38:
2404:
895:, 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. This may lead to a reevaluation of FDA procedures and better oversight.
796:
marketing of adulterated or misbranded cosmetics. However, the FDA does not have the authority to order recalls of cosmetics. 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. The FDA can and does inspect cosmetics manufacturing facilities to ensure that cosmetics are not adulterated.
740:
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." The full definition can be found in
1752:
875:
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
739:
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
563:
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. Color additives derived from natural sources, such
932:
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.
795:
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
852:
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
730:
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.
494:
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
879:
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
1749:
1309:
907:
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. Because the PMA requires a
564:
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.
755:
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.
903:
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.
2657:
1774:
883:
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.
767:
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.
1884:
463:
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
1019:
258:
1771:
1584:"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"
1704:"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"
1885:"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)"
2423:
2326:
1895:
1667:
925:
741:
294:
853:
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
1859:
1303:
1067:
300:
282:
252:
1969:
1798:
928:
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
868:
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
2696:
2418:
2393:
367:, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the
1336:
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.
1273:
892:
276:
2358:
1285:
2642:
1213:
1091:
234:
228:
1430:
2368:
2353:
1357:
1037:
2132:
2652:
2464:
1725:
1061:
2069:
1490:
2383:
2319:
2280:
1891:
1669:
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
2731:
2721:
2026:
1703:
306:
2363:
1025:
1031:
2037:
1115:
2263:
1043:
270:
2009:"De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration Staff"
1981:
1506:
2716:
2312:
1340:
1085:
2691:
2428:
2008:
1109:
264:
375:
investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about
48:
To prohibit the movement in interstate commerce of adulterated and misbranded food, drugs, devices, and cosmetics, and for other purposes.
1073:
1583:
880:
composition, energy source, manufacturing process, or intended use, the device nominally must go through a premarket approval, or PMA.
2488:
1153:
483:
368:
142:
129:
1817:
2433:
2388:
1377:
1279:
1121:
321:
1996:
1225:
845:
170:
2701:
2162:
1387:
1237:
1207:
1201:
468:, but this is often interpreted broadly and few products other than raw produce are considered outside of the scope of the act.
240:
100:
92:
2670:
2438:
2378:
1249:
1243:
1055:
359:, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was
1103:
996:
2726:
2531:
1452:
1297:
1255:
1079:
1001:
815:
360:
316:
246:
2521:
2335:
2168:
2138:
1591:
1561:
1165:
476:
372:
352:
1679:
1049:
2373:
2250:
1362:
1267:
1159:
1097:
288:
70:
2288:
1841:
1136:
2226:
989:") (April 22, 1976) prohibited the FDA from establishing standards to limit the potency of vitamins and minerals in
840:. These tend to be devices that are permanently implanted into a human body or may be necessary to sustain life. An
829:
Class II: Devices that are cleared using the 510(k) process. Diagnostic tests, cardiac catheters, hearing aids, and
2576:
1352:
1312:
1195:
1007:
1635:
1613:
2647:
2516:
1367:
1231:
1219:
1183:
979:
968:
854:
1656:
1261:
37:
1487:
1291:
946:
764:
311:
2255:
783:, spring water), and regulations covering water processing and bottling, water quality and product labeling.
2506:
1393:
2120:
2706:
2443:
2055:
1382:
1372:
1130:
398:
348:
119:
1562:"Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices"
2601:
1324:
1189:
1147:
986:
480:
210:
2073:
822:
Class I: Devices that do not require premarket approval or clearance but must follow general controls.
2556:
1177:
837:
383:
2304:
2571:
2268:
830:
779:
is regulated by the FDA as a food. The Agency has published identity standards for types of water (
17:
2293:
2272:
2551:
2546:
2259:
2246:
2192:
1684:
592:
443:
136:
1931:
1736:
1321:
2209:
2095:
2711:
2536:
1997:
FDA Impact on US Medical Device
Innovation – A Survey of Over 200 Medical Technology Companies
1951:
1872:
1732:
1446:
682:
559:
additives, such as "FD&C Yellow No. 6". The Act made the certification of some food color
394:
364:
166:
836:
Class III: Devices that are approved by the premarket approval (PMA) process, analogous to a
2606:
2581:
2541:
2476:
1943:
1310:
Pandemic and All-Hazards
Preparedness Reauthorization Act of 2013 (H.R. 307; 113th Congress)
841:
472:
174:
2096:"S.741 - 108th Congress (2003–2004): Minor Use and Minor Species Animal Health Act of 2003"
1539:
UNITED STATES V. PARK, 421 U. S. 658 (1975) – US Supreme Court Cases from Justia & Oyez
2596:
2511:
1778:
1756:
1494:
1171:
1013:
990:
972:
942:
888:
811:
509:
465:
382:
The introduction of this act was influenced by the death of more than 100 patients due to
1799:"FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated"
1527:
555:
The FD&C Act is perhaps best known to consumers because of its use in the naming of
2616:
2591:
2586:
2561:
2526:
2242:
909:
869:
805:
622:
607:
434:
146:
2133:"Limited Population Pathway for Antibacterial and Antifungal Drugs – the LPAD Pathway"
1414:
848:. Devices that do not meet either criterion are generally cleared as class II devices.
2685:
2626:
2611:
2566:
2339:
1549:
780:
776:
652:
560:
556:
387:
2658:
Regulation of food and dietary supplements by the U.S. Food and Drug
Administration
2621:
1992:
1772:"21 CFR 165.110 – Requirements for Specific Standardized Beverages: Bottled Water."
