In FDA v. R.J. Reynolds Vapor Co., the Supreme Court will decide whether an e-cigarette manufacturer can seek review of the FDA’s denial of its marketing application in a forum where it does not reside by joining a retailer who does.

Under the Family Smoking Prevention and Tobacco Control Act, 21 U.S.C. § 387 et seq., manufacturers must obtain FDA authorization before introducing a new tobacco product into interstate commerce. E-cigarettes, or vapes, are subject to the Act. The Act allows “any person adversely affected” by an FDA “regulation or denial” to petition for judicial 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 Company (Reynolds), a vape manufacturer, sought FDA authorization to market menthol-flavored vapes, which the FDA denied. Although Reynolds is incorporated and has its principal place of business in South Carolina, within the Fourth Circuit, it filed a petition for review in the Fifth Circuit. The petition was joined by a vape retailer and a trade association representing vape retailers (collectively, Retailers), both of whom sold Reynolds’ products and had a principal place of business within the Fifth Circuit. The FDA moved to dismiss or transfer the petition to the D.C. Circuit or Fourth Circuit (where Reynolds resides), but the Fifth Circuit denied those motions. The appellate court determined that the joining Retailers were “adversely affected” persons who could challenge the FDA’s denial, and that because their principal place of business is in the Fifth Circuit, all petitioners, including Reynolds, could file in that forum. The FDA appealed to the Supreme Court.

Before the Supreme Court, the FDA argues that, as to application denials, retailers cannot be “adversely affected persons” under 21 U.S.C. § 387l(a)(1) because their interest in selling new products falls outside the statute’s intended scope of protection.

Reynolds and the Retailers counter that the Act governs what products may be sold and the Retailers have an interest in FDA decisions affecting their ability to sell new products. The FDA also argues that the Fifth Circuit erred by allowing a group of petitioners to file a review petition in a circuit based on one petitioner’s principal place of business, thereby undermining the Act’s venue restrictions. Reynolds and Retailers argue that longstanding precedent allows only one challenger to establish venue in federal cases.

The Justices heard oral argument on January 21, 2025. Justice Thomas pointedly asked the FDA how the phrase “any person adversely affected” would not include retailers. The FDA responded that the phrase’s scope depends on whether a denial or regulation is being challenged. For denials, the FDA argued that only manufacturer applicants are directly harmed, whereas retailers are mere bystanders. Regulations, in contrast, may affect retailers more broadly. Chief Justice Roberts challenged this distinction, suggesting that retailers are not bystanders but key stakeholders whose businesses depend on sales. Justice Kagan also questioned the FDA’s attempt to advocate for two different definitions of the same phrase.

Conversely, Justice Jackson noted that the Act prohibits retailers from challenging FDA orders that withdraw currently marketed products from shelves, suggesting Congress did not intend to protect retailers’ interests. She questioned whether this undermined Reynolds and the Retailers’ position. On venue, Justice Barrett questioned whether the Court had discretion to decide the forum question and expressed concern that a ruling for the FDA might have broader implications for cases under other statutes. Meanwhile, Justice Jackson warned that a ruling in favor of Reynolds and the Retailers could undermine Congress’s intent to channel these actions in a particular way, permitting manufacturers to circumvent venue restrictions.  

Stay tuned for Dykema’s update after the Court issues its opinion expected later this term.

For more information, please contact Chantel Febus, James Azadian, Kyle Asher, or Ryan VanOver.