27:
2393:
884:, 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.
785:
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.
729:
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
1741:
864:
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
728:
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
552:
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
921:
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.
784:
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
841:
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
719:
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.
483:
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
868:
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
1738:
896:
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
553:
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.
744:
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.
892:
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.
1763:
1020:
872:
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.
1298:
1104:
756:
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.
1098:
1873:
2646:
452:
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
1214:
1226:
1760:
1092:
985:
1244:
1068:
1573:"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"
1693:"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"
1038:
1874:"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)"
1256:
1086:
1884:
1656:
1125:
730:
842:
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
1184:
1848:
1008:
247:
1958:
1787:
1220:
1250:
917:
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
857:
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
356:, 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
1325:
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.
2412:
2315:
1419:
914:
283:
2121:
1714:
975:
2058:
1479:
1292:
1056:
289:
271:
241:
1658:
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
2015:
2685:
2407:
2382:
1692:
1166:
1262:
881:
265:
2026:
2347:
1274:
1998:"De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration Staff"
1970:
1495:
2631:
1202:
1080:
223:
217:
2357:
2342:
1997:
1346:
1026:
364:
investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about
37:
To prohibit the movement in interstate commerce of adulterated and misbranded food, drugs, devices, and cosmetics, and for other purposes.
2641:
2453:
1050:
2372:
2308:
2269:
1880:
1572:
869:
composition, energy source, manufacturing process, or intended use, the device nominally must go through a premarket approval, or PMA.
2720:
2710:
1806:
295:
1985:
2352:
1014:
2252:
2151:
1032:
457:, but this is often interpreted broadly and few products other than raw produce are considered outside of the scope of the act.
259:
2705:
2301:
1329:
1074:
348:, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was
2680:
2417:
253:
1062:
1550:
2477:
1668:
1142:
472:
357:
131:
118:
2422:
2377:
2277:
1830:
1366:
1268:
1110:
310:
2215:
978:") (April 22, 1976) prohibited the FDA from establishing standards to limit the potency of vitamins and minerals in
829:. These tend to be devices that are permanently implanted into a human body or may be necessary to sustain life. An
818:
Class II: Devices that are cleared using the 510(k) process. Diagnostic tests, cardiac catheters, hearing aids, and
834:
159:
1624:
1602:
2690:
1376:
1196:
1190:
229:
89:
81:
1645:
2659:
2427:
2367:
1476:
1238:
1232:
1044:
2715:
2520:
2244:
1441:
1286:
990:
804:
772:, spring water), and regulations covering water processing and bottling, water quality and product labeling.
349:
305:
235:
2510:
2324:
2157:
2127:
2109:
1580:
1154:
465:
361:
341:
2044:
2362:
2239:
1551:"Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices"
1351:
1148:
277:
59:
1313:
2565:
2062:
1341:
1301:
996:
811:
Class I: Devices that do not require premarket approval or clearance but must follow general controls.
2636:
2505:
1356:
1208:
1172:
968:
957:
843:
2293:
2257:
1280:
935:
768:
is regulated by the FDA as a food. The Agency has published identity standards for types of water (
753:
300:
2282:
2261:
2495:
2181:
1382:
1920:
1725:
1310:
2695:
2432:
2198:
2084:
1371:
1361:
1119:
387:
337:
108:
1986:
FDA Impact on US Medical Device
Innovation – A Survey of Over 200 Medical Technology Companies
1861:
548:
additives, such as "FD&C Yellow No. 6". The Act made the certification of some food color
2590:
1178:
1136:
825:
Class III: Devices that are approved by the premarket approval (PMA) process, analogous to a
794:
469:
199:
1299:
Pandemic and All-Hazards
Preparedness Reauthorization Act of 2013 (H.R. 307; 113th Congress)
26:
2545:
2085:"S.741 - 108th Congress (2003–2004): Minor Use and Minor Species Animal Health Act of 2003"
1528:
UNITED STATES V. PARK, 421 U. S. 658 (1975) – US Supreme Court Cases from Justia & Oyez
826:
372:
371:
The introduction of this act was influenced by the death of more than 100 patients due to
8:
2560:
1788:"FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated"
819:
1516:
544:
The FD&C Act is perhaps best known to consumers because of its use in the naming of
2540:
2535:
2248:
2235:
2231:
1673:
581:
432:
135:
125:
2122:"Limited Population Pathway for Antibacterial and Antifungal Drugs – the LPAD Pathway"
1403:
837:. Devices that do not meet either criterion are generally cleared as class II devices.
