Editing Food and Drug Administration (section)

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

Emergency Use Authorization (EUA) is a mechanism that was created to facilitate the availability and use of medical countermeasures, including vaccines and personal protective equipment, during public health emergencies such as the Zika virus epidemic, the Ebola virus epidemic and the COVID-19 pandemic.<ref>{{Cite journal | author = Office of the Commissioner |date=August 31, 2021 |title=Emergency Use Authorization--Archived Information |url=https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information |journal=FDA |language=en |access-date=September 10, 2021 |archive-date=June 15, 2020 |archive-url=https://web.archive.org/web/20200615170705/https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information |url-status=dead }}</ref>

===Regulations===
The programs for safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy, and safety—yet FDA regulation of cosmetics focuses primarily on labeling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections. Inspection observations are documented on [[Form 483]].<ref>{{Cite journal |date=November 21, 2022 |title=Inspection Observations |url=https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations |journal=Fda.gov |language=en |access-date=January 14, 2023 |archive-date=January 14, 2023 |archive-url=https://web.archive.org/web/20230114025900/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations |url-status=dead }}</ref>

In June 2018, the FDA released a statement regarding new guidelines to help food and drug manufacturers "implement protections against potential attacks on the U.S. food supply".<ref>{{cite press release |url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611177.htm |title=Statement from FDA Commissioner Scott Gottlieb, M.D., on new guidance to help manufacturers implement protections against potential attacks on the U.S. food supply |publisher=Food and Drug Administration | vauthors = Gottlieb S |date=June 19, 2018 |access-date=June 20, 2018 |archive-date=July 24, 2018 |archive-url=https://web.archive.org/web/20180724202237/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611177.htm |url-status=dead}}</ref> One of the guidelines includes the Intentional Adulteration (IA) rule, which requires strategies and procedures by the food industry to reduce the risk of compromise in facilities and processes that are significantly vulnerable.<ref>{{Cite web |title=Federal Register :: Request Access |url=https://unblock.federalregister.gov/ |access-date=January 14, 2023 |website=unblock.federalregister.gov |archive-date=June 5, 2023 |archive-url=https://web.archive.org/web/20230605020052/https://unblock.federalregister.gov/ |url-status=live }}</ref><ref>{{Cite journal | author = Center for Food Safety and Applied Nutrition |date=September 9, 2020 |title=Full Text of the Food Safety Modernization Act (FSMA) |url=https://www.fda.gov/food/food-safety-modernization-act-fsma/full-text-food-safety-modernization-act-fsma |journal=FDA |language=en |access-date=January 14, 2023 |archive-date=September 12, 2018 |archive-url=https://web.archive.org/web/20180912032805/https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247548.htm |url-status=dead }}</ref>

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

The FDA frequently works with other federal agencies, including the [[United States Department of Agriculture|Department of Agriculture]], the [[Drug Enforcement Administration]], [[U.S. Customs and Border Protection|Customs and Border Protection]], and the [[U.S. Consumer Product Safety Commission|Consumer Product Safety Commission]]. They also often work with local and state government agencies in performing regulatory inspections and enforcement actions.<ref>{{Cite journal |date=October 7, 2022 |title=What does FDA regulate? |url=https://www.fda.gov/about-fda/fda-basics/what-does-fda-regulate |journal=FDA |language=en |access-date=January 14, 2023 |archive-date=January 14, 2023 |archive-url=https://web.archive.org/web/20230114030432/https://www.fda.gov/about-fda/fda-basics/what-does-fda-regulate |url-status=dead }}</ref>

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

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

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

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

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

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

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

The [[Center for Drug Evaluation and Research]] uses different requirements for the three main drug product types: new drugs, generic drugs, and over-the-counter drugs. A drug is considered "new" if it is made by a different manufacturer, uses different [[excipient]]s or inactive ingredients, is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to ''new molecular entities'': drugs that are not based on existing medications.<ref>{{Cite web |date=June 21, 2022 |title=Center for Drug Evaluation and Research {{!}} CDER |url=https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder |access-date=January 14, 2023 | publisher = U.S. Food and Drug Administ ration |language=en |archive-date=January 14, 2023 |archive-url=https://web.archive.org/web/20230114030540/https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder |url-status=live }}</ref>

