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<span>Location</span> </div> </a> <button aria-controls="toc-Location-sublist" class="cdx-button cdx-button--weight-quiet cdx-button--icon-only vector-toc-toggle"> <span class="vector-icon mw-ui-icon-wikimedia-expand"></span> <span>Toggle Location subsection</span> </button> <ul id="toc-Location-sublist" class="vector-toc-list"> <li id="toc-Headquarters" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Headquarters"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.1</span> <span>Headquarters</span> </div> </a> <ul id="toc-Headquarters-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-White_Oak_Federal_Research_Center" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#White_Oak_Federal_Research_Center"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.2</span> <span>White Oak Federal Research Center</span> </div> </a> <ul id="toc-White_Oak_Federal_Research_Center-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Field_locations" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Field_locations"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.3</span> <span>Field locations</span> </div> </a> <ul id="toc-Field_locations-sublist" class="vector-toc-list"> <li id="toc-Office_of_Regulatory_Affairs" class="vector-toc-list-item vector-toc-level-3"> <a class="vector-toc-link" href="#Office_of_Regulatory_Affairs"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.3.1</span> <span>Office of Regulatory Affairs</span> </div> </a> <ul id="toc-Office_of_Regulatory_Affairs-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Office_of_Criminal_Investigations" class="vector-toc-list-item vector-toc-level-3"> <a class="vector-toc-link" href="#Office_of_Criminal_Investigations"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.3.2</span> <span>Office of Criminal Investigations</span> </div> </a> <ul id="toc-Office_of_Criminal_Investigations-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Other_locations" class="vector-toc-list-item vector-toc-level-3"> <a class="vector-toc-link" href="#Other_locations"> <div class="vector-toc-text"> <span class="vector-toc-numb">2.3.3</span> <span>Other locations</span> </div> </a> <ul id="toc-Other_locations-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> </ul> </li> <li id="toc-Scope_and_funding" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#Scope_and_funding"> <div class="vector-toc-text"> <span class="vector-toc-numb">3</span> <span>Scope and funding</span> </div> </a> <ul id="toc-Scope_and_funding-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Regulatory_programs" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#Regulatory_programs"> <div class="vector-toc-text"> <span class="vector-toc-numb">4</span> <span>Regulatory programs</span> </div> </a> <button aria-controls="toc-Regulatory_programs-sublist" class="cdx-button cdx-button--weight-quiet cdx-button--icon-only vector-toc-toggle"> <span class="vector-icon mw-ui-icon-wikimedia-expand"></span> <span>Toggle Regulatory programs subsection</span> </button> <ul id="toc-Regulatory_programs-sublist" class="vector-toc-list"> <li id="toc-Emergency_approvals_(EUA)" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Emergency_approvals_(EUA)"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.1</span> <span>Emergency approvals (EUA)</span> </div> </a> <ul id="toc-Emergency_approvals_(EUA)-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Regulations" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Regulations"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.2</span> <span>Regulations</span> </div> </a> <ul id="toc-Regulations-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Food_and_dietary_supplements" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Food_and_dietary_supplements"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.3</span> <span>Food and dietary supplements</span> </div> </a> <ul id="toc-Food_and_dietary_supplements-sublist" class="vector-toc-list"> <li id="toc-"FDA-Approved"_vs._"FDA-Accepted_in_Food_Processing"" class="vector-toc-list-item vector-toc-level-3"> <a class="vector-toc-link" href="#"FDA-Approved"_vs._"FDA-Accepted_in_Food_Processing""> <div class="vector-toc-text"> <span class="vector-toc-numb">4.3.1</span> <span>"FDA-Approved" vs. "FDA-Accepted in Food Processing"</span> </div> </a> <ul id="toc-"FDA-Approved"_vs._"FDA-Accepted_in_Food_Processing"-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Medical_countermeasures_(MCMs)" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Medical_countermeasures_(MCMs)"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.4</span> <span>Medical countermeasures (MCMs)</span> </div> </a> <ul id="toc-Medical_countermeasures_(MCMs)-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Medications" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Medications"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.5</span> <span>Medications</span> </div> </a> <ul id="toc-Medications-sublist" class="vector-toc-list"> <li id="toc-New_medications" class="vector-toc-list-item vector-toc-level-3"> <a class="vector-toc-link" href="#New_medications"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.5.1</span> <span>New medications</span> </div> </a> <ul id="toc-New_medications-sublist" class="vector-toc-list"> <li id="toc-Advertising_and_promotion" class="vector-toc-list-item vector-toc-level-4"> <a class="vector-toc-link" href="#Advertising_and_promotion"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.5.1.1</span> <span>Advertising and promotion</span> </div> </a> <ul id="toc-Advertising_and_promotion-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Post-market_safety_surveillance" class="vector-toc-list-item vector-toc-level-4"> <a class="vector-toc-link" href="#Post-market_safety_surveillance"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.5.1.2</span> <span>Post-market safety surveillance</span> </div> </a> <ul id="toc-Post-market_safety_surveillance-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Generic_drugs" class="vector-toc-list-item vector-toc-level-3"> <a class="vector-toc-link" href="#Generic_drugs"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.5.2</span> <span>Generic drugs</span> </div> </a> <ul id="toc-Generic_drugs-sublist" class="vector-toc-list"> <li id="toc-Generic_drug_scandal" class="vector-toc-list-item vector-toc-level-4"> <a class="vector-toc-link" href="#Generic_drug_scandal"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.5.2.1</span> <span>Generic drug scandal</span> </div> </a> <ul id="toc-Generic_drug_scandal-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Over-the-counter_drugs" class="vector-toc-list-item vector-toc-level-3"> <a class="vector-toc-link" href="#Over-the-counter_drugs"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.5.3</span> <span>Over-the-counter drugs</span> </div> </a> <ul id="toc-Over-the-counter_drugs-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Ebola_treatment" class="vector-toc-list-item vector-toc-level-3"> <a class="vector-toc-link" href="#Ebola_treatment"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.5.4</span> <span>Ebola treatment</span> </div> </a> <ul id="toc-Ebola_treatment-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Coronavirus_(COVID-19)_testing" class="vector-toc-list-item vector-toc-level-3"> <a class="vector-toc-link" href="#Coronavirus_(COVID-19)_testing"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.5.5</span> <span>Coronavirus (COVID-19) testing</span> </div> </a> <ul id="toc-Coronavirus_(COVID-19)_testing-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Vaccines,_blood_and_tissue_products,_and_biotechnology" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Vaccines,_blood_and_tissue_products,_and_biotechnology"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.6</span> <span>Vaccines, blood and tissue products, and biotechnology</span> </div> </a> <ul id="toc-Vaccines,_blood_and_tissue_products,_and_biotechnology-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Medical_and_radiation-emitting_devices" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Medical_and_radiation-emitting_devices"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.7</span> <span>Medical and radiation-emitting devices</span> </div> </a> <ul id="toc-Medical_and_radiation-emitting_devices-sublist" class="vector-toc-list"> <li id="toc-"FDA-Cleared"_vs_"FDA-Approved"" class="vector-toc-list-item vector-toc-level-3"> <a class="vector-toc-link" href="#"FDA-Cleared"_vs_"FDA-Approved""> <div class="vector-toc-text"> <span class="vector-toc-numb">4.7.1</span> <span>"FDA-Cleared" vs "FDA-Approved"</span> </div> </a> <ul id="toc-"FDA-Cleared"_vs_"FDA-Approved"-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Cosmetics" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Cosmetics"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.8</span> <span>Cosmetics</span> </div> </a> <ul id="toc-Cosmetics-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Veterinary_products" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Veterinary_products"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.9</span> <span>Veterinary products</span> </div> </a> <ul id="toc-Veterinary_products-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Tobacco_products" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Tobacco_products"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.10</span> <span>Tobacco products</span> </div> </a> <ul id="toc-Tobacco_products-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Regulation_of_living_organisms" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Regulation_of_living_organisms"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.11</span> <span>Regulation of living organisms</span> </div> </a> <ul id="toc-Regulation_of_living_organisms-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-International_Cooperation" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#International_Cooperation"> <div class="vector-toc-text"> <span class="vector-toc-numb">4.12</span> <span>International Cooperation</span> </div> </a> <ul id="toc-International_Cooperation-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Science_and_research_programs" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#Science_and_research_programs"> <div class="vector-toc-text"> <span class="vector-toc-numb">5</span> <span>Science and research programs</span> </div> </a> <ul id="toc-Science_and_research_programs-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Data_management" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#Data_management"> <div class="vector-toc-text"> <span class="vector-toc-numb">6</span> <span>Data management</span> </div> </a> <ul id="toc-Data_management-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-History" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#History"> <div class="vector-toc-text"> <span class="vector-toc-numb">7</span> <span>History</span> </div> </a> <ul id="toc-History-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-21st-century_reforms" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#21st-century_reforms"> <div class="vector-toc-text"> <span class="vector-toc-numb">8</span> <span>21st-century reforms</span> </div> </a> <button aria-controls="toc-21st-century_reforms-sublist" class="cdx-button cdx-button--weight-quiet cdx-button--icon-only vector-toc-toggle"> <span class="vector-icon mw-ui-icon-wikimedia-expand"></span> <span>Toggle 21st-century reforms subsection</span> </button> <ul id="toc-21st-century_reforms-sublist" class="vector-toc-list"> <li id="toc-Critical_Path_Initiative" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Critical_Path_Initiative"> <div class="vector-toc-text"> <span class="vector-toc-numb">8.1</span> <span>Critical Path Initiative</span> </div> </a> <ul id="toc-Critical_Path_Initiative-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Patients'_rights_to_access_unapproved_drugs" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Patients'_rights_to_access_unapproved_drugs"> <div class="vector-toc-text"> <span class="vector-toc-numb">8.2</span> <span>Patients' rights to access unapproved drugs</span> </div> </a> <ul id="toc-Patients'_rights_to_access_unapproved_drugs-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Post-marketing_drug_safety_monitoring" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Post-marketing_drug_safety_monitoring"> <div class="vector-toc-text"> <span class="vector-toc-numb">8.3</span> <span>Post-marketing drug safety monitoring</span> </div> </a> <ul id="toc-Post-marketing_drug_safety_monitoring-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Pediatric_drug_testing" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Pediatric_drug_testing"> <div class="vector-toc-text"> <span class="vector-toc-numb">8.4</span> <span>Pediatric drug testing</span> </div> </a> <ul id="toc-Pediatric_drug_testing-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Priority_review_voucher_(PRV)" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Priority_review_voucher_(PRV)"> <div class="vector-toc-text"> <span class="vector-toc-numb">8.5</span> <span>Priority review voucher (PRV)</span> </div> </a> <ul id="toc-Priority_review_voucher_(PRV)-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Rules_for_generic_biologics" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Rules_for_generic_biologics"> <div class="vector-toc-text"> <span class="vector-toc-numb">8.6</span> <span>Rules for generic biologics</span> </div> </a> <ul id="toc-Rules_for_generic_biologics-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Mobile_medical_applications" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Mobile_medical_applications"> <div class="vector-toc-text"> <span class="vector-toc-numb">8.7</span> <span>Mobile medical applications</span> </div> </a> <ul id="toc-Mobile_medical_applications-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Electronic_Submissions_Gateway_(ESG)" class="vector-toc-list-item vector-toc-level-2"> <a class="vector-toc-link" href="#Electronic_Submissions_Gateway_(ESG)"> <div class="vector-toc-text"> <span class="vector-toc-numb">8.8</span> <span>Electronic Submissions Gateway (ESG)</span> </div> </a> <ul id="toc-Electronic_Submissions_Gateway_(ESG)-sublist" class="vector-toc-list"> </ul> </li> </ul> </li> <li id="toc-Criticism" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#Criticism"> <div class="vector-toc-text"> <span class="vector-toc-numb">9</span> <span>Criticism</span> </div> </a> <ul id="toc-Criticism-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-See_also" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#See_also"> <div class="vector-toc-text"> <span class="vector-toc-numb">10</span> <span>See also</span> </div> </a> <ul id="toc-See_also-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Notes" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#Notes"> <div class="vector-toc-text"> <span class="vector-toc-numb">11</span> <span>Notes</span> </div> </a> <ul id="toc-Notes-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-References" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#References"> <div class="vector-toc-text"> <span class="vector-toc-numb">12</span> <span>References</span> </div> </a> <ul id="toc-References-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-Further_reading" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#Further_reading"> <div class="vector-toc-text"> <span class="vector-toc-numb">13</span> <span>Further reading</span> </div> </a> <ul id="toc-Further_reading-sublist" class="vector-toc-list"> </ul> </li> <li id="toc-External_links" class="vector-toc-list-item vector-toc-level-1"> <a class="vector-toc-link" href="#External_links"> <div class="vector-toc-text"> <span class="vector-toc-numb">14</span> <span>External links</span> </div> </a> <ul id="toc-External_links-sublist" class="vector-toc-list"> </ul> </li> </ul> </div> </div> </nav> </div> </div> <div class="mw-content-container"> <main id="content" class="mw-body"> <header class="mw-body-header vector-page-titlebar"> <nav aria-label="Contents" class="vector-toc-landmark"> <div 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Available in 51 languages" > <label id="p-lang-btn-label" for="p-lang-btn-checkbox" class="vector-dropdown-label cdx-button cdx-button--fake-button cdx-button--fake-button--enabled cdx-button--weight-quiet cdx-button--action-progressive mw-portlet-lang-heading-51" aria-hidden="true" ><span class="vector-icon mw-ui-icon-language-progressive mw-ui-icon-wikimedia-language-progressive"></span> <span class="vector-dropdown-label-text">51 languages</span> </label> <div class="vector-dropdown-content"> <div class="vector-menu-content"> <ul class="vector-menu-content-list"> <li class="interlanguage-link interwiki-ar mw-list-item"><a href="https://ar.wikipedia.org/wiki/%D8%A5%D8%AF%D8%A7%D8%B1%D8%A9_%D8%A7%D9%84%D8%BA%D8%B0%D8%A7%D8%A1_%D9%88%D8%A7%D9%84%D8%AF%D9%88%D8%A7%D8%A1_(%D8%A7%D9%84%D9%88%D9%84%D8%A7%D9%8A%D8%A7%D8%AA_%D8%A7%D9%84%D9%85%D8%AA%D8%AD%D8%AF%D8%A9)" title="إدارة الغذاء والدواء (الولايات المتحدة) – Arabic" lang="ar" hreflang="ar" data-title="إدارة الغذاء والدواء (الولايات المتحدة)" data-language-autonym="العربية" data-language-local-name="Arabic" class="interlanguage-link-target"><span>العربية</span></a></li><li class="interlanguage-link interwiki-bg mw-list-item"><a href="https://bg.wikipedia.org/wiki/%D0%90%D0%B3%D0%B5%D0%BD%D1%86%D0%B8%D1%8F_%D0%B7%D0%B0_%D0%BA%D0%BE%D0%BD%D1%82%D1%80%D0%BE%D0%BB_%D0%BD%D0%B0_%D1%85%D1%80%D0%B0%D0%BD%D0%B8%D1%82%D0%B5_%D0%B8_%D0%BB%D0%B5%D0%BA%D0%B0%D1%80%D1%81%D1%82%D0%B2%D0%B0%D1%82%D0%B0_%D0%BD%D0%B0_%D0%A1%D0%90%D0%A9" title="Агенция за контрол на храните и лекарствата на САЩ – Bulgarian" lang="bg" hreflang="bg" data-title="Агенция за контрол на храните и лекарствата на САЩ" data-language-autonym="Български" data-language-local-name="Bulgarian" class="interlanguage-link-target"><span>Български</span></a></li><li class="interlanguage-link interwiki-ca mw-list-item"><a href="https://ca.wikipedia.org/wiki/Administraci%C3%B3_d%27Aliments_i_F%C3%A0rmacs" title="Administració d'Aliments i Fàrmacs – Catalan" lang="ca" hreflang="ca" data-title="Administració d'Aliments i Fàrmacs" data-language-autonym="Català" data-language-local-name="Catalan" class="interlanguage-link-target"><span>Català</span></a></li><li class="interlanguage-link interwiki-cs mw-list-item"><a href="https://cs.wikipedia.org/wiki/%C3%9A%C5%99ad_pro_kontrolu_potravin_a_l%C3%A9%C4%8Div" title="Úřad pro kontrolu potravin a léčiv – Czech" lang="cs" hreflang="cs" data-title="Úřad pro kontrolu potravin a léčiv" data-language-autonym="Čeština" data-language-local-name="Czech" class="interlanguage-link-target"><span>Čeština</span></a></li><li class="interlanguage-link interwiki-da mw-list-item"><a href="https://da.wikipedia.org/wiki/Food_and_Drug_Administration" title="Food and Drug Administration – Danish" lang="da" hreflang="da" data-title="Food and Drug Administration" data-language-autonym="Dansk" data-language-local-name="Danish" class="interlanguage-link-target"><span>Dansk</span></a></li><li class="interlanguage-link interwiki-de mw-list-item"><a href="https://de.wikipedia.org/wiki/Food_and_Drug_Administration" title="Food and Drug Administration – German" lang="de" hreflang="de" data-title="Food and Drug Administration" data-language-autonym="Deutsch" data-language-local-name="German" class="interlanguage-link-target"><span>Deutsch</span></a></li><li class="interlanguage-link interwiki-et mw-list-item"><a href="https://et.wikipedia.org/wiki/Ameerika_%C3%9Chendriikide_Toidu-_ja_Ravimiamet" title="Ameerika Ühendriikide Toidu- ja Ravimiamet – Estonian" lang="et" hreflang="et" data-title="Ameerika Ühendriikide Toidu- ja Ravimiamet" data-language-autonym="Eesti" data-language-local-name="Estonian" class="interlanguage-link-target"><span>Eesti</span></a></li><li class="interlanguage-link interwiki-es mw-list-item"><a href="https://es.wikipedia.org/wiki/Administraci%C3%B3n_de_Alimentos_y_Medicamentos" title="Administración de Alimentos y Medicamentos – Spanish" lang="es" hreflang="es" data-title="Administración de Alimentos y Medicamentos" data-language-autonym="Español" data-language-local-name="Spanish" class="interlanguage-link-target"><span>Español</span></a></li><li class="interlanguage-link interwiki-eo mw-list-item"><a href="https://eo.wikipedia.org/wiki/Usona_man%C4%9Da%C4%B5a_kaj_droga_administracio" title="Usona manĝaĵa kaj droga administracio – Esperanto" lang="eo" hreflang="eo" data-title="Usona manĝaĵa kaj droga administracio" data-language-autonym="Esperanto" data-language-local-name="Esperanto" class="interlanguage-link-target"><span>Esperanto</span></a></li><li class="interlanguage-link interwiki-eu mw-list-item"><a href="https://eu.wikipedia.org/wiki/Elikagai_eta_Sendagaien_Administrazioa" title="Elikagai eta Sendagaien Administrazioa – Basque" lang="eu" hreflang="eu" data-title="Elikagai eta Sendagaien Administrazioa" data-language-autonym="Euskara" data-language-local-name="Basque" class="interlanguage-link-target"><span>Euskara</span></a></li><li class="interlanguage-link interwiki-fa mw-list-item"><a href="https://fa.wikipedia.org/wiki/%D8%B3%D8%A7%D8%B2%D9%85%D8%A7%D9%86_%D8%BA%D8%B0%D8%A7_%D9%88_%D8%AF%D8%A7%D8%B1%D9%88_(%D8%A2%D9%85%D8%B1%DB%8C%DA%A9%D8%A7)" title="سازمان غذا و دارو (آمریکا) – Persian" lang="fa" hreflang="fa" data-title="سازمان غذا و دارو (آمریکا)" data-language-autonym="فارسی" data-language-local-name="Persian" class="interlanguage-link-target"><span>فارسی</span></a></li><li class="interlanguage-link interwiki-fr mw-list-item"><a href="https://fr.wikipedia.org/wiki/Food_and_Drug_Administration" title="Food and Drug Administration – French" lang="fr" hreflang="fr" data-title="Food and Drug Administration" data-language-autonym="Français" data-language-local-name="French" class="interlanguage-link-target"><span>Français</span></a></li><li class="interlanguage-link interwiki-ga mw-list-item"><a href="https://ga.wikipedia.org/wiki/Riarach%C3%A1n_Bia_is_Druga%C3%AD" title="Riarachán Bia is Drugaí – Irish" lang="ga" hreflang="ga" data-title="Riarachán Bia is Drugaí" data-language-autonym="Gaeilge" data-language-local-name="Irish" class="interlanguage-link-target"><span>Gaeilge</span></a></li><li class="interlanguage-link interwiki-gu mw-list-item"><a href="https://gu.wikipedia.org/wiki/%E0%AA%96%E0%AA%BE%E0%AA%A6%E0%AB%8D%E0%AA%AF_%E0%AA%85%E0%AA%A8%E0%AB%87_%E0%AA%94%E0%AA%B7%E0%AA%A7_%E0%AA%B5%E0%AA%B9%E0%AB%80%E0%AA%B5%E0%AA%9F%E0%AB%80%E0%AA%A4%E0%AA%82%E0%AA%A4%E0%AB%8D%E0%AA%B0" title="ખાદ્ય અને ઔષધ વહીવટીતંત્ર – Gujarati" lang="gu" hreflang="gu" data-title="ખાદ્ય અને ઔષધ વહીવટીતંત્ર" data-language-autonym="ગુજરાતી" data-language-local-name="Gujarati" class="interlanguage-link-target"><span>ગુજરાતી</span></a></li><li class="interlanguage-link interwiki-ko mw-list-item"><a href="https://ko.wikipedia.org/wiki/%EB%AF%B8%EA%B5%AD_%EC%8B%9D%ED%92%88%EC%9D%98%EC%95%BD%EA%B5%AD" title="미국 식품의약국 – Korean" lang="ko" hreflang="ko" data-title="미국 식품의약국" data-language-autonym="한국어" data-language-local-name="Korean" class="interlanguage-link-target"><span>한국어</span></a></li><li class="interlanguage-link interwiki-ha mw-list-item"><a href="https://ha.wikipedia.org/wiki/Hukumar_Abinci_da_Magunguna" title="Hukumar Abinci da Magunguna – Hausa" lang="ha" hreflang="ha" data-title="Hukumar Abinci da Magunguna" data-language-autonym="Hausa" data-language-local-name="Hausa" class="interlanguage-link-target"><span>Hausa</span></a></li><li class="interlanguage-link interwiki-hy mw-list-item"><a href="https://hy.wikipedia.org/wiki/%D5%8D%D5%B6%D5%B6%D5%A4%D5%AB_%D6%87_%D5%A4%D5%A5%D5%B2%D5%A5%D6%80%D5%AB_%D5%BE%D5%A1%D6%80%D5%B9%D5%B8%D6%82%D5%A9%D5%B5%D5%B8%D6%82%D5%B6" title="Սննդի և դեղերի վարչություն – Armenian" lang="hy" hreflang="hy" data-title="Սննդի և դեղերի վարչություն" data-language-autonym="Հայերեն" data-language-local-name="Armenian" class="interlanguage-link-target"><span>Հայերեն</span></a></li><li class="interlanguage-link interwiki-hi mw-list-item"><a href="https://hi.wikipedia.org/wiki/%E0%A4%AB%E0%A4%BC%E0%A5%82%E0%A4%A1_%E0%A4%8F%E0%A4%A3%E0%A5%8D%E0%A4%A1_%E0%A4%A1%E0%A5%8D%E0%A4%B0%E0%A4%97_%E0%A4%8F%E0%A4%A1%E0%A4%AE%E0%A4%BF%E0%A4%A8%E0%A4%BF%E0%A4%B8%E0%A5%8D%E0%A4%9F%E0%A5%8D%E0%A4%B0%E0%A5%87%E0%A4%B6%E0%A4%A8" title="फ़ूड एण्ड ड्रग एडमिनिस्ट्रेशन – Hindi" lang="hi" hreflang="hi" data-title="फ़ूड एण्ड ड्रग एडमिनिस्ट्रेशन" data-language-autonym="हिन्दी" data-language-local-name="Hindi" class="interlanguage-link-target"><span>हिन्दी</span></a></li><li class="interlanguage-link interwiki-id mw-list-item"><a href="https://id.wikipedia.org/wiki/Badan_Pengawas_Obat_dan_Makanan_Amerika_Serikat" title="Badan Pengawas Obat dan Makanan Amerika Serikat – Indonesian" lang="id" hreflang="id" data-title="Badan Pengawas Obat dan Makanan Amerika Serikat" data-language-autonym="Bahasa Indonesia" data-language-local-name="Indonesian" class="interlanguage-link-target"><span>Bahasa Indonesia</span></a></li><li class="interlanguage-link interwiki-is mw-list-item"><a href="https://is.wikipedia.org/wiki/Matv%C3%A6la-_og_lyfjaeftirlit_Bandar%C3%ADkjanna" title="Matvæla- og lyfjaeftirlit Bandaríkjanna – Icelandic" lang="is" hreflang="is" data-title="Matvæla- og lyfjaeftirlit Bandaríkjanna" data-language-autonym="Íslenska" data-language-local-name="Icelandic" class="interlanguage-link-target"><span>Íslenska</span></a></li><li class="interlanguage-link interwiki-it mw-list-item"><a href="https://it.wikipedia.org/wiki/Food_and_Drug_Administration" title="Food and Drug Administration – Italian" lang="it" hreflang="it" data-title="Food and Drug Administration" data-language-autonym="Italiano" data-language-local-name="Italian" class="interlanguage-link-target"><span>Italiano</span></a></li><li class="interlanguage-link interwiki-he mw-list-item"><a href="https://he.wikipedia.org/wiki/%D7%9E%D7%A0%D7%94%D7%9C_%D7%94%D7%9E%D7%96%D7%95%D7%9F_%D7%95%D7%94%D7%AA%D7%A8%D7%95%D7%A4%D7%95%D7%AA_%D7%94%D7%90%D7%9E%D7%A8%D7%99%D7%A7%D7%90%D7%99" title="מנהל המזון והתרופות האמריקאי – Hebrew" lang="he" hreflang="he" data-title="מנהל המזון והתרופות האמריקאי" data-language-autonym="עברית" data-language-local-name="Hebrew" class="interlanguage-link-target"><span>עברית</span></a></li><li class="interlanguage-link interwiki-ka mw-list-item"><a href="https://ka.wikipedia.org/wiki/%E1%83%A1%E1%83%90%E1%83%99%E1%83%95%E1%83%94%E1%83%91%E1%83%98%E1%83%A1_%E1%83%93%E1%83%90_%E1%83%AC%E1%83%90%E1%83%9B%E1%83%9A%E1%83%98%E1%83%A1_%E1%83%9B%E1%83%90%E1%83%A0%E1%83%94%E1%83%92%E1%83%A3%E1%83%9A%E1%83%98%E1%83%A0%E1%83%94%E1%83%91%E1%83%94%E1%83%9A%E1%83%98_%E1%83%A1%E1%83%90%E1%83%90%E1%83%92%E1%83%94%E1%83%9C%E1%83%A2%E1%83%9D_(%E1%83%90%E1%83%A8%E1%83%A8)" title="საკვების და წამლის მარეგულირებელი სააგენტო (აშშ) – Georgian" lang="ka" hreflang="ka" data-title="საკვების და წამლის მარეგულირებელი სააგენტო (აშშ)" data-language-autonym="ქართული" data-language-local-name="Georgian" class="interlanguage-link-target"><span>ქართული</span></a></li><li class="interlanguage-link interwiki-hu mw-list-item"><a href="https://hu.wikipedia.org/wiki/Az_Egyes%C3%BClt_%C3%81llamok_%C3%89lelmiszer-_%C3%A9s_Gy%C3%B3gyszer%C3%BCgyi_Hivatala" title="Az Egyesült Államok Élelmiszer- és Gyógyszerügyi Hivatala – Hungarian" lang="hu" hreflang="hu" data-title="Az Egyesült Államok Élelmiszer- és Gyógyszerügyi Hivatala" data-language-autonym="Magyar" data-language-local-name="Hungarian" class="interlanguage-link-target"><span>Magyar</span></a></li><li class="interlanguage-link interwiki-ml mw-list-item"><a href="https://ml.wikipedia.org/wiki/%E0%B4%AB%E0%B5%81%E0%B4%A1%E0%B5%8D_%E0%B4%86%E0%B5%BB%E0%B4%A1%E0%B5%8D_%E0%B4%A1%E0%B5%8D%E0%B4%B0%E0%B4%97%E0%B5%8D_%E0%B4%85%E0%B4%A1%E0%B5%8D%E0%B4%AE%E0%B4%BF%E0%B4%A8%E0%B4%BF%E0%B4%B8%E0%B5%8D%E0%B4%9F%E0%B5%8D%E0%B4%B0%E0%B5%87%E0%B4%B7%E0%B5%BB" title="ഫുഡ് ആൻഡ് ഡ്രഗ് അഡ്മിനിസ്ട്രേഷൻ – Malayalam" lang="ml" hreflang="ml" data-title="ഫുഡ് ആൻഡ് ഡ്രഗ് അഡ്മിനിസ്ട്രേഷൻ" data-language-autonym="മലയാളം" data-language-local-name="Malayalam" class="interlanguage-link-target"><span>മലയാളം</span></a></li><li class="interlanguage-link interwiki-arz mw-list-item"><a href="https://arz.wikipedia.org/wiki/%D8%A7%D8%AF%D8%A7%D8%B1%D8%A9_%D8%A7%D9%84%D8%A7%D8%BA%D8%B0%D9%8A%D9%87_%D9%88%D8%A7%D9%84%D8%A7%D8%AF%D9%88%D9%8A%D9%87_%D8%A7%D9%84%D8%A7%D9%85%D8%B1%D9%8A%D9%83%D9%8A%D9%87" title="ادارة الاغذيه والادويه الامريكيه – Egyptian Arabic" lang="arz" hreflang="arz" data-title="ادارة الاغذيه والادويه الامريكيه" data-language-autonym="مصرى" data-language-local-name="Egyptian Arabic" class="interlanguage-link-target"><span>مصرى</span></a></li><li class="interlanguage-link interwiki-ms mw-list-item"><a href="https://ms.wikipedia.org/wiki/Pentadbiran_Makanan_dan_Dadah" title="Pentadbiran Makanan dan Dadah – Malay" lang="ms" hreflang="ms" data-title="Pentadbiran Makanan dan Dadah" data-language-autonym="Bahasa Melayu" data-language-local-name="Malay" class="interlanguage-link-target"><span>Bahasa Melayu</span></a></li><li class="interlanguage-link interwiki-nl mw-list-item"><a href="https://nl.wikipedia.org/wiki/Food_and_Drug_Administration" title="Food and Drug Administration – Dutch" lang="nl" hreflang="nl" data-title="Food and Drug Administration" data-language-autonym="Nederlands" data-language-local-name="Dutch" class="interlanguage-link-target"><span>Nederlands</span></a></li><li class="interlanguage-link interwiki-ja mw-list-item"><a href="https://ja.wikipedia.org/wiki/%E3%82%A2%E3%83%A1%E3%83%AA%E3%82%AB%E9%A3%9F%E5%93%81%E5%8C%BB%E8%96%AC%E5%93%81%E5%B1%80" title="アメリカ食品医薬品局 – Japanese" lang="ja" hreflang="ja" data-title="アメリカ食品医薬品局" data-language-autonym="日本語" data-language-local-name="Japanese" class="interlanguage-link-target"><span>日本語</span></a></li><li class="interlanguage-link interwiki-no mw-list-item"><a href="https://no.wikipedia.org/wiki/Food_and_Drug_Administration" title="Food and Drug Administration – Norwegian Bokmål" lang="nb" hreflang="nb" data-title="Food