I-FDA Iyiqapha Kanjani Imakethe Yomkhiqizo Ye-COVID-19 |Morrison & Foerster LLP

I-FDA ngenkuthalo “iqapha [i]qapha i-ecosystem eku-inthanethi yemikhiqizo yomgunyathi ethengiswa abadlali ababi abafuna ukuzuza kulo bhubhane lomhlaba wonke.”Le nhlangano ithi ithole amakhulu emikhiqizo ye-COVID-19 yomgunyathi, okuhlanganisa nezidakamizwa, izinto zokuhlola, kanye ne-PPE ethengiswa ku-inthanethi ngezimangalo ezingaqinisekisiwe.Isebenza nezimakethe eziku-inthanethi, ababhalisi bamagama esizinda, abacubunguli bokukhokha, namawebhusayithi enkundla yezokuxhumana ukuze kususwe izimangalo ezingenabufakazi ezinkundleni zabo.

Kuze kube manje, i-FDA isikhiphe izincwadi eziyisixwayiso ezingaphezu kuka-65.Ezimweni ezithile, i-FDA ilandele lezo zincwadi eziyisixwayiso ngokucela i-DOJ ukuthi iqale izinyathelo zomthetho ezisemthethweni ngokumelene nomkhiqizi womkhiqizo.Kwezinye izigaba zemikhiqizo, i-FDA isebenzise izimemezelo zabezindaba ukuze inikeze ngempumelelo isexwayiso esijwayelekile kubo bonke abakhiqizi abasesikhaleni.Ngezansi sibhala kuthebula yonke imizamo yokuphoqelela ebilokhu isetshenziswa yi-FDA ukuzama ukugcina imikhiqizo yomgunyathi ye-COVID-19 ingangeni emakethe.

I-FDA ne-FTC bathumele umzuliswano wabo wokuqala wezincwadi eziyisixwayiso ezinyangeni ezintathu ezedlule.Manje, i-FDA isikhiphe okungenani izincwadi eziyisixwayiso ezingama-66 eziya kumafemu athengisa imikhiqizo yomgunyathi ezinezicelo zokuvikela, ukuxilonga, ukwelapha, ukunciphisa, noma ukwelapha i-COVID-19.

Imikhiqizo ihlanganisa (1) imikhiqizo ye-CBD, (2) izithako zokudla namavithamini, (3) amafutha abalulekile, (4) imikhiqizo ye-herbal, (5) imikhiqizo ye-homeopathic, (6) imikhiqizo ye-sanitizer, (7) imikhiqizo ebhalwe ukuthi iqukethe i-chlorine dioxide. noma isiliva le-colloidal, kanye (8) nabanye.I-FDA ibambene ngezimangalo ezahlukene zokumaketha—kusukela kuma-hashtag e-#coronavirus kuya ezitatimendeni ezenziwe kumafasitela azivelelayo.Ishadi elingezansi libonisa izinhlamvu zezexwayiso ngesigaba somkhiqizo futhi likhomba ezinye zezitatimende eziyinkinga i-FDA ezihlonziwe.Leli shadi lesithenjwa kufanele libe usizo ekusizeni ukunquma ukuthi i-FDA igxile kuphi emizamweni yayo yokuphoqelela uma kuziwa ezimangalweni ze-COVID-19.Izixhumanisi zezinhlamvu eziyisixwayiso nazo zinikezwe umkhiqizo ngamunye.

I-Coronavirus Protocol (I-Coronavirus Boneset Tea, I-Coronavirus Cell Protection, i-Coronavirus Core tincture, i-Coronavirus Immune System, kanye ne-Elderberry Tincture)

“Quicksilver Liposomal Vitamin C w/ Liposomal,” “Jigsaw Magnesium With SRT,” kanye nemikhiqizo enelebuli equkethe isiliva

“I-Superblue Silver Immune Gargle,” “I-SuperSilver Whitening Toothpaste,” “I-SuperSilver Wound Dressing Gel” kanye “Ne-Superblue Fluoride Yamahhala Yokuxubha Amazinyo”

I-HealthMax Nano-Silver Liquid, iSilver Biotics Silver Lozenges enoVithamini C, kanye neSilver Biotics Silver Gel Ultimate Skin & Body Care (zihlangene, “imikhiqizo yakho yesiliva”)

Isiliva, imikhiqizo ye-CBD, i-iodine, amakhowe okwelapha, i-selenium, i-zinc, i-vitamin C, i-vitamin D3, i-astragalus, ne-elderberry

