Published: Thursday, May 4, 2017
More than 20 years of NDI notification data from AHPA's New Dietary Ingredient (NDI) Database show that 931 NDI notifications have been submitted (or resubmitted) to the Food and Drug Administration (FDA) between 1995 and 2016.
FDA filed 226 (24%) of these NDI notifications without substantive comment and another 161 (17%) submissions were considered incomplete by the agency because they didn't meet the regulatory requirements for an NDI notification.
It is important to note that these numbers include many NDI notifications that were submitted, revised to address FDA comments and resubmitted (sometimes several times) before being filed by FDA without substantive comment.
Looking at the last 15 years (2002-2016) of NDI notification submissions shows:
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