1658:
F.D.A. webpage "Food
Ingredients and Packaging Terms" Page Last Updated: 02/28/2013
1476:
823:
711:
460:
376:
85:
1947:
1538:
2276:
2027:"Secrets Of The De Novo Pathway, Part 1: Why Aren't More Device Makers Using It?"
1433:. Food & Drug Administration. Archived from the original on November 15, 2017
529:
704 allows inspections of regulated entities. Inspection results are reported on
950:
637:
456:
422:
356:
1465:
397:
was used to dissolve the drug and make a liquid form. It replaced the earlier
975:(PL) 82–215 (October 26, 1951) created prescription-only status for some drugs
752:
667:
792:
1955:
818:
required that all medical devices be classified into one of three classes:
371:(DESI) to incorporate into FD&C regulations the recommendations from a
2298:
1918:
844:
meets both criteria. The most commonly recognized class III device is an
696:
530:
2038:"Secrets Of The De Novo Pathway Part 2 Is De Novo Right For Your Device"
810:
On May 28, 1976, the FD&C Act was amended to include regulation for
104:
760:
486:
cases. It is one of a very small number of criminal statutes that does.
391:
53:
1750:"21 CFR Part 129 – Processing and Bottling of Bottled Drinking Water."
2283:
1690:
Section 321, subsection (g), paragraph (1), subparagraph (A) thereof.
744:
of the FD&C Act, which provides for any additional exclusions.
2072:. U.S. Food and Drug Administration. May 20, 2009. Archived from
953:
of all products regulated by FDA, other than prescription drugs.
514:
515 is the description of the (class III) device approval process
428:
2308:
1509:. U.S. Department of Health and Human Services. 3 November 2018
421:
201(f) is the definition for a food, which explicitly includes
1466:
Homeopathic Drugs, Royal
Copeland, and Federal Drug Regulation
1020:
Drug Price Competition and Patent Term Restoration Act of 1984
259:
Drug Price Competition and Patent Term Restoration Act of 1984
1818:"Johnson & Johnson and a New War on Consumer Protection"
508:
510(k) is the section that allows for clearance of class II
1032:
Generic Animal Drug and Patent Term Restoration Act of 1988
1116:
Food Allergen Labeling and Consumer Protection Act of 2004
993:
or regulating them as drugs based solely on their potency.
961:
Descriptions of these can be found at the FDA's web site.
1636:"Code of Federal Regulations: Title 21, Section 74.302"
1614:"Code of Federal Regulations: Title 21, Section 74.250"
926:
Food and Drug Administration Modernization Act of 1997
295:
Food and Drug Administration Modernization Act of 1997
2229:. U.S. Food and Drug Administration. 3 November 2018.
1932:"Medical Device Recalls and the FDA Approval Process"
1871:
Duff Wilson for the New York Times. January 28, 2011
1507:"Federal Food, Drug, and Cosmetic Act (FD&C Act)"
1110:
Minor Use and Minor Species Animal Health Act of 2004
1680:"21 USC Ch. 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT"
2635:
2499:
2483:
2471:
2459:
2452:
2411:
2346:
2058:. U.S. Food and Drug Administration. 19 April 2021.
1397:(c. 1933 book which influenced passage of this Act)
1304:
Food and Drug Administration Amendments Act of 2007
1068:
Dietary Supplement Health And Education Act of 1994
1022:, PL 98–417 (aka Hatch-Waxman) (September 24, 1984)
505:
505 is the description of the drug approval process
301:
Food and Drug Administration Amendments Act of 2007
253:
Radiation Control for Health and Safety Act of 1968
220:
153:
135:
125:
115:
110:
91:
81:
76:
65:
52:
44:
1313:
912:it is significantly more expensive than a 510(k).
2465:Title 21 of the Code of Federal Regulations (CFR)
2419:Family Smoking Prevention and Tobacco Control Act
2394:Office of Global Regulatory Operations and Policy
1528:United States v. Dotterweich, 320 U.S. 277 (1943)
1274:Food and Drug Administration Revitalization Act
1094:(MDUFMA) of 2002, PL 107–250 (October 26, 2002)
1064:(AMDUCA) of 1994, PL 103–396 (October 22, 1994)
893:National Research Center for Women and Families
277:Food and Drug Administration Revitalization Act
1919:US FDA/CDRH: Information on Releasable 510(k)s
1286:Food and Drug Administration Modernization Act
1058:(PDUFA) of 1992, PL 102–571 (October 29, 1992)
2643:Criticism of the Food and Drug Administration
2320:
1214:The National Environmental Policy Act of 1969
1092:Medical Device User Fee and Modernization Act
235:1962 Food, Drug, and Cosmetics Act Amendments
229:1951 Food, Drug, and Cosmetics Act Amendments
8:
2369:Center for Food Safety and Applied Nutrition
2354:Center for Biologics Evaluation and Research
1038:Nutrition Labeling and Education Act of 1990
31:Federal Food, Drug, and Cosmetic Act of 1938
30:
2653:History of the Food and Drug Administration
2489:Title 21 of the United States Code (U.S.C.)
2070:"This Week In FDA History - April 22, 1976"
1873:F.D.A. Panel Is Split on Electroshock Risks
1415:Food, Drug, and Cosmetic Law Research Guide
1226:Controlled Substances Import and Export Act
1062:Animal Medicinal Drug Use Clarification Act
857:, which the FDA started reviewing in 2011.