====New medications====
{{more citations needed section|date=August 2019}}
New drugs receive extensive scrutiny before FDA approval in a process called a [[new drug application]] (NDA).<ref>{{cite web |url=https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/ |title=New Drug Application (NDA) |publisher=Food and Drug Administration |access-date=November 20, 2012 |archive-date=November 1, 2013 |archive-url=https://web.archive.org/web/20131101115332/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/ |url-status=dead}}</ref> Under the [[First presidency of Donald Trump|Presidency of Donald Trump]], the agency has worked to make the drug-approval process go faster.<ref>{{Cite journal | vauthors = Van Loo R |date=August 1, 2018 |title=Regulatory Monitors: Policing Firms in the Compliance Era |url=https://scholarship.law.bu.edu/faculty_scholarship/265 |journal=Faculty Scholarship |volume=119 |issue=2 |page=369 |access-date=October 10, 2020 |archive-date=June 4, 2020 |archive-url=https://web.archive.org/web/20200604022358/https://scholarship.law.bu.edu/faculty_scholarship/265/ |url-status=live}}</ref>'''{{rp|10}}''' Critics, however, argue that FDA standards are not sufficiently rigorous to prevent unsafe or ineffective drugs from getting approval.<ref>{{citation |title=Medical Nihilism | vauthors = Stegenga J |publisher=Oxford University Press |year=2018 |isbn=978-0-19-874704-8 |url=https://global.oup.com/academic/product/medical-nihilism-9780198747048?cc=hr&lang=en& |access-date=April 20, 2018 |archive-date=December 11, 2019 |archive-url=https://web.archive.org/web/20191211120725/https://global.oup.com/academic/product/medical-nihilism-9780198747048?cc=hr&lang=en& |url-status=live}}</ref> New drugs are available only by prescription by default. A change to over-the-counter (OTC) status is a separate process, and the drug must be approved through an NDA first. A drug that is approved is said to be "safe and effective when used as directed". Drugs being produced by a new manufacturer can be approved through one of two faster processes: the [[Abbreviated New Drug Application]] (ANDA) or the [[505(b)(2) regulatory pathway]] for  complex generic or biosimilar medications.<ref>{{Cite journal|author=Center for Drug Evaluation and Research|date=August 9, 2024 |title=Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA? |url=https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/abbreviated-approval-pathways-drug-product-505b2-or-anda |archive-url=https://web.archive.org/web/20220519201501/https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/abbreviated-approval-pathways-drug-product-505b2-or-anda |url-status=dead |archive-date=May 19, 2022 |journal=FDA |language=en}}</ref>


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 [[ZMapp]] and other experimental treatments, and for new drugs that can be used to treat debilitating and/or very rare conditions for which no existing remedies or drugs are satisfactory, or where there has not been an advance in a long period of time. The studies are progressively longer, gradually adding more individuals as they progress from stage I to stage III, normally over a period of years, and normally involve drug companies, the government and its laboratories, and often medical schools and hospitals and clinics. However, any exceptions to the aforementioned process are subject to strict review and scrutiny and conditions, and are only given if a substantial amount of research and at least some preliminary human testing has shown that they are believed to be somewhat safe and possibly effective. (See FDA Special Protocol Assessment about Phase III trials.)

