{"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":"directives-de-la-fda-concernant-lacetyl-l-cysteine","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/fda-n-acetyl-l-cysteine-guidance\/","title":{"rendered":"La FDA publie un projet de politique concernant la N-ac\u00e9tyl-L-cyst\u00e9ine : \u2026"},"content":{"rendered":"<div><a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">La Food and Drug Administration (FDA)<\/a> annonce la mise \u00e0 disposition d&#039;un projet de lignes directrices pour l&#039;industrie intitul\u00e9 \u00ab Politique concernant la N-ac\u00e9tyl-L-cyst\u00e9ine : projet de lignes directrices pour l&#039;industrie \u00bb. Le projet de lignes directrices, une fois finalis\u00e9, expliquera l&#039;intention de la FDA d&#039;exercer son pouvoir discr\u00e9tionnaire en mati\u00e8re d&#039;application de la loi concernant la vente et la distribution de certains produits contenant de la N-ac\u00e9tyl-L-cyst\u00e9ine (NAC) et \u00e9tiquet\u00e9s comme compl\u00e9ments alimentaires.<\/div>\n<div><\/div>\n<div>Cette politique de discr\u00e9tion d&#039;application s&#039;appliquerait aux produits qui seraient commercialis\u00e9s l\u00e9galement comme compl\u00e9ments alimentaires si la NAC n&#039;\u00e9tait pas exclue de la d\u00e9finition de \u00ab compl\u00e9ment alimentaire \u00bb et qui ne contrevient pas par ailleurs \u00e0 la loi f\u00e9d\u00e9rale sur les aliments, les m\u00e9dicaments et les cosm\u00e9tiques (FD&amp;C Act).<\/div>\n<div><\/div>\n<div>Les commentaires peuvent \u00eatre envoy\u00e9s jusqu&#039;au 23 mai 2022.<\/div>\n<div><\/div>\n<div><strong>Historique<\/strong><\/div>\n<div><\/div>\n<div>La FDA a d\u00e9termin\u00e9 que, conform\u00e9ment \u00e0 l&#039;article 201(ff)(3)(B)(i) de la FD&amp;C Act (21 USC 321(ff)(3)(B)(i)), la NAC est exclue de la d\u00e9finition de compl\u00e9ment alimentaire car elle a \u00e9t\u00e9 approuv\u00e9e en tant que nouveau m\u00e9dicament avant d&#039;\u00eatre commercialis\u00e9e en tant que compl\u00e9ment alimentaire ou en tant qu&#039;aliment. La FDA a re\u00e7u deux p\u00e9titions de citoyens nous demandant de conclure que la NAC n&#039;est pas exclue de la d\u00e9finition d&#039;un compl\u00e9ment alimentaire en vertu de l&#039;article 201(ff)(3)(B) de la FD&amp;C Act. Le 31 mars 2022, la FDA a rejet\u00e9 cette demande.<\/div>\n<div><\/div>\n<div><strong>En savoir plus:<\/strong><\/div>\n<div><a href=\"https:\/\/regask.com\/fr\/fda-confirms-nac-is-excluded-from-the-definition-of-a-dietary-supplement\/\">La FDA confirme que la NAC est exclue de la d\u00e9finition d&#039;un compl\u00e9ment alimentaire<\/a><\/div>\n<div><\/div>\n<div>\n<div>\n<div>\n<div>\n<p><a href=\"https:\/\/regask.com\/fr\/contact-2\/\">Contactez RegASK pour en savoir plus sur les changements de r\u00e9glementation aux \u00c9tats-Unis.\u00a0<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<a href=\"https:\/\/regask.com\/fr\/contact-2\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contactez RegASK pour plus de d\u00e9tails<\/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>En savoir plus<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-271972104\">\n\n\t<div id=\"col-963932580\" 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\/fr\/etudes-de-cas\/ressources-etudes-de-cas-alimentation-boissons\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lire les \u00e9tudes de cas sur l&#039;industrie alimentaire<\/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 Food and Drug Administration (FDA) annonce la mise \u00e0 disposition d&#039;un projet de lignes directrices pour l&#039;industrie intitul\u00e9 \u00ab Politique concernant la N-ac\u00e9tyl-L-cyst\u00e9ine : projet de lignes directrices pour l&#039;industrie \u00bb. Le projet de lignes directrices, une fois finalis\u00e9, expliquera l&#039;intention de la FDA d&#039;exercer son pouvoir discr\u00e9tionnaire en mati\u00e8re d&#039;application de la loi concernant la vente et la distribution de certains produits contenant de la N-ac\u00e9tyl-L-cyst\u00e9ine (NAC) et \u00e9tiquet\u00e9s\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\/fr\/directives-de-la-fda-concernant-lacetyl-l-cysteine\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\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\/fr\/directives-de-la-fda-concernant-lacetyl-l-cysteine\/\" \/>\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 minutes\" \/>\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\":\"fr-FR\"},{\"@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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