自我確認GRAS模式從FDA新NDI指導書草案中移除

黃怡菁 執行顧問
Self affirmed GRAS omitted from new NDI draft guidance

很多企業朋友來詢問為何我想要申辦美國FDA的GRAS列名,你們卻建議我們申辦NDI的登錄?問題還蠻頻繁的,我們在此做一個分析。

首先,魔鬼藏在細節裏!這個細節很容易被忽略,在新的NDI指導書草案中,自我確認GRAS模式(self-affirmed GRAS)不再是選項。

通常原本成分被認定為GRAS,則不適用於NDI登錄的要求。原指導書在2011年公布後,很多廠商(尤其是合成天然相似化合物synthetic nature-identical compounds)即以此捷徑繞過FDA的審查。

但可以從下列改變看出變化:

2011年的問答(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年的問答(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.”

顯示其Q的部分已移除” self- affirmed as GRAS for direct addition to food”這段文字,根據美國法律公司專家解讀,所謂的self- affirmed as GRAS是法律上不能改變的選項,但實務執行上,FDA很明顯的不願鼓勵也不傾向這個捷徑,因此在問答部分做出明顯改變。

再者,法規上,針對GRAS列名的要求遠高於NDI的登錄。GRAS列名在安全性要求上包括要預估使用情境條件(消費者使用可能的劑量)下安全與需有第三方(非廠商資助的)的學術發表論文,這兩個要求對安全性試驗的要求,一般廠商不易完成。而NDI的要求則是在使用建議量下安全即可,且可以使用自費的實驗結果(並不須第三方的學術論文)。

第三,成分於GRAS列名後,並非特定廠商專有的權利,所有符合該成分規格者,都可以輸出至美國。而NDI登錄則是申辦者通過時擁有專有的核准號,其他廠商即使有相同的成分,也必須另自行申辦核准號。

從這三個觀點來看,您還會認為申辦GRAS列名比申辦NDI登錄簡單嗎?

美國FDA食品新膳食補充成份登記(NDI)