Title 21 — Food and DrugsRelease 119-73not60

§387l Judicial Review

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

Last updated Apr 5, 2026|Official source

Summary

You can ask a federal court to review certain tobacco rules or a denial of an application, but you must file your petition within 30 days after the rule is issued or the application is denied. The court clerk will send your petition to the Secretary (the agency head). After getting the petition, the Secretary must file the case record and a written statement explaining why the rule or denial was issued. The "record" means the written and other materials used to make the decision, such as Federal Register notices, submitted information, committee work, hearings, and other relevant documents. The court will review the action under the usual federal rules for reviewing agency decisions and may give relief, even temporary relief. The court’s decision is final unless the Supreme Court agrees to hear the case. Other legal remedies still apply. Rules must include a statement of reasons in the record.

Full Legal Text

Title 21, §387l

Food and Drugs — Source: USLM XML via OLRC

(a)(1)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,

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

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

(e)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

Apr 5, 2026

Release point: 119-73not60