21 U.S.C. § 64 (2024) — Title 21: FOOD AND DRUGS / Chapter 3: FILLED MILK / Section 64: Regulations for enforcement
Regulations for enforcement
Status: in_force

The Secretary of Health and Human Services is authorized and directed to make and enforce such regulations as may in his judgment be necessary to carry out the purposes of this chapter.

(Mar. 4, 1923, ch. 262, §4, as added Aug. 27, 1935, ch. 743, 49 Stat. 885; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695.)

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted in text for "Secretary of Health, Education, and Welfare" pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration to Federal Security Agency, see notes set out under section 321 of this title.
21 U.S.C. § 321c (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter II: DEFINITIONS / Section 321c: Nonfat dry milk; "milk" defined
Nonfat dry milk; "milk" defined
Status: in_force

For the purposes of the Federal Food, Drug, and Cosmetic Act of June 26, 1938, (ch. 675, sec. 1, 52 Stat. 1040) [21 U.S.C. 301 et seq.] nonfat dry milk is the product resulting from the removal of fat and water from milk, and contains the lactose, milk proteins, and milk minerals in the same relative proportions as in the fresh milk from which made. It contains not over 5 per centum by weight of moisture. The fat content is not over 1½ per centum by weight unless otherwise indicated.

The term "milk", when used herein, means sweet milk of cows.

(Mar. 2, 1944, ch. 77, 58 Stat. 108; July 2, 1956, ch. 495, 70 Stat. 486.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act of June 26, 1938 (ch. 675, sec. 1, 52 Stat. 1040), referred to in text, probably means act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter (§301 et seq.). For complete classification of this Act to the Code, see section 301 of this title and Tables.

Codification

Section was not enacted as a part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter, but was made applicable thereto.

Amendments

1956—Act July 2, 1956, substituted "nonfat dry milk" for "nonfat dry milk solids or defatted milk solids".
21 U.S.C. § 360jj (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360jj: Studies by Secretary
Studies by Secretary
Status: in_force

(a) Report to Congress

The Secretary shall conduct the following studies, and shall make a report or reports of the results of such studies to the Congress on or before January 1, 1970, and from time to time thereafter as he may find necessary, together with such recommendations for legislation as he may deem appropriate:

(1) A study of present State and Federal control of health hazards from electronic product radiation and other types of ionizing radiation, which study shall include, but not be limited to—

(A) control of health hazards from radioactive materials other than materials regulated under the Atomic Energy Act of 1954 [42 U.S.C. 2011 et seq.];

(B) any gaps and inconsistencies in present controls;

(C) the need for controlling the sale of certain used electronic products, particularly antiquated X-ray equipment, without upgrading such products to meet the standards for new products or separate standards for used products;

(D) measures to assure consistent and effective control of the aforementioned health hazards;

(E) measures to strengthen radiological health programs of State governments; and

(F) the feasibility of authorizing the Secretary to enter into arrangements with individual States or groups of States to define their respective functions and responsibilities for the control of electronic product radiation and other ionizing radiation;

(2) A study to determine the necessity for the development of standards for the use of nonmedical electronic products for commercial and industrial purposes; and

(3) A study of the development of practicable procedures for the detection and measurement of electronic product radiation which may be emitted from electronic products manufactured or imported prior to the effective date of any applicable standard established pursuant to this part.

(b) Participation of other Federal agencies

In carrying out these studies, the Secretary shall invite the participation of other Federal departments and agencies having related responsibilities and interests, State governments—particularly those of States which regulate radioactive materials under section 274 of the Atomic Energy Act of 1954, as amended [42 U.S.C. 2021], and interested professional, labor, and industrial organizations. Upon request from congressional committees interested in these studies, the Secretary shall keep these committees currently informed as to the progress of the studies and shall permit the committees to send observers to meetings of the study groups.

(c) Organization of studies and participation

The Secretary or his designee shall organize the studies and the participation of the invited participants as he deems best. Any dissent from the findings and recommendations of the Secretary shall be included in the report if so requested by the dissenter.

(June 25, 1938, ch. 675, §533, formerly act July 1, 1944, ch. 373, title III, §533, formerly §357, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1176; renumbered §533 and amended Pub. L. 101–629, §19(a)(1)(B), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

Editorial Notes

References in Text

The Atomic Energy Act of 1954, referred to in subsec. (a)(1)(A), is act Aug. 1, 1946, ch. 724, as added by act Aug. 30, 1954, ch. 1073, §1, 68 Stat. 919, which is classified principally to chapter 23 (§2011 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 2011 of Title 42 and Tables.

Codification

Section was classified to section 263e of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.

Amendments

1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, §19(a)(4), which renumbered section 263e of Title 42, The Public Health and Welfare, as this section.

1990—Subsec. (a)(3). Pub. L. 101–629, §19(a)(1)(B), substituted "this part" for "this subpart".

Statutory Notes and Related Subsidiaries

Noninterference With Other Federal Agencies

Enactment of this section not to be construed to supersede or limit the functions under any other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.
21 U.S.C. § 458 (2024) — Title 21: FOOD AND DRUGS / Chapter 10: POULTRY AND POULTRY PRODUCTS INSPECTION / Section 458: Prohibited acts
Prohibited acts
Status: in_force

(a) No person shall—

(1) slaughter any poultry or process any poultry products which are capable of use as human food at any establishment processing any such articles for commerce, except in compliance with the requirements of this chapter;

(2) sell, transport, offer for sale or transportation, or receive for transportation, in commerce, (A) any poultry products which are capable of use as human food and are adulterated or misbranded at the time of such sale, transportation, offer for sale or transportation, or receipt for transportation; or (B) any poultry products required to be inspected under this chapter unless they have been so inspected and passed;

(3) do, with respect to any poultry products which are capable of use as human food, any act while they are being transported in commerce or held for sale after such transportation, which is intended to cause or has the effect of causing such products to be adulterated or misbranded;

(4) sell, transport, offer for sale or transportation, or receive for transportation, in commerce or from an official establishment, any slaughtered poultry from which the blood, feathers, feet, head, or viscera have not been removed in accordance with regulations promulgated by the Secretary, except as may be authorized by regulations of the Secretary;

(5) use to his own advantage, or reveal other than to the authorized representatives of the United States Government or any State or other government in their official capacity, or as ordered by a court in any judicial proceedings, any information acquired under the authority of this chapter concerning any matter which is entitled to protection as a trade secret.

(b) No brand manufacturer, printer, or other person shall cast, print, lithograph, or otherwise make any device containing any official mark or simulation thereof, or any label bearing any such mark or simulation, or any form of official certificate or simulation thereof, except as authorized by the Secretary.

(c) No person shall—

(1) forge any official device, mark, or certificate;

(2) without authorization from the Secretary use any official device, mark, or certificate, or simulation thereof, or alter, detach, deface, or destroy any official device, mark, or certificate;

(3) contrary to the regulations prescribed by the Secretary, fail to use, or to detach, deface, or destroy any official device, mark, or certificate;

(4) knowingly possess, without promptly notifying the Secretary or his representative, any official device or any counterfeit, simulated, forged, or improperly altered official certificate or any device or label or any carcass of any poultry, or part or product thereof, bearing any counterfeit, simulated, forged, or improperly altered official mark;

(5) knowingly make any false statement in any shipper's certificate or other nonofficial or official certificate provided for in the regulations prescribed by the Secretary; or

(6) knowingly represent that any article has been inspected and passed, or exempted, under this chapter when, in fact, it has respectively, not been so inspected and passed, or exempted.

(Pub. L. 85–172, §9, Aug. 28, 1957, 71 Stat. 445; Pub. L. 90–492, §9, Aug. 18, 1968, 82 Stat. 800.)

Editorial Notes

Amendments

1968—Pub. L. 90–492 made revisions in form and phraseology, added to the enumerated prohibited acts slaughtering poultry or processing any poultry products capable of use as human food, except in compliance with the requirements of this chapter, selling and transporting adulterated or misbranded poultry products or uninspected poultry products, adulterating or misbranding poultry products while they are being transported in commerce or held for sale after such transportation, treating carcasses not in accordance with regulations promulgated by the Secretary, possessing, without notifying the Secretary, any official device or any counterfeit, simulated, etc., official certificate, or any device or label bearing any counterfeit, simulated, etc., official mark, and making false representations and statements, and clarified application to brand manufacturers and printers of existing provisions prohibiting the counterfeiting of official marks, labels, or certificates.

Statutory Notes and Related Subsidiaries

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–492 effective Aug. 18, 1968, except that amendment of pars. (a)(2)(A) and (a)(3) effective upon the expiration of sixty days after Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.
21 U.S.C. § 856 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 856: Maintaining drug-involved premises
Maintaining drug-involved premises
Status: in_force

(a) Unlawful acts

Except as authorized by this subchapter, it shall be unlawful to—

(1) knowingly open, lease, rent, use, or maintain any place, whether permanently or temporarily, for the purpose of manufacturing, distributing, or using any controlled substance;

(2) manage or control any place, whether permanently or temporarily, either as an owner, lessee, agent, employee, occupant, or mortgagee, and knowingly and intentionally rent, lease, profit from, or make available for use, with or without compensation, the place for the purpose of unlawfully manufacturing, storing, distributing, or using a controlled substance.

(b) Criminal penalties

Any person who violates subsection (a) of this section shall be sentenced to a term of imprisonment of not more than 20 years or a fine of not more than $500,000, or both, or a fine of $2,000,000 for a person other than an individual.

(c) Violation as offense against property

A violation of subsection (a) shall be considered an offense against property for purposes of section 3663A(c)(1)(A)(ii) of title 18.

(d) Civil penalties

(1) Any person who violates subsection (a) shall be subject to a civil penalty of not more than the greater of—

(A) $250,000; or

(B) 2 times the gross receipts, either known or estimated, that were derived from each violation that is attributable to the person.

(2) If a civil penalty is calculated under paragraph (1)(B), and there is more than 1 defendant, the court may apportion the penalty between multiple violators, but each violator shall be jointly and severally liable for the civil penalty under this subsection.

(e) Declaratory and injunctive remedies

Any person who violates subsection (a) shall be subject to declaratory and injunctive remedies as set forth in section 843(f) of this title.

(Pub. L. 91–513, title II, §416, as added Pub. L. 99–570, title I, §1841(a), Oct. 27, 1986, 100 Stat. 3207–52; amended Pub. L. 106–310, div. B, title XXXVI, §3613(e), Oct. 17, 2000, 114 Stat. 1230; Pub. L. 108–21, title VI, §608(b)(1), (2), (c), Apr. 30, 2003, 117 Stat. 691.)

Editorial Notes

Amendments

2003—Pub. L. 108–21, §608(b)(2), substituted "Maintaining drug-involved premises" for "Establishment of manufacturing operations" in section catchline.

Subsec. (a)(1). Pub. L. 108–21, §608(b)(1)(A), substituted "open, lease, rent, use, or maintain any place, whether permanently or temporarily," for "open or maintain any place".

Subsec. (a)(2). Pub. L. 108–21, §608(b)(1)(B), added par. (2) and struck out former par. (2) which read as follows: "manage or control any building, room, or enclosure, either as an owner, lessee, agent, employee, or mortgagee, and knowingly and intentionally rent, lease, or make available for use, with or without compensation, the building, room, or enclosure for the purpose of unlawfully manufacturing, storing, distributing, or using a controlled substance."

Subsecs. (d), (e). Pub. L. 108–21, §608(c), added subsecs. (d) and (e).

2000—Subsec. (c). Pub. L. 106–310 added subsec. (c).
21 U.S.C. § 857 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 857: Repealed. Pub. L. 101-647, title XXIV, §2401(d), Nov. 29, 1990, 104 Stat. 4859
Repealed. Pub. L. 101-647, title XXIV, §2401(d), Nov. 29, 1990, 104 Stat. 4859
Status: repealed

Section, Pub. L. 99–570, title I, §1822, Oct. 27, 1986, 100 Stat. 3207–51; Pub. L. 100–690, title VI, §6485, Nov. 18, 1988, 102 Stat. 4384; Pub. L. 101–647, title XXIV, §2401(b), Nov. 29, 1990, 104 Stat. 4859, related to interstate and foreign sale and transportation of drug paraphernalia.

Subsec. (a), which related to unlawful acts, was repealed.

Subsecs. (b) to (f) were redesignated as subsecs. (b) to (f) of section 422 of the Controlled Substances Act by section 2401(b) of Pub. L. 101–647 and transferred to section 863(b) to (f) of this title.

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 99–570, title I, §1823, Oct. 27, 1986, 100 Stat. 3207–52, which provided that subtitle O (§§1821–1823) of title I of Pub. L. 99–570, enacting this section and provisions set out as a note under section 801 of this title, was to become effective 90 days after Oct. 27, 1986, was repealed by Pub. L. 101–647, title XXIV, §2401(d), Nov. 29, 1990, 104 Stat. 4859.
21 U.S.C. § 2311 (2024) — Title 21: FOOD AND DRUGS / Chapter 28: SANCTIONS WITH RESPECT TO FOREIGN TRAFFICKERS OF ILLICIT SYNTHETIC OPIOIDS / Subchapter I: SANCTIONS WITH RESPECT TO FOREIGN OPIOID TRAFFICKERS / Section 2311: Identification of foreign opioid traffickers
Identification of foreign opioid traffickers
Status: in_force

(a) Public report

(1) In general

The President shall submit to the appropriate congressional committees and leadership, in accordance with subsection (c), a report—

(A) identifying the foreign persons that the President determines are foreign opioid traffickers;

(B) detailing progress the President has made in implementing this subchapter; and

(C) providing an update on cooperative efforts with the governments of Mexico, the People's Republic of China, and other countries of concern with respect to combating foreign opioid traffickers.

(2) Identification of additional persons

If, at any time after submitting a report required by paragraph (1) and before the submission of the next such report, the President determines that a foreign person not identified in the report is a foreign opioid trafficker, the President shall submit to the appropriate congressional committees and leadership an additional report containing the information required by paragraph (1) with respect to the foreign person.

(3) Exclusion

The President shall not be required to include in a report under paragraph (1) or (2) any persons with respect to which the United States has imposed sanctions before the date of the report under this subchapter or any other provision of law with respect to opioid trafficking.

(4) Form of report

(A) In general

Each report required by paragraph (1) or (2) shall be submitted in unclassified form but may include a classified annex.

(B) Availability to public

The unclassified portion of a report required by paragraph (1) or (2) shall be made available to the public.

(b) Classified report

(1) In general

The President shall submit to the appropriate congressional committees and leadership, in accordance with subsection (c), a report, in classified form—

(A) describing in detail the status of sanctions imposed under this subchapter, including the personnel and resources directed toward the imposition of such sanctions during the preceding fiscal year;

(B) providing background information with respect to persons newly identified as foreign opioid traffickers and their illicit activities;

(C) describing actions the President intends to undertake or has undertaken to implement this subchapter; and

(D) providing a strategy for identifying additional foreign opioid traffickers.

(2) Effect on other reporting requirements

The report required by paragraph (1) is in addition to, and in no way delimits or restricts, the obligations of the President to keep Congress fully and currently informed pursuant to the provisions of the National Security Act of 1947 (50 U.S.C. 3001 et seq.).

(c) Submission of reports

Not later than 180 days after December 20, 2019, and annually thereafter until the date that is 5 years after December 20, 2019, the President shall submit the reports required by subsections (a) and (b) to the appropriate congressional committees and leadership.

(d) Exclusion of certain information

(1) Intelligence

Notwithstanding any other provision of this section, a report required by subsection (a) or (b) shall not disclose the identity of any person if the Director of National Intelligence determines that such disclosure could compromise an intelligence operation, activity, source, or method of the United States.

(2) Law enforcement

Notwithstanding any other provision of this section, a report required by subsection (a) or (b) shall not disclose the identity of any person if the Attorney General, in coordination, as appropriate, with the Director of the Federal Bureau of Investigation, the Administrator of the Drug Enforcement Administration, the Secretary of the Treasury, the Secretary of State, and the head of any other appropriate Federal law enforcement agency, determines that such disclosure could reasonably be expected—

(A) to compromise the identity of a confidential source, including a State, local, or foreign agency or authority or any private institution that furnished information on a confidential basis;

(B) to jeopardize the integrity or success of an ongoing criminal investigation or prosecution;

(C) to endanger the life or physical safety of any person; or

(D) to cause substantial harm to physical property.

(3) Notification required

If the Director of National Intelligence makes a determination under paragraph (1) or the Attorney General makes a determination under paragraph (2), the Director or the Attorney General, as the case may be, shall notify the appropriate congressional committees and leadership of the determination and the reasons for the determination.

(4) Rule of construction

Nothing in this section may be construed to authorize or compel the disclosure of information determined by the President to be law enforcement information, classified information, national security information, or other information the disclosure of which is prohibited by any other provision of law.

(e) Provision of information required for reports

The Secretary of the Treasury, the Attorney General, the Secretary of Defense, the Secretary of State, the Secretary of Homeland Security, and the Director of National Intelligence shall consult among themselves and provide to the President and the Director of the Office of National Drug Control Policy the appropriate and necessary information to enable the President to submit the reports required by subsection (a).

(Pub. L. 116–92, div. F, title LXXII, §7211, Dec. 20, 2019, 133 Stat. 2263.)

Editorial Notes

References in Text

This subchapter, referred to in subsecs. (a)(1)(B), (3) and (b)(1)(A), (C), was in the original "this subtitle", meaning subtitle A (§§7211–7217) of title LXXII of div. F of Pub. L. 116–92, which is classified principally to this subchapter. For complete classification of subtitle A to the Code, see Tables.

The National Security Act of 1947, referred to in subsec. (b)(2), is act July 26, 1947, ch. 343, 61 Stat. 495, which is classified principally to chapter 44 (§3001 et seq.) of Title 50, War and National Defense. For complete classification of this Act to the Code, see Tables.

