§ 393. — Food and Drug Administration.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 21USC393]
TITLE 21--FOOD AND DRUGS
CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IX--MISCELLANEOUS
Sec. 393. Food and Drug Administration
(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, and
devices 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) of this
section;
(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.
(June 25, 1938, ch. 675, Sec. 903, as added Pub. L. 100-607, title V,
Sec. 503(a), Nov. 4, 1988, 102 Stat. 3121; amended Pub. L. 100-690,
title II, Sec. 2631, Nov. 18, 1988, 102 Stat. 4244; Pub. L. 105-115,
title IV, Secs. 406, 414, Nov. 21, 1997, 111 Stat. 2369, 2377.)
References in Text
The provisions of title 5 governing appointments in the competitive
service, referred to in subsec. (e), are classified generally to section
3301 et seq. of Title 5, Government Organization and Employees.
Codification
Another section 903 of the Federal Food, Drug, and Cosmetic Act was
renumbered section 904 and is classified to section 394 of this title.
Amendments
1997--Subsec. (b). Pub. L. 105-115, Sec. 406(a)(2), added subsec.
(b). Former subsec. (b) redesignated (d).
Subsec. (c). Pub. L. 105-115, Sec. 414, added subsec. (c). Former
subsec. (c) redesignated (e).
Subsecs. (d), (e). Pub. L. 105-115, Sec. 406(a)(1), redesignated
subsecs. (b) and (c) as (d) and (e), respectively.
Subsecs. (f), (g). Pub. L. 105-115, Sec. 406(b), added subsecs. (f)
and (g).
1988--Subsec. (b)(2). Pub. L. 100-690 substituted ``shall be
responsible for executing this chapter and for ``shall be responsible''.
Effective Date of 1997 Amendment
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21, 1997,
except as otherwise provided, see section 501 of Pub. L. 105-115, set
out as a note under section 321 of this title.
Effective Date
Section 503(c) of title V of Pub. L. 100-607 provided that:
``(1) Except as provided in paragraph (2), the amendments made by
this title [enacting this section and amending sections 5315 and 5316 of
Title 5, Government Organization and Employees] shall take effect on the
date of enactment of this Act [Nov. 4, 1988].
``(2) Section 903(b)(1) of the Federal Food, Drug, and Cosmetic Act
[21 U.S.C. 393(b)(1)] (as added by subsection (a) of this section) shall
apply to the appointments of Commissioners of Food and Drugs made after
the date of enactment of this Act.''
Regulations for Sunscreen Products
Section 129 of Pub. L. 105-115 provided that: ``Not later than 18
months after the date of enactment of this Act [Nov. 21, 1997], the
Secretary of Health and Human Services shall issue regulations for over-
the-counter sunscreen products for the prevention or treatment of
sunburn.''
FDA Study of Mercury Compounds in Drugs and Food
Section 413 of Pub. L. 105-115 provided that:
``(a) List and Analysis.--The Secretary of Health and Human Services
shall, acting through the Food and Drug Administration--
``(1) compile a list of drugs and foods that contain
intentionally introduced mercury compounds, and
``(2) provide a quantitative and qualitative analysis of the
mercury compounds in the list under paragraph (1).
The Secretary shall compile the list required by paragraph (1) within 2
years after the date of enactment of the Food and Drug Administration
Modernization Act of 1997 [Nov. 21, 1997] and shall provide the analysis
required by paragraph (2) within 2 years after such date of enactment.
``(b) Study.--The Secretary of Health and Human Services, acting
through the Food and Drug Administration, shall conduct a study of the
effect on humans of the use of mercury compounds in nasal sprays. Such
study shall include data from other studies that have been made of such
use.
``(c) Study of Mercury Sales.--
``(1) Study.--The Secretary of Health and Human Services, acting
through the Food and Drug Administration and subject to
appropriations, shall conduct, or shall contract with the Institute
of Medicine of the National Academy of Sciences to conduct, a study
of the effect on humans of the use of elemental, organic, or
inorganic mercury when offered for sale as a drug or dietary
supplement. Such study shall, among other things, evaluate--
``(A) the scope of mercury use as a drug or dietary
supplement; and
``(B) the adverse effects on health of children and other
sensitive populations resulting from exposure to, or ingestion
or inhalation of, mercury when so used.
In conducting such study, the Secretary shall consult with the
Administrator of the Environmental Protection Agency, the Chair of
the Consumer Product Safety Commission, and the Administrator of the
Agency for Toxic Substances and Disease Registry, and, to the extent
the Secretary believes necessary or appropriate, with any other
Federal or private entity.
``(2) Regulations.--If, in the opinion of the Secretary, the use
of elemental, organic, or inorganic mercury offered for sale as a
drug or dietary supplement poses a threat to human health, the
Secretary shall promulgate regulations restricting the sale of
mercury intended for such use. At a minimum, such regulations shall
be designed to protect the health of children and other sensitive
populations from adverse effects resulting from exposure to, or
ingestion or inhalation of, mercury. Such regulations, to the extent
feasible, should not unnecessarily interfere with the availability
of mercury for use in religious ceremonies.''
Management Activities Study
Pub. L. 102-571, title II, Sec. 205, Oct. 29, 1992, 106 Stat. 4502,
directed Comptroller General to conduct a study of management of
activities of the Food and Drug Administration that are related to
dietary supplements of vitamins, minerals, herbs, or other similar
nutritional substances and submit an interim report to Congress, not
later than 6 months after Oct. 29, 1992, with a final report to be
submitted not later than 12 months after Oct. 29, 1992.
Congressional Findings
Section 502 of Pub. L. 100-607 provided that: ``Congress finds
that--
``(1) the public health has been effectively protected by the
presence of the Food and Drug Administration during the last eighty
years;
``(2) the presence and importance of the Food and Drug
Administration must be guaranteed; and
``(3) the independence and integrity of the Food and Drug
Administration need to be enhanced in order to ensure the continuing
protection of the public health.''
Section Referred to in Other Sections
This section is referred to in sections 360m, 374 of this title.
