[source: Peter Barton Hutt, The Transformation of United States Food and Drug Law]
The FDA regulates a wide range of consumer products, including food, food additives, dietary supplements, human and animal drugs, medical devices, and cosmetics.
Our modern era of food and drug regulation began with the work of scientists and legislatures in the 19th century in England and America. Between 1850 and 1900 virtually every state enacted some form of food and drug statute.
When the United States Department of Agriculture (USDA) was created by Congress in 1862, the Chemical Laboratory was designated as the USDA Chemical Division. During the first 45 years of its existenc--from 1862 to 1906--FDA (defined broadly to include its predecessor agencies) had no statutes to enforce. The FDA initially conducted its business in accordance with its formal title, the Division of Chemistry. It analyzed the food supply and provided advice to other parts of te Department on all aspects of agriculural chemistry but did not engage with the states in establishing national regulatory policy.
In 1897, the National Board of Trade (the predecessor to our current United States Chamber of Commerce) adopted a resolution establshing $1,000 in prize money for the best three drafts of a national food adulteration statute. The winning draft (by George W. Winger) ultimately became part of the Federal Food and Drugs Act of 1906 and the Federal Food, Drug and Cosmetic Act of 1938 and still can be found in the law today. At the time, however, there was a powerful obstacle in theh way. A majority of Congress firmly believed that regulation of the manufacture and sale of food and drugs within the United States involved local matters that the Constitution left entirely to the states.
Regulation of biological products represents the oldest form of government regulation of business in our country. In fact, the FDA is our oldest federal regulatory agency, and for decades it was the only federal agency charged with jurisdiction over a broad range of consumer products. (The EPA, OSHA, CPSC are all of relatively recent origin, created during 1970-72).
In 1901 contaminated smallpox vaccine caused an outbreak of tetanus in Cambeden and a lot of tetanus-infected diphtheria antitoxin resulted in the death of several children in Saint Louis. Congress promptly enacted the Biologics Act of 1902. The 1902 Act represented a turning point in the history of food and drug regulation. For the first time in history, a statute required premarket approval by the government of a category of consumer products before any product within that category could be lawfully marketed. The 1902 Act required government approval of a product license application and an establishment license application for every biological drug intended for human use. A similar act wasn't passed for another fifty years.
For roughly the first half of its existence, until 1940, FDA remained a component of USDA. The agency was transferred to the Federal Security Agency in 1940 and to the Department of Health, Education and Welfare in 1953 (when it was formed), which later became the Department of Health and Human Services in 1979.
FDA regulates one-quarter (1/4) of the United States economy. Not long after the 1906 Act became law, the Supreme Court unanimously upheld it as a valid exercise of the power of Congress to regulate interstate commerce.
In 1997, Congress enacted the Food and Drug Administration Modernization Act (FDAMA), Pub. L. No. 105-115, 111 Stat. 2296, one of the most significant set of amendments to the 1938 law in decades.
