View source for Organization:Food and Drug Administration

{{Short description|United States federal agency}}

{{Infobox government agency
| name            = Food and Drug Administration
| seal            =
| logo            = Logo of the United States Food and Drug Administration.svg
| logo_width      = 280px
| formed          = {{start date and age|1906|6|30}}<ref>{{cite web|url=https://www.fda.gov/AboutFDA/WhatWeDo/History/CentennialofFDA/default.htm|archive-url=https://web.archive.org/web/20160524231757/https://www.fda.gov/AboutFDA/WhatWeDo/History/CentennialofFDA/default.htm|url-status=dead|archive-date=May 24, 2016|title=FDA Centennial 1906–2006|access-date=September 13, 2008|publisher=Food and Drug Administration|language=en-US}}</ref>
| preceding1      = Food, Drug, and Insecticide Administration (July 1927 – July 1930)
| preceding2      = Bureau of Chemistry, [[Organization:USDA|USDA]] (July 1901 – July 1927)
| preceding3      = Division of Chemistry, USDA (established 1862)
| jurisdiction    = Federal government of the United States
| headquarters    = White Oak Campus<br />10903 New Hampshire Avenue<br />Silver Spring, Maryland 20993
| coordinates     = {{coord|39.03533200|-76.98311340|format=dms|source:wikidata_type:landmark_region:US-MD|display=inline}}
| employees       = 18,000 (2022)<ref name="fy2022"/>
| budget          = {{USD|6.5}}{{nbsp}}billion (2022)<ref name="fy2022">{{cite web |title=FY 2022 FDA Budget Request |url=https://www.fda.gov/media/149613/download |publisher=FDA |access-date=January 14, 2022}}</ref>
| chief1_name     = Robert Califf
| chief1_position = Commissioner
| chief2_name     = Janet Woodcock
| chief2_position = Principal Deputy Commissioner
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| parent_department =
| parent_agency   = Department of Health and Human Services
| child1_agency   = [[Organization:Center for Biologics Evaluation and Research|Center for Biologics Evaluation and Research]]
| child2_agency   = Center for Devices and Radiological Health
| child3_agency   = Center for Drug Evaluation and Research
| child4_agency   = Center for Food Safety and Applied Nutrition
| child5_agency   = Center for Tobacco Products
| child6_agency   = [[Organization:Center for Veterinary Medicine|Center for Veterinary Medicine]]
| child7_agency   = [[Organization:National Center for Toxicological Research|National Center for Toxicological Research]]
| child8_agency   = Office of Criminal Investigations
| child9_agency   = Office of Regulatory Affairs
| website         = {{official URL}}
}}

The United States '''Food and Drug Administration''' ('''FDA''' or '''US FDA''') is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, [[Biology:Tobacco|tobacco]] products, [[Biology:Caffeine|caffeine]] products, dietary supplements, [[Medicine:Prescription drug|prescription]] and [[Medicine:Over-the-counter drug|over-the-counter]] pharmaceutical drugs (medications), [[Biology:Vaccine|vaccine]]s, [[Medicine:Biopharmaceutical|biopharmaceutical]]s, [[Medicine:Blood transfusion|blood transfusion]]s, [[Medicine:Medical device|medical device]]s, [[Physics:Electromagnetic radiation|electromagnetic radiation]] emitting devices (ERED), cosmetics, animal foods & feed<ref>{{cite web |url= https://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/default.htm |title= Animal Food & Feeds |publisher= Food and Drug Administration |access-date= March 14, 2015 |archive-date= March 22, 2015 |archive-url= https://web.archive.org/web/20150322105837/https://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/default.htm |url-status= live }}</ref> and [[Medicine:Veterinary medicine|veterinary products]].

The FDA's primary focus is enforcement of the [[Medicine:Federal Food, Drug, and Cosmetic Act|Federal Food, Drug, and Cosmetic Act]] (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying from household pets to human sperm donated for use in assisted reproduction.

The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. Robert Califf is the current commissioner, {{as of|2022|2|17|lc=y|df=|post=.}}<ref>{{cite web|url=https://www.fda.gov/about-fda/fda-organization/robert-califf|title=Robert M. Califf M.D., MACC|website=fda.gov|date=February 17, 2022|access-date=March 20, 2022}}</ref>

The FDA has its headquarters in unincorporated White Oak, Maryland.<ref name="White Oak">{{cite web |url=https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ |title=White Oak Campus Information |publisher=Food and Drug Administration |date=February 9, 2011 |access-date=May 12, 2017 |archive-date=April 21, 2016 |archive-url=https://web.archive.org/web/20160421021526/http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ |url-status=live }}</ref> The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico.<ref name=train>{{cite web|url=https://www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM283299.pdf|title=FDA Overview|access-date=August 30, 2012|publisher=Food and Drug Administration|archive-date=November 1, 2013|archive-url=https://web.archive.org/web/20131101113740/http://www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM283299.pdf|url-status=live}}</ref> In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.<ref>{{cite web|url=http://test.fda.gov/ForConsumers/ConsumerUpdates/ucm185769.htm|title=FDA's International Posts: Improving the Safety of Imported Food and Medical Products|access-date=April 10, 2010|publisher=Food and Drug Administration|archive-url=https://web.archive.org/web/20100810183402/http://test.fda.gov/ForConsumers/ConsumerUpdates/ucm185769.htm|archive-date=August 10, 2010|url-status=dead}}</ref>

[[File:FDA Bldg 31 - Exterior (5161375422).jpg|thumb|upright|FDA Building 31 houses the Office of the Commissioner and the Office of Regulatory Department of Health and Human Services.<ref>{{cite web |title = About the FDA Organization Charts |url = https://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ucm2006146.htm |access-date = July 19, 2015 |publisher = Food and Drug Administration |quote = FDA is an agency within the Department of Health and Human Services and consists of nine Centers and Offices, which are listed on the menu to the left. |date = August 29, 2014 |archive-date = July 22, 2015 |archive-url = https://web.archive.org/web/20150722064030/http://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ucm2006146.htm |url-status = live }}</ref> The agency consists of fourteen Centers and Offices.{{NoteTag|The quoted text from the source indicates "9" but the actual count from the website indicates "14".}}|alt=]]

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

==Location==
[[File:FDA Building 66 - CDRH (5160772175).jpg|thumb|FDA Building 66 houses the Center for Devices and Radiological Health.|alt=]]

=== Headquarters ===
FDA headquarters facilities are currently located in Montgomery County and Prince George's County, Maryland.<ref>{{Cite web|date=April 27, 2020|title=Buildings and Facilities|url=https://www.fda.gov/about-fda/jobs-and-training-fda/buildings-and-facilities|access-date=October 3, 2020|website=U.S. Food and Drug Administration|language=en|archive-date=April 21, 2020|archive-url= https://web.archive.org/web/20200421020851/https://www.fda.gov/about-fda/jobs-and-training-fda/buildings-and-facilities|url-status=live}}</ref>

=== White Oak Federal Research Center ===
Since 1990, the FDA has had employees and facilities on {{Convert|130|acre|ha|abbr=off}} of the White Oak Federal Research Center in the White Oak area of Silver Spring, Maryland.<ref name="White Oak" /><ref name="coordinates">Coordinates of FDA Headquarters at White Oak, Maryland: {{coord|39.0353363|-76.9830894|region:US-MD_type:landmark|format=dms|name=FDA Headquarters at White Oak, Maryland}}</ref> In 2001, the General Services Administration (GSA) began new construction on the campus to consolidate the FDA's 25 existing operations in the Washington metropolitan area, its headquarters in Rockville, and several fragmented office buildings. The first building, the Life Sciences Laboratory, was dedicated and opened with 104 employees in December 2003. As of December 2018, the FDA campus has a population of 10,987 employees housed in approximately {{Convert|3800000|sqft|m2|abbr=off}} of space, divided into ten offices and four laboratory buildings. The campus houses the Office of the Commissioner (OC), the Office of Regulatory Affairs (ORA),&nbsp; the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the [[Organization:Center for Biologics Evaluation and Research|Center for Biologics Evaluation and Research]] (CBER) and offices for the [[Organization:Center for Veterinary Medicine|Center for Veterinary Medicine]] (CVM).<ref name="White Oak"/>

With the passing of the FDA Reauthorization Act of 2017, the FDA projects a 64% increase in employees to 18,000 over the next 15 years and wants to add approximately {{Convert|1600000|sqft|m2|abbr=off}} of office and special use space to their existing facilities. The National Capital Planning Commission approved a new master plan for this expansion in December 2018,<ref>{{Cite web|title=FDA White Oak Master Plan|url= https://www.ncpc.gov/projects/MP201/|access-date=October 3, 2020|website=National Capital Planning Commission|language=en|archive-date=October 9, 2020|archive-url= https://web.archive.org/web/20201009032259/https://www.ncpc.gov/projects/MP201/|url-status=live}}</ref> and construction is expected to be completed by 2035, dependent on GSA appropriations.<ref>{{cite journal| url= https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm057328.htm| title=White Oak Campus Project Schedule| journal=FDA| date=October 8, 2015| access-date=December 16, 2019| archive-date=April 23, 2019| archive-url=https://web.archive.org/web/20190423052101/https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm057328.htm| url-status=live}}</ref>

===Field locations===
[[File:Toxicology Research at FDA (NCTR Campus) (6023336064).jpg|thumb|upright=1.8|The Arkansas Laboratory in [[Jefferson, Jefferson County, Arkansas|Jefferson, Arkansas]] is the headquarters of the National Center for Toxicological Research.]]

==== Office of Regulatory Affairs ====
The Office of Regulatory Affairs is considered the agency's "eyes and ears," conducting the vast majority of the FDA's work in the field. Its employees, known as Consumer Safety Officers, or more commonly known simply as investigators, inspect production, warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in the case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a physical examination or take a physical sample of the product. The Office of Regulatory Affairs is divided into five regions, which are further divided into 20 districts. The districts are based roughly on the geographic divisions of the Federal court system. Each district comprises a main district office and a number of Resident Posts, which are FDA remote offices that serve a particular geographic area. ORA also includes the Agency's network of regulatory laboratories, which analyze any physical samples taken. Though samples are usually food-related, some laboratories are equipped to analyze drugs, cosmetics, and radiation-emitting devices.

==== Office of Criminal Investigations ====
[[File:US Food and Drug Administration Office 20180930.jpg|thumb|Jamaica, Queens, New York Regional Office - USFDA]]
The Office of Criminal Investigations was established in 1991 to investigate criminal cases. To do so, OCI employs approximately 200 Special Agents nationwide who, unlike ORA Investigators, are armed, have badges, and do not focus on technical aspects of the regulated industries. Rather, OCI agents pursue and develop cases when individuals and companies commit criminal actions, such as fraudulent claims or knowingly and willfully shipping known adulterated goods in interstate commerce. In many cases, OCI pursues cases involving violations of Title 18 of the United States Code (e.g., conspiracy, false statements, wire fraud, mail fraud), in addition to prohibited acts as defined in Chapter III of the FD&C Act. OCI Special Agents often come from other criminal investigations backgrounds, and frequently work closely with the Federal Bureau of Investigation, Assistant Attorney General, and even Interpol. OCI receives cases from a variety of sources—including ORA, local agencies, and the FBI, and works with ORA Investigators to help develop the technical and science-based aspects of a case.<ref>{{Cite journal |last=Affairs |first=Office of Regulatory |date=October 7, 2021 |title=About OCI |url=https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/criminal-investigations/about-oci |journal=FDA |language=en}}</ref>

==== Other locations ====
The FDA has a number of field offices across the United States, in addition to international locations in China, India, Europe, the Middle East, and Latin America.<ref>{{cite web|author=<!--Not stated-->|date=May 21, 2020|title=Buildings and Facilities|url=https://www.fda.gov/about-fda/jobs-and-training-fda/buildings-and-facilities|url-status=live|archive-url=https://web.archive.org/web/20200421020851/https://www.fda.gov/about-fda/jobs-and-training-fda/buildings-and-facilities|archive-date=April 21, 2020|access-date=May 20, 2020|website=FDA.gov|language=en}}</ref>

