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Baby formula shortage

Infant Formula Shortage: How has the FDA Altered Regulations to Help?

Over the past year, the nation has been concerned over an infant formula shortage that has become a crisis for many families in the United States. The Food and Drug Administration (FDA) is responsible for offering support and relief to families affected by this shortage in any way they can. Accordingly, the FDA loosened infant formula regulations. Specifically, the FDA allowed for an increased supply of infant formula by the announcement to infant formula manufacturers of the agency’s intention to temporarily exercise enforcement discretion. Enforcement was on a case-by-case basis, for specific infant formula requirements. This went into effect from May 16, 2022, through November 14, 2022, and was specifically designed to protect infants’ health. Essentially, selective enforcement would allow the FDA to grant permission for formulas despite not meeting all the regulations.

FDA’s Response to Baby Formula Shortage

This year the Food and Drug Administration (FDA) has come under fire for its slow response to the nationwide baby formula shortage. In September 2022, FDA Commissioner Robert M. Califf authorized the release of an internal report. The report details how the baby formula shortage occurred, the FDA’s response to the shortage, and the challenges it faced in resolving the shortage. The report also revealed the changes in FDA regulatory procedure to ensure another shortage does not occur.