FOOD AND DRUG ADMINISTRATION
One of the oldest U.S. CONSUMER PROTECTION
agencies, the Food and Drug Administration
(FDA) protects the public from unsafe foods,
drugs, medical devices, cosmetics, and other
potential hazards. As part of the DEPARTMENT
OF HEALTH AND HUMAN SERVICES, the FDA
annually regulates over $1 trillion worth of
products, which account for one-fourth of all
consumer spending in the United States. It also
protects the rights and safety of patients in clin-
ical trials of new medical products,monitors the
promotional activities of drug and device man-
ufacturers, regulates the labeling of all packaged
foods, and monitors the safety of the nation’s
blood supply.
To ensure compliance with its regulations,
the FDA employs over 1,000 investigators and
inspectors who visit over 15,000 food-process-
ing, drug-manufacturing, and other facilities
each year. If it finds violations of law, the FDA
first encourages an offending company to vol-
untarily correct the problem or to recall a faulty
product from the market. If the firm does not
voluntarily comply with the law, the FDA may
take it to court and seek criminal penalties
against it. The FDA may also seize faulty prod-
ucts, order product recalls, seek injunctive relief,
impose fines, and take other types of enforce-
ment action. Each year, the FDA declares about
3,000 products and 30,000 import shipments to
be unacceptable in various ways.
The FDA employs over 2,000 scientists—
including 900 chemists and 300 microbiolo-
gists—who provide the SCIENTIFIC EVIDENCE
to back up its regulatory and inspection duties.
These scientists analyze samples of products for
purity and review test results of new products.
The FDA itself does not do research for a new
medical product. Instead, it evaluates the results
of studies undertaken by the manufacturer.
History
Food production in the United States has
been regulated since the late eighteenth century.
Colonies and, later, states passed laws banning
impurities from selected foods. In 1848, the
United States began regulating imported drugs,
under the Drug Importation Act (Ch. LXX, 9
Stat. 237). The enforcement of food and drug
laws was first assigned to the Chemical Division
of the new U.S. DEPARTMENT OF AGRICULTURE
(USDA) in 1862 (12 Stat. 387).
The need for laws to regulate food and drug
purity became increasingly urgent in the late
nineteenth century, when substances such as
opium, cocaine, and heroin were commonly
added to medicinal elixirs and tonics. The need
for government regulation was also made evi-
dent in Upton Sinclair’s book, The Jungle, which
exposed the unsanitary conditions of Chicago’s
meatpacking industry and shocked the nation.
On June 30, 1906, Congress, with the support of
President THEODORE ROOSEVELT, passed two