Executive Documents

Delegation of Certain Functions and Authorities Under the National Defense Authorization Act for Fiscal Year 2020

Memorandum of President of the United States, Mar. 31, 2020, 85 F.R. 22343, provided:

Memorandum for the Secretary of State[,] the Secretary of the Treasury[,] the Secretary of Defense[, and] the Director of National Drug Control Policy

By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 301 of title 3, United States Code, I hereby order as follows:

Section 1. (a) I hereby delegate to the Secretary of State the functions and authorities vested in the President by section 7426 of the National Defense Authorization Act for Fiscal Year 2020 (Public Law 116–92) (the "Act") [22 U.S.C. 8791 note].

(b) I hereby delegate to the Secretary of State, in consultation with the Secretary of the Treasury, the functions and authorities vested in the President by the following provisions of the Act:

(i) section 7214 [21 U.S.C. 2314];

(ii) section 7413 [22 U.S.C. 8791 note];

(iii) section 7431 [22 U.S.C. 8791 note]; and

(iv) section 7432 [22 U.S.C. 8791 note].

(c) I hereby delegate to the Secretary of State, in consultation with the Secretary of the Treasury and the Director of National Drug Control Policy, the functions and authorities vested in the President by section 7211(a)(1)(C) of the Act [21 U.S.C. 2311(a)(1)(C)].

(d) I hereby delegate to the Secretary of the Treasury, in consultation with the Secretary of State, the functions and authorities vested in the President by the following provisions of the Act:

(i) section 7211(a)(1)(A)–(B) [21 U.S.C. 2311(a)(1)(A), (B)];

(ii) section 7211(a)(2)–(3) [21 U.S.C. 2311(a)(2), (3)];

(iii) section 7211(b) [21 U.S.C. 2311(b)];

(iv) section 7211(c) [21 U.S.C. 2311(c)];

(v) section 7212 [21 U.S.C. 2312];

(vi) section 7213(a)(4)–(9) [21 U.S.C. 2313(a)(4) to (9)];

(vii) section 7213(d) [21 U.S.C. 2313(d)];

(viii) section 7215(a) [21 U.S.C. 2315(a)];

(ix) section 7233 [21 U.S.C. 2333];

(x) section 7412(a) [22 U.S.C. 8791 note]; and

(xi) section 7412(b)(1)(A) [22 U.S.C. 8791 note].

(e) I hereby delegate to the Secretary of the Treasury the functions and authorities vested in the President by section 7433 of the Act [22 U.S.C. 8791 note].

(f) I hereby delegate to the Secretary of State and the Secretary of Defense the functions and authorities vested in the President by section 7423 of the Act [22 U.S.C. 8791 note].

Sec. 2. The delegations in this memorandum shall apply to any provisions of any future public laws that are the same or substantially the same as those provisions referenced in this memorandum.

Sec. 3. The Secretary of State is authorized and directed to publish this memorandum in the Federal Register.

Donald J. Trump.
21 U.S.C. § 384a (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VIII: IMPORTS AND EXPORTS / Section 384a: Foreign supplier verification program
Foreign supplier verification program
Status: in_force

(a) In general

(1) Verification requirement

Except as provided under subsections (e) and (f), each importer shall perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer or agent of an importer is—

(A) produced in compliance with the requirements of section 350g of this title or section 350h of this title, as appropriate; and

(B) is not adulterated under section 342 of this title or misbranded under section 343(w) of this title.

(2) Importer defined

For purposes of this section, the term "importer" means, with respect to an article of food—

(A) the United States owner or consignee of the article of food at the time of entry of such article into the United States; or

(B) in the case when there is no United States owner or consignee as described in subparagraph (A), the United States agent or representative of a foreign owner or consignee of the article of food at the time of entry of such article into the United States.

(b) Guidance

Not later than 1 year after January 4, 2011, the Secretary shall issue guidance to assist importers in developing foreign supplier verification programs.

(c) Regulations

(1) In general

Not later than 1 year after January 4, 2011, the Secretary shall promulgate regulations to provide for the content of the foreign supplier verification program established under subsection (a).

(2) Requirements

The regulations promulgated under paragraph (1)—

(A) shall require that the foreign supplier verification program of each importer be adequate to provide assurances that each foreign supplier to the importer produces the imported food in compliance with—

(i) processes and procedures, including reasonably appropriate risk-based preventive controls, that provide the same level of public health protection as those required under section 350g of this title or section 350h of this title (taking into consideration variances granted under section 350h of this title), as appropriate; and

(ii) section 342 of this title and section 343(w) of this title.1

(B) shall include such other requirements as the Secretary deems necessary and appropriate to verify that food imported into the United States is as safe as food produced and sold within the United States.

(3) Considerations

In promulgating regulations under this subsection, the Secretary shall, as appropriate, take into account differences among importers and types of imported foods, including based on the level of risk posed by the imported food.

(4) Activities

Verification activities under a foreign supplier verification program under this section may include monitoring records for shipments, lot-by-lot certification of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plan of the foreign supplier, and periodically testing and sampling shipments.

(d) Record maintenance and access

Records of an importer related to a foreign supplier verification program shall be maintained for a period of not less than 2 years and shall be made available promptly to a duly authorized representative of the Secretary upon request.

(e) Exemption of seafood, juice, and low-acid canned food facilities in compliance with HACCP

This section shall not apply to a facility if the owner, operator, or agent in charge of such facility is required to comply with, and is in compliance with, 1 of the following standards and regulations with respect to such facility:

(1) The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration.

(2) The Juice Hazard Analysis Critical Control Points Program of the Food and Drug Administration.

(3) The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the Food and Drug Administration (or any successor standards).

The exemption under paragraph (3) shall apply only with respect to microbiological hazards that are regulated under the standards for Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers under part 113 of chapter 2 21, Code of Federal Regulations (or any successor regulations).

(f) Additional exemptions

The Secretary, by notice published in the Federal Register, shall establish an exemption from the requirements of this section for articles of food imported in small quantities for research and evaluation purposes or for personal consumption, provided that such foods are not intended for retail sale and are not sold or distributed to the public.

(g) Publication of list of participants

The Secretary shall publish and maintain on the Internet Web site of the Food and Drug Administration a current list that includes the name of, location of, and other information deemed necessary by the Secretary about, importers participating under this section.

(June 25, 1938, ch. 675, §805, as added Pub. L. 111–353, title III, §301(a), Jan. 4, 2011, 124 Stat. 3953.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 2 years after Jan. 4, 2011, see section 301(d) of Pub. L. 111–353, set out as an Effective Date of 2011 Amendment note under section 331 of this title.

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

1 So in original.

2 So in original. Probably should be "title".
21 U.S.C. § 399c (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter X: MISCELLANEOUS / Section 399c: Improving the training of State, local, territorial, and tribal food safety officials
Improving the training of State, local, territorial, and tribal food safety officials
Status: in_force

(a) Training

The Secretary shall set standards and administer training and education programs for the employees of State, local, territorial, and tribal food safety officials relating to the regulatory responsibilities and policies established by this chapter, including programs for—

(1) scientific training;

(2) training to improve the skill of officers and employees authorized to conduct inspections under sections 372 and 374 of this title;

(3) training to achieve advanced product or process specialization in such inspections;

(4) training that addresses best practices;

(5) training in administrative process and procedure and integrity issues;

(6) training in appropriate sampling and laboratory analysis methodology; and

(7) training in building enforcement actions following inspections, examinations, testing, and investigations.

(b) Partnerships with State and local officials

(1) In general

The Secretary, pursuant to a contract or memorandum of understanding between the Secretary and the head of a State, local, territorial, or tribal department or agency, is authorized and encouraged to conduct examinations, testing, and investigations for the purposes of determining compliance with the food safety provisions of this chapter through the officers and employees of such State, local, territorial, or tribal department or agency.

(2) Content

A contract or memorandum described under paragraph (1) shall include provisions to ensure adequate training of such officers and employees to conduct such examinations, testing, and investigations. The contract or memorandum shall contain provisions regarding reimbursement. Such provisions may, at the sole discretion of the head of the other department or agency, require reimbursement, in whole or in part, from the Secretary for the examinations, testing, or investigations performed pursuant to this section by the officers or employees of the State, territorial, or tribal department or agency.

(3) Effect

Nothing in this subsection shall be construed to limit the authority of the Secretary under section 372 of this title.

(c) Extension service

The Secretary shall ensure coordination with the extension activities of the National Institute of Food and Agriculture of the Department of Agriculture in advising producers and small processors transitioning into new practices required as a result of the enactment of the FDA Food Safety Modernization Act and assisting regulated industry with compliance with such Act.

(d) National Food Safety Training, Education, Extension, Outreach and Technical Assistance Program

(1) In general

In order to improve food safety and reduce the incidence of foodborne illness, the Secretary shall, not later than 180 days after January 4, 2011, enter into one or more memoranda of understanding, or enter into other cooperative agreements, with the Secretary of Agriculture to establish a competitive grant program within the National Institute for Food and Agriculture to provide food safety training, education, extension, outreach, and technical assistance to—

(A) owners and operators of farms;

(B) small food processors; and

(C) small fruit and vegetable merchant wholesalers.

(2) Implementation

The competitive grant program established under paragraph (1) shall be carried out in accordance with section 7625 of title 7.

(e) Authorization of appropriations

There are authorized to be appropriated such sums as may be necessary to carry out this section for fiscal years 2011 through 2015.

(June 25, 1938, ch. 675, §1012, formerly §1011, as added Pub. L. 111–353, title II, §209(a), Jan. 4, 2011, 124 Stat. 3945; renumbered §1012, Pub. L. 114–255, div. A, title III, §3073(b)(2), Dec. 13, 2016, 130 Stat. 1137.)

Editorial Notes

References in Text

The FDA Food Safety Modernization Act, referred to in subsec. (c), is Pub. L. 111–353, Jan. 4, 2011, 124 Stat. 3885, which enacted chapter 27 (§2201 et seq.) and sections 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Welfare, amended sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2201 of this title and Tables.

Prior Provisions

A prior section 1012 of act June 25, 1938, was renumbered section 1013 and is classified to section 399d of this title.

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.
21 U.S.C. § 387h (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IX: TOBACCO PRODUCTS / Section 387h: Notification and other remedies
Notification and other remedies
Status: in_force

(a) Notification

If the Secretary determines that—

(1) a tobacco product which is introduced or delivered for introduction into interstate commerce for commercial distribution presents an unreasonable risk of substantial harm to the public health; and

(2) notification under this subsection is necessary to eliminate the unreasonable risk of such harm and no more practicable means is available under the provisions of this subchapter (other than this section) to eliminate such risk,

the Secretary may issue such order as may be necessary to assure that adequate notification is provided in an appropriate form, by the persons and means best suited under the circumstances involved, to all persons who should properly receive such notification in order to eliminate such risk. The Secretary may order notification by any appropriate means, including public service announcements. Before issuing an order under this subsection, the Secretary shall consult with the persons who are to give notice under the order.

(b) No exemption from other liability

Compliance with an order issued under this section shall not relieve any person from liability under Federal or State law. In awarding damages for economic loss in an action brought for the enforcement of any such liability, the value to the plaintiff in such action of any remedy provided under such order shall be taken into account.

(c) Recall authority

(1) In general

If the Secretary finds that there is a reasonable probability that a tobacco product contains a manufacturing or other defect not ordinarily contained in tobacco products on the market that would cause serious, adverse health consequences or death, the Secretary shall issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the tobacco product) to immediately cease distribution of such tobacco product. The order shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of the issuance of the order, on the actions required by the order and on whether the order should be amended to require a recall of such tobacco product. If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order.

(2) Amendment of order to require recall

(A) In general

If, after providing an opportunity for an informal hearing under paragraph (1), the Secretary determines that the order should be amended to include a recall of the tobacco product with respect to which the order was issued, the Secretary shall, except as provided in subparagraph (B), amend the order to require a recall. The Secretary shall specify a timetable in which the tobacco product recall will occur and shall require periodic reports to the Secretary describing the progress of the recall.

(B) Notice

An amended order under subparagraph (A)—

(i) shall not include recall of a tobacco product from individuals; and

(ii) shall provide for notice to persons subject to the risks associated with the use of such tobacco product.

In providing the notice required by clause (ii), the Secretary may use the assistance of retailers and other persons who distributed such tobacco product. If a significant number of such persons cannot be identified, the Secretary shall notify such persons under section 375(b) of this title.

(3) Remedy not exclusive

The remedy provided by this subsection shall be in addition to remedies provided by subsection (a).

(June 25, 1938, ch. 675, §908, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1804.)

Editorial Notes

Prior Provisions

A prior section 908 of act June 25, 1938, was renumbered section 1008 and is classified to section 398 of this title.
21 U.S.C. § 608 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter I: INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING / Section 608: Sanitary inspection and regulation of slaughtering and packing establishments; rejection of adulterated meat or meat food products
Sanitary inspection and regulation of slaughtering and packing establishments; rejection of adulterated meat or meat food products
Status: in_force

The Secretary shall cause to be made, by experts in sanitation or by other competent inspectors, such inspection of all slaughtering, meat canning, salting, packing, rendering, or similar establishments in which amenable species are slaughtered and the meat and meat food products thereof are prepared for commerce as may be necessary to inform himself concerning the sanitary conditions of the same, and to prescribe the rules and regulations of sanitation under which such establishments shall be maintained; and where the sanitary conditions of any such establishment are such that the meat or meat food products are rendered adulterated, he shall refuse to allow said meat or meat food products to be labeled, marked, stamped or tagged as "inspected and passed."

(Mar. 4, 1907, ch. 2907, title I, §8, formerly 6th par., 34 Stat. 1262; renumbered §8 and amended Pub. L. 90–201, §§1, 3, 12(a), (f), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 109–97, title VII, §798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

Editorial Notes

Codification

Section was formerly classified to section 76 of this title.

Amendments

2005—Pub. L. 109–97 substituted "amenable species" for "cattle, sheep, swine, goats, horses, mules, and other equines".

1967—Pub. L. 90–201, §§3, 12(a), (f), struck out "interstate or foreign" before "commerce" and "of Agriculture" after "Secretary", included horses, mules, and other equines in the list of animals, and substituted "adulterated" for "unclean, unsound, unhealthful, unwholesome, or otherwise unfit for human food", respectively.

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

Amendment by Pub. L. 109–97 effective the day after 120 days after Nov. 10, 2005, see section 798(b) of Pub. L. 109–97, set out as a note under section 601 of this title.

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.
21 U.S.C. § 384g (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VIII: IMPORTS AND EXPORTS / Section 384g: Restricting entrance of illicit drugs
Restricting entrance of illicit drugs
Status: in_force

(a) Food and Drug Administration and U.S. Customs and Border Protection cooperation

(1) In general

The Secretary of Health and Human Services (referred to in this section as the "Secretary"), acting through the Commissioner of Food and Drugs and in consultation with the U.S. Customs and Border Protection, shall develop and periodically update a mutually agreed upon list of the controlled substances that the Secretary will refer to U.S. Customs and Border Protection, unless the Secretary and U.S. Customs and Border Protection agree otherwise, when such substances are offered for import via international mail and appear to violate the Controlled Substances Act (21 U.S.C. 801 et seq.), the Controlled Substances Import and Export Act (21 U.S.C. 951 et seq.), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), or any other applicable law. The Secretary shall transfer controlled substances on such list to the U.S. Customs and Border Protection. If the Secretary identifies additional packages that appear to be the same as such package containing a controlled substance, such additional packages may also be transferred to U.S. Customs and Border Protection. The U.S. Customs and Border Protection shall receive such packages consistent with the requirements of the Controlled Substances Act (21 U.S.C. 801 et seq.).

(2) Report

Not later than 9 months after October 24, 2018, the Secretary, acting through the Commissioner of Food and Drugs and in consultation with the Secretary of Homeland Security, shall report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate on the implementation of this section.

(Pub. L. 115–271, title III, §3022(a), Oct. 24, 2018, 132 Stat. 3938.)

Editorial Notes

References in Text

The Controlled Substances Act, referred to in subsec. (a)(1), is title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, which is classified principally to subchapter I (§801 et seq.) of chapter 13 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

The Controlled Substances Import and Export Act, referred to in subsec. (a)(1), is title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285, which is classified principally to subchapter II (§951 et seq.) of chapter 13 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 951 of this title and Tables.

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Statutory Notes and Related Subsidiaries

Codification

Section was enacted as part of the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act, also known as the SCREEN Act, and also as part of the Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, also known as the SUPPORT for Patients and Communities Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
21 U.S.C. § 2332 (2024) — Title 21: FOOD AND DRUGS / Chapter 28: SANCTIONS WITH RESPECT TO FOREIGN TRAFFICKERS OF ILLICIT SYNTHETIC OPIOIDS / Subchapter II: OTHER MATTERS / Section 2332: Authorization of appropriations
Authorization of appropriations
Status: in_force

(a) Department of the Treasury

There are authorized to be appropriated to the Secretary of the Treasury such sums as may be necessary for fiscal year 2020 to carry out operations and activities of the Department of the Treasury solely for purposes of carrying out this chapter.

(b) Commission on Combating Synthetic Opioid Trafficking

Of the amount authorized to be appropriated by section 1403 for fiscal year 2020 [133 Stat. 1711] and available for Drug Interdiction and Counter-Drug Activities, Defense-wide, as specified in the funding table in section 4501 [133 Stat. 2086], the Secretary of Defense may, notwithstanding section 2215 of title 10, transfer $5,000,000 to the Commission on Combating Synthetic Opioid Trafficking established under section 7221 [133 Stat. 2270] in order to carry out the duties of the Commission.

(c) Supplement not supplant

Amounts authorized to be appropriated by subsection (a) shall supplement and not supplant other amounts available to carry out operations and activities described in such subsections.

(d) Notification requirement

Amounts authorized to be appropriated by subsection (a) may not be obligated until 15 days after the date on which the President notifies the appropriate committees of Congress of the President's intention to obligate such funds.

