Federal Food, Drug, and Cosmetic Act

{{Short description|Acts of the United States Congress}} {{Use American English|date=June 2025}} {{Infobox U.S. legislation | shorttitle = Federal Food, Drug, and Cosmetic Act of 1938 | longtitle = To prohibit the movement in interstate commerce of adulterated and misbranded food, drugs, devices, and cosmetics, and for other purposes. | acronym = FFDCA, FD&C Act | enacted by = 75th | effective date = | public law url = https://research.archives.gov/description/299847 | cite public law = 75-717 | cite statutes at large = {{usstat|52|1040}} | acts repealed = [[Pure Food and Drug Act]] | acts amended = | title amended = [[Title 21 of the United States Code|21 U.S.C.: Food and Drugs]] | sections created = {{Usc-title-chap|21|9}} § 301 et seq. | sections amended = | leghisturl = | introducedin = Senate | introducedbill = {{USBill|75|S.|5}} | introducedby = [[Royal S. Copeland|Royal Copeland]] ([[Democratic Party (United States)|D]]–[[New York (state)|NY]]) | introduceddate = January 6, 1937 | passedbody1 = Senate | passeddate1 = March 9, 1937 | passedvote1 = voice | passedbody2 = House with amendment | passeddate2 = June 1, 1938 | passedvote2 = voice | conferencedate = June 10, 1938 | passedbody3 = Senate | passeddate3 = June 10, 1938 | passedvote3 = voice | passedbody4 = House | passeddate4 = June 13, 1938 | passedvote4 = voice | signedpresident = [[Franklin D. Roosevelt]] | signeddate = June 25, 1938 | amendments = *[[1951 Food, Drug, and Cosmetics Act Amendments]], PL 82–215, 65 Stat 648 * [[1962 Food, Drug, and Cosmetics Act Amendments]], PL 87–781, 76 Stat 780 * [[Fair Packaging and Labeling Act]], PL 89–755, 80 Stat 1296 * [[Medical Device Regulation Act]], PL 94–295, 90 Stat 539 * [[Radiation Control for Health and Safety Act of 1968]], PL 90-602, 82 Stat 1173 * [[Drug Price Competition and Patent Term Restoration Act of 1984]], PL 98-471, 98 Stat 1585 * [[Nutrition Labeling and Education Act]] (1990), PL 101-535, 104 Stat 2353 * [[Safe Medical Device Amendments of 1990]], PL 101-629, 104 Stat 4511 * [[Food and Drug Administration Revitalization Act]] (1990), PL 101-635, 104 Stat 4583 * [[Dietary Supplement Health And Education Act of 1994|Dietary Supplement Health and Education Act]] (1994), PL 103-417, 108 Stat 4332 * [[Food Quality Protection Act]] of 1996 * [[Food and Drug Administration Modernization Act of 1997]], PL 105-115, 111 Stat 2296 * [[Food and Drug Administration Amendments Act of 2007]], PL 110-85, 121 Stat 823<ref>"[http://www.ll.georgetown.edu/guides/fooddruglaw.cfm Food, Drug, and Cosmetic Law Research Guide]," ''Georgetown Law Library''</ref> * [[Over-the-Counter Hearing Aid Act of 2017]] * [[Sunscreen Innovation Act]] * [[Drug Quality and Security Act]] * [[Microbead-Free Waters Act of 2015]] | unsignedpresident = | vetoedpresident = | SCOTUS cases = [[62 Cases of Jam v. United States]] (1951) }}

The '''Federal Food, Drug, and Cosmetic Act''' (abbreviated as '''FFDCA''', '''FDCA''', or '''FD&C''') is a set of laws passed by the [[United States Congress]] in 1938 giving authority to the [[Food and Drug Administration]] (FDA) to oversee the [[food safety|safety of food]], drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was [[Charles W. Crawford (chemist)|Charles W. Crawford]].<ref>{{cite web|url=https://www.fda.gov/AboutFDA/WhatWeDo/History/Leaders/Commissioners/ucm093757.htm|title=Charles Crawford |publisher=Food & Drug Administration|access-date=September 26, 2017|url-status=unfit|archive-url=https://web.archive.org/web/20171115153304/https://www.fda.gov/AboutFDA/WhatWeDo/History/Leaders/Commissioners/ucm093757.htm|archive-date=November 15, 2017}}</ref> A principal author of this law was [[Royal S. Copeland]], a three-term U.S. senator from New York.<ref>[http://www.homeowatch.org/history/reghx.html Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation]</ref> In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the [[Drug Efficacy Study Implementation]] (DESI) to incorporate into FD&C regulations the recommendations from a [[National Academy of Sciences]] investigation of effectiveness of previously marketed drugs.<ref>[https://www.fda.gov/cder/about/history/time1.htm CDER – Time Line]{{dead link|date=May 2025|bot=medic}}{{cbignore|bot=medic}}</ref> The act has been amended many times, most recently to add requirements about [[bioterrorism]] preparations.

