{"id":40854,"date":"2015-11-11T10:00:25","date_gmt":"2015-11-11T15:00:25","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-publishes-fortification-policy-guidance\/"},"modified":"2020-02-10T16:00:57","modified_gmt":"2020-02-10T16:00:57","slug":"fda-publishes-fortification-policy-guidance","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fortification-policy-guidance\/","title":{"rendered":"FDA\u53d1\u5e03\u5f3a\u5316\u98df\u54c1\u653f\u7b56\u6307\u5357"},"content":{"rendered":"<p>2015\u5e7411\u67086\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u53ca\u836f\u7269\u7ba1\u7406\u5c40(the U.S. Food and Drug Administration,FDA)\u53d1\u5e03\u4e86FDA\u5f3a\u5316\u98df\u54c1\u653f\u7b56\u7684\u6307\u5357\u6587\u4ef6\uff0c<a href=\"https:\/\/www.fda.gov\/Food\/GuidanceRegulation\/GuidanceDocumentsRegulatoryInformation\/ucm470756.htm\">FDA\u5141\u8bb8\u5382\u5bb6\u4ee5\u8fbe\u5230\u4ee5\u4e0b\u6548\u679c\u7684\u98df\u54c1\u5f3a\u5316\uff1a<\/a><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>\u81b3\u98df\u8865\u5145<\/li>\n<li>\u8425\u517b\u6c34\u5e73\u6062\u590d\u5230\u5230\u4ed3\u50a8\u3001\u5904\u7406\u548c\u52a0\u5de5\u524d<\/li>\n<li>\u6839\u636e\u98df\u54c1\u603b\u70ed\u542b\u91cf\u6309\u6bd4\u4f8b\u5747\u8861\u63d0\u4f9b\u7ef4\u751f\u7d20\u3001\u77ff\u7269\u8d28\u548c\u86cb\u767d\u8d28<\/li>\n<li>\u4f20\u7edf\u66ff\u4ee3\u98df\u54c1\u7684\u81b3\u98df\u8865\u5145<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>FDA\u81ea1980\u5e74\u4ee5\u6765\u672a\u4fee\u6539\u8fc7\u8be5\u5f3a\u5316\u653f\u7b56\uff0c\u65b0\u9881\u5e03\u6307\u5357\u65e8\u5728\u91cd\u65b0\u5f3a\u8c03\u8be5\u653f\u7b56\u548c\u7edf\u4e00\u56de\u7b54\u4e00\u76f4\u4ee5\u6765\u5e38\u5e38\u51fa\u73b0\u7684\u95ee\u9898\u3002\u6307\u5357\u8981\u70b9\u5982\u4e0b\uff1a<\/p>\n<p>&nbsp;<\/p>\n<p><em>FDA<\/em><em>\u5f3a\u5316\u653f\u7b56\u8986\u76d6\u7684\u98df\u54c1\u8303\u56f4\u662f\uff1f<\/em><\/p>\n<p>FDA\u5f3a\u5316\u653f\u7b56\u9002\u7528\u4e8e\u90e8\u5206\u4f20\u7edf\u4eba\u7c7b\u98df\u54c1\uff0c\u4e0d\u9002\u7528\u4e8e\u81b3\u98df\u8865\u5145\u5242\u3001\u52a8\u7269\u98df\u54c1\u548c\u5a74\u513f\u914d\u65b9\u98df\u54c1\u3002<\/p>\n<p><em>FDA<\/em><em>\u5f3a\u5316\u653f\u7b56\u5305\u542b\u8425\u517b\u6210\u5206\u8303\u56f4\u662f\uff1f<\/em><\/p>\n<p>FDA\u5f3a\u5316\u653f\u7b56\u8425\u517b\u6210\u5206\u5305\u542b\u4e86\u6240\u670921 CFR 