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21 U.S.C. § 337 — Proceedings in name of United States; provision as to subpoenas

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

21 U.S.C. § 337 — Proceedings in name of United States; provision as to subpoenas

**(a)** Except as provided in subsection (b), all such proceedings for the enforcement, or to restrain 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, commenced an informal or formal enforcement action pertaining to the food which would be the subject of such proceeding, or (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 pertaining to such food. In any court proceeding described in subparagraph (C), a State may intervene as a matter of right.

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Source location: Title 21, Chapter 9, § 337; chapter-009-federal-food-drug-and-cosmetic-act.md

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

21 U.S.C. § 301 — Short title

This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.

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

28 U.S.C. § 654 — Arbitration

**(a) Referral of Actions to Arbitration.—** Notwithstanding any provision of law to the contrary and except as provided in subsections (a), (b), and (c) of section 652 and subsection (d) of this section, a district court may allow the referral to arbitration of any civil action (including any adversary proceeding in bankruptcy) pending before it when the parties consent, except that referral to arbitration may not be made where— (1) the action is based on an alleged violation of a right secured by the Constitution of the United States; (2) jurisdiction is based in whole or in part on [section 1343 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title28-section1343&num=0&edition=prelim); or (3) the relief sought consists of money damages in an amount greater than $150,000. **(b) Safeguards in Consent Cases.—** Until such time as rules are adopted under chapter 131 of this title relating to procedures described in this subsection, the district court shall, by local rule adopted under section 2071(a), establish procedures to ensure that any civil action in which arbitration by consent is allowed under subsection (a)— (1) consent to arbitration is freely and knowingly obtained; and (2) no party or attorney is prejudiced for refusing to participate in arbitration. **(c) Presumptions.—** For purposes of subsection (a)(3), a district court may presume damages are not in excess of $150,000 unless counsel certifies that damages exceed such amount. **(d) Existing Programs.—** Nothing in this chapter is deemed to affect any program in which arbitration is conducted pursuant to section 11 So in original. The word “section” probably should not appear. title IX of the Judicial Improvements and Access to Justice Act (Public Law 100–702), as amended

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21 U.S.C. § 451 — Congressional statement of findings

Poultry and poultry products are an important source of the Nation’s total supply of food. They are consumed throughout the Nation and the major portion thereof moves in interstate or foreign commerce. It is essential in the public interest that the health and welfare of consumers be protected by assuring that poultry products distributed to them are wholesome, not adulterated, and properly marked, labeled, and packaged. Unwholesome, adulterated, or misbranded poultry products impair the effective regulation of poultry products in interstate or foreign commerce, are injurious to the public welfare, destroy markets for wholesome, not adulterated, and properly labeled and packaged poultry products, and result in sundry losses to poultry producers and processors of poultry and poultry products, as well as injury to consumers. It is hereby found that all articles and poultry which are regulated under this chapter are either in interstate or foreign commerce or substantially affect such commerce, and that regulation by the Secretary of Agriculture and cooperation by the States and other jurisdictions as contemplated by this chapter are appropriate to prevent and eliminate burdens upon such commerce, to effectively regulate such commerce, and to protect the health and welfare of consumers.

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21 U.S.C. § 601 — Definitions

As used in this chapter, except as otherwise specified, the following terms shall have the meanings stated below: **(a)** The term “Secretary” means the Secretary of Agriculture of the United States or his delegate. **(b)** The term “firm” means any partnership, association, or other unincorporated business organization. **(c)** The term “meat broker” means any person, firm, or corporation engaged in the business of buying or selling carcasses, parts of carcasses, meat, or meat food products of cattle, sheep, swine, goats, horses, mules, or other equines on commission, or otherwise negotiating purchases or sales of such articles other than for his own account or as an employee of another person, firm, or corporation. **(d)** The term “renderer” means any person, firm, or corporation engaged in the business of rendering carcasses or parts or products of the carcasses, of cattle, sheep, swine, goats, horses, mules, or other equines, except rendering conducted under inspection or exemption under this subchapter. **(e)** The term “animal food manufacturer” means any person, firm, or corporation engaged in the business of manufacturing or processing animal food derived wholly or in part from carcasses, or parts or products of the carcasses, of cattle, sheep, swine, goats, horses, mules, or other equines. **(f)** The term “State” means any State of the United States and the Commonwealth of Puerto Rico. **(g)** The term “Territory” means Guam, the Virgin Islands of the United States, American Samoa, and any other territory or possession of the United States, excluding the Canal Zone. **(h)** The term “commerce” means commerce between any State, any Territory, or the District of Columbia, and any place outside thereof; or within any Territory not organized with a legisl