The introduction of this act was influenced by the death of more than 100 patients due to [[elixir sulfanilamide]], a [[sulfanilamide]] medication where the toxic [[solvent]] [[diethylene glycol]] was used to dissolve the drug and make a liquid form.<ref>[http://www.ashp.org/s_ashp/article_news.asp?CID=167&DID=2024&id=3659 ASHP Website : News Article] {{webarchive|url=https://web.archive.org/web/20070927225510/http://www.ashp.org/s_ashp/article_news.asp?CID=167&DID=2024&id=3659|date=2007-09-27}}</ref> It replaced the earlier [[Pure Food and Drug Act]] of 1906.

== Contents ==

The FDC Act has ten chapters:<ref>{{cite web |title=Federal Food, Drug, and Cosmetic Act (FD&C Act) |date=3 November 2018 |url=https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/federalfooddrugandcosmeticactfdcact/default.htm |archive-url=https://web.archive.org/web/20170404003204/https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/FederalFoodDrugandCosmeticActFDCAct/default.htm |url-status=dead |archive-date=April 4, 2017 |publisher=U.S. Department of Health and Human Services |access-date=8 January 2019}}</ref> :I. Short Title :II. Definitions ::* 201(f) is the definition for a food, which explicitly includes [[chewing gum]] ::* 201(g) is the definition for a [[drug]] ::* 201(h) is the definition for a [[medical device]] ::* 201(s) is the definition of a food additive ::* 201(ff) is the definition of a [[dietary supplement]] :III. Prohibited Acts and Penalties ::This section contains both [[Private law|civil law]] and [[criminal law]] clauses. Most violations under the act are civil, though repeated, intentional, and fraudulent violations are covered as criminal law. All violations of the FD&C Act require interstate commerce because of the [[commerce clause]], but this is often interpreted broadly and few products other than raw produce are considered outside of the scope of the act. ::Notably, the FD&C Act uses [[strict liability]] due to the [[United States v. Dotterweich|Dotterweich]]<ref>[http://wings.buffalo.edu/law/bclc/web/dotterweich.htm United States v. Dotterweich, 320 U.S. 277 (1943)]</ref> and [[United States v. Park|Park]]<ref>[http://supreme.justia.com/us/421/658/index.html UNITED STATES V. PARK, 421 U. S. 658 (1975) – US Supreme Court Cases from Justia & Oyez]</ref> [[Supreme Court of the United States|Supreme Court]] cases. It is one of a very small number of criminal statutes that does. :IV. Food ::There is a distinction in food adulteration between those that are added and those that are naturally present. Substances that are added are held to a stricter "may render (it) injurious to health" standard, whereas substances that are naturally present need only be at a level that "does not ordinarily render it injurious to health"<ref>[https://web.archive.org/web/20000824071619/http://www.fda.gov/opacom/laws/fdcact/fdcact4.htm FD&C Act Chapter IV]</ref> :V. Drugs and Devices ::* 505 is the description of the drug approval process ::* 510(k) is the section that allows for clearance of class II [[medical devices]] ::* 515 is the description of the (class III) device approval process :VI. Cosmetics :VII. General Authority ::* 704 allows inspections of regulated entities. Inspection results are reported on [[Form 483]]. :VIII. Imports and Exports :IX. Tobacco Products :X. Miscellaneous