=====Advertising and promotion=====
{{more citations needed section|date=August 2019}}
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.<ref>{{Cite web | work = Center for Drug Evaluation and Research |date=October 19, 2023 |title=The Office of Prescription Drug Promotion (OPDP) |url=https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp |access-date=October 23, 2023 | publisher = U.S. Food and Drug Administration |language=en |archive-date=October 23, 2023 |archive-url=https://web.archive.org/web/20231023220954/https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp |url-status=dead }}</ref> Advertising and promotion for over-the-counter drugs is regulated by the [[Federal Trade Commission]]. 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 .<ref>{{Cite journal | vauthors = Van Loo R |date=April 1, 2020 |title=The New Gatekeepers: Private Firms as Public Enforcers |url=https://scholarship.law.bu.edu/faculty_scholarship/800 |journal=Virginia Law Review |volume=106 |issue=2 |page=467 |access-date=October 25, 2020 |archive-date=October 28, 2020 |archive-url=https://web.archive.org/web/20201028034638/https://scholarship.law.bu.edu/faculty_scholarship/800/ |url-status=live}}</ref>{{rp|4}}

The drug advertising regulation<ref>21 CFR 202: Prescription Drug Advertising.</ref> contains two broad requirements: (1) a company may advertise or promote a drug only for the specific indication or medical use for which it was approved by FDA. Also, an advertisement must contain a "fair balance" between the benefits and the risks (side effects) of a drug. The 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.<ref>{{cite journal | vauthors = Weinmeyer R | title = Direct-to-consumer advertising of drugs | journal = The Virtual Mentor | volume = 15 | issue = 11 | pages = 954–958 | date = November 2013 | pmid = 24257087 | doi = 10.1001/virtualmentor.2013.15.11.hlaw1-1311 | url = https://journalofethics.ama-assn.org/article/direct-consumer-advertising-drugs/2013-11 | url-status = live | archive-url = https://web.archive.org/web/20240131130241/https://journalofethics.ama-assn.org/article/direct-consumer-advertising-drugs/2013-11 | archive-date = January 31, 2024 | doi-access = free }}</ref>

The term [[off-label]] refers to the practice of prescribing a drug for a different purpose than what the FDA approved.<ref>{{Cite web |date=January 1, 2014 |title=Off-Label Drug Use in Cancer Treatment |url=https://www.cancer.gov/about-cancer/treatment/drugs/off-label |access-date=January 14, 2023 |website=NCI |language=en |archive-date=January 14, 2023 |archive-url=https://web.archive.org/web/20230114030805/https://www.cancer.gov/about-cancer/treatment/drugs/off-label |url-status=live }}</ref>

Due to this approval requirement, manufacturers were prohibited from advertising [[COVID-19 vaccine]]s during the period in which they had only been approved under [[Emergency Use Authorization]].<ref>{{Cite web |title=FDA rules have blocked COVID-19 vaccine makers from advertising on TV |url=https://www.tampabay.com/news/health/2021/10/25/fda-rules-have-blocked-covid-19-vaccine-makers-from-advertising-on-tv/ |website=Tampa Bay Times |access-date=September 27, 2024 |language=en |quote=Food and Drug Administration rules prohibit advertising of drugs that have not been fully approved by the FDA}}</ref>

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

While this remains the primary tool of [[Postmarketing surveillance|post-market safety surveillance]], FDA requirements for post-marketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional [[clinical trials]], called Phase IV trials. In some cases, the FDA requires risk management plans called [[Risk Evaluation and Mitigation Strategies]] (REMS) for some drugs that require actions to be taken to ensure that the drug is used safely.<ref name=Nelson>{{cite journal | vauthors = Nelson LS, Loh M, Perrone J | title = Assuring safety of inherently unsafe medications: the FDA risk evaluation and mitigation strategies | journal = Journal of Medical Toxicology | volume = 10 | issue = 2 | pages = 165–172 | date = June 2014 | pmid = 24414251 | pmc = 4057549 | doi = 10.1007/s13181-013-0374-z }}</ref><ref>{{cite journal | vauthors = Brown WV, Bramlet DA, Ross JL, Underberg JA | title = JCL roundtable: Risk evaluation and mitigation strategy | journal = Journal of Clinical Lipidology | volume = 10 | issue = 6 | pages = 1288–1296 | date = October 14, 2016 | pmid = 27919344 | doi = 10.1016/j.jacl.2016.10.007 }}</ref> For example, [[thalidomide]] can cause birth defects, but has uses that outweigh the risks if men and women taking the drugs do not conceive a child; a REMS program for thalidomide mandates an auditable process to ensure that people taking the drug take action to avoid pregnancy; many [[opioid]] drugs have REMS programs to avoid addiction and diversion of drugs.<ref name=Nelson/> The drug [[isotretinoin]] has a REMS program called [[iPLEDGE]].<ref>{{cite journal | vauthors = Kovitwanichkanont T, Driscoll T | title = A comparative review of the isotretinoin pregnancy risk management programs across four continents | journal = International Journal of Dermatology | volume = 57 | issue = 9 | pages = 1035–1046 | date = September 2018 | pmid = 29508918 | doi = 10.1111/ijd.13950 | s2cid = 3726217 }}</ref>