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

21 U.S.C. § 1031 — Congressional statement of findings

Eggs and egg products are an important source of the Nation’s total supply of food, and are used in food in various forms. They are consumed throughout the Nation and the major portion thereof moves in interstate or foreign commerce. It is essential, in the public interest, that the health and welfare of consumers be protected by the adoption of measures prescribed herein for assuring that eggs and egg products distributed to them and used in products consumed by them are wholesome, otherwise not adulterated, and properly labeled and packaged. Lack of effective regulation for the handling or disposition of unwholesome, otherwise adulterated, or improperly labeled or packaged egg products and certain qualities of eggs is injurious to the public welfare and destroys markets for wholesome, not adulterated, and properly labeled and packaged eggs and egg products and results in sundry losses to producers and processors, as well as injury to consumers. Unwholesome, otherwise adulterated, or improperly labeled or packaged products can be sold at lower prices and compete unfairly with the wholesome, not adulterated, and properly labeled and packaged products, to the detriment of consumers and the public generally. It is hereby found that all egg products and the qualities of eggs which are regulated under this chapter are either in interstate or foreign commerce, or substantially affect such commerce, and that regulation by the Secretary of Agriculture and the Secretary of Health and Human Services, and cooperation by the States and other jurisdictions, as contemplated by this chapter, are appropriate to prevent and eliminate burdens upon such commerce, to effectively regulate such commerce, and to protect the health and welfare of consumers.

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

21 U.S.C. § 343 — Misbranded food

A food shall be deemed to be misbranded— **(a) False or misleading label** If (1) its labeling is false or misleading in any particular, or (2) in the case of a food to which [section 350 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350&num=0&edition=prelim) applies, its advertising is false or misleading in a material respect or its labeling is in violation of [section 350(b)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350/b/2&num=0&edition=prelim). **(b) Offer for sale under another name** If it is offered for sale under the name of another food. **(c) Imitation of another food** If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word “imitation” and, immediately thereafter, the name of the food imitated. **(d) Misleading container** If its container is so made, formed, or filled as to be misleading. **(e) Package form** If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count, except that under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary. **(f) Prominence of information on label** If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and unde

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

21 U.S.C. § 335b — Civil penalties

**(a) In general** Any person that the Secretary finds— (1) knowingly made or caused to be made, to any officer, employee, or agent of the Department of Health and Human Services, a false statement or misrepresentation of a material fact in connection with an abbreviated drug application, (2) bribed or attempted to bribe or paid or attempted to pay an illegal gratuity to any officer, employee, or agent of the Department of Health and Human Services in connection with an abbreviated drug application, (3) destroyed, altered, removed, or secreted, or procured the destruction, alteration, removal, or secretion of, any material document or other material evidence which was the property of or in the possession of the Department of Health and Human Services for the purpose of interfering with that Department’s discharge of its responsibilities in connection with an abbreviated drug application, (4) knowingly failed to disclose, to an officer or employee of the Department of Health and Human Services, a material fact which such person had an obligation to disclose relating to any drug subject to an abbreviated drug application, (5) knowingly obstructed an investigation of the Department of Health and Human Services into any drug subject to an abbreviated drug application, (6) is a person that has an approved or pending drug product application and has knowingly— (A) employed or retained as a consultant or contractor, or (B) otherwise used in any capacity the services of, a person who was debarred under [section 335a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section335a&num=0&edition=prelim), or (7) is an individual debarred under [section 335a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-tit

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

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- t

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