==Scope and funding==
As of 2021, the FDA had responsibility for overseeing $2.7 trillion in food, medical, and tobacco products.<ref name=2021faqs/> Some 54% of its budget derives from the federal government, and 46% is covered by industry user fees for FDA services.<ref name="2021faqs">{{Cite web |publisher=US Food and Drug Administration|date=November 26, 2021|title=Fact Sheet: FDA at a Glance |url=https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance|accessdate=February 21, 2022}}</ref> For example, [[Medicine:Pharmaceutical industry|pharmaceutical firms]] pay fees to expedite drug reviews.<ref name=2021faqs/>

According to Forbes, pharmaceutical firms provide 75% of the FDA's drug review budget<ref>{{Cite web |last=LaMattina |first=John |date=June 28, 2018 |title=The Biopharmaceutical Industry Provides 75% Of The FDA's Drug Review Budget. Is This A Problem? |url=https://www.forbes.com/sites/johnlamattina/2018/06/28/the-biopharmaceutical-industry-provides-75-of-the-fdas-drug-review-budget-is-this-a-problem/ |url-status=live |archive-url=https://archive.today/20230103040036/https://www.forbes.com/sites/johnlamattina/2018/06/28/the-biopharmaceutical-industry-provides-75-of-the-fdas-drug-review-budget-is-this-a-problem/?sh=717a057449ec |archive-date=January 3, 2023 |access-date=January 3, 2023 |website=Forbes |language=en}}</ref>

==Regulatory programs==
===Emergency  approvals (EUA)===

Emergency Use Authorization (EUA) is a mechanism that was created to facilitate the availability and use of medical countermeasures, including vaccines and personal protective equipment, during public health emergencies such as the Zika virus epidemic, the Ebola virus epidemic and the COVID-19 pandemic.<ref>{{Cite journal|last=Commissioner|first=Office of the|date=August 31, 2021|title=Emergency Use Authorization--Archived Information|url=https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information|journal=FDA|language=en}}</ref>

===Regulations===
The programs for safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy, and safety—yet FDA regulation of cosmetics focuses primarily on labeling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections.  Inspection observations are documented on Form 483.<ref>{{Cite journal |date=November 21, 2022 |title=Inspection Observations |url=https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations |journal=Fda.gov |language=en}}</ref>

In June 2018, the FDA released a statement regarding new guidelines to help food and drug manufacturers "implement protections against potential attacks on the U.S. food supply".<ref>{{cite press release|url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611177.htm|title=Statement from FDA Commissioner Scott Gottlieb, M.D., on new guidance to help manufacturers implement protections against potential attacks on the U.S. food supply|publisher=Food and Drug Administration|first1=Scott|last1=Gottlieb|date=June 19, 2018|access-date=June 20, 2018|archive-date=July 24, 2018|archive-url=https://web.archive.org/web/20180724202237/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611177.htm|url-status=live}}</ref> One of the guidelines includes the Intentional Adulteration (IA) rule, which requires strategies and procedures by the food industry to reduce the risk of compromise in facilities and processes that are significantly vulnerable.<ref>{{Cite web |title=Federal Register :: Request Access |url=https://unblock.federalregister.gov/ |access-date=January 14, 2023 |website=unblock.federalregister.gov}}</ref><ref>{{Cite journal |last=Nutrition |first=Center for Food Safety and Applied |date=September 9, 2020 |title=Full Text of the Food Safety Modernization Act (FSMA) |url=https://www.fda.gov/food/food-safety-modernization-act-fsma/full-text-food-safety-modernization-act-fsma |journal=FDA |language=en}}</ref>

The FDA also uses tactics of regulatory shaming,<ref>{{Cite journal|last=Yadin|first=Sharon|date=2019|title=Regulatory Shaming|journal=Environmental Law (Lewis & Clark)|volume=49|pages=41|ssrn=3290017}}</ref> mainly through online publication of non-compliance, warning letters, and "shaming lists."  Regulation by shaming harnesses firms' sensitivity to reputational damage. For example, in 2018, the agency published an online "black list", in which it named dozens of branded drug companies that are supposedly using unlawful or unethical means to attempt to impede competition from [[Social:Generic drug|generic drug]] companies.<ref>{{Cite journal|last=Yadin|first=Sharon|date=2019|title=Shaming Big Pharma|url=http://yalejreg.com/shaming-big-pharma/|journal=Yale Journal on Regulation Bulletin|volume=36|pages=17|access-date=May 18, 2019|archive-date=May 18, 2019|archive-url=https://web.archive.org/web/20190518100524/http://yalejreg.com/shaming-big-pharma/|url-status=live}}</ref>

The FDA frequently works with other federal agencies, including the [[Organization:United States Department of Agriculture|Department of Agriculture]], the [[Organization:Drug Enforcement Administration|Drug Enforcement Administration]], Customs and Border Protection, and the Consumer Product Safety Commission. They also often work with local and state government agencies in performing regulatory inspections and enforcement actions.<ref>{{Cite journal |date=October 7, 2022 |title=What does FDA regulate? |url=https://www.fda.gov/about-fda/fda-basics/what-does-fda-regulate |journal=FDA |language=en}}</ref>

===Food and dietary supplements===
The regulation of food and dietary supplements by the Food and Drug Administration is governed by various statutes enacted by the [[United States Congress]] and interpreted by the FDA. Pursuant to the [[Medicine:Federal Food, Drug, and Cosmetic Act|Federal Food, Drug, and Cosmetic Act]] and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the [[Social:Packaging and labeling|labeling]] of both the composition and the health benefits of foods.

The FDA subdivides substances that it regulates as food into various categories—including foods, [[Chemistry:Food additive|food additive]]s, added substances (human-made substances that are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements. Dietary supplements or dietary ingredients include vitamins, minerals, herbs, [[Chemistry:Amino acid|amino acid]]s, and [[Biology:Enzyme|enzyme]]s.<ref>{{Cite web|url=http://www.fda.gov/food/dietary-supplements/dietary-supplement-products-ingredients|title=Dietary Supplement Products & Ingredients|last=Nutrition|first=Center for Food Safety and Applied|date=March 17, 2020|website=FDA|language=en|access-date=April 2, 2020|archive-date=May 28, 2020|archive-url=https://web.archive.org/web/20200528034323/https://www.fda.gov/food/dietary-supplements/dietary-supplement-products-ingredients|url-status=live}}</ref> Specific standards the FDA exercises differ from one category to the next. Furthermore, legislation had granted the FDA a variety of means to address violations of standards for a given substance category.

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA is responsible for ensuring that manufacturers and distributors of dietary supplements and dietary ingredients meet the current requirements. These manufacturers and distributors are not allowed to advertise their products in an adulterated way, and they are responsible for evaluating the safety and labeling of their product.<ref>{{Cite web|url=http://www.fda.gov/food/dietary-supplements|title=Dietary Supplements|last=Nutrition|first=Center for Food Safety and Applied|date=February 4, 2020|website=FDA|language=en|access-date=April 2, 2020|archive-date=April 3, 2020|archive-url=https://web.archive.org/web/20200403035844/https://www.fda.gov/food/dietary-supplements|url-status=live}}</ref>

The FDA has a "Dietary Supplement Ingredient Advisory List" that includes ingredients that sometimes appear on dietary supplements but need further evaluation further.<ref>{{cite web | title = Dietary Supplement Ingredient Advisory List | publisher = U.S. Food & Drug Administration | url = https://www.fda.gov/food/dietary-supplement-products-ingredients/dietary-supplement-ingredient-advisory-list | access-date = May 10, 2020 | archive-date = September 25, 2020 | archive-url = https://web.archive.org/web/20200925213510/https://www.fda.gov/food/dietary-supplement-products-ingredients/dietary-supplement-ingredient-advisory-list | url-status = live }}</ref> An ingredient is added to this list when it is excluded from use in a dietary supplement, does not appear to be an approved food additive or recognized as safe, and/or is subjected to the requirement for pre-market notification without having a satisfied requirement.<ref>{{Cite journal|last=Nutrition|first=Center for Food Safety and Applied|date=December 20, 2019|title=Dietary Supplement Ingredient Advisory List|url=http://www.fda.gov/food/dietary-supplement-products-ingredients/dietary-supplement-ingredient-advisory-list|journal=FDA|language=en|access-date=April 2, 2020|archive-date=April 16, 2020|archive-url=https://web.archive.org/web/20200416023320/https://www.fda.gov/food/dietary-supplement-products-ingredients/dietary-supplement-ingredient-advisory-list|url-status=live}}</ref>

===="FDA-Approved" vs. "FDA-Accepted in Food Processing"====
The FDA does not approve applied coatings used in the food processing industry.<ref>[http://www.decc.com/fda-acceptable-vs-fda-approved.php FDA Approved Coatings vs. FDA Acceptable Coatings – DECC Company – DECC Company] {{Webarchive|url=https://web.archive.org/web/20130911093254/http://www.decc.com/fda-acceptable-vs-fda-approved.php |date=September 11, 2013 }}. Decc.com. Retrieved on October 23, 2013.</ref> There is no review process to approve the composition of nonstick coatings; nor does the FDA inspect or test these materials. Through their governing of processes, however, the FDA does have a set of regulations that cover the formulation, manufacturing, and use of nonstick coatings. Hence, materials like [[Chemistry:Polytetrafluoroethylene|Polytetrafluoroethylene]] (Teflon) are not and cannot be considered as FDA Approved, but rather, they are a "FDA Compliant" or "FDA Acceptable".

===Medical countermeasures (MCMs)===
 Medical countermeasures (MCMs) are products such as biologics and pharmaceutical drugs that can protect from or treat the health effects of a chemical, biological, radiological, or nuclear (CBRN) attack. MCMs can also be used for prevention and diagnosis of symptoms associated with CBRN attacks or threats.<ref name="fdamcm">{{cite web|title=What are Medical Countermeasures?|url=https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/AboutMCMi/ucm431268.htm|website=FDA: Emergency Preparedness and Response|publisher=Food and Drug Administration|access-date=June 15, 2016|archive-date=April 22, 2019|archive-url=https://web.archive.org/web/20190422171542/https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/AboutMCMi/ucm431268.htm|url-status=live}}</ref> The FDA runs a program called the "FDA Medical Countermeasures Initiative" (MCMi), with programs funded by the federal government. It helps support "partner" agencies and organisations prepare for public health emergencies that could require MCMs.<ref name="fdamcm" /><ref>{{cite news|title=Alliance for Biosecurity applauds subcommittee efforts to sustain medical countermeasure funding|url=https://homelandprepnews.com/biological-threats/bioterrorism/18984-alliance-biosecurity-applauds-subcommittee-efforts-sustain-medical-countermeasure-funding/|access-date=June 15, 2016|work=Homeland Preparedness News|date=June 8, 2016|location=Washington, D.C.|archive-date=January 28, 2021|archive-url=https://web.archive.org/web/20210128183519/https://homelandprepnews.com/stories/18984-alliance-biosecurity-applauds-subcommittee-efforts-sustain-medical-countermeasure-funding/|url-status=live}}</ref>

===Medications===
[[File:FDA Bldg 51 - Main Entrance (5161374834).jpg|thumb|FDA Building 51 houses the Center for Drug Evaluation and Research.|alt=]]

The Center for Drug Evaluation and Research uses different requirements for the three main drug product types: new drugs, generic drugs, and over-the-counter drugs.  A drug is considered "new" if it is made by a different manufacturer, uses different [[Chemistry:Excipient|excipient]]s or inactive ingredients, is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to ''new molecular entities'': drugs that are not based on existing medications.<ref>{{Cite web |date=June 21, 2022 |title=Center for Drug Evaluation and Research {{!}} CDER |url=https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder |access-date=January 14, 2023 |website=FDA |language=en}}</ref>

====New medications====
New drugs receive extensive scrutiny before FDA approval in a process called a new drug application (NDA).<ref>{{cite web | url = https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/ | title = New Drug Application (NDA) | publisher = Food and Drug Administration | access-date = November 20, 2012 | archive-date = November 1, 2013 | archive-url = https://web.archive.org/web/20131101115332/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/ | url-status = live }}</ref> Under the Trump administration, the agency has worked to make the drug-approval process go faster.<ref>{{Cite journal|last=Van Loo|first=Rory|date=August 1, 2018|title=Regulatory Monitors: Policing Firms in the Compliance Era|url=https://scholarship.law.bu.edu/faculty_scholarship/265|journal=Faculty Scholarship|volume=119 |issue=2 |page=369 |access-date=October 10, 2020|archive-date=June 4, 2020|archive-url=https://web.archive.org/web/20200604022358/https://scholarship.law.bu.edu/faculty_scholarship/265/|url-status=live}}</ref>'''{{rp|10}}'''  Critics, however, argue that FDA standards are not sufficiently rigorous to prevent unsafe or ineffective drugs from getting approval.<ref>{{citation |title=Medical Nihilism |last=Stegenga |first=Jacob |publisher=Oxford University Press |year=2018 |isbn=9780198747048 |url=https://global.oup.com/academic/product/medical-nihilism-9780198747048?cc=hr&lang=en& |access-date=April 20, 2018 |archive-date=December 11, 2019 |archive-url=https://web.archive.org/web/20191211120725/https://global.oup.com/academic/product/medical-nihilism-9780198747048?cc=hr&lang=en& |url-status=live }}</ref> New drugs are available only by prescription by default.  A change to over-the-counter (OTC) status is a separate process, and the drug must be approved through an NDA first. A drug that is approved is said to be "safe and effective when used as directed".

