Additional iron may be needed in these instances.
Parents and caregivers of infants born prematurely, or with a low birth weight, infants who had low iron levels at birth, or infants who are at risk for becoming iron deficient due to illness should check with their child’s health care provider to determine if this formula is appropriate for their child. nutrient requirements, but it may not be suitable for infants born prematurely, or with a low birth weight, infants who had low iron levels at birth, or infants who are at risk for becoming iron deficient due to illness. * This infant formula is appropriate for most infants and meets U.S. Tips for Preparing Imported Infant Formula ( Consejos para preparar la fórmula infantil importada) PDF Specialty Formulas for Infants with Special Medical NeedsĬompanies That Received a Letter of Enforcement Discretion for Regular Infant Formula.The FDA stopped accepting new requests for enforcement discretion on Nov. For companies that did not provide a Letter of Intent to FDA by December 5, 2022, enforcement discretion ended on Jan. requirements according to a recommended timetable specified by the FDA. 6, 2023, if the companies demonstrate that they are working to meet all U.S. As described in a September 2022 guidance, FDA intends to continue exercising enforcement discretion beyond Jan. market and the specific formulas they intend to transition to lawful marketing. The tables below indicate which infant formula companies have expressed interest in taking steps to remain on the U.S. To increase the diversity of and support a stable supply of infant formula in the U.S., the FDA is providing a pathway for manufacturers of infant formula products that were imported, sold, and/or distributed under a letter of enforcement discretion received based on factors described in a guidance to industry issued on (see “Background” for additional information), to continue marketing their products while they work toward meeting all applicable FDA requirements.
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