Food and Drug Administration v. R.J. Reynolds Vapor Co.

In Food and Drug Administration v. R.J. Reynolds Vapor Co., the U.S. Supreme Court on June 20, 2025, reviewed the FDA's denial of marketing applications for flavored e-cigarette products submitted by R.J. Reynolds Vapor Company. The FDA had rejected the applications, citing insufficient evidence that the benefits to adult smokers outweighed the significant risks of youth nicotine addiction. The U.S. Court of Appeals for the Fifth Circuit had ruled that the FDA acted arbitrarily by failing to consider the company's specific marketing plans. The Supreme Court reversed, holding that the FDA's decisions were reasonable under the Administrative Procedure Act and did not require individualized consideration of every marketing proposal. The ruling affirmed the FDA's broad discretion in regulating new tobacco products.

The Supreme Court reversed the Fifth Circuit, holding that the FDA's marketing denial orders were lawful and not arbitrary or capricious.

Whether the FDA acted arbitrarily and capriciously in denying marketing authorization for flavored e-cigarette products without fully considering the manufacturer's proposed marketing and age-verification plans, and the proper scope of judicial review under the Administrative Procedure Act.

The decision strengthens the FDA's authority to regulate vaping products and deny marketing applications for flavored e-cigarettes, particularly to curb youth use. It provides clarity for the tobacco industry on evidentiary requirements and limits lower courts' ability to second-guess agency scientific judgments.