/>i- On December 2, 2024, FDA issued draft guidance to assist the infant formula industry in complying with section 424 of the Food, Drug, and Cosmetic Act (FD&C Act), which requires infant formula manufacturers to notify FDA of a permanent discontinuance or interruption in the manufacture of infant formula that is likely to lead to a meaningful disruption in the supply of such infant formula in the U.S. The draft guidance is titled “Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of Infant Formula.”
- Section 424 of the FD&C Act requires manufacturers to notify the FDA “as soon as practicable, but not later than 5 business days” after a permanent discontinuance or interruption of infant formula manufacture that is likely to cause a significant supply disruption. The draft guidance discusses notification requirements for infant formula manufacturers, including:
- What constitutes a permanent discontinuance or interruption;
- The definition of a “meaningful disruption;”
- What information should be included in a notification;
- How to notify FDA; and
- Consequences of a failure to notify FDA.
- The guidance is intended as one step 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.”
- FDA is accepting comments on the guidance and will consider any comments submitted before February 3, 2025, in its development of a final guidance document. Comments can be submitted through regulations.gov to docket number FDA-2024-D-1334.
FDA Issues Draft Guidance on Infant Formula Manufacture Discontinuance or Disruption Notifications
Tuesday, December 3, 2024
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