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21 U.S.C. § 393 — Food and Drug Administration
Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** There is established in the Department of Health and Human Services the Food and Drug Administration (hereinafter in this section referred to as the “Administration”).
**(b) Mission** The Administration shall—
(1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner;
(2) with respect to such products, protect the public health by ensuring that—
(A) foods are safe, wholesome, sanitary, and properly labeled;
(B) human and veterinary drugs are safe and effective;
(C) there is reasonable assurance of the safety and effectiveness of devices intended for human use;
(D) cosmetics are safe and properly labeled; and
(E) public health and safety are protected from electronic product radiation;
(3) participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and
(4) as determined to be appropriate by the Secretary, carry out paragraphs (1) through (3) in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products.
**(c) Interagency collaboration** The Secretary shall implement programs and policies that will foster collaboration between the Administration, the National Institutes of Health, and other science-based Federal agencies, to enhance the scientific and technical expertise available to the Secretary in the conduct of the duties of the Secretary with respect to the development, clinical investigation, evaluation, and postmarket monitoring of emerging
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Source location: Title 21, Chapter 9, § 393; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) In general** There is established in the Department of Health and Human Services the Food and Drug Administration (hereinafter in this section referred to as the “Administration”).
**(b) Mission** The Administration shall—
(1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner;
(2) with respect to such products, protect the public health by ensuring that—
(A) foods are safe, wholesome, sanitary, and properly labeled;
(B) human and veterinary drugs are safe and effective;
(C) there is reasonable assurance of the safety and effectiveness of devices intended for human use;
(D) cosmetics are safe and properly labeled; and
(E) public health and safety are protected from electronic product radiation;
(3) participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and
(4) as determined to be appropriate by the Secretary, carry out paragraphs (1) through (3) in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products.
**(c) Interagency collaboration** The Secretary shall implement programs and policies that will foster collaboration between the Administration, the National Institutes of Health, and other science-based Federal agencies, to enhance the scientific and technical expertise available to the Secretary in the conduct of the duties of the Secretary with respect to the development, clinical investigation, evaluation, and postmarket monitoring of emerging medical therapies, including complementary therapies, and advances in nutrition and food science.
**(d) Commissioner**
(1) **Appointment** — There shall be in the Administration a Commissioner of Food and Drugs (hereinafter in this section referred to as the “Commissioner”) who shall be appointed by the President by and with the advice and consent of the Senate.
(2) **General powers** — The Secretary, through the Commissioner, shall be responsible for executing this chapter and for—
(A) providing overall direction to the Food and Drug Administration and establishing and implementing general policies respecting the management and operation of programs and activities of the Food and Drug Administration;
(B) coordinating and overseeing the operation of all administrative entities within the Administration;
(C) research relating to foods, drugs, cosmetics, devices, and tobacco products in carrying out this chapter;
(D) conducting educational and public information programs relating to the responsibilities of the Food and Drug Administration; and
(E) performing such other functions as the Secretary may prescribe.
**(e) Technical and scientific review groups** The Secretary through the Commissioner of Food and Drugs may, without regard to the provisions of title 5 governing appointments in the competitive service and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, establish such technical and scientific review groups as are needed to carry out the functions of the Administration, including functions under this chapter, and appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups.
**(f) Agency plan for statutory compliance**
(1) **In general** — Not later than 1 year after November 21, 1997, the Secretary, after consultation with appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry, shall develop and publish in the Federal Register a plan bringing the Secretary into compliance with each of the obligations of the Secretary under this chapter. The Secretary shall review the plan biannually and shall revise the plan as necessary, in consultation with such persons.
(2) **Objectives of agency plan** — The plan required by paragraph (1) shall establish objectives and mechanisms to achieve such objectives, including objectives related to—
(A) maximizing the availability and clarity of information about the process for review of applications and submissions (including petitions, notifications, and any other similar forms of request) made under this chapter;
(B) maximizing the availability and clarity of information for consumers and patients concerning new products;
(C) implementing inspection and postmarket monitoring provisions of this chapter;
(D) ensuring access to the scientific and technical expertise needed by the Secretary to meet obligations described in paragraph (1);
(E) establishing mechanisms, by July 1, 1999, for meeting the time periods specified in this chapter for the review of all applications and submissions described in subparagraph (A) and submitted after November 21, 1997; and
(F) eliminating backlogs in the review of applications and submissions described in subparagraph (A), by January 1, 2000.
