自我确认GRAS模式从FDA新NDI指导书草案中移除

Self affirmed GRAS omitted from new NDI draft guidance

很多企业朋友来询问为何我想要申办美国FDA的GRAS列名，你们却建议我们申办NDI的登录？问题还蛮频繁的，我们在此做一个分析。

首先，魔鬼藏在细节里！这个细节很容易被忽略，在新的NDI指导书草案中，自我确认GRAS模式(self-affirmed GRAS)不再是选项。

通常原本成分被认定为GRAS，则不适用于NDI登录的要求。原指导书在2011年公布后，很多厂商(尤其是合成天然相似化合物synthetic nature-identical compounds)即以此捷径绕过FDA的审查。

但可以从下列改变看出变化：

2011年的问答(Q&A)：

Q：“Am I required to submit a NDI notification for a dietary ingredient that has been listed or affirmed by FDA as generally recognized as safe (GRAS) for direct addition to food, self- affirmed as GRAS for direct addition to food, or approved as a direct food additive in the U.S.?

A：“No, as long as the direct food additive or GRAS substance has been used in the food supply and is to be used as a NDI without chemical alteration.

2016年的问答(Q&A)：

Q：“Am I required to submit an NDI notification for a dietary ingredient that is an NDI, but has been (a) listed or affirmed by FDA as generally recognized as safe (GRAS) for direct addition to food or (b) approved as a direct food additive in the U.S.?

A：“No, as long as the following conditions are met. The direct food additive or GRAS substance (1) has been used in the food supply (i.e., in conventional foods) and (2) is to be used as a dietary ingredient without chemical alteration.”

显示其Q的部分已移除” self- affirmed as GRAS for direct addition to food”这段文字，根据美国法律公司专家解读，所谓的self- affirmed as GRAS是法律上不能改变的选项，但实务执行上，FDA很明显的不愿鼓励也不倾向这个捷径，因此在问答部分做出明显改变。

再者，法规上，针对GRAS列名的要求远高于NDI的登录。GRAS列名在安全性要求上包括要预估使用情境条件(消费者使用可能的剂量)下安全与需有第三方(非厂商资助的)的学术发表论文，这两个要求对安全性试验的要求，一般厂商不易完成。而NDI的要求则是在使用建议量下安全即可，且可以使用自费的实验结果(并不须第三方的学术论文)。

第三，成分于GRAS列名后，并非特定厂商专有的权利，所有符合该成分规格者，都可以输出至美国。而NDI登录则是申办者通过时拥有专有的核准号，其他厂商即使有相同的成分，也必须另自行申办核准号。

从这三个观点来看，您还会认为申办GRAS列名比申办NDI登录简单吗？

美国FDA食品新膳食补充成份登记(NDI)