606 U.S. 226
SCOTUS2025Background
- The Family Smoking Prevention and Tobacco Control Act (TCA) requires FDA approval for marketing any new tobacco product.
- In 2016, the FDA applied these requirements to e-cigarettes; R.J. Reynolds Vapor Co. (RJR Vapor) sought FDA approval to market its Vuse Alto products, which was denied.
- The TCA allows “any person adversely affected” by an FDA denial to seek judicial review in the D.C. Circuit or in the circuit of their residence or principal business.
- RJR Vapor (a North Carolina company) joined with a Texas retailer and a Mississippi trade association to challenge the FDA denial in the Fifth Circuit.
- The FDA moved to dismiss or transfer, arguing only manufacturers denied approval have standing; the Fifth Circuit denied the motion.
- The case reached the Supreme Court on whether retailers are “adversely affected” and have standing to challenge FDA denial orders under the TCA.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Can retailers sell new tobacco products challenge FDA denial orders under the TCA? | Retailers are "adversely affected" since denial affects their ability to sell, fitting the TCA's broad language. | Only manufacturers have statutory rights and interests under TCA; retailers are outside the zone of interests. | Yes; retailers are proper petitioners as "adversely affected" persons. |
| Should venue in multi-party petitions depend on each petitioner independently establishing it? | Venue proper where any petitioner resides, as at least one retailer has Fifth Circuit venue. | Each petitioner must independently satisfy venue; RJR Vapor alone could not file in the Fifth Circuit. | Did not decide; declined to address the argument raised for first time. |
| How should “any person adversely affected” be interpreted in administrative law statutes? | Follows the APA and related cases; includes anyone arguably within the zone of interests. | Should be limited per statutory context to only direct applicants, not broader affected third parties. | Broad reading affirmed; "adversely affected" not restricted to applicants. |
| Does the structure and purpose of the TCA exclude retailers from review rights? | TCA text does not restrict review to applicants; Congress could have limited but chose broad terms. | Statutory scheme focuses solely on manufacturers; confidentiality and rights reflect this exclusive focus. | TCA’s language supports broader coverage; Congress knows how to limit, but used inclusive terms. |
Key Cases Cited
- United States v. Detroit Timber & Lumber Co., 200 U.S. 321 (clarifies that headnotes are not part of the opinion)
- Lexmark Int’l, Inc. v. Static Control Components, Inc., 572 U.S. 118 (elaborates the zone-of-interests test for statutory causes of action)
- Director, Office of Workers’ Compensation Programs v. Newport News Shipbuilding & Dry Dock Co., 514 U.S. 122 ("adversely affected" as a term of art in admin law)
- Association of Data Processing Service Organizations, Inc. v. Camp, 397 U.S. 150 (zone of interests test for "adversely affected" persons)
- Bank of America Corp. v. Miami, 581 U.S. 189 (interprets who is an "aggrieved person" in the Fair Housing Act)
- Thompson v. North American Stainless, LP, 562 U.S. 170 (interprets standing for "person claiming to be aggrieved" in Title VII)
- Block v. Community Nutrition Institute, 467 U.S. 340 (statutory scheme may preclude consumer standing even if affected)