2700:
2525:
1940:
1721:
1538:
1435:
671:
383:
353:
155:
2647:
Regulation of food and dietary supplements by the U.S. Food and Drug
Administration
2595:
2570:
2530:
2465:
1932:
1761:"21 CFR 165.110 – Requirements for Specific Standardized Beverages: Bottled Water."
1647:
F.D.A. webpage "Food
Ingredients and Packaging Terms" Page Last Updated: 02/28/2013
1465:
830:
461:
163:
74:
1936:
1527:
2585:
2500:
2265:
2016:"Secrets Of The De Novo Pathway, Part 1: Why Aren't More Device Makers Using It?"
1767:
1745:
1483:
1422:. Food & Drug Administration. Archived from the original on November 15, 2017
1160:
1002:
979:
961:
931:
877:
800:
518:
704 allows inspections of regulated entities. Inspection results are reported on
498:
454:
2605:
2580:
2575:
2550:
2515:
1454:
898:
858:
611:
596:
423:
386:
was used to dissolve the drug and make a liquid form. It replaced the earlier
964:(PL) 82–215 (October 26, 1951) created prescription-only status for some drugs
2674:
2615:
2600:
2555:
2328:
769:
765:
641:
549:
545:
376:
2610:
1981:
1944:
904:
812:
807:
required that all medical devices be classified into one of three classes:
700:
449:
365:
360:(DESI) to incorporate into FD&C regulations the recommendations from a
2287:
1907:
939:
833:
meets both criteria. The most commonly recognized class III device is an
626:
445:
411:
345:
2027:"Secrets Of The De Novo Pathway Part 2 Is De Novo Right For Your Device"
799:
On May 28, 1976, the FD&C Act was amended to include regulation for
93:
741:
656:
475:
cases. It is one of a very small number of criminal statutes that does.
1739:"21 CFR Part 129 – Processing and Bottling of Bottled Drinking Water."
2323:
2272:
1679:
Section 321, subsection (g), paragraph (1), subparagraph (A) thereof.
781:
733:
of the FD&C Act, which provides for any additional exclusions.
685:
519:
2061:. U.S. Food and Drug Administration. May 20, 2009. Archived from
942:
of all products regulated by FDA, other than prescription drugs.
749:
503:
515 is the description of the (class III) device approval process
380:
42:
1498:. U.S. Department of Health and Human Services. 3 November 2018
410:
201(f) is the definition for a food, which explicitly includes
1455:
Homeopathic Drugs, Royal
Copeland, and Federal Drug Regulation
1009:
Drug Price Competition and Patent Term Restoration Act of 1984
248:
Drug Price Competition and Patent Term Restoration Act of 1984
1807:"Johnson & Johnson and a New War on Consumer Protection"
497:
510(k) is the section that allows for clearance of class II
1021:
Generic Animal Drug and Patent Term Restoration Act of 1988
417:
1105:
Food Allergen Labeling and Consumer Protection Act of 2004
982:
or regulating them as drugs based solely on their potency.
950:
Descriptions of these can be found at the FDA's web site.
945:
1625:"Code of Federal Regulations: Title 21, Section 74.302"
1603:"Code of Federal Regulations: Title 21, Section 74.250"
849:
915:
Food and Drug Administration Modernization Act of 1997
284:
Food and Drug Administration Modernization Act of 1997
2218:. U.S. Food and Drug Administration. 3 November 2018.