101.9(c)(8)(iv)\u6bcf\u65e5\u53c2\u8003\u6444\u5165\u7684\u5fc5\u9700\u8425\u517b\u7d20\u3002\u6307\u5357\u8fd8\u5305\u62ec\u86cb\u767d\u8d28\u548c\u94be\u5143\u7d20\uff0c\u4e0b\u8868\u4e3aFDA\u5f3a\u5316\u653f\u7b56\u8425\u517b\u6210\u5206\u4e00\u89c8\u8868\uff1a<\/p>\n<p>&nbsp;<\/p>\n<p><em>\u6240\u6709\u7684\u4f20\u7edf\u98df\u54c1\u90fd\u9700\u8981\u5f3a\u5316\u5417\uff1f<\/em><\/p>\n<p>FDA\u8ba4\u4e3a\u4ee5\u4e0b\u4ea7\u54c1\u65e0\u9700\u5f3a\u5316\uff1a<\/p>\n<ul>\n<li>\u65b0\u9c9c\u4ea7\u54c1<\/li>\n<li>\u8089\u7c7b\u3001\u5bb6\u79bd\u7c7b\u548c\u9c7c\u7c7b\u4ea7\u54c1<\/li>\n<li>\u7cd6\u7c7b<\/li>\n<li>\u96f6\u98df\uff08\u5305\u62ec\u78b3\u9178\u996e\u6599\uff09\u5305\u62ec\u4e0d\u52a0\u7cd6\u3001\u4f4e\u8102\u548c\u8131\u8102\u96f6\u98df\u3002<\/li>\n<li>\u9152\u7cbe\u996e\u6599<\/li>\n<\/ul>\n<p>\u4e0d\u6070\u5f53\u7684\u98df\u54c1\u5f3a\u5316\u4f1a\u5f15\u8d77\u6cd5\u5f8b\u95ee\u9898\uff0c2015\u5e744\u6708\uff0c<a href=\"https:\/\/regstaging.wpengine.com\/2015\/04\/fda-fortification-policy-smartcandy\/\">\u53f8\u6cd5\u90e8\u957f\u5bf9Snap Infusion LLC<\/a>\u53d1\u51fa\u4e86\u8b66\u544a\u4fe1\uff0c\u4e24\u4f4d\u5973\u58eb\u96c6\u4f53\u8d77\u8bc9<a href=\"https:\/\/regstaging.wpengine.com\/2015\/10\/lawsuit-accuses-welchs-fruit-snacks-of-violating-fda-jelly-bean-rule\/\">Welch Foods<\/a>\uff0c\u56e0\u5176\u6dfb\u52a0\u7ef4\u4ed6\u547d\u7684\u6c34\u679c\u96f6\u98df\u5bfc\u81f4\u8fc7\u654f\u3002<\/p>\n<p><em>\u5f3a\u5316\u662f\u81ea\u613f\u7684\u5417\uff1f<\/em><\/p>\n<p>\u9664\u975eFDA\u7edf\u4e00\u6807\u51c6\u8981\u6c42\uff0c\u4f20\u7edf\u4eba\u7c7b\u98df\u54c1\u7684\u5f3a\u5316\u90fd\u662f\u81ea\u613f\u7684\u3002FDA\u7edf\u4e00\u6807\u51c6\u5f3a\u5236\u8981\u6c42\u51fa\u53e3\u7f8e\u56fd\u5e02\u573a\u9500\u552e\u4ea7\u54c1\u7684\u5fc5\u9700\u6216\u6dfb\u52a0\u4ea7\u54c1\u6210\u5206\u4f7f\u7528\u89c4\u8303\u540d\u79f0\u3002\u90e8\u5206\u7edf\u4e00\u6807\u51c6\u8981\u6c42\u6dfb\u52a0\u7279\u5b9a\u6210\u5206\uff0c\u5982\u4eba\u9020\u9ec4\u6cb9\u6807\u51c6\u8981\u6c42\u6dfb\u52a0\u7ef4\u751f\u7d20A\u3002<\/p>\n<p>\u9700\u8981\u6ce8\u610f\u7684\u662f\u67d0\u4e9b\u5f3a\u5316\u98df\u54c1\u6709\u6807\u7b7e\u89c4\u8303\u8981\u6c42\u3002\u4f8b\u5982\uff0c\u98df\u76d0\u53ef\u4ee5\u9009\u62e9\u6027\u6dfb\u52a0\u7898\uff0c\u4f46\u52a0\u7898\u540e\u98df\u76d0\u540d\u79f0\u5fc5\u987b\u4e3a\u201c\u7898\u76d0\u201d\u6216\u201c\u542b\u7898\u98df\u76d0\u201d\uff0c\u6ca1\u6709\u5f3a\u5316\u7898\u7684\u98df\u76d0\u5fc5\u987b\u5728\u5305\u88c5\u4e0a\u58f0\u660e\u201c\u672c\u4ea7\u54c1\u4e0d\u542b\u6709\u5fc5\u9700\u5143\u7d20\u7898\u201d\u3002<\/p>\n<p><em>\u5982\u4f55\u6ce8\u660e\u4ea7\u54c1\u5df2\u7ecf\u8fc7\u5f3a\u5316<\/em><em>?