439:201(s) is the definition of a food additive
283:Dietary Supplement Health and Education Act
2456:
2384:National Center for Toxicological Research
2359:Center for Devices and Radiological Health
2327:
2313:
2305:
1892:United States Food and Drug Administration
1724:Posnick, Lauren M. and Kim, Henry (2002).
193:Reported by the joint conference committee
1982:21 U.S.C. § 360e. Premarket approval
1238:Lead-Based Paint Poisoning Prevention Act
495:ordinarily render it injurious to health"
199:on June 10, 1938 (voice) and by the
2697:United States federal health legislation
2121:Generic Drug User Fee Amendments of 2012
1995:, Aabed Meer, lyn Denend. November 2010
571:
307:Over-the-Counter Hearing Aid Act of 2017
2364:Center for Drug Evaluation and Research
1726:"Bottled Water Regulation and the FDA."
1406:
1127:Generic Drug User Fee Amendment of 2012
1026:Prescription Drug Marketing Act of 1987
957:Significant amendments and related laws
1444:
1044:Safe Medical Device Amendments of 1990
271:Safe Medical Device Amendments of 1990
29:
1793:
1791:
1789:
1341:California Safe Cosmetics Act of 2005
1104:Pediatric Research Equity Act of 2003
1086:Best Pharmaceuticals for Children Act
997:Drug Abuse Control Amendments of 1965
759:However, under separate authority of
363:. A principal author of this law was
351:in 1938 giving authority to the U.S.
7:
2429:Federal Food, Drug, and Cosmetic Act
2269:Federal Food, Drug, and Cosmetic Act
2036:Drues, Michael (February 18, 2014).
1256:Government Patent Policy Act of 1980
1156:(repealed; for historical reference)
1150:(repealed; for historical reference)
1080:Animal Drug Availability Act of 1996
861:Premarket notification (510(k), PMN)
333:Federal Food, Drug, and Cosmetic Act
265:Nutrition Labeling and Education Act
2119:Staff, FDA. Updated April 18, 2013
2025:Drues, Michael (February 5, 2014).
1638:. U.S. Food and Drug Administration
1616:. U.S. Food and Drug Administration
1564:. U.S. Food and Drug Administration
1074:Food Quality Protection Act of 1996
806:Medical device § United States
452:III. Prohibited Acts and Penalties
18:Federal Food, Drug and Cosmetic Act
2256:As codified in 21 U.S.C. chapter 9
2243:As codified in 21 U.S.C. chapter 9
1702:Press Release (15 November 2016).
1318:Tooltip Public Law (United States)
1154:Federal Food and Drugs Act of 1906
369:Drug Efficacy Study Implementation
27:Acts of the United States Congress
25:
2389:Office of Criminal Investigations
2299:Information on Releasable 510(k)s
2210:"FDA Reauthorization Act of 2017"
1842:"FDA Recall Policy for Cosmetics"
1378:Office of Criminal Investigations
1280:Mammography Quality Standards Act
1122:FDA Food Safety Modernization Act
1050:Medical Device Amendments of 1992
1002:Medical Device Amendments of 1976
916:Automatic Class III designation (
833:are examples of class II devices.
347:) is a set of laws passed by the
322:Microbead-Free Waters Act of 2015
285:(1994), PL 103-417, 108 Stat 4332
279:(1990), PL 101-635, 104 Stat 4583
267:(1990), PL 101-535, 104 Stat 2353
2732:Food safety in the United States
2722:Drug policy of the United States
2402:
1488:ASHP Website : News Article
1268:Sanitary Food Transportation Act
1133:, PL 114–255 (December 13, 2016)
1100:, PL 108–130 (February 20, 2003)
1098:Animal Drug User Fee Act of 2003
1046:, PL 101–629 (November 28, 1990)
1034:, PL 100–670 (November 16, 1988)
846:automated external defibrillator
36:
2284:Statute Compilations collection
1972:, last updated January 24, 2012
1588:Laws, Regulations, and Guidance
1388:Regulation of therapeutic goods
1208:Fair Packaging and Labeling Act
1202:Poultry Products Inspection Act
1137:FDA Reauthorization Act of 2017
1106:, PL 108–155 (December 3, 2003)
1070:, PL 103–417 (October 25, 1994)
1040:, PL 101–535 (November 8, 1990)
982:") PL 87–781 (October 10, 1962)
471:Notably, the FD&C Act uses
442:201(ff) is the definition of a
433:201(h) is the definition for a
427:201(g) is the definition for a
241:Fair Packaging and Labeling Act
187:Passed the House with amendment
2671:Commissioner of Food and Drugs
2453:Title 21 regulations and rules
2439:Prescription Drug User Fee Act
2379:Center for Veterinary Medicine
1250:Government in the Sunshine Act
1244:Federal Advisory Committee Act
1088:, PL 107–109 (January 4, 2002)
1082:, PL 104–250 (October 9, 1996)
1056:Prescription Drug User Fee Act
1028:, PL 100–293 (August 18, 1988)
1010:, PL 96–359 (October 26, 1980)
945:, passed in 1938, granted the
409:The FDC Act has ten chapters:
165:in the Senate as S. 5 by
1:
2434:Food Safety Modernization Act
1948:10.1001/archinternmed.2011.30
1936:Archives of Internal Medicine
1298:Project BioShield Act of 2004
1196:Reorganization Plan 1 of 1953
1148:Biologics Control Act of 1902
1139:, PL 115–52 (August 18, 2017)
1118:, PL 108–282 (August 2, 2004)
1076:, PL 104–170 (August 3, 1996)
1016:, PL 97–414 (January 4, 1983)
317:Drug Quality and Security Act
247:Medical Device Regulation Act
203:on June 13, 1938 (voice)
183:on March 9, 1937 (voice)
2717:Food and Drug Administration
2336:Food and Drug Administration
2169:Food and Drug Administration
2139:Food and Drug Administration
1782:Code of Federal Regulations.