== Food coloring == The FD&C Act is perhaps best known to consumers because of its use in the naming of [[food coloring]] additives, such as "FD&C Yellow No. 6". The Act made the certification of some food color [[Food additive|additives]] mandatory. The FDA lists nine FD&C (Food, Drugs & Cosmetics) certified color additives for use in foods in the United States, and numerous D&C (Drugs & Cosmetics) colorings allowed only in drugs for external application or cosmetics.<ref>{{cite web|title=Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices|url=https://www.fda.gov/forindustry/coloradditives/coloradditiveinventories/ucm115641.htm|publisher=U.S. Food and Drug Administration|access-date=20 May 2014}}{{dead link|date=May 2025|bot=medic}}{{cbignore|bot=medic}}</ref> Color additives derived from natural sources, such as vegetables, minerals or animals, and artificial counterparts of natural derivatives, are exempt from certification. Both artificial and naturally derived color additives are subject to rigorous standards of safety before their approval for use in foods.<ref>{{cite web |title= Guidance for Industry: Color Additive Petitions – FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices |work= Laws, Regulations, and Guidance |publisher= [[Food and Drug Administration]]|orig-year= January 1997|date= July 2009 |url= https://www.fda.gov/ForIndustry/ColorAdditives/GuidanceComplianceRegulatoryInformation/ucm171631.htm |archive-url= https://web.archive.org/web/20090810012106/http://www.fda.gov/ForIndustry/ColorAdditives/GuidanceComplianceRegulatoryInformation/ucm171631.htm |url-status= dead |archive-date= August 10, 2009 |access-date= 22 Apr 2014}}</ref>

=== Certifiable colors === {| class="wikitable" style="text-align:center" |- ! Name !! Common name !! Color !! Comment |- | FD&C Blue No. 1 | [[Brilliant blue FCF]] || blue || |- | FD&C Blue No. 2 | [[Indigo carmine]] || indigo || |- | FD&C Green No. 3 | [[Fast Green FCF]] || green || |- | FD&C Red No. 3 | [[Erythrosine]] || pink || Banned in the United States on January 15, 2025.<ref>{{Cite journal |last=Program |first=Human Foods |date=2025-01-15 |title=FD&C Red No. 3 |url=https://www.fda.gov/industry/color-additives/fdc-red-no-3 |archive-url=https://web.archive.org/web/20240118205405/https://www.fda.gov/industry/color-additives/fdc-red-no-3 |url-status=dead |archive-date=January 18, 2024 |journal=FDA |language=en}}</ref> |- | FD&C Red No. 40 | [[Allura Red AC]] || red || |- | FD&C Yellow No. 5 | [[Tartrazine]] || yellow|| |- | FD&C Yellow No. 6 | [[Sunset Yellow FCF]] || orange || |- | | [[Orange B]] || orange || Restricted to specific uses<ref>{{cite web|title=Code of Federal Regulations: Title 21, Section 74.250|url=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=74.250|publisher=U.S. Food and Drug Administration|access-date=20 May 2014}}</ref> |- | | [[Citrus Red 2|Citrus Red No. 2]] || red || Restricted to specific uses<ref>{{cite web|title=Code of Federal Regulations: Title 21, Section 74.302|url=http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=74.302|archive-url=https://web.archive.org/web/20030917005816/http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=74.302|url-status=dead|archive-date=September 17, 2003|publisher=U.S. Food and Drug Administration|access-date=20 May 2014}}</ref> |}

== Food additives == The FFDCA requires producers of food additives to demonstrate to a reasonable certainty that no harm will result from the intended use of an additive. If the FDA finds an additive to be safe the agency issues a regulation specifying the conditions under which the additive may be safely used.{{cn|date=October 2023}}

=== Definition of food additive === A shortened definition of "food additive" is defined by the FDA as "any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use); if such substance is not GRAS or sanctioned prior to 1958 or otherwise excluded from the definition of food additives."<ref>[https://web.archive.org/web/20130320034844/http://www.fda.gov/Food/IngredientsPackagingLabeling/Definitions/default.htm] F.D.A. webpage "Food Ingredients and Packaging Terms" Page Last Updated: 02/28/2013</ref> The full definition can be found in [https://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChaptersIandIIShortTitleandDefinitions/default.htm Section 201(s)]{{dead link|date=May 2025|bot=medic}}{{cbignore|bot=medic}} of the FD&C Act, which provides for any additional exclusions.<ref>[https://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChaptersIandIIShortTitleandDefinitions/default.htm]{{dead link|date=May 2025|bot=medic}}{{cbignore|bot=medic}} F.D.A. Regulatory Information webpage "FD&C Act Table of Contents and Chapters I and II: Short Title and Definitions" Page Last Updated: 01/19/2012</ref>