<\/em><\/p>\n<p>\u6839\u636eFDA\u6307\u5357\uff0cFDA\u6807\u51c6\u5316\u4ea7\u54c1\u5fc5\u987b\u4f7f\u7528\u540c\u4e00\u6807\u51c6\u5b9a\u4e49\u672f\u8bed\uff0cFDA\u6307\u5357\u5199\u9053\uff1a\u201c\u4f8b\u5982\uff0c\u4e0d\u53ef\u4ee5\u4f7f\u7528\u5f3a\u5316\u9762\u7c89\u66ff\u4ee3\u8425\u517b\u9762\u7c89\u3002\u201d<\/p>\n<p>\u5bf9\u4e8eFDA\u65e0\u6807\u51c6\u4ea7\u54c1\uff0c\u5382\u5bb6\u53ef\u4ee5\u4f7f\u7528\u4ea4\u66ff\u4f7f\u7528\u4ee5\u4e0b\u672f\u8bed\uff1a\u201c\u6dfb\u52a0\u201d\u3001\u201c\u5bcc\u542b\u201d\u3001\u201c\u8865\u5145\u201d\u3001\u201c\u5f3a\u5316\u201d\u3001\u201c\u66f4\u591a\u201d\u548c\u201c\u9644\u52a0\u201d\u3002<\/p>\n<p>Registrar Corp\u7684\u6807\u7b7e\u548c\u6210\u5206\u5ba1\u6838\u4e13\u5bb6\u719f\u77e5FDA\u5f3a\u5316\u653f\u7b56\uff0c\u53ef\u4e3a\u98df\u54c1\u4f01\u4e1a\u63d0\u4f9b\u4ee5\u4e0b\u670d\u52a1\uff1a<\/p>\n<ul>\n<li>\u5224\u65ad\u662f\u5426\u9700\u8981\u6216\u5fc5\u987b\u5f3a\u5316\u98df\u54c1<\/li>\n<li>\u786e\u4fdd\u5f3a\u5316\u98df\u54c1\u6807\u7b7e\u7b26\u5408FDA\u6cd5\u89c4\u8981\u6c42<\/li>\n<\/ul>\n<p>\u9664\u6807\u7b7e\u5ba1\u6838\u5916\uff0c<a href=\"https:\/\/regstaging.wpengine.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">Registrar Corp<\/a>\u8fd8\u4f1a\u68c0\u67e5\u6807\u7b7e\u7684\u683c\u5f0f\u662f\u5426\u6b63\u786e\u3001\u8425\u517b\u6210\u5206\u8868\u662f\u5426\u89c4\u8303\u548c\u5176\u4ed6\u66f4\u591a\u5185\u5bb9\u3002\u83b7\u53d6\u5173\u4e8eFDA\u5f3a\u5316\u548c\u6807\u7b7e\u6cd5\u89c4\u7684\u7591\u95ee\u89e3\u7b54\u548c\u6cd5\u89c4\u5e2e\u52a9\uff0c\u6b22\u8fce\u901a\u8fc7\u62e8\u6253+1-757-224-0177\u8054\u7cfb<a href=\"https:\/\/regstaging.wpengine.com\/livehelp\" target=\"_blank\" rel=\"noopener noreferrer\">Registrar Corp<\/a>\uff0c\u540c\u65f6\uff0c24\u5c0f\u65f6\u5728\u7ebf\u7cfb\u7edf\u4e3a\u60a8\u63d0\u4f9b\u5b9e\u65f6\u5e2e\u52a9\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>2015\u5e7411\u67086\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u53ca\u836f\u7269\u7ba1\u7406\u5c40(the U.S. Food and Drug