{"id":7116,"date":"2026-08-31T08:15:03","date_gmt":"2026-08-31T12:15:03","guid":{"rendered":"https:\/\/worldvapersalliance.com\/?p=7116"},"modified":"2026-08-31T08:15:03","modified_gmt":"2026-08-31T12:15:03","slug":"the-us-is-moving-fast-on-pouches-the-eu-should-follow-its-lead","status":"publish","type":"post","link":"https:\/\/worldvapersalliance.com\/ro\/the-us-is-moving-fast-on-pouches-the-eu-should-follow-its-lead\/","title":{"rendered":"SUA se mi\u0219c\u0103 rapid \u00een privin\u021ba burselor antidrog, iar UE ar trebui s\u0103-i urmeze exemplul."},"content":{"rendered":"

Chiar s\u0103pt\u0103m\u00e2na trecut\u0103, Administra\u021bia pentru Alimente \u0219i Medicamente din SUA (FDA) <\/span>autorizat<\/span><\/a> 11 noi plicule\u021be de nicotin\u0103 vor intra pe pia\u021ba american\u0103, dup\u0103 ce au trecut prin procesul de solicitare pre-comercializare a produselor din tutun (PMTA) al agen\u021biei.\u00a0<\/span><\/p>\n

Aceasta aduce num\u0103rul total de plicule\u021be cu nicotin\u0103 autorizate de FDA la <\/span>43<\/span><\/a>, dintre care 15 au fost aprobate abia \u00een august, iar 21 \u00een ultimul an. 23 din cele 43, inclusiv acest ultim lot, au trecut printr-un program pilot pe care FDA l-a creat special pentru a accelera revizuirile cererilor de comercializare a pungilor.<\/span><\/p>\n

\u00cen timp ce Washington DC construie\u0219te rute mai rapide pentru a oferi produse cu nicotin\u0103 cu risc mai sc\u0103zut fum\u0103torilor adul\u021bi, Bruxelles-ul continu\u0103 s\u0103 sus\u021bin\u0103 c\u0103 acestea sunt la fel de d\u0103un\u0103toare ca fumatul \u0219i ar trebui restric\u021bionate, dac\u0103 nu chiar interzise.<\/span><\/p>\n

Un program care ofer\u0103<\/b><\/h4>\n

FDA <\/span>program pilot pentru pungi de nicotin\u0103<\/span><\/a> face ceea ce sugereaz\u0103 \u0219i numele s\u0103u. Potrivit agen\u021biei, aceasta a dus la o rezolvare mai rapid\u0103 a problemelor \u0219tiin\u021bifice, la un timp de r\u0103spuns mai scurt pentru solicitan\u021bii care r\u0103spund la scrisori \u0219i la evalu\u0103ri mai eficiente \u00een general.\u00a0<\/span><\/p>\n

FDA implementeaz\u0103 acum aceast\u0103 metod\u0103 \u00een cadrul procesului s\u0103u mai amplu de evaluare a performan\u021bei \u00een tutun (PMTA). Dar aceasta nu este o aprobare implicit\u0103, FDA \u00eenc\u0103 mai are nevoie de dovezi care s\u0103 ateste c\u0103 un produs ofer\u0103 un beneficiu mai mare pentru s\u0103n\u0103tatea popula\u021biei dec\u00e2t un risc, iar pentru acest lot de plicule\u021be, a constatat niveluri mai sc\u0103zute de constituen\u021bi nocivi \u0219i poten\u021bial nocivi dec\u00e2t \u00een alte produse din tutun f\u0103r\u0103 fum, unele dintre ele fiind prea sc\u0103zute pentru a fi m\u0103car cuantificate!<\/span><\/p>\n

Ideea este c\u0103 rigoarea \u0219i eficien\u021ba s-au dovedit a nu se exclude reciproc, a\u0219a cum a declarat Bret Koplow, directorul interimar al Centrului pentru Produse din Tutun al FDA. <\/span>a declarat<\/span><\/a> dup\u0103 ce a aprobat alte 6 plicule\u021be de nicotin\u0103 anul trecut. Agen\u021bia a descoperit cum s\u0103 men\u021bin\u0103 \u0219tacheta ridicat\u0103, reduc\u00e2nd \u00een acela\u0219i timp timpul necesar produselor pentru a o elimina, iar fiecare zi care economise\u0219te este cu o zi mai devreme dec\u00e2t un fum\u0103tor adult poate trece la ceva mai pu\u021bin d\u0103un\u0103tor.<\/span><\/p>\n

Europa nu poate ajunge la un acord privind pungile<\/b><\/h4>\n

UE de\u021bine deja cele mai bune dovezi din lume c\u0103 plicule\u021bele de nicotin\u0103 func\u021bioneaz\u0103 \u0219i se afl\u0103 \u00een interiorul propriilor grani\u021be. Suedia a trecut<\/span> sub 5% fumat zilnic<\/span><\/a>, devenind prima \u021bar\u0103 care a atins pragul f\u0103r\u0103 fumat al OMS, cu 15 ani \u00eenainte de obiectivul UE pentru 2040.\u00a0<\/span><\/p>\n

