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 respondents to market certain e-cigarette products. The Court vacated the Fifth Circuit's decision, concluding the FDA's denial orders were consistent with its guidance and did not violate the change-in-position doctrine. The case was remanded for further consideration of the harmless-error claim.
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 revolves around the FDA's authority and procedural adherence in denying applications, which involves constitutional limits on agency authority.
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 because the FDA's denial orders were sufficiently consistent with its predecisional guidance.
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Why Judicial Review is relevant to FDA v. Wages and White Lion Investments, LLC
The Court's review of the FDA's actions under the APA involves the power of courts to review and potentially invalidate government actions.
Syllabus excerpt (verbatim)The Fifth Circuit, sitting en banc, granted respondents' petitions for review and remanded to the FDA.
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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 provided fair procedures in its application denial process, implicating procedural due process concerns.
Syllabus excerpt (verbatim)Respondents petitioned for judicial review of the FDA's denial orders under the Administrative Procedure Act (APA).
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 treatment of device type did not violate the change-in-position doctrine.
