Editor's Note
FDA announced that on Sept. 6, it will begin using a different electronic submission system for accepting and storing new dietary ingredient notification (NDIN) and structure/function claim notification (SFCN) electronic submissions. The new system—the CFSAN Online Submission Module (COSM)—is replacing the current electronic submission system (the FDA Unified Registration Listing System, also known as FURLS) for NDIN and SFCN submissions. COSM system users will submit the same information as FURLS system users. User information previously stored in the FURLS database, including login information, will automatically be transferred to the new electronic submission portal in COSM.
On September 6, 2019, the U.S. Food and Drug Administration will begin using a different electronic submission system for accepting and storing new dietary ingredient notification (NDIN) and structure/function claim notification (SFCN) electronic submissions. As part of the agency’s ongoing modernization efforts, the new system—the CFSAN Online Submission Module (COSM)—is replacing the current electronic submission system (the FDA Unified Registration Listing System, also known as FURLS) for NDIN and SFCN submissions. COSM system users will submit the same information as FURLS system users.

Beginning on September 6, 2019:

  1. All system users will see a new interface when accessing the electronic portal for NDIN and SFCN submissions; and
  2. User information previously stored in the FURLS database, including login information, will automatically be transferred to the new electronic submission portal in COSM. 

Users who currently have draft submissions pending in FURLS must complete and submit their notification within 30 days of initiating the process. For assistance with completing an application in FURLS, please contact  FURLSSupport@FDA.hhs.gov . After the 30-day period, notifications must be resubmitted in COSM for agency review.

More information about how to submit an electronic NDIN or SFCN can be accessed using the  New Dietary Ingredients Notification Process  page or the  Structure/Function Claim Notification for Dietary Supplements  page on the FDA website. If you encounter difficulties while attempting to submit a notification, please contact  Premarkt@fda.hhs.gov  or call 240-402-1200. For questions specifically related to NDINs and SFCNs, please email  ODSP@fda.hhs.gov . Firms that prefer to submit a paper notification still have the option to do so. General information about the NDIN and SFCN processes can be accessed through the links below.

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