1760:Code of Federal Regulations.
1592:Food and Drug Administration
1166:Federal Trade Commission Act
1052:, PL 102–300 (June 16, 1992)
985:Vitamin-Mineral Amendment ("
719:Restricted to specific uses
704:Restricted to specific uses
373:National Academy of Sciences
353:Food and Drug Administration
189:on June 1, 1938 (voice)
2692:75th United States Congress
2374:Center for Tobacco Products
2294:Food Ingredients and Colors
2264:US House of Representatives
1862:Last updated April 26, 2009
1363:Food Quality Protection Act
1232:Egg Products Inspection Act
1160:Federal Meat Inspection Act
1112:PL 108–282 (August 2, 2004)
735:Definition of food additive
455:This section contains both
390:medication where the toxic
297:, PL 105-115, 111 Stat 2296
289:Food Quality Protection Act
273:, PL 101-629, 104 Stat 4511
71:75th United States Congress
2748:
2289:Color Additive Status List
2227:"Other Laws Affecting FDA"
1353:Drugs in the United States
1262:Federal Anti-Tampering Act
1008:Infant Formula Act of 1980
978:Drug Efficacy Amendment ("
803:
2666:
2648:FDA Most Wanted Fugitives
2424:Modernization Act of 1997
2400:
1930:Zuckerman, Diana (2011).
1860:PMA Historical Background
1816:Cep, Casey (2022-09-12).
1451:: CS1 maint: unfit URL (
1368:Kefauver Harris Amendment
1282:(MQSA) (October 27, 1992)
1220:Controlled Substances Act
1184:Public Health Service Act
980:Kefauver Harris Amendment
969:Durham-Humphrey Amendment
949:the authority to oversee
855:electroconvulsive therapy
540:VIII. Imports and Exports
303:, PL 110-85, 121 Stat 823
261:, PL 98-471, 98 Stat 1585
255:, PL 90-602, 82 Stat 1173
243:, PL 89–755, 80 Stat 1296
225:
158:
130:21 U.S.C.: Food and Drugs
35:
2193:"21st Century Cures Act"
2163:"21st Century Cures Act"
2014:. FDA. October 30, 2017.
1970:Premarket Approval (PMA)
1332:Comparison to state laws
1292:Bioterrorism Act of 2002
1004:PL 94–295 (May 28, 1976)
947:Federal Trade Commission
899:Premarket approval (PMA)
876:be properly identified.
765:Federal Trade Commission
312:Sunscreen Innovation Act
249:, PL 94–295, 90 Stat 539
237:, PL 87–781, 76 Stat 780
231:, PL 82–215, 65 Stat 648
2042:www.meddeviceonline.com
1731:August/September 2002.
1550:FD&C Act Chapter IV
1394:100,000,000 Guinea Pigs
748:Homeopathic medications
524:VII. General Authority
197:agreed to by the Senate
2702:Pharmaceuticals policy
2444:Pure Food and Drug Act
2056:"Laws Enforced by FDA"
1419:Georgetown Law Library
1383:Pure Food and Drug Act
1373:List of food additives
1131:21st Century Cures Act
891:and Paul Brown of the
679:FD&C Yellow No. 6
664:FD&C Yellow No. 5
399:Pure Food and Drug Act
349:United States Congress
120:Pure Food and Drug Act
2602:Andrew von Eschenbach
2477:Federal Register (FR)
2198:. Public Law 114–255.
1190:Trademark Act of 1946
804:Further information:
619:FD&C Green No. 3
500:V. Drugs and Devices
355:(FDA) to oversee the
211:Franklin D. Roosevelt
2727:1938 in American law
2557:Alexander M. Schmidt
2279:) as amended in the
2215:. Public Law 115–52.
1306:(September 27, 2007)
1252:(September 13, 1976)
1168:(September 26, 1914)
838:New Drug Application
826:is a class I device.
649:FD&C Red No. 40
604:FD&C Blue No. 2
589:FD&C Blue No. 1
543:IX. Tobacco Products
384:elixir sulfanilamide
177:) on January 6, 1937
2636:Society and culture
2572:Arthur H. Hayes Jr.
2532:Charles W. Crawford
2100:Library of Congress
2076:on October 23, 2016
1358:Food Administration
1288:(November 21, 1997)
1276:(November 28, 1990)
1258:(December 12, 1980)
1234:(December 29, 1970)
1180:(February 15, 1927)
937:Related legislation
634:FD&C Red No. 3
361:Charles W. Crawford
154:Legislative history
61:FFDCA, FD&C Act
32:
2552:Charles C. Edwards
2522:Walter G. Campbell
2460:Administrative law
2260:United States Code
2247:United States Code
2173:. 13 December 2016
2143:. 13 December 2016
1777:2009-09-07 at the
1755:2009-09-26 at the
1685:United States Code
1493:2007-09-27 at the
1431:"Charles Crawford"
1270:(November 3, 1990)
1264:(October 13, 1983)
1240:(January 13, 1971)
1228:(October 27, 1970)
1222:(October 27, 1970)
1210:(November 3, 1966)
987:Proxmire Amendment
593:Brilliant blue FCF
568:Certifiable colors
444:dietary supplement
331:The United States
195:on June 10, 1938;
149:§ 301 et seq.
