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U.S. Department of Health and Human Services

About FDA

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This Week In FDA History - June 30, 1906 and June 25, 1938

Photo with caption
 
Harvey W. Wiley, M.D., was a crusader for a national food and drug law, earning him the title of "Father of the Pure Food and Drugs Act" when it became law in 1906.
  Photo with caption
 
President Franklin D. Roosevelt signed the Federal Food, Drug, and Cosmetic Act into law in 1938.
June 30, 1906 and
June 25, 1938:
In a week of landmark anniversaries, the Food and Drug Administration celebrates the passage of the Pure Food and Drugs Act in 1906 and the Federal Food, Drug, and Cosmetic Act in 1938. These two laws played a major role in the evolution of food and drug law in the United States and dramatically strengthened protections for American consumers.
FDA in 2006

Both laws came about following events that raised public and congressional awareness of deficiencies in laws at the time. The 1906 act passed following a public outcry over revelations of deplorable conditions in the nation's meat-packing plants revealed in Upton Sinclair's The Jungle.  It defined for the first time in a federal statute the terms "misbranding" and "adulteration" and provided penalties for each. It also transformed the FDA's predecessor, the Bureau of Chemistry, from a scientific bureau to a regulatory agency.
The 1938 act followed a therapeutic disaster--over 100 tragic deaths associated with an untested medicine, Elixir Sulfanilamide. The regulatory authorities granted for the first time by this law, and still in effect today, include enforcement of the requirement that drugs must be proven safe before marketing, regulation of cosmetics and therapeutic devices, the setting of "tolerances" (maximum allowed levels) for unavoidable harmful substances, and setting of standards of identity, quality, and fill-of-container for foods.