{"id":29144,"date":"2025-06-06T09:45:27","date_gmt":"2025-06-06T07:45:27","guid":{"rendered":"https:\/\/cosmeservice.com\/noticias\/mocra-u-otc-de-la-fda-que-aplica-a-tu-producto-cosmetico\/"},"modified":"2025-07-11T09:09:38","modified_gmt":"2025-07-11T07:09:38","slug":"mocra-u-otc-de-la-fda-que-aplica-a-tu-producto-cosmetico","status":"publish","type":"post","link":"https:\/\/cosmeservice.com\/es\/noticias\/mocra-u-otc-de-la-fda-que-aplica-a-tu-producto-cosmetico\/","title":{"rendered":"MoCRA u OTC de la FDA: \u00bfQu\u00e9 aplica a tu producto cosm\u00e9tico?"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"29144\" class=\"elementor elementor-29144 elementor-28329\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-929fb88 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-eae-slider=\"61795\" data-id=\"929fb88\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-0b0eda5\" data-eae-slider=\"43587\" data-id=\"0b0eda5\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-14e95d3 elementor-widget elementor-widget-text-editor\" data-id=\"14e95d3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h5 data-start=\"174\" data-end=\"538\"><strong data-start=\"174\" data-end=\"222\">MoCRA u OTC: \u00bfcu\u00e1l se aplica a tu producto?<\/strong><\/h5><p data-start=\"174\" data-end=\"538\">Con la entrada en vigor de la Modernization of Cosmetics Regulation Act (MoCRA) (MoCRA) y los requisitos existentes para los Over-the-Counter (OTC), entender si su producto entra dentro de la normativa <strong data-start=\"413\" data-end=\"429\">MoCRA u OTC<\/strong> es m\u00e1s cr\u00edtico que nunca para las empresas que pretenden vender productos cosm\u00e9ticos en Estados Unidos.<\/p><p data-start=\"540\" data-end=\"602\">Si tu producto se comercializa en Estados Unidos, quiz\u00e1 te preguntas:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-c18006d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-eae-slider=\"19087\" data-id=\"c18006d\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-61839ce\" data-eae-slider=\"56417\" data-id=\"61839ce\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3e43a34 elementor-widget elementor-widget-heading\" data-id=\"3e43a34\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\u00bfMi producto est\u00e1 sujeto a la MoCRA, a OTC o a ambas?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-54362ee elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-eae-slider=\"20856\" data-id=\"54362ee\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-d67bd80\" data-eae-slider=\"49003\" data-id=\"d67bd80\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e553f43 elementor-widget elementor-widget-text-editor\" data-id=\"e553f43\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Este art\u00edculo te ayudar\u00e1 a determinar la reglamentaci\u00f3n correcta, a entender los productos bordeline y a identificar los requisitos de cumplimiento espec\u00edficos que debe cumplir tu empresa.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-597561d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-eae-slider=\"36842\" data-id=\"597561d\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-d1df42e\" data-eae-slider=\"82783\" data-id=\"d1df42e\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-25662dc elementor-widget elementor-widget-heading\" data-id=\"25662dc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\u00bfQu\u00e9 est\u00e1 contemplado por MoCRA de la FDA?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-073289e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-eae-slider=\"54893\" data-id=\"073289e\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-122450a\" data-eae-slider=\"16316\" data-id=\"122450a\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-8682028 elementor-widget elementor-widget-text-editor\" data-id=\"8682028\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>La <strong>Modernization of Cosmetics Regulation Act de 2022 (MoCRA)<\/strong> es una importante reforma de la <strong>regulaci\u00f3n estadounidense de cosm\u00e9ticos<\/strong> en virtud de la Ley Federal de Alimentos, Medicamentos y Cosm\u00e9ticos (FD&amp;C Act). Introduce nuevos requisitos obligatorios para las empresas que venden <strong>productos cosm\u00e9ticos<\/strong> en el mercado estadounidense. <\/p><p>El cumplimiento de MoCRA se aplica a los productos destinados a <strong>limpiar, embellecer, promover el atractivo o alterar la apariencia<\/strong>, siempre que no afecten a la estructura o funci\u00f3n del organismo.