Washington, DC–As part of its modernization efforts, the FDA has a new system for accepting and storing electronic submissions for new dietary ingredient notification (NDIN) and structure/function claim notification (SFCN). The new system, called the CFSAN Online Submission Module (COSM), has replaced the the FDA Unified Registration Listing System (FURLS). Users of COSM will submit the same information as users of FURLS.
FDA announced that users will see a new interface when accessing the electronic portal for NDIN and SFCN submissions, and that information that was stored in the FURLS database will automatically be transferred to the COSM electronic submission portal. Those who currently have draft submissions pending in FURLS must complete and submit their notification within 30 days of initiating the process; after the 30-day period, FDA said, notifications must be resubmitted in COSM for review.
- Contact FURLSSupport@FDA.hhs.gov for assistance with pending submissions.
- For information about how to submit an electronic NDIN or SFCN, visit FDA’s New Dietary Ingredients Notification Process page or the Structure/Function Claim Notification for Dietary Supplements.
- Contact Premarkt@fda.hhs.gov or call 240-402-1200 for help with new submissions.
- For questions related to NDINs and SFCNs, email ODSP@fda.hhs.gov.