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Percentage of new or reformulated infant formula notification reviews completed during the month within the applicable timeframe

Dictionary: Timely review of notifications for new and reformulated infant formulas is essential for protecting the health and well being of infants, and to provide regulatory clarity to industry as they seek to bring new products to market. Since these statutory requirements are notifications rather than pre-market approvals, if FDA were not timely, the submitter could introduce a product to the market before FDA has completed its review, although we are unaware that that has occurred in practice.

Information is current as of March 31, 2023.

Footnotes

• In January 2021, due to the number and increasing complexity of new infant formula submissions received in late 2020, FDA determined that it would not be able to complete its review of submissions within 90 days after the filing dates and notified industry it would be adding up to an additional 60 days (i.e., 150 days total) to the review period for new submissions moving forward. In November 2021, FDA determined that it would need an additional 30 days (i.e., 180 days total) in order to complete reviews of submissions moving forward and notified industry. This change was fully implemented during the next reporting cycle which occurred in Q2 of fiscal year 2022.
• 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.