As part of its efforts to increase the resiliency and safety of the national infant formula supply, the U.S. Food and Drug Administration (FDA) has issued a draft guidance for industry about the steps it needs to take to notify the agency in the case of a permanent discontinuance or an interruption of the manufacture of an infant formula product when it is likely to lead to a disruption in the national supply.

The guidance is intended to help industry comply with Section 424 of the Federal Food, Drug, and Cosmetic Act (FFDC). The draft guidance discusses notification requirements under Section 424(a)(1) of FFDC as they pertain to infant formula, as well as FDA’s interpretation of key terms and recommendations for the procedures for submitting such notifications. Under Section 424 of the act, infant formula manufacturers are required to notify the FDA “as soon as practicable, but not later than five business days” after a permanent discontinuance or an interruption of the manufacture of infant formula that is likely to lead to a meaningful disruption in the supply of such food in the U.S.

The guidance also outlines FDA’s interpretation of what information must be included in a notification and provides recommendations for information that may be voluntarily included to help the agency appropriately identify the affected product(s), determine the potential for and magnitude of a supply chain disruption, and better assess the overall state of the market.

Comments may be submitted on the draft guidance until February 3, 2025 at www.regulations.gov under docket number FDA-2024-D-1334.

FDA stepped up its efforts to ensure the safety and resiliency of the U.S. infant formula supply following the infant formula shortage of 2022, which was precipitated by a major infant formula supplier halting operations after its products were linked to an outbreak of Cronobacter sakazakii infections in infants.