Whether retailers who would sell a new tobacco product if not for an FDA denial order have the right to seek judicial review under 21 U. S. C. § 387l(a)(1). Specifically, the Court must determine if such retailers are "adversely affected" by the denial within the meaning of the Family Smoking Prevention and Tobacco Control Act (TCA). This involves deciding whether these retailers fall within the statutory "zone of interests" required to invoke a cause of action.

• Only the disappointed applicant manufacturer is "adversely affected" by a denial order because they have the closest relationship to the application.
• The TCA's structure, particularly 21 U. S. C. § 387j, focuses exclusively on the interests of the manufacturer and excludes retailers from the premarket authorization process.
• Retailers are outside the statute's zone of interests and thus lack the right to seek judicial review.
• Each petitioner in a joint petition must independently establish venue under the TCA.

• Retailers are "adversely affected" by FDA denial orders because they lose the opportunity to profit from sales or risk sanctions if they sell the products anyway.
• The phrase "any person adversely affected" in 21 U. S. C. § 387l(a)(1) is broad and suggests that multiple parties, not just the applicant, may seek review.
• Retailers fall within the zone of interests protected by the TCA given the direct impact of denial orders on their business operations.

• The Court held that retailers who would sell a new tobacco product if not for the FDA's denial order may seek judicial review under 21 U. S. C. § 387l(a)(1).
• To invoke a statutory cause of action, a plaintiff must be within the "zone of interests" that the statute protects, as established in Lexmark Int'l, Inc. v. Static Control Components, Inc.
• The Court applied a broad interpretation of "adversely affected," treating it as a term of art from federal administrative law and the Administrative Procedure Act (APA), 5 U. S. C. § 702.
• Following Association of Data Processing Service Organizations, Inc. v. Camp, the Court reasoned that a plaintiff need only be "arguably within the zone of interests to be protected or regulated by the statute."
• The Court relied on Bank of America Corp. v. Miami, Thompson v. North American Stainless, LP, and Director, Office of Workers' Compensation Programs v. Newport News Shipbuilding & Dry Dock Co. to show that this broad APA-style test applies to other statutes using similar "adversely affected" or "aggrieved" language.
• Retailers are "adversely affected" because a denial order causes them to lose profit or risk imprisonment and sanctions under 21 U. S. C. §§ 331, 333(a), 387b(6)(A), and 387j(a)–(c).
• Textually, the use of "any person" in § 387l(a)(1) suggests that a denial order can affect multiple persons, rather than just the applicant.
• The Court noted a critical distinction between § 387l(a)(1), which allows "any person adversely affected" to sue, and § 387j(d)(2), which limits challenges to withdrawal orders only to the "holder of [the] application," presuming that different terms denote different ideas.