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21 U.S.C. § 387l — Judicial review

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 387l — Judicial review

**(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387g&num=0&edition=prelim) establishing, amending, or revoking a tobacco product standard; or (B) a denial of an application under [section 387j(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387j/c&num=0&edition=prelim), 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

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Stable record: federal_law:legal_authorities:record_usc_48c12d813fb4ddb8313fc3c8
Source file: Laws/federal/codes/united-states-code/title-21/section-387l-judicial-review--51397015bc.md
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Source location: Title 21, Chapter 9, § 387l; chapter-009-federal-food-drug-and-cosmetic-act.md

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**(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387g&num=0&edition=prelim) establishing, amending, or revoking a tobacco product standard; or (B) a denial of an application under [section 387j(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387j/c&num=0&edition=prelim), 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section706/2/A&num=0&edition=prelim). **(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title28-section1254&num=0&edition=prelim). **(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.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 387g — Tobacco product standards

**(a) In general** (1) **Special rules** (A) *Special rule for cigarettes* — Beginning 3 months after June 22, 2009, a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke. Nothing in this subparagraph shall be construed to limit the Secretary’s authority to take action under this section or other sections of this chapter applicable to menthol or any artificial or natural flavor, herb, or spice not specified in this subparagraph. (B) *Additional special rule* — Beginning 2 years after June 22, 2009, a tobacco product manufacturer shall not use tobacco, including foreign grown tobacco, that contains a pesticide chemical residue that is at a level greater than is specified by any tolerance applicable under Federal law to domestically grown tobacco. (2) **Revision of tobacco product standards** — The Secretary may revise the tobacco product standards in paragraph (1) in accordance with subsection (c). (3) **Tobacco product standards** (A) *In general* — The Secretary may adopt tobacco product standards in addition to those in paragraph (1) if the Secretary finds that a tobacco product standard is appropriate for the protection of the public health. (B) *Determinations* (i) *Considerations* — In making a finding described in subparagraph (A), the Secretary shall consider scientific evidence concerning— (I) the risks and benefits to the population as a whole,

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Federal law — U.S. Code and appendices · legal_authorities

28 U.S.C. § 1254 — Courts of appeals; certiorari; certified questions

Cases in the courts of appeals may be reviewed by the Supreme Court by the following methods: (1) By writ of certiorari granted upon the petition of any party to any civil or criminal case, before or after rendition of judgment or decree; (2) By certification at any time by a court of appeals of any question of law in any civil or criminal case as to which instructions are desired, and upon such certification the Supreme Court may give binding instructions or require the entire record to be sent up for decision of the entire matter in controversy.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 387l — Judicial review

Page 691 TITLE 21—FOOD AND DRUGS § 387n 387s of this title, and the Secretary may extend or re- duce the duration of one or more such time periods, ex- cept that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title. § 387l. Judicial review (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 regula- tion 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 para- graph (1) shall be transmitted by the clerk of the court involved to the Secretary. (B) Record of proceedings On receipt of a petition under subpara- graph (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 Sec- retary 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 wit

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