# FDA *Federal agency of the U.S. Department of Health and Human Services that regulates food, drugs, medical devices and related products.* The Food and Drug Administration (FDA) sits within the [[United States Department of Health and Human Services]]. Its remit covers food, tobacco, caffeine products and dietary supplements. It also covers prescription and over-the-counter medicines, vaccines, biopharmaceuticals and blood transfusions, as well as medical devices, radiation-emitting devices, cosmetics, animal feed and veterinary products.[^1] Its principal statute is the Federal Food, Drug, and Cosmetic Act. Section 361 of the Public Health Service Act and its associated regulations are among the other laws it enforces.[^1] The encyclopedia account of the agency describes it as "responsible for protecting and promoting public health." Among the instruments it lists for that work are facility inspections, whose observations are recorded on Form 483, and the online publication of non-compliance and [[warning letters]].[^1][^2] In the Minnesota record, those instruments appear in four at-issue entries concerning [[Hennepin Healthcare]]. According to those entries, FDA inspections took place there in April 2019. In May 2021 the agency issued warning letters to two of the hospital's physicians over ketamine and sedation studies conducted without [[Investigational New Drug applications]]. By the record's dates, twenty-five months separated the inspections from the letters.[^3][^4] The record assembled here does not reproduce the text of the letters. It does not establish whether the physicians or the hospital responded, or what followed.[^3] ## Who The commissioner of food and drugs heads the agency. The president appoints the commissioner with the Senate's advice and consent, and the commissioner reports to the secretary of health and human services. When the encyclopedia entry was retrieved in October 2026, it listed Marty Makary as commissioner.[^1] The agency's organizational chart places the Office of the Chief Counsel and the Office of Regulatory Affairs under the Office of the Commissioner. It also lists centers for drug evaluation and research, biologics, devices and radiological health, food safety and applied nutrition, tobacco products and veterinary medicine. Further units include the Oncology Center of Excellence, the National Center for Toxicological Research, the Office of Minority Health and Health Equity and the Office of Women's Health.[^5] ## What Much of the FDA's enforcement work concerns products other than food and drugs, such as lasers, mobile phones and condoms. Its disease-mitigation authority extends from household pets to donor sperm used in assisted reproduction.[^1] The depth of regulation differs by product. For prescription drugs, the agency covers testing, manufacturing, labeling, advertising, marketing, efficacy and safety. For cosmetics, its oversight is chiefly confined to labeling and safety.[^2] Emergency Use Authorization is a mechanism for making medical countermeasures, including vaccines and protective equipment, available during public-health emergencies. The entry names the Zika and Ebola epidemics and the [[COVID-19 pandemic]] as examples of such emergencies.[^2] ## When Before the twentieth century, federal law said little about the content and sale of food and medicines made in the United States; the Vaccine Act of 1813 was an exception. The agency's lineage runs to the Division of Chemistry of the [[Department of Agriculture]]. Harvey Washington Wiley became chief chemist there in 1883, and the division began researching the adulteration and misbranding of food and drugs.[^6] The Biologics Control Act of 1902 followed the deaths of thirteen children in St. Louis from a diphtheria antitoxin made with tetanus-contaminated serum. In June 1906 President Theodore Roosevelt signed the Pure Food and Drug Act. Under it, adulterated food moved across state lines became subject to seizure.[^6] Later milestones include the Critical Path Initiative, launched in March 2004, and the OpenFDA public-data project, launched in June 2014.[^7][^8] ## Where The agency's headquarters occupies the former Naval Ordnance Laboratory in the White Oak area of Silver Spring, Maryland. Its headquarters facilities lie in Montgomery and Prince George's counties.[^1][^9] FDA staff have worked at the White Oak Federal Research Center since 1990. In 2001 the [[General Services Administration]] began construction there to consolidate 25 Washington-area operations and the Rockville headquarters. The first building, the Life Sciences Laboratory, opened in December 2003 with 104 employees.