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."

Publication No. FS 01-1
Revised: February 2002

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