1921:"Medical Device Recalls and the FDA Approval Process"
1860:
Duff Wilson for the New York Times. January 28, 2011
1496:"Federal Food, Drug, and Cosmetic Act (FD&C Act)"
1099:
Minor Use and Minor Species Animal Health Act of 2004
1669:"21 USC Ch. 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT"
2047:. U.S. Food and Drug Administration. 19 April 2021.
1386:(c. 1933 book which influenced passage of this Act)
1293:
Food and Drug Administration Amendments Act of 2007
1057:
Dietary Supplement Health And Education Act of 1994
1011:, PL 98–417 (aka Hatch-Waxman) (September 24, 1984)
494:
505 is the description of the drug approval process
290:
Food and Drug Administration Amendments Act of 2007
242:
Radiation Control for Health and Safety Act of 1968
1302:
901:it is significantly more expensive than a 510(k).
2454:Title 21 of the Code of Federal Regulations (CFR)
2408:Family Smoking Prevention and Tobacco Control Act
2383:Office of Global Regulatory Operations and Policy
1517:United States v. Dotterweich, 320 U.S. 277 (1943)
2672:
1263:Food and Drug Administration Revitalization Act
1083:(MDUFMA) of 2002, PL 107–250 (October 26, 2002)
1053:(AMDUCA) of 1994, PL 103–396 (October 22, 1994)
882:National Research Center for Women and Families
266:Food and Drug Administration Revitalization Act
1908:US FDA/CDRH: Information on Releasable 510(k)s
1275:Food and Drug Administration Modernization Act
1047:(PDUFA) of 1992, PL 102–571 (October 29, 1992)
723:
2632:Criticism of the Food and Drug Administration
2309:
1690:
1203:The National Environmental Policy Act of 1969
1081:Medical Device User Fee and Modernization Act
224:1962 Food, Drug, and Cosmetics Act Amendments
218:1951 Food, Drug, and Cosmetics Act Amendments
2358:Center for Food Safety and Applied Nutrition
2343:Center for Biologics Evaluation and Research
1027:Nutrition Labeling and Education Act of 1990
20:Federal Food, Drug, and Cosmetic Act of 1938
2642:History of the Food and Drug Administration
2478:Title 21 of the United States Code (U.S.C.)
2059:"This Week In FDA History - April 22, 1976"
1862:F.D.A. Panel Is Split on Electroshock Risks
1404:Food, Drug, and Cosmetic Law Research Guide
1320:
1215:Controlled Substances Import and Export Act
1051:Animal Medicinal Drug Use Clarification Act
887:
846:, which the FDA started reviewing in 2011.
428:201(s) is the definition of a food additive
272:Dietary Supplement Health and Education Act
2373:National Center for Toxicological Research
2348:Center for Devices and Radiological Health
2316:
2302:
1881:United States Food and Drug Administration
1713:Posnick, Lauren M. and Kim, Henry (2002).
736:
182:Reported by the joint conference committee
1971:21 U.S.C. § 360e. Premarket approval
1918:
1227:Lead-Based Paint Poisoning Prevention Act
484:ordinarily render it injurious to health"
188:on June 10, 1938 (voice) and by the
2686:United States federal health legislation
2110:Generic Drug User Fee Amendments of 2012
1984:, Aabed Meer, lyn Denend. November 2010
296:Over-the-Counter Hearing Aid Act of 2017
2353:Center for Drug Evaluation and Research
1715:"Bottled Water Regulation and the FDA."
1116:Generic Drug User Fee Amendment of 2012
1015:Prescription Drug Marketing Act of 1987
946:Significant amendments and related laws
2673:
1033:Safe Medical Device Amendments of 1990
925:
260:Safe Medical Device Amendments of 1990
2297:
2024:
2013:
1782:
1780:
1778:
1330:California Safe Cosmetics Act of 2005
1093:Pediatric Research Equity Act of 2003
1075:Best Pharmaceuticals for Children Act
986:Drug Abuse Control Amendments of 1965
748:However, under separate authority of
556:
352:. A principal author of this law was
340:in 1938 giving authority to the U.S.
