On May 26, 2022, in Cargo Systems Messaging Service (CSMS) #52011554, the U.S. Food and Drug Administration issued instructions on the “Guidance for Industry: Infant Formula Enforcement Discretion Policy” in light of the current supply chain shortage. According to the CSMS, “FDA intends to temporarily exercise enforcement discretion with respect to certain requirements for infant formula.” The guidance includes a variety of resources, including a list of companies receiving this enforcement discretion.

CSMS #52011554 can be found here:

https://content.govdelivery.com/bulletins/gd/USDHSCBP-319a222?wgt_ref=USDHSCBP_WIDGET_2

The list of companies receiving the enforcement discretion can be found here:

https://www.fda.gov/food/infant-formula-guidance-documents-regulatory-information/enforcement-discretion-manufacturers-increase-infant-formula-supplies

The policy guidance can be found here:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-infant-formula-enforcement-discretion-policy?utm_medium=email&utm_source=govdelivery