(e) Appropriate committees of Congress defined

In this section, the term "appropriate committees of Congress" means—

(1) the Committee on Armed Services, the Committee on Banking, Housing, and Urban Affairs, the Committee on Foreign Relations, the Select Committee on Intelligence, the Committee on the Judiciary, and the Committee on Appropriations of the Senate; and

(2) the Committee on Armed Services, the Committee on Financial Services, the Committee on Foreign Affairs, the Permanent Select Committee on Intelligence, the Committee on Oversight and Reform, and the Committee on Appropriations of the House of Representatives.

(Pub. L. 116–92, div. F, title LXXII, §7232, Dec. 20, 2019, 133 Stat. 2274.)

Editorial Notes

References in Text

This chapter, referred to in subsec. (a), was in the original "this title", meaning title LXXII of div. F of Pub. L. 116–92, known as the Fentanyl Sanctions Act, which is classified principally to this chapter. For complete classification of this Act to the Code, see Tables.

Sections 1403, 4501, and section 7221, referred to in subsec. (b), mean sections sections 1403, 4501, and section 7221 of Pub. L. 116–92, respectively, which are not classified to the Code.

Statutory Notes and Related Subsidiaries

Change of Name

Committee on Oversight and Reform of House of Representatives changed to Committee on Oversight and Accountability of House of Representatives by House Resolution No. 5, One Hundred Eighteenth Congress, Jan. 9, 2023.
21 U.S.C. § 622 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter I: INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING / Section 622: Bribery of or gifts to inspectors or other officers and acceptance of gifts
Bribery of or gifts to inspectors or other officers and acceptance of gifts
Status: in_force

Any person, firm, or corporation, or any agent or employee of any person, firm, or corporation, who shall give, pay, or offer, directly or indirectly, to any inspector, deputy inspector, chief inspector, or any other officer or employee of the United States authorized to perform any of the duties prescribed by this chapter or by the rules and regulations of the Secretary any money or other thing of value, with intent to influence said inspector, deputy inspector, chief inspector, or other officer or employee of the United States in the discharge of any duty provided for in this chapter, shall be deemed guilty of a felony, and, upon conviction thereof, shall be punished by a fine not less than $5,000 nor more than $10,000 and by imprisonment not less than one year nor more than three years; and any inspector, deputy inspector, chief inspector, or other officer or employee of the United States authorized to perform any of the duties prescribed by this chapter who shall accept any money, gift, or other thing of value from any person, firm, or corporation, or officers, agents, or employees thereof, given with intent to influence his official action, or who shall receive or accept from any person, firm, or corporation engaged in commerce any gift, money, or other thing of value, given with any purpose or intent whatsoever, shall be deemed guilty of a felony and shall, upon conviction thereof, be summarily discharged from office and shall be punished by a fine not less than $1,000 nor more than $10,000 and by imprisonment not less than one year nor more than three years.

(Mar. 4, 1907, ch. 2907, title I, §22, formerly 20th par., 34 Stat. 1264; renumbered §22 and amended Pub. L. 90–201, §§1, 3, Dec. 15, 1967, 81 Stat. 584, 588.)

Editorial Notes

Codification

Section was formerly classified to section 90 of this title.

Amendments

1967—Pub. L. 90–201, §3, struck out "interstate or foreign" before "commerce" and "of Agriculture" after "Secretary".

Statutory Notes and Related Subsidiaries

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.
21 U.S.C. § 626 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter I: INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING / Section 626: Purchase of tags, labels, stamps, and certificates
Purchase of tags, labels, stamps, and certificates
Status: in_force

The Secretary of Agriculture is authorized to expend appropriations for meat inspection for the purchase of printed tags, labels, stamps, and certificates without regard to existing laws applicable to public printing.

(Sept. 21, 1944, ch. 412, title I, §101(f), 58 Stat. 734.)

Editorial Notes

Codification

Section was formerly classified to section 431 of Title 7, Agriculture, prior to editorial reclassification and renumbering as this section.

Section was enacted as part of the Department of Agriculture Organic Act of 1944, and not as part of the Federal Meat Inspection Act which is classified to subchapters I to IV–A of this chapter.

Statutory Notes and Related Subsidiaries

Authorization of Appropriation

Authorization of appropriation of sums necessary for the purposes of this section, see note under section 395 of Title 7, Agriculture.
21 U.S.C. § 14a (2024) — Title 21: FOOD AND DRUGS / Chapter 1: ADULTERATED OR MISBRANDED FOODS OR DRUGS / Subchapter I: FEDERAL FOOD AND DRUGS ACT OF 1906 / Section 14a: Transferred
Transferred
Status: transferred

Editorial Notes

Codification

Section, act June 30, 1906, ch. 3915, §10A, as added June 22, 1934, ch. 712, 48 Stat. 1204, and amended, which related to examination of sea food on request of packer, marking of food with results, fees, and penalties, was successively renumbered section 702A and then 706 of the Federal Food, Drug, and Cosmetic Act by act July 12, 1943, ch. 221, title II, §201, 57 Stat. 500, and by Pub. L. 102–571, title I, §106(3), Oct. 29, 1992, 106 Stat. 4498, and was successively classified to section 372a and then 376 of this title.
21 U.S.C. § 1001 (2024) — Title 21: FOOD AND DRUGS / Chapter 14: ALCOHOL AND DRUG ABUSE EDUCATIONAL PROGRAMS AND ACTIVITIES / Section 1001: Repealed. Pub. L. 97-35, title V, §587(a)(3), Aug. 13, 1981, 95 Stat. 480
Repealed. Pub. L. 97-35, title V, §587(a)(3), Aug. 13, 1981, 95 Stat. 480
Status: repealed

Section 1001, Pub. L. 91–527, §2, Dec. 3, 1970, 84 Stat. 1385; Pub. L. 93–422, §2(b), Sept. 21, 1974, 88 Stat. 1154; Pub. L. 95–336, §2, Aug. 4, 1978, 92 Stat. 451, set forth Congressional declaration of purpose for Alcohol and Drug Abuse Education Act.

Section 1002, Pub. L. 91–527, §3, Dec. 3, 1970, 84 Stat. 1386; Pub. L. 93–422, §2(c), Sept. 21, 1974, 88 Stat. 1155; Pub. L. 95–336, §§3, 4, Aug. 4, 1978, 92 Stat. 451, 452; S. Res. 30, Mar. 7, 1979; Pub. L. 96–88, title III, §301(a)(1), (2)(Q), (b)(1), title V, §507, Oct. 17, 1979, 93 Stat. 677, 678, 692, set forth grant and contract authority, etc., for projects and programs.

Section 1003, Pub. L. 91–527, §4, Dec. 3, 1970, 84 Stat. 1387; Pub. L. 93–422, §2(d), Sept. 21, 1974, 88 Stat. 1157; Pub. L. 96–88, title III, §301(a)(1), title V, §507, Oct. 17, 1979, 93 Stat. 677, 692, related to recordkeeping requirements, and access to and inspection of records.

Section 1004, Pub. L. 91–527, §5, Dec. 3, 1970, 84 Stat. 1388; Pub. L. 93–422, §2(e), Sept. 21, 1974, 88 Stat. 1157; Pub. L. 96–88, title V, §508(i), Oct. 17, 1979, 93 Stat. 693, related to technical assistance to local agencies, etc.

Section 1005, Pub. L. 91–527, §6, Dec. 3, 1970, 84 Stat. 1388, related to nature of payments.

Section 1006, Pub. L. 91–527, §7, Dec. 3, 1970, 84 Stat. 1388, related to utilization of services and facilities of Federal agencies and public and private agencies and institutions.

Section 1007, Pub. L. 91–527, §8, Dec. 3, 1970, 84 Stat. 1388; Pub. L. 93–422, §2(f), Sept. 21, 1974, 88 Stat. 1157; Pub. L. 95–336, §5, Aug. 4, 1978, 92 Stat. 453; Pub. L. 96–88, title III, §301(a)(1), (2)(Q), title V, §507, Oct. 17, 1979, 93 Stat. 677, 678, 692, defined "Secretary" and "State".

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal effective Oct. 1, 1982, see section 587(a) of Pub. L. 97–35, set out as section 3863(a) of Title 20, Education.
21 U.S.C. § 954 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter II: IMPORT AND EXPORT / Section 954: Transshipment and in-transit shipment of controlled substances
Transshipment and in-transit shipment of controlled substances
Status: in_force

Notwithstanding sections 952, 953, and 957 of this title—

(1) A controlled substance in schedule I may—

(A) be imported into the United States for transshipment to another country, or

(B) be transferred or transshipped from one vessel, vehicle, or aircraft to another vessel, vehicle, or aircraft within the United States for immediate exportation,

if and only if it is so imported, transferred, or transshipped (i) for scientific, medical, or other legitimate purposes in the country of destination, and (ii) with the prior written approval of the Attorney General (which shall be granted or denied within 21 days of the request).

(2) A controlled substance in schedule II, III, or IV may be so imported, transferred, or transshipped if and only if advance notice is given to the Attorney General in accordance with regulations of the Attorney General.

(Pub. L. 91–513, title III, §1004, Oct. 27, 1970, 84 Stat. 1287.)

Editorial Notes

References in Text

Schedules I, II, III, and IV, referred to in text, are set out in section 812(c) of this title.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see 1105(a) of Pub. L. 91–513, set out as a under section 951 of this title.
21 U.S.C. § 384f (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VIII: IMPORTS AND EXPORTS / Section 384f: Strengthening FDA and CBP coordination and capacity
Strengthening FDA and CBP coordination and capacity
Status: in_force

(a) In general

The Secretary of Health and Human Services (referred to in this section as the "Secretary"), acting through the Commissioner of Food and Drugs, shall coordinate with the Secretary of Homeland Security to carry out activities related to customs and border protection and in response to illegal controlled substances and drug imports, including at sites of import (such as international mail facilities), that will provide improvements to such facilities, technologies, and inspection capacity. Such Secretaries may carry out such activities through a memorandum of understanding between the Food and Drug Administration and the U.S. Customs and Border Protection.

(b) FDA import facilities and inspection capacity

(1) In general

In carrying out this section, the Secretary shall, in collaboration with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, provide that import facilities in which the Food and Drug Administration operates or carries out activities related to drug imports within the international mail facilities include—

(A) facility upgrades and improved capacity in order to increase and improve inspection and detection capabilities, which may include, as the Secretary determines appropriate—

(i) improvements to facilities, such as upgrades or renovations, and support for the maintenance of existing import facilities and sites to improve coordination between Federal agencies;

(ii) improvements in equipment and information technology enhancement to identify unapproved, counterfeit, or other unlawful controlled substances for destruction;

(iii) the construction of, or upgrades to, laboratory capacity for purposes of detection and testing of imported goods;

(iv) upgrades to the security of import facilities; and

(v) innovative technology and equipment to facilitate improved and near-real-time information sharing between the Food and Drug Administration, the Department of Homeland Security, and the United States Postal Service; and

(B) innovative technology, including controlled substance detection and testing equipment and other applicable technology, in order to collaborate with the U.S. Customs and Border Protection to share near-real-time information, including information about test results, as appropriate.

(2) Innovative technology

Any technology used in accordance with paragraph (1)(B) shall be interoperable with technology used by other relevant Federal agencies, including the U.S. Customs and Border Protection, as the Secretary determines appropriate and practicable.

(c) Report

Not later than 6 months after October 24, 2018, the Secretary, in consultation with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, shall report to the Committee on Energy and Commerce and the Committee on Homeland Security of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Homeland Security and Governmental Affairs of the Senate on the implementation of this section, including a summary of progress made toward near-real-time information sharing and the interoperability of such technologies.

(Pub. L. 115–271, title III, §3014, Oct. 24, 2018, 132 Stat. 3937.)

Statutory Notes and Related Subsidiaries

Codification

Section was enacted as part of the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act, also known as the SCREEN Act, and also as part of the Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, also known as the SUPPORT for Patients and Communities Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
21 U.S.C. § 399e (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter X: MISCELLANEOUS / Section 399e: Nanotechnology
Nanotechnology
Status: in_force

(a) In general

The Secretary of Health and Human Services (referred to in this section as the "Secretary") shall intensify and expand activities related to enhancing scientific knowledge regarding nanomaterials included or intended for inclusion in products regulated under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or other statutes administered by the Food and Drug Administration, to address issues relevant to the regulation of those products, including the potential toxicology of such nanomaterials, the potential benefit of new therapies derived from nanotechnology, the effects of such nanomaterials on biological systems, and the interaction of such nanomaterials with biological systems.

(b) Activities

In conducting activities related to nanotechnology, the Secretary may—

(1) assess scientific literature and data on general nanomaterials interactions with biological systems and on specific nanomaterials of concern to the Food and Drug Administration;

(2) in cooperation with other Federal agencies, develop and organize information using databases and models that will facilitate the identification of generalized principles and characteristics regarding the behavior of classes of nanomaterials with biological systems;

(3) promote Food and Drug Administration programs and participate in collaborative efforts, to further the understanding of the science of novel properties of nanomaterials that might contribute to toxicity;

(4) promote and participate in collaborative efforts to further the understanding of measurement and detection methods for nanomaterials;

(5) collect, synthesize, interpret, and disseminate scientific information and data related to the interactions of nanomaterials with biological systems;

(6) build scientific expertise on nanomaterials within the Food and Drug Administration, including field and laboratory expertise, for monitoring the production and presence of nanomaterials in domestic and imported products regulated under this Act;

(7) ensure ongoing training, as well as dissemination of new information within the centers of the Food and Drug Administration, and more broadly across the Food and Drug Administration, to ensure timely, informed consideration of the most current science pertaining to nanomaterials;

(8) encourage the Food and Drug Administration to participate in international and national consensus standards activities pertaining to nanomaterials; and

(9) carry out other activities that the Secretary determines are necessary and consistent with the purposes described in paragraphs (1) through (8).

(Pub. L. 112–144, title XI, §1126, July 9, 2012, 126 Stat. 1116.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter. For complete classification of this Act to the Code, see section 301 of this title and Tables.

This Act, referred to in subsec. (b)(6), is Pub. L. 112–144, July 9, 2012, 126 Stat. 993, known as the Food and Drug Administration Safety and Innovation Act. For complete classification of this Act to the Code, see Tables.

Codification

Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
21 U.S.C. § 803 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 803: Repealed. Pub. L. 95-137, §1(b), Oct. 18, 1977, 91 Stat. 1169
Repealed. Pub. L. 95-137, §1(b), Oct. 18, 1977, 91 Stat. 1169
Status: repealed

Section, Pub. L. 91–513, title II, §103, Oct. 27, 1970, 84 Stat. 1245, authorized Bureau of Narcotics and Dangerous Drugs to add, during fiscal year 1971, 300 agents, together with necessary supporting personnel, and provided for appropriations of $6,000,000 to carry out such addition.
21 U.S.C. § 360h (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360h: Notification and other remedies
Notification and other remedies
Status: in_force

(a) Notification

If the Secretary determines that—

(1) a device intended for human use which is introduced or delivered for introduction into interstate commerce for commercial distribution presents an unreasonable risk of substantial harm to the public health, and

(2) notification under this subsection is necessary to eliminate the unreasonable risk of such harm and no more practicable means is available under the provisions of this chapter (other than this section) to eliminate such risk,

the Secretary may issue such order as may be necessary to assure that adequate notification is provided in an appropriate form, by the persons and means best suited under the circumstances involved, to all health professionals who prescribe or use the device and to any other person (including manufacturers, importers, distributors, retailers, and device users) who should properly receive such notification in order to eliminate such risk. An order under this subsection shall require that the individuals subject to the risk with respect to which the order is to be issued be included in the persons to be notified of the risk unless the Secretary determines that notice to such individuals would present a greater danger to the health of such individuals than no such notification. If the Secretary makes such a determination with respect to such individuals, the order shall require that the health professionals who prescribe or use the device provide for the notification of the individuals whom the health professionals treated with the device of the risk presented by the device and of any action which may be taken by or on behalf of such individuals to eliminate or reduce such risk. Before issuing an order under this subsection, the Secretary shall consult with the persons who are to give notice under the order.

(b) Repair, replacement, or refund

(1)(A) If, after affording opportunity for an informal hearing, the Secretary determines that—

(i) a device intended for human use which is introduced or delivered for introduction into interstate commerce for commercial distribution presents an unreasonable risk of substantial harm to the public health,

(ii) there are reasonable grounds to believe that the device was not properly designed or manufactured with reference to the state of the art as it existed at the time of its design or manufacture,

(iii) there are reasonable grounds to believe that the unreasonable risk was not caused by failure of a person other than a manufacturer, importer, distributor, or retailer of the device to exercise due care in the installation, maintenance, repair, or use of the device, and

(iv) the notification authorized by subsection (a) would not by itself be sufficient to eliminate the unreasonable risk and action described in paragraph (2) of this subsection is necessary to eliminate such risk,

the Secretary may order the manufacturer, importer, or any distributor of such device, or any combination of such persons, to submit to him within a reasonable time a plan for taking one or more of the actions described in paragraph (2). An order issued under the preceding sentence which is directed to more than one person shall specify which person may decide which action shall be taken under such plan and the person specified shall be the person who the Secretary determines bears the principal, ultimate financial responsibility for action taken under the plan unless the Secretary cannot determine who bears such responsibility or the Secretary determines that the protection of the public health requires that such decision be made by a person (including a device user or health professional) other than the person he determines bears such responsibility.