**(g) Annual report** The Secretary shall annually prepare and publish in the Federal Register and solicit public comment on a report that—
(1) provides detailed statistical information on the performance of the Secretary under the plan described in subsection (f);
(2) compares such performance of the Secretary with the objectives of the plan and with the statutory obligations of the Secretary; and
(3) identifies any regulatory policy that has a significant negative impact on compliance with any objective of the plan or any statutory obligation and sets forth any proposed revision to any such regulatory policy.
**(h) Annual report regarding food** Not later than February 1 of each year, the Secretary shall submit to Congress a report, including efforts to coordinate and cooperate with other Federal agencies with responsibilities for food inspections, regarding—
(1) information about food facilities including—
(A) the appropriations used to inspect facilities registered pursuant to [section 350d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350d&num=0&edition=prelim) in the previous fiscal year;
(B) the average cost of both a non-high-risk food facility inspection and a high-risk food facility inspection, if such a difference exists, in the previous fiscal year;
(C) the number of domestic facilities and the number of foreign facilities registered pursuant to [section 350d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350d&num=0&edition=prelim) that the Secretary inspected in the previous fiscal year;
(D) the number of domestic facilities and the number of foreign facilities registered pursuant to [section 350d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350d&num=0&edition=prelim) that were scheduled for inspection in the previous fiscal year and which the Secretary did not inspect in such year;
(E) the number of high-risk facilities identified pursuant to [section 350j of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350j&num=0&edition=prelim) that the Secretary inspected in the previous fiscal year; and
(F) the number of high-risk facilities identified pursuant to [section 350j of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350j&num=0&edition=prelim) that were scheduled for inspection in the previous fiscal year and which the Secretary did not inspect in such year.
(2) information about food imports including—
(A) the number of lines of food imported into the United States that the Secretary physically inspected or sampled in the previous fiscal year;
(B) the number of lines of food imported into the United States that the Secretary did not physically inspect or sample in the previous fiscal year; and
(C) the average cost of physically inspecting or sampling a line of food subject to this chapter that is imported or offered for import into the United States; and
(3) information on the foreign offices of the Food and Drug Administration including—
(A) the number of foreign offices established; and
(B) the number of personnel permanently stationed in each foreign office.
**(i) Public availability of annual food reports** The Secretary shall make the reports required under subsection (h) available to the public on the Internet Web site of the Food and Drug Administration.
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Federal law — U.S. Code and appendices · legal_authorities
For purposes of this subpart:
(1) The term “human drug application” means an application for—
(A) approval of a new drug submitted under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim), or
(B) licensure of a biological product under subsection (a) of [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim).
Such term does not include a supplement to such an application, does not include an application with respect to whole blood or a blood component for transfusion, does not include an application with respect to a bovine blood product for topical application licensed before September 1, 1992, does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to an in vitro diagnostic biologic product licensed under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), does not include an application with respect to a large volume parenteral drug product approved before September 1, 1992, does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distribute
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 379g
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Identification and inspection of facilities**
(1) **Identification** — The Secretary shall identify high-risk facilities and shall allocate resources to inspect facilities according to the known safety risks of the facilities, which shall be based on the following factors:
(A) The known safety risks of the food manufactured, processed, packed, or held at the facility.
(B) The compliance history of a facility, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards.
(C) The rigor and effectiveness of the facility’s hazard analysis and risk-based preventive controls.
(D) Whether the food manufactured, processed, packed, or held at the facility meets the criteria for priority under [section 381(h)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/h/1&num=0&edition=prelim).
(E) Whether the food or the facility that manufactured, processed, packed, or held such food has received a certification as described in section 381(q) or 384b of this title, as appropriate.
(F) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.
(2) **Inspections**
(A) *In general* — Beginning on January 4, 2011, the Secretary shall increase the frequency of inspection of all facilities.
(B) *Domestic high-risk facilities* — The Secretary shall increase the frequency of inspection of domestic facilities identified under paragraph (1) as high-risk facilities such that each such facility is inspected—
(i) not less often than once in the 5-year period following January 4, 2011; and
(ii) not less often than once every 3 years thereafter.