====Generic drugs====
Generic drugs are chemical and therapeutic equivalents of [[name-brand]] drugs, normally whose patents have expired.<ref name="TNBK"/> Approved generic drugs should have the same dosage, safety, effectiveness, strength, stability, and quality, as well as route of administration. In general, they are less expensive than their name brand counterparts, are manufactured and marketed by rival companies and, in the 1990s, accounted for about a third of all prescriptions written in the United States.<ref name="TNBK"/> For a pharmaceutical company to gain approval to produce a generic drug, the FDA requires scientific evidence that the generic drug is interchangeable with or therapeutically equivalent to the originally approved drug.<ref name="Therapeutic Equivalance of Generic Drugs">{{cite web |url=https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm073182.htm |title=Therapeutic Equivalence of Generic Drugs |access-date=August 30, 2012 |publisher=Food and Drug Administration |year=1998 |archive-date=April 29, 2012 |archive-url=https://web.archive.org/web/20120429002732/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm073182.htm |url-status=dead}}</ref> This is called an [[Abbreviated New Drug Application]] (ANDA).<ref>{{cite web |title=Abbreviated New Drug Application (ANDA) |date=December 20, 2019 |publisher=U.S. Food & Drug Administration |url=https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda |access-date=May 10, 2020 |archive-date=September 23, 2020 |archive-url=https://web.archive.org/web/20200923221401/https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda |url-status=dead}}</ref> 80% of prescription drugs sold in the United States are generic brands.<ref>{{cite web | vauthors = Saling J | title=Generic Drugs: Answers to Common Questions | website=WebMD | date=March 5, 2024 | url=https://www.webmd.com/healthy-aging/generic-drugs-answers-to-common-questions | access-date=May 27, 2024 |quote=Almost 80% of prescription drugs sold are generics.}}</ref>

=====Generic drug scandal=====
In 1989, a major scandal erupted involving the procedures used by the FDA to approve generic drugs for sale to the public.<ref name="TNBK">{{cite encyclopedia | vauthors = Cohen L |article=Government Policies and Programs&nbsp;– United States&nbsp;– Generic Drug Scandal |title=The New Book of Knowledge&nbsp;– Medicine And Health |date=1990 |pages=276–281 |isbn=978-0-7172-8244-9}}</ref> Charges of corruption in generic drug approval first emerged in 1988 during the course of an extensive congressional investigation into the FDA. The oversight subcommittee of the [[House Energy and Commerce Committee|United States House Energy and Commerce Committee]] resulted from a complaint brought against the FDA by [[Mylan Laboratories Inc.]] of [[Pittsburgh]]. When its application to manufacture generics were subjected to repeated delays by the FDA, Mylan, convinced that it was being discriminated against, soon began its own private investigation of the agency in 1987. Mylan eventually filed suit against two former FDA employees and four drug-manufacturing companies, charging that corruption within the federal agency resulted in [[racketeering]] and in violations of [[antitrust law]]. "The order in which new generic drugs were approved was set by the FDA employees even before drug manufacturers submitted applications" and, according to Mylan, this illegal procedure was followed to give preferential treatment to certain companies. During the summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancato, Walter Kletch) pleaded guilty to criminal charges of accepting bribes from generic drugs makers, and two companies ([[Par Pharmaceutical]] and its subsidiary Quad Pharmaceuticals)<ref>{{cite news |url=https://www.nytimes.com/1989/09/12/business/fda-details-problems-at-drug-makers.html |work=The New York Times |title=F.D.A. Details Problems at Drug Makers |date=September 12, 1989 |access-date=February 7, 2017 |archive-date=March 13, 2017 |archive-url=https://web.archive.org/web/20170313215132/http://www.nytimes.com/1989/09/12/business/fda-details-problems-at-drug-makers.html |url-status=live}}</ref> pleaded guilty to giving bribes.

