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The Food And Drug Administration: A Brief History - Trusted Senior Specialists

04/08/2020 | 05:00 AM | 12 Min Read
The Food And Drug Administration: A Brief History - Trusted Senior Specialists

Up until the 20th century, there were few federal laws imposed to help regulate the contents and sale of domestically produced food and pharmaceuticals. (One exception being the short-lived Vaccine Act of 1813)  A patchwork of state laws provided varying degrees of protection against unethical sales practices, such as misrepresenting the ingredients of food products or therapeutic substances. Even though the states were expected to exercise principal control over domestically produced food and drugs there were remarkable inconsistencies from state to state.  

The history of the FDA can be traced back to the latter part of the 19th century and to the US Department of Agriculture’s Division of Chemistry, later known as the Bureau of Chemistry.  Under the guidance of Harvey Washington Wiley, the appointed chief chemist in 1883, the Division of Chemistry started doing research into the contamination and mis-branding of food and medications in the American marketplace.  Although at the time the Division of Chemistry had no real regulatory powers they published their findings from 1887 to 1902 in a ten-part series entitled Foods and Food Adulterants. These findings helped spur public outcry and concern over this very troubling issue.  Willey used these finding to help create alliances with diverse organizations such as state chemists and food and drug inspectors, the General Federation of Women’s Clubs, and national associations of physicians and pharmacists to help lobby for a new federal law to set uniform standards for food and drugs to enter into interstate commerce.  

It was in June of 1906 when President Theodore Roosevelt signed into law the Food and Drug Act, also known as the “Wiley Act” after its chief advocate.  This act, which the Bureau of Chemistry was charged to administer, prohibited the interstate transport of unlawful food and drugs under penalty of seizure of the questionable products and/or prosecution of the responsible parties. The basis of the law rested on the regulation of product labeling rather than any pre-market approval. Drugs, defined in accordance with the standards of strength, quality, and purity in the United States Pharmacopoeia and the National Formulary,could not be sold in any other condition unless the specific variations from applicable standards were plainly stated on the label. Foods were not defined according to similar standards, but the law prohibited the addition of any ingredients that would substitute for food, would conceal, damage, pose a health hazard, or constitute a filthy or decomposed substance. Interpretations of the food provisions in the law led to many court battles. If the manufacturer opted to list the weight or measurement of a food, this had to be done accurately. As well as the food or drug label could not be false or misleading in any way, and the presence and amount of eleven dangerous ingredients, including alcohol, heroin, and cocaine, had to be listed.  The bureau’s focus at the time of Wiley’s authority was, for the most part, centered on food, which he thought to be a greater public health problem than adulterated or mis-branded drugs.  After Wiley’s resignation in 1912, the bureau devoted more effort to drug regulation.

With the election of Franklin Roosevelt in 1930 the FDA now had a receptive ear to petition for much needed changes in the law.  They felt there needed to be changes in prohibition of false therapeutic claims for drugs, coverage of cosmetics and medical devices, clarification of the FDA’s right to conduct factory inspections, and control of product advertising.  A new generation of consumer protection organizations and journalists aided in pushing a reluctant Congress to sponsor a bill to replace the old law.  The bill languished in Congress for 5 years until a Tennessee drug company marketed a form of the new sulfa wonder drug that would appeal to pediatric patients, Elixir Sulfanilamide. However, the solvent in this untested product was a highly toxic chemical analogue of antifreeze; and over 100 people died, many of those being children. The public outrage not only helped reshape the drug provisions of the new law to prevent such an event from happening again, it propelled the bill itself through Congress. FDR signed the Food, Drug, and Cosmetic Act on 25 June 1938.

This new law brought cosmetics and medical devices under control, and it required that drugs be labeled with adequate directions for safe use. In addition to, it mandated pre-market approval of all new drugs, such that the manufacturer would have to prove to FDA that a drug is safe before it could be sold. It prohibited false therapeutic claims for drugs, although a separate law granted the Federal Trade Commission jurisdiction over drug advertising. The act also corrected the abuses in quality and food packaging, and it mandated legally enforceable food standards. Tolerances for certain poisonous substances were addressed. The law formally authorized factory inspections, and it added injunctions to the enforcement tools at the agency’s disposal.

The FDA and its responsibilities have gone through quite an evolution since 1906, yet the core public health mission of the agency remains the same now as it did then, and that is for the protection of the people.  Below is the mission statement of the FDA for further reading.  

FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

Finally, FDA plays a significant role in the Nation’s counter terrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

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