DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

Office of Public Affairs

5600 Fishers Lane

Rockville, MD 20857

Publication No. FS 01-1

FDA Web site: www.fda.gov

Revised: February 2002

FDA Protects the

Public Health;

Ranks High in Public Trust

The United States Food and

Drug Administration, an agency

that protects the health of the

American people, is one of the

most successful and proudest

creations of the American

democracy. The FDA’s origins go

back to the start of the 20th

century, when revelations about

filth in the Chicago stockyards

shocked the nation into awareness

that, in an industrial economy,

protection against unsafe products

is beyond any individual’s means.

The U.S. Congress responded to

Upton Sinclair’s best-selling The

Jungle by passing the Food and

Drugs Act of 1906 that prohibited

interstate commerce in

misbranded and adulterated food

and drugs. Enforcement of the law

was entrusted to the U.S.

Department of Agriculture’s

Bureau of Chemistry, which later

became the FDA.

The Act was the first of more

than 200 laws that constitute one

of the world’s most comprehensive and effective networks of

public health and consumer

protections. Here are a few of the

congressional milestones:

• The Federal Food, Drug, and

Cosmetic Act of 1938 was passed

after a legally marketed toxic

elixir killed 107 people, including

many children. The FD&C Act

completely overhauled the public

health system. Among other

provisions, the law authorized the

FDA to demand evidence of safety

for new drugs, issue standards for

food, and conduct factory

inspections.

• The Kefauver-Harris

Amendments of 1962, which

were inspired by the thalidomide

tragedy in Europe (and the FDA’s

vigilance that prevented the drug’s

marketing in the United States),

strengthened the rules for drug

safety and required manufacturers

to prove their drugs’ effectiveness.

• The Medical Device

Amendments of 1976 followed a

U.S. Senate finding that faulty

medical devices had caused

10,000 injuries, including 731

deaths. The law applied safety and

effectiveness safeguards to new

devices.

Today, the FDA regulates $1

trillion worth of products a year. It

ensures the safety of all food

except for meat, poultry and some

egg products; ensures the safety

and effectiveness of all drugs,

biological products (including

blood, vaccines and tissues for

transplantation), medical devices,

and animal drugs and feed; and

makes sure that cosmetics and

medical and consumer products

that emit radiation do no harm.

In the wake of the terrorist

attacks on September 11, 2001, the

FDA has also been entrusted with

two critical functions in the

Nation’s war on terrorism: to

prevent the willful contamination

of all regulated products, including

food, and improve the availability

of medications to prevent or treat

injuries caused by biological,

chemical or nuclear agents.

Stakeholders Trust FDA

In a 1999 nationwide survey by the

Pew Research Center and Princeton

Survey Research Associates, the

FDA received an overall favorable

rating of over 80 percent, more than

twice the approval rate of the entire

government. The pollsters noted

that “The FDA is unique among

the agencies we studied for how

similarly—and highly—its very

different customers rate its

performance. Regulated industry

as well as medical professionals,

advocates and the chronically ill

all credit the FDA for making a

positive contribution to the safety

of the Nation’s food, drugs and

other medical products.”