Very rare, limited exceptions to this multi-step process involving animal testing and controlled clinical trials can be granted out of compassionate use protocols. This was the case during the 2015 Ebola epidemic with the use, by prescription and authorization, of [[Biology:ZMapp|ZMapp]] and other experimental treatments, and for new drugs that can be used to treat debilitating and/or very rare conditions for which no existing remedies or drugs are satisfactory, or where there has not been an advance in a long period of time. The studies are progressively longer, gradually adding more individuals as they progress from stage I to stage III, normally over a period of years, and normally involve drug companies, the government and its laboratories, and often medical schools and hospitals and clinics. However, any exceptions to the aforementioned process are subject to strict review and scrutiny and conditions, and are only given if a substantial amount of research and at least some preliminary human testing has shown that they are believed to be somewhat safe and possibly effective. (See FDA Special Protocol Assessment about Phase III trials.)

=====Advertising and promotion=====
The FDA's Office of Prescription Drug Promotion reviews and regulates prescription drug advertising and promotion through surveillance activities and issuance of enforcement letters to pharmaceutical manufacturers. Advertising and promotion for over-the-counter drugs is regulated by the Federal Trade Commission.  The FDA also empowers third-party enforcer-firms to engage in some regulatory oversight, e.g. the FDA expects pharmaceutical companies to make sure that third-party suppliers and labs abide by the agency's health and safety guidelines.<ref>{{Cite journal|last=Van Loo|first=Rory|date=April 1, 2020|title=The New Gatekeepers: Private Firms as Public Enforcers|url=https://scholarship.law.bu.edu/faculty_scholarship/800|journal=Virginia Law Review|volume=106|issue=2|pages=467|access-date=October 25, 2020|archive-date=October 28, 2020|archive-url=https://web.archive.org/web/20201028034638/https://scholarship.law.bu.edu/faculty_scholarship/800/|url-status=live}}</ref>{{rp|4}}

The drug advertising regulation<ref>21 CFR 202: Prescription Drug Advertising.</ref> contains two broad requirements: (1) a company may advertise or promote a drug only for the specific indication or medical use for which it was approved by FDA. Also, an advertisement must contain a "fair balance" between the benefits and the risks (side effects) of a drug.

The term off-label refers to the practice of prescribing a drug for a different purpose than what the FDA approved.<ref>{{Cite web |date=January 1, 2014 |title=Off-Label Drug Use in Cancer Treatment - NCI |url=https://www.cancer.gov/about-cancer/treatment/drugs/off-label |access-date=January 14, 2023 |website=www.cancer.gov |language=en}}</ref>

=====Post-market safety surveillance=====
After NDA approval, the sponsor must then review and report to the FDA every single patient adverse drug experience it learns of. They must report unexpected serious and fatal adverse drug events within 15 days, and other events on a quarterly basis.<ref>21 CFR 314.80: Postmarketing Reporting of Adverse Drug Experiences</ref> The FDA also receives directly adverse drug event reports through its MedWatch program.<ref>[https://www.fda.gov/Safety/MedWatch/default.htm MedWatch: The FDA Safety Information and Adverse Event Reporting Program] {{Webarchive|url=https://web.archive.org/web/20190422112808/https://www.fda.gov/Safety/MedWatch/default.htm |date=April 22, 2019 }}. Accessed October 9, 2007</ref> These reports are called "spontaneous reports" because reporting by consumers and health professionals is voluntary.

While this remains the primary tool of [[Medicine:Postmarketing surveillance|post-market safety surveillance]], FDA requirements for post-marketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional clinical trials, called Phase IV trials. In some cases, the FDA requires risk management plans called [[Medicine:Risk Evaluation and Mitigation Strategies|Risk Evaluation and Mitigation Strategies]] (REMS) for some drugs that require actions to be taken to ensure that the drug is used safely.<ref name=Nelson>{{cite journal|last1=Nelson|first1=LS|last2=Loh|first2=M|last3=Perrone|first3=J|title=Assuring safety of inherently unsafe medications: the FDA risk evaluation and mitigation strategies.|journal=Journal of Medical Toxicology|date=June 2014|volume=10|issue=2|pages=165–72|doi=10.1007/s13181-013-0374-z|pmid=24414251|pmc=4057549}}</ref><ref>{{cite journal|last1=Brown|first1=WV|last2=Bramlet|first2=DA|last3=Ross|first3=JL|last4=Underberg|first4=JA|title=JCL roundtable: Risk evaluation and mitigation strategy.|journal=Journal of Clinical Lipidology|date=October 14, 2016 |volume=10|issue=6|pages=1288–1296|doi=10.1016/j.jacl.2016.10.007|pmid=27919344}}</ref>  For example, [[Chemistry:Thalidomide|thalidomide]] can cause birth defects, but has uses that outweigh the risks if men and women taking the drugs do not conceive a child; a REMS program for thalidomide mandates an auditable process to ensure that people taking the drug take action to avoid pregnancy; many [[Chemistry:Opioid|opioid]] drugs have REMS programs to avoid addiction and diversion of drugs.<ref name=Nelson/> The drug [[Chemistry:Isotretinoin|isotretinoin]] has a REMS program called iPLEDGE.<ref>{{cite journal|last1=Kovitwanichkanont|first1=T|last2=Driscoll|first2=T|title=A comparative review of the isotretinoin pregnancy risk management programs across four continents.|journal=International Journal of Dermatology|volume=57|issue=9|pages=1035–1046|date=March 6, 2018|doi=10.1111/ijd.13950|pmid=29508918|s2cid=3726217}}</ref>

====Generic drugs====
Generic drugs are chemical and therapeutic equivalents of name-brand drugs, normally whose patents have expired.<ref name="TNBK"/> Approved generic drugs should have the same dosage, safety, effectiveness, strength, stability, and quality, as well as route of administration. In general, they are less expensive than their name brand counterparts, are manufactured and marketed by rival companies and, in the 1990s, accounted for about a third of all prescriptions written in the United States.<ref name="TNBK"/> For a pharmaceutical company to gain approval to produce a generic drug, the FDA requires scientific evidence that the generic drug is interchangeable with or therapeutically equivalent to the originally approved drug.<ref name="Therapeutic Equivalance of Generic Drugs">{{cite web|url=https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm073182.htm|title=Therapeutic Equivalence of Generic Drugs|access-date=August 30, 2012|publisher=Food and Drug Administration|year=1998|archive-date=April 29, 2012|archive-url=https://web.archive.org/web/20120429002732/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm073182.htm|url-status=live}}</ref> This is called an Abbreviated New Drug Application (ANDA).<ref>{{cite web | title = Abbreviated New Drug Application (ANDA) | date = December 20, 2019 | publisher = U.S. Food & Drug Administration | url = https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda | access-date = May 10, 2020 | archive-date = September 23, 2020 | archive-url = https://web.archive.org/web/20200923221401/https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda | url-status = live }}</ref> As of 2012, 80% of all FDA approved drugs are available in generic form. 
=====Generic drug scandal=====
In 1989, a major scandal erupted involving the procedures used by the FDA to approve generic drugs for sale to the public.<ref name="TNBK">{{cite encyclopedia |last=Cohen |first=Lynne |article=Government Policies and Programs&nbsp;– United States&nbsp;– Generic Drug Scandal |title=The New Book of Knowledge&nbsp;– Medicine And Health |date=1990 |pages=276–281 |isbn=978-0-7172-8244-9}}</ref> Charges of corruption in generic drug approval first emerged in 1988 during the course of an extensive congressional investigation into the FDA. The oversight subcommittee of the United States House Energy and Commerce Committee resulted from a complaint brought against the FDA by Mylan Laboratories Inc. of Pittsburgh. When its application to manufacture generics were subjected to repeated delays by the FDA, Mylan, convinced that it was being discriminated against, soon began its own private investigation of the agency in 1987. Mylan eventually filed suit against two former FDA employees and four drug-manufacturing companies, charging that corruption within the federal agency resulted in racketeering and in violations of antitrust law. "The order in which new generic drugs were approved was set by the FDA employees even before drug manufacturers submitted applications" and, according to Mylan, this illegal procedure was followed to give preferential treatment to certain companies. During the summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancato, Walter Kletch) pleaded guilty to criminal charges of accepting bribes from generic drugs makers, and two companies (Par Pharmaceutical and its subsidiary Quad Pharmaceuticals)<ref>{{cite news | url=https://www.nytimes.com/1989/09/12/business/fda-details-problems-at-drug-makers.html | work=The New York Times | title=F.D.A. Details Problems at Drug Makers | date=September 12, 1989 | access-date=February 7, 2017 | archive-date=March 13, 2017 | archive-url=https://web.archive.org/web/20170313215132/http://www.nytimes.com/1989/09/12/business/fda-details-problems-at-drug-makers.html | url-status=live }}</ref> pleaded guilty to giving bribes.

