Dokar Abinci, Magunguna, da Kayan shafawa ta Tarayya

Dokar Abinci, Magunguna, da Kayan shafawa ta Tarayya (wanda aka taƙaita a matsayin FFDCA''', FDCA, ko FD&C) jerin dokoki ne da Majalisar Dattijai ta Amurka ta zartar a 1938 suna ba da iko ga Hukumar Abinci da Magunguna (FDA) don kula da amincin abinci, magunguna, na'urorin kiwon lafiya, da kayan shafawa. Babban wakilin FDA tare da mambobin majalisa a lokacin da aka tsara shi shine Charles W. Crawford .  Babban marubucin wannan dokar shine Royal S. Copeland, sanata na Amurka na uku daga New York. A shekara ta 1968, an kara tanadin Kula da Radiation na Electronic Product zuwa FD & C. Har ila yau a wannan shekarar FDA ta kafa Dokar Nazarin Ingancin Magunguna (DESI) don shigar da shawarwari daga binciken Kwalejin Kimiyya ta Kasa game da tasirin magungunan da aka sayar a baya. An yi wa dokar gyare-gyare sau da yawa, kwanan nan don ƙara buƙatu game da shirye-shiryen Ta'addanci.

Gabatar da wannan aikin ya rinjayi mutuwar fiye da marasa lafiya 100 saboda elixir sulfanilamide, magani na sulfanilamides inda aka yi amfani da mai narkewa mai guba diethylene glycol don narkar da magani da yin nau'in ruwa. Ya maye gurbin dokar Pure Food and Drug Act na 1906.

 .Abinda ke ciki 
Dokar FDC tana da surori goma: 

 I. Takaitaccen Taken
 Na biyu. Ma'anar 201 (f) ita ce ma'anar abinci, wanda a bayyane ya haɗa da cinyewa 201 (g) shine ma'anar miyagun ƙwayoyi 201 (h) shine maɓallin na'urar kiwon lafiya 201 (s) shine ma ma'anar kayan abinci 201 (ff) shine ma 'yancin ƙarin abinci
 201 (f) shine ma'anar abinci, wanda a bayyane ya haɗa da cinyewakunama gum
 201 (g) shine ma'anar maganimiyagun ƙwayoyi
 201 (h) shine ma'anar na'urar kiwon lafiya
 201 (s) shine ma'anar kayan abinci
 201 (ff) shine ma'anar kariyar abinciAbinci na abinci
 Na uku. Ayyukan da aka haramta da Hukunce-hukunce Wannan sashi ya ƙunshi sassan dokar farar hula da dokar aikata laifuka. Yawancin keta doka a ƙarƙashin dokar farar hula ne, kodayake ana maimaitawa, da gangan, da kuma keta doka a matsayin dokar aikata laifuka. Dukkanin keta dokar FD & C suna buƙatar cinikayya tsakanin jihohi saboda sashi na kasuwanci, amma sau da yawa ana fassara wannan a ko'ina kuma ana ɗaukar samfuran kaɗan ban da kayan da ba a haɗa su ba. Musamman, Dokar FD&C tana amfani da tsauraran alhakin saboda shari'ar Kotun Koli ta Dotterweich [1] da Park .[2] Yana daya daga cikin ƙananan ka'idojin aikata laifuka da ke yi.
 Wannan sashe ya ƙunshi sassan dokar farar hula da dokar aikata laifuka. Yawancin keta doka a ƙarƙashin dokar farar hula ne, kodayake ana maimaitawa, da gangan, da kuma keta doka a matsayin dokar aikata laifuka. Dukkanin keta dokar FD & C suna buƙatar cinikayya tsakanin jihohi saboda sashi na kasuwanci, amma sau da yawa ana fassara wannan a ko'ina kuma ana ɗaukar samfuran kaɗan ban da kayan da ba a haɗa su ba.
 Musamman, Dokar FD&C tana amfani da tsauraran alhakin saboda shari'ar Kotun Koli ta Dotterweich  da Park . Yana daya daga cikin ƙananan ka'idojin aikata laifuka da ke yi.
 Na huɗu. Abinci 
 Akwai bambanci a cikin cin zarafin abinci tsakanin waɗanda aka kara da waɗanda ke cikin halitta. Abubuwan da aka kara suna riƙe da su a cikin ƙa'idar da ta fi tsananin "yana iya sa (yana) cutar da lafiya", yayin da abubuwa da ke cikin halitta kawai suna buƙatar kasancewa a matakin da "ba ya sa ya cutar da lafiya" 
 V. Magunguna da Na'urori 505 shine bayanin tsarin amincewar magani 510 (k) shine ɓangaren da ke ba da damar share na'urorin kiwon lafiya na aji na II 515 shine bayanin tsarin tabbatar da na'urar (aji na III) 
 505 shine bayanin tsarin amincewa da miyagun ƙwayoyi
 510 (k) shine ɓangaren da ke ba da izinin share na'urorin kiwon lafiya na aji na IIKayan kiwon lafiya
 515 shine bayanin tsarin amincewa da na'urar (aji na III) 
 Na shida. Kayan shafawa
 Kawai. Babban Hukumomi 704 yana ba da izinin dubawa ga ƙungiyoyi masu tsarawa. An bayar da rahoton sakamakon dubawa a kan fom 483.
 704 yana ba da damar dubawa ga ƙungiyoyi masu tsarawa. An bayar da rahoton sakamakon dubawa a kan fom 483.
 Na takwas. Shigarwa da Fitarwa
 IX. Kayayyakin taba
 X. Sauran abubuwa

