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Food and Drug Administration: Difference between revisions

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[[File:Portrait of Dr. Harvey W. Wiley (FDA 107) (8203830456).jpg|thumb|upright|[[Harvey W. Wiley]], chief advocate of the Food and Drug Act]]
[[File:Portrait of Dr. Harvey W. Wiley (FDA 107) (8203830456).jpg|thumb|upright|[[Harvey W. Wiley]], chief advocate of the Food and Drug Act]]


In June 1906, President [[Theodore Roosevelt]] signed into law the [[Pure Food and Drug Act|Pure Food and Drug Act of 1906]], also known as the "Wiley Act" after its chief advocate.<ref name="FDAHist"/><ref name=swann06/> The Act prohibited, under penalty of seizure of goods, the interstate transport of food that had been "adulterated".<ref name=swann06/> The Act applied similar penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength, quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the ''[[United States Pharmacopeia]]'' or the ''[[National Formulary]]''.<ref>{{cite web |url=https://www.fda.gov/opacom/laws/wileyact.htm |title=Laws Enforced by FDA | author = Office of the Commissioner |publisher=Food and Drug Administration |access-date=December 16, 2019 |archive-date=May 12, 2009 |archive-url=https://web.archive.org/web/20090512143516/http://www.fda.gov/opacom/laws/wileyact.htm |url-status=live}}</ref><ref name=swann06/>
In June 1906, President Theodore Roosevelt signed into law the [[Pure Food and Drug Act|Pure Food and Drug Act of 1906]], also known as the "Wiley Act" after its chief advocate.<ref name="FDAHist"/><ref name=swann06/> The Act prohibited, under penalty of seizure of goods, the interstate transport of food that had been "adulterated".<ref name=swann06/> The Act applied similar penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength, quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the ''[[United States Pharmacopeia]]'' or the ''[[National Formulary]]''.<ref>{{cite web |url=https://www.fda.gov/opacom/laws/wileyact.htm |title=Laws Enforced by FDA | author = Office of the Commissioner |publisher=Food and Drug Administration |access-date=December 16, 2019 |archive-date=May 12, 2009 |archive-url=https://web.archive.org/web/20090512143516/http://www.fda.gov/opacom/laws/wileyact.htm |url-status=live}}</ref><ref name=swann06/>


The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry.<ref name="FDAHist"/> Wiley used these new regulatory powers to pursue an aggressive campaign against the manufacturers of foods with chemical additives, but the Chemistry Bureau's authority was soon checked by judicial decisions, which narrowly defined the bureau's powers and set high standards for proof of fraudulent intent.<ref name="FDAHist"/> In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide Administration.<ref>{{Cite web |date=March 14, 2019 |title=History of FDA's Internal Organization |url=https://www.fda.gov/about-fda/history-fdas-fight-consumer-protection-and-public-health/history-fdas-internal-organization |access-date=October 3, 2020 |website=U.S. Food and Drug Administration |language=en |archive-date=September 24, 2020 |archive-url=https://web.archive.org/web/20200924220535/https://www.fda.gov/about-fda/history-fdas-fight-consumer-protection-and-public-health/history-fdas-internal-organization |url-status=live }}</ref> This name was shortened to the Food and Drug Administration (FDA) three years later.<ref name="milestones">{{cite web |url=https://www.fda.gov/opacom/backgrounders/miles.html |title=Milestones in U.S. Food and Drug Law History |website=Food and Drug Administration |access-date=December 16, 2019 |archive-date=May 21, 2009 |archive-url=https://web.archive.org/web/20090521181634/http://www.fda.gov/opacom/backgrounders/miles.html |url-status=live}}</ref>
The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry.<ref name="FDAHist"/> Wiley used these new regulatory powers to pursue an aggressive campaign against the manufacturers of foods with chemical additives, but the Chemistry Bureau's authority was soon checked by judicial decisions, which narrowly defined the bureau's powers and set high standards for proof of fraudulent intent.<ref name="FDAHist"/> In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide Administration.<ref>{{Cite web |date=March 14, 2019 |title=History of FDA's Internal Organization |url=https://www.fda.gov/about-fda/history-fdas-fight-consumer-protection-and-public-health/history-fdas-internal-organization |access-date=October 3, 2020 |website=U.S. Food and Drug Administration |language=en |archive-date=September 24, 2020 |archive-url=https://web.archive.org/web/20200924220535/https://www.fda.gov/about-fda/history-fdas-fight-consumer-protection-and-public-health/history-fdas-internal-organization |url-status=live }}</ref> This name was shortened to the Food and Drug Administration (FDA) three years later.<ref name="milestones">{{cite web |url=https://www.fda.gov/opacom/backgrounders/miles.html |title=Milestones in U.S. Food and Drug Law History |website=Food and Drug Administration |access-date=December 16, 2019 |archive-date=May 21, 2009 |archive-url=https://web.archive.org/web/20090521181634/http://www.fda.gov/opacom/backgrounders/miles.html |url-status=live}}</ref>
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