iFDA has announced that it is launching a new electronic submission system for New Dietary Ingredient Notifications (NDINs) on Friday, September 6. The new system, the CFSAN Online Submission Module (COSM) is replacing the current FDA Unified Registration Listing System (FURLS).
NDINs are required to be submitted to FDA at least 75 days before marketing a dietary supplement with a new dietary ingredient. However, FDA has lamented in its NDIN guidance that NDINs are not commonly submitted. Approximately 1100 NDINs have been submitted since 1995. The new system will also be used for structure/function claim notifications (SFCNs), which are required to be submitted to FDA no later than 30 days after the first marketing a dietary supplement that bears a structure/function claim.
FDA announced this initiative in a Federal Register notice in May 2019, noting that the Agency expects an increase in the average number of NDINs being submitted over the next three years. For a preview of the COSM system, you can view screenshots on FDA’s website.