and Drug Administration" data-language-autonym="Norsk bokmål" data-language-local-name="Norwegian Bokmål" class="interlanguage-link-target"><span>Norsk bokmål</span></a></li><li class="interlanguage-link interwiki-pl mw-list-item"><a href="https://pl.wikipedia.org/wiki/Agencja_%C5%BBywno%C5%9Bci_i_Lek%C3%B3w" title="Agencja Żywności i Leków – Polish" lang="pl" hreflang="pl" data-title="Agencja Żywności i Leków" data-language-autonym="Polski" data-language-local-name="Polish" class="interlanguage-link-target"><span>Polski</span></a></li><li class="interlanguage-link interwiki-pt mw-list-item"><a href="https://pt.wikipedia.org/wiki/Food_and_Drug_Administration" title="Food and Drug Administration – Portuguese" lang="pt" hreflang="pt" data-title="Food and Drug Administration" data-language-autonym="Português" data-language-local-name="Portuguese" class="interlanguage-link-target"><span>Português</span></a></li><li class="interlanguage-link interwiki-ro mw-list-item"><a href="https://ro.wikipedia.org/wiki/Food_and_Drug_Administration" title="Food and Drug Administration – Romanian" lang="ro" hreflang="ro" data-title="Food and Drug Administration" data-language-autonym="Română" data-language-local-name="Romanian" class="interlanguage-link-target"><span>Română</span></a></li><li class="interlanguage-link interwiki-ru mw-list-item"><a href="https://ru.wikipedia.org/wiki/Food_and_Drug_Administration" title="Food and Drug Administration – Russian" lang="ru" hreflang="ru" data-title="Food and Drug Administration" data-language-autonym="Русский" data-language-local-name="Russian" class="interlanguage-link-target"><span>Русский</span></a></li><li class="interlanguage-link interwiki-simple mw-list-item"><a href="https://simple.wikipedia.org/wiki/Food_and_Drug_Administration" title="Food and Drug Administration – Simple English" lang="en-simple" hreflang="en-simple" data-title="Food and Drug Administration" data-language-autonym="Simple English" data-language-local-name="Simple English" class="interlanguage-link-target"><span>Simple English</span></a></li><li class="interlanguage-link interwiki-sk mw-list-item"><a href="https://sk.wikipedia.org/wiki/Spr%C3%A1va_potrav%C3%ADn_a_lie%C4%8Div" title="Správa potravín a liečiv – Slovak" lang="sk" hreflang="sk" data-title="Správa potravín a liečiv" data-language-autonym="Slovenčina" data-language-local-name="Slovak" class="interlanguage-link-target"><span>Slovenčina</span></a></li><li class="interlanguage-link interwiki-sl mw-list-item"><a href="https://sl.wikipedia.org/wiki/Uprava_za_hrano_in_zdravila" title="Uprava za hrano in zdravila – Slovenian" lang="sl" hreflang="sl" data-title="Uprava za hrano in zdravila" data-language-autonym="Slovenščina" data-language-local-name="Slovenian" class="interlanguage-link-target"><span>Slovenščina</span></a></li><li class="interlanguage-link interwiki-ckb mw-list-item"><a href="https://ckb.wikipedia.org/wiki/%D8%A8%DB%95%DA%95%DB%8E%D9%88%DB%95%D8%A8%DB%95%D8%B1%D8%A7%DB%8C%DB%95%D8%AA%DB%8C%DB%8C_%D8%AE%DB%86%D8%B1%D8%A7%DA%A9_%D9%88_%D8%AF%DB%95%D8%B1%D9%85%D8%A7%D9%86_%D9%88%DB%8C%D9%84%D8%A7%DB%8C%DB%95%D8%AA%DB%95_%DB%8C%DB%95%DA%A9%DA%AF%D8%B1%D8%AA%D9%88%D9%88%DB%95%DA%A9%D8%A7%D9%86" title="بەڕێوەبەرایەتیی خۆراک و دەرمان ویلایەتە یەکگرتووەکان – Central Kurdish" lang="ckb" hreflang="ckb" data-title="بەڕێوەبەرایەتیی خۆراک و دەرمان ویلایەتە یەکگرتووەکان" data-language-autonym="کوردی" data-language-local-name="Central Kurdish" class="interlanguage-link-target"><span>کوردی</span></a></li><li class="interlanguage-link interwiki-sr mw-list-item"><a href="https://sr.wikipedia.org/wiki/Uprava_za_hranu_i_lekove" title="Uprava za hranu i lekove – Serbian" lang="sr" hreflang="sr" data-title="Uprava za hranu i lekove" data-language-autonym="Српски / srpski" data-language-local-name="Serbian" class="interlanguage-link-target"><span>Српски / srpski</span></a></li><li class="interlanguage-link interwiki-sh mw-list-item"><a href="https://sh.wikipedia.org/wiki/Uprava_za_hranu_i_lekove" title="Uprava za hranu i lekove – Serbo-Croatian" lang="sh" hreflang="sh" data-title="Uprava za hranu i lekove" data-language-autonym="Srpskohrvatski / српскохрватски" data-language-local-name="Serbo-Croatian" class="interlanguage-link-target"><span>Srpskohrvatski / српскохрватски</span></a></li><li class="interlanguage-link interwiki-fi mw-list-item"><a href="https://fi.wikipedia.org/wiki/Yhdysvaltain_elintarvike-_ja_l%C3%A4%C3%A4kevirasto" title="Yhdysvaltain elintarvike- ja lääkevirasto – Finnish" lang="fi" hreflang="fi" data-title="Yhdysvaltain elintarvike- ja lääkevirasto" data-language-autonym="Suomi" data-language-local-name="Finnish" class="interlanguage-link-target"><span>Suomi</span></a></li><li class="interlanguage-link interwiki-sv mw-list-item"><a href="https://sv.wikipedia.org/wiki/U.S._Food_and_Drug_Administration" title="U.S. Food and Drug Administration – Swedish" lang="sv" hreflang="sv" data-title="U.S. Food and Drug Administration" data-language-autonym="Svenska" data-language-local-name="Swedish" class="interlanguage-link-target"><span>Svenska</span></a></li><li class="interlanguage-link interwiki-ta mw-list-item"><a href="https://ta.wikipedia.org/wiki/%E0%AE%85%E0%AE%AE%E0%AF%86%E0%AE%B0%E0%AE%BF%E0%AE%95%E0%AF%8D%E0%AE%95_%E0%AE%89%E0%AE%A3%E0%AE%B5%E0%AF%81_%E0%AE%AE%E0%AE%B1%E0%AF%8D%E0%AE%B1%E0%AF%81%E0%AE%AE%E0%AF%8D_%E0%AE%AE%E0%AE%B0%E0%AF%81%E0%AE%A8%E0%AF%8D%E0%AE%A4%E0%AF%81_%E0%AE%A8%E0%AE%BF%E0%AE%B0%E0%AF%8D%E0%AE%B5%E0%AE%BE%E0%AE%95%E0%AE%AE%E0%AF%8D" title="அமெரிக்க உணவு மற்றும் மருந்து நிர்வாகம் – Tamil" lang="ta" hreflang="ta" data-title="அமெரிக்க உணவு மற்றும் மருந்து நிர்வாகம்" data-language-autonym="தமிழ்" data-language-local-name="Tamil" class="interlanguage-link-target"><span>தமிழ்</span></a></li><li class="interlanguage-link interwiki-kab mw-list-item"><a href="https://kab.wikipedia.org/wiki/Tadbelt_n_wu%C4%8D%C4%8Di_d_isafaren" title="Tadbelt n wučči d isafaren – Kabyle" lang="kab" hreflang="kab" data-title="Tadbelt n wučči d isafaren" data-language-autonym="Taqbaylit" data-language-local-name="Kabyle" class="interlanguage-link-target"><span>Taqbaylit</span></a></li><li class="interlanguage-link interwiki-th mw-list-item"><a href="https://th.wikipedia.org/wiki/%E0%B8%AD%E0%B8%87%E0%B8%84%E0%B9%8C%E0%B8%81%E0%B8%B2%E0%B8%A3%E0%B8%AD%E0%B8%B2%E0%B8%AB%E0%B8%B2%E0%B8%A3%E0%B9%81%E0%B8%A5%E0%B8%B0%E0%B8%A2%E0%B8%B2%E0%B8%AA%E0%B8%AB%E0%B8%A3%E0%B8%B1%E0%B8%90" title="องค์การอาหารและยาสหรัฐ – Thai" lang="th" hreflang="th" data-title="องค์การอาหารและยาสหรัฐ" data-language-autonym="ไทย" data-language-local-name="Thai" class="interlanguage-link-target"><span>ไทย</span></a></li><li class="interlanguage-link interwiki-tr mw-list-item"><a href="https://tr.wikipedia.org/wiki/FDA" title="FDA – Turkish" lang="tr" hreflang="tr" data-title="FDA" data-language-autonym="Türkçe" data-language-local-name="Turkish" class="interlanguage-link-target"><span>Türkçe</span></a></li><li class="interlanguage-link interwiki-uk mw-list-item"><a href="https://uk.wikipedia.org/wiki/%D0%A3%D0%BF%D1%80%D0%B0%D0%B2%D0%BB%D1%96%D0%BD%D0%BD%D1%8F_%D0%B7_%D0%BF%D1%80%D0%BE%D0%B4%D0%BE%D0%B2%D0%BE%D0%BB%D1%8C%D1%81%D1%82%D0%B2%D0%B0_%D1%96_%D0%BC%D0%B5%D0%B4%D0%B8%D0%BA%D0%B0%D0%BC%D0%B5%D0%BD%D1%82%D1%96%D0%B2_%D0%A1%D0%A8%D0%90" title="Управління з продовольства і медикаментів США – Ukrainian" lang="uk" hreflang="uk" data-title="Управління з продовольства і медикаментів США" data-language-autonym="Українська" data-language-local-name="Ukrainian" class="interlanguage-link-target"><span>Українська</span></a></li><li class="interlanguage-link interwiki-vi mw-list-item"><a href="https://vi.wikipedia.org/wiki/C%E1%BB%A5c_qu%E1%BA%A3n_l%C3%BD_Th%E1%BB%B1c_ph%E1%BA%A9m_v%C3%A0_D%C6%B0%E1%BB%A3c_ph%E1%BA%A9m_Hoa_K%E1%BB%B3" title="Cục quản lý Thực phẩm và Dược phẩm Hoa Kỳ – Vietnamese" lang="vi" hreflang="vi" data-title="Cục quản lý Thực phẩm và Dược phẩm Hoa Kỳ" data-language-autonym="Tiếng Việt" data-language-local-name="Vietnamese" class="interlanguage-link-target"><span>Tiếng Việt</span></a></li><li class="interlanguage-link interwiki-yo mw-list-item"><a href="https://yo.wikipedia.org/wiki/%C3%80j%E1%BB%8D_t%C3%AD_%C3%B3_%C5%84_m%C3%B3j%C3%BA_t%C3%B3_o%C5%84j%E1%BA%B9_%C3%A0ti_o%C3%B2g%C3%B9n_ti_or%C3%ADl%E1%BA%B9%CC%80_%C3%A8d%C3%A8_Am%E1%BA%B9%CC%81r%C3%ADk%C3%A0" title="Àjọ tí ó ń mójú tó ońjẹ àti oògùn ti orílẹ̀ èdè Amẹ́ríkà – Yoruba" lang="yo" hreflang="yo" data-title="Àjọ tí ó ń mójú tó ońjẹ àti oògùn ti orílẹ̀ èdè Amẹ́ríkà" data-language-autonym="Yorùbá" data-language-local-name="Yoruba" class="interlanguage-link-target"><span>Yorùbá</span></a></li><li class="interlanguage-link interwiki-zh-yue mw-list-item"><a href="https://zh-yue.wikipedia.org/wiki/%E7%BE%8E%E5%9C%8B%E9%A3%9F%E5%93%81%E8%97%A5%E5%93%81%E7%9B%A3%E7%9D%A3%E7%AE%A1%E7%90%86%E5%B1%80" title="美國食品藥品監督管理局 – Cantonese" lang="yue" hreflang="yue" data-title="美國食品藥品監督管理局" data-language-autonym="粵語" data-language-local-name="Cantonese" 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title="Geographic coordinate system">Coordinates</a>: <style data-mw-deduplicate="TemplateStyles:r1156832818">.mw-parser-output .geo-default,.mw-parser-output .geo-dms,.mw-parser-output .geo-dec{display:inline}.mw-parser-output .geo-nondefault,.mw-parser-output .geo-multi-punct,.mw-parser-output .geo-inline-hidden{display:none}.mw-parser-output .longitude,.mw-parser-output .latitude{white-space:nowrap}</style><span class="plainlinks nourlexpansion"><a class="external text" href="https://geohack.toolforge.org/geohack.php?pagename=Food_and_Drug_Administration&params=39_2_7_N_76_58_59_W_type:landmark_region:US-MD"><span class="geo-default"><span class="geo-dms" title="Maps, aerial photos, and other data for this location"><span class="latitude">39°2′7″N</span> <span class="longitude">76°58′59″W</span></span></span><span class="geo-multi-punct"> / </span><span class="geo-nondefault"><span class="geo-dec" title="Maps, aerial photos, and other data for this location">39.03528°N 76.98306°W</span><span style="display:none"> / <span class="geo">39.03528; -76.98306</span></span></span></a></span></span></div></div> </div> <div id="siteSub" class="noprint">From Wikipedia, the free encyclopedia</div> </div> <div id="contentSub"><div id="mw-content-subtitle"><span class="mw-redirectedfrom">(Redirected from <a href="/w/index.php?title=FDA&redirect=no" class="mw-redirect" title="FDA">FDA</a>)</span></div></div> <div id="mw-content-text" class="mw-body-content"><div class="mw-content-ltr mw-parser-output" lang="en" dir="ltr"><div class="shortdescription nomobile noexcerpt noprint searchaux" style="display:none">United States federal agency</div> <style data-mw-deduplicate="TemplateStyles:r1236090951">.mw-parser-output .hatnote{font-style:italic}.mw-parser-output div.hatnote{padding-left:1.6em;margin-bottom:0.5em}.mw-parser-output .hatnote i{font-style:normal}.mw-parser-output .hatnote+link+.hatnote{margin-top:-0.5em}@media print{body.ns-0 .mw-parser-output .hatnote{display:none!important}}</style><div role="note" class="hatnote navigation-not-searchable"><span>"FDA" redirects here. For other uses, see <a href="/wiki/FDA_(disambiguation)" class="mw-disambig" title="FDA (disambiguation)">FDA (disambiguation)</a>.</span> <span>For the department concerned with food production, see <a href="/wiki/United_States_Department_of_Agriculture" title="United States Department of Agriculture">United States Department of Agriculture</a>.</span></div> <p class="mw-empty-elt"> </p> <style data-mw-deduplicate="TemplateStyles:r1257001546">.mw-parser-output .infobox-subbox{padding:0;border:none;margin:-3px;width:auto;min-width:100%;font-size:100%;clear:none;float:none;background-color:transparent}.mw-parser-output .infobox-3cols-child{margin:auto}.mw-parser-output .infobox .navbar{font-size:100%}@media screen{html.skin-theme-clientpref-night .mw-parser-output .infobox-full-data:not(.notheme)>div:not(.notheme)[style]{background:#1f1f23!important;color:#f8f9fa}}@media screen and (prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .infobox-full-data:not(.notheme) div:not(.notheme){background:#1f1f23!important;color:#f8f9fa}}@media(min-width:640px){body.skin--responsive .mw-parser-output .infobox-table{display:table!important}body.skin--responsive .mw-parser-output .infobox-table>caption{display:table-caption!important}body.skin--responsive .mw-parser-output .infobox-table>tbody{display:table-row-group}body.skin--responsive .mw-parser-output .infobox-table tr{display:table-row!important}body.skin--responsive .mw-parser-output .infobox-table th,body.skin--responsive .mw-parser-output .infobox-table td{padding-left:inherit;padding-right:inherit}}</style><table class="infobox"><caption class="infobox-title" style="font-size: 125%;">Food and Drug Administration</caption><tbody><tr><td colspan="2" class="infobox-image"><span typeof="mw:File"><a href="/wiki/File:Food_and_Drug_Administration_icon_2016.svg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/1/1d/Food_and_Drug_Administration_icon_2016.svg/180px-Food_and_Drug_Administration_icon_2016.svg.png" decoding="async" width="180" height="216" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/1/1d/Food_and_Drug_Administration_icon_2016.svg/270px-Food_and_Drug_Administration_icon_2016.svg.png 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/1/1d/Food_and_Drug_Administration_icon_2016.svg/360px-Food_and_Drug_Administration_icon_2016.svg.png 2x" data-file-width="95" data-file-height="114" /></a></span></td></tr><tr><th colspan="2" class="infobox-header" style="background-color: #efefef">Agency overview</th></tr><tr><th scope="row" class="infobox-label">Formed</th><td class="infobox-data">June 30, 1906<span class="noprint">; 118 years ago</span><span style="display:none"> (<span class="bday dtstart published updated">1906-06-30</span>)</span><sup id="cite_ref-1" class="reference"><a href="#cite_note-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup></td></tr><tr><th scope="row" class="infobox-label">Preceding agencies</th><td class="infobox-data"><style data-mw-deduplicate="TemplateStyles:r1126788409">.mw-parser-output .plainlist ol,.mw-parser-output .plainlist ul{line-height:inherit;list-style:none;margin:0;padding:0}.mw-parser-output .plainlist ol li,.mw-parser-output .plainlist ul li{margin-bottom:0}</style><div class="plainlist"><ul><li style="text-indent: -1em; padding-left: 1em;">Food, Drug, and Insecticide Administration (July 1927 – July 1930)</li><li style="text-indent: -1em; padding-left: 1em;">Bureau of Chemistry, <a href="/wiki/USDA" class="mw-redirect" title="USDA">USDA</a> (July 1901 – July 1927)</li><li style="text-indent: -1em; padding-left: 1em;">Division of Chemistry, USDA (established 1862)</li></ul></div></td></tr><tr><th scope="row" class="infobox-label">Jurisdiction</th><td class="infobox-data"><a href="/wiki/Federal_government_of_the_United_States" title="Federal government of the United States">Federal government of the United States</a></td></tr><tr><th scope="row" class="infobox-label">Headquarters</th><td class="infobox-data"><a href="/wiki/Silver_Spring,_Maryland" title="Silver Spring, Maryland">Silver Spring, Maryland</a>, U.S.<br /><span class="geo-inline"><style data-mw-deduplicate="TemplateStyles:r1156832818">.mw-parser-output .geo-default,.mw-parser-output .geo-dms,.mw-parser-output .geo-dec{display:inline}.mw-parser-output .geo-nondefault,.mw-parser-output .geo-multi-punct,.mw-parser-output .geo-inline-hidden{display:none}.mw-parser-output .longitude,.mw-parser-output .latitude{white-space:nowrap}</style><span class="plainlinks nourlexpansion"><a class="external text" href="https://geohack.toolforge.org/geohack.php?pagename=Food_and_Drug_Administration&params=39_2_7_N_76_58_59_W_type:landmark_region:US-MD"><span class="geo-default"><span class="geo-dms" title="Maps, aerial photos, and other data for this location"><span class="latitude">39°2′7″N</span> <span class="longitude">76°58′59″W</span></span></span><span class="geo-multi-punct"> / </span><span class="geo-nondefault"><span class="geo-dec" title="Maps, aerial photos, and other data for this location">39.03528°N 76.98306°W</span><span style="display:none"> / <span class="geo">39.03528; -76.98306</span></span></span></a></span></span></td></tr><tr><th scope="row" class="infobox-label">Employees</th><td class="infobox-data">18,000 (2022)<sup id="cite_ref-fy2022_2-0" class="reference"><a href="#cite_note-fy2022-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup></td></tr><tr><th scope="row" class="infobox-label">Annual budget</th><td class="infobox-data"><span style="white-space: nowrap">US$6.5</span><span class="nowrap"> </span>billion (2022)<sup id="cite_ref-fy2022_2-1" class="reference"><a href="#cite_note-fy2022-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup></td></tr><tr><th scope="row" class="infobox-label">Agency executives</th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li style="text-indent: -1em; padding-left: 1em;"><a href="/wiki/Robert_Califf" title="Robert Califf">Robert Califf</a>, <a href="/wiki/Commissioner_of_Food_and_Drugs" title="Commissioner of Food and Drugs">Commissioner</a></li><li style="text-indent: -1em; padding-left: 1em;"><a href="/wiki/Namandj%C3%A9_Bumpus" title="Namandjé Bumpus">Namandjé Bumpus</a>, Principal Deputy Commissioner</li></ul></div></td></tr><tr><th scope="row" class="infobox-label">Parent agency</th><td class="infobox-data"><a href="/wiki/United_States_Department_of_Health_and_Human_Services" title="United States Department of Health and Human Services">Department of Health and Human Services</a></td></tr><tr><th scope="row" class="infobox-label">Child agencies</th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li style="text-indent: -1em; padding-left: 1em;"><a href="/wiki/Center_for_Biologics_Evaluation_and_Research" title="Center for Biologics Evaluation and Research">Center for Biologics Evaluation and Research</a></li><li style="text-indent: -1em; padding-left: 1em;"><a href="/wiki/Center_for_Devices_and_Radiological_Health" class="mw-redirect" title="Center for Devices and Radiological Health">Center for Devices and Radiological Health</a></li><li style="text-indent: -1em; padding-left: 1em;"><a href="/wiki/Center_for_Drug_Evaluation_and_Research" title="Center for Drug Evaluation and Research">Center for Drug Evaluation and Research</a></li><li style="text-indent: -1em; padding-left: 1em;"><a href="/wiki/Center_for_Food_Safety_and_Applied_Nutrition" title="Center for Food Safety and Applied Nutrition">Center for Food Safety and Applied Nutrition</a></li><li style="text-indent: -1em; padding-left: 1em;"><a href="/wiki/Center_for_Tobacco_Products" title="Center for Tobacco Products">Center for Tobacco Products</a></li><li style="text-indent: -1em; padding-left: 1em;"><a href="/wiki/Center_for_Veterinary_Medicine" title="Center for Veterinary Medicine">Center for Veterinary Medicine</a></li><li style="text-indent: -1em; padding-left: 1em;"><a href="/wiki/National_Center_for_Toxicological_Research" title="National Center for Toxicological Research">National Center for Toxicological Research</a></li><li style="text-indent: -1em; padding-left: 1em;"><a href="/wiki/Office_of_Criminal_Investigations" title="Office of Criminal Investigations">Office of Criminal Investigations</a></li><li style="text-indent: -1em; padding-left: 1em;"><a href="/wiki/Office_of_Regulatory_Affairs" class="mw-redirect" title="Office of Regulatory Affairs">Office of Regulatory Affairs</a></li></ul></div></td></tr><tr><th scope="row" class="infobox-label">Website</th><td class="infobox-data"><span class="url"><a rel="nofollow" class="external text" href="https://fda.gov/">fda<wbr />.gov</a></span> <span class="mw-valign-text-top noprint" typeof="mw:File/Frameless"><a href="https://www.wikidata.org/wiki/Q204711#P856" title="Edit this at Wikidata"><img alt="Edit this at Wikidata" src="//upload.wikimedia.org/wikipedia/en/thumb/8/8a/OOjs_UI_icon_edit-ltr-progressive.svg/10px-OOjs_UI_icon_edit-ltr-progressive.svg.png" decoding="async" width="10" height="10" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/en/thumb/8/8a/OOjs_UI_icon_edit-ltr-progressive.svg/15px-OOjs_UI_icon_edit-ltr-progressive.svg.png 1.5x, //upload.wikimedia.org/wikipedia/en/thumb/8/8a/OOjs_UI_icon_edit-ltr-progressive.svg/20px-OOjs_UI_icon_edit-ltr-progressive.svg.png 2x" data-file-width="20" data-file-height="20" /></a></span></td></tr></tbody></table> <p>The United States <b>Food and Drug Administration</b> (<b>FDA</b> or <b>US FDA</b>) is a <a href="/wiki/List_of_United_States_federal_agencies" class="mw-redirect" title="List of United States federal agencies">federal agency</a> of the <a href="/wiki/United_States_Department_of_Health_and_Human_Services" title="United States Department of Health and Human Services">Department of Health and Human Services</a>. The FDA is responsible for protecting and promoting <a href="/wiki/Public_health" title="Public health">public health</a> through the control and supervision of <a href="/wiki/Food_safety" title="Food safety">food safety</a>, <a href="/wiki/Tobacco" title="Tobacco">tobacco</a> products, <a href="/wiki/Caffeine" title="Caffeine">caffeine</a> products, <a href="/wiki/Dietary_supplement" title="Dietary supplement">dietary supplements</a>, <a href="/wiki/Prescription_drug" title="Prescription drug">prescription</a> and <a href="/wiki/Over-the-counter_drug" title="Over-the-counter drug">over-the-counter</a> <a href="/wiki/Pharmaceutical_drug" class="mw-redirect" title="Pharmaceutical drug">pharmaceutical drugs</a> (medications), <a href="/wiki/Vaccine" title="Vaccine">vaccines</a>, <a href="/wiki/Biopharmaceutical" title="Biopharmaceutical">biopharmaceuticals</a>, <a href="/wiki/Blood_transfusion" title="Blood transfusion">blood transfusions</a>, <a href="/wiki/Medical_device" title="Medical device">medical devices</a>, <a href="/wiki/Electromagnetic_radiation" title="Electromagnetic radiation">electromagnetic radiation</a> emitting devices (ERED), cosmetics, <a href="/wiki/Animal_feed" title="Animal feed">animal foods & feed</a><sup id="cite_ref-3" class="reference"><a href="#cite_note-3"><span class="cite-bracket">[</span>3<span class="cite-bracket">]</span></a></sup> and <a href="/wiki/Veterinary_medicine" title="Veterinary medicine">veterinary products</a>. </p><p>The FDA's primary focus is enforcement of the <a href="/wiki/Federal_Food,_Drug,_and_Cosmetic_Act" class="mw-redirect" title="Federal Food, Drug, and Cosmetic Act">Federal Food, Drug, and Cosmetic Act</a> (FD&C). However, 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 other factors like regulating <a href="/wiki/Lasers" class="mw-redirect" title="Lasers">lasers</a>, <a href="/wiki/Cellular_phones" class="mw-redirect" title="Cellular phones">cellular phones</a>, and <a href="/wiki/Condoms" class="mw-redirect" title="Condoms">condoms</a>. In addition, the FDA takes control of diseases in the contexts varying from household pets to <a href="/wiki/Sperm_donation" title="Sperm donation">human sperm donated</a> for use in <a href="/wiki/Assisted_reproduction" class="mw-redirect" title="Assisted reproduction">assisted reproduction</a>. </p><p>The FDA is led by the <a href="/wiki/Commissioner_of_Food_and_Drugs" title="Commissioner of Food and Drugs">commissioner of Food and Drugs</a>, appointed by the President with the <a href="/wiki/Advice_and_consent" title="Advice and consent">advice and consent</a> of the <a href="/wiki/United_States_Senate" title="United States Senate">Senate</a>. The commissioner reports to the <a href="/wiki/United_States_Secretary_of_Health_and_Human_Services" title="United States Secretary of Health and Human Services">secretary of health and human services</a>. <a href="/wiki/Robert_Califf" title="Robert Califf">Robert Califf</a> is the current commissioner as of February 17, 2022.<sup id="cite_ref-4" class="reference"><a href="#cite_note-4"><span class="cite-bracket">[</span>4<span class="cite-bracket">]</span></a></sup> </p><p>The FDA's headquarters is located in the <a href="/wiki/White_Oak,_Maryland" title="White Oak, Maryland">White Oak</a> area of <a href="/wiki/Silver_Spring,_Maryland" title="Silver Spring, Maryland">Silver Spring, Maryland</a>.<sup id="cite_ref-White_Oak_5-0" class="reference"><a href="#cite_note-White_Oak-5"><span class="cite-bracket">[</span>5<span class="cite-bracket">]</span></a></sup> The agency has 223 field offices and 13 <a href="/wiki/Laboratories" class="mw-redirect" title="Laboratories">laboratories</a> located across the 50 states, the <a href="/wiki/United_States_Virgin_Islands" title="United States Virgin Islands">United States Virgin Islands</a>, and <a href="/wiki/Puerto_Rico" title="Puerto Rico">Puerto Rico</a>.<sup id="cite_ref-train_6-0" class="reference"><a href="#cite_note-train-6"><span class="cite-bracket">[</span>6<span class="cite-bracket">]</span></a></sup> In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.<sup id="cite_ref-7" class="reference"><a href="#cite_note-7"><span class="cite-bracket">[</span>7<span class="cite-bracket">]</span></a></sup> </p> <figure class="mw-default-size" typeof="mw:File/Thumb"><a href="/wiki/File:FDA_Bldg_31_-_Exterior_(5161375422).jpg" class="mw-file-description"><img alt="" src="//upload.wikimedia.org/wikipedia/commons/thumb/4/49/FDA_Bldg_31_-_Exterior_%285161375422%29.jpg/170px-FDA_Bldg_31_-_Exterior_%285161375422%29.jpg" decoding="async" width="170" height="255" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/4/49/FDA_Bldg_31_-_Exterior_%285161375422%29.jpg/255px-FDA_Bldg_31_-_Exterior_%285161375422%29.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/4/49/FDA_Bldg_31_-_Exterior_%285161375422%29.jpg/340px-FDA_Bldg_31_-_Exterior_%285161375422%29.jpg 2x" data-file-width="3329" data-file-height="4994" /></a><figcaption>FDA Building 31 houses the <a href="/wiki/Commissioner_of_Food_and_Drugs" title="Commissioner of Food and Drugs">Office of the Commissioner</a> and the Office of Regulatory <a href="/wiki/Department_of_Health_and_Human_Services" class="mw-redirect" title="Department of Health and Human Services">Department of Health and Human Services</a>.<sup id="cite_ref-8" class="reference"><a href="#cite_note-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup> The agency consists of fourteen Centers and Offices.<sup id="cite_ref-9" class="reference"><a href="#cite_note-9"><span class="cite-bracket">[</span>note 1<span class="cite-bracket">]</span></a></sup></figcaption></figure> <meta property="mw:PageProp/toc" /> <div class="mw-heading mw-heading2"><h2 id="Organizational_structure">Organizational structure</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=1" title="Edit section: Organizational structure"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1116488514">.mw-parser-output .treeview ul{padding:0;margin:0}.mw-parser-output .treeview li{padding:0;margin:0;list-style-type:none;list-style-image:none}.mw-parser-output .treeview li li{background:url("https://upload.wikimedia.org/wikipedia/commons/f/f2/Treeview-grey-line.png")no-repeat 0 -2981px;padding-left:21px;text-indent:0.3em}.mw-parser-output .treeview li li:last-child{background-position:0 -5971px}.mw-parser-output .treeview li.emptyline>ul>.mw-empty-elt:first-child+.emptyline,.mw-parser-output .treeview li.emptyline>ul>li:first-child{background-position:0 9px}</style><div class="treeview"> <ul><li><a href="/wiki/Department_of_Health_and_Human_Services" class="mw-redirect" title="Department of Health and Human Services">Department of Health and Human Services</a> <ul><li><b>Food and Drug Administration</b> <ul><li><a href="/wiki/Commissioner_of_Food_and_Drugs" title="Commissioner of Food and Drugs">Office of the Commissioner</a> (C) <ul><li>Office of the Chief Counsel (OCC)</li> <li>Office of the Executive Secretariat (OES)</li> <li>Office of the Counselor to the Commissioner</li> <li>Office of Digital Transformation (ODT)</li></ul></li> <li><a href="/wiki/Center_for_Biologics_Evaluation_and_Research" title="Center for Biologics Evaluation and Research">Center for Biologics Evaluation and Research</a> (CBER)</li> <li><a href="/wiki/Center_for_Devices_and_Radiological_Health" class="mw-redirect" title="Center for Devices and Radiological Health">Center for Devices and Radiological Health</a> (CDRH)</li> <li><a href="/wiki/Center_for_Drug_Evaluation_and_Research" title="Center for Drug Evaluation and Research">Center for Drug Evaluation and Research</a> (CDER)</li> <li><a href="/wiki/Center_for_Food_Safety_and_Applied_Nutrition" title="Center for Food Safety and Applied Nutrition">Center for Food Safety and Applied Nutrition</a> (CFSAN)</li> <li><a href="/wiki/Center_for_Tobacco_Products" title="Center for Tobacco Products">Center for Tobacco Products</a> (CTP)</li> <li><a href="/wiki/Center_for_Veterinary_Medicine" title="Center for Veterinary Medicine">Center for Veterinary Medicine</a> (CVM)</li> <li>Oncology Center of Excellence (OCE)</li> <li><a href="/wiki/Office_of_Regulatory_Affairs" class="mw-redirect" title="Office of Regulatory Affairs">Office of Regulatory Affairs</a> (ORA)</li> <li>Office of Clinical Policy and Programs (OCPP)</li> <li>Office of External Affairs (OEA)</li> <li>Office of Food Policy and Response (OFPR)</li> <li>Office of Minority Health and Health Equity (OMHHE)</li> <li>Office of Operations (OO)</li> <li>Office of Policy, Legislation, and International Affairs (OPLIA)</li> <li>Office of the Chief Scientist (OCS) <ul><li><a href="/wiki/National_Center_for_Toxicological_Research" title="National Center for Toxicological Research">National Center for Toxicological Research</a> (NCTR)</li></ul></li> <li>Office of Women's Health (OWH)</li></ul></li></ul></li></ul> </div> <div class="mw-heading mw-heading2"><h2 id="Location">Location</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=2" title="Edit section: Location"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <figure class="mw-default-size" typeof="mw:File/Thumb"><a href="/wiki/File:FDA_Building_66_-_CDRH_(5160772175).jpg" class="mw-file-description"><img alt="" src="//upload.wikimedia.org/wikipedia/commons/thumb/8/81/FDA_Building_66_-_CDRH_%285160772175%29.jpg/220px-FDA_Building_66_-_CDRH_%285160772175%29.jpg" decoding="async" width="220" height="200" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/8/81/FDA_Building_66_-_CDRH_%285160772175%29.jpg/330px-FDA_Building_66_-_CDRH_%285160772175%29.