(B) The Secretary shall approve a plan submitted pursuant to an order issued under subparagraph (A) unless he determines (after affording opportunity for an informal hearing) that the action or actions to be taken under the plan or the manner in which such action or actions are to be taken under the plan will not assure that the unreasonable risk with respect to which such order was issued will be eliminated. If the Secretary disapproves a plan, he shall order a revised plan to be submitted to him within a reasonable time. If the Secretary determines (after affording opportunity for an informal hearing) that the revised plan is unsatisfactory or if no revised plan or no initial plan has been submitted to the Secretary within the prescribed time, the Secretary shall (i) prescribe a plan to be carried out by the person or persons to whom the order issued under subparagraph (A) was directed, or (ii) after affording an opportunity for an informal hearing, by order prescribe a plan to be carried out by a person who is a manufacturer, importer, distributor, or retailer of the device with respect to which the order was issued but to whom the order under subparagraph (A) was not directed.

(2) The actions which may be taken under a plan submitted under an order issued under paragraph (1) are as follows:

(A) To repair the device so that it does not present the unreasonable risk of substantial harm with respect to which the order under paragraph (1) was issued.

(B) To replace the device with a like or equivalent device which is in conformity with all applicable requirements of this chapter.

(C) To refund the purchase price of the device (less a reasonable allowance for use if such device has been in the possession of the device user for one year or more—

(i) at the time of notification ordered under subsection (a), or

(ii) at the time the device user receives actual notice of the unreasonable risk with respect to which the order was issued under paragraph (1),

whichever first occurs).

(3) No charge shall be made to any person (other than a manufacturer, importer, distributor or retailer) for availing himself of any remedy, described in paragraph (2) and provided under an order issued under paragraph (1), and the person subject to the order shall reimburse each person (other than a manufacturer, importer, distributor, or retailer) who is entitled to such a remedy for any reasonable and foreseeable expenses actually incurred by such person in availing himself of such remedy.

(c) Reimbursement

An order issued under subsection (b) with respect to a device may require any person who is a manufacturer, importer, distributor, or retailer of the device to reimburse any other person who is a manufacturer, importer, distributor, or retailer of such device for such other person's expenses actually incurred in connection with carrying out the order if the Secretary determines such reimbursement is required for the protection of the public health. Any such requirement shall not affect any rights or obligations under any contract to which the person receiving reimbursement or the person making such reimbursement is a party.

(d) Effect on other liability

Compliance with an order issued under this section shall not relieve any person from liability under Federal or State law. In awarding damages for economic loss in an action brought for the enforcement of any such liability, the value to the plaintiff in such action of any remedy provided him under such order shall be taken into account.

(e) Recall authority

(1) If the Secretary finds that there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, the Secretary shall issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the device)—

(A) to immediately cease distribution of such device, and

(B) to immediately notify health professionals and device user facilities of the order and to instruct such professionals and facilities to cease use of such device.

The order shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of the issuance of the order, on the actions required by the order and on whether the order should be amended to require a recall of such device. If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order.

(2)(A) If, after providing an opportunity for an informal hearing under paragraph (1), the Secretary determines that the order should be amended to include a recall of the device with respect to which the order was issued, the Secretary shall, except as provided in subparagraphs (B) and (C), amend the order to require a recall. The Secretary shall specify a timetable in which the device recall will occur and shall require periodic reports to the Secretary describing the progress of the recall.

(B) An amended order under subparagraph (A)—

(i) shall—

(I) not include recall of a device from individuals, and

(II) not include recall of a device from device user facilities if the Secretary determines that the risk of recalling such device from the facilities presents a greater health risk than the health risk of not recalling the device from use, and

(ii) shall provide for notice to individuals subject to the risks associated with the use of such device.

In providing the notice required by clause (ii), the Secretary may use the assistance of health professionals who prescribed or used such a device for individuals. If a significant number of such individuals cannot be identified, the Secretary shall notify such individuals pursuant to section 375(b) of this title.

(3) The remedy provided by this subsection shall be in addition to remedies provided by subsections (a), (b), and (c).

(June 25, 1938, ch. 675, §518, as added Pub. L. 94–295, §2, May 28, 1976, 90 Stat. 562; amended Pub. L. 101–629, §8, Nov. 28, 1990, 104 Stat. 4520; Pub. L. 102–300, §4, June 16, 1992, 106 Stat. 239.)

Editorial Notes

Amendments

1992—Subsec. (b)(1)(A)(ii). Pub. L. 102–300 substituted "or" for "and" after "properly designed" and "time of its design".

1990—Subsec. (e). Pub. L. 101–629 added subsec. (e).
21 U.S.C. § 364j (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VI: COSMETICS / Section 364j: Preemption
Preemption
Status: in_force

(a) In general

No State or political subdivision of a State may establish or continue in effect any law, regulation, order, or other requirement for cosmetics that is different from or in addition to, or otherwise not identical with, any requirement applicable under this subchapter with respect to registration and product listing, good manufacturing practice, records, recalls, adverse event reporting, or safety substantiation.

(b) Limitation

Nothing in the amendments to this chapter made by the Modernization of Cosmetics Regulation Act of 2022 shall be construed to preempt any State statute, public initiative, referendum, regulation, or other State action, except as expressly provided in subsection (a). Notwithstanding subsection (a), nothing in this section shall be construed to prevent any State from prohibiting the use or limiting the amount of an ingredient in a cosmetic product, or from continuing in effect a requirement of any State that is in effect at the time of enactment of the Modernization of Cosmetics Regulation Act of 2022 for the reporting to the State of an ingredient in a cosmetic product.

(c) Savings

Nothing in the amendments to this chapter made by the Modernization of Cosmetics Regulation Act of 2022, nor any standard, rule, requirement, regulation, or adverse event report shall be construed to modify, preempt, or displace any action for damages or the liability of any person under the law of any State, whether statutory or based in common law.

(d) Rule of construction

Nothing in this section shall be construed to amend, expand, or limit the provisions under section 379s of this title.

(June 25, 1938, ch. 675, §614, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5857.)

Editorial Notes

References in Text

The amendments to this chapter made by the Modernization of Cosmetics Regulation Act of 2022, referred to in subsecs. (b) and (c), means the amendments made by subtitle E (§§3501–3508) of title III of div. FF of Pub. L. 117–328, which enacted this section and sections 364 to 364i of this title and amended sections 331, 361, 362, 374, and 381 of this title.

The time of enactment of the Modernization of Cosmetics Regulation Act of 2022, referred to in subsec. (b), probably means the date of enactment of subtitle E (§§3501–3508) of title III of div. FF of Pub. L. 117–328, which was approved Dec. 29, 2022.

Statutory Notes and Related Subsidiaries

Construction; Confidentiality

Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.
21 U.S.C. § 337a (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter III: PROHIBITED ACTS AND PENALTIES / Section 337a: Extraterritorial jurisdiction
Extraterritorial jurisdiction
Status: in_force

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 committed 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.)
21 U.S.C. § 148 (2024) — Title 21: FOOD AND DRUGS / Chapter 4: ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Subchapter IV: IMPORTATION OF MILK AND CREAM / Section 148: Powers of State with respect to milk or cream lawfully imported
Powers of State with respect to milk or cream lawfully imported
Status: in_force

Nothing in this subchapter is intended nor shall be construed to affect the powers of any State, or any political subdivision thereof, to regulate the shipment of milk or cream into, or the handling, sale, or other disposition of milk or cream in, such State or political subdivision after the milk and/or cream shall have been lawfully imported under the provisions of this subchapter.

(Feb. 15, 1927, ch. 155, §8, 44 Stat. 1103.)
21 U.S.C. § 387i (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IX: TOBACCO PRODUCTS / Section 387i: Records and reports on tobacco products
Records and reports on tobacco products
Status: in_force

(a) In general

Every person who is a tobacco product manufacturer or importer of a tobacco product shall establish and maintain such records, make such reports, and provide such information, as the Secretary may by regulation reasonably require to assure that such tobacco product is not adulterated or misbranded and to otherwise protect public health. Regulations prescribed under the preceding sentence—

(1) may require a tobacco product manufacturer or importer to report to the Secretary whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed tobacco products may have caused or contributed to a serious unexpected adverse experience associated with the use of the product or any significant increase in the frequency of a serious, expected adverse product experience;

(2) shall require reporting of other significant adverse tobacco product experiences as determined by the Secretary to be necessary to be reported;

(3) shall not impose requirements unduly burdensome to a tobacco product manufacturer or importer, taking into account the cost of complying with such requirements and the need for the protection of the public health and the implementation of this subchapter;

(4) when prescribing the procedure for making requests for reports or information, shall require that each request made under such regulations for submission of a report or information to the Secretary state the reason or purpose for such request and identify to the fullest extent practicable such report or information;

(5) when requiring submission of a report or information to the Secretary, shall state the reason or purpose for the submission of such report or information and identify to the fullest extent practicable such report or information; and

(6) may not require that the identity of any patient or user be disclosed in records, reports, or information required under this subsection unless required for the medical welfare of an individual, to determine risks to public health of a tobacco product, or to verify a record, report, or information submitted under this subchapter.

In prescribing regulations under this subsection, the Secretary shall have due regard for the professional ethics of the medical profession and the interests of patients. The prohibitions of paragraph (6) continue to apply to records, reports, and information concerning any individual who has been a patient, irrespective of whether or when he ceases to be a patient.

(b) Reports of removals and corrections

(1) In general

Except as provided in paragraph (2), the Secretary shall by regulation require a tobacco product manufacturer or importer of a tobacco product to report promptly to the Secretary any corrective action taken or removal from the market of a tobacco product undertaken by such manufacturer or importer if the removal or correction was undertaken—

(A) to reduce a risk to health posed by the tobacco product; or

(B) to remedy a violation of this subchapter caused by the tobacco product which may present a risk to health.

A tobacco product manufacturer or importer of a tobacco product who undertakes a corrective action or removal from the market of a tobacco product which is not required to be reported under this subsection shall keep a record of such correction or removal.

(2) Exception

No report of the corrective action or removal of a tobacco product may be required under paragraph (1) if a report of the corrective action or removal is required and has been submitted under subsection (a).

(June 25, 1938, ch. 675, §909, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1805.)

Editorial Notes

Prior Provisions

A prior section 909 of act June 25, 1938, was renumbered section 1009 and is classified to section 399 of this title.
21 U.S.C. § 1711 (2024) — Title 21: FOOD AND DRUGS / Chapter 22: NATIONAL DRUG CONTROL POLICY / Section 1711: Authorization of appropriations
Authorization of appropriations
Status: in_force

There are authorized to be appropriated to carry out this chapter except activities otherwise specified, to remain available until expended, $18,400,000 for each of fiscal years 2018 through 2023.

(Pub. L. 105–277, div. C, title VII, §§714, 715, Oct. 21, 1998, 112 Stat. 2681–693; Pub. L. 109–469, title VI, §§601, 602, Dec. 29, 2006, 120 Stat. 3533; Pub. L. 115–271, title VIII, §8202, Oct. 24, 2018, 132 Stat. 4110.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this title", meaning title VII of Pub. L. 105–277, div. C, Oct. 21, 1998, 112 Stat. 2681–670, which is classified principally to this chapter. For complete classification of title VII to the Code, see Short Title note set out under section 1701 of this title and Tables.

Amendments

2018—Pub. L. 115–271, §8202(b)(2), repealed Pub. L. 105–277, §715. See 1998 Amendment note below.

Pub. L. 115–271, §8202(b)(1), substituted "$18,400,000 for each of fiscal years 2018 through 2023" for "such sums as may be necessary for each of fiscal years 2006 through 2010".

Pub. L. 115–271, §8202(a), revived and restored this section as in effect on Sept. 29, 2003, and as amended by Pub. L. 109–469 and Pub. L. 112–166. See Reauthorization of the Office of National Drug Control Policy note set out under section 1701 of this title.

2006—Pub. L. 109–469, §602, amended Pub. L. 105–277, §715, which provided for the repeal of this section. See 1998 Amendment note below.

Pub. L. 109–469, §601, substituted "chapter except activities otherwise specified," for "chapter," and "2006 through 2010" for "1999 through 2003".

1998—Pub. L. 105–277, §715, as amended by Pub. L. 109–469, §602, which provided for the repeal of this section effective Sept. 30, 2010, was repealed by Pub. L. 115–271, §8202(b)(2). See former section 1712 of this title.

Statutory Notes and Related Subsidiaries

Appropriations

Provisions appropriating funds to carry out activities authorized by the Office of National Drug Control Policy Reauthorization Act of 1998, which enacted this chapter, were contained in the following appropriation acts:

Pub. L. 109–115, div. A, title V, Nov. 30, 2005, 119 Stat. 2475.

Pub. L. 108–447, div. H, title III, Dec. 8, 2004, 118 Stat. 3249, 3250.

Pub. L. 108–199, div. F, title III, Jan. 23, 2004, 118 Stat. 324.
21 U.S.C. § 387k (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IX: TOBACCO PRODUCTS / Section 387k: Modified risk tobacco products
Modified risk tobacco products
Status: in_force

(a) In general

No person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product unless an order issued pursuant to subsection (g) is effective with respect to such product.

(b) Definitions

In this section:

(1) Modified risk tobacco product

The term "modified risk tobacco product" means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.

(2) Sold or distributed

(A) In general

With respect to a tobacco product, the term "sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products" means a tobacco product—

(i) the label, labeling, or advertising of which represents explicitly or implicitly that—

(I) the tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products;

(II) the tobacco product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or

(III) the tobacco product or its smoke does not contain or is free of a substance;

(ii) the label, labeling, or advertising of which uses the descriptors "light", "mild", or "low" or similar descriptors; or

(iii) the tobacco product manufacturer of which has taken any action directed to consumers through the media or otherwise, other than by means of the tobacco product's label, labeling, or advertising, after June 22, 2009, respecting the product that would be reasonably expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful than one or more commercially marketed tobacco products, or presents a reduced exposure to, or does not contain or is free of, a substance or substances.

(B) Limitation

No tobacco product shall be considered to be "sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products", except as described in subparagraph (A).

(C) Smokeless tobacco product

No smokeless tobacco product shall be considered to be "sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products" solely because its label, labeling, or advertising uses the following phrases to describe such product and its use: "smokeless tobacco", "smokeless tobacco product", "not consumed by smoking", "does not produce smoke", "smokefree", "smoke-free", "without smoke", "no smoke", or "not smoke".

(3) Effective date

The provisions of paragraph (2)(A)(ii) shall take effect 12 months after June 22, 2009, for those products whose label, labeling, or advertising contains the terms described in such paragraph on June 22, 2009. The effective date shall be with respect to the date of manufacture, provided that, in any case, beginning 30 days after such effective date, a manufacturer shall not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with paragraph (2)(A)(ii).

(c) Tobacco dependence products

A product that is intended to be used for the treatment of tobacco dependence, including smoking cessation, is not a modified risk tobacco product under this section if it has been approved as a drug or device by the Food and Drug Administration and is subject to the requirements of subchapter V.

(d) Filing

Any person may file with the Secretary an application for a modified risk tobacco product. Such application shall include—

(1) a description of the proposed product and any proposed advertising and labeling;

(2) the conditions for using the product;

(3) the formulation of the product;

(4) sample product labels and labeling;

(5) all documents (including underlying scientific information) relating to research findings conducted, supported, or possessed by the tobacco product manufacturer relating to the effect of the product on tobacco-related diseases and health-related conditions, including information both favorable and unfavorable to the ability of the product to reduce risk or exposure and relating to human health;

(6) data and information on how consumers actually use the tobacco product; and

(7) such other information as the Secretary may require.

(e) Public availability

The Secretary shall make the application described in subsection (d) publicly available (except matters in the application which are trade secrets or otherwise confidential, commercial information) and shall request comments by interested persons on the information contained in the application and on the label, labeling, and advertising accompanying such application.

(f) Advisory Committee

(1) In general

The Secretary shall refer to the Tobacco Products Scientific Advisory Committee any application submitted under this section.

(2) Recommendations

Not later than 60 days after the date an application is referred to the Tobacco Products Scientific Advisory Committee under paragraph (1), the Advisory Committee shall report its recommendations on the application to the Secretary.

(g) Marketing

(1) Modified risk products

Except as provided in paragraph (2), the Secretary shall, with respect to an application submitted under this section, issue an order that a modified risk product may be commercially marketed only if the Secretary determines that the applicant has demonstrated that such product, as it is actually used by consumers, will—

(A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and

(B) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.

(2) Special rule for certain products

(A) In general

The Secretary may issue an order that a tobacco product may be introduced or delivered for introduction into interstate commerce, pursuant to an application under this section, with respect to a tobacco product that may not be commercially marketed under paragraph (1) if the Secretary makes the findings required under this paragraph and determines that the applicant has demonstrated that—

(i) such order would be appropriate to promote the public health;

(ii) any aspect of the label, labeling, and advertising for such product that would cause the tobacco product to be a modified risk tobacco product under subsection (b) is limited to an explicit or implicit representation that such tobacco product or its smoke does not contain or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke;

(iii) scientific evidence is not available and, using the best available scientific methods, cannot be made available without conducting long-term epidemiological studies for an application to meet the standards set forth in paragraph (1); and

(iv) the scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely in subsequent studies.

(B) Additional findings required

To issue an order under subparagraph (A) the Secretary must also find that the applicant has demonstrated that—

(i) the magnitude of the overall reductions in exposure to the substance or substances which are the subject of the application is substantial, such substance or substances are harmful, and the product as actually used exposes consumers to the specified reduced level of the substance or substances;

(ii) the product as actually used by consumers will not expose them to higher levels of other harmful substances compared to the similar types of tobacco products then on the market unless such increases are minimal and the reasonably likely overall impact of use of the product remains a substantial and measurable reduction in overall morbidity and mortality among individual tobacco users;

(iii) testing of actual consumer perception shows that, as the applicant proposes to label and market the product, consumers will not be misled into believing that the product—

(I) is or has been demonstrated to be less harmful; or

(II) presents or has been demonstrated to present less of a risk of disease than 1 or more other commercially marketed tobacco products; and

(iv) issuance of an order with respect to the application is expected to benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.