Furthermore, it was discovered that several manufacturers had falsified data submitted in seeking FDA authorization to market certain generic drugs. Vitarine Pharmaceuticals of New York, which sought approval of a generic version of the drug Dyazide, a medication for high blood pressure, submitted Dyazide, rather than its generic version, for the FDA tests. In April 1989, the FDA investigated 11 manufacturers for irregularities; and later brought that number up to 13. Dozens of drugs were eventually suspended or recalled by manufacturers. In the early 1990s, the U.S. Securities and Exchange Commission filed securities fraud charges against the Bolar Pharmaceutical Company, a major generic manufacturer based in Long Island, New York.<ref name="TNBK"/>

====Over-the-counter drugs====
Over-the-counter (OTC) are drugs like [[Chemistry:Aspirin|aspirin]] that do not require a doctor's prescription.<ref>[https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM148055.pdf Regulation of Nonprescription Drug Products] {{Webarchive|url=https://web.archive.org/web/20180226021613/https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM148055.pdf |date=February 26, 2018 }} FDA. Retrieved August 30, 2012.</ref> The FDA has a list of approximately 800 such approved ingredients that are combined in various ways to create more than 100,000 OTC drug products. Many OTC drug ingredients had been previously approved prescription drugs now deemed safe enough for use without a [[Medicine:Physician|medical practitioner]]'s supervision like [[Chemistry:Ibuprofen|ibuprofen]].<ref>{{cite web | url=https://www.fda.gov/cder/handbook/otcintro.htm | title=FDA CDER Handbook: Over-the-Counter Drug Products | website=Food and Drug Administration | access-date=October 9, 2007 | url-status=dead | archive-date=May 12, 2009 | archive-url=https://web.archive.org/web/20090512224542/https://www.fda.gov/cder/handbook/otcintro.htm }}</ref>

====Ebola treatment====
In 2014, the FDA added an [[Medicine:Ebola|Ebola]] treatment being developed by Canadian pharmaceutical company Tekmira to the Fast Track program, but halted the phase 1 trials in July pending the receipt of more information about how the drug works. This was widely viewed as increasingly important in the face of a major outbreak of the disease in West Africa that began in late March 2014 and ended in June 2016.<ref>{{cite web |last1=Kliff |first1=Sarah |title=The FDA recently halted trials on a potential Ebola treatment |url=https://www.vox.com/2014/8/3/5962381/ebola-outbreak-vaccine-fda-halted-trials |website=Vox |access-date=August 4, 2014 |date=August 3, 2014 |archive-date=August 6, 2014 |archive-url=https://web.archive.org/web/20140806035748/http://www.vox.com/2014/8/3/5962381/ebola-outbreak-vaccine-fda-halted-trials |url-status=live }}</ref>

==== Coronavirus (COVID-19) testing ====
During the coronavirus pandemic, FDA granted emergency use authorization for [[Social:Personal protective equipment|personal protective equipment]] (PPE), in vitro diagnostic equipment, [[Engineering:Ventilator|ventilator]]s and other medical devices.<ref name="FDA-EUA">{{cite web |url=https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#coronavirus2019 |title=Emergency Use Authorizations - FDA |author=<!--Not stated--> |date=May 21, 2020 |website=FDA.gov |publisher=Food and Drug Administration |access-date=May 21, 2020 |url-status=live |archive-url=https://web.archive.org/web/20200517205323/https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations |archive-date=May 17, 2020 }}</ref><ref>Rizk JG, Forthal DN, Kalantar-Zadeh K, et al. Expanded Access Programs, compassionate drug use, and Emergency Use Authorizations during the COVID-19 pandemic [published online ahead of print, 2020 Nov 27]. Drug Discov Today. 2020;S1359-6446(20)30509-2. doi:10.1016/j.drudis.2020.11.025
</ref><ref>{{Cite journal|url=https://www.fda.gov/media/144413/download|title = Comirnaty and Pfizer-BioNTech COVID-19 Vaccine|journal = FDA|date = January 3, 2022}}</ref>

On March 18, 2020, FDA inspectors postponed most foreign facility inspections and all domestic routine surveillance facility inspections.<ref name="FDA-COVID-19-inspections">{{cite web |url=https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-focuses-safety-regulated-products-while-scaling-back-domestic |title=Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections |author=Stephen M. Hahn M.D., Commissioner of Food and Drugs - Food and Drug Administration |date=March 18, 2020 |website=FDA.gov |publisher=U.S. Food and Drug Administration |access-date=May 21, 2020 |url-status=live |archive-url=https://web.archive.org/web/20200512170315/https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-focuses-safety-regulated-products-while-scaling-back-domestic |archive-date=May 12, 2020 |quote=Earlier this month, we announced that we are postponing most foreign facility inspections through April and that inspections outside the U.S. deemed mission-critical will be considered on a case-by-case basis as this outbreak continues to unfold. Today, we're announcing that for the health and well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors, we have temporarily postponed all domestic routine surveillance facility inspections. These are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical. We will continue to respond to natural disasters, outbreaks and other public health emergencies involving FDA-regulated products.}}</ref> In contrast, the [[Organization:United States Department of Agriculture|USDA's]] [[Organization:Food Safety and Inspection Service|Food Safety and Inspection Service]] (FSIS) continued inspections of meatpacking plants, which resulted in 145 FSIS field employees who tested positive for COVID-19, and three who died.<ref name="CBS-COVID">{{cite news |last=Carney |first=Josh |date=May 5, 2020 |title=3 USDA meat inspectors dead, about 145 diagnosed with COVID-19 |url=https://www.cbsnews.com/news/coronavirus-usda-meat-inspectors-3-dead-covid-19/ |url-status=live |work=CBS News |archive-url=https://web.archive.org/web/20200519054805/https://www.cbsnews.com/news/coronavirus-usda-meat-inspectors-3-dead-covid-19/ |archive-date=May 19, 2020 |access-date=May 22, 2020 }}</ref>

===Vaccines, blood and tissue products, and biotechnology===
[[File:Blood Research- Saving Lives (8352) (9759352093).jpg|thumb|FDA scientist prepares blood donation samples for testing.]]
The [[Organization:Center for Biologics Evaluation and Research|Center for Biologics Evaluation and Research]] is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents.<ref>{{cite web |url=https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ |title=About the Center for Biologics Evaluation and Research (CBER) |publisher=Food and Drug Administration |date=March 2, 2017 |access-date=May 12, 2017 |archive-date=May 9, 2017 |archive-url=https://web.archive.org/web/20170509063921/https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ |url-status=live }}.</ref> These include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products. New biologics are required to go through a premarket approval process called a [[Chemistry:Biologics license application|Biologics License Application]] (BLA), similar to that for drugs.

The original authority for government regulation of biological products was established by the 1902 [[Medicine:Biologics Control Act|Biologics Control Act]], with additional authority established by the 1944 Public Health Service Act. Along with these Acts, the [[Medicine:Federal Food, Drug, and Cosmetic Act|Federal Food, Drug, and Cosmetic Act]] applies to all biologic products, as well. Originally, the entity responsible for regulation of biological products resided under the [[Organization:National Institutes of Health|National Institutes of Health]]; this authority was transferred to the FDA in 1972.

===Medical and radiation-emitting devices===
[[File:FDA Bldg 62 - Exterior (5161375340).jpg|thumb|FDA Building 62 houses the Center for Devices and Radiological Health.|alt=]]
The Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for the premarket approval of all [[Medicine:Medical device|medical device]]s, as well as overseeing the manufacturing, performance and safety of these devices.<ref>[https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/ucm300639.htm CDRH Mission, Vision and Shared Values] {{Webarchive|url=https://web.archive.org/web/20190422142129/https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/ucm300639.htm |date=April 22, 2019 }} Retrieved August 30, 2012.</ref> The definition of a medical device is given in the FD&C Act, and it includes products from the simple [[Engineering:Toothbrush|toothbrush]] to complex devices such as implantable neurostimulators. CDRH also oversees the safety performance of non-medical devices that emit certain types of [[Physics:Electromagnetic radiation|electromagnetic radiation]]. Examples of CDRH-regulated devices include cellular phones, [[Engineering:Airport security|airport baggage screening equipment]], [[Engineering:Television|television receivers]], [[Physics:Microwave oven|microwave oven]]s, tanning booths, and [[Physics:Laser|laser products]].

CDRH regulatory powers include the authority to require certain technical reports from the manufacturers or importers of regulated products, to require that radiation-emitting products meet mandatory safety performance standards, to declare regulated products defective, and to order the recall of defective or noncompliant products. CDRH also conducts limited amounts of direct product testing.

===="FDA-Cleared" vs "FDA-Approved"====
Clearance requests are required for medical devices that prove they are "substantially equivalent" to the predicate devices already on the market. Approved requests are for items that are new or substantially different and need to demonstrate "safety and efficacy", for example they may be inspected for safety in case of new toxic hazards. Both aspects need to be proved or provided by the submitter to ensure proper procedures are followed.<ref>{{cite web|url=https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194460.htm|title=What does it mean when FDA "clears" or "approves" a medical device?|publisher=Food and Drug Administration|access-date=March 14, 2015|archive-date=March 7, 2015|archive-url=https://web.archive.org/web/20150307000034/http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194460.htm|url-status=live}}</ref>

===Cosmetics===
Cosmetics are regulated by the Center for Food Safety and Applied Nutrition, the same branch of the FDA that regulates food. Cosmetic products are not, in general, subject to premarket approval by the FDA unless they make "structure or function claims" that make them into drugs (see Cosmeceutical). However, all color additives must be specifically FDA approved before manufacturers can include them in cosmetic products sold in the U.S. The FDA regulates cosmetics labeling, and cosmetics that have not been safety tested must bear a warning to that effect.<ref>{{Cite web|url=https://www.fda.gov/cosmetics/cosmetics-labeling-regulations/summary-cosmetics-labeling-requirements|title=Summary of Cosmetics Labeling Requirements|date=August 2, 2018|website=U.S. Food and Drug Administration|access-date=December 4, 2019|archive-date=December 13, 2019|archive-url=https://web.archive.org/web/20191213121829/https://www.fda.gov/cosmetics/cosmetics-labeling-regulations/summary-cosmetics-labeling-requirements|url-status=live}}</ref>

According to the industry advocacy group, the American Council on Science and Health, though the cosmetic industry is primarily responsible for its own product safety, the FDA can intervene when necessary to protect the public. In general, though, cosmetics  do not require pre-market approval or testing. The ACSH says that companies must place a warning note on their products if they have not been tested, and that experts in cosmetic ingredient review also play a role in monitoring safety through influence on ingredients, but they lack legal authority. According to the ACSH, it has reviewed about 1,200 ingredients and has suggested that several hundred be restricted—but there is no standard or systemic method for reviewing chemicals for safety, or a clear definition of what 'safety' even means so that all chemicals get tested on the same basis.<ref>{{Cite journal|author=Ross G |title=A perspective on the safety of cosmetic products: a position paper of the American Council on Science and Health |journal=Int. J. Toxicol. |volume=25 |issue=4 |pages=269–77 |year=2006 |pmid=16815815 |doi=10.1080/10915810600746049 |s2cid=21904805 |doi-access=free }}</ref>

===Veterinary products===
The [[Organization:Center for Veterinary Medicine|Center for Veterinary Medicine]] (CVM) is a center of the FDA that regulates food additives and drugs that are given to animals.<ref name="Modric 2013">{{cite journal|last1=Modric|first1=S|title=Regulatory framework for the availability and use of animal drugs in the United States|journal=The Veterinary Clinics of North America. Small Animal Practice|date=September 2013|volume=43|issue=5|pages=1005–12|doi=10.1016/j.cvsm.2013.04.001|pmid=23890234}}</ref> CVM regulates animal drugs, animal food including pet animal, and animal medical devices. The FDA's requirements to prevent the spread of [[Medicine:Bovine spongiform encephalopathy|bovine spongiform encephalopathy]] are also administered by CVM through inspections of feed manufacturers.<ref>{{Cite web|url=http://www.fda.gov/animal-veterinary/compliance-enforcement/bovine-spongiform-encephalopathy|title=Bovine Spongiform Encephalopathy|last=Medicine|first=Center for Veterinary|date=April 11, 2019|website=FDA|language=en|access-date=February 4, 2020|archive-date=December 12, 2019|archive-url=https://web.archive.org/web/20191212171837/https://www.fda.gov/animal-veterinary/compliance-enforcement/bovine-spongiform-encephalopathy|url-status=live}}</ref> CVM does not regulate vaccines for animals; these are handled by the [[Organization:United States Department of Agriculture|United States Department of Agriculture]].<ref>{{cite book |last1=Hill |first1=R.E., Jr. |last2=Foley |first2=P.L. |last3=Clough |first3=N.E. |last4=Ludemann |first4=L.R. |last5=Murtle |first5=D.C. |editor1-last=Roth |editor1-first=J.A. |editor2-last=Richt |editor2-first=J.A. |editor3-last=Morozov |editor3-first=I.A. |title=Vaccines and diagnostics for transboundary animal diseases : Ames, Iowa, 17-19 September 2012 |date=2013 |publisher=Karger Medical and Scientific Publishers |isbn=9783318023664 |pages=53–54 |chapter-url=https://books.google.com/books?id=wZ86AQAAQBAJ&pg=PA53 |chapter=Translating research into licensed vaccines and validated and licensed diagnostic tests |access-date=June 30, 2019 |archive-date=August 1, 2020 |archive-url=https://web.archive.org/web/20200801131751/https://books.google.com/books?id=wZ86AQAAQBAJ&pg=PA53 |url-status=live }}</ref>