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-0edde57 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-eae-slider=\"27529\" data-id=\"0edde57\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-edfbf56\" data-eae-slider=\"9168\" data-id=\"edfbf56\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-8a3bb84 elementor-widget elementor-widget-heading\" data-id=\"8a3bb84\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Requisitos de MoCRA:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-de13ab1 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-eae-slider=\"68053\" data-id=\"de13ab1\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7a6f4d1\" data-eae-slider=\"42843\" data-id=\"7a6f4d1\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-399a948 elementor-widget elementor-widget-text-editor\" data-id=\"399a948\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li><strong>Registro de instalaciones FDA<\/strong><\/li><li><strong>Listado de productos cosm\u00e9ticos FDA<\/strong><\/li><li><strong>Informe de efectos adversos<\/strong> y mantenimiento de registros de seguridad<\/li><li><strong>Documentaci\u00f3n sobre seguridad<\/strong> para garantizar que el producto es seguro en las condiciones de uso indicadas en la etiqueta.<\/li><li><strong>Actualizaciones del etiquetado<\/strong>, incluida la declaraci\u00f3n obligatoria de al\u00e9rgenos<\/li><li>Cumplimiento de las <strong>Buenas Pr\u00e1cticas de Fabricaci\u00f3n (GMP)<\/strong> (exigidas por la FDA en futuras normas)<\/li><\/ul><p>\u00a0<\/p><p>MoCRA se aplica a todos los productos cosm\u00e9ticos, incluidos los de cuidado de la piel, maquillaje, fragancias y productos de higiene personal, que no est\u00e9n clasificados como medicamentos.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-9695b5c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-eae-slider=\"63143\" data-id=\"9695b5c\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5750b83\" data-eae-slider=\"72525\" data-id=\"5750b83\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-286d874 elementor-widget elementor-widget-heading\" data-id=\"286d874\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\u00bfQu\u00e9 son los OTC?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-7fa6f49 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-eae-slider=\"18886\" data-id=\"7fa6f49\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c333096\" data-eae-slider=\"92391\" data-id=\"c333096\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e2ed512 elementor-widget elementor-widget-text-editor\" data-id=\"e2ed512\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Los productos de venta libre (OTC)<\/strong> son <strong>f\u00e1rmacos<\/strong> que no requieren receta m\u00e9dica y que est\u00e1n regulados por una normativa independiente de la <strong>FDA sobre medicamentos<\/strong>. Est\u00e1n destinados a tratar, prevenir o mitigar afecciones m\u00e9dicas. <\/p><p>Los OTC suelen encontrarse en categor\u00edas de cuidado personal, como:<\/p><ul><li><strong>Tratamientos contra el acn\u00e9<\/strong> (per\u00f3xido de benzoilo, \u00e1cido salic\u00edlico)<\/li><li><strong>Protectores solares<\/strong> (Claims de SPF)<\/li><li><strong>Champ\u00fas anticaspa<\/strong><\/li><li><strong>Antitranspirantes <\/strong>(frente a los desodorantes, que son cosm\u00e9ticos)<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-c984827 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-eae-slider=\"39959\" data-id=\"c984827\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-03e5c77\" data-eae-slider=\"55320\" data-id=\"03e5c77\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c100dc8 elementor-widget elementor-widget-heading\" data-id=\"c100dc8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Principales requisitos de los OTC:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-6275109 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-eae-slider=\"16728\" data-id=\"6275109\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-9b0efa6\" data-eae-slider=\"7309\" data-id=\"9b0efa6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b7fc17a elementor-widget elementor-widget-text-editor\" data-id=\"b7fc17a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>Cumplimiento de una <strong>monograf\u00eda de la FDA <\/strong>o presentaci\u00f3n de una <strong>solicitud de nuevo medicamento (NDA)<\/strong><\/li><li><strong>Registro del establecimiento<\/strong> y <strong>listado de productos<\/strong> en la base de datos de la FDA<\/li><li><strong>Etiquetado detallado del producto<\/strong>, incluidos los principios activos, la posolog\u00eda y las advertencias.<\/li><li>Cumplimiento de las <strong>BPF (GMP)<\/strong> en la fabricaci\u00f3n de productos farmac\u00e9uticos<\/li><\/ul><p>\u00a0<\/p><p>Los OTC deben hacer <strong>claims terap\u00e9uticos<\/strong>, que no est\u00e1n permitidas por MoCRA a menos que el producto cumpla tambi\u00e9n la normativa sobre medicamentos.