{"id":3950,"date":"2019-09-11T11:20:00","date_gmt":"2019-09-11T15:20:00","guid":{"rendered":"https:\/\/www.merkley.senate.gov\/merkley-fda-e-cigarettes-move-outrageously-overdue\/"},"modified":"2023-07-24T11:07:27","modified_gmt":"2023-07-24T15:07:27","slug":"merkley-fda-e-cigarettes-move-outrageously-overdue","status":"publish","type":"post","link":"https:\/\/www.merkley.senate.gov\/es\/merkley-fda-e-cigarettes-move-outrageously-overdue\/","title":{"rendered":"Merkley: FDA e-cigarettes move &#8216;outrageously overdue&#8217;"},"content":{"rendered":"<p>WASHINGTON-&nbsp;<em>(Update: Merkley reacts to FDA move on flavored e-cigarettes)<\/em><\/p>\n<p>Sen. Jeff Merkley, D-Ore., the top Democrat on the Appropriations Subcommittee that oversees the Food and Drug Administration, released the following statement after the FDA announced that it is temporarily pulling all flavored e-cigarette products from the market:<\/p>\n<p>&#8220;This action is outrageously overdue. It&#8217;s been clear for years that an epidemic of youth e-cigarette addiction was building; that companies were surgically targeting teens in their product and marketing strategies; and that the long-term health impacts of e-cigarette use were unknown and potentially dire. Now, we have a growing crisis of serious lung disease linked to vaping, in which six have died and the average age of affected patients is just 19 years old. &nbsp;&nbsp;<\/p>\n<p>&#8220;It should never have taken multiple deaths and hundreds of cases of teenagers with lung disease for the FDA to conclude that e-cigarette flavors like &lsquo;gummy bear,&#8217; &lsquo;Scooby snacks,&#8217; and &lsquo;strawberries and cream&#8217; are insidious and have no place on the market. I can only hope that today&#8217;s action is made permanent soon, and that it will come in time to save the thousands of lives that may still be at risk.&#8221;<\/p>\n<p>Earlier Wednesday, Merkley, D-Ore., and Richard Blumenthal, D-Conn., led 21 colleagues in demanding answers from the heads of health agencies on their actions to address the health impacts of e-cigarette products, as illnesses and even deaths are increasingly linked to vaping.<\/p>\n<p>Ya, seis personas, incluida una en Oreg\u00f3n, han perdido la vida debido a una enfermedad pulmonar grave asociada con el vapeo, y m\u00e1s de 450 personas en 33 estados han sido diagnosticadas con enfermedades relacionadas con el uso de cigarrillos electr\u00f3nicos. Dado que las empresas de cigarrillos electr\u00f3nicos se dirigen a los j\u00f3venes, la edad promedio de los pacientes diagnosticados con estas graves enfermedades pulmonares es de 19 a\u00f1os.<\/p>\n<blockquote>\n<p><span>&#8220;For years, we have written to you and your predecessors about the dangers of youth use of e-cigarettes, but public health agencies&mdash;particularly the Food and Drug Administration (FDA)&mdash;have failed to act swiftly and comprehensively to address the epidemic of youth use of addictive e-cigarette products,&#8221;&nbsp;<\/span>escribieron los senadores en una carta a los jefes del Departamento de Salud y Servicios Humanos de EE. UU., la Administraci\u00f3n de Alimentos y Medicamentos y los Centros para el Control y la Prevenci\u00f3n de Enfermedades.<\/p>\n<p><span>&#8220;&hellip;We believe the spike of more than 450 cases of severe lung disease in adolescents and young adults is a public health crisis that warrants more aggressive and immediate action,&#8221;&nbsp;<\/span>continuaron los senadores.&nbsp;<span>&#8220;This action should include the following: a strong, clear message to the public about what is currently known about the dangers of e-cigarette use; immediate removal from the market of e-cigarette products that have been linked or could be linked to the pulmonary illnesses and deaths; and FDA&#8217;s immediate enforcement of the required public health review of e-cigarette products with the authority granted to FDA under the Tobacco Control Act. FDA should also immediately take action to remove flavored products from the market, until or unless they have undergone FDA review that shows they are of benefit to the public health.&#8221;<\/span><\/p>\n<section class=\"mod-ad mod-wrapper story-body-ad\" id=\"story-body-ad-7-109823423169601\">\n<div id=\"ep-ad-slot-1568906045280-5\" class=\"ep-ad-slot\" data-lazy-loaded=\"rendered\">\n<div id=\"google_ads_iframe_\/6123\/ktvz\/news_5__container__\"><\/div>\n<\/div>\n<\/section>\n<\/blockquote>\n<p>Adem\u00e1s de Merkley y Blumenthal, los cosignatarios incluyen a los senadores estadounidenses Edward J. Markey (D-MA), Sherrod Brown (D-OH), Patty Murray (D-WA), Brian Schatz (D-HI), Dick Durbin (D -IL), Tom Udall (D-NM), Chris Van Hollen (D-MD), Dianne Feinstein (D-CA), Jack Reed (D-RI), Ron Wyden (D-OR), Margaret Wood Hassan (D -NH), Bob Menendez (D-NJ), Patrick Leahy (D-VT), Jeanne Shaheen (D-NH), Robert Casey (D-PA), Sheldon Whitehouse (D-RI), Kamala Harris (D-CA ), Kirsten Gillibrand (D-NY), Elizabeth Warren (D-MA), Mazie Hirono (D-HI) y Cory Booker (D-NJ).