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/8/81/FDA_Building_66_-_CDRH_%285160772175%29.jpg/440px-FDA_Building_66_-_CDRH_%285160772175%29.jpg 2x" data-file-width="4200" data-file-height="3825" /></a><figcaption>FDA Building 66 houses the <a href="/wiki/FDA_Center_for_Devices_and_Radiological_Health" title="FDA Center for Devices and Radiological Health">Center for Devices and Radiological Health</a>.</figcaption></figure> <div class="mw-heading mw-heading3"><h3 id="Headquarters">Headquarters</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=3" title="Edit section: Headquarters"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>FDA headquarters facilities are currently located in <a href="/wiki/Montgomery_County,_Maryland" title="Montgomery County, Maryland">Montgomery County</a> and <a href="/wiki/Prince_George%27s_County,_Maryland" title="Prince George's County, Maryland">Prince George's County</a>, Maryland.<sup id="cite_ref-10" class="reference"><a href="#cite_note-10"><span class="cite-bracket">[</span>9<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="White_Oak_Federal_Research_Center">White Oak Federal Research Center</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=4" title="Edit section: White Oak Federal Research Center"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Since 1990, the FDA has had employees and facilities on 130 acres (53 hectares) of the White Oak Federal Research Center in the <a href="/wiki/White_Oak,_Maryland" title="White Oak, Maryland">White Oak</a> area of <a href="/wiki/Silver_Spring,_Maryland" title="Silver Spring, Maryland">Silver Spring, Maryland</a>.<sup id="cite_ref-White_Oak_5-1" class="reference"><a href="#cite_note-White_Oak-5"><span class="cite-bracket">[</span>5<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-coordinates_11-0" class="reference"><a href="#cite_note-coordinates-11"><span class="cite-bracket">[</span>10<span class="cite-bracket">]</span></a></sup> In 2001, the <a href="/wiki/General_Services_Administration" title="General Services Administration">General Services Administration</a> (GSA) began new construction on the campus to consolidate the FDA's 25 existing operations in the <a href="/wiki/Washington_metropolitan_area" title="Washington metropolitan area">Washington metropolitan area</a>, its headquarters in <a href="/wiki/Rockville,_Maryland" title="Rockville, Maryland">Rockville</a>, 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,<sup class="plainlinks noexcerpt noprint asof-tag update" style="display:none;"><a class="external text" href="https://en.wikipedia.org/w/index.php?title=Food_and_Drug_Administration&action=edit">[update]</a></sup> the FDA campus has a population of 10,987 employees housed in approximately 3,800,000 square feet (350,000 square metres) of space, divided into ten offices and four laboratory buildings. The campus houses the <a href="/wiki/Commissioner_of_the_Food_and_Drug_Administration" class="mw-redirect" title="Commissioner of the Food and Drug Administration">Office of the Commissioner</a> (OC), the Office of Regulatory Affairs (ORA),  the <a href="/wiki/Center_for_Drug_Evaluation_and_Research" title="Center for Drug Evaluation and Research">Center for Drug Evaluation and Research</a> (CDER), the <a href="/wiki/FDA_Center_for_Devices_and_Radiological_Health" title="FDA Center for Devices and Radiological Health">Center for Devices and Radiological Health</a> (CDRH), the <a href="/wiki/Center_for_Biologics_Evaluation_and_Research" title="Center for Biologics Evaluation and Research">Center for Biologics Evaluation and Research</a> (CBER) and offices for the <a href="/wiki/Center_for_Veterinary_Medicine" title="Center for Veterinary Medicine">Center for Veterinary Medicine</a> (CVM).<sup id="cite_ref-White_Oak_5-2" class="reference"><a href="#cite_note-White_Oak-5"><span class="cite-bracket">[</span>5<span class="cite-bracket">]</span></a></sup> </p><p>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 1,600,000 square feet (150,000 square metres) of office and special use space to their existing facilities. The <a href="/wiki/National_Capital_Planning_Commission" title="National Capital Planning Commission">National Capital Planning Commission</a> approved a new master plan for this expansion in December 2018,<sup id="cite_ref-12" class="reference"><a href="#cite_note-12"><span class="cite-bracket">[</span>11<span class="cite-bracket">]</span></a></sup> and construction is expected to be completed by 2035, dependent on GSA appropriations.<sup id="cite_ref-13" class="reference"><a href="#cite_note-13"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Field_locations">Field locations</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=5" title="Edit section: Field locations"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <figure class="mw-default-size" typeof="mw:File/Thumb"><a href="/wiki/File:Toxicology_Research_at_FDA_(NCTR_Campus)_(6023336064).jpg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/3/35/Toxicology_Research_at_FDA_%28NCTR_Campus%29_%286023336064%29.jpg/400px-Toxicology_Research_at_FDA_%28NCTR_Campus%29_%286023336064%29.jpg" decoding="async" width="400" height="114" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/3/35/Toxicology_Research_at_FDA_%28NCTR_Campus%29_%286023336064%29.jpg/600px-Toxicology_Research_at_FDA_%28NCTR_Campus%29_%286023336064%29.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/3/35/Toxicology_Research_at_FDA_%28NCTR_Campus%29_%286023336064%29.jpg/800px-Toxicology_Research_at_FDA_%28NCTR_Campus%29_%286023336064%29.jpg 2x" data-file-width="2953" data-file-height="838" /></a><figcaption>The Arkansas Laboratory in <a href="/wiki/Jefferson,_Jefferson_County,_Arkansas" title="Jefferson, Jefferson County, Arkansas">Jefferson, Arkansas</a> is the headquarters of the National Center for Toxicological Research.</figcaption></figure> <div class="mw-heading mw-heading4"><h4 id="Office_of_Regulatory_Affairs">Office of Regulatory Affairs</h4><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=6" title="Edit section: Office of Regulatory Affairs"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The <a href="/wiki/Office_of_Regulatory_Affairs" class="mw-redirect" title="Office of Regulatory Affairs">Office of Regulatory Affairs</a> 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 <a href="/wiki/United_States_federal_court_system" class="mw-redirect" title="United States federal court system">Federal court system</a>. 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. </p> <div class="mw-heading mw-heading4"><h4 id="Office_of_Criminal_Investigations">Office of Criminal Investigations</h4><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=7" title="Edit section: Office of Criminal Investigations"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <figure class="mw-default-size" typeof="mw:File/Thumb"><a href="/wiki/File:US_Food_and_Drug_Administration_Office_20180930.jpg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/7/72/US_Food_and_Drug_Administration_Office_20180930.jpg/220px-US_Food_and_Drug_Administration_Office_20180930.jpg" decoding="async" width="220" height="165" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/7/72/US_Food_and_Drug_Administration_Office_20180930.jpg/330px-US_Food_and_Drug_Administration_Office_20180930.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/7/72/US_Food_and_Drug_Administration_Office_20180930.jpg/440px-US_Food_and_Drug_Administration_Office_20180930.jpg 2x" data-file-width="4048" data-file-height="3036" /></a><figcaption>Jamaica, Queens, New York Regional Office - USFDA</figcaption></figure> <p>The <a href="/wiki/Office_of_Criminal_Investigations" title="Office of Criminal Investigations">Office of Criminal Investigations</a> 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 <a href="/wiki/Title_18_of_the_United_States_Code" title="Title 18 of the United States Code">Title 18 of the United States Code</a> (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 <a href="/wiki/Federal_Bureau_of_Investigation" title="Federal Bureau of Investigation">Federal Bureau of Investigation</a>, <a href="/wiki/United_States_Assistant_Attorney_General" title="United States Assistant Attorney General">Assistant Attorney General</a>, and even <a href="/wiki/Interpol" title="Interpol">Interpol</a>. 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.<sup id="cite_ref-14" class="reference"><a href="#cite_note-14"><span class="cite-bracket">[</span>13<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading4"><h4 id="Other_locations">Other locations</h4><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=8" title="Edit section: Other locations"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>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.<sup id="cite_ref-15" class="reference"><a href="#cite_note-15"><span class="cite-bracket">[</span>14<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Scope_and_funding">Scope and funding</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=9" title="Edit section: Scope and funding"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>As of 2021, the FDA had responsibility for overseeing $2.7 trillion in food, medical, and tobacco products.<sup id="cite_ref-2021faqs_16-0" class="reference"><a href="#cite_note-2021faqs-16"><span class="cite-bracket">[</span>15<span class="cite-bracket">]</span></a></sup> Some 54% of its budget derives from the federal government, and 46% is covered by industry user fees for FDA services.<sup id="cite_ref-2021faqs_16-1" class="reference"><a href="#cite_note-2021faqs-16"><span class="cite-bracket">[</span>15<span class="cite-bracket">]</span></a></sup> For example, <a href="/wiki/Pharmaceutical_industry" title="Pharmaceutical industry">pharmaceutical firms</a> pay fees to expedite drug reviews.<sup id="cite_ref-2021faqs_16-2" class="reference"><a href="#cite_note-2021faqs-16"><span class="cite-bracket">[</span>15<span class="cite-bracket">]</span></a></sup> </p><p>According to Forbes, pharmaceutical firms provide 75% of the FDA's drug review budget<sup id="cite_ref-17" class="reference"><a href="#cite_note-17"><span class="cite-bracket">[</span>16<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Regulatory_programs">Regulatory programs</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=10" title="Edit section: Regulatory programs"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <div class="mw-heading mw-heading3"><h3 id="Emergency_approvals_(EUA)"><span id="Emergency_approvals_.28EUA.29"></span>Emergency approvals (EUA)</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=11" title="Edit section: Emergency approvals (EUA)"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>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.<sup id="cite_ref-18" class="reference"><a href="#cite_note-18"><span class="cite-bracket">[</span>17<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Regulations">Regulations</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=12" title="Edit section: Regulations"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>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 <a href="/wiki/Form_483" class="mw-redirect" title="Form 483">Form 483</a>.<sup id="cite_ref-19" class="reference"><a href="#cite_note-19"><span class="cite-bracket">[</span>18<span class="cite-bracket">]</span></a></sup> </p><p>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".<sup id="cite_ref-20" class="reference"><a href="#cite_note-20"><span class="cite-bracket">[</span>19<span class="cite-bracket">]</span></a></sup> 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.<sup id="cite_ref-21" class="reference"><a href="#cite_note-21"><span class="cite-bracket">[</span>20<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-22" class="reference"><a href="#cite_note-22"><span class="cite-bracket">[</span>21<span class="cite-bracket">]</span></a></sup> </p><p>The FDA also uses tactics of regulatory shaming,<sup id="cite_ref-23" class="reference"><a href="#cite_note-23"><span class="cite-bracket">[</span>22<span class="cite-bracket">]</span></a></sup> 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 <a href="/wiki/Generic_drug" title="Generic drug">generic drug</a> companies.<sup id="cite_ref-24" class="reference"><a href="#cite_note-24"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup> </p><p>The FDA frequently works with other federal agencies, including the <a href="/wiki/United_States_Department_of_Agriculture" title="United States Department of Agriculture">Department of Agriculture</a>, the <a href="/wiki/Drug_Enforcement_Administration" title="Drug Enforcement Administration">Drug Enforcement Administration</a>, <a href="/wiki/U.S._Customs_and_Border_Protection" title="U.S. Customs and Border Protection">Customs and Border Protection</a>, and the <a href="/wiki/U.S._Consumer_Product_Safety_Commission" title="U.S. Consumer Product Safety Commission">Consumer Product Safety Commission</a>. They also often work with local and state government agencies in performing regulatory inspections and enforcement actions.<sup id="cite_ref-25" class="reference"><a href="#cite_note-25"><span class="cite-bracket">[</span>24<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Food_and_dietary_supplements">Food and dietary supplements</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=13" title="Edit section: Food and dietary supplements"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236090951"><div role="note" class="hatnote navigation-not-searchable">Main article: <a href="/wiki/Regulation_of_food_and_dietary_supplements_by_the_U.S._Food_and_Drug_Administration" title="Regulation of food and dietary supplements by the U.S. Food and Drug Administration">Regulation of food and dietary supplements by the U.S. Food and Drug Administration</a></div> <p>The regulation of food and dietary supplements by the Food and Drug Administration is governed by various statutes enacted by the <a href="/wiki/United_States_Congress" title="United States Congress">United States Congress</a> and interpreted by the FDA. Pursuant to the <a href="/wiki/Federal_Food,_Drug,_and_Cosmetic_Act" class="mw-redirect" title="Federal Food, Drug, and Cosmetic Act">Federal Food, Drug, and Cosmetic Act</a> 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 <a href="/wiki/Packaging_and_labeling" class="mw-redirect" title="Packaging and labeling">labeling</a> of both the composition and the health benefits of foods. </p><p>The FDA subdivides substances that it regulates as food into various categories—including foods, <a href="/wiki/Food_additive" title="Food additive">food additives</a>, added substances (human-made substances that are not intentionally introduced into food, but nevertheless end up in it), and <a href="/wiki/Dietary_supplements" class="mw-redirect" title="Dietary supplements">dietary supplements</a>. Dietary supplements or dietary ingredients include vitamins, minerals, herbs, <a href="/wiki/Amino_acid" title="Amino acid">amino acids</a>, and <a href="/wiki/Enzyme" title="Enzyme">enzymes</a>.<sup id="cite_ref-26" class="reference"><a href="#cite_note-26"><span class="cite-bracket">[</span>25<span class="cite-bracket">]</span></a></sup> 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. </p><p>Under the <a href="/wiki/Dietary_Supplement_Health_and_Education_Act_of_1994" title="Dietary Supplement Health and Education Act of 1994">Dietary Supplement Health and Education Act of 1994</a> (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.<sup id="cite_ref-27" class="reference"><a href="#cite_note-27"><span class="cite-bracket">[</span>26<span class="cite-bracket">]</span></a></sup> </p><p>The FDA has a "Dietary Supplement Ingredient Advisory List" that includes ingredients that sometimes appear on dietary supplements but need further evaluation.<sup id="cite_ref-28" class="reference"><a href="#cite_note-28"><span class="cite-bracket">[</span>27<span class="cite-bracket">]</span></a></sup> 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.<sup id="cite_ref-29" class="reference"><a href="#cite_note-29"><span class="cite-bracket">[</span>28<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading4"><h4 id=""FDA-Approved"_vs._"FDA-Accepted_in_Food_Processing""><span id=".22FDA-Approved.22_vs._.22FDA-Accepted_in_Food_Processing.22"></span>"FDA-Approved" vs. "FDA-Accepted in Food Processing"</h4><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=14" title="Edit section: "FDA-Approved" vs. "FDA-Accepted in Food Processing""><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The FDA does not approve applied coatings used in the <a href="/wiki/Food_processing_industry" class="mw-redirect" title="Food processing industry">food processing industry</a>.<sup id="cite_ref-30" class="reference"><a href="#cite_note-30"><span class="cite-bracket">[</span>29<span class="cite-bracket">]</span></a></sup> 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 <a href="/wiki/Polytetrafluoroethylene" title="Polytetrafluoroethylene">Polytetrafluoroethylene</a> (Teflon) are not and cannot be considered as FDA Approved, but rather, they are a "FDA Compliant" or "FDA Acceptable". </p> <div class="mw-heading mw-heading3"><h3 id="Medical_countermeasures_(MCMs)"><span id="Medical_countermeasures_.28MCMs.29"></span>Medical countermeasures (MCMs)</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=15" title="Edit section: Medical countermeasures (MCMs)"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236090951"><div role="note" class="hatnote navigation-not-searchable">Further information: <a href="/wiki/Biosecurity" title="Biosecurity">Biosecurity</a>, <a href="/wiki/Bioterrorism" title="Bioterrorism">Bioterrorism</a>, and <a href="/wiki/Biosecurity_in_the_United_States" title="Biosecurity in the United States">Biosecurity in the United States</a></div> <p>Medical countermeasures (MCMs) are products such as <a href="/wiki/Biologics" class="mw-redirect" title="Biologics">biologics</a> and <a href="/wiki/Pharmaceutical_drug" class="mw-redirect" title="Pharmaceutical drug">pharmaceutical drugs</a> 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.<sup id="cite_ref-fdamcm_31-0" class="reference"><a href="#cite_note-fdamcm-31"><span class="cite-bracket">[</span>30<span class="cite-bracket">]</span></a></sup> 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 <a href="/wiki/Public_health_emergency_(United_States)" title="Public health emergency (United States)">public health emergencies</a> that could require MCMs.<sup id="cite_ref-fdamcm_31-1" class="reference"><a href="#cite_note-fdamcm-31"><span class="cite-bracket">[</span>30<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-32" class="reference"><a href="#cite_note-32"><span class="cite-bracket">[</span>31<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Medications">Medications</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=16" title="Edit section: Medications"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <figure class="mw-default-size" typeof="mw:File/Thumb"><a href="/wiki/File:FDA_Bldg_51_-_Main_Entrance_(5161374834).jpg" class="mw-file-description"><img alt="" src="//upload.wikimedia.org/wikipedia/commons/thumb/3/3d/FDA_Bldg_51_-_Main_Entrance_%285161374834%29.jpg/220px-FDA_Bldg_51_-_Main_Entrance_%285161374834%29.jpg" decoding="async" width="220" height="147" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/3/3d/FDA_Bldg_51_-_Main_Entrance_%285161374834%29.jpg/330px-FDA_Bldg_51_-_Main_Entrance_%285161374834%29.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/3/3d/FDA_Bldg_51_-_Main_Entrance_%285161374834%29.jpg/440px-FDA_Bldg_51_-_Main_Entrance_%285161374834%29.jpg 2x" data-file-width="1872" data-file-height="1248" /></a><figcaption>FDA Building 51 houses the <a href="/wiki/Center_for_Drug_Evaluation_and_Research" title="Center for Drug Evaluation and Research">Center for Drug Evaluation and Research</a>.</figcaption></figure> <p>The <a href="/wiki/Center_for_Drug_Evaluation_and_Research" title="Center for Drug Evaluation and Research">Center for Drug Evaluation and Research</a> 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 <a href="/wiki/Excipient" title="Excipient">excipients</a> or inactive ingredients, is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to <i>new molecular entities</i>: drugs that are not based on existing medications.<sup id="cite_ref-33" class="reference"><a href="#cite_note-33"><span class="cite-bracket">[</span>32<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading4"><h4 id="New_medications">New medications</h4><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=17" title="Edit section: New medications"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1251242444">.mw-parser-output .ambox{border:1px solid #a2a9b1;border-left:10px solid #36c;background-color:#fbfbfb;box-sizing:border-box}.mw-parser-output .ambox+link+.ambox,.mw-parser-output .ambox+link+style+.ambox,.mw-parser-output .ambox+link+link+.ambox,.mw-parser-output .ambox+.mw-empty-elt+link+.ambox,.mw-parser-output .ambox+.mw-empty-elt+link+style+.ambox,.mw-parser-output .ambox+.mw-empty-elt+link+link+.ambox{margin-top:-1px}html body.mediawiki .mw-parser-output .ambox.mbox-small-left{margin:4px 1em 4px 0;overflow:hidden;width:238px;border-collapse:collapse;font-size:88%;line-height:1.25em}.mw-parser-output .ambox-speedy{border-left:10px solid #b32424;background-color:#fee7e6}.mw-parser-output .ambox-delete{border-left:10px solid #b32424}.mw-parser-output .ambox-content{border-left:10px solid #f28500}.mw-parser-output .ambox-style{border-left:10px solid #fc3}.mw-parser-output .ambox-move{border-left:10px solid #9932cc}.mw-parser-output .ambox-protection{border-left:10px solid #a2a9b1}.mw-parser-output .ambox .mbox-text{border:none;padding:0.25em 0.5em;width:100%}.mw-parser-output .ambox .mbox-image{border:none;padding:2px 0 2px 0.5em;text-align:center}.mw-parser-output .ambox .mbox-imageright{border:none;padding:2px 0.5em 2px 0;text-align:center}.mw-parser-output .ambox .mbox-empty-cell{border:none;padding:0;width:1px}.mw-parser-output .ambox .mbox-image-div{width:52px}@media(min-width:720px){.mw-parser-output .ambox{margin:0 10%}}@media print{body.ns-0 .mw-parser-output .ambox{display:none!important}}</style><table class="box-More_citations_needed_section plainlinks metadata ambox ambox-content ambox-Refimprove" role="presentation"><tbody><tr><td class="mbox-image"><div class="mbox-image-div"><span typeof="mw:File"><a href="/wiki/File:Question_book-new.svg" class="mw-file-description"><img alt="" src="//upload.wikimedia.org/wikipedia/en/thumb/9/99/Question_book-new.svg/50px-Question_book-new.svg.png" decoding="async" width="50" height="39" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/en/thumb/9/99/Question_book-new.svg/75px-Question_book-new.svg.png 1.5x, //upload.wikimedia.org/wikipedia/en/thumb/9/99/Question_book-new.svg/100px-Question_book-new.svg.png 2x" data-file-width="512" data-file-height="399" /></a></span></div></td><td class="mbox-text"><div class="mbox-text-span">This section <b>needs additional citations for <a href="/wiki/Wikipedia:Verifiability" title="Wikipedia:Verifiability">verification</a></b>.<span class="hide-when-compact"> Please help <a href="/wiki/Special:EditPage/Food_and_Drug_Administration" title="Special:EditPage/Food and Drug Administration">improve this article</a> by <a href="/wiki/Help:Referencing_for_beginners" title="Help:Referencing for beginners">adding citations to reliable sources</a> in this section. Unsourced material may be challenged and removed.</span> <span class="date-container"><i>(<span class="date">August 2019</span>)</i></span><span class="hide-when-compact"><i> (<small><a href="/wiki/Help:Maintenance_template_removal" title="Help:Maintenance template removal">Learn how and when to remove this message</a></small>)</i></span></div></td></tr></tbody></table> <p>New drugs receive extensive scrutiny before FDA approval in a process called a <a href="/wiki/New_drug_application" class="mw-redirect" title="New drug application">new drug application</a> (NDA).<sup id="cite_ref-34" class="reference"><a href="#cite_note-34"><span class="cite-bracket">[</span>33<span class="cite-bracket">]</span></a></sup> Under the <a href="/wiki/First_presidency_of_Donald_Trump" title="First presidency of Donald Trump">Presidency of Donald Trump</a>, the agency has worked to make the drug-approval process go faster.<sup id="cite_ref-35" class="reference"><a href="#cite_note-35"><span class="cite-bracket">[</span>34<span class="cite-bracket">]</span></a></sup><b><sup class="reference nowrap"><span title="Page / location: 10">: 10 </span></sup></b> Critics, however, argue that FDA standards are not sufficiently rigorous to prevent unsafe or ineffective drugs from getting approval.<sup id="cite_ref-36" class="reference"><a href="#cite_note-36"><span class="cite-bracket">[</span>35<span class="cite-bracket">]</span></a></sup> 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". </p><p>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 <a href="/wiki/ZMapp" title="ZMapp">ZMapp</a> 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.) </p> <div class="mw-heading mw-heading5"><h5 id="Advertising_and_promotion">Advertising and promotion</h5><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=18" title="Edit section: Advertising and promotion"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1251242444"><table class="box-More_citations_needed_section plainlinks metadata ambox ambox-content ambox-Refimprove" role="presentation"><tbody><tr><td class="mbox-image"><div class="mbox-image-div"><span typeof="mw:File"><a href="/wiki/File:Question_book-new.svg" class="mw-file-description"><img alt="" src="//upload.wikimedia.org/wikipedia/en/thumb/9/99/Question_book-new.svg/50px-Question_book-new.svg.png" decoding="async" width="50" height="39" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/en/thumb/9/99/Question_book-new.svg/75px-Question_book-new.svg.png 1.5x, //upload.wikimedia.org/wikipedia/en/thumb/9/99/Question_book-new.svg/100px-Question_book-new.svg.png 2x" data-file-width="512" data-file-height="399" /></a></span></div></td><td class="mbox-text"><div class="mbox-text-span">This section <b>needs additional citations for <a href="/wiki/Wikipedia:Verifiability" title="Wikipedia:Verifiability">verification</a></b>.<span class="hide-when-compact"> Please help <a href="/wiki/Special:EditPage/Food_and_Drug_Administration" title="Special:EditPage/Food and Drug Administration">improve this article</a> by <a href="/wiki/Help:Referencing_for_beginners" title="Help:Referencing for beginners">adding citations to reliable sources</a> in this section. Unsourced material may be challenged and removed.</span> <span class="date-container"><i>(<span class="date">August 2019</span>)</i></span><span class="hide-when-compact"><i> (<small><a href="/wiki/Help:Maintenance_template_removal" title="Help:Maintenance template removal">Learn how and when to remove this message</a></small>)</i></span></div></td></tr></tbody></table> <p>The FDA's Office of Prescription Drug Promotion (OPDP) has responsibilities that revolve around the review and regulation of prescription drug advertising and promotion. This is achieved through surveillance activities and the issuance of enforcement letters to pharmaceutical manufacturers.<sup id="cite_ref-37" class="reference"><a href="#cite_note-37"><span class="cite-bracket">[</span>36<span class="cite-bracket">]</span></a></sup> Advertising and promotion for over-the-counter drugs is regulated by the <a href="/wiki/Federal_Trade_Commission" title="Federal Trade Commission">Federal Trade Commission</a>. The FDA also implements regulatory oversight through engagement with third-party enforcer-firms. It expects pharmaceutical companies to ensure that third-party suppliers and labs comply with the agency's health and safety guidelines .<sup id="cite_ref-38" class="reference"><a href="#cite_note-38"><span class="cite-bracket">[</span>37<span class="cite-bracket">]</span></a></sup><sup class="reference nowrap"><span title="Page / location: 4">: 4 </span></sup> </p><p>The drug advertising regulation<sup id="cite_ref-39" class="reference"><a href="#cite_note-39"><span class="cite-bracket">[</span>38<span class="cite-bracket">]</span></a></sup> 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 regulation of drug advertising in the U.S. is divided between the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), based on whether the drug in question is a prescription drug or an over-the-counter (OTC) drug. The FDA oversees the advertising of prescription drugs, while the FTC regulates the advertising of OTC drugs.<sup id="cite_ref-40" class="reference"><a href="#cite_note-40"><span class="cite-bracket">[</span>39<span class="cite-bracket">]</span></a></sup> </p><p>The term <a href="/wiki/Off-label" class="mw-redirect" title="Off-label">off-label</a> refers to the practice of prescribing a drug for a different purpose than what the FDA approved.<sup id="cite_ref-41" class="reference"><a href="#cite_note-41"><span class="cite-bracket">[</span>40<span class="cite-bracket">]</span></a></sup> </p><p>Due to this approval requirement, manufacturers were prohibited from advertising <a href="/wiki/COVID-19_vaccine" title="COVID-19 vaccine">COVID-19 vaccines</a> during the period in which they had only been approved under <a href="/wiki/Emergency_Use_Authorization" title="Emergency Use Authorization">Emergency Use Authorization</a>.<sup id="cite_ref-42" class="reference"><a href="#cite_note-42"><span class="cite-bracket">[</span>41<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading5"><h5 id="Post-market_safety_surveillance">Post-market safety surveillance</h5><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=19" title="Edit section: Post-market safety surveillance"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>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.