===Tobacco products===
The FDA regulates [[Chemistry:Tobacco products|tobacco products]] with authority established by the 2009 Family Smoking Prevention and Tobacco Control Act.<ref>{{cite web |url=https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194423.htm |title=Does FDA have the authority to regulate tobacco products? |publisher=Food and Drug Administration |access-date=December 16, 2019 |archive-date=November 14, 2017 |archive-url=https://web.archive.org/web/20171114204636/https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194423.htm |url-status=live }}</ref> This Act requires color warnings on cigarette packages and printed advertising, and text warnings from the U.S. Surgeon General.<ref>{{cite news | url=http://www.foxnews.com/health/2011/09/22/cigarette-makers-fda-clash-over-new-graphic-ads/ | work=Fox News | title=Cigarette Makers, FDA Clash Over New Graphic Ads | date=September 22, 2011 | access-date=October 13, 2011 | archive-date=October 8, 2011 | archive-url=https://web.archive.org/web/20111008214526/http://www.foxnews.com/health/2011/09/22/cigarette-makers-fda-clash-over-new-graphic-ads/ | url-status=live }}</ref>

The nine new graphic warning labels were announced by the FDA in June 2011 and were scheduled to be required to appear on packaging by September 2012. The implementation date is uncertain, due to ongoing proceedings in the case of ''R.J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration''.<ref>{{cite web|url=https://www.fda.gov/TobaccoProducts/Labeling/ucm259214.htm|publisher=Food and Drug Administration|title=Overview: Cigarette Health Warnings|access-date=August 30, 2012|archive-date=September 9, 2012|archive-url=https://web.archive.org/web/20120909034823/http://www.fda.gov/TobaccoProducts/Labeling/ucm259214.htm|url-status=live}}</ref> R.J. Reynolds, Lorillard, Commonwealth Brands, Liggett Group and Santa Fe Natural Tobacco Company have filed suit in Washington, D.C. federal court claiming that the graphic labels are an unconstitutional way of forcing tobacco companies to engage in anti-smoking advocacy on the government's behalf.<ref>{{cite news | url=https://blogs.wsj.com/law/2011/09/12/fda-defends-new-graphic-cigarette-labels/ | work=The Wall Street Journal | first=Nathan | last=Koppel | title=FDA Defends New Graphic Cigarette Labels | date=September 12, 2011 | url-access=subscription | access-date=August 4, 2017 | archive-date=July 9, 2017 | archive-url=https://web.archive.org/web/20170709181720/https://blogs.wsj.com/law/2011/09/12/fda-defends-new-graphic-cigarette-labels/ | url-status=live }}</ref>

A First Amendment lawyer, Floyd Abrams, is representing the tobacco companies in the case, contending requiring graphic warning labels on a lawful product cannot withstand constitutional scrutiny.<ref>{{cite web|url=http://www.adweek.com/news/advertising-branding/big-tobacco-gets-top-first-amendment-lawyer-new-suit-134200|title=Big Tobacco Gets Top First Amendment Lawyer for New Suit|work=AdWeek|access-date=March 14, 2015|archive-date=April 11, 2015|archive-url=https://web.archive.org/web/20150411073933/http://www.adweek.com/news/advertising-branding/big-tobacco-gets-top-first-amendment-lawyer-new-suit-134200|url-status=live}}</ref> The Association of National Advertisers and the American Advertising Federation have also filed a brief in the suit, arguing that the labels infringe on commercial free speech and could lead to further government intrusion if left unchallenged.<ref>{{cite web|url=http://www.csnews.com/product-categories/tobacco/tobacco-cos-get-allies-warning-label-fight|title=Tobacco Cos. Get Allies in Warning Label Fight|work=Convenience Store News|access-date=March 14, 2015|archive-date=January 12, 2015|archive-url=https://web.archive.org/web/20150112022328/http://www.csnews.com/product-categories/tobacco/tobacco-cos-get-allies-warning-label-fight|url-status=live}}</ref> In November 2011, Federal judge Richard Leon of the U.S. District Court for the District of Columbia temporarily halted the new labels, likely delaying the requirement that tobacco companies display the labels. The U.S. Supreme Court ultimately could decide the matter.<ref>{{cite news | url=https://www.wsj.com/articles/SB10001424052970204554204577024040240467970 | work=The Wall Street Journal | first1=Mike | last1=Esterl | title=Judge Temporarily Blocks Graphic Cigarette Labels | date=November 8, 2011 | url-access=subscription | access-date=August 3, 2017 | archive-date=July 9, 2017 | archive-url=https://web.archive.org/web/20170709173439/https://www.wsj.com/articles/SB10001424052970204554204577024040240467970 | url-status=live }}</ref>

In July 2017, the FDA announced a plan that would reduce the current levels of nicotine permitted in tobacco cigarettes.<ref>{{cite web|url=https://www.npr.org/2017/07/28/540088353/fda-announces-plan-to-cut-level-of-nicotine-allowed-in-cigarettes|title=FDA Announces Plan To Cut Level Of Nicotine Allowed In Cigarettes|website=NPR|access-date=April 4, 2018|archive-date=March 20, 2018|archive-url=https://web.archive.org/web/20180320032301/https://www.npr.org/2017/07/28/540088353/fda-announces-plan-to-cut-level-of-nicotine-allowed-in-cigarettes|url-status=live}}</ref>

===Regulation of living organisms===
With acceptance of premarket notification 510(k) k033391 in January 2004,<ref name="FDA_K033391_Announcement">{{cite web |title=510(k) Premarket Notification K033391 |url=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K033391 |publisher=FDA |access-date=July 4, 2021}}</ref> the FDA granted Ronald Sherman permission to produce and market medical maggots for use in humans or other animals as a prescription medical device.<ref name="FDA_K033391_ClearanceLetter">{{cite web |title=FDA_K033391_ClearanceLetter |url=https://www.accessdata.fda.gov/cdrh_docs/pdf3/K033391.pdf |archive-url=https://web.archive.org/web/20150701125329/http://www.accessdata.fda.gov/cdrh_docs/pdf3/K033391.pdf |archive-date=July 1, 2015 |url-status=live |publisher=FDA |access-date=July 4, 2021}}</ref> Medical maggots represent the first living organism allowed by the Food and Drug Administration for production and marketing as a prescription medical device.<ref name="Greer_2005">{{cite journal |last1=Greer |first1=Kathleen |title=Age-old therapy gets new approval |journal=Advances in Skin & Wound Care |date=2005 |volume=18 |issue=1 |pages=12–15 |doi=10.1097/00129334-200501000-00003 |pmid=15716781 |doi-access=free }}</ref>

In June 2004, the FDA cleared ''[[Biology:Hirudo medicinalis|Hirudo medicinalis]]'' (medicinal leeches) as the second living organism legal to use as a medical device.<ref>{{Cite web |title=FDA approves leeches as medical devices |url=http://www.nbcnews.com/health/health-news/fda-approves-leeches-medical-devices-flna1C9447212 |access-date=January 14, 2023 |website=NBC News |language=en}}</ref>

The FDA also requires that milk be pasteurized to remove bacteria.<ref>{{Cite journal |date=January 26, 2022 |title=The Dangers of Raw Milk: Unpasteurized Milk Can Pose a Serious Health Risk |url=https://www.fda.gov/food/buy-store-serve-safe-food/dangers-raw-milk-unpasteurized-milk-can-pose-serious-health-risk |journal=FDA |language=en}}</ref>

===International Cooperation===
In February 2011, President [[Biography:Barack Obama|Barack Obama]] and Canadian Prime Minister Stephen Harper issued a "Declaration on a Shared Vision for Perimeter Security and Economic Competitiveness"<ref>{{cite press release |url=https://obamawhitehouse.archives.gov/the-press-office/2011/02/04/joint-statement-president-obama-and-prime-minister-harper-canada-regul-0 |title=Joint Statement by President Obama and Prime Minister Harper of Canada on Regulatory Cooperation |date=February 4, 2011 |access-date=February 26, 2011 |archive-date=January 22, 2017 |archive-url=https://web.archive.org/web/20170122200817/https://obamawhitehouse.archives.gov/the-press-office/2011/02/04/joint-statement-president-obama-and-prime-minister-harper-canada-regul-0 |via=National Archives |work=whitehouse.gov |url-status=live }}</ref><ref>{{cite press release |url=http://www.pm.gc.ca/eng/media.asp?id=3931 |title=PM and U.S. President Obama announce shared vision for perimeter security and economic competitiveness between Canada and the United States |publisher=Prime Minister of Canada |date=February 4, 2011 |access-date=February 26, 2011 |archive-url=https://web.archive.org/web/20110219142120/http://www.pm.gc.ca/eng/media.asp?id=3931 |archive-date=February 19, 2011 |url-status=dead  }}</ref> and announced the creation of the Canada-United States Regulatory Cooperation Council (RCC) "to increase regulatory transparency and coordination between the two countries."<ref name=OPM1>{{cite press release |date=December 7, 2011 |url=http://pm.gc.ca/eng/media.asp?id=4511 |publisher=Office of the Prime Minister of Canada |title=United States-Canada Regulatory Cooperation Council (RCC) Joint Action Plan: Developing and implementing the Joint Action Plan |url-status=dead |archive-url=https://web.archive.org/web/20130729152814/http://pm.gc.ca/eng/media.asp?id=4511 |archive-date=July 29, 2013 }}</ref>

Under the RCC mandate, the FDA and [[Organization:Health Canada|Health Canada]] undertook a "first of its kind" initiative by selecting "as its first area of alignment common cold indications for certain over-the-counter [[Chemistry:Antihistamine|antihistamine]] ingredients (GC 2013-01-10)."<ref name=GC20130110>{{cite web |publisher=Government of Canada |series=Canada's Action Plan |title=Notice: Regulatory Cooperation Council (RCC) Over-the-Counter (OTC) Products: Common Monograph Working Group: Selection of a Monograph for Alignment |url=http://actionplan.gc.ca/en/page/rcc-ccr/notice-regulatory-cooperation-council-rcc-over |date=January 10, 2013 |access-date=February 15, 2013 |archive-url=https://web.archive.org/web/20141108070216/http://actionplan.gc.ca/en/page/rcc-ccr/notice-regulatory-cooperation-council-rcc-over |archive-date=November 8, 2014 |url-status=dead  }}</ref>

A more recent example of the FDA's international work is their 2018 cooperation with regulatory and law-enforcement agencies worldwide through Interpol as part of Operation Pangea XI.<ref>{{Cite web|url=https://www.interpol.int/News-and-media/News/2018/N2018-123|title=N2018-123 / 2018 / News / News and media / Internet / Home - INTERPOL|website=Interpol.int|access-date=February 8, 2019|archive-date=February 9, 2019|archive-url=https://web.archive.org/web/20190209123957/https://www.interpol.int/News-and-media/News/2018/N2018-123|url-status=dead}}</ref><ref>{{Cite web|url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624070.htm|title=Press Announcements - FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs; including opioids|last=Commissioner|first=Office of the|publisher=Food and Drug Administration|access-date=February 8, 2019|archive-date=February 7, 2019|archive-url=https://web.archive.org/web/20190207132558/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624070.htm|url-status=live}}</ref> The FDA targeted 465 websites that illegally sold potentially dangerous, unapproved versions of [[Chemistry:Opioid|opioid]], [[Medicine:Chemotherapy|oncology]], and [[Biology:Antiviral drug|antiviral]] prescription drugs to U.S. consumers. The agency focused on [[Finance:Money laundering|transaction laundering]] schemes in order to uncover the complex online drug network.<ref>{{Cite web|url=https://www.thepaypers.com/expert-opinion/transaction-laundering-in-2019-time-to-review-the-monitoring-strategy/776727|title=Transaction laundering in 2019 – time to review the monitoring strategy|publisher=The Paypers|access-date=February 8, 2019|archive-date=July 14, 2020|archive-url=https://web.archive.org/web/20200714025734/https://thepaypers.com/expert-opinion/transaction-laundering-in-2019-time-to-review-the-monitoring-strategy/776727|url-status=live}}</ref>

