FDA Issues Draft Guidance on Notification Requirements for Infant Formula Manufacturers

On Dec. 2, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining the requirements and procedures that infant formula manufacturers should follow to notify the FDA of a permanent discontinuance or an interruption of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 infant formula in the United States.

The draft guidance is titled “Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula” aims to help the infant formula industry comply with section 424 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350m) which requires, in part, infant formula manufacturers to notify the FDA of a permanent discontinuance in the manufacture or an interruption of the manufacture of infant formula that is likely to lead to a meaningful disruption in the supply of such infant formula in the United States.

The announcement on the guidance said, “The draft guidance discusses notification requirements under section 424(a)(1) of the FD&C Act as they pertain to infant formula, as well as the FDA’s interpretation of key terms and recommendations for the procedures for submitting such notifications. Under section 424 of the FD&C Act, infant formula manufacturers are required to notify the FDA “as soon as practicable, but not later than 5 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 United States. The guidance also outlines our interpretation of what information must be included in the notification and provides recommendations relating to information that may be voluntarily included to help the FDA 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.”

Further, “This guidance is one of the steps the FDA is taking to improve the resiliency of the infant formula supply and to ensure that consumers have the utmost confidence that infant formula available in the U.S. is safe and nutritious. Providing information to assist infant formula manufacturers with notifying the FDA of potential supply disruptions supports a more resilient infant formula supply chain.”

The FDA says comments on the draft guidance are due before the close date of Feb. 3, 2025.