<sup id="cite_ref-43" class="reference"><a href="#cite_note-43"><span class="cite-bracket">[</span>42<span class="cite-bracket">]</span></a></sup> The FDA also receives directly adverse drug event reports through its <a href="/wiki/MedWatch" title="MedWatch">MedWatch</a> program.<sup id="cite_ref-44" class="reference"><a href="#cite_note-44"><span class="cite-bracket">[</span>43<span class="cite-bracket">]</span></a></sup> These reports are called "spontaneous reports" because reporting by consumers and health professionals is voluntary. </p><p>While this remains the primary tool of <a href="/wiki/Postmarketing_surveillance" title="Postmarketing surveillance">post-market safety surveillance</a>, FDA requirements for post-marketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional <a href="/wiki/Clinical_trials" class="mw-redirect" title="Clinical trials">clinical trials</a>, called Phase IV trials. In some cases, the FDA requires risk management plans called <a href="/wiki/Risk_Evaluation_and_Mitigation_Strategies" title="Risk Evaluation and Mitigation Strategies">Risk Evaluation and Mitigation Strategies</a> (REMS) for some drugs that require actions to be taken to ensure that the drug is used safely.<sup id="cite_ref-Nelson_45-0" class="reference"><a href="#cite_note-Nelson-45"><span class="cite-bracket">[</span>44<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-46" class="reference"><a href="#cite_note-46"><span class="cite-bracket">[</span>45<span class="cite-bracket">]</span></a></sup> For example, <a href="/wiki/Thalidomide" title="Thalidomide">thalidomide</a> 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 <a href="/wiki/Opioid" title="Opioid">opioid</a> drugs have REMS programs to avoid addiction and diversion of drugs.<sup id="cite_ref-Nelson_45-1" class="reference"><a href="#cite_note-Nelson-45"><span class="cite-bracket">[</span>44<span class="cite-bracket">]</span></a></sup> The drug <a href="/wiki/Isotretinoin" title="Isotretinoin">isotretinoin</a> has a REMS program called <a href="/wiki/IPLEDGE" class="mw-redirect" title="IPLEDGE">iPLEDGE</a>.<sup id="cite_ref-47" class="reference"><a href="#cite_note-47"><span class="cite-bracket">[</span>46<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading4"><h4 id="Generic_drugs">Generic drugs</h4><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=20" title="Edit section: Generic drugs"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Generic drugs are chemical and therapeutic equivalents of <a href="/wiki/Name-brand" class="mw-redirect" title="Name-brand">name-brand</a> drugs, normally whose patents have expired.<sup id="cite_ref-TNBK_48-0" class="reference"><a href="#cite_note-TNBK-48"><span class="cite-bracket">[</span>47<span class="cite-bracket">]</span></a></sup> 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.<sup id="cite_ref-TNBK_48-1" class="reference"><a href="#cite_note-TNBK-48"><span class="cite-bracket">[</span>47<span class="cite-bracket">]</span></a></sup> 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.<sup id="cite_ref-Therapeutic_Equivalance_of_Generic_Drugs_49-0" class="reference"><a href="#cite_note-Therapeutic_Equivalance_of_Generic_Drugs-49"><span class="cite-bracket">[</span>48<span class="cite-bracket">]</span></a></sup> This is called an <a href="/wiki/Abbreviated_New_Drug_Application" title="Abbreviated New Drug Application">Abbreviated New Drug Application</a> (ANDA).<sup id="cite_ref-50" class="reference"><a href="#cite_note-50"><span class="cite-bracket">[</span>49<span class="cite-bracket">]</span></a></sup> 80% of prescription drugs sold in the United States are generic brands.<sup id="cite_ref-51" class="reference"><a href="#cite_note-51"><span class="cite-bracket">[</span>50<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading5"><h5 id="Generic_drug_scandal">Generic drug scandal</h5><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=21" title="Edit section: Generic drug scandal"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>In 1989, a major scandal erupted involving the procedures used by the FDA to approve generic drugs for sale to the public.<sup id="cite_ref-TNBK_48-2" class="reference"><a href="#cite_note-TNBK-48"><span class="cite-bracket">[</span>47<span class="cite-bracket">]</span></a></sup> 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 <a href="/wiki/House_Energy_and_Commerce_Committee" class="mw-redirect" title="House Energy and Commerce Committee">United States House Energy and Commerce Committee</a> resulted from a complaint brought against the FDA by <a href="/wiki/Mylan_Laboratories_Inc." class="mw-redirect" title="Mylan Laboratories Inc.">Mylan Laboratories Inc.</a> of <a href="/wiki/Pittsburgh" title="Pittsburgh">Pittsburgh</a>. 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 <a href="/wiki/Racketeering" title="Racketeering">racketeering</a> and in violations of <a href="/wiki/Antitrust_law" class="mw-redirect" title="Antitrust law">antitrust law</a>. "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 (<a href="/wiki/Par_Pharmaceutical" class="mw-redirect" title="Par Pharmaceutical">Par Pharmaceutical</a> and its subsidiary Quad Pharmaceuticals)<sup id="cite_ref-52" class="reference"><a href="#cite_note-52"><span class="cite-bracket">[</span>51<span class="cite-bracket">]</span></a></sup> pleaded guilty to giving bribes. </p><p>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 <a href="/wiki/Dyazide" class="mw-redirect" title="Dyazide">Dyazide</a>, 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 <a href="/wiki/U.S._Securities_and_Exchange_Commission" title="U.S. Securities and Exchange Commission">U.S. Securities and Exchange Commission</a> filed securities fraud charges against the Bolar Pharmaceutical Company, a major generic manufacturer based in Long Island, New York.<sup id="cite_ref-TNBK_48-3" class="reference"><a href="#cite_note-TNBK-48"><span class="cite-bracket">[</span>47<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading4"><h4 id="Over-the-counter_drugs">Over-the-counter drugs</h4><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=22" title="Edit section: Over-the-counter drugs"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Over-the-counter (OTC) are drugs like <a href="/wiki/Aspirin" title="Aspirin">aspirin</a> that do not require a doctor's prescription.<sup id="cite_ref-53" class="reference"><a href="#cite_note-53"><span class="cite-bracket">[</span>52<span class="cite-bracket">]</span></a></sup> 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 <a href="/wiki/Physician" title="Physician">medical practitioner</a>'s supervision like <a href="/wiki/Ibuprofen" title="Ibuprofen">ibuprofen</a>.<sup id="cite_ref-54" class="reference"><a href="#cite_note-54"><span class="cite-bracket">[</span>53<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading4"><h4 id="Ebola_treatment">Ebola treatment</h4><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=23" title="Edit section: Ebola treatment"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>In 2014, the FDA added an <a href="/wiki/Ebola" title="Ebola">Ebola</a> treatment being developed by Canadian pharmaceutical company <a href="/wiki/Tekmira_Pharmaceuticals" class="mw-redirect" title="Tekmira Pharmaceuticals">Tekmira</a> to the <a href="/wiki/FDA_Fast_Track_Development_Program" class="mw-redirect" title="FDA Fast Track Development Program">Fast Track program</a>, 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 <a href="/wiki/2014_West_Africa_Ebola_outbreak" class="mw-redirect" title="2014 West Africa Ebola outbreak">major outbreak of the disease in West Africa</a> that began in late March 2014 and ended in June 2016.<sup id="cite_ref-55" class="reference"><a href="#cite_note-55"><span class="cite-bracket">[</span>54<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading4"><h4 id="Coronavirus_(COVID-19)_testing"><span id="Coronavirus_.28COVID-19.29_testing"></span>Coronavirus (COVID-19) testing</h4><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=24" title="Edit section: Coronavirus (COVID-19) testing"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236090951"><div role="note" class="hatnote navigation-not-searchable">Main article: <a href="/wiki/COVID-19_testing" title="COVID-19 testing">COVID-19 testing</a></div> <p>During the <a href="/wiki/COVID-19_pandemic_in_the_United_States" title="COVID-19 pandemic in the United States">coronavirus pandemic</a>, FDA granted <a href="/wiki/Emergency_use_authorization" class="mw-redirect" title="Emergency use authorization">emergency use authorization</a> for <a href="/wiki/Personal_protective_equipment" title="Personal protective equipment">personal protective equipment</a> (PPE), in vitro diagnostic equipment, <a href="/wiki/Ventilator" title="Ventilator">ventilators</a> and other medical devices.<sup id="cite_ref-FDA-EUA_56-0" class="reference"><a href="#cite_note-FDA-EUA-56"><span class="cite-bracket">[</span>55<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-57" class="reference"><a href="#cite_note-57"><span class="cite-bracket">[</span>56<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-58" class="reference"><a href="#cite_note-58"><span class="cite-bracket">[</span>57<span class="cite-bracket">]</span></a></sup> </p><p>On March 18, 2020, FDA inspectors postponed most foreign facility inspections and all domestic routine surveillance facility inspections.<sup id="cite_ref-FDA-COVID-19-inspections_59-0" class="reference"><a href="#cite_note-FDA-COVID-19-inspections-59"><span class="cite-bracket">[</span>58<span class="cite-bracket">]</span></a></sup> In contrast, the <a href="/wiki/United_States_Department_of_Agriculture" title="United States Department of Agriculture">USDA's</a> <a href="/wiki/Food_Safety_and_Inspection_Service" title="Food Safety and Inspection Service">Food Safety and Inspection Service</a> (FSIS) continued inspections of meatpacking plants, which resulted in 145 FSIS field employees who tested positive for COVID-19, and three who died.<sup id="cite_ref-CBS-COVID_60-0" class="reference"><a href="#cite_note-CBS-COVID-60"><span class="cite-bracket">[</span>59<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Vaccines,_blood_and_tissue_products,_and_biotechnology"><span id="Vaccines.2C_blood_and_tissue_products.2C_and_biotechnology"></span>Vaccines, blood and tissue products, and biotechnology</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=25" title="Edit section: Vaccines, blood and tissue products, and biotechnology"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1251242444"><table class="box-More_citations_needed_section plainlinks metadata ambox ambox-content ambox-Refimprove" role="presentation"><tbody><tr><td class="mbox-image"><div class="mbox-image-div"><span typeof="mw:File"><a href="/wiki/File:Question_book-new.svg" class="mw-file-description"><img alt="" src="//upload.wikimedia.org/wikipedia/en/thumb/9/99/Question_book-new.svg/50px-Question_book-new.svg.png" decoding="async" width="50" height="39" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/en/thumb/9/99/Question_book-new.svg/75px-Question_book-new.svg.png 1.5x, //upload.wikimedia.org/wikipedia/en/thumb/9/99/Question_book-new.svg/100px-Question_book-new.svg.png 2x" data-file-width="512" data-file-height="399" /></a></span></div></td><td class="mbox-text"><div class="mbox-text-span">This section <b>needs additional citations for <a href="/wiki/Wikipedia:Verifiability" title="Wikipedia:Verifiability">verification</a></b>.<span class="hide-when-compact"> Please help <a href="/wiki/Special:EditPage/Food_and_Drug_Administration" title="Special:EditPage/Food and Drug Administration">improve this article</a> by <a href="/wiki/Help:Referencing_for_beginners" title="Help:Referencing for beginners">adding citations to reliable sources</a> in this section. Unsourced material may be challenged and removed.</span> <span class="date-container"><i>(<span class="date">August 2019</span>)</i></span><span class="hide-when-compact"><i> (<small><a href="/wiki/Help:Maintenance_template_removal" title="Help:Maintenance template removal">Learn how and when to remove this message</a></small>)</i></span></div></td></tr></tbody></table> <figure class="mw-default-size" typeof="mw:File/Thumb"><a href="/wiki/File:Blood_Research-_Saving_Lives_(8352)_(9759352093).jpg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/5/58/Blood_Research-_Saving_Lives_%288352%29_%289759352093%29.jpg/220px-Blood_Research-_Saving_Lives_%288352%29_%289759352093%29.jpg" decoding="async" width="220" height="146" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/5/58/Blood_Research-_Saving_Lives_%288352%29_%289759352093%29.jpg/330px-Blood_Research-_Saving_Lives_%288352%29_%289759352093%29.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/5/58/Blood_Research-_Saving_Lives_%288352%29_%289759352093%29.jpg/440px-Blood_Research-_Saving_Lives_%288352%29_%289759352093%29.jpg 2x" data-file-width="2784" data-file-height="1848" /></a><figcaption>FDA scientist prepares blood donation samples for testing.</figcaption></figure> <p>The <a href="/wiki/Center_for_Biologics_Evaluation_and_Research" title="Center for Biologics Evaluation and Research">Center for Biologics Evaluation and Research</a> is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents.<sup id="cite_ref-61" class="reference"><a href="#cite_note-61"><span class="cite-bracket">[</span>60<span class="cite-bracket">]</span></a></sup> 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 <a href="/wiki/Biologics_license_application" title="Biologics license application">Biologics License Application</a> (BLA), similar to that for drugs. </p><p>The original authority for government regulation of biological products was established by the 1902 <a href="/wiki/Biologics_Control_Act" title="Biologics Control Act">Biologics Control Act</a>, with additional authority established by the 1944 <a href="/wiki/Public_Health_Service_Act" title="Public Health Service Act">Public Health Service Act</a>. Along with these Acts, the <a href="/wiki/Federal_Food,_Drug,_and_Cosmetic_Act" class="mw-redirect" title="Federal Food, Drug, and Cosmetic Act">Federal Food, Drug, and Cosmetic Act</a> applies to all biologic products, as well. Originally, the entity responsible for regulation of biological products resided under the <a href="/wiki/National_Institutes_of_Health" title="National Institutes of Health">National Institutes of Health</a>; this authority was transferred to the FDA in 1972. </p> <div class="mw-heading mw-heading3"><h3 id="Medical_and_radiation-emitting_devices">Medical and radiation-emitting devices</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=26" title="Edit section: Medical and radiation-emitting devices"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1251242444"><table class="box-More_citations_needed_section plainlinks metadata ambox ambox-content ambox-Refimprove" role="presentation"><tbody><tr><td class="mbox-image"><div class="mbox-image-div"><span typeof="mw:File"><a href="/wiki/File:Question_book-new.svg" class="mw-file-description"><img alt="" src="//upload.wikimedia.org/wikipedia/en/thumb/9/99/Question_book-new.svg/50px-Question_book-new.svg.png" decoding="async" width="50" height="39" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/en/thumb/9/99/Question_book-new.svg/75px-Question_book-new.svg.png 1.5x, //upload.wikimedia.org/wikipedia/en/thumb/9/99/Question_book-new.svg/100px-Question_book-new.svg.png 2x" data-file-width="512" data-file-height="399" /></a></span></div></td><td class="mbox-text"><div class="mbox-text-span">This section <b>needs additional citations for <a href="/wiki/Wikipedia:Verifiability" title="Wikipedia:Verifiability">verification</a></b>.<span class="hide-when-compact"> Please help <a href="/wiki/Special:EditPage/Food_and_Drug_Administration" title="Special:EditPage/Food and Drug Administration">improve this article</a> by <a href="/wiki/Help:Referencing_for_beginners" title="Help:Referencing for beginners">adding citations to reliable sources</a> in this section. Unsourced material may be challenged and removed.</span> <span class="date-container"><i>(<span class="date">August 2019</span>)</i></span><span class="hide-when-compact"><i> (<small><a href="/wiki/Help:Maintenance_template_removal" title="Help:Maintenance template removal">Learn how and when to remove this message</a></small>)</i></span></div></td></tr></tbody></table> <figure class="mw-default-size" typeof="mw:File/Thumb"><a href="/wiki/File:FDA_Bldg_62_-_Exterior_(5161375340).jpg" class="mw-file-description"><img alt="" src="//upload.wikimedia.org/wikipedia/commons/thumb/8/85/FDA_Bldg_62_-_Exterior_%285161375340%29.jpg/220px-FDA_Bldg_62_-_Exterior_%285161375340%29.jpg" decoding="async" width="220" height="127" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/8/85/FDA_Bldg_62_-_Exterior_%285161375340%29.jpg/330px-FDA_Bldg_62_-_Exterior_%285161375340%29.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/8/85/FDA_Bldg_62_-_Exterior_%285161375340%29.jpg/440px-FDA_Bldg_62_-_Exterior_%285161375340%29.jpg 2x" data-file-width="800" data-file-height="462" /></a><figcaption>FDA Building 62 houses the <a href="/wiki/FDA_Center_for_Devices_and_Radiological_Health" title="FDA Center for Devices and Radiological Health">Center for Devices and Radiological Health</a>.</figcaption></figure> <p>The <a href="/wiki/Center_for_Devices_and_Radiological_Health" class="mw-redirect" title="Center for Devices and Radiological Health">Center for Devices and Radiological Health</a> (CDRH) is the branch of the FDA responsible for the premarket approval of all <a href="/wiki/Medical_device" title="Medical device">medical devices</a>, as well as overseeing the manufacturing, performance and safety of these devices.<sup id="cite_ref-62" class="reference"><a href="#cite_note-62"><span class="cite-bracket">[</span>61<span class="cite-bracket">]</span></a></sup> The definition of a medical device is given in the FD&C Act, and it includes products from the simple <a href="/wiki/Toothbrush" title="Toothbrush">toothbrush</a> to complex devices such as implantable <a href="/wiki/Neurostimulator" class="mw-redirect" title="Neurostimulator">neurostimulators</a>. CDRH also oversees the safety performance of non-medical devices that emit certain types of <a href="/wiki/Electromagnetic_radiation" title="Electromagnetic radiation">electromagnetic radiation</a>. Examples of CDRH-regulated devices include <a href="/wiki/Cellular_phones" class="mw-redirect" title="Cellular phones">cellular phones</a>, <a href="/wiki/Airport_security" title="Airport security">airport baggage screening equipment</a>, <a href="/wiki/Television" title="Television">television receivers</a>, <a href="/wiki/Microwave_oven" title="Microwave oven">microwave ovens</a>, <a href="/wiki/Tanning_booth" class="mw-redirect" title="Tanning booth">tanning booths</a>, and <a href="/wiki/Laser" title="Laser">laser products</a>. </p><p>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. </p> <div class="mw-heading mw-heading4"><h4 id=""FDA-Cleared"_vs_"FDA-Approved""><span id=".22FDA-Cleared.22_vs_.22FDA-Approved.22"></span>"FDA-Cleared" vs "FDA-Approved"</h4><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=27" title="Edit section: "FDA-Cleared" vs "FDA-Approved""><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>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.<sup id="cite_ref-63" class="reference"><a href="#cite_note-63"><span class="cite-bracket">[</span>62<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Cosmetics">Cosmetics</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=28" title="Edit section: Cosmetics"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1251242444"><table class="box-More_citations_needed_section plainlinks metadata ambox ambox-content ambox-Refimprove" role="presentation"><tbody><tr><td class="mbox-image"><div class="mbox-image-div"><span typeof="mw:File"><a href="/wiki/File:Question_book-new.svg" class="mw-file-description"><img alt="" src="//upload.wikimedia.org/wikipedia/en/thumb/9/99/Question_book-new.svg/50px-Question_book-new.svg.png" decoding="async" width="50" height="39" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/en/thumb/9/99/Question_book-new.svg/75px-Question_book-new.svg.png 1.5x, //upload.wikimedia.org/wikipedia/en/thumb/9/99/Question_book-new.svg/100px-Question_book-new.svg.png 2x" data-file-width="512" data-file-height="399" /></a></span></div></td><td class="mbox-text"><div class="mbox-text-span">This section <b>needs additional citations for <a href="/wiki/Wikipedia:Verifiability" title="Wikipedia:Verifiability">verification</a></b>.<span class="hide-when-compact"> Please help <a href="/wiki/Special:EditPage/Food_and_Drug_Administration" title="Special:EditPage/Food and Drug Administration">improve this article</a> by <a href="/wiki/Help:Referencing_for_beginners" title="Help:Referencing for beginners">adding citations to reliable sources</a> in this section. Unsourced material may be challenged and removed.</span> <span class="date-container"><i>(<span class="date">August 2019</span>)</i></span><span class="hide-when-compact"><i> (<small><a href="/wiki/Help:Maintenance_template_removal" title="Help:Maintenance template removal">Learn how and when to remove this message</a></small>)</i></span></div></td></tr></tbody></table> <p>Cosmetics are regulated by the <a href="/wiki/Center_for_Food_Safety_and_Applied_Nutrition" title="Center for Food Safety and Applied Nutrition">Center for Food Safety and Applied Nutrition</a>, 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 <a href="/wiki/Cosmeceutical" title="Cosmeceutical">Cosmeceutical</a>). 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.<sup id="cite_ref-64" class="reference"><a href="#cite_note-64"><span class="cite-bracket">[</span>63<span class="cite-bracket">]</span></a></sup> </p><p>According to the industry advocacy group, the <a href="/wiki/American_Council_on_Science_and_Health" title="American Council on Science and Health">American Council on Science and Health</a>, 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.<sup id="cite_ref-65" class="reference"><a href="#cite_note-65"><span class="cite-bracket">[</span>64<span class="cite-bracket">]</span></a></sup> </p><p>However, on December 29, 2022, President Biden signed the '2023 Consolidated Budget Act', which includes the 'Cosmetics Regulatory Modernization Act of 2022 (MoCRA)', which is a stricter regulation that is different from the previous regulations. MoCRA requires compliance with matters such as serious adverse event reporting, safety substantiation, additional labeling, record keeping, and Good Manufacturing Practices (GMP). MoCRA also calls on the FDA to grant Mandatory Recall Authority and establish regulations for GMP rules, flavor allergen labeling rules, and testing methods for cosmetics containing talc.<sup id="cite_ref-66" class="reference"><a href="#cite_note-66"><span class="cite-bracket">[</span>65<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Veterinary_products">Veterinary products</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=29" title="Edit section: Veterinary products"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The <a href="/wiki/Center_for_Veterinary_Medicine" title="Center for Veterinary Medicine">Center for Veterinary Medicine</a> (CVM) is a center of the FDA that regulates food additives and drugs that are given to animals.<sup id="cite_ref-Modric_2013_67-0" class="reference"><a href="#cite_note-Modric_2013-67"><span class="cite-bracket">[</span>66<span class="cite-bracket">]</span></a></sup> CVM regulates animal drugs, animal food including pet animal, and animal medical devices. The FDA's requirements to prevent the spread of <a href="/wiki/Bovine_spongiform_encephalopathy" title="Bovine spongiform encephalopathy">bovine spongiform encephalopathy</a> are also administered by CVM through inspections of feed manufacturers.<sup id="cite_ref-68" class="reference"><a href="#cite_note-68"><span class="cite-bracket">[</span>67<span class="cite-bracket">]</span></a></sup> CVM does not regulate vaccines for animals; these are handled by the <a href="/wiki/United_States_Department_of_Agriculture" title="United States Department of Agriculture">United States Department of Agriculture</a>.<sup id="cite_ref-69" class="reference"><a href="#cite_note-69"><span class="cite-bracket">[</span>68<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Tobacco_products">Tobacco products</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=30" title="Edit section: Tobacco products"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The FDA regulates <a href="/wiki/Tobacco_products" class="mw-redirect" title="Tobacco products">tobacco products</a> with authority established by the 2009 <a href="/wiki/Family_Smoking_Prevention_and_Tobacco_Control_Act" title="Family Smoking Prevention and Tobacco Control Act">Family Smoking Prevention and Tobacco Control Act</a>.<sup id="cite_ref-70" class="reference"><a href="#cite_note-70"><span class="cite-bracket">[</span>69<span class="cite-bracket">]</span></a></sup> This Act requires color warnings on cigarette packages and printed advertising, and text warnings from the <a href="/wiki/Surgeon_General_of_the_United_States" title="Surgeon General of the United States">U.S. Surgeon General</a>.<sup id="cite_ref-71" class="reference"><a href="#cite_note-71"><span class="cite-bracket">[</span>70<span class="cite-bracket">]</span></a></sup> </p><p>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 <i>R.J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration</i>.<sup id="cite_ref-72" class="reference"><a href="#cite_note-72"><span class="cite-bracket">[</span>71<span class="cite-bracket">]</span></a></sup> <a href="/wiki/R._J._Reynolds_Tobacco_Company" title="R. J. Reynolds Tobacco Company">R.J. Reynolds</a>, <a href="/wiki/Lorillard" class="mw-redirect" title="Lorillard">Lorillard</a>, <a href="/wiki/Imperial_Tobacco" class="mw-redirect" title="Imperial Tobacco">Commonwealth Brands</a>, <a href="/wiki/Liggett_Group" title="Liggett Group">Liggett Group</a> and <a href="/wiki/Santa_Fe_Natural_Tobacco_Company" title="Santa Fe Natural Tobacco Company">Santa Fe Natural Tobacco Company</a> have filed suit in <a href="/wiki/United_States_District_Court_for_the_District_of_Columbia" title="United States District Court for the District of Columbia">Washington, D.C. federal court</a> claiming that the graphic labels are an <a href="/wiki/Unconstitutional" class="mw-redirect" title="Unconstitutional">unconstitutional</a> way of forcing tobacco companies to engage in anti-smoking advocacy on the government's behalf.<sup id="cite_ref-73" class="reference"><a href="#cite_note-73"><span class="cite-bracket">[</span>72<span class="cite-bracket">]</span></a></sup> </p><p>A <a href="/wiki/First_Amendment_to_the_United_States_Constitution" title="First Amendment to the United States Constitution">First Amendment</a> lawyer, <a href="/wiki/Floyd_Abrams" title="Floyd Abrams">Floyd Abrams</a>, is representing the tobacco companies in the case, contending requiring graphic warning labels on a lawful product cannot withstand constitutional scrutiny.<sup id="cite_ref-74" class="reference"><a href="#cite_note-74"><span class="cite-bracket">[</span>73<span class="cite-bracket">]</span></a></sup> The <a href="/wiki/Association_of_National_Advertisers" title="Association of National Advertisers">Association of National Advertisers</a> and the <a href="/wiki/American_Advertising_Federation" title="American Advertising Federation">American Advertising Federation</a> 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.<sup id="cite_ref-75" class="reference"><a href="#cite_note-75"><span class="cite-bracket">[</span>74<span class="cite-bracket">]</span></a></sup> In November 2011, Federal judge <a href="/wiki/Richard_J._Leon" title="Richard J. Leon">Richard Leon</a> 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 <a href="/wiki/Supreme_Court_of_the_United_States" title="Supreme Court of the United States">U.S. Supreme Court</a> ultimately could decide the matter.<sup id="cite_ref-76" class="reference"><a href="#cite_note-76"><span class="cite-bracket">[</span>75<span class="cite-bracket">]</span></a></sup> </p><p>In July 2017, the FDA announced a plan that would reduce the current levels of nicotine permitted in tobacco cigarettes.<sup id="cite_ref-77" class="reference"><a href="#cite_note-77"><span class="cite-bracket">[</span>76<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Regulation_of_living_organisms">Regulation of living organisms</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=31" title="Edit section: Regulation of living organisms"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>With acceptance of premarket notification 510(k) k033391 in January 2004,<sup id="cite_ref-FDA_K033391_Announcement_78-0" class="reference"><a href="#cite_note-FDA_K033391_Announcement-78"><span class="cite-bracket">[</span>77<span class="cite-bracket">]</span></a></sup> the FDA granted Ronald Sherman permission to produce and market <a href="/wiki/Medical_maggots" class="mw-redirect" title="Medical maggots">medical maggots</a> for use in humans or other animals as a prescription medical device.<sup id="cite_ref-FDA_K033391_ClearanceLetter_79-0" class="reference"><a href="#cite_note-FDA_K033391_ClearanceLetter-79"><span class="cite-bracket">[</span>78<span class="cite-bracket">]</span></a></sup> Medical maggots represent the first living organism allowed by the Food and Drug Administration for production and marketing as a prescription medical device.<sup id="cite_ref-Greer_2005_80-0" class="reference"><a href="#cite_note-Greer_2005-80"><span class="cite-bracket">[</span>79<span class="cite-bracket">]</span></a></sup> </p><p>In June 2004, the FDA cleared <i><a href="/wiki/Hirudo_medicinalis" title="Hirudo medicinalis">Hirudo medicinalis</a></i> (medicinal leeches) as the second living organism legal to use as a medical device.