FDA Modifies Internal Processes for New Dietary Ingredient Notification and Structure/Function Claim Notification Submissions

FDA Modifies Internal Processes for New Dietary Ingredient Notification and Structure/Function Claim Notification Submissions

September 4, 2019

         

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.

    

Additional Resources:

• How to Submit Notifications for a New Dietary Ingredient
• New Dietary Ingredients in Dietary Supplements - Background for Industry
• Structure/Function Claims Small Entity Compliance Guide