== Homeopathic medications == [[Homeopathy|Homeopathic]] preparations are regulated and protected under Sections 201(g) and 201(j), provided that such medications are formulated from substances listed in the Homeopathic Pharmacopoeia of the United States, which the Act recognizes as an official drug compendium.<ref>{{Cite web |title=21 USC Ch. 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT |url=https://uscode.house.gov/view.xhtml?path=/prelim@title21/chapter9&edition=prelim |access-date= |website=[[United States Code]] |quote=Section 321, subsection (g), paragraph (1), subparagraph (A) thereof.}}</ref>

However, under separate authority of [[FTC Act]], the [[Federal Trade Commission]] declared in November 2016 that homeopathic products cannot include claims of effectiveness without "competent and reliable scientific evidence". If no such evidence exists, they must state this fact clearly on their labeling.<ref>{{cite web|url=https://www.ftc.gov/news-events/press-releases/2016/11/ftc-issues-enforcement-policy-statement-regarding-marketing|title=FTC Issues Enforcement Policy Statement Regarding Marketing Claims for Over-the-Counter Homeopathic Drugs: Efficacy and Safety Claims Are Held to Same Standard as Other OTC Drug Claims|author=Press Release|publisher=FTC|date=15 November 2016|access-date=17 November 2016}}</ref>

== Bottled water == [[Bottled water]] is regulated by the FDA as a food. The Agency has published identity standards for types of water ([[mineral water]], spring water), and regulations covering water processing and bottling, water quality and product labeling.<ref>Posnick, Lauren M. and Kim, Henry (2002). [https://web.archive.org/web/20090710012924/http://www.fda.gov/downloads/Food/FoodSafety/Product-SpecificInformation/BottledWaterCarbonatedSoftDrinks/ucm077094.pdf "Bottled Water Regulation and the FDA."] ''Food Safety.'' August/September 2002. {{ISSN|1084-5984}}.</ref><ref>FDA. [http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?idno=21;region=DIV1;type=boolean;c=ecfr;cc=ecfr;sid=488f70fefe0640a86448e916ca70ef97;q1=129;rgn1=Part%20Number;op2=and;rgn2=Section;op3=and;rgn3=Section;rgn=div5;view=text;node=21%3A2.0.1.1.18 "21 CFR Part 129 – Processing and Bottling of Bottled Drinking Water."] {{Webarchive|url=https://web.archive.org/web/20090926062217/http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?idno=21;region=DIV1;type=boolean;c=ecfr;cc=ecfr;sid=488f70fefe0640a86448e916ca70ef97;q1=129;rgn1=Part%20Number;op2=and;rgn2=Section;op3=and;rgn3=Section;rgn=div5;view=text;node=21%3A2.0.1.1.18 |date=2009-09-26 }} ''Code of Federal Regulations.''</ref><ref>FDA. [http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=40900bcf73d9bab93d5c779815018b19&rgn=div8&view=text&node=21:2.0.1.1.38.2.1.1&idno=21 "21 CFR 165.110 – Requirements for Specific Standardized Beverages: Bottled Water."] {{Webarchive|url=https://web.archive.org/web/20090907040321/http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=40900bcf73d9bab93d5c779815018b19&rgn=div8&view=text&node=21:2.0.1.1.38.2.1.1&idno=21 |date=2009-09-07 }} ''Code of Federal Regulations.''</ref>

== Cosmetics == This Act defines [[cosmetics]] as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body ... for cleansing, beautifying, promoting attractiveness, or altering the appearance." Under the Act, the FDA does not approve cosmetic products, but the Act prohibits the marketing of adulterated or misbranded cosmetics.<ref name=":0">{{Cite journal |last= |first= |date=2022-03-02 |title=FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated |url=https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated |archive-url=https://web.archive.org/web/20190713080652/https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated |url-status=dead |archive-date=July 13, 2019 |journal=FDA |language=en}}</ref> However, the FDA does not have the authority to order [[Product recall|recalls]] of cosmetics.<ref>{{Cite magazine |last=Cep |first=Casey |date=2022-09-12 |title=Johnson & Johnson and a New War on Consumer Protection |url=https://www.newyorker.com/magazine/2022/09/19/johnson-johnson-and-a-new-war-on-consumer-protection |access-date=2022-10-17 |magazine=The New Yorker |language=en-US}}</ref><ref>{{Cite journal |last= |first= |date=2022-03-03 |title=FDA Recall Policy for Cosmetics |url=https://www.fda.gov/cosmetics/cosmetics-recalls-alerts/fda-recall-policy-cosmetics |archive-url=https://web.archive.org/web/20190912072408/https://www.fda.gov/cosmetics/cosmetics-recalls-alerts/fda-recall-policy-cosmetics |url-status=dead |archive-date=September 12, 2019 |journal=FDA |language=en}}</ref> If a company is selling a product that is adulterated or misbranded, the FDA can ask the company to recall their product or sue them.<ref name=":0" /> The FDA can and does inspect cosmetics manufacturing facilities to ensure that cosmetics are not adulterated.<ref name=":0" />