[^9] Outside Maryland, the entry counts 223 field offices and 13 laboratories across the 50 states, the U.S. Virgin Islands and Puerto Rico. Beginning in 2008, the agency also stationed staff abroad, in countries including China, India, Costa Rica, Chile, Belgium and the United Kingdom.[^1] ## How For most products, the agency publishes standards and enforces them through a modest number of facility inspections, with findings written up on Form 483.[^2] It also publishes warning letters and non-compliance listings online. The entry describes this as regulation by shaming that relies on firms' concern for their reputations. In 2018, for example, the agency posted a list naming dozens of branded drug companies that it said were using unlawful or unethical means to impede generic competition.[^2] In June 2018 it issued guidance to help manufacturers "implement protections against potential attacks on the U.S. food supply." That guidance includes an Intentional Adulteration rule.[^2] Concerns recorded about the agency's advisory committees include: - members' conflicts of interest and ties to the pharmaceutical industry; - agency decisions that diverged from committee recommendations, including the approval of the Alzheimer's drug aducanumab; - industry-funded support behind some public comments.[^10] ## How much As of 2021, the FDA oversaw $2.7 trillion worth of food, medical and tobacco products. The federal government supplied about 54% of its budget, and industry user fees covered the remaining 46%. Drug makers, for instance, pay fees to speed up the review of their products. The entry reports Forbes's figure that pharmaceutical firms provide 75% of the agency's drug-review budget.[^11] A 2006 Institute of Medicine report on U.S. pharmaceutical regulation cost $1.8 million. It found major deficiencies in the FDA's system for ensuring drug safety, and its authors called for more regulatory power, funding and independence for the agency.[^12] ## How many In December 2018, the White Oak campus housed 10,987 employees in about 3.8 million square feet, divided among ten office buildings and four laboratory buildings. Following the FDA Reauthorization Act of 2017, the agency projected that its workforce would grow 64% to 18,000 over 15 years. It also sought about 1.6 million additional square feet of space. The National Capital Planning Commission approved a master plan for the expansion in December 2018, with completion expected by 2035, subject to General Services Administration appropriations.[^9] ## In the at-issue record - [[At issue 071 - In May 2021 the FDA issued warning letters]] — the May 2021 warning letters to two Hennepin Healthcare physicians over ketamine and sedation studies conducted without Investigational New Drug applications.[^3] - [[At issue 072 - The FDA found the Hennepin Healthcare protocols excluded]] — the screening criteria for excluding pregnant subjects and minors.[^13] - [[At issue 073 - The FDA found one Hennepin Healthcare protocol pre-specified]] — the protocol that assigned sedatives by calendar date.[^14] - [[At issue 074 - The FDA inspections at Hennepin Healthcare occurred in]] — the interval between the April 2019 inspections and the May 2021 letters.[^4] ## In the Minnesota record ### Who The May 2021 warning letters went to two physicians at Hennepin Healthcare, which the at-issue record identifies as the county's public hospital. The record does not name the physicians.[^3] ### What According to the at-issue record, the letters concerned ketamine and sedation studies conducted on patients without the Investigational New Drug filing.[^3] The record states that the FDA found the protocols excluded pregnant subjects and minors only by whether they were "obviously gravid" or "obviously appear to be less than 18 years old."[^13] The record also states that the FDA found one protocol pre-specified which sedative emergency physicians must administer on particular calendar dates. The project's entry treats that calendar-date assignment as the feature that made the protocol research rather than clinical practice.[^14] ### When The at-issue record dates the FDA inspections at Hennepin Healthcare to April 2019 and the warning letters to May 2021, an interval of twenty-five months.[^4] ### Where Hennepin Healthcare operates in [[Hennepin County, Minnesota]].[^3] The U.S. Census Bureau's July 1, 2025 estimate puts the county's population at 1,284,784, against 1,281,565 at the April 1, 2020 census.