FDA v. R. J. Reynolds Vapor Co., Docket No. 23-1187

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Sometimes a single phrase in a law can change everything. In this case, the Supreme Court looked at the rule that lets “any person adversely affected” by an FDA decision ask a judge to review it. The FDA had said no to a new tobacco product, blocking not only the maker but also the shops that wanted to sell it.

The Court said those shops count as “adversely affected” and can challenge the FDA’s denial in court. It also agreed that the case can stay in the home circuit where the stores are located. Seven justices, led by Justice Barrett, sided with the retailers and allowed the challenge to move forward. Two justices, including Justice Jackson joined by Justice Sotomayor, disagreed and felt only the product maker should have that right.

Summary of the Case

In 2016 the FDA determined that e-cigarettes are "new tobacco products" under the Family Smoking Prevention and Tobacco Control Act (TCA) and deferred enforcement while manufacturers sought premarket approval. R.J. Reynolds Vapor Co. (RJR Vapor) applied to market its Vuse Alto e-cigarettes but the FDA denied the application for failure to show that marketing the product would be "appropriate for the protection of the public health." RJR Vapor joined with Texas and Mississippi retailers to petition the Fifth Circuit for judicial review under the TCA's "any person adversely affected" clause, thereby invoking Fifth-Circuit venue. The FDA moved to dismiss or transfer the petition, contending only the denied applicant has a statutory right to sue. A divided Fifth Circuit denied that motion, and the FDA sought certiorari.

Opinion of the Court

Justice Barrett, writing for a 7-Justice majority, held that the phrase "any person adversely affected" must be construed consistent with the Administrative Procedure Act's similarly worded cause of action, which the Court has interpreted to grant review to anyone "arguably within" a statute's zone of interests. Retailers who lose the opportunity to sell a denied product and risk enforcement penalties plainly fall within that zone. The FDA's structural argument—that only manufacturers have statutory rights to participation and notice—cannot override the TCA's grant of review to any adversely affected person. Moreover, Congress's use of the narrower term "holder of [the] application" in one section and the broader "any person adversely affected" in another signals differing scopes. Because at least one proper petitioner had venue in the Fifth Circuit, the Court affirmed the denial of dismissal or transfer.

Dissenting Opinions

Justice Jackson, joined by Justice Sotomayor, dissented. They argued that the TCA's premarket-approval regime establishes an adjudicatory process exclusively between the FDA and the manufacturer, who alone bears the burden to submit detailed product studies, components lists, manufacturing controls, and samples. Retailers have no procedural rights to comment, receive notice, or develop the record; when the FDA withdraws an existing approval, only the "holder of [the] application" may sue, reflecting Congress's intent to limit review to manufacturers. The dissenters would confine "any person adversely affected" to those within the regulated class—in this case, denied applicants—and would bar retailers from invoking the judicial review provision.

Who Can Challenge FDA Decisions: Manufacturers, Retailers, or Both?

This dispute centers on who has the legal right to challenge FDA decisions about tobacco products. The Court needed to determine whether retailers, not just manufacturers, can sue when the FDA denies approval for products they want to sell.

The majority ruled that the phrase "any person adversely affected" should be interpreted broadly, consistent with similar language in other laws. When retailers lose the ability to sell a product and face potential penalties for selling unapproved items, they clearly fall within the group of people Congress intended to protect.

The Court found it significant that Congress used different language in different parts of the law—specifically choosing broader language ("any person adversely affected") in the section about who can seek judicial review, while using narrower language ("holder of the application") elsewhere. This deliberate word choice suggests Congress intended to allow a wider group of affected parties to challenge FDA decisions.

The venue provision in the law further reflects Congress's judgment about where these challenges should be heard, though the Court didn't address whether each individual challenger must independently satisfy venue requirements.