== Medical devices == {{Further|Medical device#United States}} On May 28, 1976, the FD&C Act was amended to include regulation for [[medical devices]].<ref>Staff, FDA. [https://web.archive.org/web/20110610125920/http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm046769.htm PMA Historical Background] Last updated April 26, 2009</ref> The [[Medical Device Regulation Act|amendment]] required that all medical devices be classified into one of three classes: * Class I: Devices that do not require premarket approval or clearance but must follow general controls. [[Dental floss]] is a class I device. * Class II: Devices that are cleared using the 510(k) process. Diagnostic tests, cardiac catheters, hearing aids, and [[Amalgam (dentistry)|dental amalgams]] are examples of class II devices. * Class III: Devices that are approved by the premarket approval (PMA) process, analogous to a [[New Drug Application]]. These tend to be devices that are permanently implanted into a human body or may be necessary to sustain life. An [[artificial heart]] meets both criteria. The most commonly recognized class III device is an [[automated external defibrillator]]. Devices that do not meet either criterion are generally cleared as class II devices.

For devices that were marketed prior to the amendment (preamendment devices) and were classified as Class III, the amendment obligated the FDA to review the device to either reclassify it as a Class II device subject to premarket notification, or to require the device manufacturer to undergo the premarket authorization process and prove the safety and efficacy of the device in order to continue marketing it. Notable examples of such preamendment devices are those used for [[electroconvulsive therapy]], which the FDA started reviewing in 2011.<ref>Duff Wilson for the New York Times. January 28, 2011 [https://www.nytimes.com/2011/01/29/health/29shock.html?_r=0 F.D.A. Panel Is Split on Electroshock Risks]</ref><ref>{{cite web|archive-url=https://web.archive.org/web/20131019153738/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevicesAdvisoryCommittee/neurologicalDevicesPanel/UCM240933.pdf |archive-date=2013-10-19 |url=https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevicesAdvisoryCommittee/neurologicalDevicesPanel/UCM240933.pdf |title=FDA Executive Summary Prepared for the January 27-28, 2011 meeting of the Neurological Devices Panel Meeting to Discuss the Classification of Electroconvulsive Therapy Devices (ECT) |publisher=[[United States Food and Drug Administration]] |access-date=2012-10-25 |url-status=dead }}</ref>

=== Premarket notification (510(k), PMN) ===

'''Section 510(k)'''<ref>[https://archive.today/19961019012004/http://www.fda.gov/cdrh/510khome.html US FDA/CDRH: Information on Releasable 510(k)s]</ref> of the Federal Food, Drug, and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a [[medical device]].

This is known as premarket notification, PMN, or 510(k). It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.{{cn|date=October 2023}}

Any device that reaches market via a 510(k) notification must be "substantially equivalent" to a device on the market prior to May 28, 1976 (a "predicate device"). If a device being submitted is significantly different, relative to a pre-1976 device, in terms of design, material, chemical composition, energy source, manufacturing process, or intended use, the device nominally must go through a premarket approval, or PMA.

A device that reaches market via the 510(k) process is not considered to be "approved" by the FDA. Nevertheless, it can be marketed and sold in the United States. They are generally referred to as "cleared" or "510(k) cleared" devices.

