{"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":"fda-leitfaden-fur-acetyl-l-cystein","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/fda-n-acetyl-l-cysteine-guidance\/","title":{"rendered":"FDA ver\u00f6ffentlicht Richtlinienentwurf zu N-Acetyl-L-Cystein: \u2026"},"content":{"rendered":"
Die Food and Drug Administration (FDA)<\/a> gibt die Verf\u00fcgbarkeit eines Richtlinienentwurfs f\u00fcr die Industrie mit dem Titel \u201eRichtlinien zu N-Acetyl-L-Cystein: Richtlinienentwurf f\u00fcr die Industrie\u201c bekannt. Der Richtlinienentwurf wird nach seiner Fertigstellung die Absicht der FDA erl\u00e4utern, hinsichtlich des Verkaufs und Vertriebs bestimmter Produkte, die N-Acetyl-L-Cystein (NAC) enthalten und als Nahrungserg\u00e4nzungsmittel gekennzeichnet sind, Ermessensspielraum bei der Durchsetzung auszu\u00fcben.<\/div>\n
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Diese Ermessensfreiheitsrichtlinie zur Durchsetzung w\u00fcrde f\u00fcr Produkte gelten, die rechtm\u00e4\u00dfig als Nahrungserg\u00e4nzungsmittel vermarktet w\u00fcrden, wenn NAC nicht von der Definition des Begriffs \u201eNahrungserg\u00e4nzungsmittel\u201c ausgeschlossen w\u00e4re und die nicht auch anderweitig gegen den Federal Food, Drug, and Cosmetic Act (FD&C Act) versto\u00dfen w\u00fcrden.<\/div>\n
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Kommentare k\u00f6nnen bis zum 23. Mai 2022 eingesendet werden.<\/div>\n
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Hintergrund<\/strong><\/div>\n
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Die FDA hat entschieden, dass NAC gem\u00e4\u00df Abschnitt 201(ff)(3)(B)(i) des FD&C Act (21 USC 321(ff)(3)(B)(i)) von der Definition eines Nahrungserg\u00e4nzungsmittels ausgenommen ist, da NAC als neues Arzneimittel zugelassen wurde, bevor es als Nahrungserg\u00e4nzungsmittel oder Lebensmittel vermarktet wurde. Bei der FDA gingen zwei Petitionen ein, in denen die FDA aufgefordert wurde, zu dem Schluss zu kommen, dass NAC gem\u00e4\u00df Abschnitt 201(ff)(3)(B) des FD&C Act nicht von der Definition eines Nahrungserg\u00e4nzungsmittels ausgenommen ist. Am 31. M\u00e4rz 2022 lehnte die FDA diesen Antrag ab.<\/div>\n
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Mehr lesen:<\/strong><\/div>\n
FDA best\u00e4tigt, dass NAC von der Definition eines Nahrungserg\u00e4nzungsmittels ausgeschlossen ist<\/a><\/div>\n
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The Food and Drug Administration (FDA) is announcing the availability of draft guidance for the industry entitled \u201cPolicy Regarding N-acetyl-L-cysteine: Draft Guidance for Industry.\u201d The draft guidance, when finalized, will explain the FDA’s intent to exercise enforcement discretion with respect to the sale and distribution of certain products that contain N-acetyl-L-cysteine (NAC) and are labeled…<\/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":"\nFDA: 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\/de\/fda-leitfaden-fur-acetyl-l-cystein\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\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\/de\/fda-leitfaden-fur-acetyl-l-cystein\/\" \/>\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\u00a0Minuten\" \/>\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: …\",\"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\":\"de\"},{\"@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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