Aceast\u0103 schimbare vine \u00een urma unei cre\u0219teri a utiliz\u0103rii plicule\u021belor cu nicotin\u0103, iar rezultatul este clar: b\u0103rba\u021bii suedezi au o rat\u0103 a mortalit\u0103\u021bii prin cancer pulmonar cu 61% sub media UE, iar num\u0103rul total de decese cauzate de cancer \u00een aceast\u0103 regiune este cu 34% mai mic. Acesta este exact mecanismul men\u021bionat de FDA atunci c\u00e2nd a autorizat plicule\u021bele: un produs cu risc mai mic care \u00eei \u00eendep\u0103rteaz\u0103 pe fum\u0103tori de \u021big\u0103ri. Cu toate acestea, propria decizie a Comisiei Europene... <\/span>evaluare<\/span><\/a> din legile sale privind tutunul men\u021bioneaz\u0103 Suedia \u00een principal ca un avertisment cu privire la utilizarea plicule\u021belor de nicotin\u0103, nu ca studiul de caz care este.<\/span><\/p>\n

Reticen\u021ba de a \u00eenv\u0103\u021ba de la singura \u021bar\u0103 a UE care a rezolvat problema se reflect\u0103 \u00een mozaicul restului blocului comunitar. Fran\u021ba a interzis v\u00e2nzarea, importul, de\u021binerea \u0219i utilizarea produselor cu nicotin\u0103 pe cale oral\u0103 \u00eencep\u00e2nd cu 1 aprilie, unul dintre cele mai stricte regimuri din Europa. Belgia a interzis complet fabricarea \u0219i comercializarea din 2022. Germania trateaz\u0103 plicule\u021bele ca alimente noi, produc\u00e2nd un mozaicul de interdic\u021bii regionale \u00een loc de o singur\u0103 regul\u0103 na\u021bional\u0103. Multe alte state membre ale UE nu au \u00eenc\u0103 legisla\u021bie privind plicule\u021bele cu nicotin\u0103. O Directiv\u0103 revizuit\u0103 privind produsele din tutun, care ar putea armoniza \u00een sf\u00e2r\u0219it regulile, este a\u0219teptat\u0103 s\u0103 fie propus\u0103 de Comisia European\u0103 p\u00e2n\u0103 la sf\u00e2r\u0219itul anului.<\/span><\/p>\n

Birocra\u021bii UE \u0219tiu mai bine dec\u00e2t FDA?<\/b><\/h4>\n

Aceast\u0103 reticen\u021b\u0103 are un nume: comisarul pentru s\u0103n\u0103tate Oliv\u00e9r V\u00e1rhelyi. \u00cen septembrie 2025, V\u00e1rhelyi <\/span>tweeted<\/span><\/a> c\u0103 \u201cnicotina... provoac\u0103 cancer\u201d. \u00centr-o<\/span> r\u0103spuns scris adresat deputatului european Kristoffer Storm<\/span><\/a>, V\u00e1rhelyi a declarat c\u0103 produsele cu nicotin\u0103 f\u0103r\u0103 fum \u201cnu reduc riscurile pentru s\u0103n\u0103tate\u201d \u00een compara\u021bie cu \u021big\u0103rile. C\u00e2nd Comisia a avut nevoie de dovezi care s\u0103-\u0219i sus\u021bin\u0103 pozi\u021bia conform c\u0103reia noile produse cu nicotin\u0103 prezint\u0103 riscuri \u201ccomparabile cu cele ale fumatului\u201d,<\/span> Raportul a contrazis propriile surse citate<\/span><\/a>, care a constatat c\u0103 produsele pe baz\u0103 de nicotin\u0103 f\u0103r\u0103 combustie prezint\u0103 un risc sc\u0103zut \u00een compara\u021bie cu fumatul \u021big\u0103rilor.<\/span><\/p>\n

O <\/span>Sondajul din 2025 \u00een r\u00e2ndul eurodeputa\u021bilor<\/span><\/a> s-a constatat c\u0103 ponderea celor care consider\u0103 produsele noi pe baz\u0103 de nicotin\u0103 cel pu\u021bin la fel de d\u0103un\u0103toare ca fumatul a crescut de la 19% la 33% \u00eentr-un an. Acest lucru este important deoarece aceia\u0219i deputa\u021bi europeni vor vota asupra urm\u0103torului cadru de control al tutunului al UE, elaborat de propriul departament al lui V\u00e1rhelyi, DG SANTE, \u00eenainte ca acesta s\u0103 ajung\u0103 la Parlament \u0219i Consiliu.<\/span><\/p>\n

\u0218tiin\u021ba, nu ideologia, ar trebui s\u0103 decid\u0103 viitorul unui produs mult mai sigur dec\u00e2t \u021big\u0103rile. Dac\u0103 FDA poate fi riguroas\u0103 \u0219i rapid\u0103, factorii de decizie europeni pot fi supu\u0219i acelora\u0219i standarde.<\/span><\/p>","protected":false},"excerpt":{"rendered":"

Just last week, the US Food and Drug Administration (FDA) authorised 11 new nicotine pouches to enter the American market, clearing them through the agency\u2019s premarket tobacco product application (PMTA) process.\u00a0 That brings the total number of FDA-authorised nicotine pouches to 43, of which 15 have been approved only in August, and 21 in the […]<\/p>\n","protected":false},"author":14,"featured_media":7119,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[17],"tags":[],"class_list":["post-7116","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"yoast_head":"\nThe US is moving fast on pouches, the EU should follow its lead - World Vapers' Alliance<\/title>\n<meta name=\"description\" content=\"The FDA is speeding nicotine pouch approvals while the EU considers bans, despite Sweden\u2019s success in reducing smoking through safer alternatives.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/worldvapersalliance.com\/ro\/the-us-is-moving-fast-on-pouches-the-eu-should-follow-its-lead\/\" \/>\n<meta property=\"og:locale\" content=\"ro_RO\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The US is moving fast on pouches, the EU should follow its lead - 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