<sup id="cite_ref-81" class="reference"><a href="#cite_note-81"><span class="cite-bracket">[</span>80<span class="cite-bracket">]</span></a></sup> </p><p>The FDA also requires that milk be <a href="/wiki/Pasteurized" class="mw-redirect" title="Pasteurized">pasteurized</a> to remove bacteria.<sup id="cite_ref-82" class="reference"><a href="#cite_note-82"><span class="cite-bracket">[</span>81<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="International_Cooperation">International Cooperation</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=32" title="Edit section: International Cooperation"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>In February 2011, President <a href="/wiki/Barack_Obama" title="Barack Obama">Barack Obama</a> and Canadian Prime Minister <a href="/wiki/Stephen_Harper" title="Stephen Harper">Stephen Harper</a> issued a "Declaration on a Shared Vision for Perimeter Security and Economic Competitiveness"<sup id="cite_ref-83" class="reference"><a href="#cite_note-83"><span class="cite-bracket">[</span>82<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-84" class="reference"><a href="#cite_note-84"><span class="cite-bracket">[</span>83<span class="cite-bracket">]</span></a></sup> and announced the creation of the Canada-United States Regulatory Cooperation Council (RCC) "to increase regulatory transparency and coordination between the two countries."<sup id="cite_ref-OPM1_85-0" class="reference"><a href="#cite_note-OPM1-85"><span class="cite-bracket">[</span>84<span class="cite-bracket">]</span></a></sup> </p><p>Under the RCC mandate, the FDA and <a href="/wiki/Health_Canada" title="Health Canada">Health Canada</a> undertook a "first of its kind" initiative by selecting "as its first area of alignment common cold indications for certain over-the-counter <a href="/wiki/Antihistamine" title="Antihistamine">antihistamine</a> ingredients (GC 2013-01-10)."<sup id="cite_ref-GC20130110_86-0" class="reference"><a href="#cite_note-GC20130110-86"><span class="cite-bracket">[</span>85<span class="cite-bracket">]</span></a></sup> </p><p>A more recent example of the FDA's international work is their 2018 cooperation with regulatory and law-enforcement agencies worldwide through <a href="/wiki/Interpol" title="Interpol">Interpol</a> as part of Operation Pangea XI.<sup id="cite_ref-87" class="reference"><a href="#cite_note-87"><span class="cite-bracket">[</span>86<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-88" class="reference"><a href="#cite_note-88"><span class="cite-bracket">[</span>87<span class="cite-bracket">]</span></a></sup> The FDA targeted 465 websites that illegally sold potentially dangerous, unapproved versions of <a href="/wiki/Opioid" title="Opioid">opioid</a>, <a href="/wiki/Chemotherapy" title="Chemotherapy">oncology</a>, and <a href="/wiki/Antiviral_drug" title="Antiviral drug">antiviral</a> prescription drugs to U.S. consumers. The agency focused on <a href="/wiki/Money_laundering" title="Money laundering">transaction laundering</a> schemes in order to uncover the complex online drug network.<sup id="cite_ref-89" class="reference"><a href="#cite_note-89"><span class="cite-bracket">[</span>88<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Science_and_research_programs">Science and research programs</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=33" title="Edit section: Science and research programs"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <figure class="mw-default-size" typeof="mw:File/Thumb"><a href="/wiki/File:FDA_Bldg_64_-_Lab_(5160771733).jpg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/1/12/FDA_Bldg_64_-_Lab_%285160771733%29.jpg/220px-FDA_Bldg_64_-_Lab_%285160771733%29.jpg" decoding="async" width="220" height="146" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/1/12/FDA_Bldg_64_-_Lab_%285160771733%29.jpg/330px-FDA_Bldg_64_-_Lab_%285160771733%29.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/1/12/FDA_Bldg_64_-_Lab_%285160771733%29.jpg/440px-FDA_Bldg_64_-_Lab_%285160771733%29.jpg 2x" data-file-width="4064" data-file-height="2704" /></a><figcaption>FDA lab at Building 64 in Silver Spring, Maryland</figcaption></figure> <p>The FDA <a href="/wiki/Science_policy_of_the_United_States" title="Science policy of the United States">carries out research and development activities</a> to develop technology and standards that support its regulatory role, with the objective of resolving scientific and technical challenges before they become <a href="/wiki/Impediment" class="mw-redirect" title="Impediment">impediments</a>. 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.<sup id="cite_ref-90" class="reference"><a href="#cite_note-90"><span class="cite-bracket">[</span>89<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Data_management">Data management</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=34" title="Edit section: Data management"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The FDA has collected a large amount of data through the decades. The <a href="/wiki/OpenFDA" title="OpenFDA">OpenFDA</a> project was created to enable easy access of the data for the public and was officially launched in June 2014.<sup id="cite_ref-91" class="reference"><a href="#cite_note-91"><span class="cite-bracket">[</span>90<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-92" class="reference"><a href="#cite_note-92"><span class="cite-bracket">[</span>91<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="History">History</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=35" title="Edit section: History"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236090951"><div role="note" class="hatnote navigation-not-searchable">Main article: <a href="/wiki/History_of_the_Food_and_Drug_Administration" title="History of the Food and Drug Administration">History of the Food and Drug Administration</a></div> <p>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 <a href="/wiki/Vaccine_Act_of_1813" title="Vaccine Act of 1813">Vaccine Act of 1813</a>.<sup id="cite_ref-93" class="reference"><a href="#cite_note-93"><span class="cite-bracket">[</span>92<span class="cite-bracket">]</span></a></sup> The history of the FDA can be traced to the latter part of the 19th century and the Division of Chemistry of the <a href="/wiki/U.S._Department_of_Agriculture" class="mw-redirect" title="U.S. Department of Agriculture">U.S. Department of Agriculture</a>,<sup id="cite_ref-swann06_94-0" class="reference"><a href="#cite_note-swann06-94"><span class="cite-bracket">[</span>93<span class="cite-bracket">]</span></a></sup> which <a href="/wiki/United_States_Department_of_Agriculture#Origins_in_the_Patent_Office" title="United States Department of Agriculture">itself derived</a> from the <a href="/wiki/Copyright_and_Patent_Clause" class="mw-redirect" title="Copyright and Patent Clause">Copyright and Patent Clause</a>. Under <a href="/wiki/Harvey_Washington_Wiley" title="Harvey Washington Wiley">Harvey Washington Wiley</a>, appointed chief chemist in 1883, the Division began conducting research into the adulteration and misbranding of food and drugs on the American market.<sup id="cite_ref-swann06_94-1" class="reference"><a href="#cite_note-swann06-94"><span class="cite-bracket">[</span>93<span class="cite-bracket">]</span></a></sup> Wiley's advocacy came at a time when the public had become aroused to hazards in the marketplace by <a href="/wiki/Muckraker" title="Muckraker">muckraking</a> journalists like <a href="/wiki/Upton_Sinclair" title="Upton Sinclair">Upton Sinclair</a>, and became part of a general trend for increased federal regulations in matters pertinent to public safety during the <a href="/wiki/Progressive_Era" title="Progressive Era">Progressive Era</a>.<sup id="cite_ref-FDAHist_95-0" class="reference"><a href="#cite_note-FDAHist-95"><span class="cite-bracket">[</span>94<span class="cite-bracket">]</span></a></sup> The <a href="/wiki/Biologics_Control_Act" title="Biologics Control Act">Biologics Control Act of 1902</a> was put in place after a <a href="/wiki/Diphtheria" title="Diphtheria">diphtheria</a> 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 <a href="/wiki/Jim_(horse)" class="mw-redirect" title="Jim (horse)">Jim</a> who had contracted tetanus.<sup id="cite_ref-96" class="reference"><a href="#cite_note-96"><span class="cite-bracket">[</span>95<span class="cite-bracket">]</span></a></sup> </p> <figure class="mw-default-size" typeof="mw:File/Thumb"><a href="/wiki/File:Portrait_of_Dr._Harvey_W._Wiley_(FDA_107)_(8203830456).jpg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/3/3c/Portrait_of_Dr._Harvey_W._Wiley_%28FDA_107%29_%288203830456%29.jpg/170px-Portrait_of_Dr._Harvey_W._Wiley_%28FDA_107%29_%288203830456%29.jpg" decoding="async" width="170" height="218" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/3/3c/Portrait_of_Dr._Harvey_W._Wiley_%28FDA_107%29_%288203830456%29.jpg/255px-Portrait_of_Dr._Harvey_W._Wiley_%28FDA_107%29_%288203830456%29.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/3/3c/Portrait_of_Dr._Harvey_W._Wiley_%28FDA_107%29_%288203830456%29.jpg/340px-Portrait_of_Dr._Harvey_W._Wiley_%28FDA_107%29_%288203830456%29.jpg 2x" data-file-width="7450" data-file-height="9550" /></a><figcaption><a href="/wiki/Harvey_W._Wiley" class="mw-redirect" title="Harvey W. Wiley">Harvey W. Wiley</a>, chief advocate of the Food and Drug Act</figcaption></figure> <p>In June 1906, President <a href="/wiki/Theodore_Roosevelt" title="Theodore Roosevelt">Theodore Roosevelt</a> signed into law the <a href="/wiki/Pure_Food_and_Drug_Act" title="Pure Food and Drug Act">Pure Food and Drug Act of 1906</a>, also known as the "Wiley Act" after its chief advocate.<sup id="cite_ref-FDAHist_95-1" class="reference"><a href="#cite_note-FDAHist-95"><span class="cite-bracket">[</span>94<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-swann06_94-2" class="reference"><a href="#cite_note-swann06-94"><span class="cite-bracket">[</span>93<span class="cite-bracket">]</span></a></sup> The Act prohibited, under penalty of seizure of goods, the interstate transport of food that had been "adulterated".<sup id="cite_ref-swann06_94-3" class="reference"><a href="#cite_note-swann06-94"><span class="cite-bracket">[</span>93<span class="cite-bracket">]</span></a></sup> 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 <i><a href="/wiki/United_States_Pharmacopeia" title="United States Pharmacopeia">United States Pharmacopeia</a></i> or the <i><a href="/wiki/National_Formulary" class="mw-redirect" title="National Formulary">National Formulary</a></i>.<sup id="cite_ref-97" class="reference"><a href="#cite_note-97"><span class="cite-bracket">[</span>96<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-swann06_94-4" class="reference"><a href="#cite_note-swann06-94"><span class="cite-bracket">[</span>93<span class="cite-bracket">]</span></a></sup> </p><p>The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry.<sup id="cite_ref-FDAHist_95-2" class="reference"><a href="#cite_note-FDAHist-95"><span class="cite-bracket">[</span>94<span class="cite-bracket">]</span></a></sup> 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.<sup id="cite_ref-FDAHist_95-3" class="reference"><a href="#cite_note-FDAHist-95"><span class="cite-bracket">[</span>94<span class="cite-bracket">]</span></a></sup> In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide Administration.<sup id="cite_ref-98" class="reference"><a href="#cite_note-98"><span class="cite-bracket">[</span>97<span class="cite-bracket">]</span></a></sup> This name was shortened to the Food and Drug Administration (FDA) three years later.<sup id="cite_ref-milestones_99-0" class="reference"><a href="#cite_note-milestones-99"><span class="cite-bracket">[</span>98<span class="cite-bracket">]</span></a></sup> </p><p>By the 1930s, <a href="/wiki/Muckraker" title="Muckraker">muckraking</a> 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 <a href="/wiki/Radioactive" class="mw-redirect" title="Radioactive">radioactive</a> <a href="/wiki/Beverages" class="mw-redirect" title="Beverages">beverages</a>, mascara that could cause blindness, and worthless "cures" for <a href="/wiki/Diabetes" title="Diabetes">diabetes</a> and <a href="/wiki/Tuberculosis" title="Tuberculosis">tuberculosis</a>.<sup id="cite_ref-swann06_94-5" class="reference"><a href="#cite_note-swann06-94"><span class="cite-bracket">[</span>93<span class="cite-bracket">]</span></a></sup> The resulting proposed law did not get through the <a href="/wiki/Congress_of_the_United_States" class="mw-redirect" title="Congress of the United States">Congress of the United States</a> for five years, but was rapidly enacted into law following the public outcry over the 1937 <a href="/wiki/Elixir_sulfanilamide" title="Elixir sulfanilamide">Elixir Sulfanilamide</a> tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent.<sup id="cite_ref-100" class="reference"><a href="#cite_note-100"><span class="cite-bracket">[</span>99<span class="cite-bracket">]</span></a></sup> </p><p>President <a href="/wiki/Franklin_Delano_Roosevelt" class="mw-redirect" title="Franklin Delano Roosevelt">Franklin Delano Roosevelt</a> signed the <a href="/wiki/Federal_Food,_Drug,_and_Cosmetic_Act" class="mw-redirect" title="Federal Food, Drug, and Cosmetic Act">Federal Food, Drug, and Cosmetic Act</a> 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 <a href="/wiki/Fraudulent_intent" class="mw-redirect" title="Fraudulent intent">fraudulent intent</a>.<sup id="cite_ref-swann06_94-6" class="reference"><a href="#cite_note-swann06-94"><span class="cite-bracket">[</span>93<span class="cite-bracket">]</span></a></sup> The law also authorized the FDA to issue minimum <a href="/wiki/Standards_of_identity_for_food" title="Standards of identity for food">food standards of identity</a> for all mass-produced foods to reduce food fraud.<sup id="cite_ref-101" class="reference"><a href="#cite_note-101"><span class="cite-bracket">[</span>100<span class="cite-bracket">]</span></a></sup> </p><p>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 "<a href="/wiki/Prescription_drug" title="Prescription drug">prescription-only</a>" drugs was securely codified into law by the <a href="/wiki/Durham-Humphrey_Amendment" class="mw-redirect" title="Durham-Humphrey Amendment">Durham-Humphrey Amendment</a> in 1951. These developments confirmed extensive powers for the FDA to enforce post-marketing recalls of ineffective drugs.<sup id="cite_ref-FDAHist_95-4" class="reference"><a href="#cite_note-FDAHist-95"><span class="cite-bracket">[</span>94<span class="cite-bracket">]</span></a></sup> </p> <figure class="mw-default-size" typeof="mw:File/Thumb"><a href="/wiki/File:Examining_New_Drug_Applications_(067)_(7184535293).jpg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/5/57/Examining_New_Drug_Applications_%28067%29_%287184535293%29.jpg/170px-Examining_New_Drug_Applications_%28067%29_%287184535293%29.jpg" decoding="async" width="170" height="227" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/5/57/Examining_New_Drug_Applications_%28067%29_%287184535293%29.jpg/255px-Examining_New_Drug_Applications_%28067%29_%287184535293%29.jpg 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/5/57/Examining_New_Drug_Applications_%28067%29_%287184535293%29.jpg/340px-Examining_New_Drug_Applications_%28067%29_%287184535293%29.jpg 2x" data-file-width="5400" data-file-height="7200" /></a><figcaption>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.</figcaption></figure> <p>Outside of the US, the drug <a href="/wiki/Thalidomide" title="Thalidomide">thalidomide</a> was marketed for the relief of general nausea and <a href="/wiki/Morning_sickness" title="Morning sickness">morning sickness</a>, but caused birth defects and even the death of thousands of babies when taken during pregnancy.<sup id="cite_ref-102" class="reference"><a href="#cite_note-102"><span class="cite-bracket">[</span>101<span class="cite-bracket">]</span></a></sup> American mothers were largely unaffected as <a href="/wiki/Frances_Oldham_Kelsey" title="Frances Oldham Kelsey">Frances Oldham Kelsey</a> of the FDA refused to authorize the medication for market. In 1962, the <a href="/wiki/Kefauver-Harris_Amendment" class="mw-redirect" title="Kefauver-Harris Amendment">Kefauver-Harris Amendment</a> to the FD&C Act was passed, which represented a "revolution" in FDA regulatory authority.<sup id="cite_ref-103" class="reference"><a href="#cite_note-103"><span class="cite-bracket">[</span>102<span class="cite-bracket">]</span></a></sup> 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. </p><p>These reforms had the effect of increasing the time, and the difficulty, required to bring a drug to market.<sup id="cite_ref-'70s_180_104-0" class="reference"><a href="#cite_note-'70s_180-104"><span class="cite-bracket">[</span>103<span class="cite-bracket">]</span></a></sup> One of the most important statutes in establishing the modern American pharmaceutical market was the 1984 <a href="/wiki/Drug_Price_Competition_and_Patent_Term_Restoration_Act" title="Drug Price Competition and Patent Term Restoration Act">Drug Price Competition and Patent Term Restoration Act</a>, 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 <a href="/wiki/Abbreviated_New_Drug_Application" title="Abbreviated New Drug Application">Abbreviated New Drug Application</a> (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 <a href="/wiki/Pharmacokinetics" title="Pharmacokinetics">pharmacokinetic</a> properties ("bioequivalence") as the corresponding brand-name drug. This Act has been credited with, in essence, creating the modern generic drug industry.<sup id="cite_ref-HatchWaxman_105-0" class="reference"><a href="#cite_note-HatchWaxman-105"><span class="cite-bracket">[</span>104<span class="cite-bracket">]</span></a></sup> </p><p>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, <a href="/wiki/ACT-UP" class="mw-redirect" title="ACT-UP">ACT-UP</a> and other HIV activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV and opportunistic infections.<sup id="cite_ref-106" class="reference"><a href="#cite_note-106"><span class="cite-bracket">[</span>105<span class="cite-bracket">]</span></a></sup> 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.<sup id="cite_ref-107" class="reference"><a href="#cite_note-107"><span class="cite-bracket">[</span>106<span class="cite-bracket">]</span></a></sup> All of the initial drugs approved for the treatment of HIV/AIDS were approved through these accelerated approval mechanisms.<sup id="cite_ref-108" class="reference"><a href="#cite_note-108"><span class="cite-bracket">[</span>107<span class="cite-bracket">]</span></a></sup> Frank Young, then commissioner of the FDA, was behind the Action Plan Phase II, established in August 1987 for quicker approval of AIDS medication.<sup id="cite_ref-109" class="reference"><a href="#cite_note-109"><span class="cite-bracket">[</span>108<span class="cite-bracket">]</span></a></sup> </p><p>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,<sup class="noprint Inline-Template Template-Fact" style="white-space:nowrap;">[<i><a href="/wiki/Wikipedia:Citation_needed" title="Wikipedia:Citation needed"><span title="This claim needs references to reliable sources. (June 2014)">citation needed</span></a></i>]</sup> even in states where they are legal under state law. The first wave was the legalization by 27 states of <a href="/wiki/Laetrile" class="mw-redirect" title="Laetrile">laetrile</a> 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.<sup id="cite_ref-110" class="reference"><a href="#cite_note-110"><span class="cite-bracket">[</span>109<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-quack-laetrile_111-0" class="reference"><a href="#cite_note-quack-laetrile-111"><span class="cite-bracket">[</span>110<span class="cite-bracket">]</span></a></sup> The second wave concerned <a href="/wiki/Medical_marijuana" class="mw-redirect" title="Medical marijuana">medical marijuana</a> in the 1990s and 2000s. Though <a href="/wiki/Cannabis_in_Virginia" title="Cannabis in Virginia">Virginia passed legislation</a> allowing doctors to recommend cannabis for glaucoma or the side effects of chemotherapy, a more widespread trend began in California with the <a href="/wiki/1996_California_Proposition_215" title="1996 California Proposition 215">Compassionate Use Act of 1996</a>. </p><p>When the FDA requested <a href="/wiki/Endo_Pharmaceuticals" class="mw-redirect" title="Endo Pharmaceuticals">Endo Pharmaceuticals</a> on June 8, 2017, to remove <i><a href="/wiki/Oxymorphone_hydrochloride" class="mw-redirect" title="Oxymorphone hydrochloride">oxymorphone hydrochloride</a></i> from the market, it was the first request in FDA history to recall an effective drug over its potential for misuse.<sup id="cite_ref-112" class="reference"><a href="#cite_note-112"><span class="cite-bracket">[</span>111<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="21st-century_reforms">21st-century reforms</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=36" title="Edit section: 21st-century reforms"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <div class="mw-heading mw-heading3"><h3 id="Critical_Path_Initiative">Critical Path Initiative</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=37" title="Edit section: Critical Path Initiative"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The Critical Path Initiative<sup id="cite_ref-113" class="reference"><a href="#cite_note-113"><span class="cite-bracket">[</span>112<span class="cite-bracket">]</span></a></sup> 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.<sup id="cite_ref-114" class="reference"><a href="#cite_note-114"><span class="cite-bracket">[</span>113<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Patients'_rights_to_access_unapproved_drugs"><span id="Patients.27_rights_to_access_unapproved_drugs"></span>Patients' rights to access unapproved drugs</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=38" title="Edit section: Patients' rights to access unapproved drugs"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The <a href="/wiki/Compassionate_Investigational_New_Drug_program" class="mw-redirect" title="Compassionate Investigational New Drug program">Compassionate Investigational New Drug program</a> was created after <i>Randall v. U.S.</i> ruled in favor of <a href="/wiki/Robert_C._Randall" title="Robert C. Randall">Robert C. Randall</a> in 1978, creating a program for <a href="/wiki/Medical_marijuana" class="mw-redirect" title="Medical marijuana">medical marijuana</a>.<sup id="cite_ref-115" class="reference"><a href="#cite_note-115"><span class="cite-bracket">[</span>114<span class="cite-bracket">]</span></a></sup> </p><p>A 2006 court case, <i><a href="/wiki/Abigail_Alliance_v._von_Eschenbach" class="mw-redirect" title="Abigail Alliance v. von Eschenbach">Abigail Alliance v. von Eschenbach</a></i>, 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.<sup id="cite_ref-116" class="reference"><a href="#cite_note-116"><span class="cite-bracket">[</span>115<span class="cite-bracket">]</span></a></sup> The case won an initial appeal in May 2006, but that decision was reversed by a March 2007 rehearing. The <a href="/wiki/US_Supreme_Court" class="mw-redirect" title="US Supreme Court">US Supreme Court</a> declined to hear the case, and the final decision denied the existence of a right to unapproved medications. </p><p><a href="/wiki/Criticism_of_the_Food_and_Drug_Administration" title="Criticism of the Food and Drug Administration">Critics</a> 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.<sup id="cite_ref-117" class="reference"><a href="#cite_note-117"><span class="cite-bracket">[</span>116<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-118" class="reference"><a href="#cite_note-118"><span class="cite-bracket">[</span>117<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Post-marketing_drug_safety_monitoring">Post-marketing drug safety monitoring</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=39" title="Edit section: Post-marketing drug safety monitoring"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The widely publicized recall of <a href="/wiki/Vioxx" class="mw-redirect" title="Vioxx">Vioxx</a>, a <a href="/wiki/Non-steroidal_anti-inflammatory_drug" class="mw-redirect" title="Non-steroidal anti-inflammatory drug">non-steroidal anti-inflammatory drug</a> (NSAID) now estimated to have contributed to fatal <a href="/wiki/Myocardial_infarction" title="Myocardial infarction">heart attacks</a> 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.<sup id="cite_ref-119" class="reference"><a href="#cite_note-119"><span class="cite-bracket">[</span>118<span class="cite-bracket">]</span></a></sup> </p><p>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<sup id="cite_ref-Graham_120-0" class="reference"><a href="#cite_note-Graham-120"><span class="cite-bracket">[</span>119<span class="cite-bracket">]</span></a></sup> for reforms in the FDA's procedures for pre- and post-market drug safety regulation. </p><p>In 2006, a <a href="/wiki/United_States_congressional_committee" title="United States congressional committee">Congressional committee</a> was appointed by the <a href="/wiki/Institute_of_Medicine" class="mw-redirect" title="Institute of Medicine">Institute of Medicine</a> 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, <a href="/wiki/Biostatistics" title="Biostatistics">biostatistics</a>, law, public policy, public health, and the allied health professions, as well as current and former executives from the <a href="/wiki/Drug_company" class="mw-redirect" title="Drug company">pharmaceutical</a>, hospital, and <a href="/wiki/Health_insurance" title="Health insurance">health insurance</a> 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.<sup id="cite_ref-Henderson_2006_121-0" class="reference"><a href="#cite_note-Henderson_2006-121"><span class="cite-bracket">[</span>120<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-122" class="reference"><a href="#cite_note-122"><span class="cite-bracket">[</span>121<span class="cite-bracket">]</span></a></sup> Some of the committee's recommendations were incorporated into drafts of the PDUFA IV amendment, which was signed into law as the <a href="/wiki/Food_and_Drug_Administration_Amendments_Act_of_2007" title="Food and Drug Administration Amendments Act of 2007">Food and Drug Administration Amendments Act of 2007</a>.<sup id="cite_ref-123" class="reference"><a href="#cite_note-123"><span class="cite-bracket">[</span>122<span class="cite-bracket">]</span></a></sup> </p><p>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.<sup id="cite_ref-124" class="reference"><a href="#cite_note-124"><span class="cite-bracket">[</span>123<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Pediatric_drug_testing">Pediatric drug testing</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=40" title="Edit section: Pediatric drug testing"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>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.<sup id="cite_ref-125" class="reference"><a href="#cite_note-125"><span class="cite-bracket">[</span>124<span class="cite-bracket">]</span></a></sup> This became a major concern of <a href="/wiki/Pediatrician" class="mw-redirect" title="Pediatrician">pediatricians</a> 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.<sup id="cite_ref-PedReg_126-0" class="reference"><a href="#cite_note-PedReg-126"><span class="cite-bracket">[</span>125<span class="cite-bracket">]</span></a></sup> </p><p>Also, the belief that children are ethically restricted in their ability to give <a href="/wiki/Informed_consent" title="Informed consent">informed consent</a> brought increased governmental and institutional hurdles to approval of these clinical trials, and greater concerns about <a href="/wiki/Legal_liability" title="Legal liability">legal liability</a>. 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.<sup id="cite_ref-PedReg_126-1" class="reference"><a href="#cite_note-PedReg-126"><span class="cite-bracket">[</span>125<span class="cite-bracket">]</span></a></sup> </p><p>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 <a href="/wiki/New_Drug_Application" title="New Drug Application">New Drug Applications</a>. However, this new rule was successfully preempted in federal court as exceeding the FDA's statutory authority.<sup id="cite_ref-PedReg_126-2" class="reference"><a href="#cite_note-PedReg-126"><span class="cite-bracket">[</span>125<span class="cite-bracket">]</span></a></sup> </p><p>While this debate was unfolding, Congress used the <a href="/wiki/Food_and_Drug_Administration_Modernization_Act" class="mw-redirect" title="Food and Drug Administration Modernization Act">Food and Drug Administration Modernization Act of 1997</a> to pass incentives that gave pharmaceutical manufacturers a six-month patent term extension on new drugs submitted with pediatric trial data. The <a href="/wiki/Best_Pharmaceuticals_for_Children_Act" class="mw-redirect" title="Best Pharmaceuticals for Children Act">Best Pharmaceuticals for Children Act of 2007</a> reauthorized these provisions and allowed the FDA to request <a href="/wiki/National_Institutes_of_Health" title="National Institutes of Health">NIH</a>-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.<sup id="cite_ref-PedReg_126-3" class="reference"><a href="#cite_note-PedReg-126"><span class="cite-bracket">[</span>125<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Priority_review_voucher_(PRV)"><span id="Priority_review_voucher_.28PRV.29"></span>Priority review voucher (PRV)</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=41" title="Edit section: Priority review voucher (PRV)"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The <a href="/wiki/Priority_review_voucher" class="mw-redirect" title="Priority review voucher">priority review voucher</a> is a provision of the <a href="/wiki/Food_and_Drug_Administration_Amendments_Act_of_2007" title="Food and Drug Administration Amendments Act of 2007">Food and Drug Administration Amendments Act of 2007</a>, which awards a transferable "priority review voucher" to any company that obtains approval for a treatment for a <a href="/wiki/Neglected_tropical_diseases" title="Neglected tropical diseases">neglected tropical diseases</a>. The system was first proposed by <a href="/wiki/Duke_University" title="Duke University">Duke University</a> faculty David Ridley, Henry Grabowski, and Jeffrey Moe in their 2006 <i><a href="/wiki/Health_Affairs" title="Health Affairs">Health Affairs</a></i> paper: "Developing Drugs for Developing Countries".