21 U.S.C. § 387l — Judicial review
submitted 88 years ago by Pub. L. 111-31 to r/title-21-FOOD-AND-DRUGS · 484 words · no verdicts yet
Anyone hurt by a tobacco product standard or a denied application can appeal to a federal court. They have 30 days to file, and the Secretary must send the court the full record. The court's decision is final unless the Supreme Court agrees to review it.
(a) Right to review: (1) In general — Within 30 days after (A) the Secretary* issues a regulation under section 387g establishing, amending, or revoking a tobacco product* standard, or (B) the Secretary denies an application under section 387j(c), anyone adversely affected may file a petition for judicial review with the U.S. Court of Appeals for the District of Columbia Circuit, or for the circuit where they live or have their main place of business. (2) Requirements — (A) The court clerk must send a copy of the petition to the Secretary. (B) The Secretary must then file with that court the record of the proceedings on which the regulation or order was based, and a statement of the reasons for issuing it. (C) "Record" means all notices and other material published in the Federal Register about the regulation or order; all information submitted to the Secretary about it; the proceedings of any panel or advisory committee involved; any hearing held; and any other information the Secretary identified during the administrative process as relevant.
(b) Standard of review: Once the petition is filed, the court has jurisdiction to review the regulation or order under chapter 7 of title 5 and to grant appropriate relief, including interim relief, as that chapter allows. The regulation or denial is reviewed under the standard in section 706(2)(A) of title 5 — that is, whether the action was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.
(c) Finality of judgment: The court's judgment, affirming or setting aside the regulation or order in whole or in part, is final, subject only to review by the Supreme Court on certiorari or certification under section 1254 of title 28.
(d) Other remedies: The remedies in this section are in addition to, not instead of, any other remedies provided by law.
(e) Regulations and orders must recite basis in record: To make judicial review possible, any regulation or order issued under section 387f, 387g, 387h, 387i, 387j, or 387p must include, in the record of the proceedings that led to it, a statement of the reasons for issuing it.
Not later than 30 days after—
the promulgation of a regulation under section 387g of this title establishing, amending, or revoking a tobacco product* standard; or
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.
A copy of the petition filed under paragraph (1) shall be transmitted by the clerk of the court involved to the Secretary*.
On receipt of a petition under subparagraph (A), the Secretary shall file in the court in which such petition was filed—
the record of the proceedings on which the regulation or order was based; and
a statement of the reasons for the issuance of such a regulation or order.
In this section, the term “record” means—
all notices and other matter published in the Federal Register with respect to the regulation or order reviewed;
all information submitted to the Secretary with respect to such regulation or order;
proceedings of any panel or advisory committee with respect to such regulation or order;
any hearing held with respect to such regulation or order; and
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.
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.
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.
The remedies provided for in this section shall be in addition to, and not in lieu of, any other remedies provided by law.
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.
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.)
- 1938Enacted · Pub. L. 111-31 · 123 Stat. 1819
A history note hasn’t been published yet. The record shows enactment by Pub. L. 111-31 on 1938-06-25.
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