{"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-kein-nahrungserganzungsmittel","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/fda-nac-not-dietary-supplement\/","title":{"rendered":"FDA best\u00e4tigt, dass NAC von der Definition eines D\u2026 ausgeschlossen ist"},"content":{"rendered":"<div><a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">Die US-amerikanische Food and Drug Administration (FDA)<\/a> lehnte den Antrag in zwei B\u00fcrgerpetitionen des Council for Responsible Nutrition (CRN) und der Natural Products Association (NPA) ab. Darin wurde die Beh\u00f6rde aufgefordert, festzustellen, dass Produkte, die N-Acetyl-L-Cystein (NAC) enthalten, nicht von der Definition eines Nahrungserg\u00e4nzungsmittels gem\u00e4\u00df Abschnitt 201(ff)(3)(B)(i) des Federal Food, Drug, and Cosmetic Act (FD&amp;C Act) ausgenommen sind.<\/div>\n<div><\/div>\n<div>W\u00e4hrend die FDA in ihrer Antwort auf die B\u00fcrgerpetitionen best\u00e4tigte, dass NAC von der Definition eines Nahrungserg\u00e4nzungsmittels ausgeschlossen ist, hat die Beh\u00f6rde noch keine Entscheidung \u00fcber den Alternativantrag der NPA-B\u00fcrgerpetition getroffen, wonach die Beh\u00f6rde Vorschriften erlassen soll, um die Verwendung von NAC in Nahrungserg\u00e4nzungsmitteln zuzulassen. Die FDA pr\u00fcft diesen Antrag weiterhin.<\/div>\n<div><\/div>\n<div>Da die FDA-Pr\u00fcfung bisher keine Sicherheitsbedenken ergeben hat, erw\u00e4gt sie unter anderem, bei NAC-haltigen Produkten, die als Nahrungserg\u00e4nzungsmittel gekennzeichnet sind, einen Ermessensspielraum bei der Durchsetzung zu nutzen. Diese Produkte w\u00e4ren rechtm\u00e4\u00dfig als Nahrungserg\u00e4nzungsmittel vermarktet, wenn NAC nicht von der Definition von Nahrungserg\u00e4nzungsmitteln ausgenommen w\u00e4re und sie nicht anderweitig gegen den FD&amp;C Act versto\u00dfen. Die FDA beabsichtigt, in K\u00fcrze Leitlinien zu ihrer Politik in Bezug auf NAC-haltige Produkte, die als Nahrungserg\u00e4nzungsmittel gekennzeichnet sind, herauszugeben.<\/div>\n<div><\/div>\n<div>\n<div>\n<div>\n<p><a href=\"https:\/\/regask.com\/de\/kontakt\/\">Kontaktieren Sie RegASK, um mehr \u00fcber regulatorische \u00c4nderungen in den USA zu erfahren.\u00a0<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<a href=\"https:\/\/regask.com\/de\/kontakt\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Kontaktieren Sie RegASK f\u00fcr weitere Details<\/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>Mehr lesen<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-95184976\">\n\n\t<div id=\"col-340590022\" 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\/de\/fallstudien\/ressourcen-fallstudien-lebensmittel-getranke\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lesen Sie Fallstudien aus der Lebensmittelindustrie<\/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>Die US-amerikanische Lebensmittel- und Arzneimittelbeh\u00f6rde (FDA) wies die Antr\u00e4ge zweier B\u00fcrger, des Council for Responsible Nutrition (CRN) und der Natural Products Association (NPA), zur\u00fcck, in denen die Beh\u00f6rde aufgefordert wurde, festzustellen, dass Produkte, die N-Acetyl-L-Cystein (NAC) enthalten, nicht von der Definition eines Nahrungserg\u00e4nzungsmittels gem\u00e4\u00df Abschnitt 201(ff)(3)(B)(i) des Bundesgesetzes \u00fcber Lebensmittel, Arzneimittel und Medizinprodukte (Federal Food, Drug, and Drug Administration) ausgenommen sind.<\/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 v28.0 (Yoast SEO v28.2) - 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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