<sup id="cite_ref-Ridley06_127-0" class="reference"><a href="#cite_note-Ridley06-127"><span class="cite-bracket">[</span>126<span class="cite-bracket">]</span></a></sup> President Obama signed into law the <a href="/wiki/Food_and_Drug_Administration_Safety_and_Innovation_Act" title="Food and Drug Administration Safety and Innovation Act">Food and Drug Administration Safety and Innovation Act of 2012</a>, which extended the authorization until 2017.<sup id="cite_ref-PLAW_2012_128-0" class="reference"><a href="#cite_note-PLAW_2012-128"><span class="cite-bracket">[</span>127<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Rules_for_generic_biologics">Rules for generic biologics</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=42" title="Edit section: Rules for generic biologics"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Since the 1990s, many successful new drugs for the treatment of cancer, <a href="/wiki/Autoimmunity" title="Autoimmunity">autoimmune diseases</a>, and other conditions have been <a href="/wiki/Protein" title="Protein">protein</a>-based <a href="/wiki/Biologic_medical_product" class="mw-redirect" title="Biologic medical product">biotechnology drugs</a>, regulated by the <a href="/wiki/Center_for_Biologics_Evaluation_and_Research" title="Center for Biologics Evaluation and Research">Center for Biologics Evaluation and Research</a>. Many of these drugs are extremely expensive; for example, the anti-cancer drug <a href="/wiki/Avastin" class="mw-redirect" title="Avastin">Avastin</a> costs $55,000 for a year of treatment,<sup id="cite_ref-129" class="reference"><a href="#cite_note-129"><span class="cite-bracket">[</span>128<span class="cite-bracket">]</span></a></sup> while the <a href="/wiki/Enzyme_replacement_therapy" title="Enzyme replacement therapy">enzyme replacement therapy</a> drug <a href="/wiki/Imiglucerase" title="Imiglucerase">Cerezyme</a> costs $200,000 per year, and must be taken by <a href="/wiki/Gaucher%27s_disease" title="Gaucher's disease">Gaucher's disease</a> patients for life.<sup id="cite_ref-govtrack.us_130-0" class="reference"><a href="#cite_note-govtrack.us-130"><span class="cite-bracket">[</span>129<span class="cite-bracket">]</span></a></sup> </p><p>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 <a href="/wiki/Drug_Price_Competition_and_Patent_Term_Restoration_Act" title="Drug Price Competition and Patent Term Restoration Act">Hatch-Waxman Act</a> did not include biologics in the <a href="/wiki/Abbreviated_New_Drug_Application" title="Abbreviated New Drug Application">Abbreviated New Drug Application</a> (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.<sup id="cite_ref-govtrack.us_130-1" class="reference"><a href="#cite_note-govtrack.us-130"><span class="cite-bracket">[</span>129<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Mobile_medical_applications">Mobile medical applications</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=43" title="Edit section: Mobile medical applications"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>In 2013, a guidance was issued to regulate <a href="/wiki/Mobile_medical_apps" class="mw-redirect" title="Mobile medical apps">mobile medical applications</a> and protect users from their unintended use. This guidance distinguishes the apps subjected to regulation based on the marketing claims of the apps.<sup id="cite_ref-131" class="reference"><a href="#cite_note-131"><span class="cite-bracket">[</span>130<span class="cite-bracket">]</span></a></sup> Incorporation of the guidelines during the development phase of these apps has been proposed for expedited market entry and clearance.<sup id="cite_ref-132" class="reference"><a href="#cite_note-132"><span class="cite-bracket">[</span>131<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Electronic_Submissions_Gateway_(ESG)"><span id="Electronic_Submissions_Gateway_.28ESG.29"></span>Electronic Submissions Gateway (ESG)</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=44" title="Edit section: Electronic Submissions Gateway (ESG)"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>To standardize, automate and streamline the flow of regulatory data, FDA introduced an Electronic Submissions Gateway (ESG) in 2006. This gateway allows reporting organizations to send regulatory submissions to different centers over the internet, packaged in a center-specific format and enveloped as a GNU-compatible .tar.gz file, through either a FDA-specific WebTrader application<sup id="cite_ref-133" class="reference"><a href="#cite_note-133"><span class="cite-bracket">[</span>132<span class="cite-bracket">]</span></a></sup> or via a more generic B2B communication protocol called AS2 (Applicability Statement 2).<sup id="cite_ref-134" class="reference"><a href="#cite_note-134"><span class="cite-bracket">[</span>133<span class="cite-bracket">]</span></a></sup> </p><p>For WebTrader, which is recommended for manual, small-volume submissions, users would typically install a client application<sup id="cite_ref-135" class="reference"><a href="#cite_note-135"><span class="cite-bracket">[</span>134<span class="cite-bracket">]</span></a></sup> on their computers and upload the package through it to FDA server. In AS2, which is recommended for automated or high-volume submissions, users can use any standard AS2 software to transmit the package to FDA by including additional routing details on top of standard AS2, in the form of custom HTTP request headers.<sup id="cite_ref-136" class="reference"><a href="#cite_note-136"><span class="cite-bracket">[</span>135<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Criticism">Criticism</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=45" title="Edit section: Criticism"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236090951"><div role="note" class="hatnote navigation-not-searchable">Main article: <a href="/wiki/Criticism_of_the_Food_and_Drug_Administration" title="Criticism of the Food and Drug Administration">Criticism of the Food and Drug Administration</a></div> <p>The FDA has regulatory oversight over a large array of products that affect the health and life of American citizens.<sup id="cite_ref-FDAHist_95-5" class="reference"><a href="#cite_note-FDAHist-95"><span class="cite-bracket">[</span>94<span class="cite-bracket">]</span></a></sup> As a result, the FDA's powers and decisions are carefully monitored by several governmental and non-governmental organizations. A $1.8<span class="nowrap"> </span>million 2006 <a href="/wiki/Institute_of_Medicine" class="mw-redirect" title="Institute of Medicine">Institute of Medicine</a> 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 <a href="/wiki/Regulations" class="mw-redirect" title="Regulations">regulatory powers</a>, funding, and independence of the FDA.<sup id="cite_ref-Henderson_2006_121-1" class="reference"><a href="#cite_note-Henderson_2006-121"><span class="cite-bracket">[</span>120<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-137" class="reference"><a href="#cite_note-137"><span class="cite-bracket">[</span>136<span class="cite-bracket">]</span></a></sup> </p><p>A 2022 article from <i><a href="/wiki/Politico" title="Politico">Politico</a></i> 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.<sup id="cite_ref-138" class="reference"><a href="#cite_note-138"><span class="cite-bracket">[</span>137<span class="cite-bracket">]</span></a></sup> This might be attributed to <a href="/wiki/Lobbying" title="Lobbying">lobbying</a> and influence of <a href="/wiki/Food_politics" title="Food politics">big food</a> companies in Washington, D.C.<sup id="cite_ref-139" class="reference"><a href="#cite_note-139"><span class="cite-bracket">[</span>138<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="See_also">See also</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=46" title="Edit section: See also"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style 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.portal-bar{font-size:88%;font-weight:bold;display:flex;flex-flow:column wrap;align-items:baseline}.mw-parser-output .portal-bar-header{text-align:center;flex:0;padding-left:0.5em;margin:0 auto}.mw-parser-output .portal-bar-related{font-size:100%;align-items:flex-start}.mw-parser-output .portal-bar-content{display:flex;flex-flow:row wrap;align-items:center;flex:0;column-gap:1em;border-top:1px solid #a2a9b1;margin:0 auto;list-style:none}.mw-parser-output .portal-bar-content-related{border-top:none;margin:0;list-style:none}}.mw-parser-output .navbox+link+.portal-bar,.mw-parser-output .navbox+style+.portal-bar,.mw-parser-output .navbox+link+.portal-bar-bordered,.mw-parser-output .navbox+style+.portal-bar-bordered,.mw-parser-output .sister-bar+link+.portal-bar,.mw-parser-output .sister-bar+style+.portal-bar,.mw-parser-output .portal-bar+.navbox-styles+.navbox,.mw-parser-output .portal-bar+.navbox-styles+.sister-bar{margin-top:-1px}</style><div class="portal-bar noprint metadata noviewer portal-bar-bordered" role="navigation" aria-label="Portals"><span class="portal-bar-header"><a href="/wiki/Wikipedia:Contents/Portals" title="Wikipedia:Contents/Portals">Portals</a>:</span><ul class="portal-bar-content"><li class="portal-bar-item"><span class="nowrap"><span typeof="mw:File"><a href="/wiki/File:Foodlogo2.svg" class="mw-file-description"><img alt="icon" src="//upload.wikimedia.org/wikipedia/commons/thumb/d/d6/Foodlogo2.svg/21px-Foodlogo2.svg.png" decoding="async" width="21" height="15" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/d/d6/Foodlogo2.svg/32px-Foodlogo2.svg.png 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/d/d6/Foodlogo2.svg/42px-Foodlogo2.svg.png 2x" data-file-width="146" data-file-height="106" /></a></span> </span><a href="/wiki/Portal:Food" title="Portal:Food">Food</a></li><li class="portal-bar-item"><span class="nowrap"><span class="mw-image-border" typeof="mw:File"><span><img alt="flag" src="//upload.wikimedia.org/wikipedia/en/thumb/a/a4/Flag_of_the_United_States.svg/21px-Flag_of_the_United_States.svg.png" decoding="async" width="21" height="11" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/en/thumb/a/a4/Flag_of_the_United_States.svg/32px-Flag_of_the_United_States.svg.png 1.5x, //upload.wikimedia.org/wikipedia/en/thumb/a/a4/Flag_of_the_United_States.svg/42px-Flag_of_the_United_States.svg.png 2x" data-file-width="1235" data-file-height="650" /></span></span> </span><a href="/wiki/Portal:United_States" title="Portal:United States">United States</a></li><li class="portal-bar-item"><span class="nowrap"><span typeof="mw:File"><a href="/wiki/File:Balance,_by_David.svg" class="mw-file-description"><img alt="icon" src="//upload.wikimedia.org/wikipedia/commons/thumb/1/17/Balance%2C_by_David.svg/21px-Balance%2C_by_David.svg.png" decoding="async" width="21" height="19" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/1/17/Balance%2C_by_David.svg/32px-Balance%2C_by_David.svg.png 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/1/17/Balance%2C_by_David.svg/41px-Balance%2C_by_David.svg.png 2x" data-file-width="606" data-file-height="558" /></a></span> </span><a href="/wiki/Portal:Law" title="Portal:Law">Law</a></li><li class="portal-bar-item"><span class="nowrap"><span typeof="mw:File"><span><img alt="icon" src="//upload.wikimedia.org/wikipedia/commons/thumb/d/d6/WHO_Rod.svg/8px-WHO_Rod.svg.png" decoding="async" width="8" height="19" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/d/d6/WHO_Rod.svg/12px-WHO_Rod.svg.png 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/d/d6/WHO_Rod.svg/16px-WHO_Rod.svg.png 2x" data-file-width="107" data-file-height="250" /></span></span> </span><a href="/wiki/Portal:Medicine" title="Portal:Medicine">Medicine</a></li></ul></div> <ul><li><a href="/wiki/Adverse_reaction" class="mw-redirect" title="Adverse reaction">Adverse reaction</a></li> <li><a href="/wiki/Adverse_event" title="Adverse event">Adverse event</a></li> <li><a href="/wiki/Adverse_drug_reaction" title="Adverse drug reaction">Adverse drug reaction</a></li> <li><a href="/wiki/Biosecurity" title="Biosecurity">Biosecurity</a></li> <li><a href="/wiki/Biosecurity_in_the_United_States" title="Biosecurity in the United States">Biosecurity in the United States</a></li> <li><a href="/wiki/Drug_Efficacy_Study_Implementation" title="Drug Efficacy Study Implementation">Drug Efficacy Study Implementation</a></li> <li><a href="/wiki/Food_and_Drug_Administration_Modernization_Act_of_1997" title="Food and Drug Administration Modernization Act of 1997">Food and Drug Administration Modernization Act of 1997</a></li> <li><a href="/wiki/FDA_Food_Safety_Modernization_Act" title="FDA Food Safety Modernization Act">FDA Food Safety Modernization Act of 2011</a></li> <li><a href="/wiki/FDA_Fast_Track_Development_Program" class="mw-redirect" title="FDA Fast Track Development Program">FDA Fast Track Development Program</a> (for drugs)</li> <li><a href="/wiki/Food_and_Drug_Administration_Amendments_Act_of_2007" title="Food and Drug Administration Amendments Act of 2007">Food and Drug Administration Amendments Act of 2007</a> (e.g. drugs)</li> <li><a href="/wiki/Food_and_Drug_Administration_Safety_and_Innovation_Act" title="Food and Drug Administration Safety and Innovation Act">Food and Drug Administration Safety and Innovation Act of 2012</a> (GAIN/QIDP etc.)</li> <li><a href="/wiki/Inverse_benefit_law" title="Inverse benefit law">Inverse benefit law</a></li> <li><a href="/wiki/Investigational_Device_Exemption" class="mw-redirect" title="Investigational Device Exemption">Investigational Device Exemption</a> (for use in clinical trials)</li> <li><a href="/wiki/Kefauver_Harris_Amendment" class="mw-redirect" title="Kefauver Harris Amendment">Kefauver Harris Amendment</a> 1962 – required "proof-of-efficacy" for drugs</li></ul> <p><b>International:</b> </p> <ul><li><a href="/wiki/Food_Administration" class="mw-redirect" title="Food Administration">Food Administration</a></li> <li><a href="/wiki/International_Conference_on_Harmonisation_of_Technical_Requirements_for_Registration_of_Pharmaceuticals_for_Human_Use" class="mw-redirect" title="International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use">International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use</a> (ICH)</li> <li>African Union: <a href="/wiki/African_Medicines_Agency" title="African Medicines Agency">African Medicines Agency</a></li> <li>Australia: <a href="/wiki/Therapeutic_Goods_Administration" title="Therapeutic Goods Administration">Therapeutic Goods Administration</a></li> <li>Brazil: <a href="/wiki/National_Health_Surveillance_Agency" class="mw-redirect" title="National Health Surveillance Agency">National Health Surveillance Agency</a></li> <li>Canada: <a href="/wiki/Marketed_Health_Products_Directorate" title="Marketed Health Products Directorate">Marketed Health Products Directorate</a></li> <li>Canada: <a href="/wiki/Health_Canada" title="Health Canada">Health Canada</a></li> <li>Denmark: <a href="/wiki/Danish_Medicines_Agency" title="Danish Medicines Agency">Danish Medicines Agency</a></li> <li>European Union: <a href="/wiki/European_Medicines_Agency" title="European Medicines Agency">European Medicines Agency</a></li> <li>Germany: <a href="/wiki/Federal_Institute_for_Drugs_and_Medical_Devices" title="Federal Institute for Drugs and Medical Devices">Federal Institute for Drugs and Medical Devices</a></li> <li>India: <a href="/wiki/Food_Safety_and_Standards_Authority_of_India" title="Food Safety and Standards Authority of India">Food Safety and Standards Authority of India</a></li> <li>India: <a href="/wiki/Central_Drugs_Standard_Control_Organization" class="mw-redirect" title="Central Drugs Standard Control Organization">Central Drugs Standard Control Organization</a></li> <li>Japan: <a href="/wiki/Ministry_of_Health,_Labour_and_Welfare" title="Ministry of Health, Labour and Welfare">Ministry of Health, Labour and Welfare</a> (MHLW)</li> <li>Japan: <a href="/wiki/Pharmaceuticals_and_Medical_Devices_Agency" title="Pharmaceuticals and Medical Devices Agency">Pharmaceuticals and Medical Devices Agency</a></li> <li>Mexico: <a href="/wiki/Federal_Commission_for_the_Protection_against_Sanitary_Risk" title="Federal Commission for the Protection against Sanitary Risk">Federal Commission for the Protection against Sanitary Risk</a></li> <li>Philippines: <a href="/wiki/Food_and_Drug_Administration_(Philippines)" title="Food and Drug Administration (Philippines)">Food and Drug Administration</a> (FDA)</li> <li>Singapore: <a href="/wiki/Health_Sciences_Authority" title="Health Sciences Authority">Health Sciences Authority</a></li> <li>United Kingdom: <a href="/wiki/Medicines_and_Healthcare_products_Regulatory_Agency" title="Medicines and Healthcare products Regulatory Agency">Medicines and Healthcare products Regulatory Agency</a></li> <li>United States: Food and Drug Administration</li></ul> <div class="mw-heading mw-heading2"><h2 id="Notes">Notes</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=47" title="Edit section: Notes"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1239543626">.mw-parser-output .reflist{margin-bottom:0.5em;list-style-type:decimal}@media screen{.mw-parser-output .reflist{font-size:90%}}.mw-parser-output .reflist .references{font-size:100%;margin-bottom:0;list-style-type:inherit}.mw-parser-output .reflist-columns-2{column-width:30em}.mw-parser-output .reflist-columns-3{column-width:25em}.mw-parser-output .reflist-columns{margin-top:0.3em}.mw-parser-output .reflist-columns ol{margin-top:0}.mw-parser-output .reflist-columns li{page-break-inside:avoid;break-inside:avoid-column}.mw-parser-output .reflist-upper-alpha{list-style-type:upper-alpha}.mw-parser-output .reflist-upper-roman{list-style-type:upper-roman}.mw-parser-output .reflist-lower-alpha{list-style-type:lower-alpha}.mw-parser-output .reflist-lower-greek{list-style-type:lower-greek}.mw-parser-output .reflist-lower-roman{list-style-type:lower-roman}</style><div class="reflist"> <div class="mw-references-wrap"><ol class="references"> <li id="cite_note-9"><span class="mw-cite-backlink"><b><a href="#cite_ref-9">^</a></b></span> <span class="reference-text">The quoted text from the source indicates "9" but the actual count from the website indicates "14".</span> </li> </ol></div></div> <div class="mw-heading mw-heading2"><h2 id="References">References</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=48" title="Edit section: References"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1239543626"><div class="reflist"> <div class="mw-references-wrap mw-references-columns"><ol class="references"> <li id="cite_note-1"><span class="mw-cite-backlink"><b><a href="#cite_ref-1">^</a></b></span> <span class="reference-text"><style data-mw-deduplicate="TemplateStyles:r1238218222">.mw-parser-output cite.citation{font-style:inherit;word-wrap:break-word}.mw-parser-output .citation q{quotes:"\"""\"""'""'"}.mw-parser-output .citation:target{background-color:rgba(0,127,255,0.133)}.mw-parser-output .id-lock-free.id-lock-free a{background:url("//upload.wikimedia.org/wikipedia/commons/6/65/Lock-green.svg")right 0.1em center/9px no-repeat}.mw-parser-output .id-lock-limited.id-lock-limited a,.mw-parser-output .id-lock-registration.id-lock-registration a{background:url("//upload.wikimedia.org/wikipedia/commons/d/d6/Lock-gray-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .id-lock-subscription.id-lock-subscription a{background:url("//upload.wikimedia.org/wikipedia/commons/a/aa/Lock-red-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .cs1-ws-icon a{background:url("//upload.wikimedia.org/wikipedia/commons/4/4c/Wikisource-logo.svg")right 0.1em center/12px no-repeat}body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-free a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-limited a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-registration a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-subscription a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .cs1-ws-icon a{background-size:contain;padding:0 1em 0 0}.mw-parser-output .cs1-code{color:inherit;background:inherit;border:none;padding:inherit}.mw-parser-output .cs1-hidden-error{display:none;color:var(--color-error,#d33)}.mw-parser-output .cs1-visible-error{color:var(--color-error,#d33)}.mw-parser-output .cs1-maint{display:none;color:#085;margin-left:0.3em}.mw-parser-output .cs1-kern-left{padding-left:0.2em}.mw-parser-output .cs1-kern-right{padding-right:0.2em}.mw-parser-output .citation .mw-selflink{font-weight:inherit}@media screen{.mw-parser-output .cs1-format{font-size:95%}html.skin-theme-clientpref-night .mw-parser-output .cs1-maint{color:#18911f}}@media screen and (prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .cs1-maint{color:#18911f}}</style><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://web.archive.org/web/20160524231757/https://www.fda.gov/AboutFDA/WhatWeDo/History/CentennialofFDA/default.htm">"FDA Centennial 1906–2006"</a>. Food and Drug Administration. Archived from <a rel="nofollow" class="external text" href="https://www.fda.gov/AboutFDA/WhatWeDo/History/CentennialofFDA/default.htm">the original</a> on May 24, 2016<span class="reference-accessdate">. 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February 17, 2022. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20220321023725/https://www.fda.gov/about-fda/fda-organization/robert-califf">Archived</a> from the original on March 21, 2022<span class="reference-accessdate">. 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August 29, 2014. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20150722064030/http://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ucm2006146.htm">Archived</a> from the original on July 22, 2015<span class="reference-accessdate">. Retrieved <span class="nowrap">July 19,</span> 2015</span>. <q>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.</q></cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=About+the+FDA+Organization+Charts&rft.pub=Food+and+Drug+Administration&rft.date=2014-08-29&rft_id=https%3A%2F%2Fwww.fda.gov%2FAboutFDA%2FCentersOffices%2FOrganizationCharts%2Fucm2006146.htm&rfr_id=info%3Asid%2Fen.wikipedia.org%3AFood+and+Drug+Administration" class="Z3988"></span></span> </li> <li id="cite_note-10"><span class="mw-cite-backlink"><b><a href="#cite_ref-10">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.fda.gov/about-fda/jobs-and-training-fda/buildings-and-facilities">"Buildings and Facilities"</a>. <i>U.S. Food and Drug Administration</i>. 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Retrieved <span class="nowrap">October 3,</span> 2020</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=U.S.+Food+and+Drug+Administration&rft.atitle=Buildings+and+Facilities&rft.date=2020-04-27&rft_id=https%3A%2F%2Fwww.fda.gov%2Fabout-fda%2Fjobs-and-training-fda%2Fbuildings-and-facilities&rfr_id=info%3Asid%2Fen.wikipedia.org%3AFood+and+Drug+Administration" class="Z3988"></span></span> </li> <li id="cite_note-coordinates-11"><span class="mw-cite-backlink"><b><a href="#cite_ref-coordinates_11-0">^</a></b></span> <span class="reference-text">Coordinates of FDA Headquarters at White Oak, Maryland: <span class="geo-inline"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1156832818"><span class="plainlinks nourlexpansion"><a class="external text" href="https://geohack.toolforge.org/geohack.php?pagename=Food_and_Drug_Administration&params=39.0353363_N_76.9830894_W_region:US-MD_type:landmark&title=FDA+Headquarters+at+White+Oak%2C+Maryland"><span class="geo-default"><span class="geo-dms" title="Maps, aerial photos, and other data for this location"><span class="latitude">39°02′07″N</span> <span class="longitude">76°58′59″W</span></span></span><span class="geo-multi-punct"> / </span><span class="geo-nondefault"><span class="vcard"><span class="geo-dec" title="Maps, aerial photos, and other data for this location">39.0353363°N 76.9830894°W</span><span style="display:none"> / <span class="geo">39.0353363; -76.9830894</span></span><span style="display:none"> (<span class="fn org">FDA Headquarters at White Oak, Maryland</span>)</span></span></span></a></span></span></span> </li> <li id="cite_note-12"><span class="mw-cite-backlink"><b><a href="#cite_ref-12">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.ncpc.gov/projects/MP201/">"FDA White Oak Master Plan"</a>. <i>National Capital Planning Commission</i>. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20201009032259/https://www.ncpc.gov/projects/MP201/">Archived</a> from the original on October 9, 2020<span class="reference-accessdate">. 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June 14, 2010. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20150317084419/http://www.npr.org/templates/transcript/transcript.php?storyId=127773447">Archived</a> from the original on March 17, 2015<span class="reference-accessdate">. Retrieved <span class="nowrap">March 14,</span> 2015</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=NPR.org&rft.atitle=Medicinal+Marijuana%3A+A+Patient-Driven+Phenomenon&rft.date=2010-06-14&rft_id=https%3A%2F%2Fwww.npr.org%2Ftemplates%2Ftranscript%2Ftranscript.php%3FstoryId%3D127773447&rfr_id=info%3Asid%2Fen.wikipedia.org%3AFood+and+Drug+Administration" class="Z3988"></span></span> </li> <li id="cite_note-quack-laetrile-111"><span class="mw-cite-backlink"><b><a href="#cite_ref-quack-laetrile_111-0">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="http://www.quackwatch.com/01QuackeryRelatedTopics/Cancer/laetrile.html">"The Rise and Fall of Laetrile"</a>. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20180719022002/http://www.quackwatch.com/01QuackeryRelatedTopics/Cancer/laetrile.html">Archived</a> from the original on July 19, 2018<span class="reference-accessdate">. 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June 8, 2017. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20171104114609/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm">Archived</a> from the original on November 4, 2017<span class="reference-accessdate">. Retrieved <span class="nowrap">October 26,</span> 2017</span>. <q>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.</q></cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=FDA+requests+removal+of+Opana+ER+for+risks+related+to+abuse&rft.pub=Food+and+Drug+Administration&rft.date=2017-06-08&rft_id=https%3A%2F%2Fwww.fda.gov%2FNewsEvents%2FNewsroom%2FPressAnnouncements%2Fucm562401.htm&rfr_id=info%3Asid%2Fen.wikipedia.org%3AFood+and+Drug+Administration" class="Z3988"></span></span> </li> <li id="cite_note-113"><span class="mw-cite-backlink"><b><a href="#cite_ref-113">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFOffice_of_the_Commissioner2019" class="citation web cs1">Office of the Commissioner (February 8, 2019). <a rel="nofollow" class="external text" href="https://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/default.htm">"Critical Path Initiative"</a>. Food and Drug Administration. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20190422171814/https://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/default.htm">Archived</a> from the original on April 22, 2019<span class="reference-accessdate">. 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September 9, 2016. <a rel="nofollow" class="external text" href="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">Archived</a> from the original on October 14, 2017<span class="reference-accessdate">. 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May 12, 2023.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Setting+up+a+WebTrader+Account+Checklist&rft.pub=U.S.+Food+and+Drug+Administ+ration&rft.date=2023-05-12&rft_id=https%3A%2F%2Fwww.fda.gov%2Findustry%2Fcreate-esg-account%2Fsetting-webtrader-account-checklist&rfr_id=info%3Asid%2Fen.wikipedia.org%3AFood+and+Drug+Administration" class="Z3988"></span></span> </li> <li id="cite_note-134"><span class="mw-cite-backlink"><b><a href="#cite_ref-134">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://aayutechnologies.com/docs/as2/as2-protocol/">"AS2 Protocol"</a>. <i>Aayu Technologies</i>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=Aayu+Technologies&rft.atitle=AS2+Protocol&rft_id=https%3A%2F%2Faayutechnologies.com%2Fdocs%2Fas2%2Fas2-protocol%2F&rfr_id=info%3Asid%2Fen.wikipedia.org%3AFood+and+Drug+Administration" class="Z3988"></span></span> </li> <li id="cite_note-135"><span class="mw-cite-backlink"><b><a href="#cite_ref-135">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.fda.gov/media/156910/download?attachment">"Food and Drug Administration"</a>. U.S. Food and Drug Administ ration.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Food+and+Drug+Administration&rft.pub=U.S.+Food+and+Drug+Administ+ration&rft_id=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F156910%2Fdownload%3Fattachment&rfr_id=info%3Asid%2Fen.wikipedia.org%3AFood+and+Drug+Administration" class="Z3988"></span></span> </li> <li id="cite_note-136"><span class="mw-cite-backlink"><b><a href="#cite_ref-136">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.fda.gov/industry/about-esg/esg-appendix-f-as2-header-attributes">"ESG Appendix F: AS2 Header Attributes"</a>. U.S. Food and Drug Administ ration. June 10, 2024.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=ESG+Appendix+F%3A+AS2+Header+Attributes&rft.pub=U.S.