{"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%e3%81%ae%e3%82%a2%e3%82%bb%e3%83%81%e3%83%abl%e3%82%b7%e3%82%b9%e3%83%86%e3%82%a4%e3%83%b3%e3%81%ab%e9%96%a2%e3%81%99%e3%82%8b%e3%82%ac%e3%82%a4%e3%83%80%e3%83%b3%e3%82%b9","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/fda-n-acetyl-l-cysteine-guidance\/","title":{"rendered":"FDA \u304c N-\u30a2\u30bb\u30c1\u30eb-L-\u30b7\u30b9\u30c6\u30a4\u30f3\u306b\u95a2\u3059\u308b\u653f\u7b56\u8349\u6848\u3092\u767a\u884c: \u2026"},"content":{"rendered":"<div><a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09<\/a> FDA \u306f\u3001\u696d\u754c\u5411\u3051\u306e\u30c9\u30e9\u30d5\u30c8\u30ac\u30a4\u30c0\u30f3\u30b9\u300cN-\u30a2\u30bb\u30c1\u30eb-L-\u30b7\u30b9\u30c6\u30a4\u30f3\u306b\u95a2\u3059\u308b\u30dd\u30ea\u30b7\u30fc: \u696d\u754c\u5411\u3051\u30c9\u30e9\u30d5\u30c8\u30ac\u30a4\u30c0\u30f3\u30b9\u300d\u304c\u5229\u7528\u53ef\u80fd\u306b\u306a\u3063\u305f\u3053\u3068\u3092\u767a\u8868\u3057\u3066\u3044\u307e\u3059\u3002\u30c9\u30e9\u30d5\u30c8\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u6700\u7d42\u6c7a\u5b9a\u3055\u308c\u308c\u3070\u3001N-\u30a2\u30bb\u30c1\u30eb-L-\u30b7\u30b9\u30c6\u30a4\u30f3 (NAC) \u3092\u542b\u307f\u3001\u6804\u990a\u88dc\u52a9\u98df\u54c1\u3068\u3057\u3066\u30e9\u30d9\u30eb\u4ed8\u3051\u3055\u308c\u3066\u3044\u308b\u7279\u5b9a\u306e\u88fd\u54c1\u306e\u8ca9\u58f2\u3068\u6d41\u901a\u306b\u95a2\u3057\u3066\u3001FDA \u304c\u57f7\u884c\u88c1\u91cf\u3092\u884c\u4f7f\u3059\u308b\u610f\u56f3\u3092\u8aac\u660e\u3059\u308b\u3082\u306e\u306b\u306a\u308a\u307e\u3059\u3002<\/div>\n<div><\/div>\n<div>\u3053\u306e\u57f7\u884c\u88c1\u91cf\u30dd\u30ea\u30b7\u30fc\u306f\u3001NAC \u304c\u300c\u6804\u990a\u88dc\u52a9\u98df\u54c1\u300d\u306e\u5b9a\u7fa9\u304b\u3089\u9664\u5916\u3055\u308c\u3066\u304a\u3089\u305a\u3001\u9023\u90a6\u98df\u54c1\u533b\u85ac\u54c1\u5316\u7ca7\u54c1\u6cd5 (FD&amp;C \u6cd5) \u306b\u9055\u53cd\u3057\u3066\u3044\u306a\u3044\u5834\u5408\u306b\u5408\u6cd5\u7684\u306b\u8ca9\u58f2\u3055\u308c\u308b\u6804\u990a\u88dc\u52a9\u98df\u54c1\u3068\u306a\u308b\u88fd\u54c1\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002<\/div>\n<div><\/div>\n<div>\u30b3\u30e1\u30f3\u30c8\u306f2022\u5e745\u670823\u65e5\u307e\u3067\u306b\u9001\u4fe1\u3067\u304d\u307e\u3059\u3002<\/div>\n<div><\/div>\n<div><strong>\u80cc\u666f<\/strong><\/div>\n<div><\/div>\n<div>FDA \u306f\u3001NAC \u304c\u6804\u990a\u88dc\u52a9\u98df\u54c1\u307e\u305f\u306f\u98df\u54c1\u3068\u3057\u3066\u8ca9\u58f2\u3055\u308c\u308b\u524d\u306b\u65b0\u85ac\u3068\u3057\u3066\u627f\u8a8d\u3055\u308c\u305f\u305f\u3081\u3001FD&amp;C \u6cd5\u306e\u30bb\u30af\u30b7\u30e7\u30f3 201(ff)(3)(B)(i) (21 USC 321(ff)(3)(B)(i)) \u306b\u57fa\u3065\u304d\u3001NAC \u306f\u6804\u990a\u88dc\u52a9\u98df\u54c1\u306e\u5b9a\u7fa9\u304b\u3089\u9664\u5916\u3055\u308c\u3066\u3044\u308b\u3068\u5224\u65ad\u3057\u307e\u3057\u305f\u3002FDA \u306f\u3001NAC \u304c FD&amp;C \u6cd5\u306e\u30bb\u30af\u30b7\u30e7\u30f3 