FDA v. Wages and White Lion Investments, LLC
View Official PDFBelow are plain-language sections to help you understand what the Court decided in FDA v. Wages and White Lion Investments, LLC and why it matters. Quotes are taken from the syllabus (the Court’s short summary at the start of the opinion).
Summary
A short, plain-English overview of FDA v. Wages and White Lion Investments, LLC.
The Supreme Court reviewed whether the FDA lawfully denied authorization for Wages and White Lion Investments to market certain e-cigarette products. The Court vacated the Fifth Circuit's decision, which had found the FDA's actions arbitrary and capricious, and remanded the case for further consideration. The Court determined that the FDA's denial orders were consistent with its predecisional guidance and did not violate the change-in-position doctrine.
Holding
The single most important “bottom line” of what the Court decided in FDA v. Wages and White Lion Investments, LLC.
The Court held that the FDA's denial orders were consistent with its predecisional guidance and did not violate the change-in-position doctrine.
Constitutional Concepts
These are the Constitution-related themes that appear in FDA v. Wages and White Lion Investments, LLC. Click a concept to see other cases that involve the same idea.
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Why Administrative Law is relevant to FDA v. Wages and White Lion Investments, LLC
The case primarily involves the FDA's authority and decision-making process under the Administrative Procedure Act.
Syllabus excerpt (verbatim)Respondents petitioned for judicial review of the FDA's denial orders under the Administrative Procedure Act (APA).
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Why Judicial Review is relevant to FDA v. Wages and White Lion Investments, LLC
The Court reviews the FDA's actions under the APA, which involves the power of courts to review and invalidate government action.
Syllabus excerpt (verbatim)The Fifth Circuit's conclusion that the FDA acted arbitrarily and capriciously in its adjudication of manufacturers' premarket tobacco product applications is vacated.
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Why Procedural Due Process is relevant to FDA v. Wages and White Lion Investments, LLC
The case involves whether the FDA followed fair procedures in denying the applications, a key aspect of procedural due process.
Syllabus excerpt (verbatim)The en banc majority held that the FDA had acted arbitrarily and capriciously by applying application standards different from those articulated in its predecisional guidance documents.
Key Quotes
Short excerpts from the syllabus in FDA v. Wages and White Lion Investments, LLC that support the summary and concepts above.
The FDA's denial orders were sufficiently consistent with its predecisional guidance.
The Fifth Circuit read Calcutt too broadly.
The FDA's comparative-efficacy requirement was not inconsistent with its predecisional guidance.