Plain-English summary
Vacates Fifth Circuit, upholds FDA’s denials of new e‑cigarette market applications
The Supreme Court unanimously held that the Fifth Circuit wrongly set aside the FDA’s denials of applications to market certain e‑cigarette products. The Court vacated and remanded, finding the agency’s decisions were not arbitrary and capricious under applicable law.
Why this matters
The decision confirms that courts should give deference to the FDA’s scientific and policy judgments when the agency reasonably explains its conclusion that new tobacco products—here, e‑cigarettes—are not appropriate for the protection of public health. That standard affects how new tobacco and nicotine products are reviewed and could influence which products may lawfully be sold in interstate commerce.
Who may feel it
- E‑cigarette and vaping product manufacturers and distributors
- Tobacco and nicotine product applicants seeking FDA premarket authorization
- Public‑health regulators and agencies
- Retailers who sell vaping products
- Consumers of e‑cigarette and vaping products
Key questions
- Did the Fifth Circuit properly apply the Administrative Procedure Act when it set aside the FDA’s denials of premarket tobacco product applications?