FDA Creates New Format for NDI and Structure Function Dockets

WASHINGTONFDA has responded to calls for more information on supplement industry filings by revamping the docket for 75-day premarket new dietary ingredient notifications (NDINs) and creating a similar docket for 30-day structure-function claim notification letters. Daniel fabricant, director of the Division of Dietary Supplements Program at FDA, said documents received 2009 to 2012 will be become available significantly faster over the next couple of months at Regulations.gov.

For NDINs the new docket number format will be "75-Day Premarket Notifications for New Dietary Ingredients_2008" for filings submitted in 2008, with the year number in the format changed to reflect the year of subsequent filings through 2012. For structure-function filings, the docket number format was changed to "30-Day Structure Function Claim Notification Letters Dietary_2008 for those submitted in 2008, with the year number changed to reflect the year submitted, through 2012. Starting Jan. 1, 2013, submissions sent to Dockets Management will be reflected in the docket number with 2013. Within the Federal Document Management System (FDMS) the new dockets will be related to its respective old docket, so searches for these items can still be performed using the old docket number.