<\/p>\n<p>Adem\u00e1s de pedir acci\u00f3n inmediata, los senadores pidieron respuestas a las siguientes preguntas para la pr\u00f3xima semana:<\/p>\n<ol type=\"1\">\n<li>Proporcione descripciones de todos los productos y muestras que la FDA est\u00e1 analizando actualmente en relaci\u00f3n con la enfermedad pulmonar grave, incluido el tipo de producto y las sustancias que contienen.<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<ol type=\"1\">\n<li>\u00bfCu\u00e1l es el cronograma estimado para completar la investigaci\u00f3n y determinar si un producto o sustancia espec\u00edfica est\u00e1 relacionada con una enfermedad pulmonar, incluidas las muertes en Kansas, California, Illinois, Indiana, Minnesota y Oreg\u00f3n?<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<ol type=\"1\">\n<li>\u00bfSe identificar\u00e1n p\u00fablicamente y retirar\u00e1n del mercado los productos de cigarrillos electr\u00f3nicos que est\u00e1n vinculados, o podr\u00edan estarlo, a los casos de enfermedades pulmonares y muertes? \u00bfPor qu\u00e9 o por qu\u00e9 no?<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<ol type=\"1\">\n<li>\u00bfC\u00f3mo se coordinan la FDA y los CDC con los departamentos de salud estatales para abordar las enfermedades pulmonares asociadas con los cigarrillos electr\u00f3nicos?<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<ol type=\"1\">\n<li>\u00bfQu\u00e9 esfuerzos y consideraciones se est\u00e1n dando actualmente para comenzar de inmediato a hacer cumplir los requisitos de revisi\u00f3n de productos o establecer condiciones m\u00e1s estrictas para permitir que los productos permanezcan en el mercado antes de una revisi\u00f3n de salud p\u00fablica por parte de la FDA dado el brote actual de enfermedades pulmonares?<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<ol type=\"1\">\n<li>\u00bfLa FDA, los CDC y el HHS proporcionar\u00e1n actualizaciones semanales por teleconferencia al personal del Congreso a medida que contin\u00faa la investigaci\u00f3n?<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<p>La carta completa se encuentra&nbsp;<a href=\"https:\/\/www.merkley.senate.gov\/es\/download\/e-cigarette-letter-2019\/\">aqu\u00ed<\/a>&nbsp;y por debajo.<\/p>\n<p>&nbsp;<\/p>\n<p align=\"center\">###<\/p>\n<p>11 de septiembre de 2019<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>Estimado Secretario Azar, Comisionado Interino Sharpless y Director Redfield:<\/p>\n<p>&nbsp;<\/p>\n<p>Escribimos con gran alarma sobre el aumento de informes de enfermedad pulmonar grave en m\u00faltiples estados asociados con el uso de productos de cigarrillos electr\u00f3nicos (dispositivos, l\u00edquidos, c\u00e1psulas de recarga y\/o cartuchos). Seis personas en Kansas, California, Illinois, Indiana, Minnesota y Oreg\u00f3n ya han perdido la vida debido a una enfermedad pulmonar grave asociada con el vapeo. El uso de cigarrillos electr\u00f3nicos ha enfermado a m\u00e1s de 450 personas en 33 estados, incluidos muchos adolescentes y adultos j\u00f3venes, con una edad promedio de pacientes diagnosticados con enfermedad pulmonar grave de 19 a\u00f1os.<\/p>\n<p>&nbsp;<\/p>\n<p>Durante a\u00f1os, le hemos escrito a usted y a sus predecesores sobre los peligros del uso de cigarrillos electr\u00f3nicos por parte de los j\u00f3venes, pero las agencias de salud p\u00fablica, en particular la Administraci\u00f3n de Alimentos y Medicamentos (FDA), no han actuado de manera r\u00e1pida y exhaustiva para abordar la epidemia de la juventud. uso de productos adictivos de cigarrillos electr\u00f3nicos.<\/p>\n<p>&nbsp;<\/p>\n<p>FDA&#8217;s failure to fully implement and enforce the Family Smoking Prevention and Tobacco Control Act (TCA) and require Premarket Tobacco Applications (PMTA) for all e-cigarette products has allowed e-cigarette companies to flood the market with e-cigarette products that use nicotine salts to deliver high levels of nicotine; products are often accompanied with kid-friendly flavors. By delaying its public health review of products that were on the market as of August 8, 2016, and not rigorously enforcing the public health review requirement for products that entered the market after that date, FDA has permitted thousands of e-cigarettes to enter and remain on the market with no assessment of their health risks, addictiveness, or appeal to youth.<\/p>\n<p>&nbsp;<\/p>\n<p>While the cause of the outbreak of severe pulmonary disease is still unknown, FDA&#8217;s failure to adequately regulate e-cigarette products on the market has created an environment where dangerous products have flourished and put children&#8217;s health at risk. FDA has the authority to regulate all e-cigarette products and components&mdash;regardless of the substances and chemicals included or added to them, where and how the products are purchased, and\/or whether or not the products are modified. FDA must use this power going forward and play a leadership role in ending this epidemic.