==Science and research programs==
[[File:FDA Bldg 64 - Lab (5160771733).jpg|thumb|FDA lab at Building 64 in Silver Spring, Maryland]]
The FDA carries out research and development activities to develop technology and standards that support its regulatory role, with the objective of resolving scientific and technical challenges before they become impediments. The FDA's research efforts include the areas of biologics, medical devices, drugs, women's health, toxicology, food safety and applied nutrition, and veterinary medicine.<ref>{{cite web|title=About Science & Research at FDA|url=https://www.fda.gov/ScienceResearch/AboutScienceResearchatFDA/|publisher=Food and Drug Administration|access-date=November 25, 2011|date=June 18, 2009|archive-date=January 14, 2012|archive-url=https://web.archive.org/web/20120114151200/http://www.fda.gov/ScienceResearch/AboutScienceResearchatFDA/|url-status=live}}</ref>

==Data management==
The FDA has collected a large amount of data through the decades. The [[OpenFDA]] project was created to enable easy access of the data for the public and was officially launched in June 2014.<ref>{{Cite web|date=September 11, 2019|title=openFDA|url=https://www.fda.gov/science-research/health-informatics-fda/openfda|access-date=October 3, 2020|website=U.S. Food and Drug Administration|archive-date=October 21, 2020|archive-url=https://web.archive.org/web/20201021204036/https://www.fda.gov/science-research/health-informatics-fda/openfda|url-status=live}}</ref><ref>{{Cite news|last=|first=|date=June 7, 2014|title=FDA opens new drug database to public; hiring site draws investor interest|newspaper=Washington Post|url=https://www.washingtonpost.com/business/economy/fda-opens-new-drug-database-to-public-hiring-site-draws-investor-interest/2014/06/07/624fcbaa-eb43-11e3-9f5c-9075d5508f0a_story.html|url-status=live|access-date=|archive-date=June 23, 2014|archive-url=https://web.archive.org/web/20140623084015/http://www.washingtonpost.com/business/economy/fda-opens-new-drug-database-to-public-hiring-site-draws-investor-interest/2014/06/07/624fcbaa-eb43-11e3-9f5c-9075d5508f0a_story.html}}</ref>

==History==

Up until the 20th century, there were few federal laws regulating the contents and sale of domestically produced food and pharmaceuticals, with one exception being the short-lived [[Biology:Vaccine Act of 1813|Vaccine Act of 1813]].<ref>{{Cite book |last=Prevention |first=National Research Council (US) Division of Health Promotion and Disease |url=https://www.ncbi.nlm.nih.gov/books/NBK216821/ |title=Vaccines: Past, Present, and Future |date=1985 |publisher=National Academies Press (US) |language=en}}</ref> The history of the FDA can be traced to the latter part of the 19th century and the Division of Chemistry of the U.S. Department of Agriculture,<ref name="swann06">{{cite journal |last1=Swann |first1=John P. |title=How Chemists Pushed for Consumer Protection: The Food and Drugs Act of 1906 |journal=Chemical Heritage |date=Summer 2006 |volume=24 |issue=2 |pages=6–11 |url=https://www.fda.gov/media/110307/download}}</ref> which [[Organization:United States Department of Agriculture#Origins in the Patent Office|itself derived]] from the Copyright and Patent Clause. Under Harvey Washington Wiley, appointed chief chemist in 1883, the Division began conducting research into the adulteration and misbranding of food and drugs on the American market.<ref name=swann06/> Wiley's advocacy came at a time when the public had become aroused to hazards in the marketplace by muckraking journalists like [[Biography:Upton Sinclair|Upton Sinclair]], and became part of a general trend for increased federal regulations in matters pertinent to public safety during the [[Social:Progressive Era|Progressive Era]].<ref name="FDAHist">{{cite web|url=https://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm054819.htm|title=FDA History&nbsp;— Part I|publisher=Food and Drug Administration|access-date=March 14, 2015|archive-date=March 16, 2015|archive-url=https://web.archive.org/web/20150316152305/http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm054819.htm|url-status=live}}</ref> The [[Medicine:Biologics Control Act|Biologics Control Act of 1902]] was put in place after a [[Medicine:Diphtheria|diphtheria]] antitoxin derived from tetanus-contaminated serum caused the deaths of thirteen children in St. Louis, Missouri. The serum was originally collected from a horse named [[Medicine:Jim (horse)|Jim]] who had contracted tetanus.<ref>{{Cite web |last=cirmweb |date=June 4, 2012 |title=The surprising journey from a horse named Jim to stem cell therapies at UC Davis |url=https://blog.cirm.ca.gov/2012/06/04/surprising-journey-from-horse-named-jim/ |access-date=January 14, 2023 |website=The Stem Cellar |language=en}}</ref>

[[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 [[Biography:Theodore Roosevelt|Theodore Roosevelt]] signed into law the 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|first=Office of the|last=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}}</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>

By the 1930s, muckraking journalists, consumer protection organizations, and federal regulators began mounting a campaign for stronger regulatory authority by publicizing a list of injurious products that had been ruled permissible under the 1906 law, including [[Physics:Radioactive|radioactive]] beverages, mascara that could cause blindness, and worthless "cures" for [[Medicine:Diabetes|diabetes]] and [[Medicine:Tuberculosis|tuberculosis]].<ref name=swann06/> The resulting proposed law did not get through the Congress of the United States for five years, but was rapidly enacted into law following the public outcry over the 1937 [[Chemistry:Elixir sulfanilamide|Elixir Sulfanilamide]] tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent.<ref>{{cite journal|last=Hamowy|first=Ronald|title=Medical Disasters and the Growth of FDA|date=February 2010|page=7|journal=Independent Policy Reports|url=http://www.independent.org/pdf/policy_reports/2010-02-10-fda.pdf|access-date=January 14, 2022|archive-date=October 10, 2011|archive-url=https://web.archive.org/web/20111010101720/http://independent.org/pdf/policy_reports/2010-02-10-fda.pdf|url-status=live}}</ref>

President Franklin Delano Roosevelt signed the [[Medicine:Federal Food, Drug, and Cosmetic Act|Federal Food, Drug, and Cosmetic Act]] into law on June 24, 1938. The new law significantly increased federal regulatory authority over drugs by mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labeling without requiring that the FDA prove fraudulent intent.<ref name=swann06/>

Soon after passage of the 1938 Act, the FDA began to designate certain drugs as safe for use only under the supervision of a medical professional, and the category of "[[Medicine:Prescription drug|prescription-only]]" drugs was securely codified into law by the [[Medicine:Durham-Humphrey Amendment|Durham-Humphrey Amendment]] in 1951. These developments confirmed extensive powers for the FDA to enforce post-marketing recalls of ineffective drugs.<ref name="FDAHist"/>

[[File:Examining New Drug Applications (067) (7184535293).jpg|thumb|upright|Medical Officer Alexander Fleming, M. D., examines a portion of a 240-volume new drug application around the late 1980s. Applications grew considerably after the efficacy mandate under the 1962 Drug Amendments.]]

Outside of the US, the drug [[Chemistry:Thalidomide|thalidomide]] was marketed for the relief of general nausea and [[Medicine:Morning sickness|morning sickness]], but caused birth defects and even the death of thousands of babies when taken during pregnancy.<ref>[http://www.library.arizona.edu/exhibits/udall/congrept/87th/620817.html Report of Congressman Morris Udall on thalidomide and the Kefauver hearings] {{Webarchive|url=https://web.archive.org/web/20100729124333/http://www.library.arizona.edu/exhibits/udall/congrept/87th/620817.html |date=July 29, 2010 }}.</ref> American mothers were largely unaffected as Frances Oldham Kelsey of the FDA refused to authorize the medication for market. In 1962, the Kefauver-Harris Amendment to the FD&C Act was passed, which represented a "revolution" in FDA regulatory authority.<ref>{{cite journal |last=Temple |first=R |year=2002 |title=Policy developments in regulatory approval |journal=Statistics in Medicine |pmid=12325110 |volume=21 |issue=19 |pages=2939–2948 |doi=10.1002/sim.1298 |s2cid=24779317 |url=https://zenodo.org/record/1229361 |access-date=June 19, 2019 |archive-date=November 27, 2018 |archive-url=https://web.archive.org/web/20181127125144/https://zenodo.org/record/1229361 |url-status=live }}</ref> The most important change was the requirement that all new drug applications demonstrate "substantial evidence" of the drug's efficacy for a marketed indication, in addition to the existing requirement for pre-marketing demonstration of safety. This marked the start of the FDA approval process in its modern form.

These reforms had the effect of increasing the time, and the difficulty, required to bring a drug to market.<ref name="'70s 180">{{Cite book|title= How We Got Here: The '70s|last= Frum|first= David|year= 2000|publisher= Basic Books|location= New York, New York|isbn= 978-0-465-04195-4|page= [https://archive.org/details/howwegothere70sd00frum/page/180 180]|url= https://archive.org/details/howwegothere70sd00frum/page/180}}</ref>  One of the most important statutes in establishing the modern American pharmaceutical market was the 1984 Drug Price Competition and Patent Term Restoration Act, more commonly known as the "Hatch-Waxman Act" after its chief sponsors. The act extended the patent exclusivity terms of new drugs, and tied those extensions, in part, to the length of the FDA approval process for each individual drug. For generic manufacturers, the Act created a new approval mechanism, the Abbreviated New Drug Application (ANDA), in which the generic drug manufacturer need only demonstrate that their generic formulation has the same active ingredient, route of administration, dosage form, strength, and [[Medicine:Pharmacokinetics|pharmacokinetic]] properties ("bioequivalence") as the corresponding brand-name drug. This Act has been credited with, in essence, creating the modern generic drug industry.<ref name="HatchWaxman">{{cite journal |last=Karki |first = L. |year=2005 |title=Review of FDA Law Related to Pharmaceuticals: The Hatch-Waxman Act, Regulatory Amendments and Implications for Drug Patent Enforcement |journal=Journal of the Patent & Trademark Office Society |volume=87 |pages=602–620 }}</ref>

Concerns about the length of the drug approval process were brought to the fore early in the AIDS epidemic. In the mid- and late 1980s, ACT-UP and other HIV activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV and opportunistic infections.<ref>{{cite web|url=http://www.actupny.org/documents/cron-88.html|title=ACT UP/NY Chronology 1988|access-date=March 14, 2015|archive-date=February 2, 1998|archive-url=https://web.archive.org/web/19980202195639/http://www.actupny.org/documents/cron-88.html|url-status=live}}</ref>  Partly in response to these criticisms, the FDA issued new rules to expedite approval of drugs for life-threatening diseases, and expanded pre-approval access to drugs for patients with limited treatment options.<ref>{{cite web |url = https://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm181838.htm |title=FDA Website: Expanded Access and Expedited Approval of New Therapies Related to HIV/AIDS |website=Food and Drug Administration |url-status=dead |archive-date=November 1, 2013 |archive-url = https://web.archive.org/web/20131101115339/https://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm181838.htm }}</ref> All of the initial drugs approved for the treatment of HIV/AIDS were approved through these accelerated approval mechanisms.<ref>{{cite web |url=https://www.fda.gov/fdac/special/newdrug/speeding.html |title=FDA report on accelerated approval process |website=Food and Drug Administration |url-status=dead |archive-date=May 25, 2009 |archive-url =https://web.archive.org/web/20090525082655/https://www.fda.gov/fdac/special/newdrug/speeding.html }}</ref> Frank Young, then commissioner of the FDA, was behind the Action Plan Phase II, established in August 1987 for quicker approval of AIDS medication.<ref>{{Cite journal|title = Reagan, Regulation, and the FDA: The US Food and Drug Administration's Response to HIV/AIDS, 1980–90|last = Richert|first = Lucas|date = 2009|journal = Canadian Journal of History|volume = 44|issue = 3|pages = 467–488|doi = 10.3138/cjh.44.3.467}}</ref>

In two instances, state governments have sought to legalize drugs that the FDA has not approved. Under the theory that federal law, passed pursuant to Constitutional authority, overrules conflicting state laws, federal authorities still claim the authority to seize, arrest, and prosecute for possession and sales of these substances, even in states where they are legal under state law. The first wave was the legalization by 27 states of laetrile in the late 1970s. This drug was used as a treatment for cancer, but scientific studies both before and after this legislative trend found it ineffective.<ref>{{cite web|url=https://www.npr.org/templates/transcript/transcript.php?storyId=127773447|title=Medicinal Marijuana: A Patient-Driven Phenomenon|date=June 14, 2010|work=NPR.org|access-date=March 14, 2015|archive-date=March 17, 2015|archive-url=https://web.archive.org/web/20150317084419/http://www.npr.org/templates/transcript/transcript.php?storyId=127773447|url-status=live}}</ref><ref name="quack-laetrile">{{cite web|url=http://www.quackwatch.com/01QuackeryRelatedTopics/Cancer/laetrile.html|title=The Rise and Fall of Laetrile|access-date=March 14, 2015|archive-date=July 19, 2018|archive-url=https://web.archive.org/web/20180719022002/http://www.quackwatch.com/01QuackeryRelatedTopics/Cancer/laetrile.html|url-status=live}}</ref> The second wave concerned medical marijuana in the 1990s and 2000s. Though Virginia passed legislation allowing doctors to recommend cannabis for glaucoma or the side effects of chemotherapy, a more widespread trend began in California with the Compassionate Use Act of 1996.

