21 U.S.C. § 387l | Judicial review

(a)

Right to review

(1)

In general

Not later than 30 days after—

(A)

section 387g of this title the promulgation of a regulation under establishing, amending, or revoking a tobacco product standard; or

(B)

section 387j(c) of this title a denial of an application under ,

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

section 706(2)(A) of title 5Upon 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 .

(c)

Finality of judgment

section 1254 of title 28The 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 .

(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.

June 25, 1938, ch. 675, § 912 Pub. L. 111–31, div. A, title I, § 101(b)(3)June 22, 2009123 Stat. 1819(, as added , , .)