+Food+and+Drug+Administ+ration&rft.date=2024-06-10&rft_id=https%3A%2F%2Fwww.fda.gov%2Findustry%2Fabout-esg%2Fesg-appendix-f-as2-header-attributes&rfr_id=info%3Asid%2Fen.wikipedia.org%3AFood+and+Drug+Administration" class="Z3988"></span></span> </li> <li id="cite_note-137"><span class="mw-cite-backlink"><b><a href="#cite_ref-137">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFCommittee_on_the_Assessment_of_the_US_Drug_Safety_System2006" class="citation book cs1">Committee on the Assessment of the US Drug Safety System (2006). <a rel="nofollow" class="external text" href="https://web.archive.org/web/20100702001617/http://www.nap.edu/catalog.php?record_id=11750#toc"><i>The Future of Drug Safety: Promoting and Protecting the Health of the Public</i></a>. National Academies Press. <a href="/wiki/Doi_(identifier)" class="mw-redirect" title="Doi (identifier)">doi</a>:<a rel="nofollow" class="external text" href="https://doi.org/10.17226%2F11750">10.17226/11750</a>. <a href="/wiki/ISBN_(identifier)" class="mw-redirect" title="ISBN (identifier)">ISBN</a> <a href="/wiki/Special:BookSources/978-0-309-10304-6" title="Special:BookSources/978-0-309-10304-6"><bdi>978-0-309-10304-6</bdi></a>. Archived from <a rel="nofollow" class="external text" href="http://www.nap.edu/catalog.php?record_id=11750#toc">the original</a> on July 2, 2010.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=The+Future+of+Drug+Safety%3A+Promoting+and+Protecting+the+Health+of+the+Public&rft.pub=National+Academies+Press&rft.date=2006&rft_id=info%3Adoi%2F10.17226%2F11750&rft.isbn=978-0-309-10304-6&rft.au=Committee+on+the+Assessment+of+the+US+Drug+Safety+System&rft_id=http%3A%2F%2Fwww.nap.edu%2Fcatalog.php%3Frecord_id%3D11750%23toc&rfr_id=info%3Asid%2Fen.wikipedia.org%3AFood+and+Drug+Administration" class="Z3988"></span> <span class="cs1-visible-error citation-comment"><code class="cs1-code">{{<a href="/wiki/Template:Cite_book" title="Template:Cite book">cite book</a>}}</code>: </span><span class="cs1-visible-error citation-comment"><code class="cs1-code">|work=</code> ignored (<a href="/wiki/Help:CS1_errors#periodical_ignored" title="Help:CS1 errors">help</a>)</span></span> </li> <li id="cite_note-138"><span class="mw-cite-backlink"><b><a href="#cite_ref-138">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFBottemiller_Evich" class="citation web cs1">Bottemiller Evich H. <a rel="nofollow" class="external text" href="https://www.politico.com/interactives/2022/fda-fails-regulate-food-health-safety-hazards/">"How the FDA's food division fails to regulate health and safety hazards"</a>. <i>politico.com</i>. Politico. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20220409111829/https://www.politico.com/interactives/2022/fda-fails-regulate-food-health-safety-hazards/">Archived</a> from the original on April 9, 2022<span class="reference-accessdate">. Retrieved <span class="nowrap">April 4,</span> 2022</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=politico.com&rft.atitle=How+the+FDA%27s+food+division+fails+to+regulate+health+and+safety+hazards&rft.aulast=Bottemiller+Evich&rft.aufirst=H&rft_id=https%3A%2F%2Fwww.politico.com%2Finteractives%2F2022%2Ffda-fails-regulate-food-health-safety-hazards%2F&rfr_id=info%3Asid%2Fen.wikipedia.org%3AFood+and+Drug+Administration" class="Z3988"></span></span> </li> <li id="cite_note-139"><span class="mw-cite-backlink"><b><a href="#cite_ref-139">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFDoering" class="citation web cs1">Doering C. <a rel="nofollow" class="external text" href="https://www.fooddive.com/news/where-the-dollars-go-lobbying-a-big-business-for-large-food-and-beverage-c/607982/">"Where the dollars go: Lobbying a big business for large food and beverage CPGs"</a>. <i>fooddive.com</i>. Food Dive. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20220319090710/https://www.fooddive.com/news/where-the-dollars-go-lobbying-a-big-business-for-large-food-and-beverage-c/607982/">Archived</a> from the original on March 19, 2022<span class="reference-accessdate">. Retrieved <span class="nowrap">April 18,</span> 2022</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=fooddive.com&rft.atitle=Where+the+dollars+go%3A+Lobbying+a+big+business+for+large+food+and+beverage+CPGs&rft.aulast=Doering&rft.aufirst=C&rft_id=https%3A%2F%2Fwww.fooddive.com%2Fnews%2Fwhere-the-dollars-go-lobbying-a-big-business-for-large-food-and-beverage-c%2F607982%2F&rfr_id=info%3Asid%2Fen.wikipedia.org%3AFood+and+Drug+Administration" class="Z3988"></span></span> </li> </ol></div></div> <div class="mw-heading mw-heading2"><h2 id="Further_reading">Further reading</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=49" title="Edit section: Further reading"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1239549316">.mw-parser-output .refbegin{margin-bottom:0.5em}.mw-parser-output .refbegin-hanging-indents>ul{margin-left:0}.mw-parser-output .refbegin-hanging-indents>ul>li{margin-left:0;padding-left:3.2em;text-indent:-3.2em}.mw-parser-output .refbegin-hanging-indents ul,.mw-parser-output .refbegin-hanging-indents ul li{list-style:none}@media(max-width:720px){.mw-parser-output .refbegin-hanging-indents>ul>li{padding-left:1.6em;text-indent:-1.6em}}.mw-parser-output .refbegin-columns{margin-top:0.3em}.mw-parser-output .refbegin-columns ul{margin-top:0}.mw-parser-output .refbegin-columns li{page-break-inside:avoid;break-inside:avoid-column}@media screen{.mw-parser-output .refbegin{font-size:90%}}</style><div class="refbegin refbegin-columns references-column-width" style="column-width: 30em"> <ul><li><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFGivel2005" class="citation journal cs1">Givel M (December 2005). "Philip Morris' FDA gambit: good for public health?". <i>Journal of Public Health Policy</i>. <b>26</b> (4): 450–468. <a href="/wiki/Doi_(identifier)" class="mw-redirect" title="Doi (identifier)">doi</a>:<a rel="nofollow" class="external text" href="https://doi.org/10.1057%2Fpalgrave.jphp.3200032">10.1057/palgrave.jphp.3200032</a>. <a href="/wiki/PMID_(identifier)" class="mw-redirect" title="PMID (identifier)">PMID</a> <a rel="nofollow" class="external text" href="https://pubmed.ncbi.nlm.nih.gov/16392744">16392744</a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.jtitle=Journal+of+Public+Health+Policy&rft.atitle=Philip+Morris%27+FDA+gambit%3A+good+for+public+health%3F&rft.volume=26&rft.issue=4&rft.pages=450-468&rft.date=2005-12&rft_id=info%3Adoi%2F10.1057%2Fpalgrave.jphp.3200032&rft_id=info%3Apmid%2F16392744&rft.aulast=Givel&rft.aufirst=M&rfr_id=info%3Asid%2Fen.wikipedia.org%3AFood+and+Drug+Administration" class="Z3988"></span></li> <li><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFHenninger2002" class="citation encyclopaedia cs1"><a href="/wiki/Daniel_Henninger" title="Daniel Henninger">Henninger D</a> (2002). <a rel="nofollow" class="external text" href="http://www.econlib.org/library/Enc1/DrugLag.html">"Drug Lag"</a>. In <a href="/wiki/David_R._Henderson" title="David R. Henderson">David R. Henderson</a> (ed.). <i><a href="/wiki/Concise_Encyclopedia_of_Economics" class="mw-redirect" title="Concise Encyclopedia of Economics">Concise Encyclopedia of Economics</a></i> (1st ed.). <a href="/wiki/Library_of_Economics_and_Liberty" class="mw-redirect" title="Library of Economics and Liberty">Library of Economics and Liberty</a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.atitle=Drug+Lag&rft.btitle=Concise+Encyclopedia+of+Economics&rft.edition=1st&rft.pub=Library+of+Economics+and+Liberty&rft.date=2002&rft.aulast=Henninger&rft.aufirst=D&rft_id=http%3A%2F%2Fwww.econlib.org%2Flibrary%2FEnc1%2FDrugLag.html&rfr_id=info%3Asid%2Fen.wikipedia.org%3AFood+and+Drug+Administration" class="Z3988"></span> <link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><a href="/wiki/OCLC_(identifier)" class="mw-redirect" title="OCLC (identifier)">OCLC</a> <a rel="nofollow" class="external text" href="https://www.worldcat.org/oclc/317650570">317650570</a>, <a rel="nofollow" class="external text" href="https://www.worldcat.org/oclc/50016270">50016270</a>, <a rel="nofollow" class="external text" href="https://www.worldcat.org/oclc/163149563">163149563</a></li> <li><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFHilts2003" class="citation book cs1">Hilts PJ (2003). <i>Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation</i>. New York: Alfred A. Knopf. <a href="/wiki/ISBN_(identifier)" class="mw-redirect" title="ISBN (identifier)">ISBN</a> <a href="/wiki/Special:BookSources/0-375-40466-X" title="Special:BookSources/0-375-40466-X"><bdi>0-375-40466-X</bdi></a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Protecting+America%27s+Health%3A+The+FDA%2C+Business%2C+and+One+Hundred+Years+of+Regulation&rft.place=New+York&rft.pub=Alfred+A.+Knopf&rft.date=2003&rft.isbn=0-375-40466-X&rft.aulast=Hilts&rft.aufirst=PJ&rfr_id=info%3Asid%2Fen.wikipedia.org%3AFood+and+Drug+Administration" class="Z3988"></span></li> <li><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFFainDaubresseAlexander2013" class="citation journal cs1">Fain K, Daubresse M, Alexander GC (July 2013). "The Food and Drug Administration Amendments Act and postmarketing commitments". <i>JAMA</i>. <b>310</b> (2): 202–4. <a href="/wiki/Doi_(identifier)" class="mw-redirect" title="Doi (identifier)">doi</a>:<a rel="nofollow" class="external text" href="https://doi.org/10.1001%2Fjama.2013.7900">10.1001/jama.2013.7900</a>. <a href="/wiki/PMID_(identifier)" class="mw-redirect" title="PMID (identifier)">PMID</a> <a rel="nofollow" class="external text" href="https://pubmed.ncbi.nlm.nih.gov/23839755">23839755</a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.jtitle=JAMA&rft.atitle=The+Food+and+Drug+Administration+Amendments+Act+and+postmarketing+commitments&rft.volume=310&rft.issue=2&rft.pages=202-4&rft.date=2013-07&rft_id=info%3Adoi%2F10.1001%2Fjama.2013.7900&rft_id=info%3Apmid%2F23839755&rft.aulast=Fain&rft.aufirst=K&rft.au=Daubresse%2C+M&rft.au=Alexander%2C+GC&rfr_id=info%3Asid%2Fen.wikipedia.org%3AFood+and+Drug+Administration" class="Z3988"></span></li> <li><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFMadden2010" class="citation book cs1">Madden BJ (2010). <i>Free To Choose Medicine: How Faster Access to New Drugs Would Save Countless Lives and End Needless Suffering</i>. Chicago: The <a href="/wiki/Heartland_Institute" title="Heartland Institute">Heartland Institute</a>. <a href="/wiki/ISBN_(identifier)" class="mw-redirect" title="ISBN (identifier)">ISBN</a> <a href="/wiki/Special:BookSources/978-1-934791-32-5" title="Special:BookSources/978-1-934791-32-5"><bdi>978-1-934791-32-5</bdi></a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Free+To+Choose+Medicine%3A+How+Faster+Access+to+New+Drugs+Would+Save+Countless+Lives+and+End+Needless+Suffering&rft.place=Chicago&rft.pub=The+Heartland+Institute&rft.date=2010&rft.isbn=978-1-934791-32-5&rft.aulast=Madden&rft.aufirst=BJ&rfr_id=info%3Asid%2Fen.wikipedia.org%3AFood+and+Drug+Administration" class="Z3988"></span></li> <li><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFMoore_TJ1998" class="citation book cs1">Moore TJ (1998). <i>Prescription for Disaster: The Hidden Dangers in Your Medicine Cabinet</i>. New York, NY: Simon & Schuster. <a href="/wiki/ISBN_(identifier)" class="mw-redirect" title="ISBN (identifier)">ISBN</a> <a href="/wiki/Special:BookSources/0-684-82998-3" title="Special:BookSources/0-684-82998-3"><bdi>0-684-82998-3</bdi></a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Prescription+for+Disaster%3A+The+Hidden+Dangers+in+Your+Medicine+Cabinet&rft.place=New+York%2C+NY&rft.pub=Simon+%26+Schuster&rft.date=1998&rft.isbn=0-684-82998-3&rft.au=Moore+TJ&rfr_id=info%3Asid%2Fen.wikipedia.org%3AFood+and+Drug+Administration" class="Z3988"></span></li> <li><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFObenchainSpark2016" class="citation book cs1">Obenchain J, Spark A (2016). <i>Food policy: looking forward from the past</i>. Boca Raton, FL: CRC Press, Taylor & Francis Group. <a href="/wiki/ISBN_(identifier)" class="mw-redirect" title="ISBN (identifier)">ISBN</a> <a href="/wiki/Special:BookSources/978-1-4398-8025-8" title="Special:BookSources/978-1-4398-8025-8"><bdi>978-1-4398-8025-8</bdi></a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Food+policy%3A+looking+forward+from+the+past&rft.place=Boca+Raton%2C+FL&rft.pub=CRC+Press%2C+Taylor+%26+Francis+Group&rft.date=2016&rft.isbn=978-1-4398-8025-8&rft.aulast=Obenchain&rft.aufirst=J&rft.au=Spark%2C+A&rfr_id=info%3Asid%2Fen.wikipedia.org%3AFood+and+Drug+Administration" class="Z3988"></span></li> <li><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFShahEl-Sayed2022" class="citation journal cs1">Shah S, <a href="/wiki/Abdul_El-Sayed" title="Abdul El-Sayed">El-Sayed A</a> (January 2022). "Medical Algorithms Need Better Regulation". <i>Scientific American</i>. <b>326</b> (1): 10. <a href="/wiki/Doi_(identifier)" class="mw-redirect" title="Doi (identifier)">doi</a>:<a rel="nofollow" class="external text" href="https://doi.org/10.1038%2Fscientificamerican0122-10">10.1038/scientificamerican0122-10</a>. <q>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.</q></cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.jtitle=Scientific+American&rft.atitle=Medical+Algorithms+Need+Better+Regulation&rft.volume=326&rft.issue=1&rft.pages=10&rft.date=2022-01&rft_id=info%3Adoi%2F10.1038%2Fscientificamerican0122-10&rft.aulast=Shah&rft.aufirst=S&rft.au=El-Sayed%2C+A&rfr_id=info%3Asid%2Fen.wikipedia.org%3AFood+and+Drug+Administration" class="Z3988"></span></li></ul> </div> <div class="mw-heading mw-heading2"><h2 id="External_links">External links</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Food_and_Drug_Administration&action=edit&section=50" title="Edit section: External links"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1235681985">.mw-parser-output .side-box{margin:4px 0;box-sizing:border-box;border:1px solid #aaa;font-size:88%;line-height:1.25em;background-color:var(--background-color-interactive-subtle,#f8f9fa);display:flow-root}.mw-parser-output .side-box-abovebelow,.mw-parser-output .side-box-text{padding:0.25em 0.9em}.mw-parser-output .side-box-image{padding:2px 0 2px 0.9em;text-align:center}.mw-parser-output .side-box-imageright{padding:2px 0.9em 2px 0;text-align:center}@media(min-width:500px){.mw-parser-output .side-box-flex{display:flex;align-items:center}.mw-parser-output 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Health</a></li> <li><a href="/wiki/Center_for_Drug_Evaluation_and_Research" title="Center for Drug Evaluation and Research">Center for Drug Evaluation and Research</a></li> <li><a href="/wiki/Center_for_Food_Safety_and_Applied_Nutrition" title="Center for Food Safety and Applied Nutrition">Center for Food Safety and Applied Nutrition</a></li> <li><a href="/wiki/Center_for_Tobacco_Products" title="Center for Tobacco Products">Center for Tobacco Products</a></li> <li><a href="/wiki/Center_for_Veterinary_Medicine" title="Center for Veterinary Medicine">Center for Veterinary Medicine</a></li> <li><a href="/wiki/National_Center_for_Toxicological_Research" title="National Center for Toxicological Research">National Center for Toxicological Research</a></li> <li><a href="/wiki/Office_of_Criminal_Investigations" title="Office of Criminal Investigations">Office of Criminal Investigations</a></li> <li><a href="/wiki/Office_of_Global_Regulatory_Operations_and_Policy" title="Office of Global Regulatory Operations and Policy">Office of Global Regulatory Operations and Policy</a></li></ul> </div></td><td class="noviewer navbox-image" rowspan="5" style="width:1px;padding:0 0 0 2px"><div><span typeof="mw:File"><span><img alt="" src="//upload.wikimedia.org/wikipedia/commons/thumb/1/1d/Food_and_Drug_Administration_icon_2016.svg/100px-Food_and_Drug_Administration_icon_2016.svg.png" decoding="async" width="100" height="120" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/1/1d/Food_and_Drug_Administration_icon_2016.svg/150px-Food_and_Drug_Administration_icon_2016.svg.png 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/1/1d/Food_and_Drug_Administration_icon_2016.svg/200px-Food_and_Drug_Administration_icon_2016.svg.png 2x" data-file-width="95" data-file-height="114" /></span></span></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Major acts</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Family_Smoking_Prevention_and_Tobacco_Control_Act" title="Family Smoking Prevention and Tobacco Control Act">Family Smoking Prevention and Tobacco Control Act</a></li> <li><a href="/wiki/Food_and_Drug_Administration_Modernization_Act_of_1997" title="Food and Drug Administration Modernization Act of 1997">Modernization Act of 1997</a></li> <li><a href="/wiki/Federal_Food,_Drug,_and_Cosmetic_Act" class="mw-redirect" title="Federal Food, Drug, and Cosmetic Act">Federal Food, Drug, and Cosmetic Act</a></li> <li><a href="/wiki/FDA_Food_Safety_Modernization_Act" title="FDA Food Safety Modernization Act">Food Safety Modernization Act</a></li> <li><a href="/wiki/Prescription_Drug_User_Fee_Act" title="Prescription Drug User Fee Act">Prescription Drug User Fee Act</a></li> <li><a href="/wiki/Pure_Food_and_Drug_Act" title="Pure Food and Drug Act">Pure Food and Drug Act</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Title 21 regulations and rules</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:1%">Administrative law</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"><a href="/wiki/Title_21_of_the_Code_of_Federal_Regulations" title="Title 21 of the Code of Federal Regulations">Title 21 of the Code of Federal Regulations (CFR)</a></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Federal journal</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"><a href="/wiki/Federal_Register" title="Federal Register">Federal Register (FR)</a></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Federal law</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"><a href="/wiki/Title_21_of_the_United_States_Code" title="Title 21 of the United States Code">Title 21 of the United States Code (U.S.C.)</a></div></td></tr></tbody></table><div></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Commissioners</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Harvey_Washington_Wiley" title="Harvey Washington Wiley">Harvey W. Wiley</a></li> <li><a href="/wiki/Carl_L._Alsberg" title="Carl L. Alsberg">Carl L. Alsberg</a></li> <li><a href="/wiki/Charles_Albert_Browne_Jr." title="Charles Albert Browne Jr.">Charles A. Browne</a></li> <li><a href="/wiki/Walter_G._Campbell_(chemist)" title="Walter G. Campbell (chemist)">Walter G. Campbell</a></li> <li><a href="/wiki/Paul_B._Dunbar" title="Paul B. Dunbar">Paul B. Dunbar</a></li> <li><a href="/wiki/Charles_W._Crawford_(chemist)" title="Charles W. Crawford (chemist)">Charles W. Crawford</a></li> <li><a href="/wiki/George_P._Larrick" title="George P. Larrick">George P. Larrick</a></li> <li><a href="/wiki/James_L._Goddard" title="James L. Goddard">James L. Goddard</a></li> <li><a href="/wiki/Herbert_L._Ley_Jr." title="Herbert L. Ley Jr.">Herbert L. Ley</a></li> <li><a href="/wiki/Charles_C._Edwards" title="Charles C. Edwards">Charles C. Edwards</a></li> <li><a href="/wiki/Alexander_M._Schmidt" title="Alexander M. Schmidt">Alexander M. Schmidt</a></li> <li><a href="/wiki/Donald_Kennedy" title="Donald Kennedy">Donald Kennedy</a></li> <li><a href="/wiki/Jere_E._Goyan" title="Jere E. Goyan">Jere E. Goyan</a></li> <li><a href="/wiki/Arthur_H._Hayes_Jr." title="Arthur H. Hayes Jr.">Arthur H. Hayes Jr.</a></li> <li><a href="/wiki/Frank_E._Young_(physician)" title="Frank E. Young (physician)">Frank E. Young</a></li> <li><a href="/wiki/David_A._Kessler" title="David A. Kessler">David A. Kessler</a></li> <li><a href="/wiki/Jane_E._Henney" title="Jane E. Henney">Jane E. Henney</a></li> <li><a href="/wiki/Mark_McClellan" title="Mark McClellan">Mark McClellan</a></li> <li><a href="/wiki/Lester_Crawford" title="Lester Crawford">Lester Crawford</a></li> <li><a href="/wiki/Andrew_von_Eschenbach" title="Andrew von Eschenbach">Andrew von Eschenbach</a></li> <li><a href="/wiki/Margaret_Hamburg" title="Margaret Hamburg">Margaret Hamburg</a></li> <li><a href="/wiki/Robert_Califf" title="Robert Califf">Robert Califf</a></li> <li><a href="/wiki/Scott_Gottlieb" title="Scott Gottlieb">Scott Gottlieb</a></li> <li><a href="/wiki/Stephen_Hahn" title="Stephen Hahn">Stephen Hahn</a></li> <li><a href="/wiki/Robert_Califf" title="Robert Califf">Robert Califf</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Society and culture</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Criticism_of_the_Food_and_Drug_Administration" title="Criticism of the Food and Drug Administration">Criticism of the Food and Drug Administration</a></li> <li><a href="/wiki/FDA_Most_Wanted_Fugitives" title="FDA Most Wanted Fugitives">FDA Most Wanted Fugitives</a></li> <li><a href="/wiki/History_of_the_Food_and_Drug_Administration" title="History of the Food and Drug Administration">History of the Food and Drug Administration</a></li> <li><a href="/wiki/Regulation_of_food_and_dietary_supplements_by_the_U.S._Food_and_Drug_Administration" title="Regulation of food and dietary supplements by the U.S. Food and Drug Administration">Regulation of food and dietary supplements by the U.S. Food and Drug Administration</a></li></ul> </div></td></tr><tr><td class="navbox-abovebelow" colspan="3"><div> <ul><li><a href="/wiki/Commissioner_of_Food_and_Drugs" title="Commissioner of Food and Drugs">Commissioner of Food and Drugs</a></li></ul> </div></td></tr></tbody></table></div> <div class="navbox-styles"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1129693374"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236075235"></div><div role="navigation" class="navbox" aria-labelledby="United_States_Department_of_Health_and_Human_Services" style="padding:3px"><table class="nowraplinks hlist mw-collapsible autocollapse navbox-inner" style="border-spacing:0;background:transparent;color:inherit"><tbody><tr><th scope="col" class="navbox-title" colspan="3"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1129693374"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1239400231"><div class="navbar plainlinks hlist navbar-mini"><ul><li class="nv-view"><a href="/wiki/Template:United_States_Department_of_Health_and_Human_Services" title="Template:United States Department of Health and Human Services"><abbr title="View this template">v</abbr></a></li><li class="nv-talk"><a href="/wiki/Template_talk:United_States_Department_of_Health_and_Human_Services" title="Template talk:United States Department of Health and Human Services"><abbr title="Discuss this template">t</abbr></a></li><li class="nv-edit"><a href="/wiki/Special:EditPage/Template:United_States_Department_of_Health_and_Human_Services" title="Special:EditPage/Template:United States Department of Health and Human Services"><abbr title="Edit this template">e</abbr></a></li></ul></div><div id="United_States_Department_of_Health_and_Human_Services" style="font-size:114%;margin:0 4em"><a href="/wiki/United_States_Department_of_Health_and_Human_Services" title="United States Department of Health and Human Services">United States Department of Health and Human Services</a></div></th></tr><tr><td class="navbox-abovebelow" colspan="3"><div> <ul><li>Headquarters: <b><a href="/wiki/Hubert_H._Humphrey_Building" title="Hubert H. Humphrey Building">Hubert H. Humphrey Building</a></b></li></ul> <ul><li><a href="/wiki/Xavier_Becerra" title="Xavier Becerra">Xavier Becerra</a>, <a href="/wiki/United_States_Secretary_of_Health_and_Human_Services" title="United States Secretary of Health and Human Services">Secretary of Health and Human Services</a></li> <li><a href="/wiki/Andrea_Palm" title="Andrea Palm">Andrea Palm</a>, <a href="/wiki/United_States_Deputy_Secretary_of_Health_and_Human_Services" title="United States Deputy Secretary of Health and Human Services">Deputy Secretary of Health and Human Services</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Secretariat staff offices</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li>Office of the Secretary of Health and Human Services</li> <li>Office of the Deputy Secretary of Health and Human Services</li> <li><a href="/wiki/Office_of_Inspector_General,_U.S._Department_of_Health_and_Human_Services" title="Office of Inspector General, U.S. Department of Health and Human Services">Office of Inspector General</a></li> <li><a href="/wiki/Office_of_the_National_Coordinator_for_Health_Information_Technology" title="Office of the National Coordinator for Health Information Technology">Office of the National Coordinator for Health Information Technology</a></li></ul> </div></td><td class="noviewer navbox-image" rowspan="4" style="width:1px;padding:0 0 0 2px"><div><span typeof="mw:File"><span><img alt="" src="//upload.wikimedia.org/wikipedia/commons/thumb/b/b7/US_Department_of_Health_and_Human_Services_seal.svg/150px-US_Department_of_Health_and_Human_Services_seal.svg.png" decoding="async" width="150" height="150" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/b/b7/US_Department_of_Health_and_Human_Services_seal.svg/225px-US_Department_of_Health_and_Human_Services_seal.svg.png 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/b/b7/US_Department_of_Health_and_Human_Services_seal.svg/300px-US_Department_of_Health_and_Human_Services_seal.svg.png 2x" data-file-width="406" data-file-height="406" /></span></span></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/United_States_Public_Health_Service" title="United States Public Health Service">Public Health Service</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Office_of_the_Assistant_Secretary_for_Health" title="Office of the Assistant Secretary for Health">Office of the Assistant Secretary for Health</a> <ul><li><a href="/wiki/Surgeon_General_of_the_United_States" title="Surgeon General of the United States">Office of the Surgeon General</a></li> <li><a href="/wiki/United_States_Public_Health_Service_Commissioned_Corps" title="United States Public Health Service Commissioned Corps">Public Health Service Commissioned Corps</a></li></ul></li> <li><a href="/wiki/Agency_for_Healthcare_Research_and_Quality" title="Agency for Healthcare Research and Quality">Agency for Healthcare Research and Quality</a></li> <li><a href="/wiki/Centers_for_Disease_Control_and_Prevention" title="Centers for Disease Control and Prevention">Centers for Disease Control and Prevention</a> <ul><li><a href="/wiki/Agency_for_Toxic_Substances_and_Disease_Registry" title="Agency for Toxic Substances and Disease Registry">Agency for Toxic Substances and Disease Registry</a></li> <li><a href="/wiki/National_Center_for_Injury_Prevention_and_Control" title="National Center for Injury Prevention and Control">National Center for Injury Prevention and Control</a></li> <li><a href="/wiki/National_Institute_for_Occupational_Safety_and_Health" title="National Institute for Occupational Safety and Health">National Institute for Occupational Safety and Health</a></li></ul></li> <li><a class="mw-selflink selflink">Food and Drug Administration</a></li> <li><a href="/wiki/Health_Resources_and_Services_Administration" title="Health Resources and Services Administration">Health Resources and Services Administration</a></li> <li><a href="/wiki/Indian_Health_Service" title="Indian Health Service">Indian Health Service</a></li> <li><a href="/wiki/National_Institutes_of_Health" title="National Institutes of Health">National Institutes of Health</a></li> <li><a href="/wiki/Substance_Abuse_and_Mental_Health_Services_Administration" title="Substance Abuse and Mental Health Services Administration">Substance Abuse and Mental Health Services Administration</a> <ul><li><a href="/wiki/Center_for_Behavioral_Health_Statistics_and_Quality" class="mw-redirect" title="Center for Behavioral Health Statistics and Quality">Center for Behavioral Health Statistics and Quality</a></li></ul></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Human services agencies</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Administration_for_Children_and_Families" title="Administration for Children and Families">Administration for Children and Families</a> (<a href="/wiki/Administration_for_Native_Americans" title="Administration for Native Americans">Administration for Native Americans</a>, <a href="/wiki/Office_of_Refugee_Resettlement" title="Office of Refugee Resettlement">Office of Refugee Resettlement</a>)</li> <li><a href="/wiki/Administration_for_Community_Living" title="Administration for Community Living">Administration for Community Living</a> <ul><li><a href="/wiki/Administration_on_Aging" title="Administration on Aging">Administration on Aging</a></li></ul></li> <li><a href="/wiki/Centers_for_Medicare_%26_Medicaid_Services" title="Centers for Medicare & Medicaid Services">Centers for Medicare & Medicaid Services</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Programs</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Child_Welfare_Information_Gateway" title="Child Welfare Information Gateway">Child Welfare Information Gateway</a></li> <li><a href="/wiki/National_Toxicology_Program" title="National Toxicology Program">National Toxicology Program</a></li></ul> </div></td></tr></tbody></table></div> <div class="navbox-styles"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1129693374"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236075235"></div><div role="navigation" class="navbox" aria-labelledby="23x15px&#124;border_&#124;alt=United_States&#124;link=United_States_Pharmaceutical_industry_in_the_United_States" style="padding:3px"><table class="nowraplinks hlist mw-collapsible autocollapse navbox-inner" style="border-spacing:0;background:transparent;color:inherit"><tbody><tr><th scope="col" class="navbox-title" colspan="2"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1129693374"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1239400231"><div class="navbar plainlinks hlist navbar-mini"><ul><li class="nv-view"><a href="/wiki/Template:Pharmaceutical_industry_in_the_United_States" title="Template:Pharmaceutical industry in the United States"><abbr title="View this template">v</abbr></a></li><li class="nv-talk"><a href="/wiki/Template_talk:Pharmaceutical_industry_in_the_United_States" title="Template talk:Pharmaceutical industry in the United States"><abbr title="Discuss this template">t</abbr></a></li><li class="nv-edit"><a href="/wiki/Special:EditPage/Template:Pharmaceutical_industry_in_the_United_States" title="Special:EditPage/Template:Pharmaceutical industry in the United States"><abbr title="Edit this template">e</abbr></a></li></ul></div><div id="23x15px&#124;border_&#124;alt=United_States&#124;link=United_States_Pharmaceutical_industry_in_the_United_States" style="font-size:114%;margin:0 4em"><span class="flagicon"><span class="mw-image-border" typeof="mw:File"><a href="/wiki/United_States" title="United States"><img alt="United States" src="//upload.wikimedia.org/wikipedia/en/thumb/a/a4/Flag_of_the_United_States.svg/23px-Flag_of_the_United_States.svg.png" decoding="async" width="23" height="12" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/en/thumb/a/a4/Flag_of_the_United_States.svg/35px-Flag_of_the_United_States.svg.png 1.5x, //upload.wikimedia.org/wikipedia/en/thumb/a/a4/Flag_of_the_United_States.svg/46px-Flag_of_the_United_States.svg.png 2x" data-file-width="1235" data-file-height="650" /></a></span></span> Pharmaceutical industry in the United States</div></th></tr><tr><th scope="row" class="navbox-group" style="width:1%;text-align: left;">Companies</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Abbott_Laboratories" title="Abbott Laboratories">Abbott Laboratories</a></li> <li><a href="/wiki/Acorda_Therapeutics" title="Acorda Therapeutics">Acorda Therapeutics</a></li> <li><a href="/wiki/Adolor_Corporation" class="mw-redirect" title="Adolor Corporation">Adolor Corporation</a></li> <li><a href="/wiki/Alcon" title="Alcon">Alcon</a></li> <li><a href="/wiki/Alexion_Pharmaceuticals" title="Alexion Pharmaceuticals">Alexion Pharmaceuticals</a></li> <li><a href="/wiki/Alkermes_(company)" class="mw-redirect" title="Alkermes (company)">Alkermes</a></li> <li><a href="/wiki/Allergan" title="Allergan">Allergan</a></li> <li><a href="/wiki/Alza" title="Alza">Alza</a></li> <li><a href="/wiki/Amgen" title="Amgen">Amgen</a></li> <li><a href="/wiki/Amylin_Pharmaceuticals" title="Amylin Pharmaceuticals">Amylin Pharmaceuticals</a></li> <li><a href="/wiki/ARIAD_Pharmaceuticals" title="ARIAD Pharmaceuticals">ARIAD Pharmaceuticals</a></li> <li><a href="/wiki/Avax_Technologies" title="Avax Technologies">Avax Technologies</a></li> <li><b><a href="/wiki/Template:Pharmaceutical_companies_of_the_United_States" title="Template:Pharmaceutical companies of the United States">more...