When the FDA requested Endo Pharmaceuticals on June 8, 2017, to remove ''oxymorphone hydrochloride'' from the market, it was the first such request in FDA history.<ref>{{cite press release |date=June 8, 2017 |url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm |title=FDA requests removal of Opana ER for risks related to abuse |publisher=Food and Drug Administration |access-date=October 26, 2017 |quote=Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market... This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse...[FDA Commissioner Scott Gottlieb, M.D.]: "We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse. |archive-date=November 4, 2017 |archive-url=https://web.archive.org/web/20171104114609/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm |url-status=live }}</ref>

==21st century reforms==

===Critical Path Initiative===
The Critical Path Initiative<ref>{{cite web|url=https://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/default.htm|title=Critical Path Initiative|first=Office of the|last=Commissioner|publisher=Food and Drug Administration|date=February 8, 2019|access-date=December 16, 2019|archive-date=April 22, 2019|archive-url=https://web.archive.org/web/20190422171814/https://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/default.htm|url-status=live}}</ref> is the FDA's effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured. The Initiative was launched in March 2004, with the release of a report entitled Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products.<ref>[https://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm Innovation or Stagnation:  Challenge and Opportunity on the Critical Path to New Medical Products] {{Webarchive|url=https://wayback.archive-it.org/7993/20180125032208/https://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm |date=January 25, 2018 }} FDA. Retrieved August 30, 2012.</ref>

===Patients' rights to access unapproved drugs===
The Compassionate Investigational New Drug program was created after ''Randall v. U.S.'' ruled in favor of Robert C. Randall in 1978, creating a program for medical marijuana.<ref>{{cite web|url=https://www.vice.com/en_us/article/dp3e4y/the-us-government-has-sent-this-guy-300-joints-each-month-for-34-years|title=The US Government Has Sent This Guy 300 Joints Each Month for 34 Years|date=September 9, 2016|access-date=October 14, 2017|archive-date=October 14, 2017|archive-url=https://web.archive.org/web/20171014142910/https://www.vice.com/en_us/article/dp3e4y/the-us-government-has-sent-this-guy-300-joints-each-month-for-34-years|url-status=live}}</ref>

A 2006 court case, ''Abigail Alliance v. von Eschenbach'', would have forced radical changes in FDA regulation of unapproved drugs. The Abigail Alliance argued that the FDA must license drugs for use by terminally ill patients with "desperate diagnoses," after they have completed Phase I testing.<ref>{{cite web |url= http://www.abigail-alliance.org/WLF_FDA.pdf |title= Abigail Alliance Citizen Petition to FDA |access-date= March 11, 2007 |archive-url= https://web.archive.org/web/20070221153207/http://abigail-alliance.org/WLF_FDA.pdf |archive-date= February 21, 2007 |url-status= dead }}&nbsp;{{small|(119&nbsp;KB)}}</ref> The case won an initial appeal in May 2006, but that decision was reversed by a March 2007 rehearing. The US Supreme Court declined to hear the case, and the final decision denied the existence of a right to unapproved medications.

Critics of the FDA's regulatory power argue that the FDA takes too long to approve drugs that might ease pain and human suffering faster if brought to market sooner.  The AIDS crisis created some political efforts to streamline the approval process.  However, these limited reforms were targeted for AIDS drugs, not for the broader market.  This has led to the call for more robust and enduring reforms that would allow patients, under the care of their doctors, access to drugs that have passed the first round of clinical trials.<ref>{{cite book |last1=Madden |first1=Bartley J. |url=https://archive.org/details/freetochoosemedi0000madd |title=Free To Choose Medicine: How Faster Access to New Drugs Would Save Countless Lives and End Needless Suffering: Bartley J. Madden: 9781934791325: Amazon.com: Books |date=July 2010 |publisher=Heartland Institute |isbn=978-1934791325}}</ref><ref>{{cite news | url=https://www.wsj.com/articles/SB10001424052702303812104576441610360466984 | work=The Wall Street Journal | first1=Michele | last1=Boldrin | first2=S. Joshua | last2=Swamidass | title=A New Bargain for Drug Approvals | date=July 25, 2011 | url-access=subscription | access-date=August 3, 2017 | archive-date=July 9, 2017 | archive-url=https://web.archive.org/web/20170709173632/https://www.wsj.com/articles/SB10001424052702303812104576441610360466984 | url-status=live }}</ref>

===Post-marketing drug safety monitoring===
The widely publicized recall of Vioxx, a non-steroidal anti-inflammatory drug (NSAID) now estimated to have contributed to fatal [[Medicine:Myocardial infarction|heart attacks]] in thousands of Americans, played a strong role in driving a new wave of safety reforms at both the FDA rulemaking and statutory levels. The FDA approved Vioxx in 1999, and initially hoped it would be safer than previous NSAIDs due to its reduced risk of intestinal tract bleeding. However, a number of pre and post-marketing studies suggested that Vioxx might increase the risk of myocardial infarction, and results from the APPROVe trial in 2004 conclusively demonstrated this.<ref>{{cite journal|title= Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial|last=Bresalier |first=RS |s2cid=8161299 |pmid=15713943 |doi=10.1056/NEJMoa050493 |volume=352 |issue=11 |date=March 2005 |journal=N. Engl. J. Med. |pages=1092–102|doi-access=free }}</ref>

Faced with numerous lawsuits, the manufacturer voluntarily withdrew it from the market. The example of Vioxx has been prominent in an ongoing debate over whether new drugs should be evaluated on the basis of their absolute safety, or their safety relative to existing treatments for a given condition. In the wake of the Vioxx recall, there were widespread calls by major newspapers, medical journals, consumer advocacy organizations, lawmakers, and FDA officials<ref name="Graham">{{cite web |url= http://www.finance.senate.gov/imo/media/doc/111804dgtest.pdf |title= David Graham's 2004 testimony to Congress |access-date= August 30, 2012 |archive-date= September 25, 2012 |archive-url= https://web.archive.org/web/20120925094651/http://www.finance.senate.gov/imo/media/doc/111804dgtest.pdf |url-status= live }}&nbsp;{{small|(28.3&nbsp;KB)}} Retrieved August 30, 2012.</ref> for reforms in the FDA's procedures for pre- and post-market drug safety regulation.

In 2006, a Congressional committee was appointed by the Institute of Medicine to review pharmaceutical safety regulation in the U.S. and to issue recommendations for improvements. The committee was composed of 16 experts, including leaders in clinical medicine medical research, economics, [[Biology:Biostatistics|biostatistics]], law, public policy, public health, and the allied health professions, as well as current and former executives from the pharmaceutical, hospital, and health insurance industries. The authors found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA.<ref>{{Cite news|first=Diedtra |last=Henderson |title=Panel: FDA needs more power, funds |work=The Boston Globe |date=September 23, 2006}} [https://web.archive.org/web/20121023223500/http://www.boston.com/business/healthcare/articles/2006/09/23/panel_fda_needs_more_power_funds/ Webcitation.org]</ref><ref>[http://www.nap.edu/openbook.php?record_id=11750&page=205 Books.nap.edu] {{Webarchive|url=https://web.archive.org/web/20121025132523/http://www.nap.edu/openbook.php?record_id=11750&page=205 |date=October 25, 2012 }} Executive Summary of the 2006 IOM Report ''The Future of Drug Safety: Promoting and Protecting the Health of the Public''</ref> Some of the committee's recommendations were incorporated into drafts of the PDUFA IV amendment, which was signed into law as the Food and Drug Administration Amendments Act of 2007.<ref>{{cite web|url=https://www.fda.gov/oc/initiatives/advance/fdaaa.html|title=Food and Drug Administration Amendments Act (FDAAA) of 2007|publisher=Food and Drug Administration|access-date=March 14, 2015|archive-date=May 25, 2009|archive-url=https://web.archive.org/web/20090525082137/http://www.fda.gov/oc/initiatives/advance/fdaaa.html|url-status=live}}</ref>

As of 2011, Risk Minimization Action Plans (RiskMAPS) have been created to ensure risks of a drug never outweigh the benefits of that drug within the post-marketing period. This program requires that manufacturers design and implement periodic assessments of their programs' effectiveness. The Risk Minimization Action Plans are set in place depending on the overall level of risk a prescription drug is likely to pose to the public.<ref>{{Cite journal|vauthors=Qato DM, Alexander GC |title=Post-Marketing Drug Safety and the Food and Drug Administration's Risk Evaluation and Mitigation Strategies|journal=JAMA|volume=306|pages=1595–1596|year=2011|doi=10.1001/jama.2011.1457|pmid=21990303|issue=14}}</ref>

===Pediatric drug testing===
Prior to the 1990s, only 20% of all drugs prescribed for children in the United States were tested for safety or efficacy in a pediatric population.<ref>{{cite journal |last1=Temeck |first1=Jean |title=Pediatric Product Development in the U.S. |journal=FDA Seminar, Copenhagen |date=November 2010}}</ref> This became a major concern of pediatricians as evidence accumulated that the physiological response of children to many drugs differed significantly from those drugs' effects on adults. Children react differently to the drugs because of many reasons, including size, weight, etc. There were several reasons that few medical trials were done with children. For many drugs, children represented such a small proportion of the potential market, that drug manufacturers did not see such testing as cost-effective.<ref name = "PedReg"/>

Also, the belief that children are ethically restricted in their ability to give [[Philosophy:Informed consent|informed consent]] brought increased governmental and institutional hurdles to approval of these clinical trials, and greater concerns about [[Social:Legal liability|legal liability]]. Thus, for decades, most medicines prescribed to children in the U.S. were done so in a non-FDA-approved, "off-label" manner, with dosages "extrapolated" from adult data through body weight and body-surface-area calculations.<ref name = "PedReg"/>

In an initial FDA attempt to address this issue they produced the 1994 FDA Final Rule on Pediatric Labeling and Extrapolation, which allowed manufacturers to add pediatric labeling information, but required drugs that had not been tested for pediatric safety and efficacy to bear a disclaimer to that effect. However, this rule failed to motivate many drug companies to conduct additional pediatric drug trials. In 1997, the FDA proposed a rule to require pediatric drug trials from the sponsors of [[Chemistry:New Drug Application|New Drug Application]]s. However, this new rule was successfully preempted in federal court as exceeding the FDA's statutory authority.<ref name="PedReg">{{Cite journal|author=Politis P |year=2005 |title=Transition From the Carrot to the Stick: The Evolution of Pharmaceutical Regulations Concerning Pediatric Drug Testing |journal=Widener Law Review |volume=12 |page=271}}</ref>