A 2011 study by [[Diana Zuckerman]] and Paul Brown of the [[National Research Center for Women and Families]], and Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, showed that most medical devices recalled in the last five years for "serious health problems or death" had been previously cleared by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the 113 devices recalled, 35 were for cardiovascular issues.<ref>{{cite journal|last=Zuckerman|first=Diana|title=Medical Device Recalls and the FDA Approval Process|journal=Archives of Internal Medicine|year=2011|url=http://archinte.jamanetwork.com/article.aspx?articleid=227466|doi=10.1001/archinternmed.2011.30|pmid=21321283|volume=171|issue=11|pages=1006–11|doi-access=|url-access=subscription}}</ref>

=== Premarket approval (PMA) ===

Premarket approval (PMA) is the most stringent type of device marketing application required by FDA. Unlike the 510(k) pathway, the maker of the medical device must submit an application to the FDA and must receive approval prior to marketing the device.<ref>Staff, FDA [https://web.archive.org/web/20090604111656/http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm Premarket Approval (PMA)], last updated January 24, 2012</ref>

The PMA application contains information about how the medical device was designed and how it is manufactured, as well as preclinical and clinical studies of the device, demonstrating that it is safe and effective for its intended use.<ref>[http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec360e.htm 21 U.S.C. § 360e. Premarket approval]</ref> Because the PMA requires a [[clinical trial]] it is significantly more expensive than a 510(k).<ref>[[Josh Makower]], Aabed Meer, lyn Denend. November 2010 [http://www.nvca.org/index.php?option=com_docman&task=doc_download&gid=668&Itemid=93 FDA Impact on US Medical Device Innovation – A Survey of Over 200 Medical Technology Companies]</ref>{{rp|7}}

===Automatic Class III designation (''de novo'' classification)=== The [[Food and Drug Administration Modernization Act of 1997]] created section 513(f)(2) of the FD&C Act, which obligated the FDA to establish a risk-based regulatory system for medical devices. As a result, the FDA established a ''de novo'' pathway for devices that would automatically be classified as Class III because there was no already-existing device that could be used a predicate for a 510k submission, but for which general controls or general and special controls could provide a reasonable assurance of safety and effectiveness.<ref>{{cite web|title=De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration Staff|url=https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080197.pdf|archive-url=https://web.archive.org/web/20090710064730/http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080197.pdf|url-status=dead|archive-date=July 10, 2009|publisher=FDA|date=October 30, 2017}}</ref><ref>{{cite news|last1=Drues|first1=Michael|title=Secrets Of The De Novo Pathway, Part 1: Why Aren't More Device Makers Using It?|url=https://www.meddeviceonline.com/doc/secrets-of-the-de-novo-pathway-part-why-aren-t-more-device-makers-using-it-0001|work=Meddevice Online|date=February 5, 2014|language=en}} {{cite news|last1=Drues|first1=Michael|title=Secrets Of The De Novo Pathway Part 2 Is De Novo Right For Your Device|url=https://www.meddeviceonline.com/doc/secrets-of-the-de-novo-pathway-part-is-de-novo-right-for-your-device-0001|work=www.meddeviceonline.com|date=February 18, 2014|language=en}}</ref>

== Related legislation == The [[Wheeler-Lea Act]], passed in 1938, granted the [[Federal Trade Commission]] the authority to oversee [[advertising]] of all products regulated by FDA, other than prescription drugs.

== Significant amendments and related laws == Descriptions of these can be found at the FDA's web site.<ref>{{cite web|title=Laws Enforced by FDA |date=19 April 2021|url=https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/default.htm|archive-url=https://web.archive.org/web/20170403221727/https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/default.htm|url-status=dead|archive-date=April 3, 2017|publisher=U.S. Food and Drug Administration}}</ref>