(C) Conditions of marketing

(i) In general

Applications subject to an order under this paragraph shall be limited to a term of not more than 5 years, but may be renewed upon a finding by the Secretary that the requirements of this paragraph continue to be satisfied based on the filing of a new application.

(ii) Agreements by applicant

An order under this paragraph shall be conditioned on the applicant's agreement to conduct postmarket surveillance and studies and to submit to the Secretary the results of such surveillance and studies to determine the impact of the order on consumer perception, behavior, and health and to enable the Secretary to review the accuracy of the determinations upon which the order was based in accordance with a protocol approved by the Secretary.

(iii) Annual submission

The results of such postmarket surveillance and studies described in clause (ii) shall be submitted annually.

(3) Basis

The determinations under paragraphs (1) and (2) shall be based on—

(A) the scientific evidence submitted by the applicant; and

(B) scientific evidence and other information that is made available to the Secretary.

(4) Benefit to health of individuals and of population as a whole

In making the determinations under paragraphs (1) and (2), the Secretary shall take into account—

(A) the relative health risks to individuals of the tobacco product that is the subject of the application;

(B) the increased or decreased likelihood that existing users of tobacco products who would otherwise stop using such products will switch to the tobacco product that is the subject of the application;

(C) the increased or decreased likelihood that persons who do not use tobacco products will start using the tobacco product that is the subject of the application;

(D) the risks and benefits to persons from the use of the tobacco product that is the subject of the application as compared to the use of products for smoking cessation approved under subchapter V to treat nicotine dependence; and

(E) comments, data, and information submitted by interested persons.

(h) Additional conditions for marketing

(1) Modified risk products

The Secretary shall require for the marketing of a product under this section that any advertising or labeling concerning modified risk products enable the public to comprehend the information concerning modified risk and to understand the relative significance of such information in the context of total health and in relation to all of the diseases and health-related conditions associated with the use of tobacco products.

(2) Comparative claims

(A) In general

The Secretary may require for the marketing of a product under this subsection that a claim comparing a tobacco product to 1 or more other commercially marketed tobacco products shall compare the tobacco product to a commercially marketed tobacco product that is representative of that type of tobacco product on the market (for example the average value of the top 3 brands of an established regular tobacco product).

(B) Quantitative comparisons

The Secretary may also require, for purposes of subparagraph (A), that the percent (or fraction) of change and identity of the reference tobacco product and a quantitative comparison of the amount of the substance claimed to be reduced shall be stated in immediate proximity to the most prominent claim.

(3) Label disclosure

(A) In general

The Secretary may require the disclosure on the label of other substances in the tobacco product, or substances that may be produced by the consumption of that tobacco product, that may affect a disease or health-related condition or may increase the risk of other diseases or health-related conditions associated with the use of tobacco products.

(B) Conditions of use

If the conditions of use of the tobacco product may affect the risk of the product to human health, the Secretary may require the labeling of conditions of use.

(4) Time

An order issued under subsection (g)(1) shall be effective for a specified period of time.

(5) Advertising

The Secretary may require, with respect to a product for which an applicant obtained an order under subsection (g)(1), that the product comply with requirements relating to advertising and promotion of the tobacco product.

(i) Postmarket surveillance and studies

(1) In general

The Secretary shall require, with respect to a product for which an applicant obtained an order under subsection (g)(1), that the applicant conduct postmarket surveillance and studies for such a tobacco product to determine the impact of the order issuance on consumer perception, behavior, and health, to enable the Secretary to review the accuracy of the determinations upon which the order was based, and to provide information that the Secretary determines is otherwise necessary regarding the use or health risks involving the tobacco product. The results of postmarket surveillance and studies shall be submitted to the Secretary on an annual basis.

(2) Surveillance protocol

Each applicant required to conduct a surveillance of a tobacco product under paragraph (1) shall, within 30 days after receiving notice that the applicant is required to conduct such surveillance, submit, for the approval of the Secretary, a protocol for the required surveillance. The Secretary, within 60 days of the receipt of such protocol, shall determine if the principal investigator proposed to be used in the surveillance has sufficient qualifications and experience to conduct such surveillance and if such protocol will result in collection of the data or other information designated by the Secretary as necessary to protect the public health.

(j) Withdrawal of authorization

The Secretary, after an opportunity for an informal hearing, shall withdraw an order under subsection (g) if the Secretary determines that—

(1) the applicant, based on new information, can no longer make the demonstrations required under subsection (g), or the Secretary can no longer make the determinations required under subsection (g);

(2) the application failed to include material information or included any untrue statement of material fact;

(3) any explicit or implicit representation that the product reduces risk or exposure is no longer valid, including if—

(A) a tobacco product standard is established pursuant to section 387g of this title;

(B) an action is taken that affects the risks presented by other commercially marketed tobacco products that were compared to the product that is the subject of the application; or

(C) any postmarket surveillance or studies reveal that the order is no longer consistent with the protection of the public health;

(4) the applicant failed to conduct or submit the postmarket surveillance and studies required under subsection (g)(2)(C)(ii) or subsection (i); or

(5) the applicant failed to meet a condition imposed under subsection (h).

(k) Subchapter IV or V

A product for which the Secretary has issued an order pursuant to subsection (g) shall not be subject to subchapter IV or V.

(l) Implementing regulations or guidance

(1) Scientific evidence

Not later than 2 years after June 22, 2009, the Secretary shall issue regulations or guidance (or any combination thereof) on the scientific evidence required for assessment and ongoing review of modified risk tobacco products. Such regulations or guidance shall—

(A) to the extent that adequate scientific evidence exists, establish minimum standards for scientific studies needed prior to issuing an order under subsection (g) to show that a substantial reduction in morbidity or mortality among individual tobacco users occurs for products described in subsection (g)(1) or is reasonably likely for products described in subsection (g)(2);

(B) include validated biomarkers, intermediate clinical endpoints, and other feasible outcome measures, as appropriate;

(C) establish minimum standards for postmarket studies, that shall include regular and long-term assessments of health outcomes and mortality, intermediate clinical endpoints, consumer perception of harm reduction, and the impact on quitting behavior and new use of tobacco products, as appropriate;

(D) establish minimum standards for required postmarket surveillance, including ongoing assessments of consumer perception;

(E) require that data from the required studies and surveillance be made available to the Secretary prior to the decision on renewal of a modified risk tobacco product; and

(F) establish a reasonable timetable for the Secretary to review an application under this section.

(2) Consultation

The regulations or guidance issued under paragraph (1) shall be developed in consultation with the Institute of Medicine, and with the input of other appropriate scientific and medical experts, on the design and conduct of such studies and surveillance.

(3) Revision

The regulations or guidance under paragraph (1) shall be revised on a regular basis as new scientific information becomes available.

(4) New tobacco products

Not later than 2 years after June 22, 2009, the Secretary shall issue a regulation or guidance that permits the filing of a single application for any tobacco product that is a new tobacco product under section 387j of this title and which the applicant seeks to commercially market under this section.

(m) Distributors

Except as provided in this section, no distributor may take any action, after June 22, 2009, with respect to a tobacco product that would reasonably be expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful than one or more commercially marketed tobacco products, or presents a reduced exposure to, or does not contain or is free of, a substance or substances.

(June 25, 1938, ch. 675, §911, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1812.)

Statutory Notes and Related Subsidiaries

Modification of Deadlines for Secretarial Action

With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except 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.
21 U.S.C. § 398 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter X: MISCELLANEOUS / Section 398: Notices to States regarding imported food
Notices to States regarding imported food
Status: in_force

(a) In general

If the Secretary has credible evidence or information indicating that a shipment of imported food or portion thereof presents a threat of serious adverse health consequences or death to humans or animals, the Secretary shall provide notice regarding such threat to the States in which the food is held or will be held, and to the States in which the manufacturer, packer, or distributor of the food is located, to the extent that the Secretary has knowledge of which States are so involved. In providing notice to a State, the Secretary shall request the State to take such action as the State considers appropriate, if any, to protect the public health regarding the food involved.

(b) Rule of construction

Subsection (a) may not be construed as limiting the authority of the Secretary with respect to food under any other provision of this chapter.

(June 25, 1938, ch. 675, §1008, formerly §908, as added Pub. L. 107–188, title III, §310, June 12, 2002, 116 Stat. 673; renumbered §1008, Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)
21 U.S.C. § 501 (2024) — Title 21: FOOD AND DRUGS / Chapter 11: MANUFACTURE OF NARCOTIC DRUGS / Section 501: Repealed. Pub. L. 91-513, title III, §1101(a)(10), Oct. 27, 1970, 84 Stat. 1292
Repealed. Pub. L. 91-513, title III, §1101(a)(10), Oct. 27, 1970, 84 Stat. 1292
Status: repealed

Sections, Pub. L. 86–429, Apr. 22, 1960, 74 Stat. 55, provided for licensing and control of the manufacture of all narcotic drugs and was known as the "Narcotic Manufacturing Act of 1960". Sections 1 to 3 and 5 to 22 of said Pub. L. 86–429 were classified respectively to sections 501, 501 notes, and 502 to 517 of this title. Section 4 of Pub. L. 86–429 was classified to sections 4702, 4731, and 4731 note of Title 26, Internal Revenue Code. See section 801 et seq. of this title.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 1105(a) of Pub. L. 91–513, set out as a note under section 951 of this title. For provisions postponing such effective date if the Attorney General postpones the effective date of section 826 of this title, see section 1105(c) of Pub. L. 91–513, set out as an Effective Date note under section 951 of this title.

Savings Provision

Prosecutions for any violation of law occurring, and civil seizures or forfeitures and injunctive proceedings commenced, prior to the effective date of repeal of these sections by section 1101 of Pub. L. 91–513 not to be affected or abated by reason thereof, see section 1103 of Pub. L. 91–513, set out as a note under sections 171 to 174 of this title.
21 U.S.C. § 377 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VII: GENERAL AUTHORITY / Section 377: Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests
Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests
Status: in_force

The Secretary, in carrying into effect the provisions of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], is authorized on and after July 12, 1943, to cooperate with associations and scientific societies in the revision of the United States Pharmacopoeia and in the development of methods of analysis and mechanical and physical tests necessary to carry out the work of the Food and Drug Administration.

(July 12, 1943, ch. 221, title II, 57 Stat. 500; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in text, is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Codification

Section was enacted as part of the Labor-Federal Security Appropriation Act, 1944, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator 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.
21 U.S.C. § 1702 (2024) — Title 21: FOOD AND DRUGS / Chapter 22: NATIONAL DRUG CONTROL POLICY / Section 1702: Office of National Drug Control Policy
Office of National Drug Control Policy
Status: in_force

(a) Establishment of Office

There is established in the Executive Office of the President an Office of National Drug Control Policy, which shall—

(1) lead the national drug control effort, including coordinating with the National Drug Control Program agencies;

(2) coordinate and oversee the implementation of the national drug control policy, including the National Drug Control Strategy;

(3) assess and certify the adequacy of National Drug Control Programs and the budget for those programs;

(4) evaluate the effectiveness of national drug control policy efforts, including the National Drug Control Program Agencies' 1 programs, by developing and applying specific goals and performance measurements and monitoring the agencies' program-level spending;

(5) identify and respond to emerging drug threats related to illicit drug use;

(6) administer the Drug-Free Communities Program, the High Intensity Drug Trafficking Areas Program, and other grant programs directly authorized to be administered by the Office in furtherance of the National Drug Control Strategy; and

(7) facilitate broad-scale information sharing and data standardization among Federal, State, and local entities to support the national drug control efforts.

(b) Repealed. Pub. L. 115–271, title VIII, §8222(1), Oct. 24, 2018, 132 Stat. 4142

(c) Access by Congress

The location of the Office in the Executive Office of the President shall not be construed as affecting access by Congress, or any committee of the House of Representatives or the Senate, to any—

(1) information, document, or study in the possession of, or conducted by or at the direction of the Director; or

(2) personnel of the Office.

(d) Office of National Drug Control Policy Gift Fund

(1) Establishment

There is established in the Treasury of the United States a fund for the receipt of gifts, both real and personal, for the purpose of aiding or facilitating the work of the Office under section 1703(c) of this title.

(2) Contributions

The Office may accept, hold, and administer contributions to the Fund.

(3) Use of amounts deposited

Amounts deposited in the Fund are authorized to be appropriated, to remain available until expended for authorized purposes at the discretion of the Director.

(4) Ethics guidelines

The Director shall establish written guidelines setting forth the criteria to be used in determining whether a gift or donation should be declined under this subsection because the acceptance of the gift or donation would—

(A) reflect unfavorably upon the ability of the Director or the Office, or any employee of the Office, to carry out responsibilities or official duties under this chapter in a fair and objective manner; or

(B) compromise the integrity or the appearance of integrity of programs or services provided under this chapter or of any official involved in those programs or services.

(5) Registry of gifts

The Director shall maintain a list of—

(A) the source and amount of each gift or donation accepted by the Office; and

(B) the source and amount of each gift or donation accepted by a contractor to be used in its performance of a contract for the Office.

(6) Report to Congress

The Director shall include in the annual assessment under section 1705(g) of this title a copy of the registry maintained under paragraph (5).

(Pub. L. 105–277, div. C, title VII, §§703, 715, Oct. 21, 1998, 112 Stat. 2681–672, 2681–693; Pub. L. 109–469, title I, §102, title VI, §602, title XI, §1120, Dec. 29, 2006, 120 Stat. 3505, 3533, 3548; Pub. L. 115–271, title VIII, §§8202(a), (b)(2), 8217(a), (b), 8222(1), Oct. 24, 2018, 132 Stat. 4110, 4119, 4142; Pub. L. 116–74, §2(a)(2), (4), Nov. 27, 2019, 133 Stat. 1155.)

Editorial Notes

References in Text

This chapter, referred to in subsec. (d)(4), was in the original a reference to "this title", meaning title VII of Pub. L. 105–277, div. C, Oct. 21, 1998, 112 Stat. 2681–670, which is classified principally to this chapter. For complete classification of title VII to the Code, see Short Title note set out under section 1701 of this title and Tables.

Amendments

2019—Subsec. (a)(1). Pub. L. 116–74, §2(a)(2), substituted "National Drug Control Program agencies" for "National Drug Control Program Agencies".

Subsec. (a)(4). Pub. L. 116–74, §2(a)(4)(A)(i), substituted "programs," for "program,".

Subsec. (a)(6). Pub. L. 116–74, §2(a)(4)(A)(ii), substituted "High Intensity" for "High-Intensity".

Subsec. (d)(4). Pub. L. 116–74, §2(a)(4)(B), made technical amendment to reference in original act which appears in text as reference to this chapter in subpars. (A) and (B).

2018—Pub. L. 115–271, §8202(b)(2), repealed Pub. L. 105–277, §715. See 1998 Amendment note below.

Pub. L. 115–271, §8202(a), revived and restored this section as in effect on Sept. 29, 2003, and as amended by Pub. L. 109–469 and Pub. L. 112–166. See Reauthorization of the Office of National Drug Control Policy note set out under section 1701 of this title.

Subsec. (a). Pub. L. 115–271, §8217(a)(4), struck out concluding provisions which read as follows: "When developing the national drug control policy, any policy of the Director relating to syringe exchange programs for intravenous drug users shall be based on the best available medical and scientific evidence regarding their effectiveness in promoting individual health and preventing the spread of infectious disease, and their impact on drug addiction and use. In making any policy relating to syringe exchange programs, the Director shall consult with the National Institutes of Health and the National Academy of Sciences."

Subsec. (a)(1). Pub. L. 115–271, §8217(a)(1), added par. (1) and struck out former par. (1) which read as follows: "develop national drug control policy;".

Subsec. (a)(2). Pub. L. 115–271, §8217(a)(2), inserted before semicolon at end ", including the National Drug Control Strategy".

Subsec. (a)(4) to (7). Pub. L. 115–271, §8217(a)(3), (4), added pars. (4) to (7) and struck out former par. (4) which read as follows: "evaluate the effectiveness of the national drug control policy and the National Drug Control Program agencies' programs, by developing and applying specific goals and performance measurements."

Subsec. (b). Pub. L. 115–271, §8222(1), struck out subsec. (b) which related to Director of National Drug Control Policy and Deputy Directors.

Subsec. (d)(4) to (6). Pub. L. 115–271, §8217(b), added pars. (4) to (6).

2006—Pub. L. 109–469, §602, amended Pub. L. 105–277, §715, which provided for the repeal of this section. See 1998 Amendment note below.

Subsec. (a). Pub. L. 109–469, §1120, inserted concluding provisions.

Pub. L. 109–469, §102(a), amended subsec. (a) generally. Prior to amendment, subsec. (a) related to establishment of Office of National Drug Control Policy.

Subsec. (b). Pub. L. 109–469, §102(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to Director and Deputy Directors of National Drug Control Policy.

1998—Pub. L. 105–277, §715, as amended by Pub. L. 109–469, §602, which provided for the repeal of this section effective Sept. 30, 2010, was repealed by Pub. L. 115–271, §8202(b)(2). See former section 1712 of this title.

Statutory Notes and Related Subsidiaries

Gifts to Office of National Drug Control Policy

Pub. L. 117–328, div. E, title II, Dec. 29, 2022, 136 Stat. 4664, provided in part: "That the Office [of National Drug Control Policy] is authorized to accept, hold, administer, and utilize gifts, both real and personal, public and private, without fiscal year limitation, for the purpose of aiding or facilitating the work of the Office."

Similar provisions were contained in the following prior appropriation acts:

Pub. L. 117–103, div. E, title II, Mar. 15, 2022, 136 Stat. 253.

Pub. L. 116–260, div. E, title II, Dec. 27, 2020, 134 Stat. 1394.

Pub. L. 116–93, div. C, title II, Dec. 20, 2019, 133 Stat. 2448.

Pub. L. 116–6, div. D, title II, Feb. 15, 2019, 133 Stat. 152.

Pub. L. 115–141, div. E, title II, Mar. 23, 2018, 132 Stat. 549.