2679:
2678:
2537:George P. Larrick
2517:Charles A. Browne
2495:
2494:
1246:(October 6, 1972)
1216:(January 1, 1970)
1204:(August 28, 1957)
1124:(January 4, 2011)
791:This Act defines
723:
722:
683:Sunset Yellow FCF
395:diethylene glycol
365:Royal S. Copeland
329:
328:
181:Passed the Senate
94:Statutes at Large
16:(Redirected from
2739:
2607:Margaret Hamburg
2582:David A. Kessler
2542:James L. Goddard
2457:
2406:
2405:
2329:
2322:
2315:
2306:
2231:
2230:
2223:
2217:
2216:
2214:
2206:
2200:
2199:
2197:
2189:
2183:
2182:
2180:
2178:
2159:
2153:
2152:
2150:
2148:
2129:
2123:
2117:
2111:
2110:
2108:
2107:
2092:
2086:
2085:
2083:
2081:
2066:
2060:
2059:
2052:
2046:
2045:
2034:
2031:Meddevice Online
2022:
2016:
2015:
2013:
2005:
1999:
1990:
1984:
1979:
1973:
1966:
1960:
1959:
1927:
1921:
1916:
1910:
1909:
1907:
1906:
1900:
1894:. Archived from
1889:
1881:
1875:
1869:
1863:
1856:
1850:
1849:
1838:
1832:
1831:
1829:
1828:
1813:
1807:
1806:
1795:
1784:
1768:
1762:
1746:
1740:
1722:
1716:
1715:
1713:
1711:
1699:
1693:
1692:
1676:
1670:
1665:
1659:
1654:
1648:
1647:
1645:
1643:
1632:
1626:
1625:
1623:
1621:
1610:
1604:
1603:
1601:
1599:
1580:
1574:
1573:
1571:
1569:
1558:
1552:
1547:
1541:
1536:
1530:
1525:
1519:
1518:
1516:
1514:
1503:
1497:
1485:
1479:
1477:CDER – Time Line
1474:
1468:
1463:
1457:
1456:
1450:
1442:
1440:
1438:
1427:
1421:
1411:
1327:(March 13, 2013)
1319:
1315:
1198:(March 12, 1953)
991:food supplements
887:A 2011 study by
842:artificial heart
712:Citrus Red No. 2
572:
546:X. Miscellaneous
473:strict liability
416:II. Definitions
335:(abbreviated as
221:Major amendments
213:on June 25, 1938
139:sections created
95:
58:
40:
33:
21:
2747:
2746:
2742:
2741:
2740:
2738:
2737:
2736:
2682:
2681:
2680:
2675:
2662:
2631:
2597:Lester Crawford
2512:Carl L. Alsberg
2507:Harvey W. Wiley
2491:
2479:
2472:Federal journal
2467:
2448:
2407:
2403:
2398:
2342:
2333:
2239:
2234:
2225:
2224:
2220:
2212:
2208:
2207:
2203:
2195:
2191:
2190:
2186:
2176:
2174:
2161:
2160:
2156:
2146:
2144:
2131:
2130:
2126:
2118:
2114:
2105:
2103:
2102:. 2 August 2004
2094:
2093:
2089:
2079:
2077:
2068:
2067:
2063:
2054:
2053:
2049:
2035:
2024:
2023:
2019:
2011:
2007:
2006:
2002:
1991:
1987:
1980:
1976:
1967:
1963:
1942:(11): 1006–11.
1929:
1928:
1924:
1917:
1913:
1904:
1902:
1898:
1887:
1883:
1882:
1878:
1870:
1866:
1857:
1853:
1840:
1839:
1835:
1826:
1824:
1815:
1814:
1810:
1797:
1796:
1787:
1779:Wayback Machine
1769:
1765:
1757:Wayback Machine
1747:
1743:
1723:
1719:
1709:
1707:
1701:
1700:
1696:
1678:
1677:
1673:
1666:
1662:
1655:
1651:
1641:
1639:
1634:
1633:
1629:
1619:
1617:
1612:
1611:
1607:
1597:
1595:
1582:
1581:
1577:
1567:
1565:
1560:
1559:
1555:
1548:
1544:
1537:
1533:
1526:
1522:
1512:
1510:
1505:
1504:
1500:
1495:Wayback Machine
1486:
1482:
1475:
1471:
1464:
1460:
1443:
1436:
1434:
1429:
1428:
1424:
1412:
1408:
1404:
1349:
1334:
1317:
1300:(July 21, 2004)
1294:(June 12, 2002)
1178:Import Milk Act
1174:(March 4, 1923)
1172:Filled Milk Act
1162:(March 4, 1907)
1014:Orphan Drug Act
959:
943:Wheeler-Lea Act
939:
922:
920:classification)
901:
889:Diana Zuckerman
863:
831:dental amalgams
812:medical devices
808:
802:
800:Medical devices
789:
774:
750:
737:
728:
570:
553:
510:medical devices
466:commerce clause
407:
216:
207:Signed into law
93:
66:Enacted by
56:
28:
23:
22:
15:
12:
11:
5:
2745:
2743:
2735:
2734:
2729:
2724:
2719:
2714:
2709:
2704:
2699:
2694:
2684:
2683:
2677:
2676:
2674:
2673:
2667:
2664:
2663:
2661:
2660:
2655:
2650:
2645:
2639:
2637:
2633:
2632:
2630:
2629:
2624:
2619:
2617:Scott Gottlieb
2614:
2609:
2604:
2599:
2594:
2592:Mark McClellan
2589:
2587:Jane E. Henney
2584:
2579:
2577:Frank E. Young
2574:
2569:
2564:
2562:Donald Kennedy
2559:
2554:
2549:
2547:Herbert L. Ley
2544:
2539:
2534:
2529:
2527:Paul B. Dunbar
2524:
2519:
2514:
2509:
2503:
2501:
2497:
2496:
2493:
2492:
2487:
2485:
2481:
2480:
2475:
