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U.S. Department of Health and Human Services

Tobacco Products

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Section 912 of the Federal Food, Drug, and Cosmetic Act - Judicial Review

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    1. Right to Review

      1. In General. Not later than 30 days after

        1. the promulgation of a regulation under section 907 establishing, amending, or revoking a tobacco product standard; or
           
        2. a denial of an application under section 910(c),
           
        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
         
        1. 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.
           
        2. Record of Proceedings. On receipt of a petition under subparagraph (A), the Secretary shall file in the court in which such petition was filed

          1. the record of the proceedings on which the regulation or order was based; and
             
          2. a statement of the reasons for the issuance of such a regulation or order.
             
        3. Definition of Record. In this section, the term 'record' means

          1. all notices and other matter published in the Federal Register with respect to the regulation or order reviewed;
             
          2. all information submitted to the Secretary with respect to such regulation or order;
             
          3. proceedings of any panel or advisory committee with respect to such regulation or order;
             
          4. any hearing held with respect to such regulation or order; and
             
          5. 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.
             
    2. 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, United States Code, 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, United States Code.
       
    3. 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, United States Code.
       
    4. 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.
       
    5. Regulations and Orders Must Recite Basis in Record. To facilitate judicial review, a regulation or order issued under section 906, 907, 908, 909, 910, or 916 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.