{"id":3435,"date":"2022-05-17T09:10:25","date_gmt":"2022-05-17T01:10:25","guid":{"rendered":"https:\/\/regask.com\/?p=3435"},"modified":"2024-11-02T04:56:48","modified_gmt":"2024-11-01T20:56:48","slug":"guia-de-la-fda-sobre-la-n-acetil-l-cisteina","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/fda-n-acetyl-l-cysteine-guidance\/","title":{"rendered":"La FDA publica un proyecto de pol\u00edtica sobre la N-acetil-L-ciste\u00edna:\u2026"},"content":{"rendered":"<div><a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">La Administraci\u00f3n de Alimentos y Medicamentos (FDA)<\/a> anuncia la disponibilidad de un borrador de gu\u00eda para la industria titulado \u201cPol\u00edtica con respecto a la N-acetil-L-ciste\u00edna: borrador de gu\u00eda para la industria\u201d. El borrador de gu\u00eda, cuando est\u00e9 finalizado, explicar\u00e1 la intenci\u00f3n de la FDA de ejercer discreci\u00f3n en materia de cumplimiento con respecto a la venta y distribuci\u00f3n de ciertos productos que contienen N-acetil-L-ciste\u00edna (NAC) y est\u00e1n etiquetados como suplementos diet\u00e9ticos.<\/div>\n<div><\/div>\n<div>Esta pol\u00edtica de discreci\u00f3n de aplicaci\u00f3n se aplicar\u00eda a productos que ser\u00edan suplementos diet\u00e9ticos comercializados legalmente si el NAC no estuviera excluido de la definici\u00f3n de \u201csuplemento diet\u00e9tico\u201d y que no violaran de otro modo la Ley Federal de Alimentos, Medicamentos y Cosm\u00e9ticos (FD&amp;C Act).<\/div>\n<div><\/div>\n<div>Los comentarios se pueden enviar hasta el 23 de mayo de 2022.<\/div>\n<div><\/div>\n<div><strong>Fondo<\/strong><\/div>\n<div><\/div>\n<div>La FDA ha determinado que, seg\u00fan la secci\u00f3n 201(ff)(3)(B)(i) de la Ley FD&amp;C (21 USC 321(ff)(3)(B)(i)), la NAC est\u00e1 excluida de la definici\u00f3n de suplemento diet\u00e9tico porque la NAC fue aprobada como un medicamento nuevo antes de que se comercializara como suplemento diet\u00e9tico o como alimento. La FDA recibi\u00f3 dos peticiones de ciudadanos que solicitaban que concluy\u00e9ramos que la NAC no est\u00e1 excluida de la definici\u00f3n de suplemento diet\u00e9tico seg\u00fan la secci\u00f3n 201(ff)(3)(B) de la Ley FD&amp;C. El 31 de marzo de 2022, la FDA rechaz\u00f3 esta solicitud.<\/div>\n<div><\/div>\n<div><strong>Leer m\u00e1s:<\/strong><\/div>\n<div><a href=\"https:\/\/regask.com\/es\/fda-confirms-nac-is-excluded-from-the-definition-of-a-dietary-supplement\/\">La FDA confirma que la NAC est\u00e1 excluida de la definici\u00f3n de suplemento diet\u00e9tico<\/a><\/div>\n<div><\/div>\n<div>\n<div>\n<div>\n<div>\n<p><a href=\"https:\/\/regask.com\/es\/contacto\/\">Comun\u00edquese con RegASK para obtener m\u00e1s informaci\u00f3n sobre los cambios regulatorios en los EE. UU.\u00a0<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<a href=\"https:\/\/regask.com\/es\/contacto\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contacte con RegASK para m\u00e1s detalles<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/www.fda.gov\/food\/cfsan-constituent-updates\/fda-issues-response-two-citizen-petitions-nac-dietary-supplements\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Leer m\u00e1s<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-2033933181\">\n\n\t<div id=\"col-1638432488\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/es\/estudios-de-caso\/recursos-estudios-de-caso-alimentos-bebidas\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lea estudios de casos de la industria alimentaria<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>La Administraci\u00f3n de Alimentos y Medicamentos (FDA) anuncia la disponibilidad de un borrador de gu\u00eda para la industria titulado \u201cPol\u00edtica sobre la N-acetil-L-ciste\u00edna: borrador de gu\u00eda para la industria\u201d. Cuando est\u00e9 finalizado, el borrador de gu\u00eda explicar\u00e1 la intenci\u00f3n de la FDA de ejercer discreci\u00f3n en materia de cumplimiento con respecto a la venta y distribuci\u00f3n de ciertos productos que contienen N-acetil-L-ciste\u00edna (NAC) y est\u00e1n etiquetados\u2026<\/p>","protected":false},"author":39,"featured_media":2909,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[34],"tags":[40],"class_list":["post-3435","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-food-beverage-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA: N-Acetyl-L-Cysteine Guidance | RegASK<\/title>\n<meta name=\"description\" content=\"The FDA issues draft guidance on N-acetyl-L-cysteine. Stay informed on the latest regulations with RegASK.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/es\/guia-de-la-fda-sobre-la-n-acetil-l-cisteina\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Issues Draft Policy Regarding N-acetyl-L-cysteine: Guidance for Industry\" \/>\n<meta property=\"og:description\" content=\"The FDA issues draft guidance on N-acetyl-L-cysteine. Stay informed on the latest regulations with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/guia-de-la-fda-sobre-la-n-acetil-l-cisteina\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2022-05-17T01:10:25+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-01T20:56:48+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2021\/07\/dietary-supplement-pills-for-protecting-knee-Joints-and-bones.png\" \/>\n\t<meta property=\"og:image:width\" content=\"688\" \/>\n\t<meta property=\"og:image:height\" content=\"626\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-n-acetyl-l-cysteine-guidance\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-n-acetyl-l-cysteine-guidance\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"FDA Issues Draft Policy Regarding N-acetyl-L-cysteine: &hellip;\",\"datePublished\":\"2022-05-17T01:10:25+00:00\",\"dateModified\":\"2024-11-01T20:56:48+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-n-acetyl-l-cysteine-guidance\\\/\"},\"wordCount\":295,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-n-acetyl-l-cysteine-guidance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/07\\\/dietary-supplement-pills-for-protecting-knee-Joints-and-bones.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Food and Nutrition\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-n-acetyl-l-cysteine-guidance\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/fda-n-acetyl-l-cysteine-guidance\\\/\",\"name\":\"FDA: N-Acetyl-L-Cysteine Guidance | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-n-acetyl-l-cysteine-guidance\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-n-acetyl-l-cysteine-guidance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/07\\\/dietary-supplement-pills-for-protecting-knee-Joints-and-bones.png\",\"datePublished\":\"2022-05-17T01:10:25+00:00\",\"dateModified\":\"2024-11-01T20:56:48+00:00\",\"description\":\"The FDA issues draft guidance on N-acetyl-L-cysteine. 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