---
kind: "section"
citation: "21 U.S.C. § 387l"
title: "21"
title_heading: "Food and Drugs"
number: "387l"
heading: "Judicial review"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/387l"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter IX — Tobacco Products"
---

# §387l. Judicial review

- (a) **Right to review—**
  - (1) **In general—** Not later than 30 days after—
    - (A) the promulgation of a regulation under [section 387g of this title](/usc/21/387g.md) establishing, amending, or revoking a [tobacco product](/usc/21/321.md?p=rr-1) standard; or
    - (B) a denial of an application under [section 387j(c) of this title](/usc/21/387j.md?p=c),

    any [person](/usc/21/321.md?p=e) adversely affected by such regulation or denial may file a petition for judicial review of such regulation or denial with the [United States](/usc/21/387.md?p=22) Court of Appeals for the District of Columbia or for the circuit in which such [person](/usc/21/321.md?p=e) resides or has their principal place of business.

  - (2) **Requirements—**
    - (A) **Copy of petition—** A copy of the petition filed under [paragraph (1)](#a-1) shall be transmitted by the clerk of the court involved to the [Secretary](/usc/21/321.md?p=d).
    - (B) **Record of proceedings—** On receipt of a petition under [subparagraph (A)](#a-2-A), the [Secretary](/usc/21/321.md?p=d) 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 record—** In 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](/usc/21/321.md?p=d) with respect to such regulation or order;
      - (iii) proceedings of any panel or [advisory committee](/usc/21/360fff.md?p=1) 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](/usc/21/321.md?p=d), 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)](#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](/usc/5/chptI/ch7.md) 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)](#a) shall be reviewed in accordance with [section 706(2)(A) of title 5](/usc/5/706.md?p=2-A).
- (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](/usc/21/387.md?p=22) upon certiorari or certification, as provided in [section 1254 of title 28](/usc/28/1254.md).
- (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](/usc/21/387f.md), [387g](/usc/21/387g.md), [387h](/usc/21/387h.md), [387i](/usc/21/387i.md), [387j](/usc/21/387j.md), or [387p](/usc/21/387p.md) 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.

## Source credit

(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.)