 Launi na abinci 
Dokar FD & C watakila sananne ne ga masu amfani saboda amfani da ita wajen sanya sunan kayan ado na abinci, kamar "FD & C Yellow No. 6". Dokar ta sanya takardar shaidar wasu kayan ado na abinci ya zama tilas. FDA ta lissafa kari FD & C (Abubuwa, Magunguna & Kayayyakin shafawa) takaddun launi don amfani a cikin abinci a Amurka, da kuma D & C (Drugs & Cosmetics) launuka da yawa da aka ba da izini kawai a cikin magunguna don aikace-aikacen waje ko kayan shafawa. Abubuwan da aka samo daga tushen halitta, kamar kayan lambu, ma'adanai ko dabbobi, da takwarorinsu na wucin gadi na abubuwan da aka samo asali, an cire su daga takaddun shaida. Dukkanin kayan ado na wucin gadi da na halitta suna ƙarƙashin ƙa'idodin aminci masu tsauri kafin amincewarsu don amfani a cikin abinci.

 Launuka masu tabbatarwa 
SunanSunan gama gariLauniTa yayaFD&C Blue No. 1FCF mai launin shudi mai haskeshuɗiFD&C Blue No. 2Indigo carmineindigoFD&C Green No. 3Fast Green FCFkoreFD&C Red No. 3Erythrosineruwan hodaAn haramta shi a Amurka a ranar 15 ga Janairu, 2025. FD&C Red No. 40Allura Red ACjaFD&C Yellow No. 5TartrazinerawayaFD&C Yellow No. 6Sunset Yellow FCForangeOrange BorangeAn ƙuntata shi ga takamaiman amfani Citrus Red No. 2jaAn ƙuntata shi ga takamaiman amfani 

 Abincin abinci 
FFDCA tana buƙatar masu samar da kayan abinci don nuna tabbacin cewa babu lahani da zai haifar da amfani da kayan da aka nufa. Idan FDA ta sami ƙarin don zama lafiya hukumar ta ba da ƙa'ida da ke ƙayyade yanayin da za a iya amfani da ƙarin cikin aminci. [ana buƙatar ƙa'ida][<span title="This claim needs references to reliable sources. (October 2023)">citation needed</span>]

 Ma'anar kayan abinci 
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." The full definition can be found in Section 201(s)  of the FD&C Act, which provides for any additional exclusions.  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

 Magunguna na Homeopathic 
Ana tsara shirye-shiryen Homeopathic kuma ana kiyaye su a ƙarƙashin Sashe na 201 (g) da 201 (j), idan dai ana tsara irin waɗannan magunguna daga abubuwan da aka jera a cikin Homeopathical Pharmacopoeia na Amurka, wanda Dokar ta amince da shi a matsayin ƙididdigar magani ta hukuma.