Administration,FDA)\u53d1\u5e03\u4e86FDA\u5f3a\u5316\u98df\u54c1\u653f\u7b56\u7684\u6307\u5357\u6587\u4ef6\uff0cFDA\u5141\u8bb8\u5382\u5bb6\u4ee5\u8fbe\u5230\u4ee5\u4e0b\u6548\u679c\u7684\u98df\u54c1\u5f3a\u5316\uff1a &nbsp; \u81b3\u98df\u8865\u5145 \u8425\u517b\u6c34\u5e73\u6062\u590d\u5230\u5230\u4ed3\u50a8\u3001\u5904\u7406\u548c\u52a0\u5de5\u524d \u6839\u636e\u98df\u54c1\u603b\u70ed\u542b\u91cf\u6309\u6bd4\u4f8b\u5747\u8861\u63d0\u4f9b\u7ef4\u751f\u7d20\u3001\u77ff\u7269\u8d28\u548c\u86cb\u767d\u8d28 \u4f20\u7edf\u66ff\u4ee3\u98df\u54c1\u7684\u81b3\u98df\u8865\u5145 &nbsp; FDA\u81ea1980\u5e74\u4ee5\u6765\u672a\u4fee\u6539\u8fc7\u8be5\u5f3a\u5316\u653f\u7b56\uff0c\u65b0\u9881\u5e03\u6307\u5357\u65e8\u5728\u91cd\u65b0\u5f3a\u8c03\u8be5\u653f\u7b56\u548c\u7edf\u4e00\u56de\u7b54\u4e00\u76f4\u4ee5\u6765\u5e38\u5e38\u51fa\u73b0\u7684\u95ee\u9898\u3002\u6307\u5357\u8981\u70b9\u5982\u4e0b\uff1a &nbsp; FDA\u5f3a\u5316\u653f\u7b56\u8986\u76d6\u7684\u98df\u54c1\u8303\u56f4\u662f\uff1f FDA\u5f3a\u5316\u653f\u7b56\u9002\u7528\u4e8e\u90e8\u5206\u4f20\u7edf\u4eba\u7c7b\u98df\u54c1\uff0c\u4e0d\u9002\u7528\u4e8e\u81b3\u98df\u8865\u5145\u5242\u3001\u52a8\u7269\u98df\u54c1\u548c\u5a74\u513f\u914d\u65b9\u98df\u54c1\u3002 FDA\u5f3a\u5316\u653f\u7b56\u5305\u542b\u8425\u517b\u6210\u5206\u8303\u56f4\u662f\uff1f FDA\u5f3a\u5316\u653f\u7b56\u8425\u517b\u6210\u5206\u5305\u542b\u4e86\u6240\u670921 CFR 101.9(c)(8)(iv)\u6bcf\u65e5\u53c2\u8003\u6444\u5165\u7684\u5fc5\u9700\u8425\u517b\u7d20\u3002\u6307\u5357\u8fd8\u5305\u62ec\u86cb\u767d\u8d28\u548c\u94be\u5143\u7d20\uff0c\u4e0b\u8868\u4e3aFDA\u5f3a\u5316\u653f\u7b56\u8425\u517b\u6210\u5206\u4e00\u89c8\u8868\uff1a &nbsp; \u6240\u6709\u7684\u4f20\u7edf\u98df\u54c1\u90fd\u9700\u8981\u5f3a\u5316\u5417\uff1f FDA\u8ba4\u4e3a\u4ee5\u4e0b\u4ea7\u54c1\u65e0\u9700\u5f3a\u5316\uff1a \u65b0\u9c9c\u4ea7\u54c1 \u8089\u7c7b\u3001\u5bb6\u79bd\u7c7b\u548c\u9c7c\u7c7b\u4ea7\u54c1 \u7cd6\u7c7b \u96f6\u98df\uff08\u5305\u62ec\u78b3\u9178\u996e\u6599\uff09\u5305\u62ec\u4e0d\u52a0\u7cd6\u3001\u4f4e\u8102\u548c\u8131\u8102\u96f6\u98df\u3002 \u9152\u7cbe\u996e\u6599 \u4e0d\u6070\u5f53\u7684\u98df\u54c1\u5f3a\u5316\u4f1a\u5f15\u8d77\u6cd5\u5f8b\u95ee\u9898\uff0c2015\u5e744\u6708\uff0c\u53f8\u6cd5\u90e8\u957f\u5bf9Snap Infusion LLC\u53d1\u51fa\u4e86\u8b66\u544a\u4fe1\uff0c\u4e24\u4f4d\u5973\u58eb\u96c6\u4f53\u8d77\u8bc9Welch 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