About FDA

Percentage of NDI notification reviews completed during the month within 75 days of filing

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 the Office of Dietary Supplement Programs (ODSP) has 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 March 31, 2023.

Footnotes

• During the government shutdown (furlough) from December 22, 2018 through January 25, 2019, the majority of CFSAN employees were on furlough status, which directly impacted the FY 2019 Q2 data for various food safety programs. Because the furloughed staff were not permitted to work, CFSAN’s ability to accomplish many performance targets, including conducting timely reviews of industry submissions received during the shutdown were either delayed, deferred to the next reporting cycle, or, not met.