{"id":3337,"date":"2022-04-12T09:59:11","date_gmt":"2022-04-12T01:59:11","guid":{"rendered":"https:\/\/regask.com\/?p=3337"},"modified":"2024-10-16T02:57:07","modified_gmt":"2024-10-15T18:57:07","slug":"fda-nac-no-es-un-suplemento-dietetico","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/fda-nac-not-dietary-supplement\/","title":{"rendered":"La FDA confirma que la NAC est\u00e1 excluida de la definici\u00f3n de D\u2026"},"content":{"rendered":"<div><a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">La Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA)<\/a> rechaz\u00f3 la solicitud en dos peticiones ciudadanas, del Consejo para la Nutrici\u00f3n Responsable (CRN) y la Asociaci\u00f3n de Productos Naturales (NPA), pidiendo a la agencia que determine que los productos que contienen N-acetil-L-ciste\u00edna (NAC) no est\u00e1n excluidos de la definici\u00f3n de suplemento diet\u00e9tico seg\u00fan la secci\u00f3n 201(ff)(3)(B)(i) de la Ley Federal de Alimentos, Medicamentos y Cosm\u00e9ticos (FD&amp;C Act).<\/div>\n<div><\/div>\n<div>Si bien la respuesta de la FDA a las peticiones ciudadanas confirm\u00f3 que la NAC est\u00e1 excluida de la definici\u00f3n de suplemento diet\u00e9tico, la agencia a\u00fan no ha tomado una decisi\u00f3n sobre la solicitud alternativa de la petici\u00f3n ciudadana de la NPA de que la agencia emprenda la elaboraci\u00f3n de normas para permitir el uso de la NAC en suplementos diet\u00e9ticos. La FDA contin\u00faa analizando esta solicitud.<\/div>\n<div><\/div>\n<div>Mientras tanto, en vista de la ausencia de preocupaciones de seguridad basadas en la revisi\u00f3n de la FDA hasta la fecha, entre otros factores, la FDA est\u00e1 considerando ejercer discreci\u00f3n de cumplimiento para los productos que contienen NAC etiquetados como suplementos diet\u00e9ticos que ser\u00edan suplementos diet\u00e9ticos comercializados legalmente si la NAC no estuviera excluida de la definici\u00f3n de suplemento diet\u00e9tico y no violaran de otro modo la Ley FD&amp;C. La FDA tiene la intenci\u00f3n de emitir una gu\u00eda sobre su pol\u00edtica sobre los productos que contienen NAC etiquetados como suplementos diet\u00e9ticos en el futuro cercano.<\/div>\n<div><\/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<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-576472085\">\n\n\t<div id=\"col-2091408204\" 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 de los Estados Unidos (FDA) rechaz\u00f3 la solicitud en dos peticiones ciudadanas, del Consejo para la Nutrici\u00f3n Responsable (CRN) y la Asociaci\u00f3n de Productos Naturales (NPA), pidiendo a la agencia que determine que los productos que contienen N-acetil-L-ciste\u00edna (NAC) no est\u00e1n excluidos de la definici\u00f3n de suplemento diet\u00e9tico seg\u00fan la secci\u00f3n 201(ff)(3)(B)(i) de la Ley Federal de Alimentos, Medicamentos,\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-3337","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 v28.4 (Yoast SEO v28.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA: NAC Not a Dietary Supplement | RegASK<\/title>\n<meta name=\"description\" content=\"The FDA confirms that NAC is excluded from the definition of a dietary supplement. 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