21 U.S.C. § 337 — Proceedings in name of United States; pro-

Page 76 TITLE 21—FOOD AND DRUGS § 335c (1) $250,000, or (2) one-half of the penalty so imposed and collected, whichever is less. The decision of the Secretary on such award shall not be reviewable. (June 25, 1938, ch. 675, § 307, as added Pub. L. 102–282, § 3, May 13, 1992, 106 Stat. 159; amended Pub. L. 103–80, § 3(g), Aug. 13, 1993, 107 Stat. 776.) Editorial Notes PRIOR PROVISIONS A prior section 307 of act June 25, 1938, was renum- bered section 310 and is classified to section 337 of this title. AMENDMENTS 1993—Subsec. (b)(3)(A). Pub. L. 103–80 made technical amendment to reference to May 13, 1992, to reflect cor- rection of corresponding provision of original act. Statutory Notes and Related Subsidiaries CONSTRUCTION This section not to preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private right of action against any person for the same action subject to any action or civil penalty under an amendment made by Pub. L. 102–282, see section 7 of Pub. L. 102–282, set out as a note under section 335a of this title. § 335c. Authority to withdraw approval of abbre- viated drug applications (a) In general The Secretary— (1) shall withdraw approval of an abbre- viated drug application if the Secretary finds that the approval was obtained, expedited, or otherwise facilitated through bribery, pay- ment of an illegal gratuity, or fraud or mate- rial false statement, and (2) may withdraw approval of an abbreviated drug application if the Secretary finds that the applicant has repeatedly demonstrated a lack of ability to produce the drug for which the application was submitted in accordance with the formulations or manufacturing prac- tice set forth in the abbreviated drug applica- tion and has introduced, or attempted to in- troduce, such adulterated or misbranded drug into commerce. (b) Procedure The Secretary may not take any action under subsection (a) with respect to any person unless the Secretary has issued an order for such ac- tion made on the record after opportunity for an agency hearing on disputed issues of material fact. In the course of any investigation or hear- ing under this subsection, the Secretary may ad- minister oaths and affirmations, examine wit- nesses, receive evidence, and issue subpoenas re- quiring the attendance and testimony of wit- nesses and the production of evidence that re- lates to the matter under investigation. (c) Applicability Subsection (a) shall apply with respect to of- fenses or acts regardless of when such offenses or acts occurred. (d) Judicial review Any person that is the subject of an adverse decision under subsection (a) may obtain a re- view of such decision by the United States Court of Appeals for the District of Columbia or for the circuit in which the person resides, by filing in such court (within 60 days following the date the person is notified of the Secretary’s deci- sion) a petition requesting that the decision be modified or set aside. (June 25, 1938, ch. 675, § 308, as added Pub. L. 102–282, § 4, May 13, 1992, 106 Stat. 160.) Statutory Notes and Related Subsidiaries CONSTRUCTION This section not to preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private right of action against any person for the same action subject to any action or civil penalty under an amendment made by Pub. L. 102–282, see section 7 of Pub. L. 102–282, set out as a note under section 335a of this title. § 336. Report of minor violations Nothing in this chapter shall be construed as requiring the Secretary to report for prosecu- tion, or for the institution of libel or injunction proceedings, minor violations of this chapter whenever he believes that the public interest will be adequately served by a suitable written notice or warning. (June 25, 1938, ch. 675, § 309, formerly § 306, 52 Stat. 1045; renumbered § 309, Pub. L. 102–282, § 2, May 13, 1992, 106 Stat. 150.) Executive Documents TRANSFER OF FUNCTIONS For transfer of functions of Federal Security Admin- istrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title. § 337. Proceedings in name of United States; pro- vision as to subpoenas (a) Except as provided in subsection (b), all such proceedings for the enforcement, or to re- strain violations, of this chapter shall be by and in the name of the United States. Subpoenas for witnesses who are required to attend a court of the United States, in any district, may run into any other district in any proceeding under this section. (b)(1) A State may bring in its own name and within its jurisdiction proceedings for the civil enforcement, or to restrain violations, of section 341, 343(b), 343(c), 343(d), 343(e), 343(f), 343(g), 343(h), 343(i), 343(k), 343(q), or 343(r) of this title if the food that is the subject of the proceedings is located in the State. (2) No proceeding may be commenced by a State under paragraph (1)— (A) before 30 days after the State has given notice to the Secretary that the State intends to bring such proceeding, (B) before 90 days after the State has given notice to the Secretary of such intent if the Secretary has, within such 30 days, com- menced an informal or formal enforcement ac- tion pertaining to the food which would be the subject of such proceeding, or Page 77 TITLE 21—FOOD AND DRUGS § 341 (C) if the Secretary is diligently prosecuting a proceeding in court pertaining to such food, has settled such proceeding, or has settled the informal or formal enforcement action per- taining to such food. In any court proceeding described in subpara- graph (C), a State may intervene as a matter of right. (June 25, 1938, ch. 675, § 310, formerly § 307, 52 Stat. 1046; Sept. 3, 1954, ch. 1263, § 37, 68 Stat. 1239; Pub. L. 101–535, § 4, Nov. 8, 1990, 104 Stat. 2362; renumbered § 310, Pub. L. 102–282, § 2, May 13, 1992, 106 Stat. 150.) Editorial Notes AMENDMENTS 1990—Pub. L. 101–535 substituted ‘‘(a) Except as pro- vided in subsection (b), all’’ for ‘‘All’’ and ‘‘any pro- ceeding under this section’’ for ‘‘any such proceeding’’ and added subsec. (b). 