[^15] ## Notes [^1]: Wikipedia contributors, *Food and Drug Administration*, lead section (revision 1379958829, retrieved 2026-10-27; CC BY-SA 4.0) — the agency's scope, statutes, commissioner and reporting line, headquarters, field offices and foreign posts. https://en.wikipedia.org/wiki/Food_and_Drug_Administration [^2]: Wikipedia contributors, *Food and Drug Administration*, "Regulatory programs" (revision 1379958829, retrieved 2026-10-27) — Emergency Use Authorization, regulation by product type, inspections and Form 483, warning letters and the 2018 list, and the June 2018 food-supply guidance. https://en.wikipedia.org/wiki/Food_and_Drug_Administration [^3]: Minnesota wiki at-issue record, *AI-Hennepin-071* (Block G, rank 71; source domain fda.gov, 2 sources) — records the May 2021 FDA warning letters to two Hennepin Healthcare physicians over ketamine and sedation studies conducted without Investigational New Drug applications. The fda.gov letters are not among this record's citable URLs. The URL given is the presidential action the record pairs with this entry as its anchor, The White House, *Stopping Waste, Fraud, and Abuse by Eliminating Information Silos* (March 2025); that document does not itself document the letters. https://www.whitehouse.gov/presidential-actions/2025/03/stopping-waste-fraud-and-abuse-by-eliminating-information-silos/ [^4]: Minnesota wiki at-issue record, *AI-Hennepin-074* (Block G, rank 74; source domain fda.gov, 1 source) — dates the FDA inspections at Hennepin Healthcare to April 2019 and the warning letters to May 2021. The URL is the record's White House anchor and does not itself document these dates. https://www.whitehouse.gov/presidential-actions/2025/03/stopping-waste-fraud-and-abuse-by-eliminating-information-silos/ [^5]: Wikipedia contributors, *Food and Drug Administration*, "Organizational structure" (revision 1379958829, retrieved 2026-10-27) — the offices and centers under the Office of the Commissioner. https://en.wikipedia.org/wiki/Food_and_Drug_Administration [^6]: Wikipedia contributors, *Food and Drug Administration*, "History" (revision 1379958829, retrieved 2026-10-27) — the Vaccine Act of 1813, the USDA Division of Chemistry under Wiley from 1883, the Biologics Control Act of 1902, and the June 1906 Pure Food and Drug Act. https://en.wikipedia.org/wiki/Food_and_Drug_Administration [^7]: Wikipedia contributors, *Food and Drug Administration*, "21st-century reforms" (revision 1379958829, retrieved 2026-10-27) — the Critical Path Initiative, launched March 2004. https://en.wikipedia.org/wiki/Food_and_Drug_Administration [^8]: Wikipedia contributors, *Food and Drug Administration*, "Data management" (revision 1379958829, retrieved 2026-10-27) — the OpenFDA project, launched June 2014. https://en.wikipedia.org/wiki/Food_and_Drug_Administration [^9]: Wikipedia contributors, *Food and Drug Administration*, "Location" (revision 1379958829, retrieved 2026-10-27) — the headquarters counties, the White Oak campus history, December 2018 staffing and floor space, and the 2017 expansion projection and 2018 master plan. https://en.wikipedia.org/wiki/Food_and_Drug_Administration [^10]: Wikipedia contributors, *Food and Drug Administration*, "Advisory committees" (revision 1379958829, retrieved 2026-10-27) — recorded concerns about conflicts of interest, industry ties, divergence from committee recommendations including on aducanumab, and industry-funded comment. https://en.wikipedia.org/wiki/Food_and_Drug_Administration [^11]: Wikipedia contributors, *Food and Drug Administration*, "Scope and funding" (revision 1379958829, retrieved 2026-10-27) — the $2.7 trillion oversight figure as of 2021, the 54% / 46% budget split, and the Forbes 75% drug-review figure. https://en.wikipedia.org/wiki/Food_and_Drug_Administration [^12]: Wikipedia contributors, *Food and Drug Administration*, "Overview" (revision 1379958829, retrieved 2026-10-27) — the $1.8 million 2006 Institute of Medicine report and its findings. https://en.wikipedia.org/wiki/Food_and_Drug_Administration [^13]: Minnesota wiki at-issue record, *AI-Hennepin-072* (Block G, rank 72; source domain fda.gov, 1 source) — records the FDA finding that Hennepin Healthcare protocols excluded pregnant subjects and minors by visual criteria, quoted as given in the record. The URL is the record's White House anchor and does not itself document the finding. https://www.whitehouse.gov/presidential-actions/2025/03/stopping-waste-fraud-and-abuse-by-eliminating-information-silos/ [^14]: Minnesota wiki at-issue record, *AI-Hennepin-073* (Block G, rank 73; source domain fda.gov, 1 source) — records the FDA finding that one protocol pre-specified sedatives by calendar date, and the project's reading of that finding. The URL is the record's White House anchor and does not itself document the finding. https://www.whitehouse.gov/presidential-actions/2025/03/stopping-waste-fraud-and-abuse-by-eliminating-information-silos/ [^15]: U.S. Census Bureau, *QuickFacts: Hennepin County, Minnesota* — population 1,281,565 (April 1, 2020 census) and 1,284,784 (July 1, 2025 estimate). https://www.census.gov/quickfacts/fact/table/hennepincountyminnesota/PST045224