While this debate was unfolding, Congress used the Food and Drug Administration Modernization Act of 1997 to pass incentives that gave pharmaceutical manufacturers a six-month patent term extension on new drugs submitted with pediatric trial data. The Best Pharmaceuticals for Children Act of 2007 reauthorized these provisions and allowed the FDA to request [[Organization:National Institutes of Health|NIH]]-sponsored testing for pediatric drug testing, although these requests are subject to NIH funding constraints. In the Pediatric Research Equity Act of 2003, Congress codified the FDA's authority to mandate manufacturer-sponsored pediatric drug trials for certain drugs as a "last resort" if incentives and publicly funded mechanisms proved inadequate.<ref name="PedReg"/>

===Priority review voucher (PRV)===
The priority review voucher is a provision of the Food and Drug Administration Amendments Act of 2007, which awards a transferable "priority review voucher" to any company that obtains approval for a treatment for a [[Medicine:Neglected tropical diseases|neglected tropical diseases]]. The system was first proposed by [[Organization:Duke University|Duke University]] faculty David Ridley, Henry Grabowski, and Jeffrey Moe in their 2006 ''Health Affairs'' paper: "Developing Drugs for Developing Countries".<ref name=Ridley06>{{cite journal |vauthors=Ridley DB, Grabowski HG, Moe JL |title=Developing drugs for developing countries |journal=Health Aff (Millwood) |volume=25 |issue=2 |pages=313–24 |year=2006 |pmid=16522573 |doi=10.1377/hlthaff.25.2.313 |doi-access=free |hdl=10161/7017 |hdl-access=free }}</ref> President Obama signed into law the Food and Drug Administration Safety and Innovation Act of 2012, which extended the authorization until 2017.<ref name="PLAW_2012">{{cite web | url=http://www.gpo.gov/fdsys/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf | title=Section 529 Rare Pediatric Disease Priority Review Voucher Incentive Program, Public Law 112-144 | publisher=Public Law | date=July 9, 2012 | access-date=November 19, 2015 | archive-date=March 6, 2016 | archive-url=https://web.archive.org/web/20160306214504/https://www.gpo.gov/fdsys/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf | url-status=live }}</ref>

===Rules for generic biologics===
Since the 1990s, many successful new drugs for the treatment of cancer, [[Medicine:Autoimmunity|autoimmune diseases]], and other conditions have been [[Biology:Protein|protein]]-based biotechnology drugs, regulated by the [[Organization:Center for Biologics Evaluation and Research|Center for Biologics Evaluation and Research]]. Many of these drugs are extremely expensive; for example, the anti-cancer drug Avastin costs $55,000 for a year of treatment,<ref>{{Cite web|title=The Avastin Paradox|url=https://www.technologyreview.com/2009/07/13/30529/the-avastin-paradox/|access-date=January 6, 2022|website=MIT Technology Review|language=en}}</ref> while the [[Medicine:Enzyme replacement therapy|enzyme replacement therapy]] drug [[Chemistry:Imiglucerase|Cerezyme]] costs $200,000 per year, and must be taken by [[Medicine:Gaucher's disease|Gaucher's disease]] patients for life.<ref name="govtrack.us">{{cite web|url=https://www.govtrack.us/congress/bills/110/hr1038|title=To amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products, and for other purposes. (2007; 110th Congress H.R. 1038) – GovTrack.us|work=GovTrack.us|access-date=March 14, 2015|archive-date=January 12, 2015|archive-url=https://web.archive.org/web/20150112032213/https://www.govtrack.us/congress/bills/110/hr1038|url-status=live}}</ref>

Biotechnology drugs do not have the simple, readily verifiable chemical structures of conventional drugs, and are produced through complex, often proprietary, techniques, such as transgenic mammalian cell cultures. Because of these complexities, the 1984 Hatch-Waxman Act did not include biologics in the Abbreviated New Drug Application (ANDA) process. This precluded the possibility of generic drug competition for biotechnology drugs. In February 2007, identical bills were introduced into the House to create an ANDA process for the approval of generic biologics, but were not passed.<ref name="govtrack.us"/>

===Mobile medical applications===
In 2013, a guidance was issued to regulate mobile medical applications and protect users from their unintended use. This guidance distinguishes the apps subjected to regulation based on the marketing claims of the apps.<ref>{{cite web|url=https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/ucm255978.htm|title=Mobile Medical Applications|publisher=Food and Drug Administration|access-date=March 14, 2015|archive-date=September 4, 2015|archive-url=https://web.archive.org/web/20150904095950/http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/ucm255978.htm|url-status=live}}</ref> Incorporation of the guidelines during the development phase of these apps has been proposed for expedited market entry and clearance.<ref>{{cite journal |author1=Yetisen A. K. |author2=Martinez-Hurtado J. L. | year = 2014 | title = The regulation of mobile medical applications | journal = Lab on a Chip | volume = 14 | issue = 5| pages = 833–840 | doi = 10.1039/C3LC51235E |pmid=24425070 |display-authors=0}}</ref>

==Criticism==
The FDA has regulatory oversight over a large array of products that affect the health and life of American citizens.<ref name="FDAHist"/> As a result, the FDA's powers and decisions are carefully monitored by several governmental and non-governmental organizations. A $1.8{{nbsp}}million 2006 Institute of Medicine report on pharmaceutical regulation in the U.S. found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA.<ref name=IOM2006>{{Cite book|first=Diedtra |last=Henderson |title=Panel: FDA needs more power, funds |work= The Boston Globe |date=September 23, 2006}} [https://web.archive.org/web/20121023223500/http://www.boston.com/business/healthcare/articles/2006/09/23/panel_fda_needs_more_power_funds/ Webcitation.org]</ref><ref>Committee on the Assessment of the US Drug Safety System. (2006). ''The Future of Drug Safety: Promoting and Protecting the Health of the Public''. Institute of Medicine. [http://www.nap.edu/catalog.php?record_id=11750#toc Free full-text] {{Webarchive|url=https://web.archive.org/web/20100702001617/http://www.nap.edu/catalog.php?record_id=11750#toc |date=July 2, 2010 }}.</ref>

A 2022 article from ''Politico'' raised concerns that food is not a high priority at the FDA. The report explains the FDA has structural and leadership problems in the food division and is often deferential to industry.<ref>{{cite web |last1=Bottemiller Evich |first1=Helena |title=How the FDA's food division fails to regulate health and safety hazards |url=https://www.politico.com/interactives/2022/fda-fails-regulate-food-health-safety-hazards/ |website=politico.com |publisher=Politico |access-date=April 4, 2022}}</ref> This might be attributed to [[Social:Lobbying|lobbying]] and influence of big food companies in Washington, D.C.<ref>{{cite web |last1=Doering |first1=Christopher |title=Where the dollars go: Lobbying a big business for large food and beverage CPGs |url=https://www.fooddive.com/news/where-the-dollars-go-lobbying-a-big-business-for-large-food-and-beverage-c/607982/ |website=fooddive.com |publisher=Food Dive}}</ref>

During the COVID-19 pandemic, the FDA received criticism for punishing small distilleries that made hand sanitizers to help meet the unexpected demand. After receiving $14,000 fines from the FDA, some producers stated, "I wish we'd never done it. I will not put myself on this same chopping block again."<ref>{{cite web|title=FDA Can't Stop Harassing Distillers Who Made Hand Sanitizer During the Pandemic|url=https://reason.com/2022/08/08/fda-cant-stop-harassing-distillers-who-made-hand-sanitizer-during-the-pandemic/|date=August 8, 2022}}</ref>

==See also==
* Adverse reaction
* [[Medicine:Adverse event|Adverse event]]
* [[Medicine:Adverse drug reaction|Adverse drug reaction]]
* [[Biology:Biosecurity|Biosecurity]]
* Biosecurity in the United States
* [[Medicine:Drug Efficacy Study Implementation|Drug Efficacy Study Implementation]]
* Food and Drug Administration Modernization Act of 1997
* [[Medicine:FDA Food Safety Modernization Act|FDA Food Safety Modernization Act of 2011]]
* FDA Fast Track Development Program (for drugs)
* Food and Drug Administration Amendments Act of 2007 (e.g. drugs)
* Food and Drug Administration Safety and Innovation Act of 2012 (GAIN/QIDP etc.)
* [[Philosophy:Inverse benefit law|Inverse benefit law]]
* Investigational Device Exemption (for use in clinical trials)
* [[Medicine:Kefauver Harris Amendment|Kefauver Harris Amendment]] 1962 – required "proof-of-efficacy" for drugs

'''International:'''
* Food Administration
* International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
* African Union: African Medicines Agency
* Australia: Therapeutic Goods Administration
* Brazil: National Health Surveillance Agency
* Canada: Marketed Health Products Directorate
* Canada: [[Organization:Health Canada|Health Canada]]
* Denmark: Danish Medicines Agency
* European Union: [[Organization:European Medicines Agency|European Medicines Agency]]
* Germany: Federal Institute for Drugs and Medical Devices
* India: Food Safety and Standards Authority of India
* India: [[Organization:Central Drugs Standard Control Organization|Central Drugs Standard Control Organization]]
* Japan: [[Organization:Ministry of Health, Labour and Welfare|Ministry of Health, Labour and Welfare]] (MHLW)
* Japan: Pharmaceuticals and Medical Devices Agency
* Mexico: Federal Commission for the Protection against Sanitary Risk
* Philippines: [[Organization:Food and Drug Administration (Philippines)|Food and Drug Administration]] (FDA)
* Singapore: Health Sciences Authority
* United Kingdom: [[Organization:Medicines and Healthcare products Regulatory Agency|Medicines and Healthcare products Regulatory Agency]]
* United States: Food and Drug Administration

== Notes ==
{{NoteFoot}}

== References ==
{{Reflist}}

== Further reading ==
* Givel, Michael (December 2005). "Philip Morris' FDA Gambit: Good for Public Health?" ''Journal of Public Health Policy'' (26): pp.&nbsp;450–468
* {{cite encyclopedia |last1=Henninger |first1=Daniel |editor= David R. Henderson|encyclopedia=Concise Encyclopedia of Economics |title=Drug Lag |url=http://www.econlib.org/library/Enc1/DrugLag.html |year=2002 |edition= 1st |publisher=Library of Economics and Liberty }} {{OCLC|317650570|50016270|163149563}}
* Hilts, Philip J. (2003). ''Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation.'' New York: Alfred E. Knopf. {{ISBN|0-375-40466-X}}
* Kevin Fain, Matthew Daubresse, G. Caleb Alexander (2013). "The Food and Drug Administration Amendments Act and Postmarketing Commitments." "JAMA" 310(2): 202–204 {{doi|10.1001/jama.2013.7900}}.
* Madden, Bartley (2010) ''Free To Choose Medicine: How Faster Access to New Drugs Would Save Countless Lives and End Needless Suffering'' Chicago: The [[Organization:Heartland Institute|Heartland Institute]]. {{ISBN|978-1-934791-32-5}}
* Moore, Thomas J. (1998). ''Prescription for Disaster: The Hidden Dangers in Your Medicine Cabinet.'' New York: Simon & Schuster. {{ISBN|0-684-82998-3}}
* Obenchain, Janel, and Arlene Spark. Food Policy: Looking Forward from the Past. CRC Press, 2015.
* Shah, Soleil, and Abdul El-Sayed, "Medical Algorithms Need Better Regulation: Many do not require FDA approval, and those that do often do not undergo clinical trials", ''Scientific American'', vol. 326, no. 1 (January 2022), pp.&nbsp;10–11. "Medical algorithms are less transparent, far more complex, more likely to reflect preexisting human bias, and more apt to evolve (and fail) over time than medical devices in the past." (p.&nbsp;11.)

==External links==
* {{Official website}}
* [https://www.federalregister.gov/agencies/food-and-drug-administration Food and Drug Administration] in the Federal Register
* [https://web.archive.org/web/20130225130615/http://xml.fido.gov/stratml/carmel/FDAwStyle.xml Strategic Plan]
* {{OL author}}
* [https://onlinebooks.library.upenn.edu/webbin/book/lookupname?key=United+States.+Food+and+Drug+Administration Online books by United States Food and Drug Administration] at [[Online Books Page|The Online Books Page]]

{{DEFAULTSORT:Food And Drug Administration (United States)}}
[[Category:Regulators of biotechnology products]]

{{Sourceattribution|Food and Drug Administration}}