dessert-, candy-, and fruit-flavored products, on the one hand, and tobacco-flavored products on the other. See id., at 27–36. Third, respondents claim that the FDA abandoned earlier guidance about the importance of device type and instead denied authorization to all dessert-, candy-, and fruit-flavored e-cigarette products regardless of device type. See id., at 45–47. And fourth, according to respondents, the FDA went back on its word by failing even to consider their marketing plans. See id., at 49–50.

    As to the first three issues, we conclude that the FDA’s denial orders were sufficiently consistent with its predecisional guidance and thus did not run afoul of the change-in-position doctrine. As to the failure to consider marketing plans, the FDA does not seek review of the Fifth Circuit’s finding of error. See Brief for Petitioner 31. Rather, it asks us to clarify the harmless-error rule and remand for application of the proper standard. See id., at 38. We agree with the FDA that that is the appropriate course of action. [6]

    		”
    —Justice Samuel Alito

    Concurring opinion

    Justice Sonia Sotomayor filed a concurring opinion.

    In her concurring opinion, Justice Sotomayor wrote:[1]

    “

    I join the Court’s opinion, as it rightly rejects the contention that the FDA acted arbitrarily and capriciously in denying respondents’ applications for premarket approval of their tobacco products. I write separately, however, to clarify one point.

    I do not believe the FDA, in the lead up to denying respondents’ applications, ‘was feeling its way toward a final stance and was unable or unwilling to say in clear and specific terms precisely what applicants would have to provide.’ Ante, at 10. Instead, the record shows the agency reasonably gave manufacturers some flexibility as to the forms of evidence that would suffice for premarket approval of their products, while hewing to (and never suggesting it would stray from) its statutory duty to approve only those products that would be ‘appropriate for the protection of the public health.’ 21 U. S. C. §387j(c)(2)(A). In light of the statutory text and the well-documented and serious risks flavored e-cigarette products pose to youth, it should have come as no surprise that applicants would need to submit rigorous scientific evidence showing that the benefits of their products would outweigh those risks. See §387j(c)(4). [6]

    		”
    —Justice Sonia Sotomayor

    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.[10]

    See also

    External links

    Footnotes

    1. ↑ 1.0 1.1 1.2 1.3 1.4 U.S. Supreme Court, "Food and Drug Administration v. Wages and White Lion Investments, LLC," April 2, 2025
    2. ↑ 2.0 2.1 U.S. Supreme Court, "23-1038 FOOD AND DRUG ADMINISTRATION V. WAGES AND WHITE LION," July 2, 2024
    3. ↑ U.S. Supreme Court, "23-1038 - Food and Drug Administration v. Wages and White Lion Investments, LLC," accessed July 30, 2024
    4. ↑ Note: At the time that the Court heard this case's argument, legal counsel was provided by then-U.S. Solicitor General Elizabeth B. Prelogar. Prelogar stepped down from her position on January 20, 2025, following the swearing-in of President Donald Trump (R) to his second term. After taking office, Trump appointed Sarah M. Harris to serve as the acting U.S. Solicitor General until her successor is confirmed and sworn in.
    5. ↑ SCOTUSblog, "Justices add five cases out of clean-up conference," July 2, 2024
    6. ↑ 6.0 6.1 6.2 6.3 Note: This text is quoted verbatim from the original source. Any inconsistencies are attributable to the original source.
    7. ↑ United States Court of Appeals for the Fifth Circuit, Wages & White Lion Invs. v. Food & Drug Admin., decided January 3, 2024
    8. ↑ Supreme Court of the United States, "Oral Argument - Audio," argued December 2, 2024
    9. ↑ Supreme Court of the United States, "Oral Argument - Transcript," argued December 2, 2024
    10. ↑ SupremeCourt.gov, "The Supreme Court at Work: The Term and Caseload," accessed January 24, 2022
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