Koyaya, a ƙarƙashin ikon daban na Dokar FTC, Hukumar Ciniki ta Tarayya ta bayyana a watan Nuwamba na 2016 cewa samfuran homeopathic ba za su iya haɗawa da da'awar tasiri ba tare da "shaidar kimiyya mai ƙwarewa da abin dogaro ba". Idan babu irin wannan shaidar, dole ne su bayyana wannan gaskiyar a sarari a kan lakabin su.

 Ruwa mai kwalliya 
FDA ce ke sarrafa ruwan kwalba a matsayin abinci. Hukumar ta wallafa ka'idojin ainihi don nau'ikan ruwa (ruwa na ma'adinai, ruwan maɓuɓɓugar ruwa), da ka'idoji da ke rufe sarrafa Ruwa mai kwalliya, ingancin ruwa da lakabin samfurin. Posnick, Lauren M. and Kim, Henry (2002). "Bottled Water Regulation and the FDA." Food Safety. August/September 2002. . 

 Kayan shafawa 
Wannan Dokar ta bayyana kayan kwalliya a matsayin "abubuwan da aka nufa don shafawa, zubawa, yayyafawa, ko yayyafa, gabatar da su, ko kuma a yi amfani da su ga jikin mutum ... don tsaftacewa, kyautatawa, inganta kyawawan abubuwa, ko canza bayyanar. " A karkashin Dokar, FDA ba ta amince da kayayyakin kwalliya ba, amma Dokar ta haramta tallan kayan kwalliya ko ba daidai ba. Koyaya, FDA ba ta da ikon yin umarni da tunatar da kayan shafawa. Idan kamfani yana sayar da samfurin da aka lalata ko ba daidai ba, FDA na iya tambayar kamfanin ya dawo da samfurin su ko ya gurfanar da su. FDA na iya kuma yana bincika wuraren kera kayan kwalliya don tabbatar da cewa ba a lalata kayan kwalliya ba.

 Kayan kiwon lafiya 
A ranar 28 ga Mayu, 1976, an yi wa Dokar FD&C gyare-gyare don haɗawa da ka'idoji don na'urorin kiwon lafiya. Gyaran ya buƙaci a rarraba duk na'urorin kiwon lafiya zuwa ɗaya daga cikin aji uku:

 Class I: Na'urorin da ba sa buƙatar amincewa ko izini kafin kasuwa amma dole ne su bi sarrafawa gaba ɗaya. Dental floss na'urar aji ce ta I.
 Class II: Na'urorin da aka share ta amfani da tsarin 510 (k). Gwaje-gwaje na ganewar asali, catheters na zuciya, kayan jin, da amalgams na hakora misalai ne na na'urorin aji na II.
 Class III: Na'urorin da aka amince da su ta hanyar amincewa da pre-market (PMA), kwatankwacin Sabon Aikace-aikacen Magunguna. Wadannan suna da na'urorin da aka dasa har abada a cikin jikin mutum ko kuma suna iya zama dole don ci gaba da rayuwa. Zuciya ta wucin gadi ta cika ka'idojin biyu. Na'urar da aka fi sani da aji na III ita ce defibrillator na waje mai sarrafa kansa. Na'urorin da ba su cika kowanne ma'auni ba ana share su gabaɗaya a matsayin na'urorin aji na II.

