More than a century ago, Congress inaugurated federal regulation of foods and drugs. By today’s standards, the 1906 Act looked terribly anemic, running just five pages in length. Thirty years later, reacting to difficulties with enforcing the original statute (as tragically revealed by a series of fatalities caused by a product called Elixir sulfanilamide), Congress replaced it with the Food, Drug, and Cosmetic Act (FDCA). Although more comprehensive, the new statute continued to eschew details in favor of broad prohibitions against adulteration and misbranding. The original FDCA filled only fifteen pages in the U.S. Code. In the intervening years, Congress has both tinkered with the original language and appended brand new powers and requirements, so that the amended version of the FDCA in the latest edition of the U.S. Code occupies 230 pages. What started as a fairly simple regime of after-the-fact policing aimed at substandard foods and drugs has morphed into a complex set of product licensing requirements.
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