2473:
2469:
2468:
2463:
2461:
2454:
2450:
2449:
2447:
2446:
2441:
2436:
2431:
2426:
2421:
2415:
2413:
2409:
2408:
2401:
2399:
2397:
2396:
2391:
2386:
2381:
2376:
2371:
2366:
2361:
2356:
2350:
2348:
2344:
2343:
2334:
2332:
2331:
2324:
2317:
2309:
2303:
2302:
2296:
2291:
2286:
2266:
2253:
2238:
2237:External links
2235:
2233:
2232:
2218:
2201:
2184:
2154:
2124:
2112:
2087:
2061:
2047:
2017:
2000:
1985:
1974:
1961:
1922:
1911:
1876:
1864:
1851:
1833:
1822:The New Yorker
1808:
1785:
1763:
1741:
1717:
1694:
1671:
1660:
1649:
1627:
1605:
1575:
1553:
1542:
1531:
1520:
1498:
1480:
1469:
1458:
1422:
1405:
1403:
1400:
1399:
1398:
1390:
1385:
1380:
1375:
1370:
1365:
1360:
1355:
1348:
1345:
1344:
1343:
1333:
1330:
1329:
1328:
1307:
1301:
1295:
1289:
1283:
1277:
1271:
1265:
1259:
1253:
1247:
1241:
1235:
1229:
1223:
1217:
1211:
1205:
1199:
1193:
1192:(July 5, 1946)
1187:
1186:(July 1, 1944)
1181:
1175:
1169:
1163:
1157:
1151:
1141:
1140:
1134:
1128:
1125:
1119:
1113:
1107:
1101:
1095:
1089:
1083:
1077:
1071:
1065:
1059:
1053:
1047:
1041:
1035:
1029:
1023:
1017:
1011:
1005:
999:
994:
983:
976:
958:
955:
938:
935:
921:
914:
910:clinical trial
900:
897:
870:medical device
866:Section 510(k)
862:
859:
850:
849:
834:
827:
801:
798:
788:
785:
773:
770:
749:
746:
742:Section 201(s)
736:
733:
727:
726:Food additives
724:
721:
720:
717:
714:
709:
706:
705:
702:
699:
694:
691:
690:
688:
685:
680:
676:
675:
673:
670:
665:
661:
660:
658:
655:
650:
646:
645:
643:
640:
635:
631:
630:
628:
625:
623:Fast Green FCF
620:
616:
615:
613:
610:
608:Indigo carmine
605:
601:
600:
598:
595:
590:
586:
585:
582:
579:
576:
569:
566:
552:
549:
548:
547:
544:
541:
538:
537:
536:
535:
534:
522:
519:
518:
517:
516:
515:
512:
506:
498:
497:
496:
489:
488:
487:
469:
450:
449:
448:
447:
446:
440:
437:
435:medical device
431:
425:
414:
413:I. Short Title
406:
403:
379:preparations.
357:safety of food
327:
326:
325:
324:
319:
314:
309:
304:
298:
292:
286:
280:
274:
268:
262:
256:
250:
244:
238:
232:
223:
222:
218:
217:
215:
214:
204:
190:
184:
178:
167:Royal Copeland
159:
156:
155:
151:
150:
140:
133:
132:
127:
126:Titles amended
123:
122:
117:
113:
112:
108:
107:
97:
89:
88:
83:
79:
78:
74:
73:
67:
63:
62:
59:
50:
49:
46:
42:
41:
26:
24:
14:
13:
10:
9:
6:
4:
3:
2:
2744:
2733:
2730:
2728:
2725:
2723:
2720:
2718:
2715:
2713:
2710:
2708:
2707:Cosmetics law
2705:
2703:
2700:
2698:
2695:
2693:
2690:
2689:
2687:
2672:
2669:
2668:
2665:
2659:
2656:
2654:
2651:
2649:
2646:
2644:
2641:
2640:
2638:
2634:
2628:
2627:Robert Califf
2625:
2623:
2620:
2618:
2615:
2613:
2612:Robert Califf
2610:
2608:
2605:
2603:
2600:
2598:
2595:
2593:
2590:
2588:
2585:
2583:
2580:
2578:
2575:
2573:
2570:
2568:
2567:Jere E. Goyan
2565:
2563:
2560:
2558:
2555:
2553:
2550:
2548:
2545:
2543:
2540:
2538:
2535:
2533:
2530:
2528:
2525:
2523:
2520:
2518:
2515:
2513:
2510:
2508:
2505:
2504:
2502:
2500:Commissioners
2498:
2490:
2486:
2482:
2478:
2474:
2470:
2466:
2462:
2458:
2455:
2451:
2445:
2442:
2440:
2437:
2435:
2432:
2430:
2427:
2425:
2422:
2420:
2417:
2416:
2414:
2410:
2395:
2392:
2390:
2387:
2385:
2382:
2380:
2377:
2375:
2372:
2370:
2367:
2365:
2362:
2360:
2357:
2355:
2352:
2351:
2349:
2345:
2341:
2340:United States
2337:
2330:
2325:
2323:
2318:
2316:
2311:
2310:
2307:
2300:
2297:
2295:
2292:
2290:
2287:
2285:
2282:
2278:
2274:
2270:
2267:
2265:
2261:
2257:
2254:
2252:
2248:
2244:
2241:
2240:
2236:
2228:
2222:
2219:
2211:
2205:
2202:
2194:
2188:
2185:
2172:
2170:
2164:
2158:
2155:
2142:
2140:
2134:
2128:
2125:
2122:
2116:
2113:
2101:
2097:
2091:
2088:
2075:
2071:
2065:
2062:
2057:
2051:
2048:
2043:
2039:
2032:
2028:
2021:
2018:
2010:
2004:
2001:
1998:
1994:
1989:
1986:
1983:
1978:
1975:
1971:
1965:
1962:
1957:
1953:
1949:
1945:
1941:
1937:
1933:
1926:
1923:
1920:
1915:
1912:
1901:on 2013-10-19
1897:
1893:
1886:
1880:
1877:
1874:
1868:
1865:
1861:
1855:
1852:
1848:. 2022-03-03.