</a></b></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%;text-align: left;">Regulatory bodies</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a class="mw-selflink selflink">Food and Drug Administration</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%;text-align: left;">Professional bodies</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/American_Pharmacists_Association" title="American Pharmacists Association">American Pharmacists Association</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%;text-align: left;">Miscellaneous</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Clinical_research_associate" title="Clinical research associate">Clinical research associate</a></li> <li><a href="/wiki/Contract_research_organization" title="Contract research organization">Contract research organization</a></li> <li><a href="/wiki/Pharmaceutical_industry" title="Pharmaceutical industry">Pharmaceutical industry</a> <ul><li><a href="/wiki/Pharmaceutical_industry_in_Bangladesh" title="Pharmaceutical industry in Bangladesh">Bangladesh</a></li> <li><a href="/wiki/Pharmaceutical_industry_in_China" title="Pharmaceutical industry in China">China</a></li> <li><a href="/wiki/Pharmaceutical_industry_in_India" title="Pharmaceutical industry in India">India</a></li> <li><a href="/wiki/Pharmaceutical_industry_in_Pakistan" title="Pharmaceutical industry in Pakistan">Pakistan</a></li> <li><a href="/wiki/Pharmaceutical_industry_in_the_United_Kingdom" title="Pharmaceutical industry in the United Kingdom">United Kingdom</a></li></ul></li> <li><a href="/wiki/Pharmaceutical_sales_representative" title="Pharmaceutical sales representative">Pharmaceutical sales representative</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%;text-align: left;">Books</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><i><a href="/wiki/The_Billion-Dollar_Molecule" title="The Billion-Dollar Molecule">The Billion-Dollar Molecule</a></i> (1994)</li> <li><i><a href="/wiki/Mad_in_America" title="Mad in America">Mad in America</a></i> (2002)</li> <li><i><a href="/wiki/Marcia_Angell" title="Marcia Angell">The Truth About the Drug Companies</a></i> (2004)</li> <li><i><a href="/wiki/Big_Pharma_(book)" title="Big Pharma (book)">Big Pharma</a></i> (2006)</li> <li><i><a href="/wiki/Side_Effects_(Bass_book)" title="Side Effects (Bass book)">Side Effects</a></i> (2008)</li> <li><i><a href="/wiki/Anatomy_of_an_Epidemic" title="Anatomy of an Epidemic">Anatomy of an Epidemic</a></i> (2010)</li> <li><i><a href="/wiki/Bad_Pharma" title="Bad Pharma">Bad Pharma</a></i> (2012)</li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%;text-align: left;">Lists</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Lists_of_drugs" title="Lists of drugs">Lists of drugs</a></li> <li><a href="/wiki/List_of_largest_pharmaceutical_settlements" title="List of largest pharmaceutical settlements">List of largest pharmaceutical settlements</a></li> <li><a href="/wiki/List_of_off-label_promotion_pharmaceutical_settlements" title="List of off-label promotion pharmaceutical settlements">List of off-label promotion pharmaceutical settlements</a></li> <li><a href="/wiki/List_of_pharmaceutical_companies" title="List of pharmaceutical companies">List of pharmaceutical companies</a></li> <li><a href="/wiki/List_of_pharmaceutical_manufacturers_in_the_United_Kingdom" title="List of pharmaceutical manufacturers in the United Kingdom">List of pharmaceutical manufacturers in the United Kingdom</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%;text-align: left;">Related templates</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Template:Medicine" title="Template:Medicine">Medicine</a></li> <li><a href="/wiki/Template:Pharmaceutical_industry_by_country" title="Template:Pharmaceutical industry by country">Pharmaceutical industry by country</a> <ul><li><a href="/wiki/Template:Pharmaceutical_industry_in_the_United_Kingdom" class="mw-redirect" title="Template:Pharmaceutical industry in the United Kingdom">United Kingdom</a></li> <li><a href="/wiki/Template:Pharmaceutical_companies_of_the_United_States" title="Template:Pharmaceutical companies of the United States">United States</a></li></ul></li> <li><a href="/wiki/Template:Public_health" title="Template:Public health">Public health</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%;text-align: left;">Related categories</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li>Pharmaceutical companies <ul><li><a href="/wiki/Category:Pharmaceutical_companies_of_Australia" title="Category:Pharmaceutical companies of Australia">Australia</a></li> <li><a href="/wiki/Category:Pharmaceutical_companies_of_Canada" title="Category:Pharmaceutical companies of Canada">Canada</a></li> <li><a href="/wiki/Category:Pharmaceutical_companies_of_Finland" title="Category:Pharmaceutical companies of Finland">Finland</a></li> <li><a href="/wiki/Category:Pharmaceutical_companies_of_India" title="Category:Pharmaceutical companies of India">India</a></li> <li><a href="/wiki/Category:Pharmaceutical_companies_of_Japan" title="Category:Pharmaceutical companies of Japan">Japan</a></li> <li><a href="/wiki/Category:Pharmaceutical_companies_of_Switzerland" title="Category:Pharmaceutical companies of Switzerland">Switzerland</a></li> <li><a href="/wiki/Category:Pharmaceutical_companies_of_the_United_Kingdom" title="Category:Pharmaceutical companies of the United Kingdom">United Kingdom</a></li> <li><a href="/wiki/Category:Pharmaceutical_companies_of_the_United_States" title="Category:Pharmaceutical companies of the United States">United States</a></li></ul></li></ul> </div></td></tr><tr><td class="navbox-abovebelow" colspan="2"><div><span class="noviewer" typeof="mw:File"><span title="Category"><img alt="" src="//upload.wikimedia.org/wikipedia/en/thumb/9/96/Symbol_category_class.svg/16px-Symbol_category_class.svg.png" decoding="async" width="16" height="16" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/en/thumb/9/96/Symbol_category_class.svg/23px-Symbol_category_class.svg.png 1.5x, //upload.wikimedia.org/wikipedia/en/thumb/9/96/Symbol_category_class.svg/31px-Symbol_category_class.svg.png 2x" data-file-width="180" data-file-height="185" /></span></span> <b><a href="/wiki/Category:Pharmaceutical_industry_in_the_United_States" title="Category:Pharmaceutical industry in the United States">Category</a></b></div></td></tr></tbody></table></div> <div class="navbox-styles"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1129693374"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236075235"></div><div role="navigation" class="navbox" aria-labelledby="Consumer_food_safety" style="padding:3px"><table class="nowraplinks hlist mw-collapsible autocollapse navbox-inner" style="border-spacing:0;background:transparent;color:inherit"><tbody><tr><th scope="col" class="navbox-title" colspan="2"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1129693374"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1239400231"><div class="navbar plainlinks hlist navbar-mini"><ul><li class="nv-view"><a href="/wiki/Template:Consumer_food_safety" title="Template:Consumer food safety"><abbr title="View this template">v</abbr></a></li><li class="nv-talk"><a href="/wiki/Template_talk:Consumer_food_safety" title="Template talk:Consumer food safety"><abbr title="Discuss this template">t</abbr></a></li><li class="nv-edit"><a href="/wiki/Special:EditPage/Template:Consumer_food_safety" title="Special:EditPage/Template:Consumer food safety"><abbr title="Edit this template">e</abbr></a></li></ul></div><div id="Consumer_food_safety" style="font-size:114%;margin:0 4em"><a href="/wiki/Food_safety" title="Food safety">Consumer food safety</a></div></th></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Adulterant" title="Adulterant">Adulterants</a>, <a href="/wiki/Food_contaminant" title="Food contaminant">food contaminants</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/3-MCPD" title="3-MCPD">3-MCPD</a></li> <li><a href="/wiki/Aldicarb" title="Aldicarb">Aldicarb</a></li> <li><a href="/wiki/Antibiotic_use_in_livestock" title="Antibiotic use in livestock">Antibiotic use in livestock</a></li> <li><a href="/wiki/Cyanide" title="Cyanide">Cyanide</a></li> <li><a href="/wiki/Formaldehyde" title="Formaldehyde">Formaldehyde</a></li> <li><a href="/wiki/HGH_controversies" title="HGH controversies">HGH controversies</a></li> <li><a href="/wiki/Lead_poisoning" title="Lead poisoning">Lead poisoning</a></li> <li><a href="/wiki/Melamine" title="Melamine">Melamine</a></li> <li><a href="/wiki/Mercury_in_fish" title="Mercury in fish">Mercury in fish</a></li> <li><a href="/wiki/Sudan_I" title="Sudan I">Sudan I</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Food_additive" title="Food additive">Food additives</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Flavoring" title="Flavoring">Flavorings</a></li> <li><a href="/wiki/Monosodium_glutamate" title="Monosodium glutamate">Monosodium glutamate (MSG)</a></li> <li><a href="/wiki/Sodium_chloride" title="Sodium chloride">Salt</a></li> <li><a href="/wiki/Sugar" title="Sugar">Sugar</a> <ul><li><a href="/wiki/High-fructose_corn_syrup" title="High-fructose corn syrup">High-fructose corn syrup</a></li></ul></li> <li><a href="/wiki/Vegetable_oil" title="Vegetable oil">Vegetable oil</a> <ul><li><a href="/wiki/Seed_oil_misinformation" title="Seed oil misinformation">controversy</a></li></ul></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Intestinal_parasite_infection" title="Intestinal parasite infection">Intestinal parasites</a>, <a href="/wiki/Parasitic_disease" title="Parasitic disease">parasitic disease</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Amoebiasis" title="Amoebiasis">Amoebiasis</a></li> <li><a href="/wiki/Anisakiasis" class="mw-redirect" title="Anisakiasis">Anisakiasis</a></li> <li><a href="/wiki/Cryptosporidiosis" title="Cryptosporidiosis">Cryptosporidiosis</a></li> <li><a href="/wiki/Cyclosporiasis" title="Cyclosporiasis">Cyclosporiasis</a></li> <li><a href="/wiki/Diphyllobothriasis" title="Diphyllobothriasis">Diphyllobothriasis</a></li> <li><a href="/wiki/Pinworm_infection" title="Pinworm infection">Enterobiasis</a></li> <li><a href="/wiki/Fasciolopsiasis" title="Fasciolopsiasis">Fasciolopsiasis</a></li> <li><a href="/wiki/Fasciolosis" title="Fasciolosis">Fasciolosis</a></li> <li><a href="/wiki/Giardiasis" title="Giardiasis">Giardiasis</a></li> <li><a href="/wiki/Gnathostomiasis" title="Gnathostomiasis">Gnathostomiasis</a></li> <li><a href="/wiki/Paragonimiasis" title="Paragonimiasis">Paragonimiasis</a></li> <li><a href="/wiki/Toxocariasis" title="Toxocariasis">Toxocariasis</a></li> <li><a href="/wiki/Toxoplasmosis" title="Toxoplasmosis">Toxoplasmosis</a></li> <li><a href="/wiki/Trichinosis" title="Trichinosis">Trichinosis</a></li> <li><a href="/wiki/Trichuriasis" title="Trichuriasis">Trichuriasis</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Microorganism" title="Microorganism">Microorganisms</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Botulism" title="Botulism">Botulism</a></li> <li><i><a href="/wiki/Campylobacter_jejuni" title="Campylobacter jejuni">Campylobacter jejuni</a></i></li> <li><i><a href="/wiki/Clostridium_perfringens" title="Clostridium perfringens">Clostridium perfringens</a></i></li> <li><i><a href="/wiki/Cronobacter" title="Cronobacter">Cronobacter</a></i></li> <li><i><a href="/wiki/Enterovirus" title="Enterovirus">Enterovirus</a></i></li> <li><a href="/wiki/Escherichia_coli_O104:H4" title="Escherichia coli O104:H4"><i>Escherichia coli</i> O104:H4</a></li> <li><a href="/wiki/Escherichia_coli_O157:H7" title="Escherichia coli O157:H7"><i>Escherichia coli</i> O157:H7</a></li> <li><a href="/wiki/Hepatitis_A" title="Hepatitis A">Hepatitis A</a></li> <li><a href="/wiki/Hepatitis_E" title="Hepatitis E">Hepatitis E</a></li> <li><i><a href="/wiki/Listeria" title="Listeria">Listeria</a></i></li> <li><a href="/wiki/Norovirus" title="Norovirus">Norovirus</a></li> <li><a href="/wiki/Rotavirus" title="Rotavirus">Rotavirus</a></li> <li><i><a href="/wiki/Salmonella" title="Salmonella">Salmonella</a></i></li> <li><a href="/wiki/Shigatoxigenic_and_verotoxigenic_Escherichia_coli" title="Shigatoxigenic and verotoxigenic Escherichia coli">Shigatoxigenic and verotoxigenic <i>E. coli</i></a></li> <li><i><a href="/wiki/Vibrio_cholerae" title="Vibrio cholerae">Vibrio cholerae</a></i></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Pesticide" title="Pesticide">Pesticides</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Chlorpyrifos" title="Chlorpyrifos">Chlorpyrifos</a></li> <li><a href="/wiki/DDT" title="DDT">DDT</a></li> <li><a href="/wiki/Lindane" title="Lindane">Lindane</a></li> <li><a href="/wiki/Malathion" title="Malathion">Malathion</a></li> <li><a href="/wiki/Methamidophos" title="Methamidophos">Methamidophos</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Preservative" title="Preservative">Preservatives</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Benzoic_acid" title="Benzoic acid">Benzoic acid</a></li> <li><a href="/wiki/Ethylenediaminetetraacetic_acid" title="Ethylenediaminetetraacetic acid">Ethylenediaminetetraacetic acid (EDTA)</a></li> <li><a href="/wiki/Sodium_benzoate" title="Sodium benzoate">Sodium benzoate</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Sugar_substitute" title="Sugar substitute">Sugar substitutes</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Acesulfame_potassium" title="Acesulfame potassium">Acesulfame potassium</a></li> <li><a href="/wiki/Aspartame" title="Aspartame">Aspartame</a> <ul><li><a href="/wiki/Aspartame_controversy" title="Aspartame controversy">controversy</a></li></ul></li> <li><a href="/wiki/Saccharin" title="Saccharin">Saccharin</a></li> <li><a href="/wiki/Sodium_cyclamate" class="mw-redirect" title="Sodium cyclamate">Sodium cyclamate</a></li> <li><a href="/wiki/Sorbitol" title="Sorbitol">Sorbitol</a></li> <li><a href="/wiki/Sucralose" title="Sucralose">Sucralose</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Toxin" title="Toxin">Toxins</a>, <a href="/wiki/Poison" title="Poison">poisons</a>, <a href="/wiki/Pollution" title="Pollution">environment pollution</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Aflatoxin" title="Aflatoxin">Aflatoxin</a></li> <li><a href="/wiki/Arsenic_contamination_of_groundwater" title="Arsenic contamination of groundwater">Arsenic contamination of groundwater</a></li> <li><a href="/wiki/Benzene_in_soft_drinks" title="Benzene in soft drinks">Benzene in soft drinks</a></li> <li><a href="/wiki/Bisphenol_A" title="Bisphenol A">Bisphenol A</a></li> <li><a href="/wiki/Dieldrin" title="Dieldrin">Dieldrin</a></li> <li><a href="/wiki/Diethylstilbestrol" title="Diethylstilbestrol">Diethylstilbestrol</a></li> <li><a href="/wiki/Dioxin" title="Dioxin">Dioxin</a></li> <li><a href="/wiki/Mycotoxin" title="Mycotoxin">Mycotoxins</a></li> <li><a href="/wiki/Nonylphenol" title="Nonylphenol">Nonylphenol</a></li> <li><a href="/wiki/Shellfish_poisoning" title="Shellfish poisoning">Shellfish poisoning</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Food_fraud" class="mw-redirect" title="Food fraud">Food fraud</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Bread_fraud" class="mw-redirect" title="Bread fraud">Bread</a></li> <li><a href="/wiki/Breast_milk_fraud" class="mw-redirect" title="Breast milk fraud">Breast milk</a></li> <li><a href="/wiki/Egg_fraud" class="mw-redirect" title="Egg fraud">Egg</a></li> <li><a href="/wiki/Olive_oil_fraud" class="mw-redirect" title="Olive oil fraud">Olive oil</a></li> <li><a href="/wiki/Prawn_fraud" class="mw-redirect" title="Prawn fraud">Prawn</a></li> <li><a href="/wiki/Seafood_fraud" class="mw-redirect" title="Seafood fraud">Seafood</a></li> <li><a href="/wiki/Shrimp_fraud" class="mw-redirect" title="Shrimp fraud">Shrimp</a></li> <li><a href="/wiki/Tea_fraud" class="mw-redirect" title="Tea fraud">Tea</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Food_processing" title="Food processing">Food processing</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/4-Hydroxynonenal" title="4-Hydroxynonenal">4-Hydroxynonenal</a></li> <li><a href="/wiki/Acid-hydrolyzed_vegetable_protein" class="mw-redirect" title="Acid-hydrolyzed vegetable protein">Acid-hydrolyzed vegetable protein</a></li> <li><a href="/wiki/Acrylamide" title="Acrylamide">Acrylamide</a></li> <li><a href="/wiki/List_of_food_additives" title="List of food additives">Food additives</a></li> <li><a href="/wiki/Food_irradiation" title="Food irradiation">Food irradiation</a></li> <li><a href="/wiki/Heterocyclic_amine" title="Heterocyclic amine">Heterocyclic amines</a></li> <li><a href="/wiki/Modified_starch" title="Modified starch">Modified starch</a></li> <li><a href="/wiki/Nitrosamine" title="Nitrosamine">Nitrosamines</a></li> <li><a href="/wiki/Polycyclic_aromatic_hydrocarbon" title="Polycyclic aromatic hydrocarbon">Polycyclic aromatic hydrocarbon</a></li> <li><a href="/wiki/Shortening" title="Shortening">Shortening</a></li> <li><a href="/wiki/Trans_fat" title="Trans fat">Trans fat</a></li> <li><a href="/wiki/Variant_Creutzfeldt%E2%80%93Jakob_disease" title="Variant Creutzfeldt–Jakob disease">Variant Creutzfeldt–Jakob disease</a></li> <li><a href="/wiki/Water_fluoridation_controversy" title="Water fluoridation controversy">Water fluoridation controversy</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/List_of_food_contamination_incidents" title="List of food contamination incidents">Food contamination incidents</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Devon_colic" title="Devon colic">Devon colic</a></li> <li><a href="/wiki/Swill_milk_scandal" title="Swill milk scandal">Swill milk scandal</a></li> <li><a href="/wiki/Esing_Bakery_incident" title="Esing Bakery incident">Esing Bakery incident</a></li> <li><a href="/wiki/1858_Bradford_sweets_poisoning" title="1858 Bradford sweets poisoning">1858 Bradford sweets poisoning</a></li> <li><a href="/wiki/1900_English_beer_poisoning" title="1900 English beer poisoning">1900 English beer poisoning</a></li> <li><a href="/wiki/Morinaga_Milk_arsenic_poisoning_incident" title="Morinaga Milk arsenic poisoning incident">Morinaga Milk arsenic poisoning incident</a></li> <li><a href="/wiki/Minamata_disease" title="Minamata disease">Minamata disease</a></li> <li><a href="/w/index.php?title=Moroccan_oil_poisoning_disaster_1959&action=edit&redlink=1" class="new" title="Moroccan oil poisoning disaster 1959 (page does not exist)">Moroccan oil poisoning disaster 1959</a><span class="noprint" style="font-size:85%; font-style: normal;"> [<a href="https://ar.wikipedia.org/wiki/%D9%83%D8%A7%D8%B1%D8%AB%D8%A9_%D8%A7%D9%84%D8%B2%D9%8A%D9%88%D8%AA_%D8%A7%D9%84%D9%85%D8%B3%D9%85%D9%88%D9%85%D8%A9_%D9%81%D9%8A_%D8%A7%D9%84%D9%85%D8%BA%D8%B1%D8%A8_1959" class="extiw" title="ar:كارثة الزيوت المسمومة في المغرب 1959">ar</a>]</span></li> <li><a href="/wiki/1971_Iraq_poison_grain_disaster" title="1971 Iraq poison grain disaster">1971 Iraq poison grain disaster</a></li> <li><a href="/wiki/Toxic_oil_syndrome" title="Toxic oil syndrome">Toxic oil syndrome</a></li> <li><a href="/wiki/1985_Austrian_diethylene_glycol_wine_scandal" title="1985 Austrian diethylene glycol wine scandal">1985 Austrian diethylene glycol wine scandal</a></li> <li><a href="/wiki/United_Kingdom_BSE_outbreak" title="United Kingdom BSE outbreak">United Kingdom BSE outbreak</a></li> <li><a href="/wiki/Australian_meat_substitution_scandal" title="Australian meat substitution scandal">Australian meat substitution scandal</a></li> <li><a href="/wiki/1993_Jack_in_the_Box_E._coli_outbreak" class="mw-redirect" title="1993 Jack in the Box E. coli outbreak">Jack in the Box <i>E. coli</i> outbreak</a></li> <li><a href="/wiki/1996_Odwalla_E._coli_outbreak" title="1996 Odwalla E. coli outbreak">1996 Odwalla <i>E. coli</i> outbreak</a></li> <li><a href="/wiki/2006_North_American_E._coli_O157:H7_outbreaks" title="2006 North American E. coli O157:H7 outbreaks">2006 North American <i>E. coli</i> outbreaks</a></li> <li><a href="/wiki/ICA_meat_repackaging_controversy" title="ICA meat repackaging controversy">ICA meat repackaging controversy</a></li> <li><a href="/wiki/2008_Canada_listeriosis_outbreak" title="2008 Canada listeriosis outbreak">2008 Canada listeriosis outbreak</a></li> <li><a href="/wiki/2008_Chinese_milk_scandal" title="2008 Chinese milk scandal">2008 Chinese milk scandal</a></li> <li><a href="/wiki/2008_Irish_pork_crisis" title="2008 Irish pork crisis">2008 Irish pork crisis</a></li> <li><a href="/wiki/2008_United_States_salmonellosis_outbreak" title="2008 United States salmonellosis outbreak">2008 United States salmonellosis outbreak</a></li> <li><a href="/wiki/2011_Germany_E._coli_O104:H4_outbreak" title="2011 Germany E. coli O104:H4 outbreak">2011 Germany <i>E. coli</i> outbreak</a></li> <li><a href="/wiki/2011_United_States_listeriosis_outbreak" title="2011 United States listeriosis outbreak">2011 United States listeriosis outbreak</a></li> <li><a href="/wiki/Bihar_school_meal_poisoning_incident" title="Bihar school meal poisoning incident">Bihar school meal poisoning</a></li> <li><a href="/wiki/2013_horse_meat_scandal" title="2013 horse meat scandal">2013 horse meat scandal</a></li> <li><a href="/wiki/Mozambique_funeral_beer_poisoning" title="Mozambique funeral beer poisoning">2015 Mozambique funeral beer poisoning</a></li> <li><a href="/wiki/Operation_Weak_Meat" title="Operation Weak Meat">2017 Brazil Operation Weak Meat</a></li> <li><a href="/wiki/2017%E2%80%932018_South_African_listeriosis_outbreak" title="2017–2018 South African listeriosis outbreak">2017–2018 South African listeriosis outbreak</a></li> <li><a href="/wiki/2018_Australian_strawberry_contamination" title="2018 Australian strawberry contamination">2018 Australian strawberry contamination</a></li> <li><a href="/wiki/2024_United_Kingdom_Shigatoxigenic_E._coli_outbreak" title="2024 United Kingdom Shigatoxigenic E. coli outbreak">2024 United Kingdom Shigatoxigenic E. coli outbreak</a></li> <li><a href="/wiki/Kobayashi_red_yeast_rice_scandal" title="Kobayashi red yeast rice scandal">Kobayashi red yeast rice scandal</a></li> <li><a href="/wiki/Food_safety_incidents_in_China" title="Food safety incidents in China">Food safety incidents in China</a></li> <li><a href="/wiki/Food_safety_incidents_in_Taiwan" title="Food safety incidents in Taiwan">Food safety incidents in Taiwan</a></li> <li><a href="/wiki/Foodborne_illness" title="Foodborne illness">Foodborne illness</a> <ul><li><a href="/wiki/List_of_foodborne_illness_outbreaks" title="List of foodborne illness outbreaks">outbreaks</a></li> <li><a href="/wiki/List_of_foodborne_illness_outbreaks_by_death_toll" title="List of foodborne illness outbreaks by death toll">death toll</a></li> <li><a href="/wiki/List_of_foodborne_illness_outbreaks_in_the_United_States" title="List of foodborne illness outbreaks in the United States">United States</a></li></ul></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Regulation" title="Regulation">Regulation</a>, <a href="/wiki/Standards_organization" title="Standards organization">standards</a>, <a href="/wiki/List_of_food_safety_organisations" title="List of food safety organisations">watchdogs</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Acceptable_daily_intake" title="Acceptable daily intake">Acceptable daily intake</a></li> <li><a href="/wiki/E_number" title="E number">E number</a></li> <li><a href="/wiki/List_of_food_labeling_regulations" title="List of food labeling regulations">Food labeling regulations</a></li> <li><a href="/wiki/Food_libel_laws" title="Food libel laws">Food libel laws</a></li> <li><a href="/wiki/Food_safety_in_Australia" title="Food safety in Australia">Food safety in Australia</a></li> <li><a href="/wiki/International_Food_Safety_Network" title="International Food Safety Network">International Food Safety Network</a></li> <li><a href="/wiki/ISO_22000" title="ISO 22000">ISO 22000</a></li> <li><a href="/wiki/Nutrition_facts_label" title="Nutrition facts label">Nutrition facts label</a></li> <li><a href="/wiki/Organic_certification" title="Organic certification">Organic certification</a></li> <li><a href="/wiki/Quality_Assurance_International" title="Quality Assurance International">Quality Assurance International</a></li> <li><a href="/wiki/United_Kingdom_food_information_regulations" title="United Kingdom food information regulations">United Kingdom food information regulations</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/List_of_food_safety_organisations" title="List of food safety organisations">Institutions</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Centre_for_Food_Safety" title="Centre for Food Safety">Centre for Food Safety</a> (Hong Kong)</li> <li><a href="/wiki/European_Food_Safety_Authority" title="European Food Safety Authority">European Food Safety Authority</a></li> <li><a class="mw-selflink selflink">Food and Drug Administration</a></li> <li><a href="/wiki/Food_Information_and_Control_Agency" title="Food Information and Control Agency">Food Information and Control Agency</a> (Spain)</li> <li><a href="/wiki/Food_Standards_Agency" title="Food Standards Agency">Food Standards Agency</a> (United Kingdom)</li> <li><a href="/wiki/Institute_for_Food_Safety_and_Health" title="Institute for Food Safety and Health">Institute for Food Safety and Health</a></li> <li><a href="/wiki/International_Food_Safety_Network" title="International Food Safety Network">International Food Safety Network</a></li> <li><a href="/wiki/Ministry_of_Food_and_Drug_Safety" title="Ministry of Food and Drug Safety">Ministry of Food and Drug Safety</a> (South Korea)</li> <li><a href="/wiki/Spanish_Agency_for_Food_Safety_and_Nutrition" title="Spanish Agency for Food Safety and Nutrition">Spanish Agency for Food Safety and Nutrition</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Related topics</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Curing_(food_preservation)" title="Curing (food preservation)">Curing (food preservation)</a></li> <li><a href="/wiki/Food_and_drink_prohibitions" title="Food and drink prohibitions">Food and drink prohibitions</a></li> <li><a href="/wiki/Food_marketing" title="Food marketing">Food marketing</a></li> <li><a href="/wiki/Food_politics" title="Food politics">Food politics</a></li> <li><a href="/wiki/Food_preservation" title="Food preservation">Food preservation</a></li> <li><a href="/wiki/Food_quality" title="Food quality">Food quality</a></li> <li><a href="/wiki/Genetically_modified_food" title="Genetically modified food">Genetically modified food</a></li> <li><a href="/wiki/Conspiracy_theories" class="mw-redirect" title="Conspiracy theories">Conspiracy theories</a></li></ul> </div></td></tr><tr><td class="navbox-abovebelow" colspan="2" style="font-weight:bold;"><div> <ul><li><span class="nowrap"><span class="noviewer" typeof="mw:File"><a href="/wiki/File:Foodlogo2.svg" class="mw-file-description"><img alt="icon" src="//upload.wikimedia.org/wikipedia/commons/thumb/d/d6/Foodlogo2.svg/16px-Foodlogo2.svg.png" decoding="async" width="16" height="12" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/d/d6/Foodlogo2.svg/24px-Foodlogo2.svg.png 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/d/d6/Foodlogo2.svg/32px-Foodlogo2.svg.png 2x" data-file-width="146" data-file-height="106" /></a></span> </span><a href="/wiki/Portal:Food" title="Portal:Food">Food portal</a> <span class="nowrap"><span class="noviewer" typeof="mw:File"><span><img alt="" src="//upload.wikimedia.org/wikipedia/commons/thumb/e/e2/Goblet_Glass_%28Banquet%29.svg/9px-Goblet_Glass_%28Banquet%29.svg.png" decoding="async" width="9" height="16" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/e/e2/Goblet_Glass_%28Banquet%29.svg/14px-Goblet_Glass_%28Banquet%29.svg.png 1.5x, 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