(C) *Domestic non-high-risk facilities* — The Secretary sha
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 350j
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Registration**
(1) **In general** — The Secretary shall by regulation require that any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States be registered with the Secretary. To be registered—
(A) for a domestic facility, the owner, operator, or agent in charge of the facility shall submit a registration to the Secretary; and
(B) for a foreign facility, the owner, operator, or agent in charge of the facility shall submit a registration to the Secretary and shall include with the registration the name of the United States agent for the facility.
(2) **Registration** — An entity (referred to in this section as the “registrant”) shall submit a registration under paragraph (1) to the Secretary containing information necessary to notify the Secretary of the name and address of each facility at which, and all trade names under which, the registrant conducts business, the e-mail address for the contact person of the facility or, in the case of a foreign facility, the United States agent for the facility, and, when determined necessary by the Secretary through guidance, the general food category (as identified under section 170.3 of title 21, Code of Federal Regulations, or any other food categories as determined appropriate by the Secretary, including by guidance) of any food manufactured, processed, packed, or held at such facility. The registration shall contain an assurance that the Secretary will be permitted to inspect such facility at the times and in the manner permitted by this chapter. The registrant shall notify the Secretary in a timely manner of changes to such information.
(3) **Biennial registration renewal** — During the period beginning on October 1 and ending on December 31 of each even-numb
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 350d
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Federal law — U.S. Code and appendices · legal_authorities
For the purposes of this chapter—
**(a)**
(1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.
(2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.
**(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.
**(c)** The term “Department” means Department of Health and Human Services.
**(d)** The term “Secretary” means the Secretary of Health and Human Services.
**(e)** The term “person” includes individual, partnership, corporation, and association.
**(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
**(g)**
(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 321
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Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** A tobacco product shall be deemed to be misbranded—
(1) if its labeling is false or misleading in any particular;
(2) if in package form unless it bears a label containing—
(A) the name and place of business of the tobacco product manufacturer, packer, or distributor;
(B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;
(C) an accurate statement of the percentage of the tobacco used in the product that is domestically grown tobacco and the percentage that is foreign grown tobacco; and
(D) the statement required under [section 387t(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387t/a&num=0&edition=prelim),
except that under subparagraph (B) reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary;
(3) if any word, statement, or other information required by or under authority of this subchapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, or designs in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
(4) if it has an established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name prominently printed in type as required by the Secretary by regulation;
(5) if the Secretary has issued regulations requiring that its labeling bear adequate directions for use, or adequate warnings against use by children, that are necessary for the protection of users unless its labeling conforms in all respects to such regula
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 387c
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Reports to Congress and President; preparation; review by Office of Management and Budget**
(1) Not later than March 15 of each year, the Secretary shall submit to the President and Congress the following reports:
(A) A report on health care costs and financing. Such report shall include a description and analysis of the statistics collected under [section 242k(b)(1)(G) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section242k/b/1/G&num=0&edition=prelim).
(B) A report on health resources. Such report shall include a description and analysis, by geographical area, of the statistics collected under [section 242k(b)(1)(E) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section242k/b/1/E&num=0&edition=prelim).
(C) A report on the utilization of health resources. Such report shall include a description and analysis, by age, sex, income, and geographic area, of the statistics collected under [section 242k(b)(1)(F) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section242k/b/1/F&num=0&edition=prelim).
(D) A report on the health of the Nation’s people. Such report shall include a description and analysis, by age, sex, income, and geographic area, of the statistics collected under [section 242k(b)(1)(A) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section242k/b/1/A&num=0&edition=prelim).
(2) The reports required in paragraph (1) shall be prepared through the National Center for Health Statistics.
(3) The Office of Management and Budget may review any report required by paragraph (1) of this subsection before its submission to Congress, but the Office may not revise any such report or delay its submission beyond
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 242m
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Federal law — U.S. Code and appendices · legal_authorities
Page 701
TITLE 21—FOOD AND DRUGS
§ 393
(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 para-
graph 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 chap-
ter 5 (§ 151 et seq.) of this title. For complete classifica-
tion 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, In-
ternal Revenue Code of 1939. Such chapter 17 was cov-
ered 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,
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 393
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