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

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

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

==== Coronavirus (COVID-19) testing ====
{{Main|COVID-19 testing}}
During the [[COVID-19 pandemic in the United States|coronavirus pandemic]], FDA granted [[emergency use authorization]] for [[personal protective equipment]] (PPE), in vitro diagnostic equipment, [[ventilator]]s and other medical devices.<ref name="FDA-EUA">{{cite web |url=https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations-medical-devices |title=Emergency Use Authorizations - FDA |author=<!--Not stated--> |date=May 21, 2020 | publisher = U.S. Food and Drug Administration |access-date=May 21, 2020 |url-status=live |archive-url=https://web.archive.org/web/20200517205323/https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations |archive-date=May 17, 2020}}</ref><ref>{{cite journal | vauthors = Rizk JG, Forthal DN, Kalantar-Zadeh K, Mehra MR, Lavie CJ, Rizk Y, Pfeiffer JP, Lewin JC | title = Expanded Access Programs, compassionate drug use, and Emergency Use Authorizations during the COVID-19 pandemic | journal = Drug Discovery Today | volume = 26 | issue = 2 | pages = 593–603 | date = February 2021 | pmid = 33253920 | pmc = 7694556 | doi = 10.1016/j.drudis.2020.11.025 }}</ref><ref>{{Cite journal |url=https://www.fda.gov/media/144413/download |title=Comirnaty and Pfizer-BioNTech COVID-19 Vaccine |journal=FDA |date=January 3, 2022 |access-date=October 27, 2021 |archive-date=August 14, 2021 |archive-url=https://web.archive.org/web/20210814042307/https://www.fda.gov/media/144413/download |url-status=dead }}</ref>

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

===Vaccines, blood and tissue products, and biotechnology===
{{more citations needed section|date=August 2019}}
[[File:Blood Research- Saving Lives (8352) (9759352093).jpg|thumb|FDA scientist prepares blood donation samples for testing.]]
The [[Center for Biologics Evaluation and Research]] is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents.<ref>{{cite web |url=https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ |title=About the Center for Biologics Evaluation and Research (CBER) |publisher=Food and Drug Administration |date=March 2, 2017 |access-date=May 12, 2017 |archive-date=May 9, 2017 |archive-url=https://web.archive.org/web/20170509063921/https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ |url-status=dead}}.</ref><ref>{{Cite web |title=Center for Biologics Evaluation and Research |url=https://registries.ncats.nih.gov/glossary/center-for-biologics-evaluation-and-research/ |access-date=January 2, 2025 |website=RaDaR |language=en-US}}</ref> These include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products. New biologics are required to go through a premarket approval process called a [[Biologics license application|Biologics License Application]] (BLA), similar to that for drugs.

