Yadda FDA ke Kula da Kasuwar Samfuran COVID-19 |Morrison & Foerster LLP

FDA tana da himma sosai "ta lura da yanayin yanayin kan layi don samfuran zamba waɗanda miyagu ƴan wasan kwaikwayo ke sawa don cin gajiyar wannan annoba ta duniya."Hukumar ta ce ta gano daruruwan kayayyakin COVID-19 na damfara, wadanda suka hada da magunguna, kayan gwaji, da kuma PPE da aka siyar ta kan layi tare da da'awar da ba a tabbatar ba.Yana aiki tare da kasuwannin kan layi, masu rajistar sunan yanki, masu sarrafa biyan kuɗi, da gidajen yanar gizo na kafofin watsa labarun don cire da'awar da ba ta da tabbas daga dandamalin su.

Har zuwa yau, FDA ta fitar da wasiƙun gargaɗi sama da 65.A wasu lokuta, FDA ta bi waɗancan wasiƙun gargaɗi ta hanyar tambayar DOJ don fara ƙarar shari'a a kan masana'anta.Ga wasu nau'ikan samfuran, FDA ta yi amfani da sanarwar latsa don samar da ingantaccen faɗakarwa ga duk masana'antun a sararin samaniya.A ƙasa mun tsara duk ƙoƙarin tilastawa da FDA ke amfani da ita don ƙoƙarin kiyaye samfuran COVID-19 na yaudara daga kasuwa.

FDA da FTC sun aika da wasiƙun gargaɗi na farko watanni uku da suka gabata.Yanzu, FDA ta ba da aƙalla wasiƙun gargaɗi guda 66 ga kamfanonin da ke siyar da samfuran zamba tare da da'awar hanawa, tantancewa, magani, ragewa, ko warkar da COVID-19.

Samfuran sun haɗa da (1) samfuran CBD, (2) ƙarin abubuwan abinci da bitamin, (3) mai mai mahimmanci, (4) samfuran ganye, (5) samfuran homeopathic, (6) samfuran sanitizer, (7) samfuran da aka lakafta don ƙunshi chlorine dioxide. ko azurfa colloidal, da (8) wasu.FDA ta dauki batun tare da da'awar tallace-tallace daban-daban - kama daga #coronavirus hashtags zuwa maganganun da aka yi akan windows masu tasowa.Jadawalin da ke ƙasa yana lissafin haruffan gargaɗi ta nau'in samfur kuma yana gano wasu maganganun matsala waɗanda FDA ta gano.Wannan ginshiƙi ya kamata ya kasance da amfani don taimakawa wajen tantance inda FDA ke mai da hankali kan ƙoƙarin aiwatar da shi idan ya zo ga da'awar COVID-19.Hakanan ana ba da hanyoyin haɗin kai zuwa haruffan gargaɗi don kowane samfur.

Protocol Coronavirus (Coronavirus Boneset Tea, Coronavirus Cell Kariya, Coronavirus Core tincture, Coronavirus Immune System, da Elderberry Tincture)

"Quicksilver Liposomal Vitamin C tare da Liposomal," "Jigsaw Magnesium Tare da SRT," da samfuran da aka yi wa lakabi da azurfa.

"Superblue Azurfa Immune Gargle," "SuperSilver Whitening Man goge baki," "SuperSilver Rauni Dressing Gel" da "Superblue Fluoride Free Haƙori"

HealthMax Nano-Silver Liquid, Silver Biotics Silver Lozenges tare da Vitamin C, da Silver Biotics Silver Gel Ultimate Skin & Jiki Kulawa (gare, "kayan ku azurfa")

Azurfa, samfuran CBD, aidin, naman magani, selenium, zinc, bitamin C, bitamin D3, astragalus, da dattijon

"China Oral Nosode," wanda aka kwatanta da "AN330 - CORONA VIRAL Immune Support and/Ko Active Respiratory INFECTION DON KOWANNE ZAMANI"

Wasiƙun gargaɗi na FDA sun ƙaru zuwa matakin shari'a a cikin aƙalla lokuta biyu.Kamar yadda muka ruwaito a baya, FDA ta gargadi mai siyar da kayayyakin chlorine dioxide da ya cire kayayyakinsa daga kasuwa cikin awanni 48.Bayan mai siyar "sun bayyana cewa ba su da niyyar daukar matakin gyara," DOJ ta sami odar hana ta wucin gadi a kansa.

Hakazalika, DOJ ta sami odar taƙaitawa ta wucin gadi a kan mai siyar da samfuran azurfar colloidal wanda, duk da "cire] shafukan yanar gizon su na COVID-19 na ɗan lokaci, ...sun dawo tallata kayayyakinsu na azurfa a matsayin magani ga COVID-19 wanda ya saba wa doka."

A cikin shari'o'in biyu, FDA ta nuna akwai karancin isassun bayanai don kafa aminci da ingancin samfuran don “kowane amfani,” balle don sabon coronavirus.Hukumar ta nuna damuwarta cewa irin wadannan ikirari na iya sa masu sayayya su jinkirta ko dakatar da jinyar da ta dace.Ko da yake ya bai wa masana'antun samfurin damar daukar matakin gyara, daga karshe ya biyo baya kan barazanar daukar matakin doka.

FDA ta kuma yi amfani da sanarwar manema labarai na yau da kullun don sadarwa tare da masana'antun samfuran COVID-19, musamman a gida da masana'antun gwajin serology.

A cikin irin wannan sanarwar, FDA ta yi gargadin cewa ba ta ba da izinin kowane gwaji don tattara kai ba - duk da yunƙurin gwaje-gwajen da ke shirin shiga kasuwa.Kwanan nan ya nuna ƙarin buɗewa ga ra'ayi, kodayake.Kamar yadda muka bayar da rahoto a baya, ta ba da izinin amfani da gaggawa (EUA) zuwa kayan tattarawa na gida, na'urar tattara kayan yau da kullun a gida, da kuma na'urar tattara gida kadai.Har ma ya fara samar da Samfurin Samfuran Gida na Molecular Diagnostic EUA Template don ƙara tallafawa haɓaka gwaje-gwaje don tattara kai a gida.

Hakazalika, FDA ta buga sanarwar manema labarai da yawa kamar wannan wanda ke bayyana matsayinta akan gwajin serology.A baya hukumar ta ba da kyakkyawan tsari don gwaje-gwajen serology, tun tsakiyar watan Maris, ta ba da izinin sayar da gwajin rigakafin kasuwanci da amfani da shi ba tare da nazarin FDA EUA ba idan sun bi wasu sharudda.Amma FDA ta sabunta wannan manufar a watan da ya gabata, jim kadan bayan wani karamin kwamiti na majalisar ya soki hukumar saboda “rashin [an sanda]” kasuwar gwajin cutar sankara ta coronavirus.

RA'AYI: Saboda gabaɗayan wannan sabuntawa, bayanin da aka bayar anan bazai iya amfani da shi ba a kowane yanayi kuma bai kamata a yi aiki da shi ba tare da takamaiman shawarar doka dangane da takamaiman yanayi ba.

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Wannan gidan yanar gizon yana amfani da kukis don haɓaka ƙwarewar mai amfani, bin diddigin amfani da rukunin yanar gizo, adana alamun izini da raba izini akan hanyoyin sadarwar zamantakewa.Ta ci gaba da bincika wannan gidan yanar gizon kun yarda da amfani da kukis.Danna nan don karanta ƙarin game da yadda muke amfani da kukis.

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Lokacin aikawa: Juni-11-2020