Amendments: * [[Durham-Humphrey Amendment]], [[Act of Congress|Public Law]] (PL) 82–215 (October 26, 1951) created prescription-only status for some drugs * Drug Efficacy Amendment ("[[Kefauver Harris Amendment]]") PL 87–781 (October 10, 1962) * Vitamin-Mineral Amendment ("[[Proxmire Amendment]]") (April 22, 1976) prohibited the FDA from establishing standards to limit the potency of vitamins and minerals in [[food supplement]]s or regulating them as drugs based solely on their potency.<ref>{{cite web|title=This Week In FDA History - April 22, 1976|url=https://www.fda.gov/AboutFDA/WhatWeDo/History/ThisWeek/ucm117726.htm|publisher=U.S. Food and Drug Administration|date=May 20, 2009|url-status=dead|archive-url=https://wayback.archive-it.org/7993/20161023232851/https://www.fda.gov/AboutFDA/WhatWeDo/History/ThisWeek/ucm117726.htm|archive-date=October 23, 2016|access-date=June 13, 2014}}</ref> * [[Drug Abuse Control Amendments of 1965]] * [[Medical Device Regulation Act|Medical Device Amendments of 1976]] PL 94–295 (May 28, 1976) * [[Infant Formula Act of 1980]], PL 96–359 (October 26, 1980) * [[Orphan Drug Act]], PL 97–414 (January 4, 1983) * [[Drug Price Competition and Patent Term Restoration Act of 1984]], PL 98–417 (aka Hatch-Waxman) (September 24, 1984) * [[Prescription Drug Marketing Act of 1987]], PL 100–293 (August 18, 1988) * [[Generic Animal Drug and Patent Term Restoration Act of 1988]], PL 100–670 (November 16, 1988) * [[Nutrition Labeling and Education Act of 1990]], PL 101–535 (November 8, 1990) * [[Safe Medical Device Amendments of 1990]], PL 101–629 (November 28, 1990) * [[Medical Device Amendments of 1992]], PL 102–300 (June 16, 1992) * [[Prescription Drug User Fee Act]] (PDUFA) of 1992, PL 102–571 (October 29, 1992) * [[Animal Medicinal Drug Use Clarification Act]] (AMDUCA) of 1994, PL 103–396 (October 22, 1994) * [[Dietary Supplement Health And Education Act of 1994]], PL 103–417 (October 25, 1994) * [[Food Quality Protection Act of 1996]], PL 104–170 (August 3, 1996) * [[Animal Drug Availability Act of 1996]], PL 104–250 (October 9, 1996) * [[Best Pharmaceuticals for Children Act]], PL 107–109 (January 4, 2002) * [[Medical Device User Fee and Modernization Act]] (MDUFMA) of 2002, PL 107–250 (October 26, 2002) * [[Animal Drug User Fee Act of 2003]], PL 108–130 (February 20, 2003) * [[Pediatric Research Equity Act of 2003]], PL 108–155 (December 3, 2003) * [[Minor Use and Minor Species Animal Health Act of 2004]] PL 108–282 (August 2, 2004)<ref>{{cite web|title=S.741 - 108th Congress (2003–2004): Minor Use and Minor Species Animal Health Act of 2003|url=https://www.congress.gov/bill/108th-congress/senate-bill/741|website=Library of Congress|access-date=2018-03-17|date=2 August 2004}}</ref> * [[Food Allergen Labeling and Consumer Protection Act of 2004]], PL 108–282 (August 2, 2004) * [[FDA Food Safety Modernization Act]] (January 4, 2011) * Generic Drug User Fee Amendment of 2012<ref>Staff, FDA. Updated April 18, 2013 [https://web.archive.org/web/20110617045735/http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm Generic Drug User Fee Amendments of 2012]</ref> * [[21st Century Cures Act]], PL 114–255 (December 13, 2016)<ref>{{cite web | title=Limited Population Pathway for Antibacterial and Antifungal Drugs – the LPAD Pathway | website=U.S. [[Food and Drug Administration]] (FDA) | date=13 December 2016 | url=http://www.fda.gov/drugs/development-resources/limited-population-pathway-antibacterial-and-antifungal-drugs-lpad-pathway | archive-url=https://web.archive.org/web/20200313213822/https://www.fda.gov/drugs/development-resources/limited-population-pathway-antibacterial-and-antifungal-drugs-lpad-pathway | url-status=dead | archive-date=March 13, 2020 | access-date=13 March 2020}}</ref><ref>{{cite web | title=21st Century Cures Act | website=U.S. [[Food and Drug Administration]] (FDA) | date=13 December 2016 | url=http://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act | archive-url=https://web.archive.org/web/20190726230730/https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act | url-status=dead | archive-date=July 26, 2019 | access-date=13 March 2020}}</ref><ref>{{cite web | url=https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf | title=21st Century Cures Act | id=Public Law 114–255 }}</ref> * [[FDA Reauthorization Act of 2017]], PL 115–52 (August 18, 2017)<ref>{{cite web | url=https://www.congress.gov/115/plaws/publ52/PLAW-115publ52.pdf | title=FDA Reauthorization Act of 2017 | id=Public Law 115–52 }}</ref>

