Introduced in the Senate as S. 5 by Royal Copeland (D–NY) on January 6, 1937
Passed the Senate on March 9, 1937 (voice)
Passed the House with amendment on June 1, 1938 (voice)
Reported by the joint conference committee on June 10, 1938; agreed to by the Senate on June 10, 1938 (voice) and by the House on June 13, 1938 (voice)
The United States 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 U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford.[2] A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York.[3] 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.[4] The act has been amended many times, most recently to add requirements about bioterrorism preparations.
This section contains both 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.
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"[9]
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 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.[10] 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.[11]
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.[citation needed]
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."[14] The full definition can be found in Section 201(s) of the FD&C Act, which provides for any additional exclusions.[15]
Homeopathic medications
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.[16]
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.[17]
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.[18][19][20]
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.[21] However, the FDA does not have the authority to order recalls of cosmetics.[22][23] 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.[21] The FDA can and does inspect cosmetics manufacturing facilities to ensure that cosmetics are not adulterated.[21]
On May 28, 1976, the FD&C Act was amended to include regulation for medical devices.[24] The 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 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.[25][26]
Premarket notification (510(k), PMN)
Section 510(k)[27] 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.[citation needed]
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.[28] This may lead to a reevaluation of FDA procedures and better oversight.[citation needed]
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.[29]
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.[30] Because the PMA requires a clinical trial it is significantly more expensive than a 510(k).[31]: 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.[32][33]
Vitamin-Mineral Amendment ("Proxmire Amendment") (April 22, 1976) prohibited the FDA from establishing standards to limit the potency of vitamins and minerals in food supplements or regulating them as drugs based solely on their potency.[35]
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]
^"Charles Crawford". Food & Drug Administration. Archived from the original on November 15, 2017. Retrieved September 26, 2017.{{cite web}}: CS1 maint: unfit URL (link)
^[1] F.D.A. webpage "Food Ingredients and Packaging Terms" Page Last Updated: 02/28/2013
^[2] 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
Map all coordinates using: OpenStreetMap Download coordinates as: KML GPX (all coordinates) GPX (primary coordinates) GPX (secondary coordinates) This is a list of public art in Victoria, a district in the City of Westminster, London. Victoria is roughly described as the area around Victoria station. It includes the conservation areas of Broadway and Christchurch Gardens, Grosvenor Gardens and the environs of Westminster Cathedral. Particularly noteworthy examples of architectural sculpture c...
Brigada de Bomberos de París (BSPP) Logo de la BSPPInformación generalFundación: 1793Ámbito de actuación: París y departamentos 92, 93 y 94 (fundamentalmente) Sede: ParísParques de bomberos: 76Parque móvil: más de un centenarWeb: [1][editar datos en Wikidata] Intervención de la BSPP en 1900. Autobomba en el Salón del Automóvil de París en 1903. La Brigada de Bomberos de París en el desfile del 14 de julio de 2003. Autoescala automática en una intervención. Brigada de...
Jafafe Administração: Infraestruturas de Portugal (norte)[1] Linha(s): Ramal de Aveiro Altitude: 20 m (a.n.m) Coordenadas: 40°40′1.63″N × 8°27′39.35″W (=+40.66712;−8.46093) Localização na rede (mais mapas: 40° 40′ 01,63″ N, 8° 27′ 39,35″ O; IGeoE) Concelho: Águeda Inauguração: [quando?] Encerramento: sim[quando?] A Paragem de Jafafe foi uma gare ferroviária do Ramal de Aveiro, que servia as aldeias de Jafafe de Cima e Jafafe...
Blinky Palermo (1970) (Porträt von Lothar Wolleh) Blinky Palermo, eigentlich Peter Heisterkamp (* 2. Juni 1943 in Leipzig; † 17. Februar 1977 in Vihamanaafushi, Malediven) war ein deutscher Maler, Environment- und Objektkünstler. Inhaltsverzeichnis 1 Leben 1.1 Kindheit und Ausbildung 1.2 Düsseldorf, New York, Düsseldorf 2 Werk 3 Einschätzung 4 Ausstellungen und Retrospektiven 5 Werke 6 Blinky Palermo Stipendium 7 Literatur 8 Weblinks 9 Einzelnachweise Leben Kindheit und Ausbildung Pale...
Чемпіонат УРСР з легкої атлетики 1973 Чемпіонат УРСР з легкої атлетики 1973Загальна інформаціяМісто Київ← 1972 Харків 1974 Львів → Чемпіонат УРСР з легкої атлетики 1973 року був проведений у Києві. Характерним для чергового чемпіонату УРСР було те, що проводився паралельний...
Een autocoureur in 1965 (Denny Hulme) Ayrton Senna, Formule 1 autocoureur in 1988 Een autocoureur is een sporter die in de autosport de raceauto bestuurt tijdens een wedstrijd of kampioenschap. Verschillende disciplines als rally, Formule 1 en andere snelheidsraces of uithoudingsraces in de autosport vragen verschillende kwaliteiten van de betrokken autocoureurs. Zie ook Lijst van Formule 1-coureurs
مصطفى دياو معلومات شخصية الميلاد 31 ديسمبر 1996 (العمر 26 سنة)نواكشوط الطول 1.68 م (5 قدم 6 بوصة) مركز اللعب مدافع الجنسية موريتانيا معلومات النادي النادي الحالي نواذيبو مسيرة الشباب سنوات فريق –2014 جمعية الوئام المسيرة الاحترافية1 سنوات فريق م. (هـ.) 2014–2017 جمعية الوئ...