1847:
1843:
1837:
1834:
1823:
1819:
1812:
1809:
1805:. 2022-03-02.
1804:
1800:
1794:
1792:
1790:
1786:
1783:
1780:
1776:
1773:
1767:
1764:
1761:
1758:
1754:
1751:
1745:
1742:
1738:
1734:
1730:
1727:
1721:
1718:
1705:
1698:
1695:
1691:
1687:
1686:
1681:
1675:
1672:
1668:
1664:
1661:
1657:
1653:
1650:
1637:
1631:
1628:
1615:
1609:
1606:
1593:
1589:
1585:
1579:
1576:
1563:
1557:
1554:
1551:
1546:
1543:
1540:
1535:
1532:
1529:
1524:
1521:
1508:
1502:
1499:
1496:
1492:
1489:
1484:
1481:
1478:
1473:
1470:
1467:
1462:
1459:
1454:
1448:
1437:September 26,
1432:
1426:
1423:
1420:
1416:
1410:
1407:
1401:
1396:
1395:
1391:
1389:
1386:
1384:
1381:
1379:
1376:
1374:
1371:
1369:
1366:
1364:
1361:
1359:
1356:
1354:
1351:
1350:
1346:
1342:
1339:
1338:
1337:
1331:
1326:
1323:
1316:
1311:
1308:
1305:
1302:
1299:
1296:
1293:
1290:
1287:
1284:
1281:
1278:
1275:
1272:
1269:
1266:
1263:
1260:
1257:
1254:
1251:
1248:
1245:
1242:
1239:
1236:
1233:
1230:
1227:
1224:
1221:
1218:
1215:
1212:
1209:
1206:
1203:
1200:
1197:
1194:
1191:
1188:
1185:
1182:
1179:
1176:
1173:
1170:
1167:
1164:
1161:
1158:
1155:
1152:
1149:
1146:
1145:
1144:
1138:
1135:
1132:
1129:
1126:
1123:
1120:
1117:
1114:
1111:
1108:
1105:
1102:
1099:
1096:
1093:
1090:
1087:
1084:
1081:
1078:
1075:
1072:
1069:
1066:
1063:
1060:
1057:
1054:
1051:
1048:
1045:
1042:
1039:
1036:
1033:
1030:
1027:
1024:
1021:
1018:
1015:
1012:
1009:
1006:
1003:
1000:
998:
995:
992:
988:
984:
981:
977:
974:
970:
967:
966:
965:
962:
956:
954:
952:
948:
944:
936:
934:
931:
927:
919:
915:
913:
911:
905:
898:
896:
894:
890:
885:
881:
877:
873:
871:
867:
860:
858:
856:
847:
843:
839:
835:
832:
828:
825:
821:
820:
819:
817:
813:
807:
799:
797:
794:
786:
784:
782:
781:mineral water
778:
777:Bottled water
772:Bottled water
771:
769:
766:
762:
757:
754:
747:
745:
743:
734:
732:
725:
718:
715:
713:
710:
708:
707:
703:
700:
698:
695:
693:
692:
689:
686:
684:
681:
678:
677:
674:
671:
669:
666:
663:
662:
659:
656:
654:
653:Allura Red AC
651:
648:
647:
644:
641:
639:
636:
633:
632:
629:
626:
624:
621:
618:
617:
614:
611:
609:
606:
603:
602:
599:
596:
594:
591:
588:
587:
583:
580:
577:
574:
573:
567:
565:
562:
558:
557:food coloring
551:Food coloring
550:
545:
542:
539:
532:
528:
527:
526:
525:
523:
521:VI. Cosmetics
520:
513:
511:
507:
504:
503:
502:
501:
499:
493:
492:
490:
485:
484:Supreme Court
482:
478:
474:
470:
467:
462:
458:
454:
453:
451:
445:
441:
438:
436:
432:
430:
426:
424:
420:
419:
418:
417:
415:
412:
411:
410:
404:
402:
400:
396:
393:
389:
388:sulfanilamide
385:
380:
378:
374:
370:
366:
362:
358:
354:
350:
346:
342:
338:
334:
323:
320:
318:
315:
313:
310:
308:
305:
302:
299:
296:
293:
290:
287:
284:
281:
278:
275:
272:
269:
266:
263:
260:
257:
254:
251:
248:
245:
242:
239:
236:
233:
230:
227:
226:
224:
219:
212:
209:by President
208:
205:
202:
198:
194:
191:
188:
185:
182:
179:
176:
172:
168:
164:
161:
160:
157:
152:
148:
144:
141:
138:
134:
131:
128:
124:
121:
118:
116:Acts repealed
114:
109:
106:
102:
98:
96:
90:
87:
84:
80:
75:
72:
68:
64:
60:
55:
51:
47:
43:
39:
34:
19:
2622:Stephen Hahn
2221:
2204:
2187:
2175:. Retrieved
2166:
2157:
2145:. Retrieved
2136:
2127:
2115:
2104:. Retrieved
2099:
2090:
2078:. Retrieved
2074:the original
2064:
2050:
2041:
2030:
2020:
2003:
1993:Josh Makower
1988:
1977:
1964:
1939:
1935:
1925:
1914:
1903:. Retrieved
1896:the original
1879:
1867:
1858:Staff, FDA.
