Supreme Court Holds That Tobacco Product Retailers Can Challenge FDA Marketing Denial Orders

Client Alert  |  June 20, 2025


FDA v. R.J. Reynolds Vapor Co., No. 23-1187 – Decided June 20, 2025

Today, the Supreme Court held 7-2 that tobacco product retailers may sue the FDA for blocking the marketing of new tobacco products, allowing challenges by more than just the product manufacturer.

“If the FDA denies an application, the retailers, like the manufacturer, lose the opportunity to profit from the sale of the new tobacco product—or, if they sell the product anyway, risk imprisonment and other sanctions. . . .  Accordingly, the retailers are ‘adversely affected’ by a denial order and are therefore proper petitioners.”

Justice Barrett, writing for the Court

Background:

The Family Smoking Prevention and Tobacco Control Act (“TCA”) requires tobacco product manufacturers to apply to the Food and Drug Administration (“FDA”) for authorization to market “new” tobacco products.  If the FDA denies an application, the Act’s judicial-review provision permits “any person adversely affected by” the denial to petition for review in the D.C. Circuit or “the circuit in which such person resides or has their principal place of business.”  21 U.S.C. § 387l(a)(1).

R.J. Reynolds Vapor Co. (“RJR Vapor”), a leading e-cigarette manufacturer, is incorporated and has its principal place of business in North Carolina.  When the FDA denied its applications to market four e-cigarette products, it jointly petitioned for review of each denial along with two retailers that sell those kinds of e-cigarettes.  The companies filed the joint petition in the Fifth Circuit, where the retailers were formed and have their principal places of business.  The FDA moved to dismiss or to transfer the action to the D.C. Circuit or the Fourth Circuit, based on RJR Vapor’s residence.  The Fifth Circuit denied the motion, holding that each entity was a person adversely affected by the denial and that the petition could be filed in the Fifth Circuit because the retailers have their principal places of business there.

Issue:

May tobacco product retailers challenge FDA marketing denials, such that a petition for review can be filed in a circuit where a retailer resides or has its principal place of business?

Court’s Holding:

Yes.  A retailer who would sell a new tobacco product counts as “any person adversely affected” by an FDA order that bars marketing of that product under the TCA.  The retailer can therefore file a petition for review in any circuit in which it resides or has its principal place of business.

What It Means:

  • Today’s decision confirms that a tobacco product retailer is a “person adversely affected” under the TCA if it would have sold the new product for which the FDA issues a marketing denial.  Noting that the phrase “adversely affected” is a term of art, the Court relied on cases interpreting the Administrative Procedure Act and other statutory causes of action to conclude that the TCA review provision “extends to any petitioner ‘with an interest arguably sought to be protected by the statute.’”  The Court distinguished the statutory language here—“any person adversely affected”—from language in other statutes, which might limit judicial review to “the applicant” or a “party.”  See NRC v. Texas, 605 U.S. __ (2025) (slip op., at 9).
  • Applying that rule here, the Court held that if the FDA denies a marketing application, retailers, “like the manufacturer, lose the opportunity to profit from the sale of the new tobacco product—or, if they sell the product anyway, risk imprisonment and other sanctions.”  Therefore, retailers’ interests are not “so marginally related to or inconsistent with the purposes implicit in the statute that it cannot reasonably be assumed that Congress intended to permit the suit.”
  • By creating more opportunities to challenge FDA orders, the Court’s decision could mean that manufacturers and retailers are able to combat more effectively the FDA’s efforts to thwart marketing approval of new tobacco products.
  • The Court also held that the Fifth Circuit correctly concluded that at least one proper petitioner had venue in that court because a retailer and trade association in this case have their principal places of business in the Fifth Circuit and could therefore file petitions for review in that circuit.
  • The Court did not decide the separate question—with more far-reaching consequences—whether each petitioner in a joint petition must independently satisfy the TCA’s venue provisions.  The Court noted that “[n]o court, including the Fifth Circuit in this case, has analyzed” that question and that its resolution “would inevitably inform debates about similar [venue] statutes,” including “the general venue statute for lawsuits against the Government.”  The Fifth Circuit may consider that question on remand.
  • In dissent, Justice Jackson (joined by Justice Sotomayor)—who would have held that only manufacturers can challenge a marketing denial—suggested that the TCA‘s venue provision limits the ability of manufacturers to sue outside the circuits in which they reside or have their principal places of business, “including through proxy suits that third parties file in other places on their behalf.”  Companies should continue to think carefully about how to avail themselves of the best venue for challenging administrative action.

The Court’s opinion is available here.

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This alert was prepared by associates Zachary Tyree and Audrey Payne.

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