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

===Medical and radiation-emitting devices===
{{more citations needed section|date=August 2019}}
[[File:FDA Bldg 62 - Exterior (5161375340).jpg|thumb|FDA Building 62 houses the [[FDA Center for Devices and Radiological Health|Center for Devices and Radiological Health]].|alt=]]
The [[Center for Devices and Radiological Health]] (CDRH) is the branch of the FDA responsible for the premarket approval of all [[medical device]]s, as well as overseeing the manufacturing, performance and safety of these devices.<ref>{{cite web | url = https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/ucm300639.htm | title = CDRH Mission, Vision and Shared Values | archive-url = https://web.archive.org/web/20190422142129/https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/ucm300639.htm | archive-date=April 22, 2019 | access-date = August 30, 2012 | publisher = U.S. Food and Drug Administration }}</ref> The definition of a medical device is given in the FD&C Act, and it includes products from the simple [[toothbrush]] to complex devices such as implantable [[neurostimulator]]s. CDRH also oversees the safety performance of non-medical devices that emit certain types of [[electromagnetic radiation]]. Examples of CDRH-regulated devices include [[cellular phones]], [[Airport security|airport baggage screening equipment]], [[television|television receivers]], [[microwave oven]]s, [[tanning booth]]s, and [[laser|laser products]].<ref>{{Cite web |date=June 13, 2022 |title=FDA Center for Devices and Radiological Health (CDRH) - NCI |url=https://sbir.cancer.gov/commercialization/fda/radiological-devices |access-date=January 2, 2025 |website=sbir.cancer.gov |language=en}}</ref>

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

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

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

According to the industry advocacy group, the [[American Council on Science and Health]], though the cosmetic industry is primarily responsible for its own product safety, the FDA can intervene when necessary to protect the public. In general, though, cosmetics do not require pre-market approval or testing. The ACSH says that companies must place a warning note on their products if they have not been tested, and that experts in cosmetic ingredient review also play a role in monitoring safety through influence on ingredients, but they lack legal authority. According to the ACSH, it has reviewed about 1,200 ingredients and has suggested that several hundred be restricted—but there is no standard or systemic method for reviewing chemicals for safety, or a clear definition of what 'safety' even means so that all chemicals get tested on the same basis.<ref>{{cite journal | vauthors = Ross G | title = A perspective on the safety of cosmetic products: a position paper of the American Council on Science and Health | journal = International Journal of Toxicology | volume = 25 | issue = 4 | pages = 269–277 | year = 2006 | pmid = 16815815 | doi = 10.1080/10915810600746049 | s2cid = 21904805 | doi-access = free }}</ref>

However, on December 29, 2022, President Biden signed the '2023 Consolidated Budget Act',<ref>{{Cite web |title=Biden signs $1.7T government spending bill, ensuring funding for most of 2023 |url=https://abcnews.go.com/Politics/biden-signs-17t-government-spending-bill-ensuring-funding/story?id=95934378 |access-date=January 2, 2025 |website=ABC News |language=en}}</ref> 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).<ref>{{Cite web |title=MoCRA Cosmetic Testing and Certification |url=https://www.nsf.org/au/en/knowledge-library/fda-modernization-cosmetics-regulation-act |access-date=January 2, 2025 |website=www.nsf.org |language=en}}</ref> 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.<ref>{{cite web |title=Modernization of Cosmetics Regulation Act of 2022 (MoCRA) |url=https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra#:~:text=Mandatory%20Recall%20Authority%3A%20If%20the,if%20the%20responsible%20person%20refuses | publisher = U.S. Food and Drug Administration |date=December 14, 2023 |access-date=January 21, 2024 |archive-date=January 22, 2024 |archive-url=https://web.archive.org/web/20240122175633/https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra#:~:text=Mandatory%20Recall%20Authority%3A%20If%20the,if%20the%20responsible%20person%20refuses |url-status=dead }}</ref>

