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Food and Drug Administration (view source)

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{{Organization
|OrganizationName=Food and Drug Administration
|OrganizationType=Executive Departments (Sub-organization)
|Mission=To protect public health by ensuring 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. It promotes public health by helping to speed innovations that make medicines more effective, safer, and more affordable, and by helping the public get accurate, science-based information.
|ParentOrganization=Department of Health and Human Services
|TopOrganization=Department of Health and Human Services
|CreationLegislation=Pure Food and Drugs Act of 1906
|Employees=18000
|Budget=Approximately $6.5 billion (fiscal year 2024)
|OrganizationExecutive=Commissioner
|Services=Drug and medical device approval; food safety oversight; tobacco regulation; public health education; enforcement of regulations
|Regulations=Federal Food, Drug, and Cosmetic Act; Public Health Service Act; various regulations under Title 21 of the U.S. Code
|HeadquartersLocation=39.02886, -76.98316
|HeadquartersAddress=10903 New Hampshire Avenue, Silver Spring, MD 20993
|Website=https://www.fda.gov
}}
{{Short description|United States federal agency}}
{{Short description|United States federal agency}}


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{{Tree list}}
{{Tree list}}
* [[Department of Health and Human Services]]
* [[Department of Health and Human Services]]
{{Tree list/final branch}}'''Food and Drug Administration'''
** {{Tree list/final branch}}'''Food and Drug Administration'''
* [[Commissioner of Food and Drugs|Office of the Commissioner]] (C)
*** [[Commissioner of Food and Drugs|Office of the Commissioner]] (C)
Office of the Chief Counsel (OCC)
**** [[Office of the Chief Counsel]] (OCC)
Office of the Executive Secretariat (OES)
**** [[Office of the Executive Secretariat]] (OES)
Office of the Counselor to the Commissioner
**** [[Office of the Counselor to the Commissioner]]
{{Tree list/final branch}} Office of Digital Transformation (ODT)
**** {{Tree list/final branch}} [[Office of Digital Transformation]] (ODT)
* [[Center for Biologics Evaluation and Research]] (CBER)
*** [[Center for Biologics Evaluation and Research]] (CBER)
* [[Center for Devices and Radiological Health]] (CDRH)
*** [[Center for Devices and Radiological Health]] (CDRH)
* [[Center for Drug Evaluation and Research]] (CDER)
*** [[Center for Drug Evaluation and Research]] (CDER)
* [[Center for Food Safety and Applied Nutrition]] (CFSAN)
*** [[Center for Food Safety and Applied Nutrition]] (CFSAN)
* [[Center for Tobacco Products]] (CTP)
*** [[Center for Tobacco Products]] (CTP)
* [[Center for Veterinary Medicine]] (CVM)
*** [[Center for Veterinary Medicine]] (CVM)
* Oncology Center of Excellence (OCE)
*** [[Oncology Center of Excellence]] (OCE)
* [[Office of Regulatory Affairs]] (ORA)
*** [[Office of Regulatory Affairs]] (ORA)
* Office of Clinical Policy and Programs (OCPP)
*** [[Office of Clinical Policy and Programs]] (OCPP)
* Office of External Affairs (OEA)
*** [[Office of External Affairs]] (OEA)
* Office of Food Policy and Response (OFPR)
*** [[Office of Food Policy and Response]] (OFPR)
* Office of Minority Health and Health Equity (OMHHE)
*** [[Office of Minority Health and Health Equity]] (OMHHE)
* Office of Operations (OO)
*** [[Office of Operations]] (OO)
* Office of Policy, Legislation, and International Affairs (OPLIA)
*** [[Office of Policy, Legislation, and International Affairs]] (OPLIA)
* Office of the Chief Scientist (OCS)
*** [[Office of the Chief Scientist]] (OCS)
{{Tree list/final branch}}[[National Center for Toxicological Research]] (NCTR)
**** {{Tree list/final branch}}[[National Center for Toxicological Research]] (NCTR)
* Office of Women's Health (OWH)
*** [[Office of Women's Health]] (OWH)
{{Tree list/end}}
{{Tree list/end}}


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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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