1854:
1845:
1836:
1825:. Retrieved
1821:
1811:
1802:
1781:
1766:
1759:
1744:
1729:Food Safety.
1728:
1720:
1708:. Retrieved
1697:
1689:
1683:
1674:
1663:
1652:
1640:. Retrieved
1630:
1618:. Retrieved
1608:
1596:. Retrieved
1594:. July 2009
1587:
1578:
1566:. Retrieved
1556:
1545:
1534:
1523:
1511:. Retrieved
1501:
1483:
1472:
1461:
1435:. Retrieved
1425:
1418:
1409:
1392:
1335:
1322:113–5 (text)
1143:Other laws:
1142:
964:Amendments:
963:
960:
940:
929:
923:
917:
906:
902:
886:
882:
878:
874:
865:
864:
851:
824:Dental floss
809:
790:
775:
758:
751:
738:
729:
554:
461:criminal law
408:
381:
377:bioterrorism
344:
340:
336:
332:
330:
206:
200:
196:
192:
186:
180:
162:
111:Codification
57:(colloquial)
2484:Federal law
1968:Staff, FDA
1710:17 November
951:advertising
753:Homeopathic
638:Erythrosine
578:Common name
477:Dotterweich
475:due to the
423:chewing gum
2686:Categories
2412:Major acts
2301:at the FDA
2106:2018-03-17
1905:2012-10-25
1827:2022-10-17
1402:References
973:Public Law
668:Tartrazine
163:Introduced
82:Public law
45:Long title
2347:Divisions
2262:from the
2249:from the
1737:1084-5984
1513:8 January
816:amendment
793:cosmetics
787:Cosmetics
561:additives
491:IV. Food
457:civil law
401:of 1906.
143:21 U.S.C.
77:Citations
2712:Food law
2177:13 March
2147:13 March
2080:June 13,
1956:21321283
1775:Archived
1753:Archived
1491:Archived
1447:cite web
1347:See also
697:Orange B
584:Comment
531:Form 483
405:Contents
345:FD&C
99:52
54:Acronyms
2338:of the
2277:details
2258:of the
2245:of the
1314:Pub. L.
930:de novo
918:de novo
761:FTC Act
392:solvent
291:of 1996
1954:
1735:
1642:20 May
1620:20 May
1598:22 Apr
1568:20 May
1320:
814:. The
763:, the
701:orange
687:orange
672:yellow
612:indigo
137:U.S.C.
103:
86:75-717
2213:(PDF)
2196:(PDF)
2171:(FDA)
2167:U.S.
2141:(FDA)
2137:U.S.
2012:(PDF)
1899:(PDF)
1888:(PDF)
1770:FDA.
1748:FDA.
1706:. FTC
1325:(PDF)
627:green
581:Color
343:, or
337:FFDCA
201:House
147:ch. 9
145:
101:Stat.
2179:2020
2149:2020
2082:2014
1952:PMID
1733:ISSN
1712:2016
1644:2014
1622:2014
1600:2014
1570:2014
1515:2019
1453:link
1439:2017
941:The
924:The
642:pink
597:blue
575:Name
481:Park
479:and
459:and
429:drug
386:, a
341:FDCA
105:1040
69:the
2281:GPO
2273:PDF
2251:LII
1944:doi
1940:171
1846:FDA
1803:FDA
1417:,"
716:red
657:red
2688::
2165:.
2135:.
2098:.
2040:.
2029:.
1950:.
1938:.
1934:.
1890:.
1844:.
1820:.
1801:.
1788:^
1688:.
1682:.
1590:.
1586:.
1449:}}
1445:{{
971:,
872:.
339:,
175:NY
2328:e
2321:t
2314:v
2275:/
2271:(
2181:.
2151:.
2109:.
2084:.
2044:.
2033:.
1958:.
1946::
1908:.
1830:.
1739:.
1714:.
1646:.
1624:.
1602:.
1572:.
1517:.
1455:)
1441:.
1413:"
533:.
173:–
171:D
169:(
20:)
Text is available under the Creative Commons Attribution-ShareAlike License. Additional terms may apply.