2418:Federal Food, Drug, and Cosmetic Act
2258:Federal Food, Drug, and Cosmetic Act
2025:Drues, Michael (February 18, 2014).
1245:Government Patent Policy Act of 1980
1145:(repealed; for historical reference)
1139:(repealed; for historical reference)
1069:Animal Drug Availability Act of 1996
850:Premarket notification (510(k), PMN)
322:Federal Food, Drug, and Cosmetic Act
254:Nutrition Labeling and Education Act
2108:Staff, FDA. Updated April 18, 2013
2014:Drues, Michael (February 5, 2014).
1804:
1627:. U.S. Food and Drug Administration
1605:. U.S. Food and Drug Administration
1553:. U.S. Food and Drug Administration
1063:Food Quality Protection Act of 1996
795:Medical device § United States
441:III. Prohibited Acts and Penalties
13:
2245:As codified in 21 U.S.C. chapter 9
2232:As codified in 21 U.S.C. chapter 9
1775:
1691:Press Release (15 November 2016).
1307:Tooltip Public Law (United States)
1143:Federal Food and Drugs Act of 1906
788:
358:Drug Efficacy Study Implementation
16:Acts of the United States Congress
14:
2732:
2378:Office of Criminal Investigations
2288:Information on Releasable 510(k)s
2225:
2199:"FDA Reauthorization Act of 2017"
1831:"FDA Recall Policy for Cosmetics"
1367:Office of Criminal Investigations
1269:Mammography Quality Standards Act
1111:FDA Food Safety Modernization Act
1039:Medical Device Amendments of 1992
991:Medical Device Amendments of 1976
905:Automatic Class III designation (
822:are examples of class II devices.
714:
336:) is a set of laws passed by the
311:Microbead-Free Waters Act of 2015
274:(1994), PL 103-417, 108 Stat 4332
268:(1990), PL 101-635, 104 Stat 4583
256:(1990), PL 101-535, 104 Stat 2353
2721:Food safety in the United States
2711:Drug policy of the United States
2391:
1477:ASHP Website : News Article
1257:Sanitary Food Transportation Act
1122:, PL 114–255 (December 13, 2016)
1089:, PL 108–130 (February 20, 2003)
1087:Animal Drug User Fee Act of 2003
1035:, PL 101–629 (November 28, 1990)
1023:, PL 100–670 (November 16, 1988)
835:automated external defibrillator
760:
539:
25:
2273:Statute Compilations collection
2208:
2191:
2174:
2144:
2114:
2102:
2077:
2051:
2037:
2007:
1990:
1975:
1964:
1961:, last updated January 24, 2012
1951:
1912:
1901:
1866:
1854:
1841:
1823:
1798:
1753:
1731:
1707:
1684:
1661:
1650:
1639:
1617:
1595:
1577:Laws, Regulations, and Guidance
1565:
1543:
1377:Regulation of therapeutic goods
1197:Fair Packaging and Labeling Act
1191:Poultry Products Inspection Act
1126:FDA Reauthorization Act of 2017
1095:, PL 108–155 (December 3, 2003)
1059:, PL 103–417 (October 25, 1994)
1029:, PL 101–535 (November 8, 1990)
971:") PL 87–781 (October 10, 1962)
460:Notably, the FD&C Act uses
431:201(ff) is the definition of a
422:201(h) is the definition for a
416:201(g) is the definition for a
230:Fair Packaging and Labeling Act
176:Passed the House with amendment
2660:Commissioner of Food and Drugs
2442:Title 21 regulations and rules
2428:Prescription Drug User Fee Act
2368:Center for Veterinary Medicine
1532:
1521:
1510:
1488:
1470:
1459:
1448:
1412:
1396:
1239:Government in the Sunshine Act
1233:Federal Advisory Committee Act
1077:, PL 107–109 (January 4, 2002)
1071:, PL 104–250 (October 9, 1996)
1045:Prescription Drug User Fee Act
1017:, PL 100–293 (August 18, 1988)
999:, PL 96–359 (October 26, 1980)
934:, passed in 1938, granted the
398:The FDC Act has ten chapters:
154:in the Senate as S. 5 by
1:
2423:Food Safety Modernization Act
1937:10.1001/archinternmed.2011.30
1925:Archives of Internal Medicine
1390:
1287:Project BioShield Act of 2004
1185:Reorganization Plan 1 of 1953
1137:Biologics Control Act of 1902
1128:, PL 115–52 (August 18, 2017)
1107:, PL 108–282 (August 2, 2004)
1065:, PL 104–170 (August 3, 1996)
1005:, PL 97–414 (January 4, 1983)
306:Drug Quality and Security Act
236:Medical Device Regulation Act
192:on June 13, 1938 (voice)
172:on March 9, 1937 (voice)
2706:Food and Drug Administration
2325:Food and Drug Administration
2158:Food and Drug Administration
2128:Food and Drug Administration
1771:Code of Federal Regulations.
1749:Code of Federal Regulations.
1581:Food and Drug Administration
1155:Federal Trade Commission Act
1041:, PL 102–300 (June 16, 1992)
974:Vitamin-Mineral Amendment ("
775:
708:Restricted to specific uses
693:Restricted to specific uses
362:National Academy of Sciences
342:Food and Drug Administration
178:on June 1, 1938 (voice)
7:
2681:75th United States Congress
2363:Center for Tobacco Products
2283:Food Ingredients and Colors
2253:US House of Representatives
1851:Last updated April 26, 2009
1352:Food Quality Protection Act
1335:
1221:Egg Products Inspection Act
1149:Federal Meat Inspection Act
1101:PL 108–282 (August 2, 2004)
724:Definition of food additive
444:This section contains both
393:
379:medication where the toxic
286:, PL 105-115, 111 Stat 2296
278:Food Quality Protection Act
262:, PL 101-629, 104 Stat 4511
60:75th United States Congress
10:
2737:
2278:Color Additive Status List
2216:"Other Laws Affecting FDA"
1342:Drugs in the United States
1251:Federal Anti-Tampering Act
997:Infant Formula Act of 1980
967:Drug Efficacy Amendment ("
792:
2655:
2637:FDA Most Wanted Fugitives
2624:
2488:
2472:
2460:
2448:
2441:
2413:Modernization Act of 1997
2400:
2389:
2335:
1919:Zuckerman, Diana (2011).
1849:PMA Historical Background
1805:Cep, Casey (2022-09-12).
1440:: CS1 maint: unfit URL (
1357:Kefauver Harris Amendment
1271:(MQSA) (October 27, 1992)
1209:Controlled Substances Act
1173:Public Health Service Act
969:Kefauver Harris Amendment
958:Durham-Humphrey Amendment
938:the authority to oversee
844:electroconvulsive therapy
529:VIII. Imports and Exports
292:, PL 110-85, 121 Stat 823
250:, PL 98-471, 98 Stat 1585
244:, PL 90-602, 82 Stat 1173
232:, PL 89–755, 80 Stat 1296
214:
209:
147:
142:
124:
119:21 U.S.C.: Food and Drugs
114:
104:
99:
80:
70:
65:
54:
41:
33:
24:
2182:"21st Century Cures Act"
2152:"21st Century Cures Act"
2003:. FDA. October 30, 2017.
1959:Premarket Approval (PMA)
1321:Comparison to state laws
1281:Bioterrorism Act of 2002
993:PL 94–295 (May 28, 1976)
936:Federal Trade Commission
888:Premarket approval (PMA)
865:be properly identified.