Pub. L. 115–31, div. E, title II, May 5, 2017, 131 Stat. 340.

Pub. L. 114–113, div. E, title II, Dec. 18, 2015, 129 Stat. 2436.

Pub. L. 113–235, div. E, title II, Dec. 16, 2014, 128 Stat. 2344.

Pub. L. 113–76, div. E, title II, Jan. 17, 2014, 128 Stat. 195.

Pub. L. 112–74, div. C, title II, Dec. 23, 2011, 125 Stat. 895.

Pub. L. 111–117, div. C, title II, Dec. 16, 2009, 123 Stat. 3170.

Pub. L. 111–8, div. D, title II, Mar. 11, 2009, 123 Stat. 641.

Pub. L. 110–161, div. D, title II, Dec. 26, 2007, 121 Stat. 1983.

Pub. L. 109–115, div. A, title V, Nov. 30, 2005, 119 Stat. 2475.

Pub. L. 108–447, div. H, title III, Dec. 8, 2004, 118 Stat. 3249.

Pub. L. 108–199, div. F, title III, Jan. 23, 2004, 118 Stat. 324.

Pub. L. 108–7, div. J, title III, Feb. 20, 2003, 117 Stat. 446.

Pub. L. 107–67, title III, Nov. 12, 2001, 115 Stat. 530.

Pub. L. 106–554, §1(a)(3) [title III], Dec. 21, 2000, 114 Stat. 2763, 2763A–139.

Pub. L. 106–58, title III, Sept. 29, 1999, 113 Stat. 447.

Pub. L. 105–277, div. A, §101(h) [title III], Oct. 21, 1998, 112 Stat. 2681–480, 2681–496.

Pub. L. 105–61, title III, Oct. 10, 1997, 111 Stat. 1293.

Pub. L. 104–208, div. A, title I, §101(f) [title III], Sept. 30, 1996, 110 Stat. 3009–314, 3009–329.

Pub. L. 104–52, title III, Nov. 19, 1995, 109 Stat. 479.

Pub. L. 103–329, title III, Sept. 30, 1994, 108 Stat. 2394.

Pub. L. 103–123, title III, Oct. 28, 1993, 107 Stat. 1237.

Pub. L. 102–393, title III, Oct. 6, 1992, 106 Stat. 1741.

Pub. L. 102–141, title III, Oct. 28, 1991, 105 Stat. 847.

Pub. L. 101–509, title III, Nov. 5, 1990, 104 Stat. 1402.

Pub. L. 101–136, title III, Nov. 3, 1989, 103 Stat. 793.

Executive Documents

Ex. Ord. No. 12911. Seal for Office of National Drug Control Policy

Ex. Ord. No. 12911, Apr. 25, 1994, 59 F.R. 21121 [22121], provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:

Section 1. There is approved for the Office of National Drug Control Policy in the Executive Office of the President an official seal described as follows:

On a blue disc the Arms of the United States proper above a curved gold scroll inscribed "OFFICE OF NATIONAL DRUG CONTROL POLICY" in blue letters, all within a white border edged in gold and inscribed "EXECUTIVE OFFICE OF THE PRESIDENT OF THE UNITED STATES" in blue letters.

This design is appropriate for the Office of National Drug Control Policy. The dark blue in this seal is suggested by the Seal of the President and denotes the direct organizational link of the Office of National Drug Control Policy with the Presidential office. The Arms of the United States refer to the entire Nation and represent the involvement in drug control policies that are necessary to assist the President in his role as Chief Executive of the United States.

Sec. 2. The seal shall be of the design that is attached hereto and made a part of this order.

William J. Clinton.      

 

1 So in original. Probably should be "agencies' ".
21 U.S.C. § 350f (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IV: FOOD / Section 350f: Reportable food registry
Reportable food registry
Status: in_force

(a) Definitions

In this section:

(1) Responsible party

The term "responsible party", with respect to an article of food, means a person that submits the registration under section 350d(a) of this title for a food facility that is required to register under section 350d(a) of this title, at which such article of food is manufactured, processed, packed, or held.

(2) Reportable food

The term "reportable food" means an article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.

(b) Establishment

(1) In general

Not later than 1 year after September 27, 2007, the Secretary shall establish within the Food and Drug Administration a Reportable Food Registry to which instances of reportable food may be submitted by the Food and Drug Administration after receipt of reports under subsection (d), via an electronic portal, from—

(A) Federal, State, and local public health officials; or

(B) responsible parties.

(2) Review by Secretary

The Secretary shall promptly review and assess the information submitted under paragraph (1) for the purposes of identifying reportable food, submitting entries to the Reportable Food Registry, acting under subsection (c), and exercising other existing food safety authorities under this chapter to protect the public health.

(c) Issuance of an alert by the Secretary

(1) In general

The Secretary shall issue, or cause to be issued, an alert or a notification with respect to a reportable food using information from the Reportable Food Registry as the Secretary deems necessary to protect the public health.

(2) Effect

Paragraph (1) shall not affect the authority of the Secretary to issue an alert or a notification under any other provision of this chapter.

(d) Reporting and notification

(1) In general

Except as provided in paragraph (2), as soon as practicable, but in no case later than 24 hours after a responsible party determines that an article of food is a reportable food, the responsible party shall—

(A) submit a report to the Food and Drug Administration through the electronic portal established under subsection (b) that includes the data elements described in subsection (e) (except the elements described in paragraphs (8), (9), and (10) of such subsection); and

(B) investigate the cause of the adulteration if the adulteration of the article of food may have originated with the responsible party.

(2) No report required

A responsible party is not required to submit a report under paragraph (1) if—

(A) the adulteration originated with the responsible party;

(B) the responsible party detected the adulteration prior to any transfer to another person of such article of food; and

(C) the responsible party—

(i) corrected such adulteration; or

(ii) destroyed or caused the destruction of such article of food.

(3) Reports by public health officials

A Federal, State, or local public health official may submit a report about a reportable food to the Food and Drug Administration through the electronic portal established under subsection (b) that includes the data elements described in subsection (e) that the official is able to provide.

(4) Report number

The Secretary shall ensure that, upon submission of a report under paragraph (1) or (3), a unique number is issued through the electronic portal established under subsection (b) to the person submitting such report, by which the Secretary is able to link reports about the reportable food submitted and amended under this subsection and identify the supply chain for such reportable food.

(5) Review

The Secretary shall promptly review a report submitted under paragraph (1) or (3).

(6) Response to report submitted by a responsible party

After consultation with the responsible party that submitted a report under paragraph (1), the Secretary may require such responsible party to perform, as soon as practicable, but in no case later than a time specified by the Secretary, 1 or more of the following:

(A) Amend the report submitted by the responsible party under paragraph (1) to include the data element described in subsection (e)(9).

(B) Provide a notification—

(i) to the immediate previous source of the article of food, if the Secretary deems necessary;

(ii) to the immediate subsequent recipient of the article of food, if the Secretary deems necessary; and

(iii) that includes—

(I) the data elements described in subsection (e) that the Secretary deems necessary;

(II) the actions described under paragraph (7) that the recipient of the notification shall perform, as required by the Secretary; and

(III) any other information that the Secretary may require.

(7) Subsequent reports and notifications

Except as provided in paragraph (8), the Secretary may require a responsible party to perform, as soon as practicable, but in no case later than a time specified by the Secretary, after the responsible party receives a notification under subparagraph (C) or paragraph (6)(B), 1 or more of the following:

(A) Submit a report to the Food and Drug Administration through the electronic portal established under subsection (b) that includes those data elements described in subsection (e) and other information that the Secretary deems necessary.

(B) Investigate the cause of the adulteration if the adulteration of the article of food may have originated with the responsible party.

(C) Provide a notification—

(i) to the immediate previous source of the article of food, if the Secretary deems necessary;

(ii) to the immediate subsequent recipient of the article of food, if the Secretary deems necessary; and

(iii) that includes—

(I) the data elements described in subsection (e) that the Secretary deems necessary;

(II) the actions described under this paragraph that the recipient of the notification shall perform, as required by the Secretary; and

(III) any other information that the Secretary may require.

(8) Amended report

If a responsible party receives a notification under paragraph (6)(B) or paragraph (7)(C) with respect to an article of food after the responsible party has submitted a report to the Food and Drug Administration under paragraph (1) with respect to such article of food—

(A) the responsible party is not required to submit an additional report or make a notification under paragraph (7); and

(B) the responsible party shall amend the report submitted by the responsible party under paragraph (1) to include the data elements described in paragraph (9), and, with respect to both such notification and such report, paragraph (11) of subsection (e).

(e) Data elements

The data elements described in this subsection are the following:

(1) The registration numbers of the responsible party under section 350d(a)(3) 1 of this title.

(2) The date on which an article of food was determined to be a reportable food.

(3) A description of the article of food including the quantity or amount.

(4) The extent and nature of the adulteration.

(5) If the adulteration of the article of food may have originated with the responsible party, the results of the investigation required under paragraph (1)(B) or (7)(B) of subsection (d), as applicable and when known.

(6) The disposition of the article of food, when known.

(7) Product information typically found on packaging including product codes, use-by dates, and names of manufacturers, packers, or distributors sufficient to identify the article of food.

(8) Contact information for the responsible party.

(9) The contact information for parties directly linked in the supply chain and notified under paragraph (6)(B) or (7)(C) of subsection (d), as applicable.

(10) The information required by the Secretary to be included in a notification provided by the responsible party involved under paragraph (6)(B) or (7)(C) of subsection (d) or required in a report under subsection (d)(7)(A).

(11) The unique number described in subsection (d)(4).

(f) Critical information

Except with respect to fruits and vegetables that are raw agricultural commodities, not more than 18 months after January 4, 2011, the Secretary may require a responsible party to submit to the Secretary consumer-oriented information regarding a reportable food, which shall include—

(1) a description of the article of food as provided in subsection (e)(3);

(2) as provided in subsection (e)(7), affected product identification codes, such as UPC, SKU, or lot or batch numbers sufficient for the consumer to identify the article of food;

(3) contact information for the responsible party as provided in subsection (e)(8); and

(4) any other information the Secretary determines is necessary to enable a consumer to accurately identify whether such consumer is in possession of the reportable food.

(g) Grocery store notification

(1) Action by Secretary

The Secretary shall—

(A) prepare the critical information described under subsection (f) for a reportable food as a standardized one-page summary;

(B) publish such one-page summary on the Internet website of the Food and Drug Administration in a format that can be easily printed by a grocery store for purposes of consumer notification.

(2) Action by grocery store

A notification described under paragraph (1)(B) shall include the date and time such summary was posted on the Internet website of the Food and Drug Administration.

(h) Consumer notification

(1) In general

If a grocery store sold a reportable food that is the subject of the posting and such establishment is part of 2 chain of establishments with 15 or more physical locations, then such establishment shall, not later than 24 hours after a one page summary described in subsection (g) is published, prominently display such summary or the information from such summary via at least one of the methods identified under paragraph (2) and maintain the display for 14 days.

(2) List of conspicuous locations

Not more than 1 year after January 4, 2011, the Secretary shall develop and publish a list of acceptable conspicuous locations and manners, from which grocery stores shall select at least one, for providing the notification required in paragraph (1). Such list shall include—

(A) posting the notification at or near the register;

(B) providing the location of the reportable food;

(C) providing targeted recall information given to customers upon purchase of a food; and

(D) other such prominent and conspicuous locations and manners utilized by grocery stores as of January 4, 2011, to provide notice of such recalls to consumers as considered appropriate by the Secretary.

(i) Coordination of Federal, State, and local efforts

(1) Department of Agriculture

In implementing this section, the Secretary shall—

(A) share information and coordinate regulatory efforts with the Department of Agriculture; and

(B) if the Secretary receives a report submitted about a food within the jurisdiction of the Department of Agriculture, promptly provide such report to the Department of Agriculture.

(2) States and localities

In implementing this section, the Secretary shall work with the State and local public health officials to share information and coordinate regulatory efforts, in order to—

(A) help to ensure coverage of the safety of the food supply chain, including those food establishments regulated by the States and localities that are not required to register under section 350d of this title; and

(B) reduce duplicative regulatory efforts.

(j) Maintenance and inspection of records

The responsible party shall maintain records related to each report received, notification made, and report submitted to the Food and Drug Administration under this section for 2 years. A responsible party shall, at the request of the Secretary, permit inspection of such records as provided for section 3 350c of this title.

(k) Request for information

Except as provided by section 350d(a)(4) 1 of this title, section 552 of title 5 shall apply to any request for information regarding a record in the Reportable Food Registry.

(l) Safety report

A report or notification under subsection (d) shall be considered to be a safety report under section 379v of this title and may be accompanied by a statement, which shall be part of any report released for public disclosure, that denies that the report or the notification constitutes an admission that the product involved caused or contributed to a death, serious injury, or serious illness.

(m) Admission

A report or notification under this section shall not be considered an admission that the article of food involved is adulterated or caused or contributed to a death, serious injury, or serious illness.

(n) Homeland Security notification

If, after receiving a report under subsection (d), the Secretary believes such food may have been deliberately adulterated, the Secretary shall immediately notify the Secretary of Homeland Security. The Secretary shall make relevant information from the Reportable Food Registry available to the Secretary of Homeland Security.

(June 25, 1938, ch. 675, §417, as added Pub. L. 110–85, title X, §1005(b), Sept. 27, 2007, 121 Stat. 965; amended Pub. L. 111–353, title II, §211(a), Jan. 4, 2011, 124 Stat. 3951.)

Editorial Notes

References in Text

Section 350d(a)(3), (4) of this title, referred to in subsecs. (e)(1) and (k), was redesignated section 350d(a)(4), (5), respectively, of this title by Pub. L. 111–353, title I, §102(a)(2), Jan. 4, 2011, 124 Stat. 3887.

Amendments

2011—Subsecs. (f) to (n). Pub. L. 111–353 added subsecs. (f) to (h) and redesignated former subsecs. (f) to (k) as (i) to (n), respectively.

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 110–85, title X, §1005(e), Sept. 27, 2007, 121 Stat. 969, provided that: "The requirements of section 417(d) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350f(d)], as added by subsection (a) [probably should be (b)], shall become effective 1 year after the date of the enactment of this Act [Sept. 27, 2007]."

Construction of 2011 Amendment

Nothing in amendment by Pub. L. 111–353 to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

Findings

Pub. L. 110–85, title X, §1005(a), Sept. 27, 2007, 121 Stat. 964, provided that: "Congress makes the following findings:

"(1) In 1994, Congress passed the Dietary Supplement Health and Education Act of 1994 (Public Law 103–417) [see Short Title of 1994 Amendments note set out under section 301 of this title] to provide the Food and Drug Administration the legal framework which is intended to ensure that dietary supplements are safe and properly labeled foods.

"(2) In 2006, Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109–462) [see Short Title of 2006 Amendment note set out under section 301 of this title] to establish a mandatory reporting system of serious adverse events for nonprescription drugs and dietary supplements sold and consumed in the United States.

"(3) The adverse event reporting system created under the Dietary Supplement and Nonprescription Drug Consumer Protection Act is intended to serve as an early warning system for potential public health issues associated with the use of these products.

"(4) A reliable mechanism to track patterns of adulteration in food would support efforts by the Food and Drug Administration to target limited inspection resources to protect the public health."

Guidance

Pub. L. 110–85, title X, §1005(f), Sept. 27, 2007, 121 Stat. 969, provided that: "Not later than 9 months after the date of the enactment of this Act [Sept. 27, 2007], the Secretary [of Health and Human Services] shall issue a guidance to industry about submitting reports to the electronic portal established under section 417 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350f] (as added by this section) and providing notifications to other persons in the supply chain of an article of food under such section 417."

1 See References in Text note below.

2 So in original. Probably should be followed by "a".

3 So in original. Probably should be "in section".
21 U.S.C. § 2354 (2024) — Title 21: FOOD AND DRUGS / Chapter 28A: FENTANYL ERADICATION AND NARCOTICS DETERRENCE OFF FENTANYL / Subchapter I: SANCTIONS IN RESPONSE TO NATIONAL EMERGENCY RELATING TO FENTANYL TRAFFICKING / Section 2354: Penalties; waivers; exceptions
Penalties; waivers; exceptions
Status: in_force

(a) Penalties

Any person that violates, attempts to violate, conspires to violate, or causes a violation of this subchapter or any regulation, license, or order issued to carry out this subchapter shall be subject to the penalties set forth in subsections (b) and (c) of section 1705 of title 50 to the same extent as a person that commits an unlawful act described in subsection (a) of that section.

(b) National security waiver

The President may waive the application of sanctions under this subchapter with respect to a foreign person if the President determines that such waiver is in the national security interest of the United States.

(c) Exceptions

(1) Exception for intelligence activities

This subchapter shall not apply with respect to activities subject to the reporting requirements under title V of the National Security Act of 1947 (50 U.S.C. 3091 et seq.) or any authorized intelligence activities of the United States.

(2) Exception for compliance with international obligations and law enforcement activities

Sanctions under this subchapter shall not apply with respect to an alien if admitting or paroling the alien into the United States is necessary—

(A) to permit the United States to comply with the Agreement regarding the Headquarters of the United Nations, signed at Lake Success on June 26, 1947, and entered into force November 21, 1947, between the United Nations and the United States, or other applicable international obligations of the United States; or

(B) to carry out or assist law enforcement activity of the United States.

(3) Humanitarian exemption

The President may not impose sanctions under this subchapter with respect to any person for conducting or facilitating a transaction for the sale of agricultural commodities, food, medicine, or medical devices or for the provision of humanitarian assistance.

(Pub. L. 118–50, div. E, title I, §3104, Apr. 24, 2024, 138 Stat. 937.)