===Veterinary products===
The [[Center for Veterinary Medicine]] (CVM) is a center of the FDA that regulates food additives and drugs that are given to animals.<ref name="Modric 2013">{{cite journal | vauthors = Modric S | title = Regulatory framework for the availability and use of animal drugs in the United States | journal = The Veterinary Clinics of North America. Small Animal Practice | volume = 43 | issue = 5 | pages = 1005–1012 | date = September 2013 | pmid = 23890234 | doi = 10.1016/j.cvsm.2013.04.001 }}</ref> CVM regulates animal drugs, animal food including pet animal, and animal medical devices. The FDA's requirements to prevent the spread of [[bovine spongiform encephalopathy]] are also administered by CVM through inspections of feed manufacturers.<ref>{{Cite web |url=https://www.fda.gov/animal-veterinary/compliance-enforcement/bovine-spongiform-encephalopathy |title=Bovine Spongiform Encephalopathy | work = Center for Veterinary Medicine |date=April 11, 2019 | publisher = U.S. Food and Drug Administ ration |language=en |access-date=February 4, 2020 |archive-date=December 12, 2019 |archive-url=https://web.archive.org/web/20191212171837/https://www.fda.gov/animal-veterinary/compliance-enforcement/bovine-spongiform-encephalopathy |url-status=live}}</ref> CVM does not regulate vaccines for animals; these are handled by the [[United States Department of Agriculture]].<ref>{{cite book | vauthors = Hill R Jr, Foley P, Clough N, Ludemann L, Murtle D | veditors = Roth J, Richt J, Morozov I |title=Vaccines and diagnostics for transboundary animal diseases: Ames, Iowa, 17-19 September 2012 |date=2013 |publisher=Karger Medical and Scientific Publishers |isbn=978-3-318-02366-4 |pages=53–54 |chapter-url=https://books.google.com/books?id=wZ86AQAAQBAJ&pg=PA53 |chapter=Translating research into licensed vaccines and validated and licensed diagnostic tests |access-date=June 30, 2019 |archive-date=August 1, 2020 |archive-url=https://web.archive.org/web/20200801131751/https://books.google.com/books?id=wZ86AQAAQBAJ&pg=PA53 |url-status=live}}</ref>

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

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

A [[First Amendment to the United States Constitution|First Amendment]] lawyer, [[Floyd Abrams]], is representing the tobacco companies in the case, contending requiring graphic warning labels on a lawful product cannot withstand constitutional scrutiny.<ref>{{cite web |url=http://www.adweek.com/news/advertising-branding/big-tobacco-gets-top-first-amendment-lawyer-new-suit-134200 |title=Big Tobacco Gets Top First Amendment Lawyer for New Suit |work=AdWeek |date=August 18, 2011 |access-date=March 14, 2015 |archive-date=April 11, 2015 |archive-url=https://web.archive.org/web/20150411073933/http://www.adweek.com/news/advertising-branding/big-tobacco-gets-top-first-amendment-lawyer-new-suit-134200 |url-status=live}}</ref> The [[Association of National Advertisers]] and the [[American Advertising Federation]] have also filed a brief in the suit, arguing that the labels infringe on commercial free speech and could lead to further government intrusion if left unchallenged.<ref>{{cite web |url=http://www.csnews.com/product-categories/tobacco/tobacco-cos-get-allies-warning-label-fight |title=Tobacco Cos. Get Allies in Warning Label Fight |work=Convenience Store News |date=September 19, 2011 |access-date=March 14, 2015 |archive-date=January 12, 2015 |archive-url=https://web.archive.org/web/20150112022328/http://www.csnews.com/product-categories/tobacco/tobacco-cos-get-allies-warning-label-fight |url-status=live}}</ref> In November 2011, Federal judge [[Richard J. Leon|Richard Leon]] of the U.S. District Court for the District of Columbia temporarily halted the new labels, likely delaying the requirement that tobacco companies display the labels. The [[Supreme Court of the United States|U.S. Supreme Court]] ultimately could decide the matter.<ref>{{cite news |url=https://www.wsj.com/articles/SB10001424052970204554204577024040240467970 |work=The Wall Street Journal | vauthors = Esterl M |title=Judge Temporarily Blocks Graphic Cigarette Labels |date=November 8, 2011 |url-access=subscription |access-date=August 3, 2017 |archive-date=July 9, 2017 |archive-url=https://web.archive.org/web/20170709173439/https://www.wsj.com/articles/SB10001424052970204554204577024040240467970 |url-status=live}}</ref>

