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:
- 816 NDI notifications were submitted (or resubmitted)
- 167 (20%) were submitted without substantive FDA comment
- 152 (19%) were considered incomplete by FDA
- The most notifications submitted in a single year was 81 in 2007 and the least was 33 in 2013
- The most notifications submitted without substantive FDA comment was 18 in 2010 and the least was six in 2004
- The most incomplete notifications submitted was 21 in 2006 and the least submitted was two in 2004 and 2011
- On average 54 notifications are submitted every year, 11 are received without comment and 10 are considered incomplete