When must a Head Start program have a medical statement on file for an infant formula to be part of a reimbursable meal?
The Head Start program must determine whether the formula is listed as an FDA Exempt Infant Formula. An exempt formula is labeled for use by infants who have inborn errors of metabolism or low birth weight, or who otherwise have unusual medical or dietary problems (21 CFR 107.3). Formulas classified as Exempt Infant Formulas by FDA require a medical statement in order to be served to infants under the CACFP as part of a reimbursable meal. A medical statement must be signed by a licensed physician or a recognized medical authority specified by the State agency if an infant is considered disabled according to USDA’s regulation or if an infant has medical or other special dietary needs. To check whether or not an infant formula is an FDA Exempt Infant Formula, visit FDA’s website at http://www.cfsan.fda.gov/~dms/inf-exmp.html.
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