Title 21, Food and DrugsRelease 119-110

§387l Judicial Review

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER IX — TOBACCO PRODUCTS › § 387l

Last updated Sep 22, 2026|Official source

Summary

Within 30 days after the government creates, changes, or cancels a tobacco product standard under section 387g, or after it denies an application under section 387j(c), anyone hurt by that action can ask a federal appeals court to review it. They may file in the U.S. Court of Appeals for the District of Columbia or the court for the circuit where they live or have their main business. The court clerk must send a copy of the filing to the Secretary. The Secretary must then put the record of the case and a written statement of the reasons for the action into the court files. The “record” means the Federal Register notices, materials sent to the Secretary, panel or advisory committee records, any hearings, and other information the Secretary says is relevant. Courts will review the action under chapter 7 of title 5 and section 706(2)(A) of title 5 and can give proper relief, including temporary relief. The court’s decision is final unless the Supreme Court reviews it under 28 U.S.C. 1254. These remedies do not replace other legal remedies. Regulations or orders under sections 387f, 387g, 387h, 387i, 387j, or 387p must include a statement of reasons in the record.

Full Legal Text

Title 21, §387l

Food and Drugs, Source: USLM XML via OLRC

(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 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 proceedings

On 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 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 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.

Reference

Citations & Metadata

Citation

21 U.S.C. § 387l

Title 21, Food and Drugs

Last Updated

Sep 22, 2026

Release point: 119-110