The question
Whether the FDA acted arbitrarily and capriciously when it denied respondents' premarket applications to market flavored e-cigarette products.
FDA v. Wages and White Lion Investments, LLC
What the Court decided
The Court vacated the Fifth Circuit's ruling that the FDA acted arbitrarily and capriciously when it denied respondents authorization to market flavored e-cigarette products. The FDA's denial orders were sufficiently consistent with its predecisional guidance as to scientific evidence, comparative efficacy, and device type, so they did not run afoul of the change-in-position doctrine. The Court separately declined to reach respondents' argument that the FDA erred by using standards developed in adjudication rather than notice-and-comment rulemaking, finding that question outside the question presented and inadequately briefed.
How the justices split
UnanimousThe Court's opinion
Alito, joined by Roberts, Thomas, Sotomayor, Kagan, Gorsuch, Kavanaugh, Barrett, Jackson
Delivered the opinion for a unanimous Court. The FDA's denial orders were sufficiently consistent with its predecisional guidance regarding scientific evidence, comparative efficacy, and device type, so the agency did not violate the change-in-position doctrine, which permits agencies to change policy if they provide a reasoned explanation, show awareness of the change, and consider serious reliance interests. The TCA left the FDA broad discretion to decide what scientific evidence applicants must submit. The Court declined to reach whether the FDA improperly evaluated the applications under standards developed in adjudication rather than notice-and-comment rulemaking, finding that question beyond the question presented and inadequately briefed.
Concurring
Sotomayor, writing alone
Filed a concurring opinion. The syllabus identifies the concurrence but does not state its reasoning.
How we know · 5 sourced claims
The Fifth Circuit's conclusion that the FDA acted arbitrarily and capriciously was vacated.
Source: syllabus, Held
The FDA's denial orders were sufficiently consistent with its predecisional guidance as to scientific evidence, comparative efficacy, and device type.
Source: syllabus, Held
The Court declined to reach respondents' argument that the FDA should have used notice-and-comment rulemaking rather than adjudication, finding it beyond the question presented and inadequately briefed.
Source: syllabus, Held
Justice Alito delivered the opinion for a unanimous Court.
Source: syllabus, lineup
Justice Sotomayor filed a concurring opinion.
Source: syllabus, lineup