Ga na'urorin da aka tallata kafin gyare-gyare (na'urorin gyare-garen) kuma an rarraba su a matsayin Class III, gyare- gyare-gine ya tilasta FDA ta sake duba na'urar don sake rarraba ta a matsayin na'urar Class II wanda ke ƙarƙashin sanarwar kafin kasuwa, ko kuma ya buƙaci mai ƙera na'urar ya shiga cikin tsarin izinin kafin kasuwa kuma ya tabbatar da aminci da ingancin na'urar domin ci gaba da tallata shi. Shahararrun misalai na irin waɗannan na'urorin gyare-gyare sune waɗanda aka yi amfani da su don maganin electroconvulsive, wanda FDA ta fara sake dubawa a cikin 2011. 

 Sanarwar tallace-tallace (510 (k), PMN) Sashe na 510 (k) '''  na Dokar Abinci, Magunguna, da Kayan shafawa ta Tarayya tana buƙatar waɗancan masana'antun na'urorin da dole ne su yi rajista don sanar da FDA, aƙalla kwanaki 90 a gaba, game da niyyar su sayar da na'urar kiwon lafiya.

Wannan an san shi da sanarwar kafin kasuwa, PMN, ko 510 (k). Yana bawa FDA damar tantance ko na'urar ta yi daidai da na'urar da aka riga aka sanya a cikin ɗayan nau'ikan rarrabuwa guda uku. Don haka, na'urorin "sabon" (ba a cikin rarraba kasuwanci ba kafin Mayu 28, 1976) waɗanda ba a rarraba su ba za a iya gano su yadda ya kamata. [ana buƙatar ƙa'ida][<span title="This claim needs references to reliable sources. (October 2023)">citation needed</span>]

Duk wani na'urar da ta kai kasuwa ta hanyar sanarwar 510 (k) dole ne ta kasance "daidai" ga na'urar a kasuwa kafin Mayu 28, 1976 ("na'urar da aka tsara"). Idan na'urar da aka gabatar ta bambanta sosai, dangane da na'urar kafin 1976, dangane da ƙira, kayan aiki, sinadarai, tushen makamashi, tsarin masana'antu, ko amfani da aka nufa, na'urar dole ne ta wuce ta hanyar amincewar riga ta sayar, ko PMA.

Na'urar da ta kai kasuwa ta hanyar tsarin 510 (k) ba a dauke ta da FDA a matsayin "an amincewa". Duk da haka, ana iya tallata shi kuma ana sayar da shi a Amurka. Ana kiran su da na'urorin "cikinye" ko "510 (k) share".

Binciken da Diana Zuckerman da Paul Brown na Cibiyar Bincike ta Kasa don Mata da Iyalai, da Steven Nissen na Cibiyar Kula da Lafiya ta Cleveland, wanda aka buga a cikin Tarihin Magunguna na Cikin Gida, sun nuna cewa yawancin na'urorin kiwon lafiya da aka tunatar a cikin shekaru biyar da suka gabata don "matsalar kiwon lafiya mai tsanani ko mutuwa" FDA ta riga ta share su ta amfani da tsarin da ba shi da ya fi tsayi, kuma mafi arha, 510 (k). A wasu lokuta an dauki na'urorin da ba su da haɗari sosai har ba su buƙatar ƙa'idar FDA ba. Daga cikin na'urorin 113 da aka tuno, 35 sun kasance don matsalolin zuciya.

 Samun amincewa da tallace-tallace (PMA) 
Samun amincewa (PMA) shine mafi tsananin nau'in aikace-aikacen tallace-tallace na'urar da FDA ke buƙata. Ba kamar hanyar 510 (k) ba, mai yin na'urar kiwon lafiya dole ne ya gabatar da aikace-aikace ga FDA kuma dole ne ya sami amincewa kafin ya tallata na'urar.