Building in Kabukichō, Shinjuku, Tokyo, Japan You can help expand this article with text translated from the corresponding article in Japanese. (November 2019) Click [show] for important translation instructions. Consider adding a topic to this template: there are already 3,646 articles in the main category, and specifying|topic= will aid in categorization. Do not translate text that appears unreliable or low-quality. If possible, verify the text with references provided in the...
New Japan Aviation新日本航空Shin Nihon Kōkū IATA ICAO Kode panggil -- NJA SHIN NIHON DidirikanJuli 1969Armada5Tujuan2Kantor pusatBandar Udara Kagoshima, JepangSitus webnewj.co.jp New Japan Aviation (新日本航空code: ja is deprecated , Shin Nihon Kōkū), juga dikenal sebagai Shinnikkō (新日航code: ja is deprecated ) atau NJA, adalah perusahaan layanan penerbangan Jepang yang mengoperasikan layanan penerbangan berjadwal antara Niigata dan Pulau Sado, serta pelatihan penerbangan ...
American football player (born 1998) For the American mixed martial artist, see Devonte Smith. American football player DeVonta SmithSmith with the Eagles in 2021No. 6 – Philadelphia EaglesPosition:Wide receiverPersonal informationBorn: (1998-11-14) November 14, 1998 (age 25)Amite City, Louisiana, U.S.Height:6 ft 0 in (1.83 m)Weight:170 lb (77 kg)Career informationHigh school:Amite (LA)College:Alabama (2017–2020)NFL Draft:2021 / Round: 1 / Pick...
Canadian TV series or program Knights of BloodsteelWritten bySam EganDirected byPhillip SpinkCountry of originCanadaUnited StatesOriginal languageEnglishNo. of episodes2Original releaseNetworkSyFy Knights of Bloodsteel is a 2009 television miniseries, produced by Reunion Pictures. RHI Entertainment distributed the project internationally. It originally aired on April 19, 2009 on SyFy.[1] Plot In the faraway land of Mirabilis, the warlord Dragon-Eye has unleashed his terrifying fo...
This article needs additional citations for verification. Please help improve this article by adding citations to reliable sources. Unsourced material may be challenged and removed.Find sources: Polokwane City F.C. – news · newspapers · books · scholar · JSTOR (August 2023) (Learn how and when to remove this template message) Association football club Football clubPolokwane City F.C.Full namePolokwane City Football ClubFounded2012; 11 year...
This is a list of museums, galleries, and related building structures in Pakistan. Museums and galleries View of entrance to Lahore Museum Front view of National Museum of Pakistan, Karachi Archaeological and historical museums Harappa Museum, Harappa Bahawalpur Museum, Bahawalpur Bannu Museum, Bannu Chitral Museum City Museum, Gorkhatri, Peshawar Dir Museum, Chakdara Hund Museum, Swabi Kasur Museum, Kasur Kalasha Dur Museum, Chitral Lahore Museum, Lahore Lok Virsa Museum, Islamabad Lyallpur ...
هذه المقالة عن قرية الفاو الأثرية بالمملكة العربية السعودية. لمعانٍ أخرى، طالع الفاو (توضيح). قرية الفاورأس من البرونز يعود إلى سيدة عربية من القرن الأول ق م وجد في قرية الفاومعلومات عامةنوع المبنى قرية تاريخيةالمكان محافظة السليل، منطقة الرياضالمنطقة الإدارية منط...
Species of mammal Ovis dalli ram eweboth in Denali National Park in Alaska Conservation status Least Concern (IUCN 3.1)[1] Scientific classification Domain: Eukaryota Kingdom: Animalia Phylum: Chordata Class: Mammalia Order: Artiodactyla Family: Bovidae Subfamily: Caprinae Tribe: Caprini Genus: Ovis Species: O. dalli Binomial name Ovis dalliNelson, 1884 Subspecies O. d. dalli O. d. stonei Ovis dalli, also known as the Dall sheep or thinhorn sheep, is a species of wild sheep ...
Запрос «Движение Сопротивления» перенаправляется сюда; см. также другие значения. У этой статьи надо проверить нейтральность. На странице обсуждения должны быть подробности. В статье не хватает ссылок на источники (см. рекомендации по поиску). Информация должна быть п...
German painter You can help expand this article with text translated from the corresponding article in German. (September 2017) Click [show] for important translation instructions. Machine translation, like DeepL or Google Translate, is a useful starting point for translations, but translators must revise errors as necessary and confirm that the translation is accurate, rather than simply copy-pasting machine-translated text into the English Wikipedia. Consider adding a topic to this tem...
Public high school in Dearborn, Michigan, United StatesFordson High SchoolAddress13800 Ford RoadDearborn, Michigan 48126United StatesCoordinates42°19′48″N 83°10′44″W / 42.33°N 83.179°W / 42.33; -83.179InformationTypePublic High SchoolEstablished1922School districtDearborn Public SchoolsPrincipalHeyam AlcodrayFaculty134.60 (FTE)[1]Grades9-12Enrollment2,756 (2018–19)[1]Student to teacher ratio20.48[1]CampusSuburbanColor(s)Maize and B...