0541 21 USC 393d2

From the U.S. Code Online via GPO Access

[wais.access.gpo.gov]

[Laws in effect as of January 3, 2005]

[Document not affected by Public Laws enacted between

January 3, 2005 and August 11, 2006]

[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.