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U.S. Department of Health and Human Services

About FDA

Percentage of NDI notification reviews completed to which FDA objected

Dictionary: Timely review of notifications of new dietary ingredients impacts the public health by preventing substances that are not actually dietary ingredients from being used in dietary supplements, and assuring that new dietary ingredients have adequate evidence for presumption of safety. Since these statutory requirements are notifications rather than pre-market approvals, it is essential that ONLDS have completed review of the information before the submitter markets the product, to notify them of any safety or regulatory concerns before the product reaches consumers.

Information is current as of December 31, 2015.

Fiscal Year - 2013

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Oct 2012N/AN/A
Nov 2012N/A75
Dec 2012N/A83
Jan 2013N/A100
Feb 2013N/AN/A
Mar 2013N/A0
Apr 2013N/A80
May 2013N/A100
Jun 2013N/A0
Jul 2013N/A50
Aug 2013N/A33
Sep 2013N/A50

FY 2013 Overall: 52%


Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.