<\/p>\n<p>&nbsp;<\/p>\n<p>Although your agencies have launched public health awareness campaigns, sent warning letters to some manufacturers whose products have violated the FDA&#8217;s 2016 &#8220;deeming rule,&#8221; released a recent health advisory, and taken other moderate steps, we believe the spike of more than 450 cases of severe lung disease in adolescents and young adults is a public health crisis that warrants more aggressive and immediate action. This action should include the following: a strong, clear message to the public about what is currently known about the dangers of e-cigarette use; immediate removal from the market of e-cigarette products that have been linked or could be linked to the pulmonary illnesses and deaths; and FDA&#8217;s immediate enforcement of the required public health review of e-cigarette products with the authority granted to FDA under the Tobacco Control Act. FDA should also immediately take action to remove flavored products from the market, until or unless they have undergone FDA review that shows they are of benefit to the public health.<\/p>\n<p>&nbsp;<\/p>\n<p>Estamos listos para apoyar sus esfuerzos para abordar esta crisis de salud p\u00fablica y solicitamos sus respuestas a lo siguiente a m\u00e1s tardar el viernes 20 de septiembre de 2019:<\/p>\n<p>&nbsp;<\/p>\n<ol type=\"1\">\n<li>Proporcione descripciones de todos los productos y muestras que la FDA est\u00e1 analizando actualmente en relaci\u00f3n con la enfermedad pulmonar grave, incluido el tipo de producto y las sustancias que contienen.<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<ol type=\"1\">\n<li>\u00bfCu\u00e1l es el cronograma estimado para completar la investigaci\u00f3n y determinar si un producto o sustancia espec\u00edfica est\u00e1 relacionada con una enfermedad pulmonar, incluidas las muertes en Kansas, California, Illinois, Indiana, Minnesota y Oreg\u00f3n?<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<ol type=\"1\">\n<li>\u00bfSe identificar\u00e1n p\u00fablicamente y retirar\u00e1n del mercado los productos de cigarrillos electr\u00f3nicos que est\u00e1n vinculados, o podr\u00edan estarlo, a los casos de enfermedades pulmonares y muertes? \u00bfPor qu\u00e9 o por qu\u00e9 no?<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<ol type=\"1\">\n<li>\u00bfC\u00f3mo se coordinan la FDA y los CDC con los departamentos de salud estatales para abordar las enfermedades pulmonares asociadas con los cigarrillos electr\u00f3nicos?<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<ol type=\"1\">\n<li>\u00bfQu\u00e9 esfuerzos y consideraciones se est\u00e1n dando actualmente para comenzar de inmediato a hacer cumplir los requisitos de revisi\u00f3n de productos o establecer condiciones m\u00e1s estrictas para permitir que los productos permanezcan en el mercado antes de una revisi\u00f3n de salud p\u00fablica por parte de la FDA dado el brote actual de enfermedades pulmonares?<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<ol type=\"1\">\n<li>\u00bfLa FDA, los CDC y el HHS proporcionar\u00e1n actualizaciones semanales por teleconferencia al personal del Congreso a medida que contin\u00faa la investigaci\u00f3n?<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<p>Atentamente,<\/p>","protected":false},"excerpt":{"rendered":"<p>WASHINGTON &#8211;&nbsp;(Update: Merkley reacts to FDA move on flavored e-cigarettes) Sen. Jeff Merkley, D-Ore., the top Democrat on the Appropriations Subcommittee that oversees the Food and Drug Administration, released the following statement after the FDA announced that it is temporarily pulling all flavored e-cigarette products from the market: &#8220;This action is outrageously overdue. It&#8217;s been [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[26],"tags":[],"class_list":["post-3950","post","type-post","status-publish","format-standard","hentry","category-in-the-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Merkley: FDA e-cigarettes move &#039;outrageously overdue&#039; - Merkley<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.merkley.senate.gov\/es\/merkley-fda-e-cigarettes-move-outrageously-overdue\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Merkley: FDA e-cigarettes move &#039;outrageously overdue&#039; - Merkley\" \/>\n<meta property=\"og:description\" content=\"WASHINGTON &#8211;&nbsp;(Update: Merkley reacts to FDA move on flavored e-cigarettes) Sen. Jeff Merkley, D-Ore., the top Democrat on the Appropriations Subcommittee that oversees the Food and Drug Administration, released the following statement after the FDA announced that it is temporarily pulling all flavored e-cigarette products from the market: &#8220;This action is outrageously overdue. 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