The Supreme Court held in Drug Administration v. R.J. Reynolds Vapor Co. that retailers of e-cigarette products are "persons adversely affected" by an FDA denial order under the Family Smoking Prevention and Tobacco Control Act (TCA), and therefore have standing to seek judicial review.
As previously discussed in Dykema's February 2025 edition, the TCA requires manufacturers of tobacco products, including e-cigarettes or vapes, to obtain FDA authorization before marketing new products in interstate commerce. When the FDA denies authorization, "any person adversely affected" by that decision may petition for review in the D.C. Circuit or the circuit in which the petitioner resides or has its principal place of business. 21 U.S.C. § 387l(a)(1).
In this case, Reynolds, a manufacturer based in South Carolina, filed a joint petition for review in the Fifth Circuit alongside a vape retailer and a retailer trade association, both based in that circuit. The FDA moved to dismiss or transfer the case, arguing that retailers were "adversely affected" parties under the statute and thus lacked standing to file in the Fifth Circuit.
The Supreme Court, in a 7-2 decision authored by Justice Barrett, rejected the FDA's narrow interpretation. Applying a well-established understanding of the phrase "adversely affected," the Court found that Congress intended the term to cover parties whose commercial interests may be harmed by FDA denial orders. Justice Barrett emphasized that the use of this familiar phrase reflects Congress's intent to align with longstanding administrative law principles—namely, that any party within the statute's "zone of interests" has a right to judicial review. Vape retailers qualify because they face potential profit losses from being unable to sell new tobacco products.
Justice Jackson, joined by Justice Sotomayor, dissented, taking the position that a holistic reading of the TCA suggests Congress intended to distinguish between the roles and rights of manufacturers and retailers, affording review rights only to the former.
Takeaways:
- Retailers of e-cigarette products that are economically harmed by an FDA denial order now have a clear statutory right to challenge that decision in federal court—specifically, in the circuit where they reside or do business. This ruling broadens access to judicial review under the TCA and underscores the Court's commitment to traditional standing principles in administrative law.
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