Editorial Notes

References in Text

The National Security Act of 1947, referred to in subsec. (c)(1), is act July 26, 1947, ch. 343, 61 Stat. 495. Title V of the Act is classified generally to subchapter III (§3091 et seq.) of chapter 44 of Title 50, War and National Defense. For complete classification of this Act to the Code, see Tables.
21 U.S.C. § 392 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter X: MISCELLANEOUS / Section 392: Exemption of meats and meat food products
Exemption of meats and meat food products
Status: in_force

(a) Law determinative of exemption

Meats and meat food products shall be exempt from the provisions of this chapter to the extent of the application or the extension thereto of the Meat Inspection Act, approved March 4, 1907, as amended [21 U.S.C. 601 et seq.].

(b) Laws unaffected

Nothing contained in this chapter shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of section 351 of Public Health Service Act [42 U.S.C. 262] (relating to viruses, serums, toxins, and analogous products applicable to man); the virus, serum, toxin, and analogous products provisions, applicable to domestic animals, of the Act of Congress approved March 4, 1913 (37 Stat. 832–833) [21 U.S.C. 151 et seq.]; the Filled Cheese Act of June 6, 1896 (U.S.C., 1934 ed., title 26, ch. 10), the Filled Milk Act of March 4, 1923 [21 U.S.C. 61 et seq.]; or the Import Milk Act of February 15, 1927 [21 U.S.C. 141 et seq.].

(June 25, 1938, ch. 675, §1002(b), (c), formerly §902(b), (c), 52 Stat. 1059; Pub. L. 90–399, §107, July 13, 1968, 82 Stat. 353; renumbered §1002(b), (c), Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784.)

Editorial Notes

References in Text

The Meat Inspection Act, approved March 4, 1907, as amended, referred to in subsec. (a), is act Mar. 4, 1907, ch. 2907, titles I to IV, as added Dec. 15, 1967, Pub. L. 90–201, 81 Stat. 584, which are classified generally to subchapters I to IV (§601 et seq.) of chapter 12 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 601 of this title and Tables.

Act of March 4, 1913, referred to in subsec. (b), is act Mar. 4, 1913, ch. 145, 37 Stat. 828. The provisions of such act referred to relating to viruses, etc., applicable to domestic animals, are contained in the eighth paragraph under the heading "Bureau of Animal Industry", 37 Stat. 832, as amended, popularly known as the Virus-Serum-Toxin Act, which is classified generally to chapter 5 (§151 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 151 of this title and Tables.

The Filled Cheese Act of June 6, 1896 (U.S.C., 1934 ed., title 26, ch. 10), referred to in subsec. (b), is act June 6, 1896, ch. 337, 29 Stat. 253, which had been classified to chapter 10 (§1000 et seq.) of Title 26, Internal Revenue, and included as chapter 17 (§2350 et seq.) of Title 26, Internal Revenue Code of 1939. Such chapter 17 was covered by section 4831 et seq. of Title 26, Internal Revenue Code, prior to the repeal of section 4831 et seq. of Title 26 by Pub. L. 93–490, §3(a)(1), Oct. 26, 1974, 88 Stat. 1466.

The Filled Milk Act of March 4, 1923, referred to in subsec. (b), is act Mar. 4, 1923, ch. 262, 42 Stat. 1486, which is classified generally to chapter 3 (§61 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 61 of this title and Tables.

The Import Milk Act of February 15, 1927, referred to in subsec. (b), is act Feb. 15, 1927, ch. 155, 44 Stat. 1101, which is classified generally to subchapter IV (§141 et seq.) of chapter 4 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 141 of this title and Tables.

Codification

Subsecs. (a) and (b) of this section comprise respectively subsecs. (b) and (c) of section 1002 of act June 25, 1938. Subsecs. (a) and (d) of section 1002 of act June 25, 1938, which prescribed the effective date of this chapter and made appropriations available, are set out as notes under section 301 of this title and this section, respectively.

Amendments

1968—Subsec. (b). Pub. L. 90–399 substituted "section 351 of Public Health Service Act (relating to viruses, serums, toxins, and analogous products applicable to man); the virus, serum, toxin, and analogous products provisions, applicable to domestic animals, of the Act of Congress approved March 4, 1913 (37 Stat. 832–833);" for "the virus, serum, and toxin Act of July 1, 1902 (U.S.C., 1934 ed., title 42, chap. 4);".

Statutory Notes and Related Subsidiaries

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–399 effective on first day of thirteenth calendar month after July 13, 1968, see section 108(a) of Pub. L. 90–399, set out as an Effective Date and Transitional Provisions note under section 360b of this title.

Availability of Appropriations

Act June 25, 1938, ch. 675, §1002(d), formerly §902(d), 52 Stat. 1059; renumbered §1002(d), Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784, provided that: "In order to carry out the provisions of this Act which take effect [see section 1002(a) of act June 25, 1938, set out as an Effective Date note under section 301 of this title] prior to the repeal of the Food and Drugs Act of June 30, 1906, as amended [former sections 1 to 5 and 7 to 15 of this title], appropriations available for the enforcement of such Act of June 30, 1906, are also authorized to be made available to carry out such provisions."
21 U.S.C. § 451 (2024) — Title 21: FOOD AND DRUGS / Chapter 10: POULTRY AND POULTRY PRODUCTS INSPECTION / Section 451: Congressional statement of findings
Congressional statement of findings
Status: in_force

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.

(Pub. L. 85–172, §2, Aug. 28, 1957, 71 Stat. 441; Pub. L. 90–492, §2, Aug. 18, 1968, 82 Stat. 791.)

Editorial Notes

Amendments

1968—Pub. L. 90–492 inserted provisions stating it to be necessary 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, provisions that misbranded poultry products impair the effective regulation of poultry products and 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, and provisions that all articles and poultry which are regulated by 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 serve the specified aims, and struck out provisions that all poultry and poultry products which have or are required to have inspection under this chapter are either in the current of interstate or foreign commerce or directly affect such commerce, provisions that that part entering directly into the current of interstate or foreign commerce cannot be effectively inspected and regulated without also inspecting and regulating all poultry and poultry products in the same establishment, and provisions authorizing the Secretary to designate major consuming areas.

Statutory Notes and Related Subsidiaries

Effective Date of 1968 Amendment

Pub. L. 90–492, §20, Aug. 18, 1968, 82 Stat. 808, provided that: "This Act [see Short Title of 1968 Amendment note below] shall become effective upon enactment [Aug. 18, 1968] except as provided in paragraphs (a) through (c):

"(a) The provisions of subparagraphs (a)(2)(A) and (a)(3) of section 9 of the Poultry Products Inspection Act, as amended by section 9 of this Act [section 458(a)(2)(A) and (a)(3) of this title], shall become effective upon the expiration of sixty days after enactment hereof [Aug. 18, 1968].

"(b) Section 14 of this Act, amending section 15 of the Poultry Products Inspection Act [section 464 of this title], shall become effective upon the expiration of sixty days after enactment hereof [Aug. 18, 1968].

"(c) Paragraph 11(d) of the Poultry Products Inspection Act, as added by section 11 of this Act [section 460(d) of this title], shall become effective upon the expiration of sixty days after enactment hereof [Aug. 18, 1968]."

Effective Date

Pub. L. 85–172, §29, formerly §22, Aug. 28, 1957, 71 Stat. 449, as renumbered by Pub. L. 90–492, §17, Aug. 18, 1968, 82 Stat. 805, provided that: "This Act [this chapter] shall take effect upon enactment [Aug. 28, 1957], except that no person shall be subject to the provisions of this Act [this chapter] prior to January 1, 1959, unless such person after January 1, 1958, applies for and receives inspection for poultry or poultry products in accordance with the provisions of this Act [this chapter] and pursuant to regulations promulgated by the Secretary hereunder, in any establishment processing poultry or poultry products in commerce or in a designated major consuming area. Any person who voluntarily applies for and receives such inspection after January 1, 1958, shall be subject, on and after the date he commences to receive such inspection, to all of the provisions and penalties provided for in this Act [this chapter] with respect to all poultry or poultry products handled in the establishment for which such said application for inspection is made."

Short Title of 1968 Amendment

Pub. L. 90–492, §1, Aug. 18, 1968, 82 Stat. 791, provided: "That this Act [enacting sections 467a to 467f and 470 of this title, amending this section and sections 452 to 461, 463 to 465, and 467 of this title, and enacting provisions set out as notes under this section] may be cited as the 'Wholesome Poultry Products Act'."

Short Title

Pub. L. 85–172, §1, Aug. 28, 1957, 71 Stat. 441, provided: "That this Act [enacting this chapter and provisions set out as notes under this section] may be cited as the 'Poultry Products Inspection Act'."

Separability

Pub. L. 90–492, §19, Aug. 18, 1968, 82 Stat. 808, provided that: "If any provisions of this Act or of the amendments made hereby [see Short Title of 1968 Amendment note above] or the application thereof to any person or circumstances is held invalid, the validity of the remainder of the Act and the remaining amendments and of the application of such provision to other persons and circumstances shall not be affected thereby."

Pub. L. 85–172, §28, formerly §21, Aug. 28, 1957, 71 Stat. 449, as renumbered by Pub. L. 90–492, §17, Aug. 18, 1968, 82 Stat. 805, provided that: "If any provision of this Act [this chapter] or the application thereof to any person or circumstances is held invalid, the validity of the remainder of the Act and of the application of such provision to other persons and circumstances shall not be affected thereby."

Food Additives Amendment of 1958

Pub. L. 85–929, §7, Sept. 6, 1958, 72 Stat. 1789, provided that: "Nothing in this Act [amending sections 321, 331, 342, 346, and 348 of this title and section 210 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under sections 321 and 342 of this title] shall be construed to exempt any meat or meat food product or any person from any requirement imposed by or pursuant to the Poultry Products Inspection Act (21 U.S.C. 451 and the following) [this chapter] or the Meat Inspection Act of March 4, 1907, 34 Stat. 1260, as amended and extended (21 U.S.C. 71 and the following) [see section 601 et seq. of this title]."
21 U.S.C. § 851 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 851: Proceedings to establish prior convictions
Proceedings to establish prior convictions
Status: in_force

(a) Information filed by United States Attorney

(1) No person who stands convicted of an offense under this part shall be sentenced to increased punishment by reason of one or more prior convictions, unless before trial, or before entry of a plea of guilty, the United States attorney files an information with the court (and serves a copy of such information on the person or counsel for the person) stating in writing the previous convictions to be relied upon. Upon a showing by the United States attorney that facts regarding prior convictions could not with due diligence be obtained prior to trial or before entry of a plea of guilty, the court may postpone the trial or the taking of the plea of guilty for a reasonable period for the purpose of obtaining such facts. Clerical mistakes in the information may be amended at any time prior to the pronouncement of sentence.

(2) An information may not be filed under this section if the increased punishment which may be imposed is imprisonment for a term in excess of three years unless the person either waived or was afforded prosecution by indictment for the offense for which such increased punishment may be imposed.

(b) Affirmation or denial of previous conviction

If the United States attorney files an information under this section, the court shall after conviction but before pronouncement of sentence inquire of the person with respect to whom the information was filed whether he affirms or denies that he has been previously convicted as alleged in the information, and shall inform him that any challenge to a prior conviction which is not made before sentence is imposed may not thereafter be raised to attack the sentence.

(c) Denial; written response; hearing

(1) If the person denies any allegation of the information of prior conviction, or claims that any conviction alleged is invalid, he shall file a written response to the information. A copy of the response shall be served upon the United States attorney. The court shall hold a hearing to determine any issues raised by the response which would except the person from increased punishment. The failure of the United States attorney to include in the information the complete criminal record of the person or any facts in addition to the convictions to be relied upon shall not constitute grounds for invalidating the notice given in the information required by subsection (a)(1). The hearing shall be before the court without a jury and either party may introduce evidence. Except as otherwise provided in paragraph (2) of this subsection, the United States attorney shall have the burden of proof beyond a reasonable doubt on any issue of fact. At the request of either party, the court shall enter findings of fact and conclusions of law.

(2) A person claiming that a conviction alleged in the information was obtained in violation of the Constitution of the United States shall set forth his claim, and the factual basis therefor, with particularity in his response to the information. The person shall have the burden of proof by a preponderance of the evidence on any issue of fact raised by the response. Any challenge to a prior conviction, not raised by response to the information before an increased sentence is imposed in reliance thereon, shall be waived unless good cause be shown for failure to make a timely challenge.

(d) Imposition of sentence

(1) If the person files no response to the information, or if the court determines, after hearing, that the person is subject to increased punishment by reason of prior convictions, the court shall proceed to impose sentence upon him as provided by this part.

(2) If the court determines that the person has not been convicted as alleged in the information, that a conviction alleged in the information is invalid, or that the person is otherwise not subject to an increased sentence as a matter of law, the court shall, at the request of the United States attorney, postpone sentence to allow an appeal from that determination. If no such request is made, the court shall impose sentence as provided by this part. The person may appeal from an order postponing sentence as if sentence had been pronounced and a final judgment of conviction entered.

(e) Statute of limitations

No person who stands convicted of an offense under this part may challenge the validity of any prior conviction alleged under this section which occurred more than five years before the date of the information alleging such prior conviction.

(Pub. L. 91–513, title II, §411, Oct. 27, 1970, 84 Stat. 1269.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.
21 U.S.C. § 2355 (2024) — Title 21: FOOD AND DRUGS / Chapter 28A: FENTANYL ERADICATION AND NARCOTICS DETERRENCE OFF FENTANYL / Subchapter I: SANCTIONS IN RESPONSE TO NATIONAL EMERGENCY RELATING TO FENTANYL TRAFFICKING / Section 2355: Treatment of forfeited property of transnational criminal organizations
Treatment of forfeited property of transnational criminal organizations
Status: in_force

(a) Transfer of forfeited property to forfeiture funds

(1) In general

Any covered forfeited property shall be deposited into the Department of the Treasury Forfeiture Fund established under section 9705 of title 31 or the Department of Justice Assets Forfeiture Fund established under section 524(c) of title 28.

(2) Report required

Not later than 180 days after April 24, 2024, and every 180 days thereafter, the President shall submit to the appropriate congressional committees a report on any deposits made under paragraph (1) during the 180-day period preceding submission of the report.

(3) Covered forfeited property defined

In this subsection, the term "covered forfeited property" means property—

(A) forfeited to the United States under chapter 46 or section 1963 of title 18; and

(B) that belonged to or was possessed by an individual affiliated with or connected to a transnational criminal organization subject to sanctions under—

(i) this subchapter;

(ii) the Fentanyl Sanctions Act (21 U.S.C. 2301 et seq.); or

(iii) Executive Order 14059 (50 U.S.C. 1701 note; relating to imposing sanctions on foreign persons involved in the global illicit drug trade).

(b) Blocked Assets Under Terrorism Risk Insurance Act of 2002

Nothing in this subchapter may be construed to affect the treatment of blocked assets of a terrorist party described in section 201(a) of the Terrorism Risk Insurance Act of 2002 (28 U.S.C. 1610 note).

(Pub. L. 118–50, div. E, title I, §3105, Apr. 24, 2024, 138 Stat. 938.)

Editorial Notes

References in Text

The Fentanyl Sanctions Act, referred to in subsec. (a)(3)(B)(ii), is title LXXII of div. F of Pub. L. 116–92, which is classified principally to chapter 28 (§2301 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2301 of this title and Tables.

Section 201(a) of the Terrorism Risk Insurance Act of 2002, referred to in subsec. (b), is section 201(a) of Pub. L. 107–297, which is set out as a note under section 1610 of Title 28, Judiciary and Judicial Procedure.
21 U.S.C. § 1179 (2024) — Title 21: FOOD AND DRUGS / Chapter 16: DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION / Subchapter IV: OTHER FEDERAL PROGRAMS / Section 1179: National Drug Abuse Training Center
National Drug Abuse Training Center
Status: in_force

(a) Establishment; functions; general policies; transfer of supervision

The Director shall establish a National Drug Abuse Training Center (hereinafter in this section referred to as the "Center") to develop, conduct, and support a full range of training programs relating to drug abuse prevention functions. The Director shall consult with the National Advisory Council for Drug Abuse Prevention regarding the general policies of the Center. The Director may supervise the operation of the Center initially, but shall transfer the supervision of the operation of the Center to the National Institute on Drug Abuse not later than December 31, 1974.

(b) Activities and material

The Center shall conduct or arrange for training programs, seminars, meetings, conferences, and other related activities, including the furnishing of training and educational materials for use by others.

(c) Persons eligible for services and facilities

The services and facilities of the Center shall, in accordance with regulations prescribed by the Director, be available to (1) Federal, State, and local governmental officials, and their respective staffs, (2) medical and paramedical personnel, and educators, and (3) other persons, including drug dependent persons, requiring training or education in drug abuse prevention.

(d) Authorization of appropriations; fiscal year availability

(1) For the purpose of carrying out this section, there are authorized to be appropriated $1,000,000 for the fiscal year ending June 30, 1972, $3,000,000 for the fiscal year ending June 30, 1973, $5,000,000 for the fiscal year ending June 30, 1974, and $6,000,000 for the fiscal year ending June 30, 1975.

(2) Sums appropriated under this subsection shall remain available for obligation or expenditure in the fiscal year for which appropriated and in the fiscal year next following.

(Pub. L. 92–255, title IV, §412, Mar. 21, 1972, 86 Stat. 84.)

Editorial Notes

References in Text

The National Advisory Council for Drug Abuse Prevention, referred to in subsec. (a), was established by section 1151 of this title, which was repealed by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.
21 U.S.C. § 679 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter IV: AUXILIARY PROVISIONS / Section 679: Application of Federal Food, Drug, and Cosmetic Act
Application of Federal Food, Drug, and Cosmetic Act
Status: in_force

(a) Authorities under food, drug, and cosmetic provisions unaffected

Notwithstanding any other provisions of law, including section 1002(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 392(a)), the provisions of this chapter shall not derogate from any authority conferred by the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] prior to December 15, 1967.

