FDA v. Wages and White Lion Investments, LLC

Background

The dispute is between the Food and Drug Administration (an agency) and two companies that make flavored e‑liquids for open‑system e‑cigarettes. After Congress gave the FDA authority to regulate tobacco products, the FDA required premarket applications. Respondents submitted applications for dessert, candy, and fruit flavors; the FDA denied them for failing to show their products were appropriate for public health, and appended technical reviews explaining its concerns about youth use and flavor appeal. The Fifth Circuit, sitting en banc, held the FDA acted arbitrarily and remanded to the agency.

Reasoning

The central question was whether the FDA unlawfully changed its standards and so acted arbitrarily. The Court applied the change‑in‑position framework and concluded the FDA’s denial orders were consistent with its prior guidance on the kinds of scientific evidence, cross‑product comparisons, and device‑type concerns. The Court rejected the idea that internal memoranda created a secret, binding new rule and treated the agency’s representations with a presumption of regularity. The Court agreed the FDA did not review marketing plans despite earlier saying they were “critical,” and it declined to decide whether that error was harmless.

Real world impact

The decision means many FDA denials can remain in effect while the appeals court reconsiders whether the agency’s failure to evaluate marketing plans was prejudicial. Manufacturers of flavored e‑liquids and the FDA retain their roles in the regulatory process, and the case is not a final merits ruling — lower courts will now revisit the procedural harmless‑error question.

Dissents or concurrances

Justice Sotomayor joined the opinion but emphasized that the FDA reasonably required rigorous evidence given clear risks to youth and did not think the agency left applicants without fair notice.