201(ff)(3)(B) \u306b\u57fa\u3065\u304f\u6804\u990a\u88dc\u52a9\u98df\u54c1\u306e\u5b9a\u7fa9\u304b\u3089\u9664\u5916\u3055\u308c\u3066\u3044\u306a\u3044\u3068\u7d50\u8ad6\u4ed8\u3051\u308b\u3088\u3046\u6c42\u3081\u308b 2 \u4ef6\u306e\u5e02\u6c11\u8acb\u9858\u3092\u53d7\u3051\u53d6\u308a\u307e\u3057\u305f\u30022022 \u5e74 3 \u6708 31 \u65e5\u3001FDA \u306f\u3053\u306e\u8981\u6c42\u3092\u5374\u4e0b\u3057\u307e\u3057\u305f\u3002<\/div>\n<div><\/div>\n<div><strong>\u7d9a\u304d\u3092\u8aad\u3080\uff1a<\/strong><\/div>\n<div><a href=\"https:\/\/regask.com\/ja\/fda-confirms-nac-is-excluded-from-the-definition-of-a-dietary-supplement\/\">FDA\u3001NAC \u304c\u6804\u990a\u88dc\u52a9\u98df\u54c1\u306e\u5b9a\u7fa9\u304b\u3089\u9664\u5916\u3055\u308c\u308b\u3053\u3068\u3092\u8a8d\u3081\u308b<\/a><\/div>\n<div><\/div>\n<div>\n<div>\n<div>\n<div>\n<p><a href=\"https:\/\/regask.com\/ja\/%e6%8e%a5%e8%a7%a6\/\">\u7c73\u56fd\u306e\u898f\u5236\u5909\u66f4\u306e\u8a73\u7d30\u306b\u3064\u3044\u3066\u306f\u3001RegASK \u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002\u00a0<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<a href=\"https:\/\/regask.com\/ja\/%e6%8e%a5%e8%a7%a6\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>\u8a73\u7d30\u306b\u3064\u3044\u3066\u306fRegASK\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044<\/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>\u7d9a\u304d\u3092\u8aad\u3080<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-529844941\">\n\n\t<div id=\"col-378745558\" 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\/ja\/%e3%82%b1%e3%83%bc%e3%82%b9%e3%82%b9%e3%82%bf%e3%83%87%e3%82%a3-2\/%e3%83%aa%e3%82%bd%e3%83%bc%e3%82%b9-%e3%82%b1%e3%83%bc%e3%82%b9%e3%82%b9%e3%82%bf%e3%83%87%e3%82%a3-%e9%a3%9f%e5%93%81-%e9%a3%b2%e6%96%99\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>\u98df\u54c1\u696d\u754c\u306e\u30b1\u30fc\u30b9\u30b9\u30bf\u30c7\u30a3\u3092\u8aad\u3080<\/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>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&#8217;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 as dietary supplements. This enforcement discretion policy would apply to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of \u201cdietary supplement\u201d and that is not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act). Comments can be sent by May 23, 2022. Background&#8230;<\/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 v27.3 (Yoast SEO v27.4) - 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. 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Stay informed on the latest regulations with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/ja\/fda\u306e\u30a2\u30bb\u30c1\u30ebl\u30b7\u30b9\u30c6\u30a4\u30f3\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\/\" \/>\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=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"2\u5206\" \/>\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\":\"ja\"},{\"@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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