{"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\/es\/the-us-is-moving-fast-on-pouches-the-eu-should-follow-its-lead\/","title":{"rendered":"Estados Unidos est\u00e1 avanzando r\u00e1pidamente en materia de bolsas de pl\u00e1stico; la UE deber\u00eda seguir su ejemplo."},"content":{"rendered":"<p><span style=\"font-weight: 400;\">La semana pasada, la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) <\/span><a href=\"https:\/\/www.fda.gov\/tobacco-products\/ctp-newsroom\/fda-authorizes-11-new-nicotine-pouches\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">autorizado<\/span><\/a><span style=\"font-weight: 400;\"> Once nuevos envases de bolsitas de nicotina entrar\u00e1n en el mercado estadounidense, tras superar el proceso de solicitud de autorizaci\u00f3n previa a la comercializaci\u00f3n de productos de tabaco (PMTA, por sus siglas en ingl\u00e9s) de la agencia.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Eso eleva el n\u00famero total de bolsitas de nicotina autorizadas por la FDA a <\/span><a href=\"https:\/\/www.fda.gov\/tobacco-products\/market-and-distribute-tobacco-product\/nicotine-pouch-products-authorized-fda\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">43<\/span><\/a><span style=\"font-weight: 400;\">, De las cuales, 15 fueron aprobadas solo en agosto y 21 en el \u00faltimo a\u00f1o. Veintitr\u00e9s de las 43, incluido este \u00faltimo lote, pasaron por un programa piloto que la FDA cre\u00f3 espec\u00edficamente para acelerar las revisiones de las solicitudes de comercializaci\u00f3n de envases tipo bolsa.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Mientras que Washington D.C. est\u00e1 creando v\u00edas m\u00e1s r\u00e1pidas para que los fumadores adultos puedan acceder a productos de nicotina de menor riesgo, Bruselas sigue argumentando que son tan da\u00f1inos como fumar y que deber\u00edan restringirse, si no prohibirse.<\/span><\/p>\n<h4><b>Un programa que ofrece<\/b><\/h4>\n<p><span style=\"font-weight: 400;\">La FDA <\/span><a href=\"https:\/\/www.fda.gov\/tobacco-products\/ctp-newsroom\/fda-launches-program-more-efficiently-review-nicotine-pouch-applications\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">programa piloto de bolsitas de nicotina<\/span><\/a><span style=\"font-weight: 400;\"> Hace lo que su nombre indica. Seg\u00fan la agencia, ha propiciado una resoluci\u00f3n m\u00e1s r\u00e1pida de los problemas cient\u00edficos, una menor demora en la respuesta de los solicitantes a las cartas y revisiones m\u00e1s eficientes en general.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">La FDA ahora lo est\u00e1 incorporando a su proceso PMTA m\u00e1s amplio. Pero esto no es una aprobaci\u00f3n autom\u00e1tica; la FDA a\u00fan requiere evidencia de que un producto ofrece mayores beneficios para la salud p\u00fablica que riesgos, y para este lote de bolsitas, encontr\u00f3 niveles m\u00e1s bajos de componentes da\u00f1inos y potencialmente da\u00f1inos que en otros productos de tabaco sin humo, \u00a1varios de ellos demasiado bajos incluso para cuantificarlos!<\/span><\/p>\n<p><span style=\"font-weight: 400;\">La cuesti\u00f3n aqu\u00ed es que el rigor y la eficiencia no resultaron ser mutuamente excluyentes, como lo afirm\u00f3 Bret Koplow, director interino del Centro de Productos de Tabaco de la FDA. <\/span><a href=\"https:\/\/www.fda.gov\/tobacco-products\/ctp-newsroom\/fda-authorizes-6-nicotine-pouch-products-completing-review-record-time\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">fijado<\/span><\/a><span style=\"font-weight: 400;\"> Tras aprobar otras seis bolsitas de nicotina el a\u00f1o pasado, la agencia logr\u00f3 mantener los est\u00e1ndares altos a la vez que reduc\u00eda el tiempo necesario para que los productos los superaran. Cada d\u00eda que se ahorra, es un d\u00eda antes de que un fumador adulto pueda cambiar a algo menos da\u00f1ino.<\/span><\/p>\n<h4><b>Europa no logra ponerse de acuerdo sobre las bolsas.<\/b><\/h4>\n<p><span style=\"font-weight: 400;\">La UE ya tiene la mejor evidencia del mundo de que las bolsitas de nicotina funcionan, y se encuentra dentro de sus propias fronteras. Suecia cruz\u00f3<\/span><a href=\"https:\/\/smokefreesweden.org\/2026\/04\/07\/sensational-new-data-shows-sweden-already-smoke-free\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\"> por debajo de 5% fumando diariamente<\/span><\/a><span style=\"font-weight: 400;\">, Con ello, se convierte en el primer pa\u00eds en alcanzar el umbral de la OMS para un pa\u00eds libre de humo, 15 a\u00f1os antes del objetivo de la UE para 2040.