U.S. flag An official website of the United States government
  1. Home
  2. About FDA
  3. FDA History
  4. Changes in Science, Law and Regulatory Authorities
  1. FDA History

Changes in Science, Law and Regulatory Authorities

FDA's Predecessors

In his 1837 annual report, Patent Commissioner Henry L. Ellsworth recommended a national agency for the encouragement of agriculture. Congress responded in 1839 by an appropriation of $1000 to the Commissioner of Patents for “the collection of agricultural statistics, and for other agricultural purposes.” From then on, the Patent Office collected and reported agricultural statistics, sponsored or conducted chemical investigations on agricultural matters, monitored agricultural developments, and reported on all of these in its annual reports.  Beginning in 1849, a separate report was made by the Patent Commissioner to Congress on agricultural matters. An Agricultural Division was established in the Patent Office and a chemical laboratory was created in that Division. 

When the U.S. Department of Agriculture was created in 1862, the Patent Office's Agricultural Division was transferred to the new Department, becoming the Division of Chemistry in 1890 and the Bureau of Chemistry in 1901. In 1927, the Bureau of Chemistry became the United States Food, Drug and Insecticide Administration, and in 1930 the name was shortened to the U.S. Food and Drug Administration.  Ten years later, in 1940, the FDA was transferred from the U.S. Department of Agriculture to the newly created Federal Security Agency, which was renamed the Department of Health Education and Welfare in 1953, and again renamed the Department of Health and Human Services in 1979.

Brief Organizational History

Since its beginnings as the USDA's Bureau of Chemistry, FDA's institutional organization has changed significantly.  In 1914, FDA's field offices were organized into three districts -- Eastern, Central and Western--with a total of 16 field laboratories (later renamed "stations") organized underneath them.  This general structure remained more or less the same until 1948 when in a general move towards greater centralization, the field offices began reporting to a headquarters office, the Division of Field Operations. 

In the 1950s and 60s, the Agency's activities were organized under a number of different Bureaus that typically reflected the expertise of the staff -- e.g., the Bureau of Biological and Physical Sciences, the Bureau of Enforcement, the Bureau of Field Administration, the Bureau of Medicine, the Bureau of Foods, the Bureau of Veterinary Medicine, the Bureau of Drug Abuse Control, the Bureau of Regulatory Compliance and the Bureau of Education and Voluntary Compliance. 

In 1968, the field operations were reorganized under the leadership of Regional Food and Drug Directors, and the Department of Health, Education, and Welfare transferred some of FDA's product safety, environmental health and consumer education functions to the newly created Consumer Protection and Environmental Health Service (CPEHS). When CPEHS was dissolved in 1970, many of these functions were transferred back to the FDA, and were reincorporated as the Agency reorganized along product lines under the Bureau of Drugs, the Bureau of Foods and Pesticides, the Bureau of Veterinary Medicine, and the Bureau of Product Safety. 

By 1976, the FDA inherited regulatory authority over new product areas, stimulating the creation of four new Bureaus:  the Bureau of Biologics, the Bureau of Radiological Health, the Bureau of Medical Devices and the National Center for Toxicological Research.  In 1984, the "Bureaus" were all renamed "Centers," and at the same time, regulation of devices and radiological health were united in one center, as were drugs and biologics (though their union only lasted until 1987).

In 2009, pursuant to the enactment of the Family Smoking Prevention and Tobacco Control Act FDA was given regulatory control over tobacco products, and created its most recent center:  the Center for Tobacco Products.

Today, FDA is organized into eight centers with responsibility for regulating specific product areas, as well as a number of administrative and program offices under the Office of the Commissioner.  To learn more about FDA's current organizational framework, please consult the resources offered here: FDA Organization

Evolving Scientific Research and Regulatory Authorities

The FDA's authority to regulate products has changed significantly overtime.  The agency has inherited the responsibility to regulate new product areas and lost others.   New laws and court rulings have reshaped the FDA's powers over these product areas.  Transformations in the marketplace have created new regulatory challenges.  Advancements in science have provided new tools to protect the public health.  At times, public health crises have compelled urgent changes, and at other times, reform has taken places slowly through a length and controlled administrative process.  Through it all, FDA's steadfast commitment to protect the public health has remained at the core of all regulatory action.

Back to Top