"I-China Oral Nosode," echazwa ngokuthi "I-AN330 - UKUSEKELWA KWAMAMMUNE E-CORONA KANYE/NOMA OKUTHILE OKUSEBENZAYO OKUPHUMELELA KUYO YONKE IMINYAKA"

Izincwadi zesexwayiso ze-FDA zikhuphukele esenzweni somthetho okungenani ezimeni ezimbili.Njengoba sike sabika ngaphambilini, i-FDA ixwayise umthengisi wemikhiqizo ye-chlorine dioxide ukuthi asuse imikhiqizo yayo emakethe phakathi namahora angama-48.Ngemuva kokuthi umdayisi “ekubeke kwacaca ukuthi ubengenayo inhloso yokuthatha isinyathelo sokulungisa,” i-DOJ ithole incwadi yesivimbelo sesikhashana ngokumelene nayo.

Ngokufanayo, i-DOJ yathola umyalelo wokuvinjelwa kwesikhashana kumthengisi wemikhiqizo yesiliva eyi-colloidal okwathi, naphezu “kokususa] amakhasi ewebhu ahlobene ne-COVID-19 isikhathi esithile, ...baqale kabusha ukumaketha imikhiqizo yabo yesiliva eyi-colloidal njengendlela yokwelapha i-COVID-19 bephula umthetho.”

Kuzo zombili izimo, i-FDA iveze ukuthi kunokuntuleka kwedatha eyanele yokusungula ukuphepha nokusebenza kwemikhiqizo “noma yikuphi ukusetshenziswa,” ingasaphathwa eye-coronavirus yenoveli.Le nhlangano izwakalise ukukhathazeka ngokuthi izicelo ezinjalo zingabangela abathengi ukuba baphuze noma bayeke ukwelashwa okufanele.Nakuba inikeze abakhiqizi bomkhiqizo ithuba lokuthatha izinyathelo zokuyilungisa, ekugcineni ilandele usongo lokuthathelwa izinyathelo zomthetho.

I-FDA iphinde yasebenzisa izimemezelo zansuku zonke zabezindaba ukuxhumana nabakhiqizi bemikhiqizo ye-COVID-19, ikakhulukazi abakhiqizi basekhaya nabahlolwa be-serology.

Kwesinye isimemezelo esinjalo, i-FDA ixwayise ngokuthi ibingakagunyazi noma yikuphi ukuhlolwa kokuziqoqa-naphezu kwegagasi lezivivinyo ebezilungiselela ukungena emakethe.Isanda kukhombisa ukuvuleka okwengeziwe kulo mqondo, nokho.Njengoba sike sabika ngaphambilini, inikeze ukugunyazwa kokusetshenziswa kwezimo eziphuthumayo (i-EUA) ekhithi yokuqoqa ekhaya, ikhithi yeqoqo lasekhaya elisuselwa kumathe, kanye nekhithi yokuqoqa ezimele yasekhaya.Sesiqalile nokuhlinzeka Ngesifanekiso Se-Home Specimen Collection Molecular Diagnostic EUA ukuze siqhubeke sisekela ukuthuthukiswa kokuhlolwa kokuziqoqa ngokwakho ekhaya.

Ngokufanayo, i-FDA ishicilele izimemezelo zabezindaba ezimbalwa njengalesi esichaza ukuma kwayo ekuhlolweni kwe-serology.Le nhlangano phambilini ibigcina inqubomgomo exegiswe kahle yokuhlolwa kwe-serology, kusukela maphakathi no-Mashi, ivumela ukuhlolwa kwe-antibody ukuze kudayiswe futhi kusetshenziswe ngaphandle kokubuyekezwa kwe-FDA EUA uma belandela izindlela ezithile.Kepha i-FDA ibuyekeze le nqubomgomo ngenyanga edlule, ngemuva nje kokuthi ikomidi elincane lengqungquthela ligxeke le nhlangano “ngokungaphumeleli” kwemakethe yokuhlola i-coronavirus serological antibody.

UMUZI Wokuzihlangula: Ngenxa yokuvama kwalesi sibuyekezo, ulwazi oluhlinzekwe lapha lungase lungasebenzi kuzo zonke izimo futhi akufanele kusetshenzwe ngaphandle kweseluleko sezomthetho esisekelwe ezimweni ezithile.

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Isikhathi sokuthumela: Jun-11-2020