U.S. Code » Title 21 » Chapter CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER IX— TOBACCO PRODUCTS

21 U.S.C. § 387l

Judicial review

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(a) Right to review(1) In generalNot later than 30 days after—(A) the promulgation of a regulation under section 387g of this title establishing, amending, or revoking a tobacco product standard; or(B) a denial of an application under section 387j(c) of this title,any person adversely affected by such regulation or denial may file a petition for judicial review of such regulation or denial with the United States Court of Appeals for the District of Columbia or for the circuit in which such person resides or has their principal place of business.(2) Requirements(A) Copy of petition

A copy of the petition filed under paragraph (1) shall be transmitted by the clerk of the court involved to the Secretary.

(B) Record of proceedingsOn receipt of a petition under subparagraph (A), the Secretary shall file in the court in which such petition was filed—(i) the record of the proceedings on which the regulation or order was based; and(ii) a statement of the reasons for the issuance of such a regulation or order.(C) Definition of recordIn this section, the term “record” means—(i) all notices and other matter published in the Federal Register with respect to the regulation or order reviewed;(ii) all information submitted to the Secretary with respect to such regulation or order;(iii) proceedings of any panel or advisory committee with respect to such regulation or order;(iv) any hearing held with respect to such regulation or order; and(v) any other information identified by the Secretary, in the administrative proceeding held with respect to such regulation or order, as being relevant to such regulation or order.(b) Standard of review

Upon the filing of the petition under subsection (a) for judicial review of a regulation or order, the court shall have jurisdiction to review the regulation or order in accordance with chapter 7 of title 5 and to grant appropriate relief, including interim relief, as provided for in such chapter. A regulation or denial described in subsection (a) shall be reviewed in accordance with section 706(2)(A) of title 5.

(c) Finality of judgment

The judgment of the court affirming or setting aside, in whole or in part, any regulation or order shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification, as provided in section 1254 of title 28.

(d) Other remedies

The remedies provided for in this section shall be in addition to, and not in lieu of, any other remedies provided by law.

(e) Regulations and orders must recite basis in record

To facilitate judicial review, a regulation or order issued under section 387f, 387g, 387h, 387i, 387j, or 387p of this title shall contain a statement of the reasons for the issuance of such regulation or order in the record of the proceedings held in connection with its issuance.

