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Monday Morning eBriefing

FDA Identifies Infant Formula Firms/Products Receiving Enforcement Discretion

May 30, 2022 by Luke Zimmer
To increase availability of infant formula, the Food and Drug Administration (FDA) outlined the procedures for processing certain infant formula products from specific overseas companies which will be afforded enforcement discretion. The list of firms/products can be found here. This process will remain in effect until Nov. 14.

Specific ACE transmission instructions are provided in this CSMS Message #52010923.

Questions regarding the importation of infant formula or including entry filing requirements should be sent to InfantFormulaImports@fda.hhs.gov. Contact ACE_Support@fda.hhs.gov for ACE rejects and processing questions.

Questions regarding the United States Department of Agriculture (USDA) certificates should be sent to APIE@usda.gov (note “Infant Formula” in subject line).