FDA Issues Guidance for Industry: Infant Formula Enforcement Discretion Policy

Infant Baby Milk Formula
A voluntary recall and facility shutdown conducted by the main Infant formula manufacturer in the US has created supply disruption on already strained supply chains due to COVID-19.
The shortage of infant formula is leading FDA to consider exercising enforcement discretion (i.e. waving compliance with certain regulatory requirements) for infant formula that is safe and nutritionally adequate).
FDA has issued a guidance document to help increase the supply of infant formula in the United States.  FDA intends to temporarily exercise enforcement discretion with respect to certain requirements for infant formulas that may not comply with certain regulatory requirements and is seeking information from manufacturers regarding the safety and nutritional adequacy of their products.  This guidance document is intended to:
  • explain factors that the FDA intends to consider in making case-by-case determinations about whether to exercise enforcement discretion to allow the introduction into interstate commerce (including importation) of infant formula that is safe and nutritionally adequate, but that may not comply with all statutory and regulatory requirements; and
  • advise infant formula manufacturers about the type of information to provide to the FDA, if they would like the FDA to consider whether to exercise enforcement discretion with regard to particular products.
This guidance document will remain in effect until November 14, 2022, and FDA will evaluate whether any extension is necessary.
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