1954—Act Sept. 3, 1954, struck out reference to section 654 of title 28. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1990 AMENDMENT Amendment by Pub. L. 101–535 effective 24 months after Nov. 8, 1990, except that such amendment effec- tive Dec. 31, 1993, with respect to dietary supplements of vitamins, minerals, herbs, or other similar nutri- tional substances, see section 10(a)(1)(C) of Pub. L. 101–535, set out as a note under section 343 of this title. CONSTRUCTION OF AMENDMENTS BY PUB. L. 101–535 Amendments by Pub. L. 101–535 not to be construed to alter authority of Secretary of Health and Human Services and Secretary of Agriculture under the Fed- eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see section 9 of Pub. L. 101–535, set out as a note under section 343 of this title. § 337a. Extraterritorial jurisdiction There is extraterritorial jurisdiction over any violation of this chapter relating to any article regulated under this chapter if such article was intended for import into the United States or if any act in furtherance of the violation was com- mitted in the United States. (June 25, 1938, ch. 675, § 311, as added Pub. L. 112–144, title VII, § 718, July 9, 2012, 126 Stat. 1077.) SUBCHAPTER IV—FOOD § 341. Definitions and standards for food Whenever in the judgment of the Secretary such action will promote honesty and fair deal- ing in the interest of consumers, he shall pro- mulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of identity, a reasonable standard of quality, or reasonable standards of fill of con- tainer. No definition and standard of identity and no standard of quality shall be established for fresh or dried fruits, fresh or dried vegeta- bles, or butter, except that definitions and standards of identity may be established for avocadoes, cantaloupes, citrus fruits, and mel- ons. In prescribing any standard of fill of con- tainer, the Secretary shall give due consider- ation to the natural shrinkage in storage and in transit of fresh natural food and to need for the necessary packing and protective material. In the prescribing of any standard of quality for any canned fruit or canned vegetable, consider- ation shall be given and due allowance made for the differing characteristics of the several vari- eties of such fruit or vegetable. In prescribing a definition and standard of identity for any food or class of food in which optional ingredients are permitted, the Secretary shall, for the purpose of promoting honesty and fair dealing in the in- terest of consumers, designate the optional in- gredients which shall be named on the label. Any definition and standard of identity pre- scribed by the Secretary for avocadoes, canta- loupes, citrus fruits, or melons shall relate only to maturity and to the effects of freezing. (June 25, 1938, ch. 675, § 401, 52 Stat. 1046; Apr. 15, 1954, ch. 143, § 1, 68 Stat. 54; Aug. 1, 1956, ch. 861, § 1, 70 Stat. 919; Pub. L. 103–80, § 3(h), Aug. 13, 1993, 107 Stat. 776.) Editorial Notes AMENDMENTS 1993—Pub. L. 103–80 substituted ‘‘or reasonable stand- ards of fill of container. No definition’’ for ‘‘and/or rea- sonable standards of fill of container: Provided, That no definition’’. 1956—Act Aug. 1, 1956, designated provisions consti- tuting subsec. (a) as entire section and repealed subsec. (b) which provided the procedure for establishment of regulations and is covered by section 371(e) of this title. 1954—Act Apr. 15, 1954, designated existing provisions as subsec. (a) and added subsec. (b). Statutory Notes and Related Subsidiaries SAVINGS PROVISION Act Aug. 1, 1956, ch. 861, § 3, 70 Stat. 919, provided that: ‘‘In any case in which, prior to the enactment of this Act [Aug. 1, 1956], a public hearing has been begun in accordance with section 401 of the Federal Food, Drug, and Cosmetic Act [341 of this title] upon a pro- posal to issue, amend, or repeal any regulation con- templated by such section, or has been begun in accord- ance with section 701(e) of such Act [section 371(e) of this title] upon a proposal to issue, amend, or repeal any regulation contemplated by section 403(j), 404(a), 406(a) or (b), 501(b), 502(d), 502(h), 504 or 604 of such Act [section 343(j), 344(a), 346(a) or (b), 351(b), 352(d), 352(h), 354, or 364 of this title], the provisions of such section 401 or 701(e), as the case may be, as in force imme- diately prior to the date of the enactment of this Act [Aug. 1, 1956], shall be applicable as though this Act [amending this section and section 371(e) of this title] had not been enacted.’’ FOOD SAFETY AND SECURITY STRATEGY Pub. L. 107–188, title III, § 301, June 12, 2002, 116 Stat. 662, provided that: ‘‘(a) IN GENERAL.—The President’s Council on Food Safety (as established by Executive Order No. 13100 [set out below]) shall, in consultation with the Secretary of Transportation, the Secretary of the Treasury, other relevant Federal agencies, the food industry, consumer and producer groups, scientific organizations, and the States, develop a crisis communications and education strategy with respect to bioterrorist threats to the food supply. Such strategy shall address threat assessments; technologies and procedures for securing food proc-