FDA creates new NDIN and structure function docket formats

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FDA creates new NDIN and structure function docket formats
The Food and Drug Administration has created new dockets for new dietary ingredient notifications (NDINs) and structure-function claim notification letters.

“In an effort to be more responsive and provide current postings of 30-Day Structure Function Claim Letters Dietary and 75-Day Premarket Notifications for New Dietary Ingredients at www.regulations.gov​, and to find better ways to maintain these documents in the FDMS database, we established the new dockets,” ​explained Dr Daniel Fabricant, director of the Division of Dietary Supplements Program at FDA, in an email.

For NDINs, the new docket number format will be "75-Day Premarket Notifications for New Dietary Ingredients_2008" for filings submitted in 2008, “75-Day Premarket Notifications for New Dietary Ingredients_2009” for 2009 filings, and so on through 2012.

Likewise for structure-function filings, the format is changing to "30-Day Structure Function Claim Notification Letters Dietary_2008” for 2008 filings, through 2012.

75-Day Premarket Notifications for New Dietary Ingredients_2013 and 30-Day Structure Function Claim Notification Letters Dietary_2013 will be created from January 1, 2013 onwards.

“These ‘new’ dockets will be related in the FDMS database to its respective ‘old’ docket (FDA-1995-S-0039 and FDA-1997-S-0039), so searches can still be performed using the ‘old’ docket number,” ​added Dr Fabricant.

Related topics: Regulation

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