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Protecting and Promoting Public Health

For the past 100 years, the health of Americans and their confidence in the quality of their food and medicines have been protected by a sophisticated public health system that ensures the quality of food, drugs, vaccines, and medical equipment.

The development of these protections goes back to 1906, when Congress entrusted the Bureau of Chemistry of the U.S. Department of Agriculture with the implementation of the Food and Drugs Act, the first federal law to regulate food and drugs in interstate commerce. The bureau later became the Food and Drug Administration, an agency of the Department of Health and Human Services.

Since then, Congress has expanded the FDA's regulatory role over products that represent more than 20 percent of U.S. consumer spending and that are used daily by most Americans. The FDA is responsible for ensuring that human and animal medications, blood products, tissues for transplantation, and medical devices are safe and effective; that food and dietary supplements are safe and truthfully labeled; and that animal feed, cosmetics, and radiation-emitting equipment do no harm.

To fulfill its mission, the FDA has created a science-based system of product standards and requirements that is recognized worldwide as second to none.

Years of Growth

1906-1938: The Bureau of Chemistry and the FDA use their limited powers to protect consumers from adulterated and misbranded foods and drugs.

1938-1962: The FDA carries out major expansion under the Food, Drug, and Cosmetic Act of 1938 (FD&C Act), which includes a requirement that new drugs be shown to be safe prior to marketing and that authorizes high standards for foods.

1962-1976: The FDA expands its drug review system to require clinical evidence of effectiveness prior to marketing, as mandated by the Kefauver-Harris Amendments to the FD&C Act. The agency prevents the marketing of thalidomide, a sedative that caused thousands of birth defects in Europe.

1968-1977: The FDA acts to ensure the safety of microwave ovens and other radiation-emitting equipment, and begins requiring evidence of safety and effectiveness for medical devices.

1972: The federal component regulating vaccines, sera, and blood products is moved into the FDA.

Years of Achievement

1987: The FDA approves AZT, the first effective treatment for HIV/AIDS.

1990-1992: The FDA works with consumer groups and industry to develop new nutrition labeling for foods, which is enacted by Congress.

1990: The FDA is a founding party to the International Conference on Harmonization, which helps develop globally acceptable standards for various aspects of drug development.

1992: The FDA, Congress, and industry agree on user fees that enable the agency to double the efficiency of its drug reviews without compromising its standards.

1997: The FDA strengthens animal feed safeguards to help prevent the widespread dissemination of “mad cow disease” in the U.S. cattle herd.

2002: The FDA is charged with helping to secure the nation's food supply from unintentional and intentional contamination (bioterrorism).

2003-2005: The FDA launches reforms to help increase the availability of generic drugs, modernize drug manufacturing, and strengthen the safety of marketed medicines.

The Next Century

Together with other researchers, FDA experts are using state-of-the-art sciences to advance product development and precise diagnosis of diseases. FDA scientists also are working to create novel means for delivering medicines and to find treatments for diseases and conditions that today have no cure.

As part of those efforts the FDA is carrying out its innovative "Critical Path" initiative to transform medical product development and to pave the way for medical advances that will emerge from research labs during the 21st century.

Equally important during the FDA’s next century will be the advancement of public health through the enhancement of both the safety and security, as well as the quality, of the foods we eat. Building on its century-old tradition, the FDA is using its regulatory powers and scientific prowess not only to enforce product standards, but also to facilitate scientific progress to advance public health in the United States and around the world.

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