Title 21 — Food and DrugsRelease 119-73

§387l Judicial review

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

Last updated Apr 6, 2026|Official source

Summary

You must ask a court to review a tobacco regulation or a denial of an application within 30 days after the rule is made or the denial happens. After the petition is filed, the court clerk must send a copy to the Secretary. The Secretary then must put into the court record the full file and a written explanation for the rule or denial. The file includes Federal Register notices, information sent to the Secretary, panel or committee work, any hearings, and any other material the Secretary says is relevant. The court will review the matter under chapter 7 of title 5 and may give appropriate relief, including temporary orders, using the review standard in section 706(2)(A) of title 5. The court’s decision is final unless the Supreme Court takes the case under section 1254 of title 28. These remedies are extra to any other legal remedies. Rules 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)(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 6, 2026

Release point: 119-73