754:Federal Trade Commission
301:Sunscreen Innovation Act
238:, PL 94–295, 90 Stat 539
226:, PL 87–781, 76 Stat 780
220:, PL 82–215, 65 Stat 648
2031:www.meddeviceonline.com
1720:August/September 2002.
1539:FD&C Act Chapter IV
1383:100,000,000 Guinea Pigs
737:Homeopathic medications
513:VII. General Authority
186:agreed to by the Senate
2691:Pharmaceuticals policy
2433:Pure Food and Drug Act
2045:"Laws Enforced by FDA"
1408:Georgetown Law Library
1372:Pure Food and Drug Act
1362:List of food additives
1120:21st Century Cures Act
880:and Paul Brown of the
668:FD&C Yellow No. 6
653:FD&C Yellow No. 5
388:Pure Food and Drug Act
338:United States Congress
109:Pure Food and Drug Act
2591:Andrew von Eschenbach
2466:Federal Register (FR)
2187:. Public Law 114–255.
1179:Trademark Act of 1946
793:Further information:
608:FD&C Green No. 3
489:V. Drugs and Devices
344:(FDA) to oversee the
200:Franklin D. Roosevelt
2716:1938 in American law
2546:Alexander M. Schmidt
2268:) as amended in the
2204:. Public Law 115–52.
1295:(September 27, 2007)
1241:(September 13, 1976)
1157:(September 26, 1914)
827:New Drug Application
815:is a class I device.
638:FD&C Red No. 40
593:FD&C Blue No. 2
578:FD&C Blue No. 1
532:IX. Tobacco Products
373:elixir sulfanilamide
166:) on January 6, 1937
2625:Society and culture
2561:Arthur H. Hayes Jr.
2521:Charles W. Crawford
2089:Library of Congress
2065:on October 23, 2016
1347:Food Administration
1277:(November 21, 1997)
1265:(November 28, 1990)
1247:(December 12, 1980)
1223:(December 29, 1970)
1169:(February 15, 1927)
926:Related legislation
623:FD&C Red No. 3
350:Charles W. Crawford
143:Legislative history
50:FFDCA, FD&C Act
21:
2541:Charles C. Edwards
2511:Walter G. Campbell
2449:Administrative law
2249:United States Code
2236:United States Code
2162:. 13 December 2016
2132:. 13 December 2016
1766:2009-09-07 at the
1744:2009-09-26 at the
1674:United States Code
1482:2007-09-27 at the
1420:"Charles Crawford"
1259:(November 3, 1990)
1253:(October 13, 1983)
1229:(January 13, 1971)
1217:(October 27, 1970)
1211:(October 27, 1970)
1199:(November 3, 1966)
976:Proxmire Amendment
582:Brilliant blue FCF
557:Certifiable colors
433:dietary supplement
320:The United States
184:on June 10, 1938;
138:§ 301 et seq.
19:
2668:
2667:
2526:George P. Larrick
2506:Charles A. Browne
2484:
2483:
1235:(October 6, 1972)
1205:(January 1, 1970)
1193:(August 28, 1957)
1113:(January 4, 2011)
780:This Act defines
712:
711:
672:Sunset Yellow FCF
384:diethylene glycol
354:Royal S. Copeland
318:
317:
170:Passed the Senate
83:Statutes at Large
2728:
2596:Margaret Hamburg
2571:David A. Kessler
2531:James L. Goddard
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980:food supplements
876:A 2011 study by
831:artificial heart
701:Citrus Red No. 2
561:
560:
535:X. Miscellaneous
462:strict liability
405:II. Definitions
324:(abbreviated as
210:Major amendments
202:on June 25, 1938
128:sections created
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1003:Orphan Drug Act
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940:advertising
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466:Dotterweich
464:due to the
412:chewing gum
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2290:at the FDA
2095:2018-03-17
1894:2012-10-25
1816:2022-10-17
1391:References
962:Public Law
657:Tartrazine
152:Introduced
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2336:Divisions
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2701:Food law
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