FDA Yemerera Kwamamaza Ibicuruzwa bishya byitabi mu kanwa binyuze muri Premarket Itabi ryibicuruzwa byinzira

Amakuru Yerekana Urubyiruko, Abatanywa itabi, nabahoze banywa itabi ntibishoboka gutangiza cyangwa kongera gukoresha itabi hamwe nibicuruzwa.

Uyu munsi, Ikigo cy’Amerika gishinzwe ibiryo n’ibiyobyabwenge cyatangaje ko cyemereye kwamamaza ibicuruzwa bine bishya by’itabi byo mu kanwa byakozwe na US Smokeless Tobacco Company LLC ku izina rya Verve.Hashingiwe ku bushakashatsi bwakozwe na FDA ku bimenyetso bifatika bya siyansi biboneka mu isosiyete ikora ibicuruzwa by’itabi mbere y’isosiyete (PMTAs), ikigo cyemeje ko ibicuruzwa by’ibicuruzwa bizaba bihuje n’amategeko, “bikwiriye kurengera ubuzima rusange.”Ibi birimo gusubiramo amakuru yerekana ko urubyiruko, abatanywa itabi nabahoze banywa itabi bidashoboka gutangiza cyangwa gusubizaho itabi hamwe nibicuruzwa.Ibicuruzwa bine ni: Verve Disiki Yubururu, Verv Disk Icyatsi kibisi, Verv Chews Blue Mint, na Verv Chews Green Mint.

Yakomeje agira ati: "Kugenzura niba ibicuruzwa bishya by'itabi bisuzumwa neza na FDA ni kimwe mu bintu by'ingenzi mu nshingano zacu zo kurengera abaturage - cyane cyane abana.Mu gihe ibyo ari ibicuruzwa bifite uburyohe, amakuru yashyikirijwe FDA yerekana ko ibyago byo gufata urubyiruko kuri ibyo bicuruzwa ari bike, kandi gukumira ibicuruzwa bikaze bizafasha gukumira urubyiruko. ”, Mitch Zeller, JD, umuyobozi w'ikigo cya FDA gishinzwe ibicuruzwa by’itabi. .Ati: "Icy'ingenzi, ibimenyetso byerekana ko ibyo bicuruzwa bishobora gufasha abanywa itabi banywa ibiyobyabwenge bakoresha ibicuruzwa byangiza cyane bahinduranya ibicuruzwa bifite imiti ishobora kwangiza."

Ibicuruzwa bya Verve nibicuruzwa byitabi byo munwa birimo nikotine ikomoka ku itabi, ariko ntabwo irimo itabi ryaciwe, ubutaka, ifu cyangwa amababi.Ibicuruzwa byose uko ari bine birashya hanyuma bikajugunywa, aho kumirwa, iyo umukoresha arangije nibicuruzwa.Disiki na chew biratandukanye mubice byimiterere yabyo.Byombi biroroshye, ariko disiki zirakomeye, kandi guhekenya biroroshye.Ibicuruzwa bigenewe abakoresha itabi bakuze.

Mbere yo kwemerera ibicuruzwa bishya by’itabi binyuze mu nzira ya PMTA, FDA igomba, mu mategeko, kuzirikana, mu bindi, bishoboka ko abakoresha itabi muri iki gihe bahagarika gukoresha ibicuruzwa by’itabi ndetse n’uko bishoboka ko abakoresha ubu batangira gukoresha ibicuruzwa by’itabi.Ubushakashatsi bwerekana ko bishoboka cyane ko urubyiruko, abatanywa itabi, cyangwa abahoze banywa itabi bashobora gutangiza cyangwa kugarura itabi hamwe nibicuruzwa bya Verve.Muri iki gihe abakoresha ibicuruzwa bya Verve hamwe n’abakoresha bahindura rwose ibicuruzwa bya Verve muri rusange bahura n’ibintu bike byangiza kandi bishobora kwangiza ugereranije n’itabi n’ibindi bicuruzwa by’itabi bitagira umwotsi.Ikigo cyashyize ahagaragara incamake yicyemezo gisobanura neza ishingiro ryo gutanga ibicuruzwa byamamaza ibicuruzwa bine.

Uruhushya rwo kwamamaza rwatanzwe uyu munsi rwemerera ibicuruzwa bine by’itabi kugurishwa mu buryo bwemewe n’amategeko muri Amerika, ariko ntibisobanura ko ibicuruzwa bifite umutekano cyangwa “FDA byemewe,” kubera ko nta bicuruzwa by’itabi bifite umutekano.

Byongeye kandi, FDA ishyiraho amategeko akomeye yukuntu ibicuruzwa bya Verve bigurishwa ku isoko, harimo binyuze ku mbuga za interineti ndetse no ku mbuga nkoranyambaga, kugira ngo bifashe kumenya niba intego yo kwamamaza abantu bakuru gusa.FDA izasuzuma amakuru mashya aboneka yerekeye ibicuruzwa binyuze mu nyandiko zerekana ibicuruzwa na raporo zisabwa mu buryo bwo kwamamaza.Isosiyete isabwa gutanga raporo buri gihe muri FDA hamwe namakuru ajyanye nibicuruzwa ku isoko, harimo, ariko ntibigarukira gusa, ubushakashatsi burambye kandi bwuzuye bw’ubushakashatsi bw’umuguzi, kwamamaza, gahunda yo kwamamaza, amakuru yo kugurisha, amakuru ku bakoresha ubu n’abashya, impinduka z’inganda n'uburambe bubi.

FDA izakuraho itegeko ryo kwamamaza niba ryemeje ko gukomeza kwamamaza ibicuruzwa bitagikenewe mu kurengera ubuzima rusange bw’abaturage, urugero, biturutse ku gufata cyane ibicuruzwa n’urubyiruko.

Iki kigo gikomeje gukora isuzuma ryibanze ry’ibihumbi by’ibicuruzwa by’itabi kandi bikomeje kwiyemeza kuvugana n’abaturage ku iterambere, harimo no gutanga amabwiriza yo guhakana ibicuruzwa ku bicuruzwa birenga miliyoni by’ibicuruzwa bya e-itabi bidafite ibimenyetso bifatika byerekana ko bifite inyungu. ku bantu banywa itabi bakuze bihagije kugira ngo batsinde impungenge z’ubuzima rusange ziterwa n’inyandiko zanditse neza kandi zishimishije cyane ku bicuruzwa nk’urubyiruko.