In July 2017, the FDA announced a plan that would reduce the current levels of nicotine permitted in tobacco cigarettes.<ref>{{cite web |url=https://www.npr.org/2017/07/28/540088353/fda-announces-plan-to-cut-level-of-nicotine-allowed-in-cigarettes |title=FDA Announces Plan To Cut Level Of Nicotine Allowed In Cigarettes |website=[[NPR]] |access-date=April 4, 2018 |archive-date=March 20, 2018 |archive-url=https://web.archive.org/web/20180320032301/https://www.npr.org/2017/07/28/540088353/fda-announces-plan-to-cut-level-of-nicotine-allowed-in-cigarettes |url-status=live}}</ref> The proposed regulation, identified as RIN 0910-AI76, titled ''"Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products,"'' seeks to reduce the nicotine content in cigarettes to approximately 0.7 milligrams per gram of tobacco.

===Regulation of living organisms===
With acceptance of premarket notification 510(k) k033391 in January 2004,<ref name="FDA_K033391_Announcement">{{cite web |title=510(k) Premarket Notification K033391 |url=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K033391 |publisher=FDA |access-date=July 4, 2021 |archive-date=July 9, 2021 |archive-url=https://web.archive.org/web/20210709184153/https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K033391 |url-status=dead }}</ref> the FDA granted Ronald Sherman permission to produce and market [[medical maggots]] for use in humans or other animals as a prescription medical device.<ref name="FDA_K033391_ClearanceLetter">{{cite web |title=FDA_K033391_ClearanceLetter |url=https://www.accessdata.fda.gov/cdrh_docs/pdf3/K033391.pdf |archive-url=https://web.archive.org/web/20150701125329/http://www.accessdata.fda.gov/cdrh_docs/pdf3/K033391.pdf |archive-date=July 1, 2015 |url-status=dead |publisher=FDA |access-date=July 4, 2021}}</ref> Medical maggots represent the first living organism allowed by the Food and Drug Administration for production and marketing as a prescription medical device.<ref name="Greer_2005">{{cite journal | vauthors = Sherman R | title = Age-old therapy gets new approval | journal = Advances in Skin & Wound Care | volume = 18 | issue = 1 | pages = 12–15 | date = 2005 | pmid = 15716781 | doi = 10.1097/00129334-200501000-00003 | doi-access = free }}</ref>

In June 2004, the FDA cleared ''[[Hirudo medicinalis]]'' (medicinal leeches) as the second living organism legal to use as a medical device.<ref>{{Cite web |title=FDA approves leeches as medical devices |url=http://www.nbcnews.com/health/health-news/fda-approves-leeches-medical-devices-flna1C9447212 |access-date=January 14, 2023 |website=NBC News |date=June 28, 2004 |language=en |archive-date=January 14, 2023 |archive-url=https://web.archive.org/web/20230114031405/https://www.nbcnews.com/health/health-news/fda-approves-leeches-medical-devices-flna1C9447212 |url-status=live }}</ref>

The FDA also requires that milk be [[pasteurized]] to remove bacteria.<ref>{{Cite journal |date=January 26, 2022 |title=The Dangers of Raw Milk: Unpasteurized Milk Can Pose a Serious Health Risk |url=https://www.fda.gov/food/buy-store-serve-safe-food/dangers-raw-milk-unpasteurized-milk-can-pose-serious-health-risk |journal=FDA |language=en |access-date=January 14, 2023 |archive-date=April 4, 2021 |archive-url=https://web.archive.org/web/20210404003528/https://www.fda.gov/food/buy-store-serve-safe-food/dangers-raw-milk-unpasteurized-milk-can-pose-serious-health-risk |url-status=live }}</ref>

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

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

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