Aikace-aikacen PMA ya ƙunshi bayani game da yadda aka tsara na'urar kiwon lafiya da kuma yadda aka ƙera ta, da kuma binciken preclinical da na asibiti na'urar, yana nuna cewa tana da aminci kuma tana da tasiri don amfani da ita. Saboda PMA tana buƙatar gwajin asibiti yana da tsada sosai fiye da 510 (k).  : 7 

 Bayyanawa ta atomatik Class III (de novo classification) 
Dokar Kula da Abinci da Magunguna ta 1997 ta kirkiro sashi na 513 (f) (2) na Dokar FD & C, wanda ya tilasta FDA ta kafa tsarin tsarin tsarin haɗari don na'urorin kiwon lafiya. A sakamakon haka, FDA ta kafa hanyar de novo don na'urorin da za a rarraba su ta atomatik a matsayin Class III saboda babu na'urar da ta riga ta wanzu da za a iya amfani da ita don ƙaddamar da 510k, amma wanda sarrafawa gaba ɗaya ko sarrafawa na musamman zasu iya samar da tabbacin aminci da tasiri.

 Dokokin da suka danganci 
Dokar Wheeler-Lea, ta zartar a 1938, ta ba Hukumar Ciniki ta Tarayya ikon kula da tallace-tallace na duk samfuran da FDA ta tsara, ban da magungunan magani.

 Muhimman gyare-gyare da dokoki masu alaƙa 
Ana iya samun bayanin waɗannan a shafin yanar gizon FDA.

Gyara:

 Durham-Humphrey Amendment, Public Law (PL) 82-215 (Oktoba 26, 1951) ya haifar da matsayin magani kawai don wasu kwayoyi
 Amincewar Magunguna ("Kefauver Harris Amendment") PL 87-781 (Oktoba 10, 1962) 
 Vitamin-Mineral Amendment ("Proxmire Amendment") (Afrilu 22, 1976) ya haramta FDA daga kafa ka'idoji don iyakance ƙarfin bitamin da ma'adanai a cikin kayan abinci ko tsara su a matsayin magunguna bisa ga ƙarfin su kawai.
 Gyaran Kula da Cin Hanci da Magunguna na 1965
 Gyaran Kayan Kiwon Lafiya na 1976 PL 94-295 (Mayu 28, 1976) 
 Dokar Tsarin Jariri ta 1980, PL 96-359 (Oktoba 26, 1980) 
 Dokar Magungunan Marayu, PL 97-414 (Janairu 4, 1983) 
 Dokar Gasar Farashin Magunguna da Dokar Maido da Lokaci na 1984, PL 98-417 (aka Hatch-Waxman) (Satumba 24, 1984) 
 Dokar Kasuwancin Magunguna ta 1987, PL 100-293 (18 ga Agusta, 1988) 
 Dokar Maido da Magungunan Dabbobi na 1988, PL 100-670 (Nuwamba 16, 1988) 
 Dokar Labarin Abinci da Ilimi ta 1990, PL 101-535 (8 ga Nuwamba, 1990) 
 Gyaran Kayan Kiwon Lafiya na 1990, PL 101-629 (Nuwamba 28, 1990) 
 Gyaran Kayan Kiwon Lafiya na 1992, PL 102-300 (Yuni 16, 1992) 
 Dokar Haraji ta Mai Amfani da Magunguna (PDUFA) ta 1992, PL 102-571 (29 ga Oktoba, 1992) 
 Dokar Bayyana Amfani da Magunguna ta Dabbobi (AMDUCA) ta 1994, PL 103-396 (Oktoba 22, 1994) 
 Dokar Kula da Lafiya da Ilimi ta 1994, PL 103-417 (Oktoba 25, 1994) 
 Dokar Kare Ingancin Abinci ta 1996, PL 104-170 (Agusta 3, 1996) 
 Dokar Samun Magungunan Dabbobi ta 1996, PL 104-250 (Oktoba 9, 1996) 
 Dokar Magunguna mafi Kyawu ga Yara, PL 107-109 (Janairu 4, 2002) 
 Dokar Haraji da Sabuntawa (MDUFMA) na 2002, PL 107-250 (Oktoba 26, 2002) 
 Dokar Haraji ta Mai Amfani da Magunguna ta 2003, PL 108-130 (Fabrairu 20, 2003) 
 Dokar Daidaitaccen Binciken Yara ta 2003, PL 108-155 (Disamba 3, 2003) 
 Dokar Lafiya ta Dabbobi ta 2004 PL 108-282 (Agusta 2, 2004) 
 Dokar Labarin Abinci da Dokar Kare Abokin Ciniki ta 2004, PL 108-282 (2 ga Agusta, 2004) 
 Dokar Sabunta Tsaro ta Abinci ta FDA (Janairu 4, 2011) 
 Amincewa da Kudin Mai Amfani da Magunguna na 2012 
 Dokar Magunguna ta Karni na 21, PL 114-255 (Disamba 13, 2016)   
 Dokar Sabuntawa ta FDA ta 2017, PL 115-52 (Agusta 18, 2017) 