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Ese cambio se produce tras un aumento en el uso de bolsitas de nicotina, y el resultado es claro: los hombres suecos tienen una tasa de mortalidad por c\u00e1ncer de pulm\u00f3n 61% inferior a la media de la UE, y el total de muertes por c\u00e1ncer all\u00ed es 34% menor. Este es precisamente el mecanismo que cit\u00f3 la FDA cuando autoriz\u00f3 las bolsitas: un producto de menor riesgo que aleja a los fumadores de los cigarrillos. Sin embargo, la propia Comisi\u00f3n Europea <\/span><a href=\"https:\/\/health.ec.europa.eu\/tobacco\/evaluation-legislative-framework-tobacco-control_en\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">evaluaci\u00f3n<\/span><\/a><span style=\"font-weight: 400;\"> En sus leyes sobre el tabaco, Suecia se menciona principalmente como una advertencia sobre el uso de bolsitas de nicotina, y no como el caso de estudio que realmente es.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">La reticencia a aprender del \u00fanico pa\u00eds de la UE que resolvi\u00f3 el problema se refleja en el mosaico normativo del resto del bloque. Francia prohibi\u00f3 la venta, importaci\u00f3n, posesi\u00f3n y uso de productos de nicotina oral a partir del 1 de abril, uno de los reg\u00edmenes m\u00e1s estrictos de Europa. B\u00e9lgica prohibi\u00f3 su fabricaci\u00f3n y comercializaci\u00f3n por completo desde 2022. Alemania considera las bolsitas como nuevos alimentos, lo que genera un mosaico de prohibiciones regionales en lugar de una normativa nacional \u00fanica. Muchos otros Estados miembros de la UE a\u00fan no cuentan con legislaci\u00f3n sobre las bolsitas de nicotina. Se espera que la Comisi\u00f3n Europea proponga a finales de a\u00f1o una Directiva revisada sobre productos del tabaco que podr\u00eda armonizar finalmente la normativa.<\/span><\/p>\n<h4><b>\u00bfAcaso los bur\u00f3cratas de la UE saben m\u00e1s que la FDA?<\/b><\/h4>\n<p><span style=\"font-weight: 400;\">Esa desgana tiene un nombre: el comisario de Sanidad, Oliv\u00e9r V\u00e1rhelyi. En septiembre de 2025, V\u00e1rhelyi <\/span><a href=\"https:\/\/clearingtheair.eu\/en\/post\/exclusive-varheyli-tweets-then-deletes-false-claim-that-nicotine-causes-cancer\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">tuite\u00f3<\/span><\/a><span style=\"font-weight: 400;\"> que \u201cla nicotina\u2026causa c\u00e1ncer\u201d. En un<\/span><a href=\"https:\/\/worldvapersalliance.com\/en_gb\/commissioner-varhelyi-denies-science-again\/\" target=\"_blank\" rel=\"noopener\"> <span style=\"font-weight: 400;\">Respuesta escrita al eurodiputado Kristoffer Storm<\/span><\/a><span style=\"font-weight: 400;\">, V\u00e1rhelyi afirm\u00f3 que los productos de nicotina sin humo \u201cno reducen el riesgo para la salud\u201d en comparaci\u00f3n con los cigarrillos. Cuando la Comisi\u00f3n necesit\u00f3 pruebas para respaldar su postura de que los nuevos productos de nicotina conllevan riesgos \u201ccomparables a los del tabaquismo\u201d,<\/span><a href=\"https:\/\/clearingtheair.eu\/en\/post\/factually-wrong-experts-destroy-study-used-by-eu-commission-to-justify-nicotine-clampdown\/\" target=\"_blank\" rel=\"noopener\"> <span style=\"font-weight: 400;\">El informe contradec\u00eda sus propias fuentes citadas.<\/span><\/a><span style=\"font-weight: 400;\">, que concluy\u00f3 que los productos de nicotina sin combusti\u00f3n conllevan un riesgo bajo en comparaci\u00f3n con fumar cigarrillos.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">A <\/span><a href=\"https:\/\/clearingtheair.eu\/en\/post\/a-third-of-meps-say-novel-nicotine-products-are-as-harmful-as-smoking\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Encuesta de eurodiputados de 2025<\/span><\/a><span style=\"font-weight: 400;\"> Se constat\u00f3 que el porcentaje de personas que consideran que los nuevos productos de nicotina son al menos tan da\u00f1inos como fumar aument\u00f3 de 191 TP4T a 331 TP4T en un a\u00f1o. Esto es importante porque esos mismos eurodiputados votar\u00e1n el pr\u00f3ximo marco de control del tabaco de la UE, redactado por el propio departamento de V\u00e1rhelyi, la DG SANTE, antes de que llegue al Parlamento y al Consejo.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">La ciencia, no la ideolog\u00eda, deber\u00eda decidir el futuro de un producto mucho m\u00e1s seguro que los cigarrillos. Si la FDA puede ser rigurosa y r\u00e1pida, los legisladores europeos pueden estar sujetos al mismo est\u00e1ndar.<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>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 [&hellip;]<\/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":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>The US is moving fast on pouches, the EU should follow its lead - World Vapers&#039; 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