(b) Enforcement proceedings; detainer authority of representatives of Secretary of Health and Human Services

The detainer authority conferred by section 672 of this title shall apply to any authorized representative of the Secretary of Health and Human Services for purposes of the enforcement of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] with respect to any carcass, part thereof, meat, or meat food product of cattle, sheep, swine, goats, or equines that is outside any premises at which inspection is being maintained under this chapter, and for such purposes the first reference to the Secretary in section 672 of this title shall be deemed to refer to the Secretary of Health and Human Services.

(Mar. 4, 1907, ch. 2907, title IV, §409, as added Pub. L. 90–201, §16, Dec. 15, 1967, 81 Stat. 600; amended Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 111–31, div. A, title I, §103(o), June 22, 2009, 123 Stat. 1838.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Amendments

2009—Subsec. (a). Pub. L. 111–31 substituted "section 1002(b)" for "section 902(b)".

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in subsec. (b) pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.
21 U.S.C. § 25 (2024) — Title 21: FOOD AND DRUGS / Chapter 1: ADULTERATED OR MISBRANDED FOODS OR DRUGS / Subchapter II: MISCELLANEOUS PROVISIONS / Section 25: Oleomargarine, butterine, or imitation butter or cheese transported into a State subject to its police powers
Oleomargarine, butterine, or imitation butter or cheese transported into a State subject to its police powers
Status: in_force

All articles known as oleomargarine, butterine, imitation, process, renovated, or adulterated butter, or imitation cheese, or any substance in the semblance of butter or cheese not the usual product of the dairy and not made exclusively of pure and unadulterated milk or cream, transported into any State or Territory or the District of Columbia, and remaining therein for use, consumption, sale, or storage therein, shall, upon the arrival within the limits of such State or Territory or the District of Columbia, be subject to the operation and effect of the laws of such State or Territory or the District of Columbia, enacted in the exercise of its police powers to the same extent and in the same manner as though such articles or substances had been produced in such State or Territory or the District of Columbia, and shall not be exempt therefrom by reason of being introduced therein in original packages or otherwise.

(May 9, 1902, ch. 784, §1, 32 Stat. 193.)
21 U.S.C. § 203 (2024) — Title 21: FOOD AND DRUGS / Chapter 7: PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR DISTRICTS IN CHINA / Section 203: Application for license; requirements; qualifications for license
Application for license; requirements; qualifications for license
Status: in_force

Every person whose permanent allegiance is due to the United States desiring to practice as a pharmacist in the consular districts in China shall file with the consul an application, duly verified under oath, setting forth the name and age of the applicant, the place or places at which he pursued and the time spent in the study of pharmacy, the experience which the applicant has had in compounding physicians' prescriptions under the direction of a licensed pharmacist, and the name and location of the school or college of pharmacy, if any, of which he is a graduate, and shall submit evidence sufficient to show to the satisfaction of said consul that he is of good moral character and not addicted to the use of alcoholic liquors or narcotic drugs so as to render him unfit to practice pharmacy. Applicants shall be not less than twenty-one years of age and shall have had at least four years' experience in the practice of pharmacy or shall have served three years under the instruction of a regularly licensed pharmacist, and any applicant who has been graduated from a school or college of pharmacy recognized by the proper board of his State, Territory, District of Columbia, or other possession of the United States as in good standing shall be entitled to practice upon presentation of his diploma.

(Mar. 3, 1915, ch. 74, §2, 38 Stat. 818.)

Editorial Notes

Codification

The words "now practicing as a pharmacist or," which preceded "desiring to practice" in the original text of this section, were omitted as obsolete.
21 U.S.C. § 616 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter I: INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING / Section 616: Inspectors of carcasses, etc., meat of which is intended for export; certificates of condition
Inspectors of carcasses, etc., meat of which is intended for export; certificates of condition
Status: in_force

For the purpose of section 615 of this title the Secretary may appoint inspectors who shall be authorized to give an official certificate stating the condition in which said cattle, sheep, swine, goats, horses, mules, or other equines, and the meat thereof, are found.

(Mar. 4, 1907, ch. 2907, title I, §16, formerly 14th par., 34 Stat. 1263; renumbered §16 and amended Pub. L. 90–201, §§1, 3(b), 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592.)

Editorial Notes

Codification

Section was formerly classified to section 84 of this title.

Amendments

1967—Pub. L. 90–201, §§3(b), 12(a), struck out "of Agriculture" after "Secretary", and included horses, mules, or other equines in the list of animals.

Statutory Notes and Related Subsidiaries

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.
21 U.S.C. § 1041 (2024) — Title 21: FOOD AND DRUGS / Chapter 15: EGG PRODUCTS INSPECTION / Section 1041: Enforcement provisions
Enforcement provisions
Status: in_force

(a) Violations of section 1037; term of imprisonment and fine

Any person who commits any offense prohibited by section 1037 of this title shall upon conviction be subject to imprisonment for not more than one year, or a fine of not more than $5,000, or both such imprisonment and fine, but if such violation involves intent to defraud, or any distribution or attempted distribution of any article that is known to be adulterated (except as defined in section 1033(a)(8) of this title), such person shall be subject to imprisonment for not more than three years or a fine of not more than $10,000, or both.

(b) Persons preventing enforcement of chapter; term of imprisonment and fine

Any person who forcibly assaults, resists, opposes, impedes, intimidates, or interferes with any person while engaged in or on account of the performance of his official duties under this chapter shall be fined not more than $5,000 or imprisoned not more than three years or both. Whoever, in the commission of any such act, uses a deadly or dangerous weapon, shall be fined not more than $10,000 or imprisoned not more than ten years, or both. Whoever kills any person while engaged in or on account of the performance of his official duties under this chapter shall be punished as provided under sections 1111 and 1112 of title 18.

(c) Civil penalty

(1)(A) Except as otherwise provided in this subsection, any person who violates any provision of this chapter or any regulation issued under this chapter, other than a violation for which a criminal penalty has been imposed under this chapter, may be assessed a civil penalty by the Secretary of not more than $5,000 for each such violation. Each violation to which this subparagraph applies shall be considered a separate offense.

(B) No penalty shall be assessed against any person under this subsection unless the person is given notice and opportunity for a hearing on the record before the Secretary in accordance with sections 554 and 556 of title 5.

(C) The amount of the civil penalty imposed under this subsection—

(i) shall be assessed by the Secretary, by written order, taking into account the gravity of the violation, degree of culpability, and history of prior offenses; and

(ii) may be reviewed only as provided in paragraph (2).

(2)(A) The determination and order of the Secretary under this subsection shall be final and conclusive unless the person against whom such a violation is found under paragraph (1) files an application for judicial review within 30 days after service of the order in the United States court of appeals for the circuit in which the person has its principal place of business or in the United States Court of Appeals for the District of Columbia Circuit.

(B) Judicial review of any such order shall be based on the record on which the determination and order are based.

(C) If the court determines that additional evidence needs to be taken, the court shall order the hearing to be reopened for this purpose in such manner and on such terms and conditions as the court considers proper. The Secretary may modify the findings of the Secretary as to the facts, or make new findings, on the basis of the additional evidence so taken.

(3) If any person fails to pay an assessment of a civil penalty after the penalty has become a final and unappealable order, or after the appropriate court of appeals has entered a final judgment in favor of the Secretary, the Secretary shall refer the matter to the Attorney General. The Attorney General shall institute a civil action to recover the amount assessed in an appropriate district court of the United States. In the collection action, the validity and appropriateness of the Secretary's order imposing the civil penalty shall not be subject to review.

(4) All penalties collected under this subsection shall be paid into the Treasury of the United States.

(5) The Secretary may compromise, modify, or remit, with or without conditions, any civil penalty assessed under this subsection.

(6) Paragraph (1) shall not apply to an official plant.

(d) Scope of liability for violations of section 1037

When construing or enforcing the provisions of section 1037 of this title, the act, omission, or failure of any person acting for or employed by any individual, partnership, corporation, or association within the scope of his employment or office shall in every case be deemed the act, omission, or failure of such individual, partnership, corporation, or association, as well as of such person.

(e) Penalties applicable to carriers or warehousemen

No carrier or warehouseman shall be subject to the penalties of this chapter, other than the penalties for violation of section 1040 of this title or paragraph (c) 1 of this section, by reason of his receipt, carriage, holding, or delivery, in the usual course of business, as a carrier or warehouseman of eggs or egg products owned by another person unless the carrier or warehouseman has knowledge, or is in possession of facts which would cause a reasonable person to believe that such eggs or egg products were not eligible for transportation under, or were otherwise in violation of, this chapter, or unless the carrier or warehouseman refuses to furnish on request of a representative of the Secretary the name and address of the person from whom he received such eggs or egg products and copies of all documents, if there be any, pertaining to the delivery of the eggs or egg products to, or by, such carrier or warehouseman.

(Pub. L. 91–597, §12, Dec. 29, 1970, 84 Stat. 1628; Pub. L. 102–237, title X, §1012(d), Dec. 13, 1991, 105 Stat. 1899.)

Editorial Notes

References in Text

This chapter, referred to in subsecs. (b), (c)(1)(A), and (e), was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Amendments

1991—Subsec. (a). Pub. L. 102–237, §1012(d)(1), (2), substituted "$5,000" for "$1,000" in first sentence, and redesignated last sentence, relating to scope of liability for violations of section 1037 of this title, as subsec. (d).

Subsec. (b). Pub. L. 102–237, §1012(d)(4), redesignated subsec. (c) as (b). Former subsec. (b) redesignated (e).

Subsec. (c). Pub. L. 102–237, §1012(d)(5), added subsec. (c). Former subsec. (c) redesignated (b).

Subsec. (d). Pub. L. 102–237, §1012(d)(2), designated last sentence of subsec. (a), relating to scope of liability for violations of section 1037 of this title, as subsec. (d).

Subsec. (e). Pub. L. 102–237, §1012(d)(3), redesignated subsec. (b) as (e).

Statutory Notes and Related Subsidiaries

Effective Date of 1991 Amendment

Amendment by Pub. L. 102–237 effective 12 months after promulgation of final implementing regulations, see section 1012(h) of Pub. L. 102–237, set out as a note under section 1034 of this title.

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

1 So in original. Probably should be "subsection (c)".
21 U.S.C. § 1037 (2024) — Title 21: FOOD AND DRUGS / Chapter 15: EGG PRODUCTS INSPECTION / Section 1037: Prohibited acts
Prohibited acts
Status: in_force

(a)(1) No person shall buy, sell, or transport, or offer to buy or sell, or offer or receive for transportation, in any business in commerce any restricted eggs, capable of use as human food, except as authorized by regulations of the Secretary under such conditions as he may prescribe to assure that only eggs fit for human food are used for such purpose.

(2) No egg handler shall possess with intent to use, or use, any restricted eggs in the preparation of human food for commerce except that such eggs may be so possessed and used when authorized by regulations of the Secretary under such conditions as he may prescribe to assure that only eggs fit for human food are used for such purpose.

(b)(1) No person shall process any egg products for commerce at any plant except in compliance with the requirements of this chapter.

(2) No person shall buy, sell, or transport, or offer to buy or sell, or offer or receive for transportation, in commerce any egg products required to be inspected under this chapter unless they have been so inspected and are labeled and packaged in accordance with the requirements of section 1036 of this title.

(3) No operator of any official plant shall fail to comply with any requirements of section 1035(a) of this title or the regulations thereunder.

(4) No operator of any official plant shall allow any egg products to be moved from such plant if they are adulterated or misbranded and capable of use as human food.

(c) No egg handler shall possess any eggs after the eggs have been packed into a container that is destined for the ultimate consumer unless the eggs are stored and transported under refrigeration at an ambient temperature of no greater than 45 degrees Fahrenheit, as prescribed by rules and regulations promulgated by the Secretary.

(d) No person shall violate any provision of section 1039, 1040 or 1046 of this title.

(e) No person shall—

(1) manufacture, cast, print, lithograph, or otherwise make any device containing any official mark or simulation thereof, or any label bearing any such mark or simulation, or any form of official certificate or simulation thereof, except as authorized by the Secretary;

(2) forge or alter any official device, mark, or certificate;

(3) without authorization from the Secretary, use any official device, mark, or certificate, or simulation thereof, or detach, deface, or destroy any official device or mark; or use any labeling or container ordered to be withheld from use under section 1036 of this title after final judicial affirmance of such order or expiration of the time for appeal if no appeal is taken under said section;

(4) contrary to the regulations prescribed by the Secretary, fail to use, or to detach, deface, or destroy any official device, mark, or certificate;

(5) knowingly possess, without promptly notifying the Secretary or his representative, any official device or any counterfeit, simulated, forged, or improperly altered official certificate or any device or label, or any eggs or egg products bearing any counterfeit, simulated, forged, or improperly altered official mark;

(6) knowingly make any false statement in any shipper's certificate or other nonofficial or official certificate provided for in the regulations prescribed by the Secretary;

(7) knowingly represent that any article has been inspected or exempted, under this chapter, when, in fact, it has, respectively, not been so inspected or exempted; and

(8) refuse access, at any reasonable time, to any representative of the Secretary of Agriculture or the Secretary of Health and Human Services, to any plant or other place of business subject to inspection under any provisions of this chapter.

(f) No person, while an official or employee of the United States Government or any State or local governmental agency, or thereafter, shall use to his own advantage, or reveal other than to the authorized representatives of the United States Government or any State or other government in their official capacity, or as ordered by a court in a judicial proceeding, any information acquired under the authority of this chapter concerning any matter which is entitled to protection as a trade secret.

(Pub. L. 91–597, §8, Dec. 29, 1970, 84 Stat. 1626; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102–237, title X, §1012(c), Dec. 13, 1991, 105 Stat. 1899.)

Editorial Notes

References in Text

This chapter, referred to in subsecs. (b)(1), (2), (e)(7), (8), and (f), was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Amendments

1991—Subsecs. (c) to (f). Pub. L. 102–237 added subsec. (c) and redesignated former subsecs. (c) to (e) as (d) to (f), respectively.

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in subsec. (e)(8) pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Effective Date of 1991 Amendment

Amendment by Pub. L. 102–237 effective 12 months after promulgation of final implementing regulations, see section 1012(h) of Pub. L. 102–237, set out as a note under section 1034 of this title.

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.
21 U.S.C. § 360ii (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360ii: Program of control
Program of control
Status: in_force

(a) Establishment

The Secretary shall establish and carry out an electronic product radiation control program designed to protect the public health and safety from electronic product radiation. As a part of such program, he shall—

(1) pursuant to section 360kk of this title, develop and administer performance standards for electronic products;

(2) plan, conduct, coordinate, and support research, development, training, and operational activities to minimize the emissions of and the exposure of people to, unnecessary electronic product radiation;

(3) maintain liaison with and receive information from other Federal and State departments and agencies with related interests, professional organizations, industry, industry and labor associations, and other organizations on present and future potential electronic product radiation;

(4) study and evaluate emissions of, and conditions of exposure to, electronic product radiation and intense magnetic fields;

(5) develop, test, and evaluate the effectiveness of procedures and techniques for minimizing exposure to electronic product radiation; and

(6) consult and maintain liaison with the Secretary of Commerce, the Secretary of Defense, the Secretary of Labor, the Atomic Energy Commission, and other appropriate Federal departments and agencies on (A) techniques, equipment, and programs for testing and evaluating electronic product radiation, and (B) the development of performance standards pursuant to section 360kk of this title to control such radiation emissions.

(b) Powers of Secretary

In carrying out the purposes of subsection (a), the Secretary is authorized to—

(1)(A) collect and make available, through publications and other appropriate means, the results of, and other information concerning, research and studies relating to the nature and extent of the hazards and control of electronic product radiation; and (B) make such recommendations relating to such hazards and control as he considers appropriate;

(2) make grants to public and private agencies, organizations, and institutions, and to individuals for the purposes stated in paragraphs (2), (4), and (5) of subsection (a) of this section;

(3) contract with public or private agencies, institutions, and organizations, and with individuals, without regard to section 3324 of title 31 and section 6101 of title 41; and

(4) procure (by negotiation or otherwise) electronic products for research and testing purposes, and sell or otherwise dispose of such products.

(c) Record keeping

(1) Each recipient of assistance under this part pursuant to grants or contracts entered into under other than competitive bidding procedures shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such assistance, the total cost of the project or undertaking in connection with which such assistance is given or used, and the amount of that portion of the cost of the project or undertaking supplied by other sources, and such other records as will facilitate an effective audit.

(2) The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the recipients that are pertinent to the grants or contracts entered into under this part under other than competitive bidding procedures.

(June 25, 1938, ch. 675, §532, formerly act July 1, 1944, ch. 373, title III, §532, formerly §356, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1174; renumbered §532 and amended Pub. L. 101–629, §19(a)(1)(B), (2)(A), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

Editorial Notes

Codification

In subsec. (b)(3), "section 6101 of title 41" substituted for "section 3709 of the Revised Statutes of the United States (41 U.S.C. 5)" on authority of Pub. L. 111–350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

Section was classified to section 263d of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.

Amendments

1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, §19(a)(4), which renumbered section 263d of Title 42, The Public Health and Welfare, as this section.

1990—Subsec. (a)(1), (6). Pub. L. 101–629, §19(a)(2)(A)(i), substituted "section 360kk" for "section 263f".

Subsec. (b)(3). Pub. L. 101–629, §19(a)(2)(A)(ii), substituted reference to section 3324 of title 31 for reference to section 3648 of the Revised Statutes (31 U.S.C. 529).

Subsec. (c)(1), (2). Pub. L. 101–629, §19(a)(1)(B), substituted "this part" for "this subpart".

Statutory Notes and Related Subsidiaries

Transfer of Functions

Atomic Energy Commission abolished and functions transferred by sections 5814 and 5841 of Title 42, The Public Health and Welfare. See also Transfer of Functions notes set out under those sections.

Noninterference With Other Federal Agencies

Enactment of this section not to be construed to supersede or limit the functions under any other provision of law or any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.