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-441e976 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-eae-slider=\"28840\" data-id=\"441e976\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-71d7e21\" data-eae-slider=\"18946\" data-id=\"71d7e21\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3e2ac11 elementor-widget elementor-widget-heading\" data-id=\"3e2ac11\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Productos borderline: Puede aplicarse la doble condici\u00f3n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-c52b3cd elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-eae-slider=\"44418\" data-id=\"c52b3cd\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6accb64\" data-eae-slider=\"55722\" data-id=\"6accb64\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-295d949 elementor-widget elementor-widget-text-editor\" data-id=\"295d949\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Algunos productos se sit\u00faan en la intersecci\u00f3n entre los cosm\u00e9ticos y los medicamentos, lo que se conoce como <strong>productos bordeline<\/strong>. Estos productos pueden estar regulados tanto por MoCRA como por OTC en <strong>funci\u00f3n de su uso previsto<\/strong>,<strong> etiquetado<\/strong> y <strong>claims<\/strong>. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-7a82e1f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-eae-slider=\"65977\" data-id=\"7a82e1f\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-993afe0\" data-eae-slider=\"27967\" data-id=\"993afe0\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-39911e6 elementor-widget elementor-widget-heading\" data-id=\"39911e6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Ejemplos habituales de productos borderline:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-42eb8d9 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-eae-slider=\"42910\" data-id=\"42eb8d9\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-a5873e7\" data-eae-slider=\"28452\" data-id=\"a5873e7\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c208491 elementor-widget elementor-widget-text-editor\" data-id=\"c208491\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>Una crema hidratante facial con SPF \u2192 <strong>OTC + cosm\u00e9tico<\/strong>.<\/li><li>Un champ\u00fa con claims anticaspa \u2192 <strong>OTC + cosm\u00e9tico<\/strong><\/li><li>Un limpiador facial con propiedades antiacn\u00e9 \u2192<strong> OTC + cosm\u00e9tico<\/strong><\/li><li>Una loci\u00f3n corporal que dice aliviar los s\u00edntomas del eczema \u2192 <strong>OTC<\/strong><\/li><\/ul><p>\u00a0<\/p><p>La clasificaci\u00f3n bordeline no se basa \u00fanicamente en los ingredientes, sino principalmente en los <strong>claims de marketing<\/strong> y la funcionalidad del producto. Las empresas deben tener cuidado con la forma en que presentan su producto en las etiquetas, los sitios web y los materiales promocionales.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-243f8ad elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-eae-slider=\"71136\" data-id=\"243f8ad\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-3aa791f\" data-eae-slider=\"22589\" data-id=\"3aa791f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-877d3b4 elementor-alert-info elementor-widget elementor-widget-alert\" data-id=\"877d3b4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"alert.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-alert\" role=\"alert\">\n\n\t\t\t\t\t\t<span class=\"elementor-alert-title\">Tenga en cuenta:<\/span>\n\t\t\t\n\t\t\t\t\t\t<span class=\"elementor-alert-description\"> Cuando un producto se califica a la vez de cosm\u00e9tico y de OTC, siempre se aplicar\u00e1n los requisitos reglamentarios m\u00e1s estrictos. Las empresas deben garantizar el pleno cumplimiento del marco de medicamentos, adem\u00e1s de las obligaciones de MoCRA, especialmente en lo que respecta a las normas BPF y las normas del etiquetado. <\/span>\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-e48d0d7 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-eae-slider=\"90273\" data-id=\"e48d0d7\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-2af8dec\" data-eae-slider=\"16407\" data-id=\"2af8dec\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-40755b0 elementor-widget elementor-widget-heading\" data-id=\"40755b0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">C\u00f3mo ayuda Cosmeservice a cumplir con la FDA<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9af393b elementor-widget elementor-widget-text-editor\" data-id=\"9af393b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Cosmeservice