21 U.S.C. § 387n — Jurisdiction of and coordination with the

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 with respect to such regulation or order; and (v) any other information identified by the Secretary, in the administrative pro- ceeding held with respect to such regula- tion or order, as being relevant to such regulation or order. (b) Standard of review Upon the filing of the petition under sub- section (a) for judicial review of a regulation or order, the court shall have jurisdiction to review the regulation or order in accordance with chap- ter 7 of title 5 and to grant appropriate relief, including interim relief, as provided for in such chapter. A regulation or denial described in sub- section (a) shall be reviewed in accordance with section 706(2)(A) of title 5. (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 Su- preme Court of the United States upon certio- rari or certification, as provided in section 1254 of title 28. (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 state- ment of the reasons for the issuance of such reg- ulation or order in the record of the proceedings held in connection with its issuance. (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.) § 387m. Equal treatment of retail outlets The Secretary shall issue regulations to re- quire that retail establishments for which the predominant business is the sale of tobacco products comply with any advertising restric- tions applicable to retail establishments acces- sible to individuals under the age of 18. (June 25, 1938, ch. 675, § 913, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1820.) § 387n. Jurisdiction of and coordination with the Federal Trade Commission (a) Jurisdiction (1) In general Except where expressly provided in this sub- chapter, nothing in this subchapter shall be construed as limiting or diminishing the au- thority of the Federal Trade Commission to enforce the laws under its jurisdiction with re- spect to the advertising, sale, or distribution of tobacco products. (2) Enforcement Any advertising that violates this sub- chapter or a provision of the regulations re- ferred to in section 387a–1 of this title, is an unfair or deceptive act or practice under sec- tion 45(a) of title 15 and shall be considered a violation of a rule promulgated under section 57a of title 15. (b) Coordination With respect to the requirements of section 4 of the Federal Cigarette Labeling and Adver- tising Act [15 U.S.C. 1333] and section 3 of the Comprehensive Smokeless Tobacco Health Edu- cation Act of 1986 [15 U.S.C. 4402]— (1) the Chairman of the Federal Trade Com- mission shall coordinate with the Secretary concerning the enforcement of such Act as such enforcement relates to unfair or decep- tive acts or practices in the advertising of cigarettes or smokeless tobacco; and (2) the Secretary shall consult with the Chairman of such Commission in revising the label statements and requirements under such sections. Page 692 TITLE 21—FOOD AND DRUGS § 387o (June 25, 1938, ch. 675, § 914, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1820.) Editorial Notes REFERENCES IN TEXT The Federal Cigarette Labeling and Advertising Act, referred to in subsec. (b), is Pub. L. 89–92, July 27, 1965, 79 Stat. 282, which is classified generally to chapter 36 (§ 1331 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1331 of Title 15 and Tables. The Comprehensive Smokeless Tobacco Health Edu- cation Act of 1986, referred to in subsec. (b), is Pub. L. 99–252, Feb. 27, 1986, 100 Stat. 30, which is classified principally to chapter 70 (§ 4401 et seq.) of Title 15, Com- merce and Trade. For complete classification of this Act to the Code, see Short Title note set out under sec- tion 4401 of Title 15 and Tables. § 387o. Regulation requirement (a) Testing, reporting, and disclosure Not later than 36 months after June 22, 2009, the Secretary shall promulgate regulations under this chapter that meet the requirements of subsection (b). (b) Contents of rules The regulations promulgated under subsection (a)— (1) shall require testing and reporting of to- bacco product constituents, ingredients, and additives, including smoke constituents, by brand and subbrand that the Secretary deter- mines should be tested to protect the public health, provided that, for purposes of the test- ing requirements of this paragraph, tobacco products manufactured and sold by a single to- bacco product manufacturer that are identical in all respects except the labels, packaging de- sign, logo, trade dress, trademark, brand name, or any combination thereof, shall be considered as a single brand; and (2) may require that tobacco product manu- facturers, packagers, or importers make dis- closures relating to the results of the testing of tar and nicotine through labels or adver- tising or other appropriate means, and make disclosures regarding the results of the testing of other constituents, including smoke con- stituents, ingredients, or additives, that the Secretary determines should be disclosed to the public to protect the public health and will not mislead consumers about the risk of tobacco-related disease. (c) Authority The Secretary shall have the authority under this subchapter to conduct or to require the testing, reporting, or disclosure of tobacco prod- uct constituents, including smoke constituents. (d) Small tobacco product manufacturers (1) First compliance date The initial regulations promulgated under subsection (a) shall not impose requirements on small tobacco product manufacturers be- fore the later of— (A) the end of the 2-year period following the final promulgation of such regulations; and (B) the initial date set by the Secretary for compliance with such regulations by manufacturers that are not small tobacco product manufacturers. (2) Testing and reporting initial compliance pe- riod (A) 4-year period The initial regulations promulgated under subsection (a) shall give each small tobacco product manufacturer a 4-year period over which to conduct testing and reporting for all of its tobacco products. Subject to para- graph (1), the end of the first year of such 4- year period shall coincide with the initial date of compliance under this section set by the Secretary with respect to manufacturers that are not small tobacco product manufac- turers or the end of the 2-year period fol- lowing the final promulgation of such regu- lations, as described in paragraph (1)(A). A small tobacco product manufacturer shall be required— (i) to conduct such testing and reporting for 25 percent of its tobacco products dur- ing each year of such 4-year period; and (ii) to conduct such testing and reporting for its largest-selling tobacco products (as determined by the Secretary) before its other tobacco products, or in such other order of priority as determined by the Sec- retary. (B) Case-by-case delay Notwithstanding subparagraph (A), the Secretary may, on a case-by-case basis, delay the date by which an individual small tobacco product manufacturer must conduct testing and reporting for its tobacco prod- ucts under this section based upon a showing of undue hardship to such manufacturer. Notwithstanding the preceding sentence, the Secretary shall not extend the deadline for a small tobacco product manufacturer to con- duct testing and reporting for all of its to- bacco products beyond a total of 5 years after the initial date of compliance under this section set by the Secretary with re- spect to manufacturers that are not small tobacco product manufacturers. (3) Subsequent and additional testing and re- porting The regulations promulgated under sub- section (a) shall provide that, with respect to any subsequent or additional testing and re- porting of tobacco products required under this section, such testing and reporting by a small tobacco product manufacturer shall be conducted in accordance with the timeframes described in paragraph (2)(A), except that, in the case of a new product, or if there has been a modification described in section 387j(a)(1)(B) of this title of any product of a small tobacco product manufacturer since the last testing and reporting required under this section, the Secretary shall require that any subsequent or additional testing and reporting be conducted in accordance with the same timeframe applicable to manufacturers that are not small tobacco product manufacturers.