(June 25, 1938, ch. 675, § 912, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1819.)
Notes of Decisions
Cited in 22 cases (21 in the last 5 years), 2020–2026 · leading case: Prohibition Juice Co. v. FDA, 45 F.4th 8 (D.C. Cir. 2022).
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Prohibition Juice Co. v. FDA, 45 F.4th 8 (D.C. Cir. 2022). · cites it 3× “And the manufacturers have standing to challenge the FDA’s marketing denial orders, which deny them the authorization the Tobacco Control Act requires before they may lawfully sell their products. The manufacturers assert that the FDA exceeded its statutory authority under the…”
Wages & White Lion Invst v. FDA, 41 F.4th 427 (5th Cir. 2022). · cites it 3× “Jurisdiction & Standard of Review We have jurisdiction under 21 U.S.C. § 387l(a)(1)(B), which authorizes federal court review of the denial of premarket tobacco product applications in a U.”
Breeze Smoke, LLC v. FDA, 18 F.4th 499 (6th Cir. 2021). · cites it 2× “Under the Family Smoking Prevention and Tobacco Control Act (“TCA”), however, “any person adversely affected by” the denial of a Premarket Tobacco Product Application may seek judicial review of the denial, 21 U.S.C. § 387l(a)(1)(B), and “the court shall have jurisdiction to…”
Liquid Labs LLC v. FDA, 52 F.4th 533 (3rd Cir. 2022). · cites it 2× “4 This Court has jurisdiction pursuant to 21 U.S.C. § 387l(a)(1)(B). 5 We review the FDA’s order denying the PMTAs under the standards set forth in the APA, see 21 U.”
Logic Tech. Dev. LLC v. FDA, 84 F.4th 537 (3rd Cir. 2023). · cites it 4× “§ 1331 and 21 U.S.C. § 387l(a)(1)(B). The Tobacco Control Act directs petitioners to file in the D.”
R.J. Reynolds Vapor v. FDA, 65 F.4th 182 (5th Cir. 2023). “5 21 U.S.C. § 387l(a)(1)(B). Also, because it is undisputed that “at least one” petitioner—namely, RJRV—has standing, Article III’s case-or-controversy _____________________ 3 RJRV’s application for Vuse Vibe already spanned over 150,000 pages.”
FDA v. R. J. Reynolds Vapor Co., 606 U.S. 226 (2025). · cites it 2× “” 21 U. S. C. §387l(a)(1). “Adversely affected” (and its variations like “adversely af- fected or aggrieved”) is a term of art with a “long history in federal administrative law.”
Fontem Us, LLC v. Fda, 82 F.4th 1207 (D.C. Cir. 2023). · cites it 2× “See 21 U.S.C. § 387l(a)(1). On June 6, 2022, Fontem also submitted an administrative appeal, seeking supervisory review of the order.”
Avail Vapor, LLC v. FDA, 55 F.4th 409 (4th Cir. 2022). “See 21 U.S.C. § 387l(b) (citing 5 U.S.C. § 706 (2)(A)).”
Moose Jooce v. FDA, 981 F.3d 26 (D.C. Cir. 2020). “137, 147 (1993); 21 U.S.C. § 387l (2018). B. Notwithstanding Commissioner Gottlieb’s effective ratification, appellants contend that Appointments Clause violations are per se harmful, not curable by ratification, and so the court should consider the merits of their challenge to…”
Magellan Tech., Inc. v. United States Food & Drug Admin., 70 F.4th 622 (2d Cir. 2023). “See 21 U.S.C. § 387l(b) (citing 17 5 U.S.C. § 706 (2)(A)).”
Bidi Vapor LLC v. U.S. Food & Drug Admin., 134 F.4th 1282 (11th Cir. 2025). · cites it 2× “” This timely appeal followed, when Bidi Vapor filed its Peti- tion for Review on January 26, 2024 pursuant to 21 U.S.C. § 387l(a). On February 2, 2024, Bidi Vapor moved for a stay pending appeal, which this Court denied on February 16.”
Show all 22 citing cases →
— 21 U.S.C. § 387l(a) — 2 cases
Bidi Vapor LLC v. U.S. Food & Drug Admin., 134 F.4th 1282 (11th Cir. 2025). “” This timely appeal followed, when Bidi Vapor filed its Peti- tion for Review on January 26, 2024 pursuant to 21 U.S.C. § 387l(a). On February 2, 2024, Bidi Vapor moved for a stay pending appeal, which this Court denied on February 16.”
Nude Nicotine Inc. v. Fda (9th Cir. 2023).
— 21 U.S.C. § 387l(a)(1) — 5 cases
FDA v. R. J. Reynolds Vapor Co., 606 U.S. 226 (2025). “” 21 U. S. C. §387l(a)(1). “Adversely affected” (and its variations like “adversely af- fected or aggrieved”) is a term of art with a “long history in federal administrative law.”
Fontem Us, LLC v. Fda, 82 F.4th 1207 (D.C. Cir. 2023). “See 21 U.S.C. § 387l(a)(1). On June 6, 2022, Fontem also submitted an administrative appeal, seeking supervisory review of the order.”
SWT Global Supply, Inc. v. U.S. Food & Drug Admin., 139 F.4th 957 (8th Cir. 2025).
Shenzhen Youme v. FDA (5th Cir. 2025).
Fumizer, LLC v. United States Food & Drug Admin. (9th Cir. 2026).
— 21 U.S.C. § 387l(a)(1)(B) — 10 cases
Prohibition Juice Co. v. FDA, 45 F.4th 8 (D.C. Cir. 2022). “And the manufacturers have standing to challenge the FDA’s marketing denial orders, which deny them the authorization the Tobacco Control Act requires before they may lawfully sell their products. The manufacturers assert that the FDA exceeded its statutory authority under the…”
Breeze Smoke, LLC v. FDA, 18 F.4th 499 (6th Cir. 2021). “Under the Family Smoking Prevention and Tobacco Control Act (“TCA”), however, “any person adversely affected by” the denial of a Premarket Tobacco Product Application may seek judicial review of the denial, 21 U.S.C. § 387l(a)(1)(B), and “the court shall have jurisdiction to…”
R.J. Reynolds Vapor v. FDA, 65 F.4th 182 (5th Cir. 2023). “5 21 U.S.C. § 387l(a)(1)(B). Also, because it is undisputed that “at least one” petitioner—namely, RJRV—has standing, Article III’s case-or-controversy _____________________ 3 RJRV’s application for Vuse Vibe already spanned over 150,000 pages.”
Logic Tech. Dev. LLC v. FDA, 84 F.4th 537 (3rd Cir. 2023). “§ 1331 and 21 U.S.C. § 387l(a)(1)(B). The Tobacco Control Act directs petitioners to file in the D.”
Wages & White Lion Invst v. FDA, 41 F.4th 427 (5th Cir. 2022). “Jurisdiction & Standard of Review We have jurisdiction under 21 U.S.C. § 387l(a)(1)(B), which authorizes federal court review of the denial of premarket tobacco product applications in a U.”
— 21 U.S.C. § 387l(a)(2)(C) — 1 case
Logic Tech. Dev. LLC v. FDA, 84 F.4th 537 (3rd Cir. 2023). “§ 1331 and 21 U.S.C. § 387l(a)(1)(B). The Tobacco Control Act directs petitioners to file in the D.”
— 21 U.S.C. § 387l(b) — 12 cases
Prohibition Juice Co. v. FDA, 45 F.4th 8 (D.C. Cir. 2022). “And the manufacturers have standing to challenge the FDA’s marketing denial orders, which deny them the authorization the Tobacco Control Act requires before they may lawfully sell their products. The manufacturers assert that the FDA exceeded its statutory authority under the…”
Wages & White Lion Invst v. FDA, 41 F.4th 427 (5th Cir. 2022). “Jurisdiction & Standard of Review We have jurisdiction under 21 U.S.C. § 387l(a)(1)(B), which authorizes federal court review of the denial of premarket tobacco product applications in a U.”
Breeze Smoke, LLC v. FDA, 18 F.4th 499 (6th Cir. 2021). “Under the Family Smoking Prevention and Tobacco Control Act (“TCA”), however, “any person adversely affected by” the denial of a Premarket Tobacco Product Application may seek judicial review of the denial, 21 U.S.C. § 387l(a)(1)(B), and “the court shall have jurisdiction to…”
Liquid Labs LLC v. FDA, 52 F.4th 533 (3rd Cir. 2022). “4 This Court has jurisdiction pursuant to 21 U.S.C. § 387l(a)(1)(B). 5 We review the FDA’s order denying the PMTAs under the standards set forth in the APA, see 21 U.”
Avail Vapor, LLC v. FDA, 55 F.4th 409 (4th Cir. 2022). “See 21 U.S.C. § 387l(b) (citing 5 U.S.C. § 706 (2)(A)).”
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