by: Kevin Bogert, President of GxP Partners, LLC
This content highlights the history of the Food, Drug and Cosmetic Act from the Food and Drug Act of 1906 to the major amendments to the FDC Act of 1938.
In 1883 Harvey Washington Wiley, Chief Chemist of the Bureau of Chemistry at the U.S. Department of Agriculture, became the main crusader of food standards. The concerns related to the adulteration and misbranding of foods embolden him to form the famous "Poison Squad," which tested the safety of preservatives in food. Wiley's quest for food standards did not become a national issue however until the publication of the 1906 Upton Sinclair's novel "The Jungle." This novel detailed the conditions of a Chicago meat packing plant and was the force behind both a meat inspection law and a comprehensive food and drug law.
In 1906, then President Roosevelt signed on the same day both the Food and Drug Act and the Meat Inspection Act, which constituted the first federal regulations of food and drugs. The Food and Drug Act prohibited the interstate transport of misbranded and adulterated foods, drink and drugs. The law prohibited the addition of any ingredients that would substitute for the food, conceal damage, pose a health hazard or constitute a filthy or decomposed substance. Attempts to change the law were unsuccessful until the elixir Sulfanilamide incident of 1937.
On June 25, 1938 President Franklin D. Roosevelt signed the Food, Drug and Cosmetic Act into law. This Act, in response to a public outcry over the death of 107 people, brought cosmetics and medical devices under control. It required that drugs be labeled with adequate directions for safe use. The Act mandated scientific proof of safety for new drugs before those drugs could be marketed and prohibited false therapeutic claims for drugs. The Act also corrected abuses in food packaging and quality and introduced authority for factory inspections and federal court injunctions against violations1-2.
In 1951, the Durham-Humphrey Amendment resolved what constituted prescription and over-the-counter drugs. In 1962, the Kefauver-Harris Amendments were made into law to address the safety requirements for testing on human subjects. It also required that patients be informed if they are taking a drug that is experimental; that the manufacturer must report to the United States Food and Drug Administration (FDA) any adverse effects of drug use found during clinical trials, that new drugs be proven effective as well as safe, that the drug label carry common or generic names of the product as well as brand names and that prescription drug advertisements to physicians list the side effects of a drug as well as its benefits3.
Finally, the Medical Device Amendments of 1976 was a significant change in that it gave the FDA authority to regulate medical devices for safety and effectiveness. This amendment broke devices into three classes based on risk and the amount of control required. Many more amendments have and continue to be enacted based on the ever changing complexity of the products being developed.
Kevin Bogert is currently President of GxP Partners, LLC. He has become an information technology, project management, quality systems and validation expert during more than 20 years holding leadership roles within the pharmaceutical industry, in positions for the U.S. Air Force and the U.S. Naval Postgraduate School, and as an independent consultant. His background includes statistics, quality systems, and computer and process validation. Kevin was president of Valtrain, Inc., a company that provided regulatory-compliant learning management solutions and validation services to the pharmaceutical industry and that co-founded GxP Partners.
Kevin holds a master's degree in Systems Management from Golden Gate University, a bachelor's degree in Business Management from University of Maryland and is currently pursuing a master degree in Regulatory Affairs from Northeastern University. He has also completed numerous certificate programs and coursework in data processing, quality management, and applied statistics. Kevin has served on the PhRMA Statistics and Validation Committees, the SAS Users Group, and as a member of the American Society for Quality Control. He is certified as a PMI Project Management Professional. Email: email@example.com or by phone at 215.752.8699