ayuda a empresas de todo el mundo a cumplir la regulaci\u00f3n cosm\u00e9ticos y OTC de la FDA para entrar en el mercado estadounidense. Tanto si su producto est\u00e1 sujeto a la normativa <strong>MoCRA<\/strong> como a <strong>OTC<\/strong>, o a ambas, nosotros se lo proporcionamos:<\/p><ul><li>Servicios de registro de instalaciones y listado de productos de la FDA<\/li><li>Revisi\u00f3n de las clasificaciones de productos borderline y estrategia reguladora<\/li><li>Orientaci\u00f3n sobre el etiquetado, la documentaci\u00f3n de seguridad y la evaluaci\u00f3n de los claims<\/li><li>Apoyo para el cumplimiento de la monograf\u00eda OTC y los pasos de entrada en el mercado de EE.UU.<\/li><li>Actualizaciones normativas constantes y asesoramiento para sus necesidades de cumplimiento.<\/li><\/ul><p>Si desea comercializar su producto OTC en EE.UU., visite nuestra nueva p\u00e1gina de registro <strong><span style=\"text-decoration: underline;\"><a href=\"https:\/\/cosmeservice.com\/es\/servicios\/regulacion-ee-uu\/registro-otc\/\">OTC para iniciar el proceso de regulaci\u00f3n<\/a><\/span><\/strong> con Cosmeservice. Ponte en contacto con nosotros para evaluar tu producto y agilizar el proceso normativo con la FDA: <span style=\"text-decoration: underline;\"><a href=\"mailto:info@cosmeservice.com\"><strong>info@cosmeservice.com<\/strong><\/a><\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-5d35a9a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-eae-slider=\"32027\" data-id=\"5d35a9a\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-df40947\" data-eae-slider=\"85391\" data-id=\"df40947\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2004bbe elementor-mobile-align-left elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-button\" data-id=\"2004bbe\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/cosmeservice.com\/es\/servicios\/regulacion-ee-uu\/registro-otc\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Registro OTC<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-f76c892\" data-eae-slider=\"58050\" data-id=\"f76c892\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-f5b477b elementor-mobile-align-left elementor-widget elementor-widget-button\" data-id=\"f5b477b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/cosmeservice.com\/es\/servicios\/mocra-agente-eeuu\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">MoCRA<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-9bcf057 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-eae-slider=\"61272\" data-id=\"9bcf057\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-e31ef29\" data-eae-slider=\"75838\" data-id=\"e31ef29\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-acca0a5 elementor-widget elementor-widget-text-editor\" data-id=\"acca0a5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h5><strong>Referencias<\/strong><\/h5><ul><li><span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/modernization-cosmetics-regulation-act-2022-mocra\">FDA: MoCRA Compliance Overview<\/a><\/span><\/li><li><a href=\"https:\/\/www.fda.gov\/drugs\/over-counter-otc-nonprescription-drugs\/over-counter-otc-drug-review-otc-monograph-reform-cares-act\"><span style=\"text-decoration: underline;\">FDA: OTC Drug Monograph Reform<\/span><\/a><\/li><li><a href=\"https:\/\/www.fda.gov\/regulatory-information\/laws-enforced-fda\/federal-food-drug-and-cosmetic-act-fdc-act\"><span style=\"text-decoration: underline;\">Federal Food, Drug, and Cosmetic Act (FD&amp;C Act)<\/span><\/a><\/li><li><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/cfrsearch.cfm\"><span style=\"text-decoration: underline;\">21 CFR \u2013 Code of Federal Regulations<\/span><\/a><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>MoCRA u OTC: \u00bfcu\u00e1l se aplica a tu producto? Con la entrada en vigor de la Modernization of Cosmetics Regulation Act (MoCRA) (MoCRA) y los requisitos existentes para los Over-the-Counter (OTC), entender si su producto entra dentro de la normativa MoCRA u OTC es m\u00e1s cr\u00edtico que nunca para las empresas que pretenden vender productos [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":29124,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAowjay7DA:productID":"","_joinchat":[],"footnotes":""},"categories":[364],"tags":[],"class_list":["post-29144","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-noticias"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MoCRA o OTC: \u00bfQu\u00e9 aplica tus cosm\u00e9ticos? | Cosmeservice<\/title>\n<meta name=\"description\" content=\"\u00bfTu producto cosm\u00e9tico est\u00e1 sujeto a MoCRA o OTC? 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