Sauran dokoki: 

 Dokar Kula da Biology ta 1902 (an soke ta; don tarihin tarihi) 
 Dokar Abinci da Magunguna ta Tarayya ta 1906 (an soke ta; don tarihin tarihi) 
 Dokar Binciken Nama ta Tarayya (Maris 4, 1907) 
 Dokar Hukumar Ciniki ta Tarayya (Satumba 26, 1914) 
 Dokar Fitar da Milk (Maris 4, 1923) 
 Dokar shigo da madara (Fabrairu 15, 1927) 
 Dokar Kula da Lafiya ta Jama'a (Yuli 1, 1944) 
 Dokar Kasuwanci ta 1946 (Yuli 5, 1946) 
 Shirin sake tsarawa 1 na 1953 (Maris 12, 1953) 
 Dokar Binciken Kayayyakin Tsuntsu (Agusta 28, 1957) 
 Dokar Kayan kwalliya da lakabi (Nuwamba 3, 1966) 
 Dokar Manufofin Muhalli ta Kasa ta 1969 (Janairu 1, 1970) 
 Dokar Kula da Abubuwa (Oktoba 27, 1970) 
 Dokar Kula da Abubuwa da Fitarwa (Oktoba 27, 1970) 
 Dokar Binciken Kayayyakin Kwai (29 ga Disamba, 1970) 
 Dokar Rigakafin Kiwon Lafiya ta Lead-Based Paint (Janairu 13, 1971) 
 Dokar Kwamitin Ba da Shawara ta Tarayya (Oktoba 6, 1972) 
 Gwamnati a cikin Dokar Sunshine (Satumba 13, 1976) 
 Dokar Manufofin Gwamnati ta 1980 (12 ga Disamba, 1980) 
 Dokar Tsayayya da Takarda ta Tarayya (Oktoba 13, 1983) 
 Dokar Sufurin Abinci na Sanitary (Nuwamba 3, 1990) 
 Dokar Sabunta Abinci da Magunguna (Nuwamba 28, 1990) 
 Dokar Ingancin Mammography (MQSA) (Oktoba 27, 1992) 
 Dokar Gudanar da Abinci da Magunguna (Nuwamba 21, 1997) 
 Dokar Ta'addanci ta 2002 (Yuni 12, 2002) 
 Dokar BioShield ta 2004 (Yuli 21, 2004) 
 Dokar Gyaran Abinci da Magunguna ta 2007 (Satumba 27, 2007) 
 Dokar Gyara izini ta 2013 (H.R. 307; Majalisa ta 113) Pub.  L.   (Maris 13, 2013) 

 Kwatanta da dokokin jihar 
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.[<span title="This claim needs references to reliable sources. (February 2017)">citation needed</span>]

 Dokar Kula da Kayan shafawa ta California ta 2005

 Dubi kuma 

 Magunguna a Amurka
 Gudanar da Abinci
 Dokar Kare Ingancin Abinci
 Kefauver Harris Amendment
 Jerin kayan abinci
 Ofishin Binciken Laifuka
 Dokar Abinci Mai Tsarki da Magunguna
 Gudanar da kayan warkewa
 100,000,000 Guinea Pigs (c. 1933 littafin da ya rinjayi sashi na wannan Dokar) 

 Manazarta 

Rukuni:Shafuka masu fassarorin da ba'a duba ba