Other laws:<ref>{{cite web|title=Other Laws Affecting FDA|date=3 November 2018|url=https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/OtherLaws/default.htm|archive-url=https://web.archive.org/web/20170404011441/https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/OtherLaws/default.htm|url-status=dead|archive-date=April 4, 2017|publisher=U.S. Food and Drug Administration}}</ref> * [[Biologics Control Act|Biologics Control Act of 1902]] (repealed; for historical reference) * [[Federal Food and Drugs Act of 1906]] (repealed; for historical reference) * [[Federal Meat Inspection Act]] (March 4, 1907) * [[Federal Trade Commission Act]] (September 26, 1914) * [[Filled Milk Act]] (March 4, 1923) * [[Import Milk Act]] (February 15, 1927) * [[Public Health Service Act]] (July 1, 1944) * [[Trademark Act of 1946]] (July 5, 1946) * [[Reorganization Plan 1 of 1953]] (March 12, 1953) * [[Poultry Products Inspection Act]] (August 28, 1957) * [[Fair Packaging and Labeling Act]] (November 3, 1966) * [[The National Environmental Policy Act of 1969]] (January 1, 1970) * [[Controlled Substances Act]] (October 27, 1970) * [[Controlled Substances Import and Export Act]] (October 27, 1970) * [[Egg Products Inspection Act]] (December 29, 1970) * [[Lead-Based Paint Poisoning Prevention Act]] (January 13, 1971) * [[Federal Advisory Committee Act]] (October 6, 1972) * [[Government in the Sunshine Act]] (September 13, 1976) * [[Government Patent Policy Act of 1980]] (December 12, 1980) * [[Federal Anti-Tampering Act]] (October 13, 1983) * [[Sanitary Food Transportation Act]] (November 3, 1990) * [[Food and Drug Administration Revitalization Act]] (November 28, 1990) * [[Mammography Quality Standards Act]] (MQSA) (October 27, 1992) * [[Food and Drug Administration Modernization Act]] (November 21, 1997) * [[Bioterrorism Act of 2002]] (June 12, 2002) * [[Project BioShield Act of 2004]] (July 21, 2004) * [[Food and Drug Administration Amendments Act of 2007]] (September 27, 2007) * [[Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (H.R. 307; 113th Congress)]] {{uspl|113|5}} (March 13, 2013)

== Comparison to state laws == Some US states have adopted the FD&C Act as an equivalent state law and will by default adopt any changes to the Federal law as changes to the state law as well.{{citation needed|date=February 2017}} * [[California Safe Cosmetics Act of 2005]]

== See also == * [[Drugs in the United States]] * [[Center for Food Safety and Applied Nutrition|Food Administration]] * [[Food Quality Protection Act]] * [[Kefauver Harris Amendment]] * [[List of food additives]] * [[Office of Criminal Investigations]] * [[Pure Food and Drug Act]] * [[Regulation of therapeutic goods]] * ''[[100,000,000 Guinea Pigs]]'' (c. 1933 book which influenced passage of this Act)

== References == {{Reflist|2}}

== External links == * [https://www.law.cornell.edu/uscode/text/21/chapter-9 As codified in 21 U.S.C. chapter 9] of the [[United States Code]] from the [[Legal Information Institute|LII]] * [https://uscode.house.gov/browse/prelim@title21/chapter9&edition=prelim As codified in 21 U.S.C. chapter 9] of the [[United States Code]] from the [[United States House of Representatives|US House of Representatives]] * [https://www.govinfo.gov/content/pkg/COMPS-973/uslm/COMPS-973.xml Federal Food, Drug, and Cosmetic Act] ([https://www.govinfo.gov/content/pkg/COMPS-973/pdf/COMPS-973.pdf PDF]/[https://www.govinfo.gov/app/details/COMPS-973/ details]) as amended in the [[United States Government Publishing Office|GPO]] [https://www.govinfo.gov/help/comps Statute Compilations collection] * [https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=ColorAdditives Color Additive Status List] * [https://web.archive.org/web/20090607082742/http://www.fda.gov/Food/FoodIngredientsPackaging/ucm094211.htm Food Ingredients and Colors] * [https://archive.today/19961019012004/http://www.fda.gov/cdrh/510khome.html Information on Releasable 510(k)s] at the FDA

[[Category:75th United States Congress]] [[Category:United States federal health legislation|Food, Drug, and Cosmetic Act]] [[Category:Pharmaceuticals policy]] [[Category:Cosmetics law]] [[Category:Food law]] [[Category:Food and Drug Administration]] [[Category:Drug policy of the United States]] [[Category:1938 in American law]] [[Category:Food safety in the United States]]